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Executive Summary
• The Indian medical devices market is significantly smaller than other overseas markets. However, macroeconomic factors suggest a huge potential for
double-digit growth in the Indian medical device market
• Evolving behavior of consumers is driving the medical devices market
Market overview • Patients/consumers are becoming more proactive. They are actively involved with their healthcare providers in decision-making and are very accustomed
to asking for the latest device
• In FY 2022, the medical devices market in India was valued at INR 909.32 Bn. It is expected to reach INR 4,358.64 Bn by FY 2027, expanding at a
compound annual growth rate (CAGR) of ~41.93% during the FY 2023 – FY 2027 period
Drivers Challenges
• Changing landscape of medical devices • Recalls and lawsuits
Drivers and • Increase in incidence of non-communicable diseases • Cybersecurity concerns
challenges • Growth in medical tourism • Shallow penetration of medical devices
• Aging of the population • Shortage of healthcare professionals and infrastructure
• Shift towards homecare settings • Regulatory challenges
• High reliance on imports
• The medical devices market witnessed a drastic drop in sales due to various operational challenges, such as lack of resources, restrictions on the movement
Impact of COVID- of people and goods, and supply-chain challenges
19 • The market was already struggling due to financial and operational challenges
Major players
Competitive Centenial Surgical Suture Limited Opto Circuits (India) Limited Philips India Limited Poly Medicure Limited
landscape
Wipro GE Healthcare Private
Becton Dickinson Private Limited Medtronic, Inc. Siemens Healthineers, Inc.
Limited
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Socio-economic Indicators
Total population
1.438 1.451
1.411 1.425
1.383 1.397
1.354 1.368
1.324 1.339
Bn
1.309
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Population density
483.9 488.3
479.3
Persons per sq. km
470 474.7
460.4 465.2
450.4 455.4
440.3 445.4
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Axis Title
34.10% 35.30%
36.40%
37.30%
107.1
19% 18.50% 18% 17.30%
30.80% 28.40% 26.20% 24.20%
Urban Rural
67.20% 66.80% 66.40% 66% 65.50% 65.10% 64.60% 64.10% 63.60% 63.10% 62.60%
33.20% 33.60% 34% 34.50% 34.90% 35.40% 35.90% 36.40% 36.90% 37.40%
32.80%
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Total fertility rate (children per woman) Infant mortality rate (deaths per 1,000 live births)
2.4 39
32
27
2.24
2.14
121.2 48.7
Mn
Mn
119.7 46.2
82.10%
75.30% 74%
64.80% 65.50%
53.70%
2001 2011
Gross domestic product (GDP) growth rate Total Foreign direct investment (FDI) inflows
74.39
4.04%
60.97 62.00
to previous year
USD Bn
2017 2018 2019 2020
-7.25%
FY 2018 FY 2019 FY 2020 FY 2021
9.63% 7.11%
5.24%
4.00% 3.69%
2001 2011
Exchange rate
Period maximum Period average Period minimum
73.87
68.36 70.79 72.34
66.11 63.62 63.37
61.38
74.1 73.94 78.62
INR vs USD
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Introduction – Medical Devices
• Under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, a medical device is any instrument, apparatus, appliance, implant, in vitro reagent or calibrator, software, material or
other similar or related article
▪ The manufacturers of medical devices design and produce them for use as either single instruments, or in combination with others for diagnosis, prevention, monitoring, treatment, and/or
alleviation of diseases
• The medical devices sector in the country is growing steadily
▪ There are opportunities not just for Indian players, but also for foreign manufacturers
• The industry is supported by liberalized government policies and the provision for allowing up to 100% foreign direct investment (FDI) through the automatic route
• There is a high demand for advanced and specialized medical equipment due to the rapid growth of the luxury healthcare and medical tourism industries
▪ Demand for surgical instruments, prosthetic and orthopedic equipment, dental and orthodontic implants, electromedical equipment, cancer diagnostics, and imaging devices is high
• To capitalize on the business opportunities, several multinational companies (MNCs) are setting up their manufacturing units in the country
• Medical devices are classified based on their risk levels and intended use, and are divided into different classes
• The classification is on the basis of annex IX of schedule M-III provided by the Drugs Technical Advisory Board (DTAB)
Class A (low risk) Class B (low-moderate risk) Class C (moderate-high risk) Class D (high risk)
Devices such as thermometers and Instruments such as hypodermic needles and Apparatus for lung ventilator and bone Implants for heart valves and implantable
tongue depressors suction equipment fixation plate defibrillators
If a manufacturer wants to reclassify a device to a lower class, a justification must be submitted to the Central Licensing Approval Authority (CLAA) for evaluation. It should state that
