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

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
Disadvantages of In Vitro

The 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:
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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-Rad’s customers include:

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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:
◦
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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-Rad’s 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:





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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 Coulter’s 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=LXLATB-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.

A handle is attached for easy lifting of the
rotor.
Source:
https://www.beckmancoulter.com/wsrportal/techdocs?docname=LXLA-TB-003
Worldwide Players


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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 rotor’s rated maximum are
detected.
Magnets have been inserted in the overspeed 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:

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
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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)
◦ HPLC
◦ Quality Control
◦ 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.
2.
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4.
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8.
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15.
16.
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18.
19.
Randox
Quantimetrix Corporation
CisBiotech
IVD Technologies
LTA S.R.L
RECIPE Chemical + Instruments GmbH
Sentinel Diagnostics
DiaMetra
Express Diagnostics
HIMedia Laboratories
BioGroup Medical System
Pilots Point
BIOCRATES
Biocroi Ltd.
Boditech
Princeton BioMitech Corporation
IVD Research Inc.
ACCESS BIO, Inc.
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
15
revenue growth
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 largest IVD segments
are:
◦ 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 world’s
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 & Farmer’s 2011 report on
China’s 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 & Farmer’s 2011 report on
India’s 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 2017—especially 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: