2018 Healthcare Research Review - BCC 2019

2018 Healthcare
Research Review
March 2019
Various Analysts
Report Code: HLC068G
Additional segmentations and data sets available upon request. Email custom@bccresearch.com
Table of Contents
Chapter 1: Foreward .............................................................................................. 1
Foreword....................................................................................................................................................... 1
Chapter 2: Global 3D Medical and Surgical Imaging Platform Market (HLC216A) .. 3

Introduction .................................................................................................................................................. 3
Study Goals and Objectives ....................................................................................................................... 3
Reasons for Doing This Study .................................................................................................................... 3
Scope of Report ......................................................................................................................................... 4
Information Sources .................................................................................................................................. 4
Methodology ............................................................................................................................................. 4
Geographic Breakdown ............................................................................................................................. 5
Analyst’s Credentials ................................................................................................................................. 5
BCC Custom Research ............................................................................................................................... 5
Related BCC Research Reports .................................................................................................................. 6
Report Summary ........................................................................................................................................... 6
3D Medical and Surgical Imaging Platforms by Application ......................................................................... 7
Ultrasound ................................................................................................................................................. 8
Digital Radiography ................................................................................................................................... 8
Advantages of X-Ray Machines ................................................................................................................. 8
Magnetic Resonance Imaging (MRI) ......................................................................................................... 9
Computed Tomography (CT) ..................................................................................................................... 9
Nuclear Imaging....................................................................................................................................... 10
Mammography ........................................................................................................................................ 10
Endoscopy ............................................................................................................................................... 11
Advantages of 3D Endoscopy System ..................................................................................................... 11
Regulations ................................................................................................................................................. 11
End Users .................................................................................................................................................... 12
Opportunities .............................................................................................................................................. 13
Patient-Centric Trend .............................................................................................................................. 13
Technological Advancements in 3D Medical and Surgical Imaging Platforms ........................................ 14
Artificial Intelligence and Analytics ......................................................................................................... 15
Block-Chain and Internet of Things (IoT) ................................................................................................. 15
Robotics ................................................................................................................................................... 16
Innovative Solutions by Platform Providers in the Market ..................................................................... 16
Future Outlook ............................................................................................................................................ 17
Chapter 3: Transcatheter Treatment: Procedures and Heart Valve Market

(HLC204A) ............................................................................................................ 20
Introduction ................................................................................................................................................ 20
Study Goals and Objectives ..................................................................................................................... 21
Reasons for Doing This Study .................................................................................................................. 21
Scope of Report ....................................................................................................................................... 22
Information Sources ................................................................................................................................ 23
Methodology and Information Sources .................................................................................................. 23
Geographic Breakdown ........................................................................................................................... 23
Analyst’s Credentials ............................................................................................................................... 23
Related BCC Research Reports ................................................................................................................ 24
Report Summary ......................................................................................................................................... 24
Structural Heart Disease ............................................................................................................................. 27
Symptoms and Risk Factors of Structural Heart Disease ............................................................................ 27
Causes of Structural Heart Disease ............................................................................................................. 28
Diagnosis of Structural Heart Disease ......................................................................................................... 28
Treatment of Structural Heart Disease ....................................................................................................... 28
Surgical Intervention: Heart Valve Repair and Replacement .................................................................. 29
Aortic Valve Disease.................................................................................................................................... 30
Mitral Valve Disease.................................................................................................................................... 31
Competitive Landscape ............................................................................................................................... 32
Pricing and Reimbursement........................................................................................................................ 34
Future Outlook ............................................................................................................................................ 34
Chapter 4: Medical Imaging Instrumentation: Global Market and Technologies

Through 2022 (HLC189A) ..................................................................................... 36
Introduction ................................................................................................................................................ 36
Scope of Report ....................................................................................................................................... 37
Methodology ........................................................................................................................................... 37
Report Summary ......................................................................................................................................... 39
X-ray Equipment/Instruments .................................................................................................................... 41
MRI Equipment/Instruments ...................................................................................................................... 43
CT Scanners ................................................................................................................................................. 43
Ultrasound Equipment/Instruments........................................................................................................... 43
Nuclear Imaging Equipment/Instruments .................................................................................................. 44
Industry Structure ....................................................................................................................................... 44
Raw Material Suppliers ........................................................................................................................... 44
Manufacturers ......................................................................................................................................... 45
Distributors .............................................................................................................................................. 46
End Users ................................................................................................................................................. 46
Manufacturing Process of Medical Imaging Instrument ............................................................................ 47
Procurement of Raw Materials/Parts ..................................................................................................... 47
Testing of Procured Products .................................................................................................................. 47
Production of Remaining Parts/Raw Materials ....................................................................................... 47
Assembling .............................................................................................................................................. 48
Testing of the Product ............................................................................................................................. 48
Cost-Effective Components ..................................................................................................................... 48
Patent Analysis ............................................................................................................................................ 49
U.S. Patents ............................................................................................................................................. 49
European Patents .................................................................................................................................... 51
Japanese Patents ..................................................................................................................................... 54
Future Outlook ............................................................................................................................................ 55
Chapter 5: Global Markets and Technologies for Electronic Health Records

(HLC205A) ............................................................................................................ 57
Introduction ................................................................................................................................................ 57
Scope of Report ....................................................................................................................................... 57
Methodology ........................................................................................................................................... 58
Report Summary ......................................................................................................................................... 58
Electronic Health Records Defined ............................................................................................................. 60
Electronic Healthcare Technologies............................................................................................................ 62
Hardware ................................................................................................................................................. 63
Software .................................................................................................................................................. 63
Electronic Health Records Applications ...................................................................................................... 64
Administration Systems........................................................................................................................... 64
Computerized Health Records ................................................................................................................ 64
Billing Automation ................................................................................................................................... 64
Decision Support Tools ............................................................................................................................ 65
Document and Image Management Systems ......................................................................................... 65
E-Prescriptions......................................................................................................................................... 66
Electronic Health Records Markets............................................................................................................. 67
Future Outlook ............................................................................................................................................ 68
Chapter 6: Non-opioid Pain Treatment: Global Markets to 2022 (HLC206A) ....... 70

Introduction ................................................................................................................................................ 70
Scope of Report ....................................................................................................................................... 70
Methodology ........................................................................................................................................... 72
Report Summary ......................................................................................................................................... 73
Diseases Causing Chronic Pain .................................................................................................................... 75
Arthritis.................................................................................................................................................... 75
Cancer...................................................................................................................................................... 76
Fibromyalgia ............................................................................................................................................ 77
Migraine .................................................................................................................................................. 77
HIV/AIDS .................................................................................................................................................. 78
Non-Narcotic, or Non-opioid, Pain Control................................................................................................. 78
Non-Opioid Treatment Market ................................................................................................................... 79
Medical Cannabis .................................................................................................................................... 80
Capsaicin-derived Therapies ................................................................................................................... 81
Menthol-containing Therapies ................................................................................................................ 82
Omega-3 Fatty Acid-containing Therapies .............................................................................................. 82
Botulinum Toxin Treatments ................................................................................................................... 82
Growing Trend in Cannabis Treatment for Pain ......................................................................................... 83
Adoption of Medical Cannabis: A Global Analysis................................................................................... 84
Laws and Legalization Trends .................................................................................................................. 84
Patents Overview ........................................................................................................................................ 84
Non-opioid Pain Relief Categories .............................................................................................................. 85
Future Outlook ............................................................................................................................................ 86
Chapter 7: Single Blood Drop Analysis: Technologies and Global Market (HLC207A)
............................................................................................................................. 88
Introduction ................................................................................................................................................ 88
Scope of Report ....................................................................................................................................... 89
Methodology ........................................................................................................................................... 90
Report Summary ......................................................................................................................................... 92
An Overview of Chemical Sensors and Biosensors ..................................................................................... 94
Chemical Sensors..................................................................................................................................... 94
Biosensors ............................................................................................................................................... 94
Diagnosis of Multiple Diseases by Single-Drop Blood Testing .................................................................... 95
Advantage Over Conventional Methods..................................................................................................... 96
Blood Collection Technologies .................................................................................................................... 97
Finger Prick .............................................................................................................................................. 97
Capillary Puncture Method ..................................................................................................................... 97
Intravenous Blood Collection .................................................................................................................. 97
Single Blood Drop Analysis: Applications .................................................................................................... 98
Diagnosis ................................................................................................................................................. 98
Patient Monitoring .................................................................................................................................. 99
Drug Response Monitoring ..................................................................................................................... 99
Competitive Lanscape ............................................................................................................................... 100
Patent Analysis .......................................................................................................................................... 101
Future Outlook .......................................................................................................................................... 104
Chapter 8: Cognitive Computing and Artificial Intelligence Systems Market in

Healthcare (HLC208A) ........................................................................................ 106
Introduction .............................................................................................................................................. 106
Study Goals and Objectives ................................................................................................................... 106
Reasons for Doing This Study ................................................................................................................ 106
Scope of Report ..................................................................................................................................... 106
Information Sources and Methodology ................................................................................................ 107
Geographic Breakdown ......................................................................................................................... 107
Analyst’s Credentials ............................................................................................................................. 108
Related BCC Research Reports .............................................................................................................. 108
Report Summary ....................................................................................................................................... 108
Cognitive Computing................................................................................................................................. 110
Artificial intelligence (AI) ........................................................................................................................... 111
Artificial Intelligence and Cognitive Computing in Healthcare ................................................................. 112
Market by Technology .............................................................................................................................. 113
Government Regulations .......................................................................................................................... 115
Future Outlook .......................................................................................................................................... 116
About BCC Research ......................................................................................... 118
About BCC Research.................................................................................................................................. 119
BCC Membership ...................................................................................................................................... 119
Additional segmentations and data sets available upon request. Email custom@bccresearch.com
List of Tables
Table 1 Global Market for 3D Medical and Surgical Imaging Platforms, by Component, Through 2023
($ Millions) .................................................................................................................................................... 7
Table 2 Global Market for 3D Medical and Surgical Imaging Platforms, by End User, Through 2023
($ Millions) .................................................................................................................................................. 13
Table 3 Technological Advancements, 2015–2018..................................................................................... 14
Table 4 Global Market for Transcatheter Treatment Devices, by Region, Through 2023 ($ Millions) ....... 25
Table 5 Scope of Structural Heart Diseases ................................................................................................ 27
Table 6 Structural Heart Disease, Management Through Medication ....................................................... 29
Table 7 Structural Heart Valve Disease Treatment Through Surgical Intervention .................................... 29
Table 8 Types of Aortic Valve and Repair Techniques ................................................................................ 31
Table 9 Types of Mitral Valve Repair .......................................................................................................... 32
Table 10 Global Market for Transcatheter Treatment Devices, by Leading Company, 2017 ($ Millions/%)
.................................................................................................................................................................... 33
Table 11 Global Market for Medical Imaging Equipment/Instruments, by Product Type, Through 2022
($ Millions) .................................................................................................................................................. 39
Table 12 Examples of Examinations and Procedures in Which X-ray Machines are Used to Either
Diagnose or Treat Disease .......................................................................................................................... 42
Table 13 Instrument and Their Raw Material/Parts ................................................................................... 45
Table 14 Medical Imaging Equipment/Instruments Manufacturers and Products .................................... 46
Table 15 U.S. Medical Imaging Equipment/Instruments Patents, 2016 Through June 2018 ..................... 49
Table 16 European Patents and Patent Applications on Medical Imaging Equipment/Instruments, 2015
Through June 2018...................................................................................................................................... 51
Table 17 Japanese Patents and Patent Applications on Medical Imaging Equipment/Instruments, 2015
Through May 2018 ...................................................................................................................................... 54
Table 18 Global Market for Electronic Health Records, by Region, Through 2022 ($ Billions) .................. 59
Table 19 Key Trends in Electronic Health Records...................................................................................... 61
Table 20 Global Market Share for Electronic Health Records, by Technology Type, 2016 (%) .................. 62
Table 21 Global Market for Non-opioid Pain Treatments, by Product Segment, Through 2022 ($ Millions)
.................................................................................................................................................................... 74
Table 22 Global Market Shares of Capsaicin-derived Pain Treatments, by Indication, 2017 (%)............... 81
Table 23 U.S. Market for Allergan’s Botox, by Treatment Area, 2016 ($ Millions/%) ................................ 82
Table 24 Adoption of Medical Cannabis, by Select Country (Age 15 and Over), 2017 (%/Thousands)...... 84
Table 25 Global Market for Single Blood Drop Analysis, by Application, Through 2027 ($ Millions) ......... 93
Table 26 Applications of Biosensor in Healthcare ...................................................................................... 95
Table 27 Finger Prick Method Versus Venous Blood Samples.................................................................... 98
Table 28 Approved Products for the Single Blood Drop Analysis Technology Industry ........................... 100
Table 29 Patent for Single Blood Drop Analysis, by Technology, 2015–2017 .......................................... 101
Table 30 Patent for Single Blood Drop Analysis, by Assignee, 2015–2017 ............................................... 102
Table 31 Patents for Single Blood Drop Analysis, by Patent Office, 2015–2017 ...................................... 103
Table 32 Patent for Single Blood Drop Analysis, by Technology, 2015–2017 .......................................... 103
Table 33 Global Market for Cognitive Computing and AI Systems in Healthcare, by Region, Through 2022
($ Millions) ................................................................................................................................................ 109
Table 34 Global Market for Cognitive Computing and AI Systems in Healthcare, by Technology, Through
2022 ($ Millions) ....................................................................................................................................... 115
List of Figures
Figure 1 Global Market for 3D Medical and Surgical Imaging Platforms, by Component, 2017–2023
($ Millions) .................................................................................................................................................... 7
Figure 2 Block-Chain Capabilities Across Supply Chain............................................................................... 16
Figure 3 Cloud Computing in Medical and Surgical Imaging ...................................................................... 17
Figure 4 Global Market for Transcatheter Treatment Devices, by Region, 2017–2023 ($ Millions) .......... 25
Figure 5 Global Market Share for Transcatheter Treatment Devices, by Leading Company, 2017 (%) ..... 33
Figure 6 Global Market for Medical Imaging Equipment/Instruments, by Product Type, 2016–2022
($ Millions) .................................................................................................................................................. 40
Figure 7 Manufacturing Process of Medical Imaging Equipment/Instruments .......................................... 47
Figure 8 Global Market for Electronic Health Records, by Region, 2016–2022 ($ Billions)........................ 59
Figure 9 Global Market Share for Electronic Health Records, by Technology Type, 2016 (%) ................... 63
Figure 10 Global Market Share for Electronic Health Records, by Application, 2016 (%) .......................... 67
Figure 11 Global Market for Non-opioid Pain Treatments, by Product Segment, 2016–2022 ($ Millions) 75
Figure 12 Global Market Shares of Medical Cannabis Pain Treatments, by Indication, 2017 (%).............. 81
Figure 13 Non-opioid Pain Management Market Drivers and Restraints .................................................. 83
Figure 14 Total U.S. Patents on Non-opioid Pain Treatments, by Type, Through 2017 (Number/% Share of
Total) ........................................................................................................................................................... 85
Figure 15 Global Market for Single Blood Drop Analysis, by Application, 2016–2027 ($ Millions) ............ 94
Figure 16 Global Market for Cognitive Computing and AI Systems in Healthcare, by Region, 2016–2022 ($
Millions) .................................................................................................................................................... 110
Figure 17 Cognitive Computing and AI Systems in Healthcare Applications ............................................ 111
Figure 18 Segmentation of the Global Market for Cognitive Computing and AI Systems in Healthcare, by
Technology ................................................................................................................................................ 114
Figure 19 Emerging AI and Cognitive Computing Technologies and Government Implications .............. 116
Chapter 1
Foreward
© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 1

Chapter 1: Foreward
Foreword
The global healthcare system is in a constant state of disruptive transformation, facing megatrends like
demographic shifts, pandemics, workforce remodeling, rapid digitization and a patient-centric focus.
Emerging trends in the healthcare sector are all set to leverage the benefits of cutting-edge technology
like artificial intelligence (AI), three-dimensional (3D) imaging, and healthcare IT to enhance care
delivery, and reduce healthcare costs, especially, considering the imminent transition to a value-based
reimbursement model.
From newer evidence-based technologies to advanced analytics, the healthcare industry is experiencing
one of the most rapid changes in history, with no signs of slowing down.
This BCC Research Review is a collection of highlights from several healthcare market research reports
that were published in 2018. This review was compiled with an intent of providing a sampling of the
type of market information, guidance and analysis, that have been guiding business decisions, since the
inception of BCC Research in 1971. This Healthcare Research Review includes highlights and excerpts
from the following reports, published by BCC Research in 2018 and early 2019:
• HLC216A Global 3D Medical and Surgical Imaging Platform Market.

• HLC204A Transcatheter Treatment: Procedures and Heart Valve Market.
• HLC189A Medical Imaging Instrumentation: Global Markets and Technologies Through 2022.
• HLC205A Global Markets and Technologies for Electronic Health Records.
• HLC206A Non-opioid Pain Treatment: Global Markets to 2022.
• HLC207A Single Blood Drop Analysis: Technologies and Global Market.
• HLC208A Cognitive Computing and Artificial Intelligence Systems Market in Healthcare.
We hope that you find this Research Review valuable, and we look forward to serving our customers’
healthcare market research needs.
BCC Research Staff

The BCC Research staff is comprised of expert analysts skilled in conducting primary research, secondary
research and data analysis. The analysts have decades of combined experience covering a wide range of
industries including healthcare, advanced materials and emerging technologies. Collectively, the team
represents a diverse set of educational achievements, with individual graduate work completed in fields
such as microbiology, electrical engineering, business administration and surgery.

Chapter 2
Global 3D Medical and

Surgical Imaging Platform
Market (HLC216A)

Chapter 2: Global 3D Medical and Surgical
Imaging Platform Market (HLC216A)
Introduction
Study Goals and Objectives
BCC Research’s goal for this study was to determine the status of the 3D medical and surgical imaging
platforms market and assess the global growth potential over the five-year period from 2018 to 2023.
The market was analyzed via the main 3D medical and surgical imaging platform components: hardware,
software and services.
The application segment is characterized by various types (i.e., ultrasound, digital radiography, magnetic
resonance imaging, computed tomography, nuclear imaging and mammography) and by end-use
industry (e.g. hospitals, ambulatory and healthcare settings, diagnostic and research centers).
The main focus of this study is the market for software in the global 3D medical and surgical imaging
platforms market, which highlights a future market segment for 3D medical and surgical imaging
platforms. In addition, the market has been analyzed on various deployment types including on-
premise-based platforms, cloud-based platforms and web-based platforms.
The overall report objective was to present a comprehensive discussion of 3D medical and surgical
imaging platforms, along with current and future commercial potential for each key market segment.
Reasons for Doing This Study

The global 3D medical and surgical imaging platforms market includes hardware, software and services
in imaging modalities that are meant to improve patient outcomes. Companies are striving to develop
software as a service (SaaS) and infrastructure as a service (IaaS) based imaging platforms to transform
the medical imaging industry. The 3D medical and surgical imaging platform industry and market are
important components of the healthcare industry and of interest to a wide audience.
This report seeks to provide a qualitative and quantitative description of the 3D medical and surgical
imaging platform industry so that emerging market opportunities can be identified and utilized by the
reader.
The report achieves this objective by examining the main product applications and markets, helping the
reader to prioritize product opportunities and strategic opportunities. The report highlights key industry
and market trends and quantifies main market segments. With this report, the reader is able to better
understand industry structure and changes.
Surging development of modern visualization methods and technology platforms coupled with rising
demand for 3D imaging in diagnosis and monitoring of chronic diseases propel the global 3D medical
and surgical imaging platforms market. These demands create unique market opportunities. This report
analyzes trends and their impact on future markets for 3D imaging platform products.

Based on these market and technology dynamics, the global 3D medical and surgical imaging platform
industry is examined, here.
Scope of Report
The scope of this report is broad. It covers components, applications, end users and modes of
deployment in 3D medical and surgical platforms. The market has been segmented by components into
hardware, software and services. Revenue forecasts for 2018-2023 are given for each segment and
regional market with estimated value derived from the revenue of manufacturers’ total revenues. The
main geographic markets—North America, Europe, Asia-Pacific and Rest of World (ROW) are included.
The report also includes a discussion of the major players across each region in the 3D medical and
surgical imaging platforms market. Further, it explains the major drivers and regional dynamics of the
global 3D medical and surgical imaging platforms market and current trends within the industry.
Key industry acquisitions and strategic alliances are given for the three-year period 2015-2018 (June).
This report also examines the main patent trends within the industry and profiles 25 market players that
deal in 3D medical and surgical imaging platforms.
The report concludes with a special focus on the vendor landscape and includes detailed profiles of the
main vendors in the global 3D medical and surgical imaging platforms market.
Information Sources
Primary sources for this report include key industry companies and leading research institutions. Data
were also compiled from secondary sources, including company websites and industry, trade and
government publications.
Methodology
This report is a descriptive study with trend analysis of the global market for 3D medical and surgical
imaging platforms using quantitative and qualitative approaches.
BCC Research collects data through various primary and secondary sources, including interviews with
industry vendors, public financial proceedings, white papers, business journals and historical market
data from the internet. Market data is assessed and validated considering interrelated market attributes
and the impact of global economic variables.
The value of the market is then obtained through a combination of bottom-up and top-down
approaches using exclusive market modeling tools to generate BCC Research’s market data and
forecasts. Estimated values used are based on manufacturers’ total revenues.

Geographic Breakdown
In this report, the geographic regions considered for market analysis include and only include:
North America
• United States.
• Mexico.
• Canada.
Europe
• France.
• Germany.
• U.K.
• Rest of Europe.
Asia-Pacific
• China.
• India.
• Japan.
• Australia.
• Rest of Asia-Pacific.
Rest of the World

• Latin America.
• Middle East and Africa.
Analyst’s Credentials
Vijay Laxmi has more than 20 years of experience in the healthcare domain. In addition to producing
business research and consulting, she has conducted corporate briefings for top players in a wide range
of market segments. She has worked with major market research firms and handled projects for various
consultancies. Her market research studies include reports on:
• Various medical device markets.

• High-growth and niche markets in healthcare and life sciences.
• Home healthcare market.
• Medical tourism.
BCC Custom Research

Our experts provide custom research projects to those working to identify new markets, introduce new
products, validate existing market share, analyze competition and assess the potential for products to
impact existing markets. With impressive academic credentials and broad and deep knowledge of global
industrial markets, our independent analysts and consultants develop the facts, figures, analysis and
assessments to inform the decisions that will move your company ahead. Confidential inquiries to
custom@bccresearch.com or 781/205-2429.

Related BCC Research Reports
• IAS004G Global Markets for Spectroscopy Equipment.
• HLC040E Biologic and Medical Imaging Reagents: Global Markets.
• HLC189A Medical Imaging instrumentation: Global Markets and Technologies Through 2022.
• PHO024A Biophotonics: Technologies and Global Markets.
Report Summary
3D medical and surgical imaging platforms refer to the incorporation of various components including
hardware, software and services in imaging modalities. These pieces come together in order to improve
patient outcomes by offering premium optics with uncompromised platform integration, cross specialty
functionality, advanced imaging capabilities, etc. Medical and surgical imaging platforms are an
important part of the healthcare industry, widely used for clinical purposes. 3D medical and surgical
platforms enable imaging techniques used to create 3D images of the body or body parts to help doctors
diagnose accurately. The advantages proposed by 3D medical and surgical imaging platforms are image
pre-processing, virtual cutting, volume rendering, manipulation, surface rendering and virtual
endoscopy.
Rising demand for 3D imaging in the diagnosis and monitoring of chronic diseases is the main driver for
the growth in the global 3D medical and surgical imaging platforms market. Increased demand for 3D
medical imaging is noted due to its vast applications in cardiology and oncology. Heart valve
replacement is the most common procedure in cardiology. Transcatheter aortic valve replacement is
one minimally invasive heart valve replacement procedure. Positioning the new heart valve is a serious
concern for surgeons. Due to the importance of positioning, surgeons prefer 3D angiography imaging
software to view the anatomy during placement of heart valves.
As the number of heart surgeries increases across the globe, use of 3D medical imaging and surgical
platforms is expected to increase over the forecast period 2018-2023. Preference for minimally invasive
procedures also calls for the adoption of 3D medical and surgical imaging platforms. According to the
International Society of Aesthetic Plastic Surgery, non-surgical procedures accounted for a 10% increase
from 2015-2016. In 2015, the total number of non-surgical procedures were around 12.0 million, then
13.2 million in 2016.
The global 3D medical and surgical imaging platforms market is projected to rise at a CAGR of 18.1%
during the forecast period of 2018-2023. In 2023, total revenues are expected to reach more than $10.4
billion (an increase of nearly $6.5 billion) from $3.9 billion in 2017.
This report provides an analysis based on each market segment including components, applications,
deployment and end users. The components segment is further sub-segmented into hardware, software
and services. The software segment of the 3D medical and surgical imaging platforms market held the
largest market share (48.8% in 2017) in terms of revenue, followed by hardware and services. By 2023,
total revenue from software in the 3D medical and surgical imaging platforms market is expected to
reach nearly $5.2 billion. Additionally, the software segment is expected to rise at the highest CAGR
(18.5%) of all segments, through 2023.
The figure below shows market revenue in the 3D medical and surgical imaging platforms market by
component segment for the forecast period of 2017-2023.

Table 1
Global Market for 3D Medical and Surgical Imaging Platforms, by Component,
Through 2023
($ Millions)
CAGR%
Component 2017 2018 2023
2018-2023
Software 1,904 2,209 5,169 18.5
Hardware 1,292 1,488 3,352 17.6
Services 707 816 1,855 17.9
Total 3,903 4,513 10,376 18.1
Source: BCC Research
Figure 1
Global Market for 3D Medical and Surgical Imaging Platforms, by Component,
2017–2023
($ Millions)
6,000
5,000
4,000
$ Millions
3,000
2,000
1,000
0
2017 2018 2023
Software Hardware Services
3D Medical and Surgical Imaging Platforms by Application

The application segment is comprised of 3D medical and surgical imaging platforms used in oncology,
cardiology, orthopedic and others. Various imaging techniques include ultrasound, digital radiography,
MRI, CT, nuclear imaging and mammography.

Ultrasound
Ultrasound technology is a diagnostic and therapeutic imaging technique that uses sound waves to
produce images of internal organs. Ultrasound technology offers significant potential health benefits to
people suffering from life threatening or painful diseases including breast cancer, cardiac disease,
uterine fibroids, gynecological disorders and others through the discovery anomalies. Market growth of
the ultrasound technique is driven by its wide applicability, ongoing technological advancements in the
field of 3D/4D ultrasound and affordability compared to other imaging technologies like CT and MRI.
Some benefits of 3D imaging software used in an ultrasound application are:
• Ability to save sonograms as image files, DICOM and ultrasound reports.

• Can capture high resolution medical images.
• Remote control for image capturing and printing.
• Share medical images with others.
• Image enhancement and effects.
• Save time and money with automatic operations.
• Use any computer printer to print sonograms and reports.
3D medical and surgical imaging platforms are being widely adopted in the ultrasound application. The
demand for ultrasound imaging significantly drives the 3D medical and surgical imaging platforms
market. Ultrasound imaging uses sound waves to produce images of the inside of the body. It is
employed to aid in diagnosing the causes of swelling, pain and infection in internal organs. It can also be
used to inspect a fetus in pregnant women and the hips and brain in infants. Ultrasound is a useful tool
to aid diagnose heart conditions, guide biopsies and assess damage after a heart attack. Ultrasound is
non-invasive, safe and does not use ionizing radiation.
Digital Radiography
Digital radiography is a form of X-ray imaging that uses X-ray sensors instead of traditional photographic
film to produce images. Digital radiography is used in dental, chest imaging, orthopedics, general
surgery and other fields. This technique offers fast image production, digital transfer and enhanced
images. The market growth of digital radiography is driven by rising orthopedic surgeries along with
emergence of portable digital radiography systems.
Advantages of X-Ray Machines

X-ray imaging exams are recognized as a valuable medical tool for a wide variety of examinations and
procedures. They are used for the following purposes:
• Painless and non-invasive diagnosis of disease and monitor therapy.
• Support surgical and medical treatment planning.
• Guide medical personnel as they insert catheters, stents, or other devices inside the body, treat
tumor, or remove blood clots or other blockages.

Some of the main applications of digital radiography are:
• General radiography.
• Dental.
• Mammography.
• Chest Imaging.
• Orthopedic.
• Cardiovascular.
• Others.
Digital radiography is widely used for general radiography and bone imaging. A growing geriatric
population with bone disorders worldwide is expected to fuel the demand for digital radiography. As
bone density decreases with age, the risk of bone fractures increases. The geriatric population suffers
from more bone related problems due to low bone density. According to the U.S based Population
Reference Bureau organization, it is estimated that the number of Americans age 65+ was around 46
million in 2016 and anticipated to be around 98 million by 2060.
Magnetic Resonance Imaging (MRI)

MRI is an imaging technique that uses a magnetic field and radio waves to generate detailed images of
the human body. MRI has applications in the diagnosis of several diseases such as cancer, neurological
and cardiac disorders. It is also used to provide more information regarding problems detected via X-ray,
ultrasound scan or CT scan, as it provides a detailed picture of the severity of an anomaly. Market
growth is driven by the introduction of technologically advanced MRI systems with better image quality
and increasing application in areas such as detection of metastasis in cancer.
3D imaging software for MRI has been shown to be helpful in the evaluation and diagnosis of diseases of
vascular anatomy using a single acquisition technique. 3D imaging allows the display of fine anatomic
expansions and the radiologist or healthcare provider can remove images in the context of unwanted
underlying structures emphasizing areas of transparent interest. 3D imaging software allows radiologists
and surgeons to better understand anatomic relationships. 3D MRI can be very useful in planning
surgical procedures such as pre-operative assessment of vascular and peptic ducts, surgical treatment,
preoperative liver and tumor volume measurements and patients passing through virtual hepatectomy
in living liver donors. Adoption of MRI is expected to fuel the demand for 3D medical and surgical
imaging platforms.
Computed Tomography (CT)

CT scans are advanced forms of X-rays and provide numerous advantages over other imaging
technologies such as MRI and conventional X-rays. CT scans have application in soft tissue injury
detection and surgery involving cardiovascular implants, dental implants and cochlear implants. CT scans
are better imaging techniques for cancer, pneumonia, abnormal chest X-rays, bleeding in the brain
(especially from injury) and broken bones and vertebrae. In addition, CT scans display organ tears and
organ injuries more quickly, so this technology may be the best choice for accident victims. The market
growth of CT is driven by rising numbers of internal injuries resulting from accidents, increasing product
innovation, research and development activities.

Common Applications
• CT imaging is one of the fastest and most accurate tools for examining the abdomen, pelvis and
chest due to its detailed cross-sectional views of all types of tissues.
• CT scans are used to examine patients with injuries from trauma such as chest or abdominal
pain or difficulty breathing.
• CT scans confirm the presence of tumors, measure size, identify the precise location and
determine the extent of involvement with other nearby tissue. CT scan are one of the best
methods for detecting cancer in the chest, abdomen and pelvis such as lymphoma and cancers
of the lung, liver, kidney, pancreas and ovary.
• CT scans play a significant role in detection, diagnosis and treatment of vascular disease that can
lead to kidney failure and stroke.
• CT scanning is also used to assess for pulmonary embolism and aortic aneurysms.
Nuclear Imaging
Nuclear imaging procedures are non-invasive imaging procedures with the exception of intravenous
injections. The imaging procedures are usually painless and used to diagnose and evaluate a variety of
medical conditions such as cancer, coronary heart disease (CHD), bone tumors, Alzheimer’s disease and
more. These imaging scans involve the use of radioactive materials known as radiotracers or
radiopharmaceuticals. The increasing incidence of cancer and cardiovascular disease is primarily driving
the market growth of nuclear imaging. Technological advancements in nuclear imaging technologies
such as SPECT and hybrid PET will contribute to market growth during the forecast period.
3D medical and surgical imaging platforms are widely used in various nuclear imaging techniques such as
in positron emission computed tomography (PET) imaging, single photon emission computed
tomography (SPECT) imaging and scintigraphy imaging. 3D functional nuclear imaging is widely used to
locate potentially cancerous lymph nodes in breast cancer cases. However, the volumetric information
from pre-operative SPECT scans loses validity quickly due to posture changes and manipulation of the
soft tissue during surgery. During the intervention, surgeons have to rely on the acoustic feedback
provided by handheld gamma detectors in order to localize the marked structures.
Mammography
Mammography uses low radiation X-rays to diagnose tumors in the human breast. Mammography
imaging provides radiologists with thin-section, multiple images, thereby facilitating layer by layer
examination of breast tissue. The market growth of mammography is attributed to high prevalence of
breast cancer along with initiatives by various governments and NGOs such as U.S. CDC (Centers for
Disease Control and Prevention), the Breast Cancer Organization and the National Breast Cancer
Foundation to raise awareness about early diagnosis of mammary gland calcification.

Endoscopy
3D medical and surgical imaging platforms are used in endoscopy to offer different observation
possibilities such as narrow band imaging or infrared imaging to improve patient outcomes during
diagnostics or surgery. 3D imaging solutions offer surgeons greater depth perception and anatomical
spatial view compared to 2D. 3D imaging solutions offer improved speed, greater accuracy, precision
and shorter learning curve.
3D endoscopic systems provide higher resolution compared to previous 3D prototypes. 3D endoscopes

do not induce adverse symptoms compared to previous 3D prototypes. Adverse symptoms include
visual disturbance, nausea, visual fatigue and more.
Advantages of 3D Endoscopy System

• Three-dimensional and realistic image of the surgical area.
• Optimized full HD image quality in 3D and 2D.
• Improved hand to eye coordination.
• More precise spatial orientation.
• Helps improve surgical precision.
• Easier and safer handling of instruments and tissue.
• 3D image for surgical team.
• Shorter learning curves.
• Shorter operating time.
• Minimized operation costs.
Regulations
Regulations play a vital role in the healthcare industry. To introduce a new product into the market
minimum standards set by the medical device regulating authority must be met. The regulatory bodies
of different countries have different rules for software and hardware used for medical purposes. It can
be an ambiguous situation for product manufacturers due to lack of common standards. A product
certified in one country may not be fit for certification in other countries. International organizations
such as the World Health Organization (WHO), the International Organization for Standardization (ISO)
and the International Medical Device Regulators Forum (IMDRF) have emphasized the need for common
standards. These organizations advocate for the use of international standards from regulatory
authorities on developing medical devices. Medical software is regulated by various regulatory bodies
across various countries.
Digital Imaging and Communication in Medicine (DICOM) is an international standard used for storing,
exchanging and transmitting medical images. DICOM proposes various protocols for imaging techniques
including radiography, CT, ultrasonography, MRI and radiation therapy. DICOM also presents standards
for image exchange, image compression, 3D visualization, result reporting and image presentation.
In the U.S, The Center for Devices and Radiological Health (CDRH) regulates software used in medical
devices. Medical software devices are classified into three classes based on risk assessment:
• Class I — General controls applied.

• Class II — Special and general controls applied.
• Class III — Needs pre-market approval and general controls.
Software is regulated by Sec 820.30 (concerned with design controls), Sec. 820.50 (concerned with
purchasing controls) and Sec. 820.100 (concerned with corrective and preventive action).
Further, 21 CFR 820 quality system regulations are required for medical software. According to 21 CFR
820.30 (g), software requires a design validation that must include risk analysis and software validation.
Evaluation must be documented according to 21 CFR 820.50 (a).
According to the Medical Imaging & Technology Alliance (MITA), the FDA’s CDRH regulates medical
imaging devices including CT systems, fluoroscopy, mammography, ultrasound, nuclear medicine, X-ray
and magnetic resonance for sales in the U.S. Furthermore, MITA has collaborated with the FDA on
various initiatives from the improvement of a product through its clearance. Both of these regulatory
bodies seek reduction of exposure to unnecessary radiation for patients. Transparency is the key to a
smooth regulatory process. Lack of regulatory predictability results in significant barriers to product
innovation, according to MITA.
HIPAA laws have established national standards to protect individual medical records and other
personal health information. Information sources include health care clearinghouses, health plans and
health care providers that conduct health care transactions electronically.
HIPAA limits the disclosure and use of an individual’s health information known as protected health
information by organizations subject to the privacy rule known as covered entities. Privacy rules are in
place to assure that individual health information is protected properly while permitting the flow of
information that is essential to promote and provide high quality health care and protect the public
interest.
End Users
The 3D medical and surgical imaging platforms market is widely deployed by several end users such as
hospitals, ambulatory and healthcare facilities, diagnostic centers and research centers. These 3D
medical and surgical imaging platforms are deployed by end users for the treatment of patients with
improved surgical procedures. These platforms deliver efficiency in diagnostic testing and disease
detection.

Table 2
Global Market for 3D Medical and Surgical Imaging Platforms, by End User,
Through 2023
($ Millions)
CAGR%
End User 2017 2018 2023
2018-2023
Hospitals 1,568 1,823 4,299 18.7
Diagnostic centers 1,154 1,337 3,104 18.3
Ambulatory and healthcare settings 720 831 1,896 17.9
Research centers 461 522 1,077 15.6
Total 3,903 4,513 10,376 18.1
Source: BCC research
Hospitals are the dominant segment in 3D medical and surgical imaging platforms. Hospitals accounted
for revenues of nearly $1.8 billion in 2018, increased from nearly $1.6 billion in 2017 and expected to
increase to $4.3 billion by the end of 2023. Also, hospitals are the fastest growing segment in 3D medical
and surgical imaging platforms with a CAGR of 18.7% from 2017 through 2023.
Factors positively driving the growth of the 3D medical and surgical imaging platforms in hospitals are a
high number of hospitals across the globe, adoption of hybrid operating rooms and the patient-centric
trend. These platforms are especially useful in healthcare settings and ambulatory services for remote
areas where healthcare infrastructure is lacking.
Diagnostic centers are expected to grow due to the presence of key growth factors including, increased
healthcare expenditure and technological advancements in 3D medical and surgical imaging platforms.
Research centers as end users are expected to grow due to increased R&D spending.
Opportunities
Patient-Centric Trend
Patient-centric trends are expected to drive adoption of 3D medical imaging and surgical platforms in
hospitals.
Benefits of a Patient-Centric Approach
• Increased engagement with all stakeholders (patients, providers and others), leading to
decreased overall expenses.
• Enhanced knowledge and understanding among patients of their own health and healthcare
choices, leading to improved care.
• By collaborating and engaging with patients in the decision-making process, health providers
can make better decisions regarding patient health.

• Increased competitive advantage: more hospitals are now competing for patients based on both
cost and quality of care.
• Patient care emphasis on improving outcomes is achieved by improving three main areas:
practice, analytics and adoption.
• Better patient care can be achieved by deploying advances practices that focus on minimally
invasive procedures and on effective and improved surgeries. To achieve the highest possible
parameters of patient care, doctors use advance techniques in procedures. 3D imaging software
is used in various surgeries to improve the outcome of the procedure and to enhance surgical
efficiency.
Technological Advancements in 3D Medical and Surgical Imaging Platforms

Technological advancements and innovations in 3D medical and surgical imaging promote the growth of
the global diagnostic centers market segment during the forecast period.
Table 3
Technological Advancements, 2015–2018
Year Title Description

• Low-cost 3D ultrasound imaging platform
• Uses the platform on a Vimedix simulator, on phantom and in-vivo
targets by the use of multiple clinical ultrasound probes and systems
Volumetric 3D
2018 • Lowers operator dependent barriers
ultrasound platform
• Improved data acquisition and image reconstruction schemes
• Provides real-time visual feedback
• Streamlines workflow and increases image quality
• Accurate and intuitive analysis of anatomical relationship in
diagnosis and surgery planning
• Illustrates 3D human pathology and anatomy in real-time via 3D
Software platform
tissue model (with an interactive transfer function module) and
2015 (interactive analysis
oblique clipping image
on 3D medical data)
• Provides realistic understanding of medical imaging technology
• Offers novel resolution to improve the assessment of anatomical
structures
• Mainly used for oculofacial surgical planning
• Facilitates surgical planning and post-operative assessment
• Flexible and accurate
3D surface imaging • Consists of a stereo camera and two monocular cameras that can be
2016 and measurement positioned and focused individually in order to obtain crisp images
platform • Can achieve up to the mark scale reconstruction with range of
accuracy between 97.46% to 99.83% in different oculofacial
measurements
• Requires minimal training to operate
Source: Institute of Electrical and Electronics Engineers

Manufacturing companies are adopting new cutting-edge technologies for improving supply chain
efficiency. From cloud computing to AI, technologies are playing a major role in shaping the future
supply chain. New disruptive technologies and business to business supply chains will change the way
companies procure raw materials or components, keep stock inventory and adhere to regulatory
standards. Some of the trends shaping supply chains include AI and analytics, block-chain and IoT and
robotics.
Artificial Intelligence and Analytics

Companies are investing in technologies that can increase process efficiency throughout the value chain.
Through AI companies can enhance business, automate decision-making processes and create new
business models that can aid in overall growth for the company. AI and analytics systems skim out
patterns and predict scenarios for institutions to tackle in the future. Using artificial intelligence and
analytics companies keep up with inventory levels and help customers more efficiently. Through AI and
analytics companies can provide tailored solutions to customers when procuring sensitive instruments
like 3D medical and surgical imaging systems.
Block-Chain and Internet of Things (IoT)

Using block-chain and internet of things, companies can track products or components from
manufacturer to trader. Block chain enables companies to compare quality of products and streamline
logistic networks helping in delivery to distant clients. Using IoT and block-chain companies can track
real-time location of their product or component and its condition. Block chain can help companies
store data with respect to product unit manufacturing, distribution network and sales and can be used
further for performance analysis. Combining block-chain and IoT brings about flexibility within
institutions in terms of process delivery.

Figure 2
Block-Chain Capabilities Across Supply Chain
•Provides full audit •All transactions of

trail of data/ record block chain are
keeping of supply secure/ paves way
chain activities to data integrity
Auditability Immutability
Smart Contracts Disintermediation
•Real-time tracking •Helps with peer to

of data facilitates peer interactions
use of smart based on digital
contracts across signatures
supply chain
Robotics
Most of the tasks in the supply chain category are monotonous. 3D medical and surgical imaging
systems are sensitive, costly and must be handled with care. Any damage to the system will result in
delayed delivery and loss for the manufacturer. Using robotics, manufacturers are looking forward to
addressing issues with respect to product handling, delivery and containment of operation costs. In April
2017, leading global logistics firm, DHL, announced that it was testing collaborative robotics systems in
warehouse facilities in the U.S. DHL Ltd. collaborated with Locus Robotics Inc. to use LocusBots for
handling various warehouse activities like pallet handling, packaging, etc., especially for life science
technology products. LocusBots can be programmed to work 24/7 and is compatible with DHL’s existing
warehouse management system. Demand for robotics in logistics is increasing exponentially. According
to the Robotics Industries Association, the global logistic robotics market is anticipated to reach
revenues of $22.4 billion by 2021, from $1.9 billion in 2016, growing at a CAGR of 63.8%.
Innovative Solutions by Platform Providers in the Market

Cloud computing or cloud-based platforms are leading trends in imaging technology. The National
Center for Biotechnology Information stated that healthcare and research institutions are opting to use
cloud computing platforms in order to store data and carry out process exchange of medical data. Cloud
computing is currently being used for image processing, sharing, computing data at remote locations
and offering data management services. These tasks require large capacity data storage and computing.
Cloud computing platforms offer improved image processing services (via platforms like GIS image
processing). Cloud computing can serve huge databases to assess image processing algorithms in
segmentation, registration, denoising, fusion and others.

Figure 3
Cloud Computing in Medical and Surgical Imaging
Diagnose
and
Collect
Analyze
Refine
and Store
Cloud
Technology
Map and
Treat
Match
Access
and
Compute
One important component of such databases is realistic simulated medical image datasets, the initial
step for evaluating image processing algorithms. Such simulations require huge amount of data for
comparison and analysis. All such purposes are served by the cloud and due to rising adoption of cloud
computing, the medical imaging instruments market is gaining significant traction.
Cloud computing is used to facilitate cost-effective patient health records management and medical
images through numerous imaging modalities available at medical centers or hospitals. Health care
institutions are increasingly investing in cloud computing. According to a survey captioned Cloud
Computing Healthcare published in the International Journal of Students Research in Technology and
Management, over 37% of healthcare providers around the globe are looking forward to adopting cloud
computing within 2023. Rising adoption of cloud computing technologies would supplement growth of
the 3D medical and surgical imaging systems market for the forecast period.
Future Outlook
Increased prevalence of chronic disease is expected to boost demand for the 3D medical and surgical
imaging market. According to WHO, chronic diseases like unipolar depressive disorder, cerebrovascular
disease, ischemic heart disease and road accidents will account for the top four leading causes of death,
through 2030, and are expected to result in large scale adoption of medical devices aiding disease

detection and treatment, driving the global 3D medical and surgical imaging instruments market during
the forecast period. Increasing healthcare expenditure will aid in the adoption of state of the art
treatment facilities that feature 3D medical and surgical imaging systems and aiding market growth for
the forecast period. North America, Europe and Asia-Pacific are readily investing in new technologies for
better disease diagnosis and treatment, leading to surging development of modern visualization
methods and technology platforms. A shift toward minimally invasive procedures and rising adoption of
hybrid operating rooms will provide additional traction for the market.

Chapter 3
Transcatheter Treatment:
Procedures and Heart Valve
Market (HLC204A)

Chapter 3: Transcatheter Treatment:
Procedures and Heart Valve Market
(HLC204A)
Introduction
Use of transcatheter valve procedures is increasing worldwide due to the rising incidence of valvular
diseases including valvular stenosis and regurgitation. Valvular stenosis and regurgitation are commonly
formed in the aortic and mitral valve area. Valvular stenosis leads to the narrowing of valves, and
regurgitation leads to the leaking of valves, possibly leading further to severe consequences or even
death if not treated in time.
Aortic stenosis is considered as one of the most common and most serious heart valve problems. Aortic
stenosis can be a birth heart defect (congenital heart defect) or acquired due to degeneration or
rheumatic fever. Aortic regurgitation occurs as a result of acquired abnormalities in the aortic leaflets,
adjacent supporting structures in the aortic root and annulus. Mitral valve stenosis occurs when the
mitral valve narrows and results in restricted blood flow into the main pumping chamber of the heart.
Mitral regurgitation is also referred to as mitral incompetence or mitral insufficiency. It progresses
slowly and does not show any significant outward symptoms unless it becomes moderate or severe.
Heart valve disease is a progressive disease condition and can be characterized by its origin, symptoms,
and disease stage. It is more prevalent in older patients aged 75 and above.
Open surgical repair and transcatheter repair and replacement are the two main surgical options
available for the treatment of valvular disease. Transcatheter valve repair is a relatively new procedure
in which an artificial heart valve is deployed with a catheter.
A catheter is inserted in an artery in the groin and guided up to the heart. Once the valve is placed
correctly, it takes over the function of the diseased valve. This surgery is noninvasive and does not
require major open-heart surgery. Transcatheter aortic valve repair (TAVR), transcatheter aortic valve
implantation (TAVI), and transcatheter mitral valve repair (TMVR) are the few common procedures
frequently performed for the treatment of aortic and mitral valves, respectively.
Transcatheter mitral valve repair (TMVR) is a relatively new procedure and offers several benefits over
the traditional open surgical procedure; it uses a transcatheter valve system and is a quick procedure
with improved outcomes, faster recovery, and several other benefits including minimal long-term
complications. Transcatheter mitral valve implantation (TMVI) is another procedure currently under
development for the replacement of the mitral valve.
The world is moving towards minimally invasive surgical options. Therefore, the use of transcatheter
procedures is growing worldwide as treatment continues to shift from open surgical repair to
transcatheter repair and replacement.

This study provides an overview of TAVR, TAVI, TMVR, and TMVI and their uses in the treatment of
valvular diseases. In addition, it gives a detailed analysis of the competitive environment. It covers a
wide variety of devices and techniques that greatly improve the treatment of heart valves. This study
includes information about emerging transcatheter treatment procedures, devices, market players,
issues, trends, and other pertinent information related to the healthcare, pharmaceutical, and medical
device industry.
The study analyzes the global healthcare, pharmaceutical, and medical device industry in light of the
most recently available information. In addition to looking at current and future markets, this report
considers the technological, demographic and economic developments that may have a long-term
impact on the size and structure of the healthcare, pharmaceutical, and medical device market. The
future of transcatheter treatment is also discussed with forecasts.
More specific objectives are to:
• Identify and segment the key transcatheter procedures (TAVR, TAVI, TMVR, and TMVI), heart
valve systems, and techniques used for the treatment of valvular diseases.
• Analyze current and future device technologies by region, market segments, and procedures.
• Identify and evaluate the impact of demographic, economic, and other factors that will drive
future demand for the transcatheter treatment devices and technologies market.
• Identify promising new transcatheter techniques and devices still in the development and
testing stages and assess the probability that they will be commercialized successfully in the
next five years.
• Forecast the potential market based on pipeline devices, taking into account the estimated
probability that they will be commercialized.
• Provide readers with knowledge to adequately view and assess transcatheter techniques and
offer insights into the market potential of these techniques.

Heart valve disease is a complicated and potentially deadly condition affecting millions of patients
worldwide. Valvular stenosis and regurgitation are known as diseases of the valve that result in
narrowing of the valve and leakage of the valve, disrupting the blood supply from the heart to the rest
of the body. Valvular stenosis can lead to a narrow valve, which may further lead to death due to poor
blood supply. The mortality rate of a valvular abnormality and failure is significantly high.
Open surgical repair was introduced in the early 1950s and has become the gold standard of heart valve
treatment. It has long-term follow-up data and is considered as a safe and durable surgical option.
However, substantial blood loss during the procedure is a widespread concern. Transcatheter valve
treatment is a relatively new procedure and offers several benefits over the traditional open procedure.

It is a minimally invasive approach used to insert a heart valve system (aortic and mitral valve) to repair
or replace the diseased valve of the heart. Earlier it was considered as an alternative treatment for
patients with severe comorbidities. However, now TAVR, TAVI and TMVR procedures have become the
preferred treatment options for patients suffering from valvular disease. Increasing acceptance of
transcatheter treatment is helping patients, surgeons, payers, and providers because of improved
procedure technique, faster recovery, and fewer complications.
The U.S. dominates the global transcatheter treatment market, followed by Europe, Asia, and the Rest
of the World (ROW). The large market shares of the U.S. and Europe can be attributed to greater
accessibility of advanced technologies and the presence of a large number of leading market players.
The growth of the transcatheter devices and technology field during the forecast period is reflective of
an increasing disease incidence, rising healthcare needs, escalated healthcare spending, improvement of
regional infrastructure, and growing investments by the leading players and respective government
agencies.
This report is the first edition to cover the market for transcatheter treatment devices and the
technologies used to improve heart valve repair and replacement, with analysis of key growth areas and
quantitative market projections for technologies and devices. This study attempts to provide the reader
with information about and analysis of transcatheter valve repair and replacement techniques and their
applications in dealing with today’s current challenges associated with heart valve treatment.
Scope of Report
Transcatheter treatment includes procedure types such as TAVR, TAVI, TMVR, and TMVI. Transcatheter
procedure approaches include transfemoral, transapical and transaortic procedures. This report is an
analytical business tool with the primary purpose of providing a thorough evaluation of the global
market for transcatheter treatment for heart valve diseases. The format of this study includes
the following:
• Detailed description, including demographics and cost burden, of heart valve diseases (e.g.,
valvular stenosis and regurgitation) and transcatheter procedure approaches (e.g., transfemoral,
transapical and transaortic.)
• Detailed description and analysis of transcatheter treatments devices including TAVR, TAVI,
TMVR, and TMVI devices.
• Market characterization, unmet need, market size, and segmentation (by region and treatment).
• Market drivers and restraints.
• Detailed market projections through 2023.
• Competition and market shares.
• Key marketed and pipeline (R&D) products along with information about their regulatory status.
• Strategic landscape (mergers and acquisitions).
• Regulatory structure.
• Pricing and reimbursement.
• Observations and conclusions on the future of transcatheter treatment.
• Profiles of market participants and associations.

Information Sources
This report has been written for vendors of the healthcare, pharmaceutical, and advanced medical
equipment sector seeking to understand the potential market for their products and their competitors’
products in key markets, as well as for governmental and international agencies seeking to understand
the commercial and medical potential of transcatheter treatment. This study is especially intended for
readers in the following industries or communities:
• Healthcare, pharmaceutical, and medical device industry.

• Executive management and marketing community.
• Medical research institution community.
• Investment community.
• Financial and business analyst community.
Methodology and Information Sources

The findings and conclusions of this report are based on information gathered through primary and
secondary data collection methods. Primary methods included interviews with key executives, product
managers, clinical specialists, and other related key personnel involved in the healthcare, medical
device, and diagnostics industry. Secondary sources included published literature, investment reports,
trade publications, trade associations, company literature, online databases, and various business
journals covering related medical devices and diagnostic areas. All of these sources were used to
produce the market estimates contained in this report.
Market forecasts were developed for 2017 to 2023, using 2017 as a baseline. These projections were
based on a consensus of primary contacts together with the expertise of BCC Research in the area of key
market drivers and their impact from a historical and analytical perspective. The analytical
methodologies used to generate the market estimates are described comprehensively in the sections on
detailed market projections in Chapter 6. All dollar projections presented in this report are in 2017
constant dollars.
In this report, the geographic regions considered for market analysis are limited to:
• North America.
• Europe.
• Asia-Pacific.
• Rest of the World (ROW).
Dr. Ritu Thakur is an independent consultant based in New Delhi, India with 10+ years of experience in
consulting, business/market research, business & report writing, analytics, content development &
management and translation. She has prior work experience with Panasonic (Healthcare Division),
GlobalData (U.K.-based market research firm) and several other development stage/early stage

companies including Biovo, Diabesity, Medibrane, ScaleThings, EndoGI, Ramot Biomedical Eng and
NeverWet. In her previous assignments, she has delivered hundreds of small to large scale custom
projects on pharmaceutical, medical and biotechnology subjects. She has developed reports for BCC
Research for more than four years and has worked as an author for healthcare and other related
industries such as pharmaceuticals, biotechnology and medical devices
Select reports include:
• Bariatric Surgery: Global Markets for Services and Devices (HLC153B).

• Wearable Medical Devices: Technologies and Global Markets (HLC192A).
• Global Markets for Emerging Medical Device Technologies (HLC191A).
• Needle-Free Devices: Technologies and Global Markets (HLC178A).
• Medication Automation: Systems, Technologies and Global Markets (PHM182A).
• Smart Pills: Applications and Global Markets (PHM181A).