the shift to the less stringent class will assure sufficient safety and effectiveness of the device
Medical devices
Therapeutic
Syringes Lancets Dental implants Drugs
equipment
Patient monitoring
Apparel Contact lenses Spinal implants Valves
system
Handheld/homecare
Pacing devices Cosmetics
Focus of the report products
Key products
Diagnostic imaging Therapeutic equipment Patient monitoring system Handheld/homecare products
Ultrasound scan, X-ray, computed Ventilators, syringe pump, infusion pump, Bedside monitors, electrocardiogram (ECG), Glucometers, digital thermometers, and sleep-
tomography scan (CT scan), magnetic dialysis equipment, sleep lab, continuous renal electroencephalograph (EEG), and disordered breathing (SDB) equipment
resonance imaging (MRI), gamma replacement therapy (CRRT), diathermy, heart- electronystagmography (ENG)
camera, pulmonary function test (PFT), lung machines, anticoagulation timer,
catheterization laboratory, holter warmer/incubator, and bubble scraper
recorder, echo color doppler, and C-arm
X-ray
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Global Medical Devices Market – An Overview
56,770.09
49,848.13 52,829.05
44,308.70 45,762.02 47,560.47
32,814.57
INR Bn
Key highlights
• In 2022, the global medical devices market in India was valued at INR 44,308.70 Bn
• It is expected to reach INR 56,770.09 Bn by 2027, expanding at a CAGR of ~5.54 % during the 2023 –2027 period
• Evolving behavior of consumers is driving the medical devices market
• Patients/consumers are becoming more proactive. They are actively involved with their healthcare providers in decision-making and are very accustomed to asking for the latest device
• Rising consumerism leads to preferences for devices or diagnostics that are more “user-friendly,” reliable, and built to last
• International trade also plays a significant role in the medical device industry. 35 to 40 percent of domestic US production is ultimately exported, and a similar share of domestic US
consumption is imported
• The largest export markets for US medical device companies have traditionally been the countries in the European Union and Japan. As of December 2022, the US is the largest single
market for medical devices and accounts for about 40% of worldwide sales
• Despite some major drivers of the market, more consumers are using technology for health monitoring and are willing to share their data
▪ Therefore, continuous change in medical devices has resulted in relentless downward pressure on pricing. Further uncertainty lies ahead, with the new EU device regulation in 2020 and price
capping imposed by the Indian government on essential medical devices
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Medical Devices Market in India – An Overview
4,358.64
2,728.93
INR Bn
1,854.65
1,361.31
909.32 1,074.18
816.42
Key highlights
• In FY 2022, the medical devices market in India was valued at INR 909.32 Bn. It is expected to reach INR 4,358.64 Bn by FY 2027, expanding at a CAGR of ~41.93% during the FY 2023 –
FY 2027 period
• The Indian medical device market is significantly smaller than other overseas markets. However, macroeconomic factors suggest a huge potential for double-digit growth in the Indian
medical device market
• Upcoming developments in the regulatory and policy framework are expected to accelerate growth of the Indian medical devices market
• Rising income levels, an ageing population, increased prevalence of lifestyle-related diseases, and the government's commitment to provide healthcare services at a reasonable cost to
both the rural and urban population are some of the factors attracting domestic and global players in the Indian medical device market
• The Indian medical device sector is also characterized by import dependency and a highly fragmented domestic industry. Presently, imports are preferred over domestic manufacturing
mainly due to the inverted duty structure and the lack of favorable policy and regulatory framework
• Recent changes in foreign exchange regulations with respect to the medical device market has allowed 100% FDI in both greenfield and brownfield projects. This provides a great
opportunity for foreign players to enter the highly attractive Indian market
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Impact of COVID-19
• Delays and halting of ongoing clinical • Significant reduction in production • Closure of international borders • Decreasing demand for non-COVID
trials of medical technologies and capacities due to lockdowns impacted global trade medical devices and equipment
devices • Shortage of raw material owing to • Limited movement of freight • Sharp drop in sales volumes during
• Stalling of development of new restrictions on travel exacerbated the supply chain the first quarter of FY 2021
products
• Massive surge in demand for challenges • Decline in medical tourism and
• Trimming of R&D investments, leading
masks, personal protective • Unavailability of contractual labor outpatient services, and
