In Vitro Market

2013 Market Analysis

Historical Trends
2013 Market Analysis

Historical Information

In Vitro, of Latin origin, literally

means in glass due to the initial
administration of drugs and
biological specimens via a small
glass tube.

In Vitro takes place in a test tube,

culture dish, or elsewhere outside of
a living organism.

Source:
http://en.wikipedia.org/wiki/In_vitro

Historical Information
Common

examples of in vitro experiments

include work that uses:
Cells derived from multicellular organisms (cell culture or
tissue culture)
Subcellular components (e.g. mitochondria or
ribosomes)
Cellular or subcellular extracts (e.g. wheat germ or
reticulocyte extracts)
Purified molecules in the test tube (often proteins, DNA,
or RNA, either individually or in combination).
Source:
http://en.wikipedia.org/wiki/In_vitro

Historical Information
Living

organisms are extremely

complex functional systems that
are made up of, at a minimum,
many tens of thousands of genes,
protein molecules, RNA
molecules, small organic
compounds, inorganic ions and
complexes in an environment that
is spatially organized by
membranes and, in the case of
multicellular organisms, organ
systems

Source:
http://en.wikipedia.org/wiki/In_vitro

Historical Information
In

short, living organisms are very

complex, but In Vitro allows simplicity.

Advantages and Disadvantages of In Vitro

2013 Market Analysis

Advantages of In Vitro

Disadvantages of In Vitro

The

The

primary
advantage of in vitro
work is that it permits
an enormous level of
simplification of the
system under study,
so that the
investigator can focus
on a small number of
components

primary
disadvantage of in
vitro is that it can
sometimes be very
challenging to
extrapolate from the
results of in vitro work
back to the biology of
the intact organism.

Source:
http://en.wikipedia.org/wiki/In_vitro

Example of In Vitro Advantages

The

identity of proteins of the immune system (e.g.

antibodies), and the mechanism by which they
recognize and bind to foreign antigens would remain
very obscure if not for the extensive use of in vitro
work to:
Isolate the proteins
Identify the cells and genes that produce them
Study the physical properties of their interaction with antigens
and
Identify how those interactions lead to cellular signals that
activate other components of the immune system.

Source:
http://en.wikipedia.org/wiki/In_vitro

Examples of In Vitro Disadvantages

Scientists

developing a new viral drug to treat an

infection with a pathogenic virus (e.g. HIV-1) may
find that a candidate drug functions to prevent
viral replication in an in vitro setting (typically cell
culture). However, before this drug is used in the
clinic, it must progress through a series of in vivo
trials to determine if it is safe and effective in
intact organisms (typically small animals, primates
and humans in succession).

Typically,

most candidate drugs that are effective

in vitro prove to be ineffective in vivo because of
issues associated with delivery of the drug to the
affected tissues, toxicity towards essential parts of
the organism that were not represented in the
initial in vitro studies, or other issues.
Source:
http://en.wikipedia.org/wiki/In_vitro

Examples of In Vitro testing and uses

2013 Market Analysis

Examples of In Vitro testing and

uses
Polymerase

chain
reaction is a method
for selective
replication of
specific DNA and
RNA sequences in
the test tube.

Source:
http://en.wikipedia.org/wiki/In_
vitro

Examples of In Vitro testing and

uses
Protein

purification
involves the isolation
of a specific protein of
interest from a
complex mixture of
proteins, often
obtained from
homogenized cells or
tissues.
Source:
http://en.wikipedia.org/wiki/In_
vitro

Examples of In Vitro testing and

uses
In

vitro fertilization is used to allow

spermatozoa to fertilize eggs in a culture
dish before implanting the resulting
embryo or embryos into the uterus of the
prospective mother.

Source:
http://en.wikipedia.org/wiki/In_
vitro

Examples of In Vitro testing and

uses
In

vitro diagnostics refers to a

wide range of medical and
veterinary laboratory tests that
are used to diagnose diseases
and monitor the clinical status
of patients using samples of
blood, cells or other tissues
obtained from a patient.