• HLC153B Bariatric Surgery: Global Markets for Services and Devices.
• BIO043F Therapeutics for Women’s Health: Technologies and Global Markets.
• HLC165A Joint Reconstruction and Replacement: Materials, Technologies, and Global Markets.
• HLC178A Needle-Free Devices, Technologies and Global Markets.
• HLC191A Global Markets for Emerging Medical Device Technologies.
• HLC192A Wearable Medical Devices: Technologies and Global Markets.
• PHM181A Smart Pills: Applications and Global Markets.
• PHM182A: Medication Adherence: Systems, Technologies and Global Markets.
• HLC203A Endovascular Treatment Devices: EVAR and TEVAR Emphasis.
Report Summary
The global market for transcatheter treatment devices was worth nearly $3.5 billion in 2017. The market
is expected to reach nearly $4.0 billion in 2018 and approximately $8.0 billion by 2023, increasing at a
compound annual growth rate (CAGR) of 14.8% from 2018 through 2023. This high growth is fueled by
increasing acceptance of transcatheter procedures (e.g., TAVR/TAVI and TMVR/TMVI) and increasing
diagnosis of heart valve disease (e.g., aortic stenosis, mitral regurgitation, etc.) worldwide.
In 2017, the U.S. accounted for 60% of the global market, or $2.1 billion. The U.S. market should
approach nearly $2.3 billion in 2018 and reach $4.8 billion by 2023, increasing at a CAGR of 15.5% from
2018 through 2023. Regionally, the U.S. is expected to maintain dominance in the global market of
transcatheter treatment devices. Those wishing to invest in the transcatheter treatment devices market
ought to strongly consider high-growth areas such as transcatheter aortic valve repair (TAVR),
transcatheter mitral valve implantation (TMVI), and transcatheter mitral valve repair (TMVR) devices
and technologies.
The market is growing primarily due to the growing geriatric population, increasing prevalence of
chronic diseases, continuous technological advancements, increasing adoption of transcatheter
techniques, and positive reimbursement and other healthcare reforms.

Table 4
Global Market for Transcatheter Treatment Devices, by Region, Through 2023
($ Millions)
CAGR%
Region 2017 2018 2023
2018-2023
U.S. 2,064 2,313 4,750 15.5
Europe 1,071 1,291 2,478 13.9
Asia 172 214 460 16.5
ROW 147 168 272 10.1
Total 3,454 3,986 7,960 14.8
Figure 4
Global Market for Transcatheter Treatment Devices, by Region, 2017–2023
($ Millions)
5,000
4,500
4,000
3,500
3,000
$ Millions
2,500
2,000
1,500
1,000
500
0
2017 2018 2023
U.S. Europe Asia ROW
In 2017, Europe, Asia and ROW (Rest of the World) had shares of about 31%, 5% and 4% of the global
market, or $1.1 billion, $172 million and $147 million, respectively. The Europe, Asia and ROW markets
should approach $1.3 billion, $214 million and $168 million in 2018 and are predicted to reach $2.5
billion, $460 million and $272 million by 2023, increasing at CAGRs of 13.9%, 16.5% and 10.1% from
2018 through 2023, respectively.
Europe is the second largest market after the U.S. and there are many established and early-stage
companies that are working to enter the European TAVR market by developing improved transcatheter

heart valve devices. Although a few products are already approved and available in the market, new
features and more advanced technologies are expected to further expand the eligible patient
population.
The Asian market for transcatheter treatments devices is expected to witness the highest growth during
the next five years for various reasons: a growing aging (> 60 years) population, increasing availability
and affordability of treatment, increasing acceptance of transcatheter procedures, and advanced
technology-enabled products and solutions. Japan is an established market in Asia, while China and India
are emerging markets and growing rapidly.
With regard to the European transcatheter treatments devices market, it is growing mainly due to
improved healthcare infrastructure, increasing prevalence of heart diseases, improving diagnosis rates,
and a growing demand for minimally invasive and catheter-based treatment options.
In 2017, approximately 116,360 procedures were performed globally, including both transcatheter
aortic and mitral valve repair procedures such as TAVR/TAVI and TMVR. Transcatheter aortic procedures
(TAVR and TAVI) accounted for the largest share with 102,560 procedures (88% of all transcatheter
procedures), followed by transcatheter mitral valve repair with 13,800 procedures (12% of all
transcatheter procedures).
In the last decade, several new and improved devices have been developed and introduced to the
market for the treatment of simple to complex valvular pathologies. Transcatheter heart valve
implantation is a procedure with a less invasive approach that helps in replacing the heart valve with a
prosthetic valve for treatment of severe aortic stenosis and mitral regurgitation. It is the effective
alternative to open-heart surgery, especially for high-risk patients.
Transcatheter treatment offers a shorter procedure, better results, and fast recovery compared to open
surgery. The procedure helps reduce severe degenerative aortic stenosis and increases the survival rate
of patients. The increasing number of percutaneous transcatheter prosthetic valve implantations
worldwide is expected to drive demand for transcatheter heart valve devices, as the risk of valvular
heart disease is higher among the geriatric population, owing to increasing prevalence of severe aortic
stenosis and asymptomatic severe mitral regurgitation. The market has witnessed the treatment shifting
from open surgical repair to transcatheter repair due to various advantages of transcatheter procedures
over open surgical repair.
There is an increasing acceptance of transcatheter procedures worldwide, as they offer more comfort to
high-risk patients such as the elderly and have several advantages in terms of operative risk and patient
recovery time compared to open surgical repair. However, high costs of transcatheter heart valves,
reimbursement issues, lack of awareness about valvular disease, stringent regulatory approval
procedures, lack of healthcare infrastructure in the developing world, long-term durability of heart
valves, the need for lifelong surveillance of artificial valves, risk associated with procedures and certain
devices (e.g., device recalls), malpositioning during implantation, and other complications associated
with transcatheter procedures are significant barriers to market growth and may restrict growth in
future years.

Structural Heart Disease
Structural heart disease is a common condition involving abnormalities or defects pertaining to heart
structure. Defects can occur in heart valves, heart muscles, or heart walls during fetus development or
at a later stage of life. The term structural heart disease was first used by Martin Leon in 1999 during a
Transcatheter Cardiovascular Therapeutics meeting. The term covers a wide spectrum of diseases,
categorized as congenital (birth disorder) or acquired in terms of origin. In most cases, valvular heart
disease is acquired and becomes severe over time. Aged patients (65 and above) are at higher risk for
this type of heart disorder.
Table 5
Scope of Structural Heart Diseases
Structural Heart Diseases Defect Type

Atrial septal defect (ASD) Congenital heart defect
Patent foramen ovale (PFO) Congenital heart defect
Ventricular septal defects (VSD) Congenital heart defect
Patent ductus arteriosus (PDA) Congenital heart defect/fetal structure defect
Left atrial appendage (LAA) Non-valvular atrial fibrillation
Left ventricular aneurysm (LVA) Aneurysmal disease
Paravalvular leak (PVL) Post-surgery (valve replacement) complication
Ventricular septal rupture (VSR) Post-surgery (valve replacement) complication
Hypertrophic obstructive cardiomyopathy (HOCM) Myocardial hypertrophy
Aortic stenosis Valvular heart disease (aortic valve disease)
Mitral stenosis Valvular heart disease (mitral valve disease)
Mitral regurgitation Valvular heart disease (mitral valve disease)
Symptoms and Risk Factors of Structural Heart Disease

Symptoms of structural heart and valve disease depend on the complexity and stage of the disease.
People do not experience any major symptoms at mild stages, but symptoms become noticeable as
soon as the disease approaches moderate or severe stages. Damage in valve leaflets leads to narrowing
of the aortic valve opening and makes the heart muscles weaker than normal. Some of the common
disease symptoms within adults or aged populations may include noticeable heartbeats, fatigue,
breathlessness, and chest pain during routine activities. Other symptoms include weight gain, swelling of
the feet, or hand and heart murmur. Heart murmur may lead to several other cardiac symptoms such as
dyspnea, edema, dizziness, and arrhythmia. Children with congenital defect also show similar
symptoms; however, weight loss or failure to gain weight at an early age and inadequate feeding are the
other symptoms specific to this patient group.
Valvular disease can be a birth defect, or it can be caused by aging, infection, or other cardiac diseases.
Age-related stenosis or regurgitation usually occurs after the age of 60, but significant observable
symptoms present themselves only after the age of 70 or 80. A large number of people are unaware or
undiagnosed with valvular disease and are diagnosed only when they go for a checkup following heart

murmur symptoms. Symptoms are not always related to the seriousness of the valve disease; however,
they can be a trigger to take necessary steps before the disease becomes severe. Early diagnosis and
treatment can help to control or reverse the progression of this disease.
Causes of Structural Heart Disease

As discussed in an earlier section, heart valve disease can develop before birth or it can be acquired
sometime over a person’s lifetime as a result of other diseases. Calcium buildup on the valve leaflets,
valve deformation, valve tissue degeneration, bacterial endocarditis, high blood pressure, heart attack,
and rheumatic fever are some of the common causes of valvular disease. However, in some cases it is
difficult to find out the cause of valvular disease. Other causes of valvular disease include coronary
artery disease, heart muscle disease or cardiomyopathy, syphilis, hypertension, aortic aneurysms, and
other connective tissue diseases. Development of tumors and associated treatment involving drugs and
radiation also may cause valvular disease; however, these are less common causes.
Diagnosis of Structural Heart Disease

Structural heart disease can be diagnosed by a physical examination followed by diagnostic imaging and
other tests, depending on symptoms. During a physical exam, doctors try to hear heart sounds,
especially those of the valve opening and closing. A heart murmur, swishing sound, or irregular beats
confirm the possibility of a stenotic or leaky valve. Doctors also try to listen around the lungs to ensure
that the lungs are retaining enough fluid, which confirms if the heart is able to pump sufficient blood or
not. The physical exam also helps doctors gain more insight about proper circulation and the functioning
of other vital organs. Apart from physical examinations, doctors also ask patients to undergo one or
more of the following tests to confirm the disease stage and to make decisions about treatment:
• Cardiac catheterization.
• Chest X-ray.
• Echocardiogram.
• Electrocardiogram.
• Stress test.
• Echocardiography.
• Transesophageal echocardiography.
• Cardiac catheterization or angiogram.
• Radionuclide scans.
• Magnetic resonance imaging.
Treatment of Structural Heart Disease

Treatment for structural heart valve disease depends on the type and severity of the disease. The
disease affects both children and the aged population, and it demands proper management and
treatment so that it can be managed or treated in time. Management of disease includes protecting the
valve from further damage (using medicine and precautions), controlling symptoms, and repairing or
replacing valves (through surgery) when the disease becomes severe.

Table 6
Structural Heart Disease, Management Through Medication
Type of Medication Key Objective

Remove extra fluid from the tissues and bloodstream; minimize and control the
Diuretics
symptoms of heart failure.
Antiarrhythmics These medications are intended to control the heart's rhythm.
Prescribed to minimize the workload of the heart by pushing the blood to flow in a
Vasodilators
forward, instead of backward, direction through a leaky or porous valve.
ACE inhibitors Vasodilators intended to treat high blood pressure and heart failure.
Very commonly prescribed medicine type to treat high blood pressure, lessen
Beta blockers palpitations, and minimize the workload of the heart by helping the heart to beat
slower and less forcefully.
Blood thinners intended to prolong the clotting time of blood for individuals at risk
Anticoagulants
for developing blood clots of the heart valve.
Surgical Intervention: Heart Valve Repair and Replacement

Each type of heart valve has its own specific problems and treatments. However, surgery and other
alternate procedures are explored when the disease becomes severe or when medications fail to control
symptoms. Stenosis and regurgitation are the common problems associated with the aortic and mitral
valves. Problems with regurgitation and stenosis can also involve the tricuspid valve, which controls
blood flow between the right atrium and the right ventricle. Proper diagnosis is required to identify the
location, type and extent of the valvular disease before planning for nonsurgical or surgical treatment.
Aortic valves are mostly replaced rather than repaired. However, problems with other valves can be
repaired with surgical procedures.
Table 7
Structural Heart Valve Disease Treatment Through Surgical Intervention
Type of Surgery Key Objective

Gold standard open or minimally invasive surgical procedure option for the
Traditional heart surgery repair or replacement of heart valves in patients with a low risk of having
surgical complications.
Transcatheter aortic valve Transcatheter procedure to treat low-, intermediate- and high-risk patients
repair/replacement (TAVR) suffering from aortic stenosis.
Transcatheter mitral valve Transcatheter procedure to treat high-risk patients with mitral valve
replacement (TMVR) disorders.
Transcatheter aortic valve Transcatheter procedure to replace a diseased valve with a new valve in
implantation (TAVI) high-risk patients suffering from aortic stenosis.
Transcatheter mitral valve Transcatheter procedure to replace a diseased valve with a new valve in
implantation (TMVI) high-risk patients suffering from mitral disease.
Transcatheter mitral valve repair Transcatheter procedure to treat patients with mitral regurgitation or leaky
(MitraClip) heart valves using FDA-approved MitraClip device.

Type of Surgery Key Objective
Percutaneous paravalvular leak Minimally invasive surgical technique intended to repair a leaky valve that
closure (aortic, mitral) occurs following valvular interventions.
Percutaneous left atrial appendage Minimally invasive surgical technique to close the left atrial appendage using
closure an FDA-approved Watchman device.
Alcohol septal ablation Technique to treat patients with hypertrophic cardiomyopathy
Indicated to widen heart valves with valvular stenosis through inserting a
Balloon valvuloplasty
balloon catheter (inflated) to open up the valves.
Advanced minimally invasive surgical procedure to close the valvular defect
Closure procedures for congenital
for various congenital conditions such as atrial septal defect (ASD),
heart defects
ventricular septal defect (VSD), and patent foramen ovale.
There are more than 100,000 heart valve procedures performed each year in the U.S. Most of these
procedures target mitral or aortic valves. Although heart valve repair is preferred over the replacement
method, certain patients fail to meet the eligibility criteria. Diagnostic test results, structure of the heart,
age, and other lifestyle-related details help cardiologists to decide the best suitable treatment for
the disease.
Aortic Valve Disease

Aortic valve disease includes aortic stenosis and aortic regurgitation. Aortic stenosis is known as
abnormal narrowing of the aortic heart valve opening and is considered as one of the most common and
most serious heart valve problems. Aortic stenosis obstructs the blood flow from the left ventricle to the
ascending aorta and results in irregular pressure in the left atrium of the heart. It is considered as one of
the most common progressive valvular heart diseases diagnosed in the aged population worldwide and
results in poor health outcomes if left untreated.
Management of aortic stenosis depends on the symptoms and severity of the disease. A large group of
patients do not show any outward symptom unless the disease progresses from the mild to moderate
stage. Physicians advise regular monitoring and follow-up when there are no symptoms or when
symptoms are mild; however, surgery is prescribed when the disease becomes severe due to restricted
blood flow. Severe symptomatic aortic stenosis is the most common valvular heart disease in the aged
population, and it may lead to poor health outcomes if left untreated.

Table 8
Types of Aortic Valve and Repair Techniques
Repair
Valve Type Indication Criteria Advantages Limitations
Technique
Gold standard procedure
Aortic stenosis patients Invasive technique,
Surgical with an established track
-- with low to high surgical not suitable for all
repair record of safety, efficacy
risk ages
and durability
Severe aortic stenosis
Surgical patients with good Does not require Limited long-term
Tissue valve
repair anticoagulation unlikely (> anticoagulation therapy durability
65 years of age)
Increased risk of
Severe aortic stenosis bleeding, patients
Surgical Mechanical
patients on Long-term durability need lifetime
repair valve
anticoagulation therapy anticoagulation
therapy
Minimally invasive
Unknown long-term
Transcathe Transcatheter Very severe aortic stenosis technique, suitable for all
durability, risk of
ter repair valve or prohibitive surgical risk ages and disease
paravalvular leaks
complexity
Mitral Valve Disease

Mitral valve disease includes mitral stenosis and mitral regurgitation. Mitral valve stenosis occurs when
the mitral valve narrows and results in restricted blood flow into the main pumping chamber of the
heart. The mitral valve directs blood flow from the left atrium into the left ventricle. The left atrium and
ventricle are also integrally involved with mitral valve function while pumping the blood. Mitral
regurgitation is the most common type of heart valve disorder and occurs due to abnormalities of any
part of the mitral valve including valve leaflets, annulus, chordae tendineae, and papillary muscles. It
affects the natural functioning of the mitral valve and does not allow the mitral valve to close properly,
which results in backward blood flow from the left ventricle into the left atrium.
Management of mitral valve disease depends on the symptoms and severity of the disease. A large
group of patients do not show any outward symptoms unless the disease progresses from the mild to
moderate stage. Although patients with chronic mitral regurgitation can remain asymptomatic for many
years, regular clinical monitoring and noninvasive tests are necessary to monitor disease progression.
Physicians advise regular monitoring and follow-up when there are no symptoms or when symptoms are
mild; however, surgery is prescribed when the disease becomes severe.

Table 9
Types of Mitral Valve Repair
Type of Repair Technique

Edge-to-edge repair A clip (e.g., MitraClip) applied through femoral vein
Indirect annuloplasty Nitinol wire placed in the coronary sinus
Direct annuloplasty Anchors placed in the posterior annulus
Chordal repair Device (e.g., NeoChord) applied through transapical approach
Valve spacer Balloon device (e.g., Mitra-Spacer) placed in the mitral valve
Chamber remodeling Silicone band placed externally
Growth in the global heart valve replacement market will continue to be affected by global
demographics such as the growth of the aging populations in developed nations. The heart valve repair
and replacement market has undergone changes in the past several years, and it is expected to continue
changing through the forecast period as the availability of minimally invasive heart valve techniques
(especially transcatheter valve replacement and repair technologies) significantly reduces the risks and
costs associated with heart valve procedures. Additionally, innovations such as collapsible valves,
innovative annuloplasty valve repair technologies, and anti-calcification treatments are among the key
developments that will influence the market.
Although both heart valve repair and replacement are growing segments, one factor that will negatively
affect the replacement market for traditional heart valves is the growing adoption of minimally invasive
technologies for valve repair and replacement, most notably transcatheter valve repair. The demand for
valve replacement will also be affected by innovations such as new annuloplasty valve repair
technologies and anti-calcification treatments.
Competitive Landscape
The global market for transcatheter treatment devices (TAVR/TAVI and TMVR/TMVI) is a highly
specialized market that has been dominated for many years by Edwards Lifesciences, Medtronic, and
Abbott Laboratories, with the three companies having a combined market share of about 98%. In 2017,
Edwards Lifesciences led the global transcatheter treatment devices market with a 55% share, followed
by Medtronic and Abbott Laboratories, with 29% and 14% shares, respectively.
All of the market leaders have focused on merger and acquisition (M&A) activities and have
strengthened their market position through acquisitions, minority investments, and financing activities
to be in the position to buy targeted early-stage companies. Abbott Laboratories is a new entrant to the
market after acquiring St. Jude, which was a growing company in the transcatheter treatment devices
market and helped Abbott to establish its strong footprint in this market. Acquisition of St. Jude Medical
by Abbott is known as one of the major acquisitions in the cardiovascular segment. Edwards Lifesciences
and Medtronic have also made a few acquisitions to retain their leadership position in the market.

Table 10
Global Market for Transcatheter Treatment Devices, by Leading Company, 2017
($ Millions/%)
Revenue Share
Company
($ Millions) (%)
Edwards Lifesciences 1,900 55
Medtronic 1,002 29
Abbott Laboratories 484 14
Others* 68 2
Total 3,454 100
Note: *Others include Boston Scientific, JenaValve Technology Inc., Transcatheter Technologies GmbH, Neovasc
Inc., BIOTRONIK, Bracco SpA, Braile Biomédica, Colibri Heart Valve LLC, Hansen Medical Inc., Advanced
Bioprosthetic Surface Ltd., New Valve Technology AG, Thubrikar Aortic Valve Inc., Vascular Innovations Co. Ltd.,
ValveXchange Inc., LivaNova PLC, Cephea Valve Technologies Inc., Gorman Cardiovascular Research Group, HT
Consultant, Micro Interventional Devices Inc., MitraGen Inc., Mitral Heal Ltd., and Mitralix Ltd.
Figure 5
Global Market Share for Transcatheter Treatment Devices, by Leading Company,
2017
(%)
Others*
Abbott Laboratories 2%
14%
Edwards Lifesciences
55%
Medtronic
29%
Note: *Others include Boston Scientific, JenaValve Technology Inc., Transcatheter Technologies GmbH, Neovasc
Inc., BIOTRONIK, Bracco SpA, Braile Biomédica, Colibri Heart Valve LLC, Hansen Medical Inc., Advanced
Bioprosthetic Surface Ltd., New Valve Technology AG, Thubrikar Aortic Valve Inc., Vascular Innovations Co. Ltd.,
ValveXchange Inc., LivaNova PLC, Cephea Valve Technologies Inc., Gorman Cardiovascular Research Group, HT
Consultant, Micro Interventional Devices Inc., MitraGen Inc., Mitral Heal Ltd., and Mitralix Ltd.

Pricing and Reimbursement
Pricing and reimbursement are two sides of the medical device sector and define the current and future
market growth opportunities in every country worldwide. High product/service pricing and poor
reimbursement lead to slow market acceptance, while positive reimbursement fuels market growth and
encourages fast market penetration especially for transcatheter and other interventional devices. The
reimbursement system in the U.S. is based on a mixed public and private third-party payment system,
while reimbursement systems vary significantly in countries other than the U.S. and are not limited to
government-sponsored healthcare insurance providers. Private health insurance plans are among the
top providers of reimbursement in many countries. A few countries operate a kind of list system
(positive and/or negative) and allow companies to market products at agreed-upon reimbursed prices.
Transcatheter aortic valve procedures (e.g., TAVR/TAVI) are currently reimbursed in the U.S. for all types
of aortic stenosis with simple to complex pathologies. However, some payers may deny reimbursement
if they conclude that the treatment given was unnecessary or that the device used was not cost-
effective or was used for a non-approved indication. Diagnosis-related group (DRG) codes such as 266 or
267 (listed in the table below) and International Classification of Diseases–Ninth Revision (ICD-9)
procedure codes such as 35.05 are commonly used for the billing and reimbursement of transcatheter
procedures at hospitals.
Each country in the EU has its own authority, and companies are required to submit specific pricing and
reimbursement dossiers to the relevant competent authorities in each country. Although the EU has
some common guidelines, pricing and reimbursement decisions are independent and vary from country
to country. The authorities use health technology assessment (HTA) guidelines to decide which products
are formally approved for use in a procedure, ensuring that only those medical devices that are shown
to be clinically and economically effective are reimbursed. However, the decision concerning which
medical device will qualify for reimbursement (and often also what price will be paid) by the
government or the patient’s health insurance provider is driven by local government healthcare policy.
As such, there can be considerable variation in the medical device reimbursement approval process and
data requirements from country to country. Additionally, the processes can be subject to regulatory
changes, as countries reform their respective healthcare systems and budgets in line with their
current policies.
Future Outlook
Continuous technological advancements with respect to transcatheter valve repair and replacement are
expected to reduce the invasiveness of existing procedures and further expand the patient population
for whom surgery is a realistic option. Companies are also focused on developing more advanced
ultralow-profile devices to improve proximal and distal placement accuracy, along with offering better
customization options for surgeons. These advancements will be focused both valve graft systems and
the types of surgery used to place the artificial heart valve. The medical device technology market is
being shaped by worldwide demographic and economic trends, and access to modern medicine is
directly correlated with income trends. At present, the developing markets outside of North America,
Europe, and Japan account for a relatively small share of medical technology, but in the long term, as
their income levels rise, these emerging markets should become increasingly important outlets for new
and advanced medical technologies.

Chapter 4
Medical Imaging Instrumentation:

Global Market and Technologies
Through 2022 (HLC189A)

Chapter 4: Medical Imaging
Instrumentation: Global Market and
Technologies Through 2022 (HLC189A)
Introduction
The goals and objectives of this report are to:
• Determine segments and key market structures in global medical imaging instruments market
and assessment of the factors that impact the market growth.
• Identify key market players, product portfolios, recent developments and application areas.
• Identify various strategies adopted by market players to enhance their market position,
including expansion, product launch, acquisition and merger, innovation, partnership and joint
venture.
• Assess and analyze the market trends, drivers, restraints, opportunities and influencers and
their impact on market revenue and growth (2017-2022).
• Provide analysis for each of the market segments based on the product type (X-ray systems,
magnetic resource imaging equipment/instruments, computed tomography (CT) scanners,
ultrasound systems and nuclear imaging equipment/instruments), technology and application
segments of each product type, and end user (hospitals, diagnostic centers and research
centers), regional and country level analysis.
• Study challenges that need to be addressed in global medical imaging instruments market to
achieve fiscal success.
• Present a conclusion from the study conducted through intensive primary and secondary
research.
Medical imaging instruments refer to the equipment and devices that are used for early detection and
diagnosis of disease for its effective treatment. These devices include magnetic resonance imaging
systems, X-ray systems, ultrasound devices, nuclear imaging and computed tomography. These
instruments are widely adopted across various end-users including hospitals, diagnostic centers and
research centers.

Due to the prevalence of chronic diseases coupled with an increasing geriatric population, the need for
proper imaging of body parts has expanded. Manufacturers have launched several innovative products
that tend to provide the images at higher resolution and increased efficiency. Some of the innovations
include 3D medical imaging equipment, magneto-acoustic technology, etc. Also, integration of computer
processing and digital data collection techniques into the medical devices and integration of 4K UHD
(ultra-high-definition) along with touch screen integration into the display systems have been a
significant innovation in the imaging industry. The existing techniques along with the innovations
regarding medical imaging instruments are discussed throughout this report.

The imaging technologies including X-ray systems, magnetic resonance imaging equipment/instruments,
CT scanners, ultrasound systems and nuclear imaging equipment are studied based on various grounds
such as type of disease on which the device is used, versatility, interoperability and others. The report
also tries to showcase the innovations in imaging industry including mammography and 3D Ultrasonic
holography.
Scope of Report
The scope of this report is broad and covers various types of products available in the medical imaging
instruments market and potential application sectors across various industries. The medical imaging
instruments market is broken down into product types such as X-ray systems, ultrasound devices, MRI,
computed tomography and nuclear imaging. Revenue forecasts from 2017 to 2022 are given for each
product type, technologies, application and end users with estimated valued derived from the revenue
of manufacturers’ total revenues.
The report also includes a discussion of the major players across each regional medical imaging
instrument market. It explains the major drivers and regional dynamics of the global medical imaging
instruments market and current trends within the industry.
The report concludes with a special focus on the vendor landscape and includes detailed profiles of the
major vendors in the global medical imaging instruments market.
Methodology
A bottom-up approach was used to estimate the size of the global medical imaging instruments market
that was further verified with the revenue figures obtained by a top-down approach. The research
methodology used to calculate market size also includes the following details:
• Market revenues of key players were determined through primary and secondary research,
including a study of annual reports of top market players, and interviews with key opinion
leaders such as chief executive officers and directors.
• Secondary research included general search by keywords through paid and unpaid sources, such
as Factiva and One Source, and other government websites, publicly available websites and
company websites.
• The penetration percentage and forecast of micro markets were established through primary
and secondary sources and were validated through primary sources.
In this report, the geographic regions considered for market analysis include, and only include:
North America
• United States.
• Mexico.
• Canada.