to delays in innovation
• Low productivity due to remote equipment (PPE), ventilators, and for operations postponing of elective medical
working arrangements diagnostic test equipment • Limited storage space due to procedures resulted in a drop in
• Manufacturers of these increased warehousing of non- sales
aforementioned products COVID-19 medical devices
augmented their production
capacities
Healthcare providers, healthcare professionals and researchers are increasingly using artificial intelligence, machine learning,
and natural language processing in order to track and contain coronavirus, and gain a comprehensive understanding of the
ongoing Covid-19 pandemic, globally
• AI has emerged as a powerful tool to fight against the deadly novel coronavirus
• The technology is used to train computers to leverage big data-enabled models for disease pattern recognition, interpretation, and prediction using ML, natural
language processing (NLP) and Computer Vision
• Using predictive analytics, healthcare device data scientists and researchers are analyzing large amounts of patient data sets in order to determine hotspot
areas of the disease outbreak, recommend strategies for quarantining people to prevent the disease outbreak, and most importantly, deploy and test new
vaccines and drugs
• Major medical device companies are currently using a number of AI-enabled systems to detect COVID-19 on chest CT or X-ray scans
• These deep learning tools are being used in hospitals to screen mild cases, decide the order of treatment of new infections, and keep a check on the progress
of the disease
• Medtronic, Inc., a medical device company developing AI-powered solutions, provides a data analytics platform for imaging COVID-19 infection from chest
scans
▪ The company claims that the results of these tests were 98% accurate, which indicates that these AI-powered tools will replace standard nucleic acid tests as
the primary diagnostic tool for coronavirus infection
• Zhongnan Hospital in China uses an AI-powered CT scan interpreter to identify COVID-19 without the help of radiologists
• Baidu, the Chinese technology giant, has developed a no-contact infrared sensor system that can quickly recognize individuals with fever in thick crowds
• Amazon Web Services (AWS), Google Cloud, and many other technology companies have recently offered healthcare researchers free access to open datasets
and analytics tools, which are otherwise paid, in order to help them develop vaccines and drugs to treat COVID-19
81.39
69.93 69.82
57.67
US US
3.41%
Germany Germany
China 41.19% China
FY 2021 7.24% FY 2022
Brazil Brazil
57.97% 6.12% Turkey Turkey
38.29%
Others Others
3.89%
2.94% 3.21% 1.58%
HS Code 9018 refers to instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and
sight-testing instruments
| MEDICAL DEVICES MARKET IN INDIA 2023 24
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Import: 9018
Import (based on value)
164.28
INR Bn
21.55% 20.33%
China China
36.07% 37.73% US
US
Germany Germany
FY 2021 FY 2022
Singapore Singapore
Japan Japan
19.05%
18.27%
5.25% Others 4.91% Others
5 901819 Apparatus for functional exploratory examination, and parts and accessories 7,695.23 6,794.36 7,306.66 6,450.10
8 901832 Tubular metal needles and needles for suture 2,488.23 2,737.43 3,663.71 2,705.76
Dental drill engines, whether or not combined on a single base with other dental
10 901841 2.67 9.45 0.60 2.56
equipment
11 901849 Other instruments and appliances, used In dental science 916.24 1,057.29 932.63 1,498.04
12 901850 Other ophthalmic instruments and appliances 1,593.81 1,909.72 1,573.68 2,228.87
13 901890 Instruments and appliances used in medical, surgical or veterinary sciences 15,298.08 22,426.54 21,844.20 26,322.96
Dental drill engines, whether or not combined on a single base with other dental
19 90184100 2.67 9.45 0.60 2.56
equipment
20 90184900 Other instruments and appliances, used in dental sciences 916.24 1,057.29 932.63 1,498.04
24 90185090 Ophthalmic surgical instrument and appliances 1,561.07 1,862.80 1,549.11 2,184.17
28 90189021 Bone saws, drills and trephines 39.19 25.75 32.07 38.83
29 90189022 Surgical knives, scissors and blade 1850.36 1824.20 1828.33 2306.31
Forceps, forcep clamps, clips, needle holders, introducers, cephalotribe bone
30 90189023 124.26 154.78 157.34 198.25
holding and other holding instruments
31 90189024 Chisel, gauges, elevators, raspatones, osteotome, craniotome, bone cutters 28.14 41.15 16.42 71.41
32 90189025 Retractors, spatulaprobes, hooks dialators, sounds, mallets 12.17 15.50 13.48 17.97
35 90189032 Blood transfusion apparatus including plastic container / bags 1953.66 2344.41 1806.41 2434.57
5 901819 Apparatus for functional exploratory examination, and parts and accessories 4334.64 4827.39 5182.50 8591.11
8 901832 Tubular metal needles and needles for suture 3626.32 3706.00 3122.47 4229.60
Dental drill engines, whether or not combined on a single base with other dental
10 901841 59.80 34.64 38.33 82.48