Source:
http://en.wikipedia.org/wiki/In_
vitro

Worldwide players
2013 Market Analysis
Source:

Worldwide Players
Bio-Rad Laboratories

Source:

Worldwide Players
Bio-Rad

Founded in 1952 in Berkley, California

Manufacturer and supplier of:
Life science research
Healthcare
Analytical chemistry
Other markets with products and systems used to
separate complex chemical and biological
materials and to identify, analyze, and purify their
components

Source: http://www.bio-rad.com/

Worldwide Players
Bio-Rad

operates in six industry

segments:

Life Science Research

Clinical Diagnostics
Process Separations
Food Science
Spectroscopy
Life Science Education

Source: http://www.bio-rad.com/

Worldwide Players
All

segments operate worldwide.

Bio-Rads customers include:

Hospitals
Universities
Major research institutions
Biotechnology
Pharmaceutical companies
Secondary and tertiary academic institutions

Source:
http://www.bio-rad.com/

Worldwide Players
Bio-Rad

is the number one specialty

diagnostics company in the world.

The

Clinical Diagnostics Group develops,

manufactures, sells and supports a large
portfolio of products for medical screening
and diagnostics.
Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
Bio-Rad

holds leadership positions in

diabetes monitoring and quality control
(QC) systems.

Bio-Rad

is well known for:

Blood virus testing and detection

Blood typing
Autoimmune and genetic disorders testing
Internet-based software products.
Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
Bio-Rad's

Clinical Diagnostics segment

encompasses a broad array of
technologies incorporated into a variety of
products used to detect, identify, monitor,
and quantify substances in patient and
donor blood, other bodily fluids, and
tissue samples.
The vast majority of these tests are
performed in vitro (outside the body)
Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
The

market is split into several subsegments consisting of:

Clinical chemistry
Immunoassay
Microbiology
Hematology
Molecular
Coagulation
Blood banking
Blood typing
Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
Bio-Rad

has significant positions in:

Blood virus testing (blood banking and

immunoassay)
Immunohematology (blood typing)
Hemoglobin A1c testing for diabetes monitoring
(clinical chemistry and immunoassay)
Autoimmune disease testing (immunoassay)
Quality control (crossing all sub-segments).

Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
One

medically significant
product is Bio-Rads rapid
dengue test, called the
NS1 antigen test, which
allows for dengue
detection the first day of
fever, rather than when
antibodies rise some five
or more days later.
Source: http://en.wikipedia.org/wiki/BioRad_Laboratories

Worldwide Players
Beckman Coulter

Source:

Worldwide Players
Beckman

Coulter

Founded in 1935 as National Technical Laboratories to

commercialize a pH meter
Headquarters in Brea, California.
Locations worldwide:
Americas
Europe
Africa
Middle East
Pacific
Asia
Source: https://www.beckmancoulter.com

Worldwide Players
Beckman

Coulter

Develops, manufactures, and markets products that

simplify, automate and innovate complex biomedical
testing.
Beckman Coulter diagnostic systems are found in
hospitals and other critical care settings around the
world and produce information used by physicians to
diagnose disease, make treatment decisions and
monitor patients.
Life science research instruments are used to study
complex biological problems including causes of
disease and potential new therapies or drugs.
Source: https://www.beckmancoulter.com

Worldwide Players
Beckman

Coulters core customers:

Core clinical diagnostic customers are:

Hospital laboratories

Core life science customers are:

Pharmaceutical and biotechnology companies
Universities
Medical schools
Research institutions.

Source: https://www.beckmancoulter.com

Worldwide Players
Beckman

Coulter Analytical Machines

An-50 Ti and An-60 Ti Rotors

An-50 TI
Analytical rotor with an eight-place titanium rotor
(painted black), rated for 50,000 RPM.
Seven holes are for sample cells and the eighth is for the
counterbalance; all are parallel to the axis of rotation.