Europe
• United Kingdom.
• France.
• Germany.
• Spain.
• Italy.
• Rest of Europe.
Asia-Pacific
• China.
• India.
• Japan.
• Australia.
• South Korea.
Rest of the World

• Latin America.
• Middle East and North Africa.
Bhavna Joshi has more than 10 years of experience in healthcare and biotechnology research. In
addition to business research and consulting, she has conducted corporate briefings for top players in a
wide range of market segments. She holds an MBA in the marketing and finance from Chennai
University and has worked with major market research firms.
Bhavna Joshi has authored several market research studies on subjects in the healthcare domain,
including:
• Healthcare tracking technologies.

• Molecular diagnostics market.
• High-growth markets in healthcare and life sciences.
• Adoption rates and analysis of over-the-counter (OTC) diabetic medicines and supplements.
• Radio frequency identification (RFID), real-time locating systems (RTLS), internet protocol (IP)
surveillance, and other emerging technologies in the healthcare domain.

• HLC040E Biologic and Medical Imaging Reagents: Global Markets.
• HLC215A Dental Imaging Systems: Global Markets to 2023.
• HLC078D Medical Magnetic Resonance Imaging (MRI): Technologies and Global Markets.
• HLC093D Endoscopy Devices: Applications and Global Markets.
• HLC173B Ophthalmic Devices: Technologies and Global Markets.

Report Summary
Medical imaging technologies are used for diagnosis and monitoring of medical problems in humans.
These technologies are constantly evolving into newer and better products that provide additional and
in-depth data, resulting in less cost and better clinical outcomes. These technological advancements
have introduced novel and superior X-ray systems for different applications, such as the detection of
tumor outgrowths, breast cancer, and many other chronic diseases. The demand for innovative systems
is rapidly expanding for early detection of diseases and to ensure efficient treatment and/or
management of the disease.
Companies are focusing on the continuous development of products that support novel imaging
technologies such as colored and 3D imaging due to their rising demand. Surging investments on
technological advancements for increasing resolution and pixel capabilities, wider disease detection
capabilities and more advanced software can be observed in the market.
The imaging technologies are used across various end users including hospitals, diagnostic centers and
research centers. In hospitals, the imaging instruments are used for imaging body parts in cases of
chronic diseases or accidents. In diagnostic centers, the imaging instruments are widely adopted for
diagnosing a particular body part or the whole body. The imaging instruments are used for molecular
imaging in the research centers for drug discovery purposes.
The global medical imaging instruments market is projected to rise during the forecast period of 2017-
2022, and by 2022, total revenue is expected to reach nearly $42.1 billion.
Table 11
Global Market for Medical Imaging Equipment/Instruments, by Product Type,
Through 2022
($ Millions)
CAGR%
Product Type 2016 2017 2022
2017-2022
X-ray equipment/instruments 11,533 11,997 15,437 5.2
Ultrasound equipment/instruments 6,345 6,604 8,510 5.2
MRI equipment/instruments 5,357 5,568 7,129 5.1
CT scanners 4,662 4,861 6,321 5.4
Nuclear imaging equipment/instruments 3,392 3,548 4,689 5.7
Total 31,289 32,578 42,086 5.3

Figure 6
Global Market for Medical Imaging Equipment/Instruments, by Product Type,
2016–2022
($ Millions)
18,000
16,000
14,000
12,000
$ Millions
10,000
8,000
6,000
4,000
2,000
0
2016 2017 2022
X-ray equipment/instruments Ultrasound equipment/instruments
MRI equipment/instruments CT scanners
Nuclear imaging equipment/instruments
Five major categories of imaging devices analyzed in this report are:
X-ray systems
• Stationary.
• Floor to ceiling mounted systems.
• Ceiling mounted systems.
• Portable.
• Mobile X-ray systems.
• Handheld X-ray systems.
MRI equipment/instruments
• Closed.
• Open.
Computed Tomography (CT) scanners

• Stationary.
• Mobile.
Ultrasound systems
• Cart/trolley-based ultrasound system.
• Compact/portable ultrasound system.

Nuclear imaging equipment/instruments
• SPECT scanner.
• Hybrid SPECT systems.
• Standalone SPECT systems.
• Hybrid PET.
• Planar scintigraphy.
X-ray systems dominated the global medical imaging instruments market in 2016, with total revenue of
about $11.5 billion. The dominance of X-ray systems is justified by increasing chronic diseases coupled
with a surging number of accidents. Nuclear imaging instruments are the fastest-growing segment. Due
to the prevalence of chronic diseases such as cancers, cardiovascular diseases and others, the demand
for nuclear imaging instruments has surged as these imaging instruments are adopted in diagnosis of
these diseases.
North America dominated the market for global medical imaging instruments in 2016; the dominance is
justified by a well-established medical device industry coupled with increasing healthcare expenditure.
Asia-Pacific is the fastest-growing market, and the growth is attributed to investments in medical
imaging instruments coupled with high projections of chronic diseases and geriatric population.
BCC Research forecasts some of the trends in the medical imaging instruments market that would boost
the market revenue through 2022. Following are some of the trends in the medical imaging industry:
• Evolution of innovative imaging modalities such as mammography and 3Dultrasonic holography.

• Commencement of mobile and IoT (Internet of Things) in the medical imaging industry.
• Big data and analytics tools in imaging workflows.
• Cloud computing and platforms.
• Interoperability within imaging instruments.
There are a few challenges that could hamper the medical imaging industry, which are addressed in the
following. These are some of the issues faced in radiology.
• Fragmented ecosystem and outdated equipment.

• Quality variance and lack of standardization.
• Radiation and contrast dose variance.
• Growing complexity and radiological education.
• Restrictive reimbursement.
X-ray Equipment/Instruments
X-ray machines produce X-ray radiation. This radiation is then used for medical diagnosis and
interventional purposes (e.g., catheter placement). Based on movement of equipment, X-ray device
technologies are segmented into portable and stationary. Stationary X-ray device technologies were the
first to be introduced into the market. X-ray machines are generally utilized in a variety of applications
including electronic assembly inspection, fluorescence, medicine and measurement of material
thickness in manufacturing operations.

The demand for medical imaging equipment is expected to increase as they improve and provide more
sophisticated, in-depth and real-time data. The demand for handheld X-ray systems has increased, and it
is now greater than for conventional X-ray systems, exclusively due to ease of use.
Table 12
Examples of Examinations and Procedures in Which X-ray Machines are Used to
Either Diagnose or Treat Disease
Examples of Examinations and

Description
Procedures
Diagnostic
It can detect bone fractures, pneumonia, certain tumors and other abnormal
X-ray radiography masses, various kinds of injuries, dental problems, calcifications, foreign
objects, etc.
Mammograms can detect tiny bits of calcium, called microcalcifications, that
show up as identical bright specks on a mammogram. Though generally
benign, microcalcifications may occasionally specify the occurrence of a
Mammography specific type of cancer. A radiograph of the breast is used for cancer detection
and diagnosis. Tumors tend to appear as regular or irregular-shaped masses
that are somewhat brighter than the background on the radiograph (i.e.,
whiter on a black background or blacker on a white background).
Fluoroscopy is used to view the movement of the beating heart, with the aid
of radiographic contrast agents, to view blood flow to the heart muscle as well
as through blood vessels and organs. It uses X-rays and fluorescent screen to
acquire real-time pictures of movement within the body or to interpret
Fluoroscopy diagnostic processes, such as following the path of an injected or swallowed
contrast agent. This technology, generally coupled with a radiographic
contrast agent to guide an inside threaded catheter during cardiac
angioplasty, is a slightly invasive process for opening clogged arteries that
supply blood to the heart.
CT images are more comprehensive than plain radiographs and provide
doctors greater detailed, cross-sectional views of all types of tissue within the
CT (computed tomography) body from many different angles. It deploys traditional X-ray technology with
computer processing to make a series of cross-sectional images of the body
that can later be combined to form a three-dimensional X-ray image.
Therapeutic
Therapeutic radiation can come from a machine outside of the body or from a
Radiation therapy in cancer radioactive material that is placed in the body, inside or near tumor cells, or
treatment injected into the bloodstream. The radiation dose used for treating cancer is
much higher than the radiation dose used for diagnostic imaging.
Source: National Institutes of Health
X-ray imaging exams are recognized as a valuable medical tool for a wide variety of examinations and
procedures. They are used for the following purposes:
• Painless and noninvasive diagnosis of disease and monitor therapy.

• Support surgical and medical treatment planning.

• Guide medical personnel as they insert catheters, stents or other devices inside the body, treat
tumor or remove blood clots or other blockages.
MRI Equipment/Instruments
MRI equipment is a diagnostic instrument for medical investigations. It is more sensitive as compared to
CT, and MRI does not use ionizing radiations. MRI is extensively used in the diagnosis of several diseases
including neurological, cancers and cardiac disorders. MRI is used to discover complications such as
bleeding, tumor, injury, blood vessel diseases or infection. MRI scanners generally use strong radio
waves, electric field gradients and magnetic fields to create pictures of the organs in the body.
MRI is the diagnostic instrument of choice for neurological cancers, as it has better resolution compared
to CT scan and delivers better imaging of the posterior fossa. MRI uses magnetic fields and radio waves
to create high-quality two- or three-dimensional pictures of brain structures without the use of
radioactive tracers or ionizing radiation (X-rays).
With the rising role of MRI in diagnosis of musculoskeletal conditions, clinicians have been willing to
discover the opportunity from using MR guidance for musculoskeletal procedures. Applications in the
musculoskeletal system comprise such as soft tissue tumors, assessment of joint disease and spinal
imaging. Hepatobiliary MRI is used to illustrate and detect lesions of the pancreas, liver and bile ducts.
MRI plays a progressively significant role for assessment of patients with chronic liver disease.
CT Scanners
A CT scanner is a diagnostic imaging equipment that uses a combination of X-rays and computer
technology to produce axial, or horizontal, images (often called slices) of the body. A CT scan displays
comprehensive pictures of any part of the body, including muscles, bones, fat and organs. CT scanners
are more comprehensive than standard X-rays. In computed tomography, an X-ray beam moves in a
circle around the body. This enables various diverse views of the same organ or structure and offers
much superior detail than other technologies.
Ultrasound Equipment/Instruments
Medical ultrasound (also called ultrasonography or diagnostic sonography) is a diagnostic imaging
technique based on the application of ultrasound. Ultrasound systems are used to perform medical
ultrasound for diagnosis of internal body structures such as blood vessels, muscles, tendons, joints and
other internal organs. Ultrasound systems are being widely used in a variety of clinical settings including
obstetrics and gynecology, cardiology and urology. The major advantage of ultrasound over other
imaging procedures is that this procedure does not involve the use of radiation; therefore, it is the
preferred method of imaging of a developing fetus during pregnancy. Ultrasound can be performed
faster than X-rays and other radiographic imaging techniques.

Nuclear Imaging Equipment/Instruments
Nuclear medicine imaging procedures are noninvasive with the exception of intravenous injections. The
imaging procedures are usually painless and are used to diagnose and evaluate a variety of medical
conditions such as cancer, coronary heart disease (CHD), bone tumors, and Alzheimer’s disease. These
imaging scans involve the use of radioactive materials known as radiotracers or radiopharmaceuticals.
The market for medical imaging systems is highly competitive, and thus manufacturers make heavy R&D
investments to support the process of new product development and to ensure sustainability. In
addition, these market players constantly endeavor to invent new products in congruence with changing
buyer preferences and demand.
Developing cost-effective retrofit kits, handheld and mobile devices, and digital radiography systems
capable of conducting diagnostic examinations of soft tissues are some of the imperative attributes
taken into consideration by market players. In January 2018, Philips Healthcare introduced its new line
of AI-powered imaging devices Dura Diagnostic F30 Digital X-ray, Ingenia Prodiva 1.5T MRI, and Access
CT 32 Slice, specifically developed to help radiologists diagnose faster and more accurately, with the
added benefit of lower ownership costs and better patient experience. In March 2018, Shimadzu Corp.
introduced its new MobileDaRt Evolution MX8 version digital mobile X-ray system, which features a
lockable Flat Panel Detector (FPD) housing compartment, a large completely flat monitor screen,
improved operability and an extensive selection of options designed to provide multifaceted support.
Major drivers of the global MRI equipment market include increasing healthcare expenditure and the
growing elderly global population base. New and advanced MRI equipment is being increasingly used in
diagnosis and treatment in many specialties although the effect on improved health outcomes is
uncertain. There is an increasing need for early diagnosis to ensure effective treatment and/or
management of disease, so the demand for advanced systems will continue to grow. The market for MRI
equipment/instruments is highly competitive, and thus manufacturers make heavy R&D investments to
support the process of new product development and to ensure sustainability. These market players
constantly endeavor to invent new products in congruence with changing buyer preferences and
demand.
Industry Structure
Raw Material Suppliers
Raw material suppliers are major strategic partners of medical imaging instrument manufacturers. Most
medical imaging instrument companies depend upon suppliers for components. Suppliers generally
make parts of medical imaging instrument such as display monitors, CPUs, printers, anode and cathode
electrodes, rectifiers, magnetic gradient coils, electromagnets and other electronic and body parts.

Table 13
Instrument and Their Raw Material/Parts
Medical Imaging Instrument Raw Material/Parts

Disk storage, Keyboard, display monitor, Piezoelectric (PZ) crystals, printer,
Ultrasound device
transducer pulse controls, other electronic parts.
Anode and cathode electrodes, rectifiers, tungsten filaments, X-ray collimator,
X-ray equipment/instruments vertical bucky stand, exposure switches, control panels, other electronic and
body parts.
Magnetic gradient coil, electromagnet, display screen, computer, RF detectors,
MRI instruments RF coils, amplifiers, data storage, ferromagnetic materials, RF Coils, RF
transmitter, other electronic and body parts.
Anode and cathode electrodes, rectifiers, tungsten filaments, detectors,
CT scanners computer system, collimators, filters, X-ray tube, other electronic and body
parts.
Scintillation crystals, photomultiplier tubes, low-noise amplifier, variable-gain
Nuclear imaging instruments
amplifier, detectors, computer system, collimators, other electronic and body
(SPECT scanner/hybrid PET)
parts.
Manufacturers
Manufacturers of medical imaging instruments can reduce the total exposure time of patients in
radiation and improve the image quality by using different technology, by adopting different
movements of detectors and by using different movements of X-ray tubes of CT scanners and keep the
cost very competitive. Cost has always been a challenging factor for manufacturers due to longer
approval processes, high expenses related to technology upgrades and research and development
activities. It is important to focus on both factors, reduction in total exposure time of patients and image
quality, equally at the same time.

Table 14
Medical Imaging Equipment/Instruments Manufacturers and Products
Medical Imaging
Manufacturers
Equipment/Instruments
Siemens Healthineers (Germany), GE Healthcare (U.K.), Philips Healthcare
X-ray equipment/instruments
(U.S.), Shimadzu Corp. (Japan), Varian Medical Systems (U.S.)
GE Healthcare (US), Siemens Healthineers (Germany), Hitachi (Japan), Philips
MRI instruments
(Netherlands), Canon Medical Systems (Japan), Bruker Corp. (U.S.)
Koninklijke Philips NV (Netherlands), Toshiba Corp. (Japan), GE Healthcare
CT scanners (U.S.), Samsung Electronics Co. Ltd. (South Korea), Shimadzu Corp. (Japan),
Hitachi Ltd. (Japan)
Koninklijke Philips NV (Netherlands), Toshiba Corp. (Japan), Siemens
Ultrasound devices Healthineers (Germany), GE Healthcare (U.S.), Shimadzu Corp. (Japan),
Samsung Electronics Co. Ltd. (South Korea)
GE Healthcare (U.S.), Koninklijke Philips NV (Netherlands), Shimadzu Corp.
PET/CT scan
(Japan), PerkinElmer Inc. (U.S.), Siemens Healthineers (Germany)
Nuclear imaging
Toshiba Corp. (Japan), GE Healthcare (U.S.), Siemens Healthineers (Germany),
SPECT scan
Bruker Corp. (U.S.), Mediso Medical Imaging Systems (Hungary)
Source: Company websites
Distributors
Distributors play an important role in the medical imaging instrument market and help the companies to
increase their market share, revenue, customer base and area served. For every company it is not
possible to open a separate and independent office or contact point in every country or city. Distributors
or national sales companies are chosen by looking into their sales track record and product portfolio.
Companies with medical device product portfolios and products related to relevant industries such as
medical imaging equipment and others are preferred by manufacturers. Distributors are point of contact
or representatives of manufacturers to end users and therefore they are selected based on:
• Quality assurance.
• Supply chain.
• Excellent past record.
• Contacts.
• Vast market approach.
End Users
Hospitals, diagnostic centers and research centers are the major end users of the global medical imaging
instrument market. Diagnostic centers are the main buyers of medical imaging instruments, used for
diagnosis of various types of diseases and health conditions. The demand for medical imaging
instruments in diagnostic centers is mainly driven by the rising prevalence of noncommunicable diseases
(NCDs) such as heart disease, cancer and stroke. Also, the rising number of accidents globally is
increasing the demand for X-rays, MRI systems and other imaging instruments in diagnostic centers and
hospitals.

Manufacturing Process of Medical Imaging Instrument
Figure 7
Manufacturing Process of Medical Imaging Equipment/Instruments
Production of
Procurement of raw Testing of procured
remaining parts/raw
materials/parts products
materials
Testing of Product Assembling
Procurement of Raw Materials/Parts

The process of procurement includes the steps of selection of the company/supplier for the order,
placing an order of raw materials/parts and receiving the order and storing. The selection of
company/supplier depends upon factors such as brand name in the market, history of the company,
price of the raw materials/parts offered, technology being used and delivery time. The manufacturer of
medical imaging devices tends to compare all these factors before selection of the supplier. The supplier
needs to offer competitive market prices and updated technology to attract more customers and
increase their market share. Brand name and price offered by the suppliers are the major factors
influencing the buying criteria of medical imaging instrument manufacturers.
Testing of Procured Products

Testing of procured products is performed to examine quality and functioning of the product. Testing of
the raw materials/parts helps in reducing the errors at the time of assembling and testing of the final
product.
Production of Remaining Parts/Raw Materials

In this step, parts are produced by manufacturers. Generally, medical imaging instrument manufacturers
prefer to produce some vital parts in their own factory. These parts are usually the core of medical
imaging instruments and complete functioning of the device depends on these parts. For instance, X-ray
tubes in play a vital role in X-ray systems.

Assembling
In this step, the assembling of all parts is performed for producing the complete instrument. Usually,
assembling is performed using robots and human manpower together, followed by the installation of
required software. Manufacturing companies also collaborate with other independent software
companies for their advanced software technology, which can offer more precise and in-depth image
facility. Overall time for complete assembling depends upon the size of the assembly line facility and
manpower present with the company.
Testing of the Product

Testing of the product is executed after the assembling of all the parts. Usually, testing is performed for
examining the image quality, measuring the radiation level, software algorithms and others.
Cost-Effective Components
Suppliers need to provide cost-effective products to the manufacturers. In the current scenario,
manufacturers require products/components that comply with government regulatory requirements,
especially FDA.
Suppliers need to work constantly on research and development of their products in terms of innovation
and quality to survive in the highly competitive market and deliver advanced and cost-effective products
to the manufacturers. For instance, in 2015, according to company sources, Power Photonic Ltd. (U.K.)
received about $2.7 million from Archangels and Scottish Investment Bank for new product
development and to perform research activities and increase manufacturing capabilities. In 2015,
according to company sources, Hamamatsu Photonics (Japan) completed expansion of its
photomultiplier tubes (PMT) production unit with an investment of $59.8 million. The company is
performing research activities to develop 20-inch PMT, the largest of its kind across the globe.

Patent Analysis
U.S. Patents
Table 15
U.S. Medical Imaging Equipment/Instruments Patents, 2016 Through June 2018
Patent No. Date Assignee/Inventors Patent Title

Biomarkers for differentiating
Metanomics Health GmbH between non-alcoholic
10001468 June 19, 2018 Universitätsklinikum Schleswig- steatohepatitis (NASH) and non-
Holstein alcoholic fatty liver disease
(NAFLD)
9999752 June 19, 2018 Acclarent Inc. Multi-conduit balloon catheter
D820445 June 12, 2018 Ultradent Products Inc. Cheek retractor device
Patch clamp technique with
International Business
9995686 June 12, 2018 complementary Raman
Machines Corp.
spectroscopy
Elongated surgical manipulator
9993617 June 12, 2018 Endosense SA with body position and distal force
sensing
9993278 June 12, 2018 Boston Scientific Scimed Inc. Co-access bipolar ablation probe
9991014 June 5, 2018 Gelbart Daniel Fast positionable X-ray filter
Assay for Trichomonas vaginalis by
amplification and detection of
9988692 June 5, 2018 Becton, Dickinson and Co.
Trichomonas vaginalis AP65-1
gene
Nanostars and nanoconstructs for
9987358 June 5, 2018 Duke University
detection, imaging and therapy
Cardinal Health Switzerland 515
9987156 June 5, 2018 Endoprothesis delivery system
GMBH
MRI with Dixon-type water/fat
separation and prior knowledge
9983284 May 29, 2018 Koninklijke Philips NV
about inhomogeneity of the main
magnetic field
The Trustees of the University
9983219 May 29, 2018 Biomarkers for seizures
of Pennsylvania
Gesture recognition for on-board
9977593 May 22, 2018 AutoConnect Holdings LLC
display
Cern—European Organization Portable radiation detection
9977134 May 22, 2018 for Nuclear Research device for operation in intense
Politecnico di Milano magnetic fields
9976188 May 22, 2018 Myriad Genetics Inc. Cancer biomarkers
Handheld medical-data capture-
device having variation
amplification and interoperation
9974438 May 22, 2018 Arc Devices Ltd.
with an electronic medical record
system on a specific segment of a
network

Image projector for a medical
D818127 May 15, 2018 Canon Medical Systems Corp.
device
Radiographic image capturing
9973988 May 15, 2018 Konica Minolta Inc.
system
The United States of America,
as Represented by the
Small molecule imaging of fungi by
Secretary; Department of
9968693 May 15, 2018 positron emission tomography
Health and Human Services;
scanning
The Research Foundation of the
State University of New York
Multi-detector imaging system
9968310 May 15, 2018 General Electric Co.
with X-ray detection
Magnetic resonance guidance of a
shaft to a target zone
MR image reconstruction using
compressed sensing
The Board of Trustees of the Arrays of accelerating structures
9962562 May 8, 2018 Leland Stanford Junior and rapid imaging for facilitating
University rapid radiation therapies
Erasmus University Medical Intravascular optical imaging
9962127 May 8, 2018
Center Rotterdam system
9962108 May 8, 2018 Given Imaging Ltd. Implantable monitoring probe
Devices, methods and systems of
9962075 May 8, 2018 Northwestern University functional optical coherence
tomography
Carotid body ablation with a
9955946 May 1, 2018 Cibiem Inc. transvenous ultrasound imaging
and ablation catheter
Magnetic resonance imaging
system using sub-volumes and
9958523 May 1, 2018 Samsung Electronics Co. Ltd.
magnetic resonance imaging
method using sub-volumes
Radiation imaging method and
9953463 April 24, 2018 Nucare Medical Systems Inc.
system
9950194 April 24, 2018 Mevion Medical Systems Inc Patient positioning system
Image-guided heart valve
9949831 April 24, 2018 Medtronic Inc.
placement
Fully integrated pinhole camera
9948895 April 17, 2018 Verily Life Sciences LLC
for eye-mountable imaging system
Biosensors International Group Radio imaging using low dose
9943274 April 17, 2018
Ltd. isotope
Respiration suppressing mat and
9927502 March 27, 2018 Toshiba Medical Systems Corp. magnetic resonance imaging
apparatus and method
Magnetic resonance imaging
9921279 March 20, 2018 Hitachi Ltd.
device
Targeted dual-axes confocal
The Regents of the University
9921406 March 20, 2018 imaging apparatus with vertical
of Michigan
scanning capabilities
9901484 Feb. 27, 2018 Katalyst Surgical LLC Steerable laser probe

University of Virginia Patent Interferometric techniques for
9811924 Nov. 7, 2017
Foundation magnetic resonance imaging
Motion tracking system for real
Kineticor Inc.; The University of
time adaptive motion
9782141 Oct. 10, 2017 Hawaii; The Queen’s Medical
compensation in biomedical
Center
imaging
Probe for ultrasonic diagnostic
9763643 Sept. 19, 2017 Samsung Electronics Co. Ltd.
apparatus
Hand-held optical probe-based
The Florida International
9709733 July 18, 2017 imaging system with 3D tracking
University Board of Trustees
facilities
MRI-guided interventional systems
that can track and generate
9439735 Sept. 13, 2016 MRI Interventions Inc.
dynamic visualizations of flexible
intrabody devices in near real time
Radio frequency identification tag
9361568 June 7, 2016 Tego Inc.
with hardened memory system
Source: freepatentsonline.com
European Patents
Table 16
European Patents and Patent Applications on Medical Imaging
Equipment/Instruments, 2015 Through June 2018

EP2939597 June 13, 2018 General Electric Co. X-ray imaging apparatus
EP1868505 June 13, 2018 Planmeca Oy Computer tomography apparatus
3D ultrasound system for intuitive
displaying of an abnormality of a
EP2444002 June 13, 2018 Samsung Medison Co. Ltd.
fetus and method for operating 3D
ultrasound system
Apparatus for obtaining trigger
EP3128923 June 13, 2018 Koninklijke Philips NV
signals from ultrasound systems
Automated classification technique
for Alzheimer’s disease using
Department of Biotechnology (IN);
EP2355703 May 30, 2018 magnetic resonance imaging signal
National Brain Research Centre (IN)
from ventricular zone contour of
brain
Medical imaging system, computer-
implemented method and computer
EP2630633 May 30, 2018 Koninklijke Philips NV
program product for identifying a
treated region in a medical image
Computed tomography apparatus for
EP2503941 May 23, 2018 Planmeca Oy
odontology

Koninklijke Philips NV; Philips Intellectual
EP2640270 May 16, 2018 PET-CT system with single detector
Property & Standards GmbH
Fraunhofer-gesellschaft V, Zur Förderung Computed tomography device and
EP3201612 May 9, 2018
der Angewandten Forschung use thereof
Consejo Superior de Investigaciones
Científicas (CSIC); Universidad de
Compact, hybrid and integrated
Valencia (UV); Universidad Politécnica de
gamma/RF system used to form
EP2383586 May 2, 2018 Valencia (UPV); General Equipment for
simultaneous PET or SPECT and MR
Medical Imaging SA; Exploraciones
images
Radiológicas Especiales SA (ERESA);
Bruker BioSpin AG
EP3142557 April 25, 2018 Koninklijke Philips NV Multi-focal spot imaging system
EP3105772 April 4, 2018 Luxbright AB An X-ray device
Efficient synthesis of chelators for
The Board of Regents of the University of
EP2079486 April 4, 2018 nuclear imaging and radiotherapy:
Texas System; CellPoint LLC
compositions and applications
March 21, Imaging-guided delivery of X-ray
EP2814573 Convergent R.N.R Ltd.
2018 radiation
March 7,
EP2749228 Esaote SPA Portable ultrasound system
2018
Guiding system for positioning a
EP3157435 Jan. 31, 2018 Koninklijke Philips NV
patient for medical imaging
Versatile superconducting magnet for
EP2972443 Jan. 17, 2018 Pourrahimi, Shahin extremities magnetic resonance
imaging
EP2614773 Jan. 3, 2018 Takara Telesystems Corp. X-ray tomogram imaging device
EP2979639 Nov. 29, 2017 General Electric Co. Mammography apparatus
Metal artifact reduction from metallic
Koninklijke Philips NV; Philips dental fillings and/or crowns in
EP2806801 Nov. 29, 2017
Deutschland GmbH (Hamburg, DE) computed tomography (CT) and/or X-
ray
X-ray emitting device with an
EP3094254 Nov. 15, 2017 Koninklijke Philips NV (Eindhoven, NL) attenuating element for an X-ray
imaging apparatus
EP2303128 Nov. 15, 2017 Planmeca Oy Dental care and imaging apparatus
EP3151750 Nov. 8, 2017 Koninklijke Philips NV Imaging system for a vertebral level
Computed tomography (CT) hybrid
EP3102109 Nov. 8, 2017 Koninklijke Philips NV
data acquisition
CT imaging apparatus with sparse
EP3161792 Oct. 25, 2017 Koninklijke Philips NV
angular sampling
EP2818114 Oct. 25, 2017 Yoshida Dental Mfg. Co. Ltd. X-ray imaging apparatus
Scivis wissenschaftliche Bildverarbeitung Phantom for a tomographic medical
EP2267484 Oct. 4, 2017
GmbH imaging apparatus
Koninklijke Philips NV; Philips Intellectual CT surrogate by auto-segmentation
EP2252204 Oct. 4, 2017
Property & Standards GmbH of magnetic resonance images
EP2151681 Aug. 30, 2017 CXR Ltd. X-ray tomography inspection systems
Scivis wissenschaftliche Bildverarbeitung Phantom for a tomographic medical
EP2267484 Aug. 9, 2017
GmbH imaging apparatus
High-resolution computed
EP3035038 July 19, 2017 Illinois Tool Works Inc.
tomography

X-ray generator, X-ray imaging
apparatus including the X-ray
EP2840871 May 10, 2017 Samsung Electronics Co. Ltd.
generator, and method of controlling
the X-ray generator
Ceiling mounted medical imaging
EP2777502 May 3, 2017 Dental Imaging Technologies Corp.
system
Calibrating ultrasound imaging
EP1774312 April 12, 2017 Elekta Ltd.
devices
Industry-University Cooperation
EP2241905 April 5, 2017 PET-MRI combination apparatus
Foundation Sogang University
March 29,
EP2255224 Rapiscan Systems Inc. Scanning systems
2017
Dynamic tomographic image
March 8,
EP2278921 Real-Time Tomography LLC reconstruction and rendering on-
2017
demand
Improved computed tomography
EP2219525 Jan. 4, 2017 BEARF LLC
breast imaging and biopsy system
Koninklijke Philips NV; Philips Intellectual X-ray imaging system with detector
EP2614507 Dec. 28, 2016
Property & Standards GmbH having pixels
Carestream Health Inc.; The Johns Extremity imaging apparatus for cone
EP2903523 Dec. 14, 2016
Hopkins University beam computed tomography
MRI surgical systems for real-time
EP2195676 Dec. 14, 2016 MRI Interventions Inc. visualizations using MRI image data
and predefined data of surgical tools
Carestream Health Inc.; Siewerdsen, Imaging apparatus for cone beam
EP2427111 Nov. 2, 2016
Jeffery H. computed tomography
Carestream Health Inc.; The Johns Extremity imaging apparatus for cone
EP2903522 Sept. 21, 2016
Hopkins University beam computed tomography
Ultrasound CT registration for
EP2723268 Sept. 14, 2016 Synthes GmbH
positioning
EP2210559 Sept. 7, 2016 J. Morita Manufacturing Corp. X-ray CT imaging device
Apparatus for anatomical and
EP1328189 Aug. 24, 2016 Crosetto, Dario B.
functional medical imaging
System for rapid quantitative
EP2713855 July 27, 2016 Bayer Medical Care Inc.
dynamic molecular imaging scans
Dark field computed tomography
EP2850595 April 6, 2016 Koninklijke Philips NV; Philips GmbH
imaging
EP2708188 April 6, 2016 Morpheus Co. Ltd. X-ray imaging apparatus
Cardiac imaging system for planning
EP1643911 April 6, 2016 General Electric Co.
surgery

Japanese Patents
Table 17
Japanese Patents and Patent Applications on Medical Imaging
Equipment/Instruments, 2015 Through May 2018

Radiation image capturing
JP2016208229A1 April 12, 2018 Konica Minolta Co. Ltd. (Tokyo) apparatus and radiation image
capturing system
JP2018509990A April 12, 2018 Koninklijke Philips NV Medical imaging equipment
JP2018509982A April 12, 2018 Koninklijke Philips NV Ultrasound imaging device
Medical diagnostic imaging
Educational Foundation Fujita
March 28, equipment, a medical image
JP6301102B2 School and Canon Medical Systems
2018 processing device and a medical
Corp.
image processing program
A medical processing unit,
JP2018027298A Feb. 22, 2018 Canon Medical Systems Corp. ultrasonic diagnostic equipment
and a medical processing program
A magnetic resonance imaging
JP2018015307A Feb. 1, 2018 Hitachi Ltd. system and a fixed-quantity value
calculation program
JP2018015262A Feb. 1, 2018 Kyoto University Optical sound imaging instrument
JP2018015144A Feb. 1, 2018 Toshiba Medical Systems Corp. Ultrasonic diagnostic equipment
Radiation image photographing
WO2016208154A1 Jan. 11, 2018 Fuji Photo Film Co. Ltd. (Tokyo)
instrument
A medical image processing
JP2018005841A Jan. 11, 2018 Topcon Corp. method and a medical image
processing device
An image display device and a
JP2018000403A Jan. 11, 2018 Konica Minolta Inc.
program
Nihon University, Medical An ultrasonic system for medical
JP2018000241A Jan. 11, 2018 Ultrasound Laboratory Co. Ltd., science and an ultrasonic device for
Teikyo University medical science
JP2017229057A Dec. 28, 2017 Panasonic IP Management Corp. Imaging device
An image processing device, an
image processing method, an
JP2017228975A Dec. 28, 2017 Sony Semiconductor Solutions Corp.
image sensor, an information
processor and a program
An image sensor and electronic
JP2017222885A Dec. 28, 2017 Sony Semiconductor Solutions Corp.
equipment
A piezoelectric element, an
JP2017228562A Dec. 28, 2017 Konica Minolta Inc. ultrasound probe and an ultrasonic
imaging apparatus
An image processing device, a
radiation photographing device, an
JP2017225871A Dec. 28, 2017 Canon Inc.
image processing method, a
computer program and a storage

JP2017225835A Dec. 28, 2017 Canon Inc. Image processing device
A medical image processing unit
JP2017225644A Dec. 28, 2017 Konica Minolta Inc. and a medical image photography
system
An ultrasonographic image display,
JP2017225645A Dec. 28, 2017 Honda Electronic Co. Ltd. a method and a recording medium
that stored a program
Image processing apparatus,
radiation image capturing system,
JP2017043106A1 Dec. 21, 2017 Fuji Photo Film Co. Ltd. (Tokyo)
image processing method and
image processing program
JP2017217474A Dec. 14, 2017 Toshiba Medical Systems Corp. equipment and a medical image
processing device
JP2017217479A Dec. 14, 2017 Toshiba Medical Systems Corp.
equipment
An imaging instrument for medical
JP2017209386A Nov. 30, 2017 Shimadzu Corp.
science
Image processing device and image
JP2017200613A Nov. 9, 2017 Canon Inc.
processing method
Future Outlook
Technological advancements, such as introduction of digital portable X-ray systems and the
implementation of picture archiving and communication systems (PACS), are expected to drive the
market. Due to the prevalence of chronic diseases coupled with the increasing geriatric population and
number of road accidents, stronger demand for better imaging has emerged. Chronic diseases such as
cancer, strokes, neurodegenerative diseases, COPD (chronic obstructive pulmonary disease),
cardiovascular diseases and others require imaging of body parts for proper diagnosis of the disease. ,
and such high instances of chronic diseases require improved and advanced imaging technologies such
as MRI, ultrasound and others. Also, an increase in the number of road accidents is expected to boost
the market for imaging technologies in major and minor fractures. An increasing geriatric population,
coupled with increasing demand of 3D medical imaging equipment, are other pertinent factors that will
provide traction to the global medical imaging instruments market.

Chapter 5
Global Markets and

Technologies for Electronic
Health Records (HLC205A)

Chapter 5: Global Markets and
Technologies for Electronic Health
Records (HLC205A)
Introduction
This report covers these trends and the market size and forecast they drive. The report identifies market
opportunities for suppliers of medical products and services as well as IT firms to address the growing
demand.

BCC Research believes the market for electronic health records is undergoing a transformation that will
create opportunities for new entrants and challenges for incumbents. The beneficiaries will be the
suppliers and the participants in the healthcare ecosystem who will have better access to vital cross-
discipline medical records.
Scope of Report
The report segments the technology for electronic health records and IT suppliers by hardware,
software and services by application, including:
• Administration.
• Computerized health records.
• Billing automation.
• Decision support tools.
• Document and image management (RIS/PACS).
• e-Prescriptions.
Use segments will also be addressed, including healthcare providers, private and public payers and
consumers.
Information Sources
Primary information sources include manufacturers and suppliers of electronic health records
technology, major users of these products, research organizations, government agencies and trade
associations. Secondary sources, such as databases, trade literature, specialized journals and
government statistics, were also researched while compiling this report.

Methodology
A top down and bottom up methodology was used. The top down aspect was used to size and forecast
the overall electronic health records market through secondary research and initial interviews with
industry participants. The bottom up aspect encompassed collecting and aggregating market spending
by key user segments and the revenue and future growth expectations of major suppliers. These
methods are combined to triangulate and validate the market size and forecast data.
In this report, the geographic regions considered for market analysis are:
• North America.
• Latin America.
• Europe.
• Middle East and Africa.
• Asia-Pacific.
• Rest of the World.
Michael Sullivan is currently Senior Editor for Information Technology at BCC Research. He is also an IT
industry analyst with more than 20 years of experience investigating, studying and reporting on
information technology development and applications. Previous reports include coverage of connected
medical devices, medical device security, mobile technologies, voice recognition systems, content
delivery networks, sensors for the Internet of Things and robotics and zero net energy buildings.

• HLC048E Healthcare Information Technology.
• HLC202A Healthcare Cloud Computing: Global Markets to 2022.
• IFT114A Storage, Transfer and Analysis of Medical Images: Global Markets.
• IFT152A Internet of Things (IoT) Sensors in Healthcare: Global Markets and Technologies.
Report Summary
Since the introduction of information technology, the healthcare industry has been gradually converting
its processes and methods from paper and analog to digital. Given the diversity, volume and various
tiers of information, as well as the need to maintain privacy and accuracy, healthcare medical records
have proven difficult to transition to a homogenous electronic form that serves all the needs of patients,
providers, payers and suppliers. Yet government regulations and advisory statements, such as those
initiated in the United States since 2009, have served as an incentive to spur the advancement of
electronic health records and promote interoperability across suppliers and healthcare providers.

The global market for electronic health records was $20.5 billion in 2016. The market is expected to
increase from an estimated $22.0 billion in 2017 to $39.1 billion by 2022, a compound average growth
rate (CAGR) of 12.2%.
North America will continue to lead spending due to the combination of the large number of suppliers
and providers in the region, as well as the pressure to reduce expenses amid government mandates to
increase interoperability. Spending in the region will grow from an estimated $10.1 billion in 2017 to
$18.4 billion in 2022 at a CAGR of 12.7%.
Table 18
Global Market for Electronic Health Records, by Region, Through 2022
($ Billions)
CAGR%
Region 2016 2017 2022
2017-2022
North America 9.4 10.1 18.4 12.7
Europe 4.1 4.4 7.4 11.0
Asia-Pacific 2.9 3.1 6.6 16.3
Middle East and Africa 1.8 2.0 3.1 9.2
Latin America 1.2 1.3 2.0 9.0
Rest of World 1.1 1.1 1.6 7.8
Total 20.5 22.0 39.1 12.2
Figure 8
Global Market for Electronic Health Records, by Region, 2016–2022
($ Billions)
20
18
16
14
12
$ Billions
10
8
6
4
2
0
2016 2017 2022
North America Europe Asia-Pacific Middle East and Africa Latin America Rest of World

Europe and APAC will be the next largest markets, representing a 34% share of global spending. Europe
will increase spending for electronic health records from $4.4 billion in 2017 to $7.4 billion in 2022, a
CAGR of 11%. APAC will achieve a spending level of $3.1 billion in 2017, increasing to $6.6 billion in
2022, at a 16.3% CAGR. APAC’s faster growth rate indicates lower market penetration in the early years
of the forecast and while growth of electronic health records in North America and Europe are as much
regulatory-driven as technology-driven, APAC’s adoption of new technology is the strongest driver.
Latin America, Middle East and Africa and remaining Rest of World countries will comprise the
remaining 25% of the market with electronic healthcare records advancing at a slower but steady rate of
between 7% and 10%.
The advent of cloud technologies in recent years has added further economic incentive and opened a
world of standardization to the computing market that is being leveraged by the healthcare market in
general and electronic healthcare records in particular.
Healthcare IT costs are high because the nature of medical applications – from patient records and
treatment history to image picture archiving and communication systems (PACS), radiological
information systems (RIS) and cardiovascular information systems (CVIS) – requires large amounts of
storage that constantly scales up with additional layers of data on a daily basis. Consequently,
healthcare organizations must continuously add to storage and server assets.
Cloud computing enables continuous scaling using shared assets. Cloud also facilities interoperability
because cost barriers are reduced to creating multiple instances of databases, applications and end user
interfaces. Cloud enables healthcare IT organizations to realize the benefits of new architectures in
terms of cost and flexibility.
Cloud also enables easier customization of applications for different constituents because custom
configurations are modeled in the database rather than in the application. This also facilitates
collaboration across applications. The ability to generate multiple end user interfaces across a single
database, for example, can support collaboration across departments when access to a patient record is
needed by different specialists or administrators.
Electronic Health Records Defined

While the healthcare industry has been transferring records to digital form for more than 30 years,
these records are computerized and do not necessarily meet the requirements of electronic health
records. Specifically, electronic health records must provide documentation and access to patient data
for healthcare providers, patients, payers and administrators. The objective is to enable documentation
and access to the patient’s entire record of care, no matter the provider, treatment type or location of
the patient.
EHRs and other types of clinical software have been promoted as important tools for improving the
quality of care patients receive by:
• Point-of-care decision support.

• Rapid and remote access to patient information.
• Improved continuity of care.
• Integration of evidence-based clinical guidelines.

• Tracking patient adherence to therapy (e.g., through electronic communication with the
pharmacy to determine compliance through refill frequency).
• Scheduling appropriate follow-up.
• Improved delivery of patient education materials through a PHR module.
Table 19
Key Trends in Electronic Health Records
EFFECT ON
TREND ELECTRONIC HEALTH RECORDS
The demand for multi-provider access to patient Mandates for interoperability are opening new
records to improve quality of care is being supported opportunities for new and existing EHR suppliers to
by industry and government interoperability revamp or add extensions to existing systems or
initiatives. replace them altogether with more compliant ones.
The advent of cloud technologies promises to alleviate Cloud requirements are another driver for EHR
the healthcare market's insatiable need for data transformation. Suppliers are finding a strong market
storage. for cloud-enabled solutions.
Analytics, and eventually AI-based knowledge
Analytics that help measure care quality and cost are
management systems, are another next generation
becoming increasingly important tools in healthcare,
EHR capability causing system enhancements or
requiring updated records systems.
upgrades.
According to some estimates, 80% of a typical healthcare organization’s information is stored as free
text. Fully developed clinical ontologies will enable these organizations to extract and reuse discrete
data elements that would otherwise sit within those free text clinical documents. The result will be
unstructured medical documents that become functional databases that will serve as the driving force
behind core programs such as medical coding, billing and quality of care initiatives.
The field of computable ontologies, particularly clinical ontologies, is still in the early stages of
commercialization. Companies active in this field include Ontology Works (Baltimore, Md.), Language
and Computing (Bethesda, Md.) and IBM (Armonk, N.Y.).
In addition, EHR systems must follow appropriate privacy and security standards, especially as they
relate to HIPAA regulations. Several organizations create standards related to EHRs, including Health
Level Seven (HL7), Comité Européen de Normalization–Technical Committee (CEN TC) 215, the American
Society for Testing and Materials (ASTM) E31 and the International Organization for Standardization
(ISO). HL7, which operates in the U.S., develops the most widely used healthcare-related electronic data
exchange standards in North America. CEN TC 215, which operates in 19 European member states, is the
preeminent organization/developer of healthcare IT standards in Europe.

Electronic Healthcare Technologies
The core EHR computing technologies are:
• Hardware: On-premise or cloud-based multi-socket, multicore servers and persistent storage

hardware devices.
• Software: Legacy applications or those running on virtual machine software and implementing
Web services. Also included are software clients and software platforms such as database,
security and management systems.
• Services: Consulting, design, installation and maintenance services are also part of the EHR
landscape.
Of these, the largest investment is in software, totaling more than 50% of the expenditure and growing
at a 13.5% CAGR from 2017 to 2022. This segment is expanding due to several factors including the vast
amount of data collected, the migration or enhancement of legacy applications, extensions of systems
for interoperability as well new cloud-based applications.
The hardware segment is also growing, comprising a third of the market. The growth is also due to data
growth, though overall it is mitigated by the migration of applications to cloud solutions. The
requirement for services is also increasing as providers and payers require additional third-party support
to supplement IT organizations and provide cloud infrastructure expertise.
Table 20
Global Market Share for Electronic Health Records, by Technology Type, 2016
(%)
Technology Type Share (%)

Software 52
Hardware 33
Services 15
Total 100

Figure 9
Global Market Share for Electronic Health Records, by Technology Type, 2016
(%)
Services
15%
Hardware
33%
Software
52%
Hardware
Hardware requirements for electronic medical records begin with the access points which can consist of
mobile devices such as tablets and smartphones carried by medical personnel, laptops or desktop
workstations or dedicated workstations for a given medical device or system. Though simple compared
to the cloud and server infrastructure required for the bulk of the application process, these entry point
workstations are vital for real time reporting of medical record information during the course of patient
diagnosis and treatment.
Software
While hardware whether in the cloud or on-premise provides the capacity and information processing to
record and store electronic medical records data and applications, the software must conform to the
technical requirements of records systems. These requirements include the ability to record and
consolidate data from ambulatory in-hospital departments including administration, radiology,
laboratory and pharmacy. In addition, medication administration records, nursing plans and physician
orders can be a part of the records system.
Systems can also extend to encompass payers such as lawyers, insurance companies, government
agencies and individuals and families. Some applications also include the medical device and pharmacy
industries.

Electronic Health Records Applications
Administration Systems
Though targeted primarily at providing access to patient records during the course of diagnosis and
treatment, electronic health records are also providing valuable functions for administration. These
include systems that integrate appointment scheduling, report creation and coding, enabling these
systems to work more cohesively and be part of the workflow for patient records.
Providing about 17% of the total electronic health records market, administration systems investments
totaled $3.5 billion in 2016. This investment increased to $4 billion in 2017 and is expected to grow to $7
billion in 2022 at a CAGR of 11.8%.
Electronic health record systems provide documentation from clinical records in real time enabling
organizations to apply coding before patients are discharged. If there is also a parallel process of record
scanning to capture any patient paper records, the electronic health record system can provide a
complete and accurate view of the patient encounter supported by coding to facilitate reimbursement.
In addition, administrative systems are among the first to participate in cloud-based electronic health
record systems because many of their functions are already designed for cloud services. Healthcare
organizations tend to have more control over administrative systems in hospital information systems,
therefore it has been easier for IT organizations to experiment with the systems in cloud computing
scenarios.
Computerized Health Records

Computerized health record systems constitute another significant investment area, accumulating $3.7
billion in investments by 2022 at a CAGR of 13.1%. This segment comprises about 18% of the total. The
reason for the large investment is that medical records are legal documents and are seen as confidential
communications governed by HIPPA.
Though they are protected in this way there is still a requirement for many types of personnel in the
healthcare system to access digital records. However, the process of providing access to the records has
to be closely managed to ensure that appropriate access is given to personnel based on their needs and
permissions. Electronic health records management supports the ability to design security controls and
audit logs to provide appropriate access to medical records for clinicians and internal use groups such as
business administrators, risk management staff and other appropriate personnel.
Billing Automation
Electronic health records contribute to billing automation and will provide a $6.3 billion share of the
market in 2022 at a growth rate of 12.5%. Integration of electronic health records with billing systems
that include service pricing, insurance information and additional charges can be facilitated with an
electronic healthcare system. Interoperability between the systems and insurance company and payer
systems is also a productive use of electronic health record systems.
Electronic healthcare records suppliers offer billing services as part of their solutions. Electronic health
record systems can send charges automatically into a records management system billing module and

the systems often share a single database. While this is the case, it is unlikely that billing services will go
out of business anytime soon as most of them specialize in the second component of billing services,
collections, which is often not necessarily a function of automation as much as having the right
personnel and system to implement the collection activity.
While electronic health record billings systems automate filing claims, pulling payments and posting
remittances, specialists are often required to pursue unpaid patient bills resulting from denied insurance
claims. Capturing revenue from claim denials and self-pay from patients is as important, especially to a
small practice, as being reimbursed appropriately by insurance.
Decision Support Tools

Electronic health records systems also contribute to decision support capabilities. The ideal decision
support, however, is different than the reality as improved decision support for electronic health
records is an evolving capability. Nevertheless, the segment will generate $7 billion in revenue for
electronic health records in 2022 at a CAGR 13.6%.
Clinical decision support systems are interactive applications that help physicians and other healthcare
professionals make diagnoses and determine treatments, as well as perform other tasks. Clinical
decision support systems vary greatly in their complexity, function and application.
Clinical decision support systems provide clinicians, staff, patients or other individuals with knowledge
and person-specific information that is intelligently filtered or presented at appropriate times to
enhance health and healthcare. It encompasses a variety of tools and interventions such as
computerized alerts and reminders, clinical guidelines, order sets, patient data reports and dashboards,
documentation templates, diagnostic support and clinical workflow tools. The usefulness of the tool is
clearly dependent on the programmed logic. A system that provides erroneous information and
guidance has the potential for broad deleterious impact.
Successful decision support tools must allow treatment providers to navigate quickly and efficiently to
the most critical information that they need at the point of treatment. Very often decision support tools
have been designed more with the focus on quantity of information rather than flexibility in offering
relevant pieces of clinical data at the behest of the user.
Document and Image Management Systems

Healthcare investments in document and image management systems is one of the largest investments
as the systems are supporting significant diagnostic devices leading to treatment recommendations and
analysis. The role of electronic healthcare systems in this field is somewhat smaller in terms of the data
processing because records of the procedures are secondary to the storage and archiving of the many
complex documents and images which are maintained in independent systems. For electronic health
records it is more about linking to existing documents and image management systems.
Nevertheless, the investment in linking electronic health records to document and image management
systems generated a $3.3 billion investment in 2017 and will drive a $5.9 billion investment in 2022 at a
CAGR of 11.0%.

One of the market drivers is the expectation that in the incentive-based U.S. meaningful use initiatives
there will be interoperability and data exchange between the electronic health records systems and
picture archiving and communication systems (PACS) in radiology, cardiology and endoscopy.
E-Prescriptions
Electronic prescribing is a technology that enables a prescriber to electronically send an accurate, error-
free and understandable prescription directly to a pharmacy from the point of care.
Electronic prescribing involves the use of an automated data entry system to generate a prescription,
rather than writing it on paper. The term electronic prescribing is usually used in connection with
outpatient or ambulatory prescribing. E-prescribing in an inpatient or hospital setting is generally
considered part of the computerized physician order entry.
Given the automated nature of e-prescribing, it is understandable that electronic health record systems
are also engaging in providing e-prescription systems. This aspect of the market will provide about $5.5
billion in 2022 at a CAGR of 10.8%. According to U.S. government statistics, more than 40% of all
prescriptions written by eligible professionals were transmitted electronically using certified EHR
technology.
E-prescribing in the ambulatory setting is carried out using a mobile device (e.g., a PDA or smartphone)
loaded with e-prescribing software, an ambulatory EHR system on a PC or, less frequently, a handheld
device. Technologies involved in e-prescribing are:
• Software applications.
• Mobile interface devices.
• An electronic data interchange system.

Figure 10
Global Market Share for Electronic Health Records, by Application, 2016
(%)
e-Prescriptions Administration
16% 17%
Document and image

management Computerized health
(RIS/PACS) records
16% 18%
Decision support
tools
17% Billing automation
16%
Electronic Health Records Markets

The largest firms in the market include Cerner, McKesson and Epic. Cerner continues to add new
business by producing new services that improve the ability of hospital IT departments to meet their
organizational needs. The company is also focusing on revenue cycle functions. The acquisition of
Siemens Health IT greatly advanced Cerner’s market share as well. Its recent contract with the U.S.
Department of Defense also bolstered its position.
When viewed from the perspective of the large companies, electronic health records are seen as a single
market with many functional modules and customer types. But the industry is also comprised of
individual vendors pursuing each submarket independently. There are more than 300 software vendors
addressing various segments. In addition to functional segmentation there is also segmentation based
on the size of practice, specialties of medical services, inpatient and outpatient and other types of
categorizations.
One way to measure the market is to assess the depth of functionality of the records systems. Baseline
functionality includes:
• Patient demographic information.

• Patient problem lists.
• Clinical notes.
• Orders for prescriptions.
• Laboratory imaging results.

Fully functional electronic health records include all base line functionalities as well as:
• Medical history.
• Follow-up orders for test prescriptions.
• Electronic test orders.
• Warnings of drug interactions or contraindications.
• Highlighting of out of range test levels.
• Electronic images returned.
• Reminders for guideline-based interventions.
In addition to new buyers, the market includes a significant replacement/displacement market.

However, the majority of buyers are still seeking new systems to replace their paper-based ones.
Replacing cumbersome systems to improve performance and conforming to government regulations
such as the U.S. Meaningful Use incentive program are key drivers for market upgrades.
Future Outlook
Migrating massive amounts of patient data to a cloud will help to more accurately assess health issues
and treatments across the healthcare ecosystem and facilitate big data analytics to investigate public
health metrics. Increasingly, suppliers in the electronic healthcare records market will also offer more
demographic and population analysis tools within their cloud solutions. There is a growing demand for
RIS and cardiovascular information system (CVIS) which are increasingly being used to achieve
multidisciplinary patient care. The need for workflow enhancements and integration will drive the
demand for PACS, RIS and CVIS. Initiatives taken by public and private healthcare sectors around the
globe, in conjunction with significant advancements in healthcare information technology, are expected
to boost the adoption of PACS, and the need to reduce healthcare expenditures while providing
enhanced quality and greater access to healthcare will drive governments to adopt digital information
technology in the future.

Chapter 6
Non-opioid Pain Treatment:

Global Markets to 2022
(HLC206A)

Chapter 6: Non-opioid Pain Treatment:
Global Markets to 2022 (HLC206A)
Introduction
This BCC Research report, Non-opioid Pain Treatment: Global Markets to 2022, provides an overview of
products included in this market, and a detailed analysis of the markets and market opportunities. The
study includes information about significant products categories, issues and trends, market influences,
regulatory issues and other information affecting the pain management industry, and more specifically,
the non-opioid treatment market.

This study will provide the reader with the knowledge to adequately view and assess alternative areas of
pain treatment that are penetrating the conventional pain treatment market. In response to the new
treatment areas, the industry is faced with unprecedented challenges regarding patient quality of life,
treatment liability and government limitations and compliance. The study provides insights into the
market potential in the segments discussed in the report as these areas are the most pressing in terms
of their potential benefits and how they compare when being evaluated against prescription opioid
therapies.
The report is designed to provide the reader with a background of the pain management industry and
current factors influencing growth and provide decision-makers with the tools to make decisions
regarding expanding into the newest areas of pain management treatment in regard to non-opioid
treatments.
Scope of Report
This BCC Research report is designed to be a helpful business tool that will provide a thorough
evaluation of the markets for pain management. The geographical scope of this study is global. This
study addresses acute versus chronic pain, treatments and regulatory issues facing healthcare workers.
Also provided is detailed information based on product categories, use of products, forecasts and
competitive analyses.
The report identifies five general product segments for non-opioid treatment of pain:
• Medical cannabis treatments.

• Capsaicin-derived treatments.
• Menthol-containing treatments.
• Omega 3 fatty acid-containing treatments.
• Botulinum toxins.

Within the segment several sub-segments are discussed as they pertain to each product segment;
diseases or disorders are the basis for these sub-segments, including:
• Arthritis.
• Cancer⎯brain, breast, colorectal, leukemia/lymphoma, melanoma, prostate, others.
• Dental.
• Epilepsy.
• Fibromyalgia.
• Migraine.
• Multiple sclerosis.
• Surgical.
A regional analysis of these product segments is also provided, including the specific countries listed
below and including countries not listed as a “rest of the world” market.
• Argentina.
• Australia/New Zealand.
• Brazil.
• Canada.
• China.
• France.
• Germany.
• Italy.
• Japan.
• Mexico.
• Russia.
• Spain.
• United Kingdom.
• United States.
Each market segment provides detailed information based on product categories, product use, current
market value and forecasts.
Not covered in the report are drugs or devices that are considered “conventional” in professional
treatment guidelines that are due to either controversial issues such as those with medical cannabis or
those that are not commonly prescribed or recommended due to a lack of clinical data, education or
other factors.
Information Sources
Information sources used to compile this report include:
• AbbVie Inc.
• Acorda Therapeutics Inc.
• Allergan PLC.
• Australian Department of Health.
• Bedrocan BV.

• Central Intelligence Agency.
• Consumer Healthcare Products Association.
• Corporate Pharmacy (California).
• Food and Drug Administration.
• Government of Canada, Health Canada.
• Grünenthal Group.
• GW Pharmaceuticals.
• Hydra Biosciences Inc.
• Medical Marijuana Inc.
• Merz Pharma.
• Metagenics Inc.
• National Institute on Drug Abuse.
• Oregon Department of Agriculture.
• Oregon Health Authority.
• Oregon Liquor Control Commission.
• Organization for Economic Cooperation and Development.
• The American Oil Chemists’ Society.
• The World Bank.
• The World Health Organization.
• U.S. Bureau of Economic Analysis.
• U.S. Census Bureau.
• U.S. Central Intelligence Agency.
• U.S. Department of Labor, Bureau of Labor Statistics.
• U.S. WorldMeds LLC.
• United Nations Office on Drugs and Crime.
• University of Michigan.
Methodology
This report is based on extensive primary research, including interviews with market participants, pain
management physicians and care providers, government personnel and researchers. Secondary research
is used to supplement primary methods, which include insurance and reimbursement databases,
government health and lifestyle databases, relevant journals, company literature and investment
reports. The report is global in scope with a special emphasis on major global markets such as the United
States, Canada, France and Germany. Market data is based on 2017 market conditions, using 2017 as
the base year. Historical data is provided for 2016 while forecast data is provided for 2022.
In this report, the geographic regions considered for market analysis are divided into four broad regions:
• North America.
• Europe, Middle East, Africa (EMEA).
• Asia-Pacific.
• Latin America.

Melissa Elder is an experienced healthcare market analyst specializing in medical treatments, equipment
and devices. Ms. Elder holds a B.S. in Business Management and is currently working to complete her
M.B.A. in Health Care Management. Ms. Elder has been involved in the healthcare industry since 1996,
providing more than 20 years of industry expertise. She has specialized in market research for the past
18 years, focusing on the areas of advanced medical technologies, biological products and animal health.
In-depth analysis into more than 100 health-related topics has given Ms. Elder substantial insight into
industry dynamics, market influences and the future direction of various health markets. Her work in the
medical community, including emergency room medical training and healthcare information system
coordination, has enhanced her ability to provide insight into many healthcare specialties. She has
authored several industry specific documents and is a well-respected contributor to the market research
community. Her writings are published in magazines, newspapers and professional journals. She is also
an experienced custom market research writer who has worked with a large variety of clients in many
fields who require innumerable variations to their research documents.

• BIO022H Botanical and Plant-Derived Drugs: Global Markets.
• HLC026F The Global Market for Pain Management Drugs and Devices.
Report Summary
The global non-opioid pain treatment market, which focuses on alternative non-opioid treatments,
reached a total market value of nearly $9.9 billion in 2017. The market is divided into five general
segments for this report, including medical cannabis, capsaicin-derived treatments, menthol-containing
treatments, omega-3 fatty acid-containing and botulinum toxins.
Various findings specific to each segment are discussed below:
Medical cannabis
• Largest alternative non-opioid market segment, accounting for a 73% market share.
• The United States is the largest market for medical cannabis, accounting for 50% of global sales.
• The street cost of cannabis is the highest in Japan (it is illegal for all uses in Japan).
• Medical cannabis is most often used to control pain in orthopedic and musculoskeletal
conditions. Arthritis and fibromyalgia are the most common individual indications. About 57% of
sales are for this group of indications.
• Increasing use in neuropathic pain has shown effectiveness.
• Growing number of medical cannabis clinical trial listings.
Capsaicin-derived treatments
• Smallest market segment, accounting for just 3% of the global non-opioid pain treatment
market.

Menthol-containing treatments
• Second-largest alternative non-opioid market segment, accounting for a 9% market share.

• Menthol-containing treatments have been shown to be effective in treating neuropathies.
• Increasing rate of diabetes and other conditions with high prevalence of neuropathies will fuel
growth.
• Major market segment in Latin American pain treatment markets.
Omega-3 fatty acid-containing
• Accounts for 9% of the global non-opioid pain treatment market.

• Aging populations will be a strong driver for growth.
• Increasing orthopedic conditions and injuries will support growth.
• Major segment in Asia-Pacific pain treatment markets, accounting for 30% to 50% of non-opioid
pain treatment sales in developed countries.
Botulinum toxins
• Accounts for 5% of the global non-opioid pain treatment market.

• Botox is the leading product in the segment and is marketed by Allergan.
• The U.S. market is the largest market due to the availability and reimbursement of Botox.
• Global push for education in alternative migraine treatments and awareness.
Table 21
Global Market for Non-opioid Pain Treatments, by Product Segment,
Through 2022
($ Millions)
CAGR%
Product Segment 2016 2017 2022
2017–2022
Medical cannabis 4,843 7,255 19,775 22.2
Menthol-containing 919 926 966 0.8
Omega 3 fatty acid-containing 900 911 966 1.2
Botulinum toxins 511 542 697 5.2
Capsaicin-derived 250 252 258 0.5
Total 7,423 9,886 22,662 18.0

Figure 11
Global Market for Non-opioid Pain Treatments, by Product Segment, 2016–2022
($ Millions)
20,000
18,000
16,000
14,000
$ Millions
12,000
10,000
8,000
6,000
4,000
2,000
0
2016 2017 2022
Medical cannabis Menthol-containing Omega 3 Fatty acid-containing

Botulinum toxins Capsaicin-derived
Diseases Causing Chronic Pain

IPain is the primary complaint in approximately 80% of patients who visit the doctor. Globally, pain
affects at least 1.5 billion people and as many as 2 billion people at any one time.
The incidence of pain varies according to the location of the pain and individual factors. The most
common incidences of pain are experienced in orthopedic pain (back pain and joint pain), headaches,
burn pain, diabetic pain, cancer pain, dental and facial pain, HIV/AIDS pain, obstetrical pain, pediatric
pain and surgical pain.
A hallmark of many chronic conditions, pain affects more people than diabetes, heart disease and
cancer combined. Taking into account healthcare expenses, lost income and productivity, chronic pain is
estimated to cost several billion dollars annually for treatment and more when considering the indirect
costs associated with pain.
Arthritis
Arthritis is one of the most common conditions affecting the population today, with more than 100
different types reported. Each year more than 500 million people worldwide are affected by arthritis
and arthritis-related conditions, with approximately 55 million of these in the United States alone. For
people in the over 55-age group, this is the most commonly reported condition.

Several factors are contributing to the rising incidence of arthritis. The CDC reported in its National
Health Interview Survey, 2013–2015, that the incidence of arthritis in the U.S. will increase to 78.4
million by 2040, accounting for 25.9% of the adult population. The report does claim to be conservative
due to not accounting for the full impact of obesity, which contributes to the future incidence of
osteoarthritis.
Taking the current trends of obesity into consideration, BCC Research estimates that the incidence of
arthritis will reach 105 million by 2050, representing a 1.0% CAGR. Worldwide, the incidence of arthritis
is likely to reach 750 million.
Some of the most common arthritic problems are osteoarthritis and rheumatoid arthritis.
• Osteoarthritis is a highly prevalent condition that affects more than 250 million people
worldwide, and accounts for approximately half of all arthritis conditions. Osteoarthritis has
been diagnosed in more than 30 million Americans with the frequency of the condition
increasing with age. Around the world, the prevalence varies from 6% to 10% of the general
population.
• Several characteristics and risk factors are associated with osteoarthritis. Women over 55
account for the highest rate of incidence, followed by men in their mid-40s. Obese populations
have a higher rate of osteoarthritis primarily due to increased weight on joints. Among races,
whites and blacks tend to have the highest osteoarthritis rates followed by Asians. Educational
status and income level also can play a role in the prevalence of osteoarthritis, with lower
education and income levels showing the highest rates compared to mid- and higher-income
populations at a rate of 2:1.
• Rheumatoid arthritis is present in more than 30 million people worldwide. The United States has
nearly 3 million cases, with women affected more than men at a rate of 5:1. Rheumatoid
arthritis is known to have some genetic background and is associated with the tissue type
antigen HLA-DR4. Race is an important factor, with Native Americans having one of the highest
rates and blacks in the Caribbean having the lowest. An interesting finding of many studies
worldwide has been the fact that rheumatoid arthritis is more prevalent in smokers versus
nonsmokers at a rate of 4:1.
Cancer
Pain is a burdensome aspect of cancer. It affects from 25% to 60% of patients undergoing treatment.
Because more than 14 million people are diagnosed with cancer each year and many more living with
one form of the disease or another, the importance of controlling cancer pain has increased. For
effective pain management in cancer cases, it is very necessary to first evaluate the type of pain. Cancer
pain can be divided according to the region of pain, and once it is identified, it can be classified
according to the duration of pain.
• Somatic pain—Somatic pain is generally a result of pain receptor activity on the surface of the
body or deep within the tissues. An example of pain on the surface is the surgical incision site
where pain is very intense. In the case of pain in deep tissues, for example, where the cancer
has spread to the bones, the site cannot be pinpointed, but has a dull pain.

• Neuropathic pain—This type of pain arises due to injury to the nervous system. It may also be a
result of pressure on the nerves or the spinal cord by the tumor. This type of pain continues for
long after the treatment and is one of the most difficult types of cancer pain to treat. This type
of pain produces a burning or tingling sensation.
• Visceral pain—Visceral pain is experienced in the cavities of the body, such as the abdomen,
chest or pelvis. This pain is generated when the cancer tumor puts pressure on one or more
organs in the cavity. This pain produces a throbbing and pressurized sensation.
Once the type of pain according to the region of pain is classified, pain can be further categorized as
acute or chronic pain.
Fibromyalgia
Fibromyalgia is surprisingly common worldwide with reports as low as 3% to as high as 6% of the general
population suffering from this condition. It is diagnosed in women over men at a rate of 7:1. All racial
and ethnic groups have shown nearly equal incidence and the same holds true with regard to
occupations and social status. The only distinct difference in fibromyalgia onset is within age groups,
with a diagnosis more frequently made in the years between 21 and 55. However, the condition has
been known to occur outside of these years as well.
In the United States, the National Fibromyalgia & Chronic Pain Association reports that more than 10
million people are affected by the condition. The condition has received greater attention in recent
years and more people have been diagnosed now that more information is known about the condition.
Drug therapy is the most common treatment option with drugs that affect the central nervous system at
the center of options. Pfizer’s Lyrica is the most prescribed drug for fibromyalgia pain.
Migraine
Headache is one of the most common pains experienced by humankind. Headache can be a symptom of
a serious disease or a condition in itself—one that is not fatal but is severe enough to make the person
feel miserable and be incapacitated. Headaches are painful, and the fact that they can be accompanied
by convulsions, confusion, loss of consciousness, fever, stiff neck, slurred speech and weakness, makes
them more unbearable and affects quality of life.
According to a CDC report and the National Headache Foundation, about 55 million people in the U.S.
suffer from chronic headaches—one in six Americans. Of these, between 65% and 70% are classified as
migraines. This includes a figure for school-age children, which have an incidence of headaches of about
20%. It is estimated that 90% of people experience a headache—mild to severe—at some time each
year.
Migraines involve changes in the blood pressure of the vessels serving the head. Migraines are
considered chronic. Genetic factors are involved in determining who will have migraines, but there are
more factors involved.
Global estimates for headaches show nearly half of the population suffers from a headache at least once
each year. For about 10% of the global population, migraines affect daily activities and quality of life. In

fact, the World Health Organization reported in its Global Burden of Disease Study (2004) that migraines
were responsible for 1.3% of years lost due to disability (YLD). Migraines are estimated to be the sixth
highest cause worldwide of years lost due to disability and collectively headaches were the third highest
(World Health Organization, 2016).
HIV/AIDS
Approximately 2.1 million people worldwide were newly infected with HIV in 2014. Despite the 2 million
plus number of new infections, there has been an overall decrease in infections over the past years,
declining from 3 million in 2001 to 2.7 million in 2008 and 2.5 million in 2011. About 37 million people
are currently living with the disease, with 1.1 million deaths (2015). Death rates associated with
HIV/AIDS has also declined over the past decade. The World Health Organization reports about 70% of
those living with HIV are in African regions.
In the United States, HIV was first identified in 1981. During the 1980s, the spread of the virus was at its
peak, with about 150,000 people infected per year. In the 1990s, that number fell to roughly 40,000
infections per year. In 2000 and later, the number has stayed close to 35,000 to 40,000. In 2015, there
were 39,513 people diagnosed with HIV infection in the United States according to the CDC. The CDC
currently estimates that the number of people living with HIV or AIDS in the United States is
approximately 1.2 million and one in eight of those are unaware of their disease.
Non-Narcotic, or Non-opioid, Pain Control

Pain is one of the most undertreated medical conditions, especially cancer pain. Despite the availability
of adequate painkillers and other methods, in many instances, doctors seem to under treat pain. In
medical journals and textbooks, this undertreatment of pain is known an opiophobia. Doctors are leery
of the drugs derived from opium and synthetics that resemble them, substances like morphine and
codeine, hydromorphone (Dilaudid) and meperidine (Demerol).
Acetaminophen is one of the most common painkillers used. It is an OTC product and hence is freely
available in drug stores without the need for a physician’s prescription. It has always been a first line of
treatment for mild forms of cold and fever. Acetaminophen, also called paracetamol, is available under
many brand names worldwide. The market-leading branded acetaminophen is Tylenol, manufactured by
Johnson & Johnson, although many varieties of acetaminophen are available on the market.
Nonsteroid anti-inflammatory drugs (NSAIDs) are used to control mild to moderate pain. NSAIDs act
primarily by inhibition of prostaglandin synthesis. In lower doses, NSAIDs have analgesic properties; in
higher doses, there is anti-inflammatory action in addition to analgesic activity. The principal uses of
NSAIDs are control of moderate pain associated with dysmenorrhea, musculoskeletal disorders,
postoperative pain and migraine pain. NSAIDs, like aspirin, inhibit platelet aggregation with resulting
increased bleeding time. Common side effects include gastrointestinal disturbances, dizziness, tinnitus
and headache. Examples of NSAIDs used for pain control are as follows:
• Celecoxib (Celebrex) is primarily indicated for treating osteoarthritis (OA), rheumatoid arthritis
(RA), ankylosing spondylitis (AS) and juvenile rheumatoid arthritis (JRA).

• Diclofenac sodium (Cataflam), which is indicated for the treatment of acute and chronic
osteoarthritis and rheumatoid arthritis.
• Etodolac (Lodine), which is indicated for acute and long-term use in the management of
osteoarthritis and rheumatoid arthritis.
Indomethacin (Indocin), which is an indoleacetic acid derivative with analgesic and anti-inflammatory
properties.
Several products are used in pain management to enhance analgesic efficacy, treat concurrent
symptoms and provide independent analgesia for specific types of pain. These products include the
following:
• Antidepressants—Tricyclics and serotonin reuptake inhibitors such as Elavil, Pamelor,

Norpramin, Prozac and Zoloft are used as an adjunct to treat mild pain. Another antidepressant,
Remeron, seems to be useful in treating chronic pain because it has activity on both
noradrenergic and serotonergic transmission. The product has 5HT1 agonistic properties and
blocks 5HT2 and 5HT3. This reduces the likelihood of side effects related to nonselective
serotonin activation.
• Anticonvulsants such as Neurontin, Dilantin and Tegretol are used as adjuncts in managing
neuropathic pain.
• Antihistamines such as Vistaril produce a mild sedating effect that is useful in treating the
anxious patient experiencing pain.
• Antianxiety agents such as Xanax and Klonopin are used as adjuncts for patients experiencing
moderate to severe pain.
Non-Opioid Treatment Market

The market for alternative non-opioid pain therapies is divided into five broad categories:
• Medical cannabis.
• Capsaicin-derived.
• Menthol-containing.
• Omega 3 fatty acid-containing.
• Botulinum toxin.
Combined these segments accounted for a market valued at $9.9 billion worldwide in 2017. The market,
despite its size, is just a fraction of the total conventional pain management market, exceeding $50
billion annually.
Driving the market for pain therapies includes:
• Steady number of cancer patients.

• Aggressive cancer treatment regimens.

• Increasing chronic disease patients.
• Increasing aging population.
• Lengthening of survival rates for patients with critical diseases.
• Expanded educational efforts.
Medical Cannabis
There is an expanding list of ailments that cannabis is being used to treat. Medical cannabis is currently
used to treat the following conditions (not a comprehensive list):
• Asthma/respiratory disorders.
• Crohn’s disease and similar gastrointestinal conditions.
• Glaucoma.
• Hepatitis.
• HIV/AIDS.
• Insomnia.
• Nausea.
• Pain.
• Psychological conditions (anxiety, PTSD, schizophrenia, Tourette syndrome).
• Seizures.
The market for medical cannabis in pain treatment has developed into a large market opportunity with
it continuing to increase in value over the forecast period. Several factors are driving the market,
including the overall effectiveness of cannabis in treating pain symptoms but also the growing
acceptance by the medical community and world governments. Relaxed laws regarding the medicinal
use of the substance overcomes the major hurdles to the industry’s limited market opportunities.

Figure 12
Global Market Shares of Medical Cannabis Pain Treatments, by Indication, 2017
(%)
Other pain
27.0%
Cancer pain
7.0% Orthopedic/musculoskeletal
pain
Neuropathic pain
9.0%
Capsaicin-derived Therapies
Capsaicin-derived therapies have been used for decades to treat pain. However, until recent years it was
only used by a small percentage of the population and was largely non-existent in conventional medical
professional discussions. More advanced research studies have discovered that many of the older
treatments lacked dosages needed to provide the most effective result. Currently, several clinical trials
are underway involving the use of capsaicin, including both transdermal patches and topical creams.
Table 22
Global Market Shares of Capsaicin-derived Pain Treatments, by Indication, 2017
(%)
Indication Share (%)

Orthopedic/musculoskeletal pain 48
Neuropathic pain 39
Cancer pain 4
Other pain 9
Total 100

Menthol-containing Therapies
Fewer menthol-containing therapies are in development for pain management than any other area
covered in this report. This is largely due to the saturated market in the consumer segment of the pain
management industry and the limited opportunities for prescription therapies to expand. However, a
current Phase I/II trial in Canada by the University of British Columbia is evaluating a topical menthol
preparation for treating painful diabetic neuropathy. Growth will continue to be fueled by an aging
population looking for non-invasive, non-harmful pain therapies. The option of topical menthol-
containing preparations meets this need in the most common indications.
Omega-3 Fatty Acid-containing Therapies

The use of omega-3 fatty acids for preventing and possibly treating pain has been under recent
observation after a long lag in development efforts. The primary pain relief use for these supplements
has been in the areas of rheumatoid arthritis pain treatment with omega-3 fatty acids acting as a natural
anti-inflammatory and thus reducing symptoms of rheumatoid arthritis, primarily joint pain. In 2017, the
market for omega-3 fatty acids used for pain treatments was driven by the treatment of pain associated
with orthopedic and musculoskeletal conditions. Sales are relatively stable across the pain indications
due to stable pricing across all segments and highly saturated market environment.
The market will be influenced by the growing aging population and the incidence of diseases associated
with this demographic. Additionally, the rising rate of obesity, nutritional deficiencies and chronic
diseases will create a stable market environment over the 2017-2022 period.
Botulinum Toxin Treatments

In Nov. 2010, Allergan received FDA approval to market its onabotulinumtoxinA, Botox, specifically for
the treatment of chronic migraine prevention. Prior to the approval, Botox was used off-label for this
indication, but an official approval allows for wider access to the treatment and reimbursement
opportunities. Allergan noted in 2012 and 2013, sales of Botox increased by double-digit rates, which
were largely supported by sales for migraine prevention. Botox is also approved for cervical dystonia
and neck pain associated with the condition. Sales of Botox are outlined by treatment area below.
Table 23
U.S. Market for Allergan’s Botox, by Treatment Area, 2016
($ Millions/%)
Value Share
Treatment Area
($ Millions) (%)
Botox therapeutics 1,512 54
Botox cosmetic 1,209 43
Botox hyperhidrosis* 65 2
Total 2,786 100
*U.S. Sales only included; International sales included in Botox Therapeutic sales.
Source: Allergan financial data

Figure 13
Non-opioid Pain Management Market Drivers and Restraints
Drivers
•Multidiciplinary approach supports non-opioids as a

primary or additional treatment
•Lower cost for treatment in most cases
•Relaxing government regulations
•Research supports use of non-opioid treatments
•Lower side-effects compared to conventional therapies
Restraints
•Government regulation
•Abuse in recreational use of cannabis
•Many alternative therapies not FDA or CE approved
Growing Trend in Cannabis Treatment for Pain

For decades the role of cannabis in treating pain has been scrutinized, largely by the conventional
medicine sector. The use of medical cannabis has become mainstream in some U.S. states for the past
two decades, and in some regions of the world, it has become a common treatment option. Countries
with full or limited medicinal use of marijuana include:
• Australia.
• Canada.
• Colombia.
• Germany.
• Israel.
• Mexico.
• Poland.
• Puerto Rico.
• Spain.
• Turkey.
• United States.
• Uruguay.
Additionally, several countries state that it is illegal to possess, sell, transport or cultivate any form of
cannabis, but decriminalize the use of cannabis for medicinal use or for very small quantities.

Adoption of Medical Cannabis: A Global Analysis
Table 24
Adoption of Medical Cannabis, by Select Country (Age 15 and Over), 2017
(%/Thousands)
No. of Users of Medical Cannabis

% of Population Using Medical
Country Based Total on Population
Cannabis, 2017
(Thousands)
Argentina 0.7 193
Australia/New Zealand 0.8 145
Brazil 0.2 355
Canada 1.2 283
France 0.7 304
Germany 0.4 214
Italy 1.2 500
Mexico 0.1 94
Spain 0.9 294
United Kingdom 0.6 234
United States 1.7 3,640
Note: In countries where cannabis is still highly restricted, an estimate is provided by BCC Research
based on various interviews and reports.
Source: BCC Research compilation of country health databases
Laws and Legalization Trends

In the United States, the use of marijuana is illegal at the federal level. At the state level, 29 states have
passed laws for the legal use of the substance at some level. The table below outlines the state laws
regarding marijuana use. In response to the growing adoption of cannabis treatment in pain
management, companies have expanded clinical trial activity and development efforts. One such
program is cannabis with the use of the Volcano Medic Vaporizer, currently in Phase II development.
The use of vaporized cannabis is being evaluated for use in patients with osteoarthritis of the knee to
determine the analgesic dose-response characteristics of vaporized cannabinoids with varying degrees
of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) ratios. Prairie Plan Systems Inc. is sponsoring
the trial in collaboration with McGill University Health Center and Dalhousie University.
Patents Overview
Patents are granted in most developed countries around the world to protect the intellectual property
used in the development or design of a product. A patent is essentially a property right granted by a
patent authority. It allows an inventor or an assigned company to protect an applicable invention from
infringement. The patent term in the U.S. is 20 years from the date of filing. In some cases, the date an
earlier related patent was filed also applies. A patent holder must also notify others of the patent
protection it holds on a product by displaying the word “patent” and the patent number.

Generally, a patent authority allows for the protection of patent rights only in the country that it is
based. The USPTO grants patent rights in the U.S. and U.S. territories.
Figure 14
Total U.S. Patents on Non-opioid Pain Treatments, by Type, Through 2017
(Number/% Share of Total)
Botulinum Toxin Acupuncture

#800 #635
7% 6%
Capsaicin
#1,407 Medical Marijuana
13% #4,850
44%
Topical Analgesics
#3,394
30%
Source: USPTO
Non-opioid Pain Relief Categories

From the previous table it can be seen that more than 11,000 patents have been issued that reflect
some level of involvement in non-opioid pain treatment from the period of 1976 through Nov. 2017.
• The largest share of non-opioid pain relief patents comes from the various stages of cannabis for
medicine production. From growing to manufacturing, cannabis patents run the gamut and just
over 4,800 patents have been listed since 1976.
• The second largest category of patents are topical analgesics for pain relief. With products like
menthol containing rubs and oils, the U.S. Patent and Trademark Office has around 3,400
different patents registered.
• The third type of alternative pain relief is capsaicin-containing products. Currently, 1,400 patents
are listed.
• The fourth biggest group is botulinum toxin-containing medical treatments. Currently, 800
different patents have been granted on medicines using the toxin.
• The smallest group of patents belongs to acupuncture and its use in pain relief. There are 630
patents related to acupuncture and its industry.

Future Outlook
As the healthcare industry continues to focus on cost-effective pain management, finding treatments
that have minimal side effects and control pain effectively will be the most valuable to providers and
patients. Many studies have shown good pain management reduces complications and hospital lengths
of stay, with significant savings that far exceed the cost of the technology or drugs used.
Changes in government regulation regarding alternative treatments, such as medical cannabis, are
expected to continue. Relaxed regulation regarding the use of both the medical and recreational use of
cannabis show a growing acceptance of the substance in general, and is predicted to improve further in
the future.
The health industry is shifting to a patient outcomes-based treatment system, building guidelines for
treatment and compensating payors based on performance measurements. A focus on patient
outcomes research is expected to provide a platform for alternative therapies for chronic ailments like
pain, thus boosting the growth of non-opioid pain management agents.

Chapter 7
Single Blood Drop Analysis:

Technologies and Global
Market (HLC207A)

Chapter 7: Single Blood Drop Analysis:
Technologies and Global Market
(HLC207A)
Introduction
The single blood drop analysis market is expected to grow modestly during the forecast period. The
report will include single blood drop analysis equipment, processes, reagents and various factors that
provide insights into the single blood drop analysis market. Recent developments, patent analyses, new
technologies and innovations are included in the study to understand this exclusive market. The report
also targets various government regulations and policies, research and development (R&D) exploration,
government programs, and campaigns and more to deduce market trends and scope of the single blood
drop analysis market.
The analysis of a single drop of blood can determine the presence of diseases such as diabetes,
HIV/AIDS, malaria, dengue, cancer, cardiovascular, viral and bacterial infections and more. The
capabilities and possibilities of this new technology create the scope of the market for single blood drop
analysis. Blood analysis is essential for diagnoses, patient monitoring, drug response and drug
discoveries. Conventionally, blood analysis is performed in a lab or diagnostic centers; however, single
blood drop analysis technology is capable of providing test results anywhere at any time. The
advantages of this new technology could change the entire blood analysis market. Single drop blood
analysis could impact the healthcare system in remote areas and underdeveloped countries. Currently,
the single blood drop analysis tests are becoming more popular in the detection of various diseases and
no longer limited to diabetes patient monitoring. BCC Research’s goal in conducting this study is to
provide an overview of the current and future characteristics of the global market for single blood drop
analysis equipment and technologies.
This report explores the present and future strategies within the single blood drop analysis/low
volumetric blood analysis technology market, divided by diagnoses, patient and drug response
monitoring. The market outlook along with its setbacks and needs are discussed in this report.
Classifications and usage of single blood drop analysis products are also described in this study. In
addition, various patents, innovations, recent developments and other relevant information are also
discussed at length.
The report provides a detailed analysis of the single blood drop analysis technology. The revenues are
broken down by region while sales figures are estimated for the ten-year period from 2017 through
2027. The applications of single blood drop analysis are discussed separately in the report.

The rising prevalence of sedentary lifestyles, bad eating habits, the rising incidence of acquired diseases,
such as cancer and diabetes, as well as an upsurge in infectious viral and bacterial diseases, are creating
opportunities for the point-of-care (POC) testing market, especially for single blood drop analysis. The
global rise in the infectious and noninfectious diseases, growing population, technological
advancements and innovation are creating considerable demand for blood analysis technologies.
Conventional technologies, such as all blood tests performed in laboratories, may not be sufficient for
the wellness of entire populations. The single blood drop analysis offers cost-effective solutions in less
time. Additionally, these procedures can be done anywhere without the need for trained professionals.
This new technology has the potential to improve the health of a large population.
Moreover, considerable R&D spending, along with increasing competition and new technologies are
giving direction to the market. These advancements, new product launches, and changing lifestyles are
influencing future market growth. This study looks at almost all the systems affected by these factors.
Merger and acquisition strategies and collaborations by companies are also covered in this report.
Additionally, this study also discusses the strengths and weaknesses of each strategy type in light of the
new technologies, growing competition and changing customer needs.
Scope of Report
The scope of this study entails the current market for blood analyzers, especially the single blood drop
analyzer. The report also includes regulatory aspects, current and developing technologies, market
projections and market share. An analysis of patents, clinical trials, innovations and opportunities, as
well as the latest trends are also discussed. The report intends to explain the key trends of blood
analysis technologies. It discusses the market determinants that act as motivating and restraining factors
and provides insights to stakeholders and potential entrants. The report will be a key decision-making
tool for the intended audience which includes blood analysis equipment manufacturers, POC device
manufacturers, biochemical sensor manufacturers, angel investors, potential entrants and so forth. This
study contributes to the areas of market growth among single blood drop analyzers and related
technology manufacturers. Genomic research centers, academic institutions, government and private
laboratories, various hospital settings as well as pharmaceutical, diagnostic and biotechnology
companies and physicians will find this study to be of interest.
In order to provide a better understanding of the market, the report is divided into segments based on
applications, technology, end user, and geography. The technologies segment includes blood collection,
blood analyzers, and consumable technologies; the applications section includes diagnostic testing for
various diseases such as cancer, diabetes, cardiovascular, viral or bacterial infection, fertility, and allergy.
Additionally, the report also focuses on patient monitoring and drug response monitoring. The report
provides regional insight of leading market segments. Geographically, the global market is divided into
North America, Europe, Asia-Pacific (APAC), and Rest of World. Further, the country-level market is
analyzed according to its geographical region.
The report provides useful information to all the market players, potential entrants, government
agencies and other interested parties. As the report also covers various geographic regions in detail,
companies interested in expanding their geographic reach will also find the report useful.

Information Sources
Key information was derived from various sources which included government organizations from
various countries including the U.S., China, India, the E.U. and Canada. International organizations were
also used as sources to gain raw data for the final estimations. Such organizations include the World
Health Organization (WHO), Centers for Disease Control & Prevention (CDC), and the World Bank.
Information was also obtained from the regulatory authorities such as the U.S. Food and Drug
Administration (FDA), European Food Safety Agency (EFSA), China Food and Drug Administration (CFDA)
and Food Safety and Standards Authority of India (FSSAI). Secondary data were also collected from
official websites of manufacturers and distributors of blood analyzers. Data were likewise gathered from
key end users in the markets, which include healthcare, pharmaceutical, veterinary markets and so
forth.
Sales data for the global and regional markets were corroborated for the present and forecasted values
based on statistical analysis. Regions are categorized into the U.S., Europe and the emerging markets of
India, China, Japan, South Korea, Taiwan, Canada, Africa, Australia and New Zealand. The application of
single blood drop analysis in various diseases is discussed from both a commercial and R&D perspective.
Key players involved in the single blood drop analysis market were surveyed to obtain data for this
study. Companies involved in blood analyzer technology including sensor manufacturers were also
surveyed to obtain insightful information. Data were also gathered from various other industry sources.
In addition, the author interviewed industry officials, consulted newsletters, company literature,
product literature and various technical articles, journals, indexes and abstracts. Exhaustive
investigations of databases by key terminology were completed. In addition, data were compiled from
current financial, trade and government sources.
The information collected was utilized to derive the forecast numbers. The data collected was further
validated by industry participants via phone, email, and Skype interviews.
Methodology
Both primary and secondary research methodologies were used in preparing this study. BCC Research
conducted a comprehensive literature search, which included technical newsletters, journals, and many
other sources. Data were collected through interviews and correspondence with manufacturers and
users of single blood drop analyzers. Projections were based on estimates such as the current number of
end users, potential end users, mergers and acquisitions, and market trends.
The annual revenues of major blood analyzer manufacturers, annual reports and forward-looking
statements as well as government data for blood analysis were analyzed to derive the size of the
market. Key information from published literature was used to conduct interviews with a number of
industry participants to validate and obtain expert opinions on current and future trends in the single
blood drop analysis market. Interviews were the primary basis for information regarding the
development of market size and were obtained by email and telephone. Interviews were also used to
confirm and adjust market size and market share estimates, as well as in formulating market
projections.

All market data pertain to the global market at the manufacturer’s level. Total revenues and forecast
revenue values are in constant U.S. dollars, unadjusted for inflation. Recent activities were tracked for
the major companies involved in the single blood drop analysis market in order to understand the
market trends. The forecast market size was based on these trends. The base year was 2017. Historical
data are provided for 2016 and forecast data are provided for 2027. Historical, base year, and forecast
data are provided for each market segment and sub-segment. Market shares are provided for each
market segment for the 2017 base year.
In this report, the geographic regions considered for market analysis include, and only include:
North America
o The United States.
o Canada.
Europe
o The United Kingdom.
o France.
o Germany.
o Italy.
Asia
o China.
o India.
o Japan.
Rest of the World.
Anuj Pathak is a market research analyst and holds an MBA and BSc from Devi Ahilya University (Indore,
India) in computer management with an emphasis on the healthcare field as well as information and
communication technologies (ICT). The analyst has applied his extensive knowledge of the healthcare
industry to a variety of projects across various domains including the pharmaceutical, medical device,
biotechnology, and the surgical instrument markets as well as other niche markets.

• HLC043E Point of Care Diagnostics.
• HLC184B Blood Testing: Technologies and Global Markets.
• IAS027E MEMS: Biosensors and Nanosensors Market.

Report Summary
The global single blood drop analysis market is expected to increase at a compound annual growth rate
(CAGR) of 10.6% during the 10-year forecast period of 2017 through 2027. Technological advancements
are the major driving force for this market. Single blood drop analysis provides quality results which are
similar to conventional lab testing. Single blood drop analysis is highly popular in POC devices especially
among diabetes patients for diagnosis and monitoring of blood glucose. A number of leading players
such as Bayer, Abbott, Alere, Siemens, Koninklijke Philips
Philips, and Becton Dickinson (BD) are already performing well in the diabetes care market. In the
current market scenario, single blood drop analysis is not limited to diabetes testing and monitoring. A
variety of tests can be performed on a single drop of blood. For example, i-STAT, a POC designed by
Abbott can perform 26 tests by analyzing chemistries, electrolytes, hematology and blood gasses from
single blood drop. Presently, single blood drop tests are becoming more popular and attracting
investors. In 2016, Genalyte, a startup engaged in single blood drop analysis, received $36 million in
funding. Additionally, 1Drop Diagnostics received several investments from 2015 to 2017. During 2015,
it received $350,000, and in 2016, it received another $924,000 from an undeclared source. With its
testing kits, 1Drop facilitates the early detection, prevention and management of disease, thus enabling
individuals to live better lives.
Theranos, once a popular and pioneering company in this market, received overall funding of around
$800 million. However, the company did not perform well in the market and failed. The failure of
Theranos did not affect the growth of the market and many new players, mainly startups such as
Genalyte, Nueon Inc., 1Drop Diagnostics, GRAIL, Graphene Frontiers, Karius Inc., and Seventh Sense
Biosystems have entered the market since. Apart from these new entrants, some well-established
players such as Abbott, Philips, BD, Bayer, Roche, Siemens Healthcare, Danaher, and Alere are actively
participating in the market to bring new technologies.
The single blood drop analysis test has various advantages over conventional lab testing; however, there
is a question on the accuracy of these tests. The reliability issue is a major restraining factor in this
market. Government regulations and the product approval process also act as restraints in the market.
Currently, many individual or pre-defined group of tests can be performed using single blood drop;
however, a single drop cannot perform all the tests.
The factors that drive the single drop blood analysis market include the cost-effectiveness of the
technology, equipment cost, and the cost of consumables. The complete test cost is much less
compared to conventional tests. In conventional testing, various factors that increase the cost such as
equipment cost, wages of trained professionals, sample collection and transportation expenses. On the
other hand, single blood drop analysis can be performed at home without the need of a trained
professional, there is no need to transport the sample to the lab, and most single blood drop analysis
devices provide instant results. The rising prevalence of diseases such as diabetes, HIV/AIDS,
cardiovascular, cancer, viral and bacterial infections are also driving the market growth.
Other restraining market factors include lack of awareness, specificity of the test, accuracy, and
regulations. Most of the single blood drop analysis tests are disease-specific; for example, a device
designed for HIV will only look for HIV. Single blood drop analysis devices only diagnose a set of
predefined diseases. Another consideration is that a test conducted from capillary blood may not be

sufficient for routine screening purposes or may not provide accuracy, that is, equivalent to the standard
of testing that venous samples provide due to the small sample size.
For the purposes of this report, the market has been segmented by application, end users, and
technology. By application, the market is divided into diagnosis, patient monitoring, and drug response.
The technologies market is segmented into blood collection, blood analyzers, and consumables. For end
users, the market is divided into hospitals, clinics, individuals, labs and pathology, and R&D
organizations. In the end-user segment, the individual segment, which had the highest market share in
2016 with 69.7%, is estimated to fuel the growth of the market with 71.4% of the market share in 2027.
There are mainly two types of sensors, chemical and biosensors, being used in the single blood drop
analyzer which detects antigens, bacteria, microbes and specific blood compounds. The chemical
sensors are utilized to convert chemical information into useful signals that are used in the detection of
antigens present in the solution. The devices that capture the biological signal convert it into a
noticeable electrical signal, known as a biosensor. A biosensor contains the mix of organic elements such
as microbial, DNA, RNA, proteins, and chemicals for the electrochemical transducers to recognize and
watch for certain natural analytes, for example, a counteracting agent antigen connection.
Geographically, North America is expected to dominate the market due to the technological
advancement and infrastructure capability. Additionally, North America is home to many leading as well
as emerging players. In the longer run, developing regions such as Asia-Pacific and Africa will dominate
the market. A major portion of the population in these regions are undiagnosed for various diseases due
to lack of resources and infrastructure. Cost-cutting technologies, such as single blood drop analysis, are
expected to improve the healthcare system in these regions. Single blood drop tests for Zika, dengue,
HIV, sepsis, pregnancy, allergies, cancer and heart disease are expected to improve the rate diagnosis in
these regions.
Table 25
Global Market for Single Blood Drop Analysis, by Application, Through 2027
($ Millions)
CAGR%
Application 2016 2017 2027
2017-2027
Patient monitoring 7,605 8,134 18,473 8.5
Diagnosis 676 874 5,933 21.1
Drug response monitoring 169 192 734 14.4
Total 8,450 9,200 25,140 10.6

Figure 15
Global Market for Single Blood Drop Analysis, by Application, 2016–2027
($ Millions)
20,000
18,000
16,000
14,000
12,000
$ Millions
10,000
8,000
6,000
4,000
2,000
0
2016 2017 2027
Patient monitoring Diagnosis Drug response monitoring
An Overview of Chemical Sensors and Biosensors

Chemical Sensors
A chemical sensor is a device that converts chemical information into an analytically useful signal.
Chemical sensors contain a receptor and transducer part which performs the conversion. In addition,
some sensors can include a membrane separator. The ideal chemical sensor device is portable,
inexpensive, and safe. The chemical sensor responds to a specific chemical substance (analyte) present
in any desired medium in order to generate a measurable signal output at any required analyte
concentration. In reality, chemical sensors are complex devices and generally optimized for a particular
application. The capability of chemical sensing technology in blood analysis is important and has grown
steadily over the times.
Biosensors
The device that captures the biological signal and converts it into a detectable electrical signal is known
as a biosensor. The purpose of the biosensor is to produce a digital electronic signal which is
proportional to the concentration of a specific chemical or set of chemicals. This emerging technology
crosses conventional tools and offers a powerful new tool. Biosensors contain a combination of
biological elements such as microbial, DNA, RNA, proteins, and enzymes to the electrochemical
transducers to detect and observe certain biological analytes such as antibody-antigen interaction.
There are several types of biosensors that are employed in the fields of biomedical, environmental and
food industries successfully and which are used to detect and remove certain non-living or living entities

and contaminants. Optical, amperometric, surface plasmon resonance, DNA, enzymatic, phage, and
bacterial sensors are the most common sensors being employed across the globe.
Many companies such as Roche and HICOMP MicroTech Co. Ltd. are manufacturing biosensors for
cancer detection, glucose level monitoring, insulin level detection, and more. In 2015, Roche and
BioMed X collaborated to develop nanomaterial-based biosensors for near-patient testing. Other
companies such as LifeScan Inc., Abbot, and Bayer are using biosensors in their blood analysis products.
Table 26
Applications of Biosensor in Healthcare
Application Description
The biosensors are generally recognized for measuring blood gases, ions and
Measurement of metabolites metabolites. Biosensors allow for a better estimation of the metabolic state
of a patient.
Biosensors are widely used in the diagnosis of diabetes across the globe.
Diabetic patients have a lack of insulin, which is essential in the metabolism
of a number of carbon sources. Due to this deficiency, various metabolic
Diabetes
abnormalities happen including higher than normal blood glucose levels. The
biosensor detects the deficiency of insulin in the human blood and notifies
the patient.
The glucose in the blood has been estimated on finger-prick blood samples
with a colorimetric test strip, or more recently, with an amperometric pen-
Insulin therapy size biosensor device operated by the patients themselves. The insulin
diagnostic kits are portable, very simple to use, and require minimum of
expert interpretation.
The closed-loop system becomes an artificial pancreas, where the glycemic
Artificial pancreas
control is achieved through an implantable glucose sensor.
Source: Gateway Coalition Org.
Diagnosis of Multiple Diseases by Single-Drop Blood Testing

A major advantage of the single drop blood analysis is that it can diagnose multiple diseases with a
single drop. The technology distinguishes more than 100 types of allergies and detects 13 types of
cancers and other diseases. The advantage of diagnosis of multiple diseases through a single drop of
blood test is less time requirement, a smaller number of samples, and less diagnosis cost. In 2014,
researchers at the DNA Medical Institute (DMI) in Massachusetts created a portable handheld device
which can diagnose hundreds of diseases using a single drop of blood with high accuracy. The product is
known as rHEALTH. The technology was developed in seven years with grants from NASA, the National
Institutes of Health, and the Bill and Melinda Gates Foundation. The DMI is also trying to create a
technology through which diagnosis is made possible even in space. The sample goes through a spiral
micro-mixer and is streamed past lasers that use variations in light intensity and scattering to come up
with a diagnosis, from flu to a more serious illness such as pneumonia or even Ebola within a few
minutes. The device is also used for continuous monitoring of heart rate, body temperature and so on; it
can be linked to smartphones. The institute has developed a smartphone application called CHAS

(Comprehensive Health Assessment Unit) for the self-diagnosis of the user. Three models that are
available for rHEALTH are include the rHEALTH One, rHEALTH X and rHEALTH X1. The rHEALTH One will
be used in translational research, the rHEALTH X as a type of power tool for clinicians; and the rHEALTH
X1 will be available as a consumer product.
The single drop blood test can be used to diagnose various types of allergies in a person. Generally,
diagnosis takes place with a skin test (scratch test) which can be itchy and uncomfortable, or by drawing
blood. However, in May 2017, a new blood test called the Allergy Pro was made available in Bellaire, the
Woodlands, and Lake Jackson, Texas. Allergies can be 70 environmental allergens and 50 food allergens.
The test can identify more than 100 allergens, and with four drops of blood, up to 120 allergens can be
confirmed.
The single drop blood test is also finding opportunities in the diagnosis of cancer. There are more than
100 types of known cancer. In 2017, a team of researchers in Japan directed by the National Cancer
Center (NCC) in Tokyo, Japan with Toray Industries Inc., and other institutions, has worked on the
diagnosis of cancer. They have developed a new method for the diagnosis of 13 different cancer types
with just a single drop of blood. This method detects differences in microRNA (miRNA). It can find the
alteration between healthy cells and cancer cells. The method is able to detect severe cancers including
cancers in the breast, lung, stomach, colorectal tract, esophagus, liver, and pancreas.
The miRNA cancer detection rate is more than 95% accurate. Due to the introduction of this new
method, it is possible to detect cancer at the early stages of development. The chances of survival in a
cancer patient will increase if the diagnosed in the initial stage. Similar technology for detecting cancer
through miRNA is being actively followed in Europe; however, there haven’t been any studies where
research was conducted on patients as in Japan. The researchers are preparing the test for government
approval, and it is expected that it will be launched commercially in the next three years.
Advantage Over Conventional Methods

Single drop blood analysis is point-of-care testing. POCT can be defined as medical diagnostic testing at
or near the time and place of patient care. POCT is a reverse of conventional testing methods in which
most of the testing is limited to a medical laboratory. In traditional methods, there can be a waiting
period of hours to days for the results and an observable delay in the proper action and treatment of the
disease.
POC technology includes blood glucose testing, rapid coagulation testing, rapid cardiac markers
diagnostics, fecal occult blood analysis, blood gas and electrolytes analysis, pregnancy testing,
hemoglobin diagnostics (HemoCue), infectious disease testing, and cholesterol screening. The POCT is
carried through the use of portable, easier to transport and handle instruments like the blood glucose
meter and other test kits such as the CRP, HBA1C, Homocysteine, HIV salivary assay and more.
In addition, the POCT method is less expensive compared to conventional testing methods for many
diseases which majorly include diabetes, carpal tunnel syndrome (CTS) and acute coronary syndrome.
The POCT provides diagnosis results immediately in an electronic medical record, and hence results can
be shared instantaneously with medical professionals. The POCT has a vital application in disaster
situations such as floods, earthquakes and other catastrophic events along with the treatment of
military personnel in remote fields where the requirement for fast action is even more critical.

Blood Collection Technologies
The blood collection method refers to the process of drawing blood from the body for the purpose of
analyzing a blood sample for diagnosis. Conventionally, the intravenous method of obtaining blood is
the most common. However, with the advancement in technology, many novel methods and
apparatuses have been developed for making the procedure efficient and painless. Single-drop blood
diagnostics have been the outcome of making the diagnoses efficient, ensuring patient convenience.
The blood collection market is segmented into finger prick, capillary, and intravenous methods of blood
collection. Blood collection is expected to generate a revenue of $2.1 billion by 2027 from $739 million
in 2017. The finger-prick method of blood collection is estimated to be the largest and fastest growing
market in blood collection technology during the forecast period owing to the ease of administration
and minimally invasive procedure that makes it a desirable option for blood sample collection. The
market is expected to grow at a CAGR of 11.0% from 2017 through 2027.
Finger Prick
The finger-prick method is a type of blood test conducted on venous blood obtained by a fingerstick,
and the blood is captured in a capillary tube. This method is basically used in adults for collecting blood
samples and a heel prick is employed for use in infants, which is less painful. This method of blood
collection is performed when a small amount of blood is adequate for needed tests. Finger-prick blood
tests offer low-pain and low-drain blood diagnostics, making patient care more pleasant.
Capillary Puncture Method

Capillary punctures are used when a small amount of blood, that is, less than 1 ml is needed. Capillary
puncture collections are usually employed in children and are advantageous in certain adult
populations. A capillary puncture, however, is not suitable for patients suffering from dehydration or
who have poor peripheral circulation. Areas of fingers and heels that are cold, swollen, scarred or
covered with a rash should be avoided.
Intravenous Blood Collection

The market for intravenous single drop blood collection method is growing at a CAGR of 10.7% and is
expected to grow to $304 million through 2027 from $110 million in 2017. The intravenous method of
blood collection, or venipuncture, draws blood from a vein. The intravenous method of blood collection
varies with the age of the patient, equipment available and tests required. This method is suitable for
elderly people, oncology patients, severely burned patients, obese patients and patients with fragile
veins.
Many practitioners may use a syringe-needle technique for venepuncture, which involves puncturing in
the vein to draw blood for collection. This process consists of evacuated tube system with a needle, tube
holder and evacuated tubes. The needle is attached to the tube holder by the needle practitioner post
blood collection.

Table 27
Finger Prick Method Versus Venous Blood Samples
Finger Prick method Venous Blood Samples

It is relatively costlier than finger prick method as it is
It is a cost-effective blood test.
performed by a skilled practitioner.
The finger-prick method is prone to some
inaccuracies. The blood obtained from the
Venous blood samples provide more reliable and
fingerstick may not be sufficiently and analytically
accurate blood test results. The success rate is 99%.
sensitive to that of standard testing with venous
samples.
It is sent to the lab for testing and can take 1-2 days
Results are available immediately.
for results.
It causes some pain and may not be a good option for
It is a less invasive method.
the elderly and children.
Less risks associated with the finger-prick method
include temporary scaring, blood-borne infection Slight bleeding, fainting, infection, and hematoma are
and tenderness or soreness, which can be observed some of the risks associated with this procedure.
up to 3 days after testing.
Venous samples have major advantages over finger-
Only a definite number of pre-defined tests can be prick tests. The relatively large volume of blood
performed on a finger-prick sample. collected and sent to a lab means that 200-300
Technological advances are underway to develop routine blood analysis can be carried out on a single
finger-prick blood tests to make them more accurate sample. A full blood count to identify certain
and comprehensive, the future of blood analysis is conditions, monitor metabolism through hormone
uncertain. levels, examine cholesterol levels that influence
cardiovascular health, check liver and kidney function.
Single Blood Drop Analysis: Applications

On the basis of application, the market for single drop blood analysis is segmented by diagnosis, patient
monitoring, and drug response monitoring. The market for single blood drop diagnostics for diagnosis is
dominating the market owing to the higher penetration of glucose testing point-of care-devices in the
market. Further, extensive R&D by researchers to introduce single drop tests for other diseases is
augmenting the growth of the single drop blood analysis for diagnosis.
Diagnosis
Point-of-care technology for cancer diagnosis is boosting the growth of the market. North America is
expected to dominate the market for single blood drop cancer diagnosis due to the extensive research
ongoing in this region. Many major companies are U.S.-based, and the company that introduced the
concept and technology for single drop testing was U.S.-based Theranos.
Genalyte, a start-up company, is bringing a technology platform that counts the binding of biomolecules
including proteins, antibodies, etc. to silicon photonic biosensors. Its technology is being used by various

pharmaceutical companies as well as academic researchers to monitor autoimmune diseases, detect
anti-drug antibodies, screen for cancer biomarkers, and test for infectious agents such as Ebola.
Widespread R&D is being conducted globally for the development of single drop blood analysis for
cancer diagnosis. Novel technologies are driving the growth of POC devices in cardiology owing to
increasing R&D of new technologies for faster diagnoses.
Currently, single blood drop testing technologies are available for HIV and the Zika virus. Additionally,
diarrhea-causing diseases are highly infectious and a significant danger to the health of immune-
compromised or elderly patients; such infections can be life-threatening when not caught in time to
allow for appropriate therapy. Alere provides diagnostic products for detecting infectious bacteria.
Alere’s HIV diagnosis product, SD BIOLINE HIV/Syphilis Duo test, is an immunochromatographic assay for
the qualitative detection of antibodies to all isotypes and can detect HIV with single blood drop. Alere
additionally provides lab-based analyzers for blood analysis called Alere q analyzer that provides POC
results in real-time.
Patient Monitoring
Patient monitoring has become a crucial factor in providing efficient healthcare in both healthcare
facilities and the home to the population. Routine cholesterol monitoring and blood glucose monitoring
for keeping these diseases in check has become important. Patient parameters such as heart rate and
rhythm, respiratory rate, blood pressure, blood-oxygen saturation, and many other parameters have
become a common feature of care for critically ill patients. Patient monitoring plays an important role
when accurate and immediate decision-making is required for the further diagnosis of a specific disease,
and electronic monitors are frequently used to collect and display physiological data.
• With technological advancements, patient monitoring has been made possible. Data is collected
using non-invasive sensors from less seriously ill patients in a hospital’s medical-surgical units,
labor and delivery suites, nursing homes, or in patients’ homes to detect unexpected life-
threatening conditions, or to record routine and required data efficiently. The Apollo Dx
monitoring platform is one such example that uses mobile-based technology to deliver results
with a single drop of blood. Increasing rates of chronic diseases such as diabetes and heart
problems are a serious concern due to lack of sufficient facilities and extremely high cost.
• Increasing rates of chronic diseases such as diabetes and heart problems in the aging population
are becoming severe and require patient monitoring systems. The situation is difficult for the
people residing in remote areas far from medical facilities as delays in diagnosis and treatment
may lead to mortalities. Timely diagnosis and treatment is enabled with effective patient
monitoring.
• Advancements in wireless communications and wearable sensor technology are creating

opportunities for real-time healthcare monitoring systems.
Drug Response Monitoring

The market for single blood drop diagnosis for drug response monitoring is growing owing to the
increasing demand for personalized healthcare and medicine. Additionally, blood tests are done to

check whether a medication is right or not for a patient. A small blood sample or saliva can enable to
check drug response for specific medications. Drug response tests for changes or variants in the genes of
a patient to check whether a medication could be an effective treatment or could possibly have harmful
side effects to a specific medication. Drug response testing is one tool that enables healthcare providers
to determine the best medication for an individual.
Competitive Lanscape
Single drop blood testing as a point-of-care technology is widely accepted for glucose monitoring in
blood. Hence, companies are developing similar devices for the diagnosis of the other diseases such as
tuberculosis, malaria, sepsis, cancer, HIV and so on. Companies are also investing in significant research
in regular cholesterol monitoring as a point-of-care technology. A number of companies, startups, and
universities are investing time and money in the discovery of new devices or increasing the accuracy of
the product, and it is expected that new products with better accuracy will be approved by the
government and will be launched during the forecast period.
Table 28
Approved Products for the Single Blood Drop Analysis Technology Industry
Company Date Description

The FreeStyle Precision Neo Blood Glucose Monitoring System received Food and
March-
Drug Administration (FDA) clearance and is now available at the cost of $14-$17 USD
2015
for 25 strips and a one-time fee for the meter, which ranges from $22-$28 USD.
Abbott received U.S. Food and Drug Administration (FDA) clearance for its i-STAT Total
April 2015
β-hCG test.
Abbott announced that the U.S. Food and Drug Administration (FDA) had approved
September
the company's FreeStyle Libre Pro system, a revolutionary continuous glucose
2016
monitoring (CGM) system for healthcare professionals to help patients with diabetes.
Abbott Abbott (NYSE: ABT) announced that the FreeStyle Libre system is now available for
September reimbursement in the U.K. The National Health Service (NHS) Business Services
2017 Authority has approved the listing on the Drug Tariff for the FreeStyle Libre system for
people with diabetes using insulin.
Abionic SA, an engineer of disrupter nanotechnology-based rapid diagnostic
arrangements reported that its quick sensitivity test, IVD CAPSULE Aeroallergens, and
September
the simple to utilize testing stage, abioSCOPEâ have been enrolled in the U.S. by the
2017
FDA. Abionic expects to begin commercialization of its IVD CAPSULE Aeroallergens in
the market in 2018.
February The company received FDA clearance for Xpert Xpress Flu and Xpert Xpress Flu/RSV.
2017 Both tests claim to provide reference-quality molecular results for flu in 20 minutes.
Danaher Corp. completed the acquisition of Cepheid for $4 billion. In the merger, the
December
share of Cepheid common stock was cancelled and converted into the right to receive
Cepheid 2016
$53 per share in cash.
The company received FDA clearance for its Xpert TV assay. It is a diagnostic test for
September
potentially dangerous and sexually transmitted infections in men. It delivers results in
2016
35 minutes.
Genteel November The company received FDA clearance for its gentle lancing device. It is the blood
LLC 2016 drawing device which is performed using an application vacuum and has eliminated
Company Date Description
the requirement of fingerprick.
The company received FDA approval for its Enlite Sensor for use with the iPro2
September
Professional Continuous Glucose Monitoring (CGM) system. The Enlite sensor is a
2016
disposable glucose sensor which can be worn up to six days to provide better comfort.
Medtronic
Guardian (TM) Connect mobile continuous glucose monitoring (CGM) system received
PLC
the CE mark of approval for people with diabetes using insulin injection therapy. It is
July 2016
Medtronics' first smartphone-enabled CGM system. The product had been launched
in European countries in the second quarter of 2017.
One Drop announced Health Canada approval for One Drop | Chrome in November
November 2017. One Drop's complete diabetes management platform is now available
One Drop
2017 throughout the U.S., E.U., Canada and the U.K. It is now bringing affordable, accessible
and clinically effective diabetes care to people in 30 countries.
January The company received its second FDA clearance for the modified version of its novel,
Velano
2016 needle-free blood draw device.
Vascular
February The company received its third FDA approval for its product, PIVO, a needle-free
Inc.
2017 blood device.
Source: Company websites, BCC Research
Patent Analysis
Patent analysis is a tool to analyze the recent developments and interests of the key players. It provides
the knowledge of competitor’s technology and the product or service development process. Interpreting
patent information into focused knowledge enables the firm to measure its present specialized
intensity, to figure technological patterns, and to plan for potential rivalry in light of new innovations.
The patent by technology for the single blood drop analysis has been categorized by blood analyzer,
blood collection technology, low volumetric testing, POC devices, and sensor technology. The patent
numbers have been increasing with every year as there has been much technological development. The
patent for blood collection technology is increasing as it has been as easy for an individual to collect and
send in for testing, the new blood collection technology is painless and can be easily utilized. In 2015, 12
patents were published, and in 2016, the number was 14. Until November 2017, around 12 patents
were awarded to innovative companies and the research institutes.
Table 29
Patent for Single Blood Drop Analysis, by Technology, 2015–2017
Technology 2015 2016 2017* Total

Sensor technology 5 2 5 12
Blood collection technology 3 5 5 13
Point of care devices 2 2 - 4
Blood analyzer 1 1 - 2
Low volumetric test 1 4 2 7
Grand Total 12 14 12 38
Source: Google Patents, Free Patent Online, BCC Research (*Note: The data were recorded until
November 2017)
Several companies that are developing new technologies include Abbott, DNT Scientific Research LLC,
Panasonic Healthcare Holdings Co. Ltd., and others. The market players have been developing new
technologies. The technologies have been developed for testing of the diseases using low volumes of
blood.
Table 30
Patent for Single Blood Drop Analysis, by Assignee, 2015–2017
Count of Patent Number 2015 2016 2017* Total

Abbott 2 1 1 4
Abionic SA - - 1 1
ARKRAY Inc. 1 - - 1
Bayer HealthCare LLC - 1 - 1
Becton, Dickinson and Company - - 1 1
Bio Amd Holdings Limited 1 - - 1
Bionime Corp. - 1 - 1
Individuals 1 - 1 2
DNT Scientific Research LLC - - 2 2
Fabpulous B.V. 1 - - 1
Fio Corp. - 1 - 1
Joinsoon Medical Technology Co. Ltd. 1 - - 1
Leadway (HK) Limited - 1 - 1
Lifescan Scotland Limited - - 1 1
MedMira Inc. 1 - - 1
Northwestern University - - 1 1
Panasonic Healthcare Holdings Co. Ltd. - 2 - 2
ProteinSimple 1 - - 1
Rapidx Ltd. - - 1 1
Robert Bosch Healthcare Systems Inc. 1 - - 1
Roche Group 1 2 - 3
Samsung Electronics Co. Ltd. - 1 - 1
Sanofi-Aventis Deutschland GMBH - 2 - 2
Sorin Group USA Inc. - 1 - 1
Sysmex Corp. 1 - - 1
The Leland Stanford Junior University - - 2 2
Theranos Inc. - 1 - 1
Vanderbilt University - - 1 1
November 2017)
There has been a total of 35 patents registered in the U.S. that includes 12 patents in the year 2015, 12
patents registered in the year 2016 and 11 in the until Nov. 2017. The U.S. is considered to have the
largest number of patents registered as there are several key players that are U.S.-based. Several startup
companies are receiving funding, and there has been noted technological development. Several
research and development projects are ongoing in the U.S. The healthcare expenditures in the U.S. are
considered to be higher as compared to that of Europe.
Table 31
Patents for Single Blood Drop Analysis, by Patent Office, 2015–2017
Patent Office 2015 2016 2017* Grand Total

The U.S. 12 12 11 35
Europe -- 2 1 3
Total 12 14 12 38
Source: Google Patents, Free Patent Online, BCC Research (*Note: The data has been recorded until
November 2017)
Table 32
Patent for Single Blood Drop Analysis, by Technology, 2015–2017
Technology 2015 2016 2017* Total

Sensor technology 5 2 5 12
Blood collection technology 3 5 5 13
Point of care devices 2 2 - 4
Blood analyzer 1 1 - 2
Low volumetric test 1 4 2 7
November 2017)
Several companies that are developing new technologies include Abbott, DNT Scientific Research LLC,
Panasonic Healthcare Holdings Co. Ltd., and others. The market players have been developing new
technologies. The technologies have been developed for testing of the diseases using low volumes of
blood.
There has been a total of 35 patents registered in the U.S. that includes 12 patents in the year 2015, 12
patents registered in the year 2016 and 11 in the until Nov. 2017. The U.S. is considered to have the
largest number of patents registered as there are several key players that are U.S.-based. Several startup
companies are receiving funding, and there has been noted technological development. Several
research and development projects are ongoing in the U.S. The healthcare expenditures in the U.S. are
considered to be higher as compared to that of Europe.
Future Outlook
Companies are expected to continue to invest in the single blood drop diagnosis market globally to find
new methods of diagnosis for different diseases. Various companies and universities are researching on
a single drop blood test for different diseases which includes cancer, tuberculosis (TB), HIV AIDS, and
more. New devices such as the Marti TB Diagnostic which is used for TB single drop blood analysis, is
under development and expected to launch in 2019. Due to the wide scope of opportunities in remote
areas of developing and under-developed countries, the companies are targeting these areas to produce
cost-effective devices along with POC technology. Remote areas with a lack of infrastructure are
considered as great opportunities for the market. Additionally, POC devices being developed for
individuals show great potential for growth in this market.
Chapter 8
Cognitive Computing and

Artificial Intelligence Systems
Market in Healthcare
(HLC208A)
Chapter 8: Cognitive Computing and
Artificial Intelligence Systems Market
in Healthcare (HLC208A)
Introduction
• Define as well as identify key market segments and the market structure of cognitive computing
and artificial intelligence systems in healthcare technologies.
• Measure as well as estimate the global market for cognitive computing and artificial intelligence
systems in healthcare and its market segments by cognitive systems type and geographic
segmentation.
• Identify key market dynamics and the factors impacting the global market for cognitive
computing and artificial intelligence systems in healthcare and its subsegments.
• Identify the trends, gaps and opportunities in each of the micromarkets.
• Focus exclusively on segmentation based on offering, technology, application, end users and
geography. Analyze trends and opportunities in the major regions of North America, Europe,
Asia and the Rest of the World (ROW).
• Identify major stakeholders, product portfolio and recent developments as well as draw a
competitive landscape of the market leaders.

Cognitive computing and artificial intelligence systems are increasingly being used in various healthcare
applications ranging from diagnosis of disease to treatment management. As the implementation of
advanced technologies, such as machine learning, helps improve the efficiency of various applications
and reduces human effort, there is a growing demand for cognitive computing and artificial intelligence
systems.
Scope of Report
This research report presents an in-depth analysis of the global market for cognitive computing and
artificial intelligence systems in healthcare by offering, technology, application, end users and
geographic markets. The report includes key factors driving growth of cognitive computing and artificial
intelligence systems in healthcare. The report discusses the role of supply chain members ranging from
manufacturers to researchers. The report has an in-depth analysis of key companies operating in the
global market for cognitive computing and artificial intelligence systems in healthcare. The report’s
in-depth patent analysis will focus on providing extensive technological trends across years and
geographies such as the U.S., Europe and China.
The market for cognitive computing and artificial intelligence systems in healthcare is mainly segmented
into five major components: type of offering, technology, application, end user and geography. Based on
offering, the market is segmented into hardware, software and services.
Based on technology, the market is categorized into natural language processing, context aware
processing, deep learning and querying method. The market is classified by applications into robot-
assisted surgery, preliminary diagnosis, clinical trial participant identifier, dosage error reduction, virtual
nursing assistant, administrative workflow assistance, fraud detection and others. Based on end users,
the market is divided into healthcare provider, pharmaceutical and biotechnology company, patient and
payer. The market is segmented by region into the North America, Europe, Asia-Pacific and ROW.
Information Sources and Methodology

The global market for cognitive computing and artificial intelligence systems in healthcare was assessed
and calculated through a bottom-up approach that involved identifying the market revenues of the
micromarkets that make up the macromarkets. The following process was followed to ensure quality
and consistency of estimates.
• In-depth primary and secondary research was conducted.

• Primary research included gathering intelligence from key market players. The participants of
the interview include CEOs, key opinion leaders, product heads and directors.
• Secondary research not only included collation of data from freely available sources but also
paid subscription from specialized industry magazines and websites.
• To best assure triangulation of market estimates, the derived values were again validated
through primary research.
• Key factors considered during market estimations were price, volumes, incidence and
prevalence rates, number of procedures, among others.
The geographic segmentation was assessed through various parameters such as the number of players
in a particular region, incidence and prevalence rates, the extent of research activity occurring in that
geography and future potential.
In this report, the geographic regions considered for market analysis include and only include:
North America
• United States.
• Mexico.
• Canada.
Europe
• U.K.
• France.
• Germany.
• Rest of Europe.
Asia
• China.
• Japan.
• India.
• Australia.
Rest of the world (ROW)

• Brazil.
• Saudi Arabia.
• South Africa.
• Others.
Sangeeta Rai is a senior researcher who has analyzed and forecasted healthcare and advanced chemicals
markets since 2011. She holds a Bachelor of Science in biotechnology and a Master of Business
Administration in marketing. Prior to joining BCC Research, she has held senior research roles at Global
Data and Infinity Research. Sangeeta Rai is a pseudonym of the author.

• HLC196A Bionics: Technologies and Global Markets.
• IFT041B Artificial Intelligence: Applications and Global Markets.
• IFT145A Internet of Things (IoT) Technologies for Process Manufacturing: Global Markets.
• IFT152A Internet of Things (IoT) Sensors in Healthcare: Global Markets and Technologies.
• IFT117A Cognitive Computing: Applications and Global Markets.
• HLC189A Medical Imaging Instrumentation: Global Markets and Technologies Through 2022.
• HLC216A Global 3D Medical and Surgical Imaging Platform Market.
Report Summary
Artificial intelligence (AI) and cognitive technologies have gained significant traction and have been
more widely adopted in recent years. Increased adoption of cognitive and AI platforms can be attributed
to their wide application potential across the healthcare industry, including patients and hospitals.
Major market players such as IBM, Microsoft and Google have made significant investments in finding
healthcare uses for cognitive computing and providing a platform for various startup firms that create
specialized applications.
The cognitive healthcare industry represents a new partnership between human beings and technology
that has the potential to transform healthcare on a global scale. Cognitive systems that understand,
reason and learn are assisting people expand their knowledge base, improve their productivity and
deepen their expertise. This has proven extremely useful in various areas of the healthcare industry.
With the increasing integration of cognitive computing, users can now see health data that were
previously inaccessible which can in turn can have a great impact on the healthcare industry by greatly
improving patient care.
The market for cognitive computing and AI in healthcare is segmented based on type of offering,
technology, application, end user and region. The market by type of offering is classified into hardware,
software and services. Whereas, based on technology, the market is classified natural language
processing, context aware processing, deep learning and querying method. Further, based on
application the market is categorized into robot assisted surgery, virtual nursing assistants,
administrative workflow assistance, fraud detection, dosage error reduction, clinical trial participant
identifier, preliminary diagnosis and others. Moreover, based on end users, the market is divided into
healthcare providers, pharmaceutical and biotechnology companies, patients and payers.
The research for cognitive computing and artificial intelligence systems in healthcare is being
increasingly utilized to improve efficiency of various healthcare applications such as diagnosis and
medical imaging.
Developed regions of North America show predominant application of cognitive computing and artificial
intelligence systems in healthcare, however, the developing regions of Asia-Pacific display lucrative
opportunities for the expansion of cognitive computing and artificial intelligence systems in healthcare.
Table 33
Global Market for Cognitive Computing and AI Systems in Healthcare,
by Region, Through 2022
($ Millions)
CAGR%
Region 2016 2017 2022
2017-2022
North America 789 1,152 7,104 43.9
Europe 462 679 4,333 44.9
Asia-Pacific 260 400 3,180 51.4
ROW 131 198 1,461 49.1
Total 1,642 2,429 16,078 45.9
Figure 16
by Region, 2016–2022
($ Millions)
8,000
7,000
6,000
5,000
$ Millions
4,000
3,000
2,000
1,000
0
2016 2017 2022
North America Europe Asia-Pacific ROW
Cognitive Computing
Cognitive computing systems are developed for cognitive and perceptive knowledge processing. These
systems are based on contemporary denotational mathematics and are centered by the parallel
autonomous inference and perception mechanisms of the brain. Cognitive computing has helped in
designing next generation cognitive computers and autonomous intelligent systems that have the ability
to think and feel. These intelligent computing systems uses autonomous inferences and perceptions to
mimic the mechanism of the brain.
Computing technologies and systems can be classified into the following categories: imperative,
autonomic and cognitive. Imperative computing is a traditional technology and is passive in nature. This
technology is based on stored-program controlled behaviors for data processing. Autonomic computing
is a goal-driven technology and is capable of self-decision. It does not rely on instructive and procedural
information. When compared to imperative and autonomic computing, cognitive computing is a more
intelligent technology. It represents major natural intelligence behaviors of the brain such as inference,
learning, thinking and perceptions.
Artificial intelligence (AI)
Artificial intelligence (AI) can be defined as the use of computers to carry out tasks such as speech
recognition, decision-making, visual perception and translation between languages. Although AI
simulates human decision-making, it does not replace human intelligence. AI involves understanding
natural language that is written-out text. AI technology can be trained to make more logical decisions by
understanding natural language and generating hypotheses based on evidence and learning.
Figure 17
Cognitive Computing and AI Systems in Healthcare Applications
Artificial intelligence systems have been designed Apps like Babylon, used in the U.K., integrate AI to
to analyze data that contain notes and reports offer medical consultation based on personal
from a patient’s file, external research and clinical medical history and common medical knowledge.
expertise to help select the correct, individually
customized treatment path.
Applications
The National Institutes of Health has developed

Molly is a digital nurse to help people monitor
the AiCure app to monitor the use of medication
patient’s condition as well as follow up with
by a patient. A smartphone’s webcam is connected
treatments between doctor visits. The program
with AI to autonomously confirm that patients are
incorporates machine learning to support patients,
taking their prescriptions and helps them manage
specializing in chronic illnesses.
their condition.
In modern terms AI can be defined as an intelligent agent that acts within an environment to perform
successful actions. Some of the actions which artificial intelligence performs, but are not limited to, are
learning, reasoning, perception, problem solving and language-understanding.
• Learning: Learning is differentiated into various forms. The basic form of learning is trial-and-
error. It allows the user to perform tasks better in situations that it has not previously
encountered.
• Reasoning: Reasoning comprises drawing inferences which are applicable to the task or situation
at hand. However, it is challenging to develop AI with the capability to differentiate the relevant
from the irrelevant.
• Perception: In perception-based actions, a situation is scanned by various sense organs, real or
artificial. It also processes the internal data to the perceiver and analyses the objects and their
features and relationships between objects.
• Problem solving: Various types of problems can be addressed in AI, but generally they fall into
two categories: special purpose and general purpose. A special-purpose method is also known
to be tailor made and only solves a specific problem, whereas the general-purpose method
solves problems in a step by step process.
• Language understanding: Language is a system of symbols having meaning by convention,

where the languages could be in different forms, distinguishing it from that of a native human
speaker.
The increasing availability of large data sets, such as the World Wide Web or genomic sequences, as well
as increased available computational power, has created opportunities for new AI methods that rely
more on data than on algorithms. For example, the traditional approach to answering a natural language
query from a data repository emphasized deep understanding of the query, which is a very complex
task. However, when the repository is as large as the World Wide Web, one may simply provide a
template for the answer, being very likely that it will be matched by some information on the web.
Progress in various areas of AI has led to a renewed interest in developing agents that integrate multiple
cognitive functions. This, in turn, has led to an understanding that various approaches and methods
developed in the isolated subfields of AI (natural language processing, knowledge representation,
problem solving and planning, machine learning, robotics, computer vision, etc.) need to be
interoperable to both facilitate and take advantage of their integration.
Artificial Intelligence and Cognitive Computing in Healthcare

The implementations of cognitive healthcare applications are proceeding along two different paths:
customer or user engagement applications and discovery applications. Customer engagement
applications are designed to help find personalized answers to questions. For example, several emerging
companies have developed cognitive applications that provide consumers with answers to questions
about managing their own health and wellness.
Other cognitive systems provide support for healthcare-payer customer service agents. With a corpus, a
large and structured set of texts, that contains more relevant information than people could possibly
consume and retain, these systems answer relevant questions and provide new insight about their
health. Discovery applications are used in situations such as drug discovery or to discover the optimal
treatment for a patient.
In both types of cases, the healthcare organization needs to begin by defining the end user of the
system, the types of questions that will be asked and the content that is required to build the knowledge
base for the system. The cognitive system is used to understand relationships and discover patterns in
data that may lead to improved healthcare outcomes.
Healthcare taxonomies and ontologies—a coding system or semantic network of medical terms and the
relationships among these terms—are important to the development of a corpus for cognitive
healthcare applications. These ontologies are used to map the relationships between terms with similar
meanings. There are many ontologies that are already widely used in healthcare to organize terminology
related to medical conditions, medical treatments, diagnostic tests, ingredients and dosing for clinical
drugs as well as drug complications.
One example of a medical ontology is the International Classification of Diseases (ICD). The ICD‐10 is the
current version endorsed by the World Health Organization. However, it has not yet become the
standard in all countries. The ICD‐10 has become standard in the United States as of October 1, 2015.
The ICD includes codes for diseases, disease symptoms and medical findings about diseases. The ICD is
only one of many different taxonomies and ontologies in use across the healthcare ecosystem. To build
an efficient corpus for a healthcare application, one needs to find a common language to ensure that
data from different sources can be integrated and shared. Without a taxonomy of terms, the cognitive
system cannot learn as quickly, and the accuracy of results will be insufficient. Systems will miss a lot of
terms that have the same meaning.
Market by Technology
Artificial intelligence in healthcare uses algorithms and software to analyze complex medical data. Based
on technology, the market is categorized into deep learning, querying method, natural language
processing and context aware processing. As machine learning and deep learning capabilities of artificial
intelligence achieve better clinical outcomes during diagnosis and surgical procedures, it is expected to
grow at the highest CAGR during the forecast period. Natural language processing is the largest
contributor towards the market growth, as it plays a vital role in decision-making processes of
healthcare professionals.
Natural language processing is a subset of AI, where the machine is programmed to understand and
interpret human language. This helps fill the communication gap between humans and computers. The
advancement in natural language processing is expected to enhance the interface between human and
machines using AI applications, which in turn improves patients’ ability to take charge of their health.
Natural language processing techniques can be used to extract actionable insights from complex and
varied data sets which may help to develop a new generation of clinical decision support tools.
Figure 18
Segmentation of the Global Market for Cognitive Computing and AI Systems
in Healthcare, by Technology
Natural
language
processing
Context
Querying
Technology aware
method
processing
Deep
learning
Deep learning is a type of machine learning mechanism where the machine can learn from a variety of
data representations. These capabilities provide the possibility of using machines to improve care
provided to the patient, diagnostics and reproducibility in surgical procedures, which in turn, may
improve the probability of better clinical outcomes. This technology can also be used to generate
reports and perform administrative duties, increasing physicians’ time for patient care. In the querying
method, AI helps to understand and solve the query of the physician and patient regarding any health-
related problems.
Context aware processing is the ability of AI to adapt to changing circumstances and respond
accordingly to the situation. This may help anticipate immediate needs of patients depending on
situational and environmental information available. The technology utilizes various applications to
enhance the patient experience and provide the most appropriate approach to fulfil the needs of the
patient.
Table 34
by Technology, Through 2022
($ Millions)
CAGR%
Technology 2016 2017 2022
2017–2022
Natural language processing 824 1,212 7,766 45.0
Querying method 339 500 3,258 45.5
Context aware processing 316 469 3,159 46.4
Deep learning 163 248 1,895 50.2
Total 1,642 2,429 16,078 45.9
Government Regulations
A significant increase in the number of computer applications incorporating machine learning (ML) and
artificial intelligence (AI) techniques has been witnessed in recent years. AI and cognitive computing
platforms are designed to make interacting with devices increasingly seamless, which will ultimately
make technology easier to use while making humans more efficient in finding and managing
information. In addition, AI technologies have been largely adopted by government organizations for the
management of unprecedented amounts of available data.
Figure 19
Emerging AI and Cognitive Computing Technologies and Government Implications
AI and cognitive computing This has further resulted in the

technologies have gained rise in demand for relatively
significant traction owing to inexpensive massively parallel
increasing demand for computational capabilities and
management of large-scale improved learning techniques.
data.
This is expected to boost the

Such developments taking
demand for AI and cognitive
place over the years have
computing technologies
resulted in significant leaps in
further.
AI capabilities.
However, professionals have stated that the government should consider regulations for artificial
intelligence. This is attributed to the fact that artificial intelligence technologies may pose fundamental
existential risk for human civilization.
The pace of introducing AI and cognitive computing technologies to the market is accelerating and the
government must figure out an appropriate method to deal with it. The government must imply proper
regulations to harness opportunities and mitigate threats posed by AI technologies. If so, AI technologies
can help users overcome many of the healthcare industry’s severe challenges and improve people’s
lives. Thus, it is considered that AI can truly bring about transformation with its wide array of potential
applications, provided they are regulated with thoughtful foresight by the government.
Future Outlook
Increases in the processing power and capabilities of AI systems and the dearth of skilled healthcare
professionals are expected to drive market growth, whereas, limitations of AI decision-making and
limited acceptance from healthcare professionals due to risk of injury and misinterpretation are
expected to restrain the market growth. Conversely, application of AI for novel surgeries and screening
in conjunction with an untapped market in developing regions offer lucrative opportunities for market
expansion. Some of the future applications of AI and cognitive computing in healthcare application
include:
• Management of Alzheimer’s disease.
• Diagnosis predict treatment outcome and prognosis of various types of cancer such as breast
cancer and nonsmall cell lung cancers.
• Management of diabetic complications.
• Artificial neural network in diagnosis of cardiovascular diseases.
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DISCLAIMER
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professional nature. This information does not constitute managerial, legal or accounting advice, nor should it be considered as
a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is speculative in
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reported information or from its use.
March 2019

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2018 Healthcare

Chapter 2: Global 3D Medical and Surgical Imaging Platform Market (HLC216A) .. 3

Chapter 3: Transcatheter Treatment: Procedures and Heart Valve Market

Chapter 4: Medical Imaging Instrumentation: Global Market and Technologies

Chapter 5: Global Markets and Technologies for Electronic Health Records

Chapter 6: Non-opioid Pain Treatment: Global Markets to 2022 (HLC206A) ....... 70

Chapter 8: Cognitive Computing and Artificial Intelligence Systems Market in

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 1

• HLC216A Global 3D Medical and Surgical Imaging Platform Market.

BCC Research Staff

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Global 3D Medical and

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Reasons for Doing This Study

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© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 4

Rest of the World

• Various medical device markets.

BCC Custom Research

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Source: BCC Research

Software Hardware Services

Source: BCC Research

3D Medical and Surgical Imaging Platforms by Application

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 7

Some benefits of 3D imaging software used in an ultrasound application are:

• Ability to save sonograms as image files, DICOM and ultrasound reports.

Advantages of X-Ray Machines

• Painless and non-invasive diagnosis of disease and monitor therapy.

• Support surgical and medical treatment planning.

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 8

Magnetic Resonance Imaging (MRI)

Computed Tomography (CT)

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 9

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3D endoscopic systems provide higher resolution compared to previous 3D prototypes. 3D endoscopes

Advantages of 3D Endoscopy System

• Class I — General controls applied.

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Source: BCC research

Benefits of a Patient-Centric Approach

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Technological Advancements in 3D Medical and Surgical Imaging Platforms

Year Title Description

Source: Institute of Electrical and Electronics Engineers

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Artificial Intelligence and Analytics

Block-Chain and Internet of Things (IoT)

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•Provides full audit •All transactions of

Smart Contracts Disintermediation

•Real-time tracking •Helps with peer to

Source: BCC Research

Innovative Solutions by Platform Providers in the Market

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Source: BCC Research

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© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 18

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 19

© 2019 | BCC Research LLC HLC068G 2018 Healthcare Research Review | 20

More specific objectives are to:

Reasons for Doing This Study