equipment
11 901849 Other instruments and appliances, used In dental science 4395.69 4651.08 2846.98 5675.94
12 901850 Other ophthalmic instruments and appliances 11594.47 11727.19 6781.19 11337.00
13 901890 Instruments and appliances used in medical, surgical or veterinary sciences 51886.12 52506.31 51661.72 72007.17
Dental drill engines, whether or not combined on a single base with other dental
19 90184100 59.80 34.64 38.33 82.48
equipment
20 90184900 Other instruments and appliances, used in dental sciences 4395.69 4651.08 2846.98 5675.94
24 90185090 Ophthalmic surgical instrument and appliances 10921.66 11286.49 6494.35 10693.32
28 90189021 Bone saws, drills and trephines 111.77 98.46 146.53 116.45
31 90189024 Chisel, gauges, elevators, raspatones, osteotome, craniotome, bone cutters 211.23 198.90 130.15 199.72
32 90189025 Retractors, spatulaprobes, hooks dialators, sounds, mallets 60.32 58.47 56.60 74.08
35 90189032 Blood transfusion apparatus including plastic container / bags 998.94 1323.27 1073.63 1651.24
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Government Initiatives
• The Indian government undertook several initiatives such as tax reliefs and import duty relaxations, research and development (R&D), and 100% FDI for
medical devices to boost the market
• It initiated Atmanirbhar Bharat to improve the market
• The Make in India initiative gave an impetus to Indian manufacturers to meet the growing demand for essential healthcare equipment
Make in India • Under the Make in India program, several state governments have taken up the responsibility of setting up medical device manufacturing parks in their
respective states
▪ This would support domestic manufacturing of high-end medical equipment at a low cost and rapidly enhance job creation
• In July 2020, the government released the production linked incentives (PLI) scheme for medical devices
Incentive • Under the scheme, an incentive at 5% of incremental sales over the base year (2019 – 2020) was provided to different segments of the medical devices market
• The incentive will be offered to the following segments of the market:
schemes ▪ Cancer care and radiotherapy
▪ Radiology and imaging
▪ Anesthetics and cardio-respiratory
▪ All implants such as cochlear and pacemakers
• In November 2019, the government approved to build four medical device parks in Tamil Nadu, Telangana, Andhra Pradesh, and Kerala, and granted INR 1 Bn to
Introduction of each of the states
medical parks • This initiative was undertaken to bolster the capabilities of Indian manufacturers and reduce manufacturing costs of medical devices
• These parks will be well-equipped with the necessary advanced infrastructure
• The medical device parks scheme by the government is anticipated to integrate the market and generate more than 33,000 additional jobs in the next five years
• A production linked incentive (PLI) scheme with an outlay of Rs. 3,420 crore for FY21 – FY28 was announced in February 2021 to promote domestic
manufacturing of medical devices
• The Indian Council of Medical Research (ICMR) and Indian Institutes of Technology (IITs) collaborated in November 2021 to form 'ICMR at IITs' by establishing
Centres of Excellence (CoE)
Investment ▪ This will assist in Make in India product development and commercialization in the medical devices and diagnostics space
promotion ▪ The ICMR-DHR CoEs at IITs will develop a pipeline of innovative medical devices and start-ups, incentivizing local manufacturing and providing holistic support to
technologies on the verge of commercialization
• The government also approved applications for nine eligible projects, which are expected to result in a total committed investment of INR 7.29 Bn by
companies, resulting in the creation of 2,304 jobs
• The Ministry of Health and Family Welfare (MOHFW) announced in September 2021 that the government has decided to form a committee to draft the 'New
Drugs, Cosmetics, and Medical Devices Bill' to create new drugs, cosmetics, and medical devices
• The government drafted a new drugs, cosmetics, and medical devices bill in October 2021 in order to increase the acceptability of Indian medical devices
in the global market
• The government approved a proposal worth INR 50 Bn to build a medical devices park in Himachal Pradesh's industrial township of Nalagarh, in the Solan
district, in September 2021
Other • The government approved for setting up a medical devices park in Oragadam (Tamil Nadu) in September 2021, which is expected to attract an estimated
initiatives investment of INR 35 Bn and provide direct and indirect employment to 10,000 people
• The government announced to build a medical park in Uttar Pradesh in July 2021, which is expected to generate an estimated INR 5 Bn revenue for the
state
• The Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical
Devices (ICMED) 13485 Plus scheme in June 2021 to verify the quality, safety, and efficacy of medical devices