An-60 Ti
Analytical rotor with a four-place titanium rotor (painted
black), rated for 60,000 RPM. Three holes are for sample
cells and the fourth is for the counterbalance; all are
parallel to the axis of rotation.
Source: https://www.beckmancoulter.com/wsrportal/techdocs?
docname=LXLA-TB-003

Worldwide Players
Both

rotors cell holes are numbered for

easy identification, together with the
windows in the cells, allow light to pass
through the cells for analysis of the
material being processed.

handle is attached for easy lifting of the

rotor.
Source: https://www.beckmancoulter.com/wsrportal/techdocs?docname=LXLATB-003

Worldwide Players
For

over-speed protection, a photoelectric

detector in the XL-A/XL-I system monitors the
over-speed disk on the bottom of the rotor and
shuts down the run if speeds exceeding the
rotors rated maximum are detected.
Magnets have been inserted in the over-speed
disk between cell holes 1 and 4 (An-60 Ti) or 1
and 8 (An-50 Ti).
A sensor in the rotor chamber, triggered by these
magnets, is used for timing the light sources
Source:
https://www.beckmancoulter.com/wsrportal/techdocs?docname=LXLA-TB-003

Worldwide Players
AKSA Medical

Source:

Worldwide Players
AKSA

Medical
Located in the Netherlands
An independent distributor in the Benelux.
Product range of AKSA Medical consists of the
following product groups:
Clinical Chemistry
Immunochemistry
Drugs of Abuse
Hematology
Microbiology / Virology
Point of Care Testing (POCT)
HPLC and LCMS/MS reagents, controls, calibrators
Source: http://www.aksamedical.com/

Worldwide Players
Aska

Products:

General Diagnostic Assays

Reagents

Infectious Diseases

Special products

Life Sciences

Lipoprint

Point of care Testing (POCT)

Quality Control

HPLC
LC-MS/MS Applications

QC software

Happy Cell / 3D Cell Culture in HCS &

HTS

Laboratory Instruments

Toxicologie

Source: http://www.aksamedical.com/

Worldwide Players
AKSA

has 19 suppliers, all of which are displayed below

1.Randox
2.Quantimetrix Corporation
3.CisBiotech
4.IVD Technologies
5.LTA S.R.L
6.RECIPE Chemical + Instruments GmbH
7.Sentinel Diagnostics
8.DiaMetra
9.Express Diagnostics
10.
HIMedia Laboratories
11.
BioGroup Medical System
12.
Pilots Point
13.
BIOCRATES
14.
Biocroi Ltd.
15.
Boditech
16.
Princeton BioMitech Corporation
17.
IVD Research Inc.
18.
ACCESS BIO, Inc.
19.
LifeSign

Source: http://www.aksamedical.com/

Future prospects and growth

2013 Market Analysis- European market
Source:

European Sector
It

is anticipated that the IVD market in

Western Europe will grow at a rate of 5%
per annum.
Germany has the biggest market share with
sales of almost Euro 1.6 billion, accounting
for 24% of the total European market.
Italy has the next highest sales with revenues of
Euro 1.1 billion and 18% of the market.
After Italy come France, Spain, United Kingdom, Belgium
and Switzerland.

Source:
http://www.researchandmarkets.com/reports/35139/the_
top_100_in_vitro_diagnostics_manufacturing

European Sector
30
25
20
market share
revenue growth

15
10
5
0

Germany

Italy

Market share in
percentages
Revenue growth in
billions

European Sector
The global IVD market is worth an estimated
EUR 19.5 billion, broken down as follows:
European sector (numbers in millions)
Clinical Chemistry- 5,271
Infectious Diseases- 5,627
Rapid Tests Coagulation Endocrine Testing Glucose4,209
Haematology- 1,253
Blood Grouping/Typing

Source:
http://www.researchandmarkets.com/reports/35139/t
he_top_100_in_vitro_diagnostics_manufacturing

European Sector
The

are:

largest IVD segments

Infectious diseases
Clinical chemistry
Glucose

Glucose and rapid tests are

the fastest growing tests in
the European sector.
Source: The largest IVD segments are infectious diseases, clinical chemistry
and glucose. Glucose and rapid tests are the fastest growing.