• The Finance Minister allocated INR 86.2 Bn to the Ministry of Health and Family Welfare (MoHFW) in FY 2023 budget, a 16.5% increase from the previous
year
• The government has also assigned a major portion of the fund for the development of the COVID-19 vaccination program, Mission Indradhanus
Financial • Furthermore, it introduced a pan-India program called the Aatmanirbhar Health Yojana
benefits of ▪ This scheme was introduced to strengthen the healthcare infrastructure of the country to detect and treat new diseases
Mission Poshan ▪ The government has allotted a fund of INR 641.80 Bn for the project
2.0 • The union has also announced the launch of the second phase of the Poshan Abhiyaan scheme, ‘Mission Poshan 2.0‘
▪ Mission Poshan or the Poshan Abhiyaan is a flagship program of the Indian government, to be launched to improve the nutritional outcome for pregnant women,
children, and lactating mothers
• Apart from financing, the government has declared to invest in setting up 15 health emergency centers by 2022
• Improved surgical techniques and new implant materials for joint replacement (e.g., hybrid replacement method used in hip replacement surgery) propel the growth
of the orthopedic segment
• Introduction of advanced and dependable diagnostic technology has led the medical society to increase its dependence on diagnoses
• Besides, the advent of the latest techniques lead to fast obsolescence of existing medical devices, thereby creating demand for upgradation or replacement of these
products
• Apart from this, Indian consumers, especially in urban areas, are increasingly becoming aware about the advancement in medical devices. Therefore, the demand for
advanced medical treatments has picked up
▪ Medical industry members conduct training and educational workshops for medical service providers
▪ This resulted in the rise in the demand for new medical devices
• The government promotes medical tourism. As a result, the nation has emerged as a medical tourism hub for patients from across the world
• International medical tourists come to India for advanced medical treatments
▪ The rise in medical tourists is expected to drive the demand for high-quality healthcare services, medical devices, and technology
▪ This has also boosted private healthcare providers to upgrade their medical technology infrastructure
• India is regarded as one of Asia's fastest-growing medical tourism destinations, with a market value of INR 581.86 Bn in 2022
• Increased medical tourism means a surge in the number of patients in hospitals
▪ As a result, there is a greater demand for advanced and high-quality medical care from doctors and medical institutions
• Healthcare service providers have invested in the installation of high-tech medical equipment and advancement of medical technology in order to achieve quality
recognition
• As a result, the sales volume of indigenous medical device manufacturers is expected to rise
• The increase in income and affordability have resulted in the demand for utilization of healthcare services
• A booming economy has increased disposable income and led to an improvement in the standard of living
• Healthcare expenditure rose significantly from INR2730 Bn in FY 2019 to INR 4720 Bn in FY 2021
• India’s per capita disposable income increased substantially between 2010 and 2020. The share of the healthcare expenditure in household consumption also rose
noticeably
▪ As a result, many people are now able to afford high quality healthcare services
• Moreover, health insurance coverage has also expanded in the past few years, and this resulted in rising demand for advanced medical treatments
▪ The life insurance business earned a premium income of INR 6.29 Trn in FY 2021, up from INR.5.73 Trn in FY 2020, a 9.74% increase
• Therefore, an increasingly affluent population in major cities has been driving the demand for new and advanced medical devices
• The rising prevalence of chronic medical conditions and treatment of patients suffering from these diseases are exerting huge pressure on the healthcare ecosystem
of the country
• This had led to a significant rise in the economic burden of treating these diseases. The overall cost of treating a patient in a hospital inpatient setting is significantly
higher, and longer hospital stays are associated with a higher economic burden
• Due to this increasing economic population and a rising population in the above-60 age group, there is a paradigm shift of preference toward home healthcare
services
• Additionally, with the increasing effort of key players, healthcare agencies are planning to develop and launch new and easy-to-use medical equipment, such as
portable and wearable devices for the treatment of chronic diseases
• In a market as diverse and demanding as the medical device sector, recalls and lawsuits are frequent
▪ Many times, the former preempts the latter. As they continue to iterate and innovate, many manufacturers recall old models as a precautionary measure—a move that costs
money yet could save time and cost more by avoiding a lawsuit
• Likewise, lawsuits are common in a market where definitive medical claims may draw scrutiny from the FDA and customer expectations are high
• Medical device manufacturers need to set and maintain patient and practitioner expectations to avoid litigation. Also, a better medical device approval process would
deescalate tension and safeguard both producers and consumers
Cybersecurity concerns
• As more and more devices become digital, cybersecurity concerns have increased rapidly
• Even something as simple as a Bluetooth-enabled device serves as an access point for data theft
• Device manufacturers now find themselves facing concerns about patient privacy and protection per HIPAA, which makes manufacturing smart devices more complex
and costly
• A staunch cybersecurity approach can add months to the development timeline, zeros to the production cost, and headaches when it comes to seeking approval from
regulators. In simpler terms, data security isn’t optional and it’s creating challenges for manufacturers
• Despite the significant growth of the medical devices market in India in the past few years, the market witnessed low penetration
• The growth of the medical devices industry is rapid, and the requirement comes chiefly from major cities
• Adoption of healthcare facilities remains low in rural areas, small cities, and towns due to lack of awareness, accessibility, and affordability
• Although heart diseases are a key concern, cardiac pacemaker penetration is lesser in India than western countries
• Besides, public healthcare infrastructure is disorganized and insufficient, with low investments in medical equipment
▪ As a result, access to healthcare is inadequate in rural areas
▪ Distribution of medical technology in these areas becomes a challenging task
• Dearth of healthcare professionals and infrastructure is a major reason behind the under-penetration of the medical technology market
• According to the World Bank data, in 2019, India had only 0.9 physicians per 1,000 people
▪ India also had much lower doctor density than China and Brazil
• To extend the reach of healthcare solutions to remote areas, virtual doctors, as well as time-efficient medical technology solutions are needed
• Furthermore, the healthcare sector faces challenges in terms of infrastructure
▪ India has an estimated 1.1 beds per 1,000 people, which is far behind the 3.5 beds per 1,000 people as recommended by the World Health Organization (WHO)
• The government spends only 1.3% of its GDP on the public healthcare sector
• Lack of trained professionals and clinical staff needed for installing, functioning, servicing, and repairing medical devices is a major limiting factor
• The hospital resources fall short on the number of people they are expected to serve
▪ In 2019, there were only 0.5 government hospital beds per 1,000 patients, while China and Brazil had 4.3 and 2.1 beds respectively per 1,000 patients
• Medical technology costs 30% – 40% of the total investment required to establish a tertiary care hospital and contributes to 20% – 25% in total healthcare costs to a
patient
• Thus, affordable medical technology is a crucial challenge in improving the health infrastructure
Regulatory challenges
• Absence of an autonomous regulatory authority for medical devices act as a major challenge for the industry
• Drug Controller General India (DCGI), Ministry of Health and Family Welfare (MoHFW), Atomic Energy Regulatory Board (AERB), and Bureau of Indian Standards (BIS),
regulate various aspects of the medical electronics sector
▪ However, the medical devices market has no separate regulatory status in India, and Central Drugs Standard Control Organisation (CDSCO) is mainly responsible for its
regulation
• Besides, regulatory changes such as price control of medical devices with steep price cuts lead to an environment of uncertainty
• Moreover, the medical technology market experiences inadequate quality standards, lack of tax incentives to promote indigenous manufacturing, and meagre
government funding to encourage innovation
• In the absence of industry-specific regulation, products of inferior quality have been introduced into the market, resulting in wider price and quality disparities within
the same product category
• There have been some cases of counterfeit products, for example, illegal reprocessing and re-packaging of syringes for re-sale, which creates serious risk for consumers
• The healthcare market does not have a manufacturing base of medical devices and technologies
• The market is reliant on imports for meeting its domestic needs
▪ Import constitutes nearly 75% of the medical technology market
• It is highly dependent on China for its electric components and raw materials such as orthopedic implants, bandages, syringes, gloves, computed tomography, and
magnetic resonance imaging devices
▪ In the wake of the pandemic, the medical products industry was severely impacted by the shortage of supply of critical medical devices
• The major challenge behind the lack of medical devices is the huge capital required for the expansion of the medical technology market
• While the healthcare industry is on a growth trajectory; the medical devices market has limited accessibility
• At the same time, while the medical technology market is highly import-dependent, 60% of indigenously manufactured components are exported
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Market Trends
• During the lockdowns and social distancing protocols required by the COVID-19 pandemic, telemedicine has seen significant
growth in popularity
• With increases in fiber optics and networking speed and availability, computer-assisted surgery and telesurgery are becoming
Fibre optic technology increasingly possible
• Currently, surgical robots have become more common and are accepted in hospital operating rooms and networks like 5G offer
increased speed and stability
▪ Therefore, telesurgery has become more possible and increases precision and efficiency while minimizing time and costs
• In 2022, 3D printing in the medical field was valued at INR 7.26 Bn. Many 3D-printed pieces are used in prosthetics, and printing
living tissue has become a possibility
• There are also major project lineups for printing usable organs soon
3D Printing • Several organizations are working toward solving a worldwide donor organ shortage using 3D printers
• Medical technology continues to refine the design of organs and the materials available for use as printing material. Since their
introduction, 3D printers have increased in speed and reliability, and many designs are freely shared
• Patient monitoring cables make up crucial monitoring systems and control the flow of patient information to any device or
medical professional
• These systems can track cardiac or respiratory activity and many other vital signs and can handle many of them almost
simultaneously, letting the doctors and nurses know if patients are stable or if an emergency needs attention
Patient monitoring • But without solid, reliable cable assemblies to connect and transmit data from patients to their doctors — from well-organized
cables assemblies in an ICU to tiny surgical assemblies — all other medical technology devoted to gathering that data is effectively
useless
• Currently, major medical devices companies, such as Philips India and Poly Medicure Limited, have developed high-end patient
monitoring systems
• Pharmaceutical error rates vary from roughly 1% to over 100% based on the setting
• Resolving the source of these errors could save thousands of lives every year
Pharmaceutical • Recent years have seen various advancements in prescription disbursement technology that reduces the number of errors and
ensures that patients are receiving the correct drugs
distribution
• Integrating technology from robots to checklists into the disbursement of medications has significantly reduced the number of
errors and improved patient outcomes
• Robotics is used in the development of medical devices as it improves the quality and efficiency of operations
• Selective Compliance Articulated Robot Arm (SCARA) robots can be fixed on a tabletop and fit well in small spaces
Robotics and patient- • Robotics has also been used in laboratory settings and medical testing facilities
specific medical • Robotic surgery technology, which is at its nascent stage, is slowly gaining traction
technology • Robotic surgery is being used in the treatment of cancer of the neck and head, colon, lung, and rectum, apart from some
gynecological lignancies
▪ Robotic surgery offers several advantages as compared to conventional surgery
▪ It allows fast recovery, reduced blood loss, short stay in the hospital, and less likelihood of post-surgical depression
• Medical devices and individual therapies are increasingly being developed based on patient-specific data
• Wearables such as exercise trackers, glucose monitors, and devices that measure heart rate have become popular
• The overall healthcare wearables market was valued at 300 Mn in 2017 and is expected to expand in the future as wearable
Wearables for technology is beginning to pick up
continuous health • Self-monitoring devices such as wearables and breast examination devices can sync data to patients’ smartphones via the internet
monitoring or Bluetooth, enabling early diagnosis
• After being discharge from hospitals, self-use medical devices enable patients to monitor their health regularly, reducing the
probability of readmissions
• The market is growing at a fast pace backed by constant research and innovations that make medical devices accessible and
affordable
• Several Indian start-ups and SMEs have entered the medical technology market and are contributing with innovative solutions,
Start-ups creating market suitable offering, and disrupting the medical technology industry landscape
• With the entry of start-ups, capital investments are being witnessed in the market
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