Future prospects and growth

2013 Market Analysis- China and India
Source:

China and India

The

IVD markets of China and India,

two countries that account for roughly
one-third of the worlds population,
have demonstrated remarkable growth
during the past 15 years.
The IVD markets have seen steady
growth rates:
10-20% per year during the past 15 years
Growth in India is starting from a
substantially lower point.
Pace

of growth for both countries has

increased
China 25% growth
India 18% growth
Source: http://www.ivdtechnology.com/article/china-and-india-comparingtwo-fast-growing-ivd-markets

China and India

Increased

prosperity
and urbanization in both
countries are allowing
for a rapid increase of
IVD use.

Source: http://www.ivdtechnology.com/article/china-and-indiacomparing-two-fast-growing-ivd-markets

China and India

McEvoy

& Farmers 2011 report on

Chinas IVD market estimates the
size of the market to be $2.1 billion
with a growth rate of about 25%

Source: http://www.ivdtechnology.com/article/china-and-indiacomparing-two-fast-growing-ivd-markets

China and India

McEvoy

& Farmers 2011 report on

Indias IVD market estimates the
market size to be $531 million and
growing at approximately 18%

Source: http://www.ivdtechnology.com/article/china-andindia-comparing-two-fast-growing-ivd-markets

Future Prospects and Growth

2013 Market Analysis- US Market
Source:

Future Prospects and Growth

Causes

of significant market growth:

Introduction of the Patient Protection and

Affordable Care Act (PPACA) in 2014
This will significantly affect the United States in vitro
diagnostics (IVD) market landscape.
Most notably, the implementation of this Act will
increase the percentage of people covered by
insurance, which will drive test volumes, especially as
the US population ages and the demand for IVD
increases.
Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017#ixzz2M4meCZXp

Future Prospects and Growth

Causes

of significant market growth (cont..)

The PPACA will also lead to increased

centralization of IVD testing as more laboratories,
hospitals and care facilities consolidate in the
wake of health care reform.
Although the rise of centralized labs will leave
manufacturers with fewer potential sites for capital
sales, these facilities will see high testing volumes
and ultimately have the resources to purchase a
broader array of diagnostic tests.
Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017#ixzz2M4of25cl

Future Prospects and Growth

High

testing volumes at
centralized sites will mean that
labs will look for vendors that
can offer a broad range of
instrumentation and
automation equipment.

Labs

will prefer to purchase all

of their equipment from one
vendor to improve workflow
logistics and reduce costs.
Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017#ixzz2M4qaxKgI

Future Prospects and Growth

Overall

results of growth:

Majority of market share will be held by a few

key multi-segment players, like:
Siemens Healthcare
Roche
Abbott Laboratories

Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017

Future Prospects and Growth

Large multinational companies will likely continue to

dominate the market through 2017especially those
players with a finger in molecular diagnostics technologies.

This market segment will grow rapidly through 2017,

cannibalizing sales from more mature segments such as
immunoassay and microbiology testing.

Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017

Future Prospects and Growth

There

is still uncertainty surrounding the

PPACA and health care reform in the US.
This has caused many facilities to delay
purchasing IVD capital equipment

Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017

Future Prospects and Growth

However,

the increase
in test volumes will
outweigh these
negative effects, and
the US IVD market
will see steady
growth.
Source:
http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly86-billion-2017

Future Prospects and Growth

Overall growth projections of the In Vitro market:

Nearly $8.6 Billion by 2017 in the U.S.

Source: http://www.fiercemedicaldevices.com/pressreleases/us-vitro-diagnostics-market-grow-nearly-86billion-2017
:

Conclusions
2013 In Vitro Market Analysis
Source:

Conclusions
The

In Vitro diagnostic market is growing

rapidly worldwide
Rapid growth potential is certain virtually
worldwide as developed countries readily
use IVD testing
As developing countries become
westernized, the use of IVD testing will
ensue as well.

Source:

Conclusions

It

is vital to ensure that Asian and Pacific

markets are not ignored as they are
rapidly growing as leaders in the usage of
IVD tests.

Source: