in vitro market 2013 market analysis. historical trends 2013 market analysis

In Vitro Market2013 Market Analysis

Historical Trends2013 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).


Historical InformationLiving 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 InformationIn 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 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

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.


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.


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.


Examples of In Vitro testing and uses2013 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.


Examples of In Vitro testing and usesProtein purification

involves the isolation of a specific protein of interest from a complex mixture of proteins, often obtained from homogenized cells or tissues.


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.


Examples of In Vitro testing and usesIn 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.


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Worldwide players2013 Market Analysis

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Worldwide Players

Bio-Rad Laboratories

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 PlayersBio-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-Rad’s 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/Bio-Rad_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.


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)


Worldwide Players

The market is split into several sub-segments consisting of:◦Clinical chemistry◦Immunoassay◦Microbiology ◦Hematology◦Molecular◦Coagulation◦Blood banking◦Blood typing


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).


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.


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Worldwide Players

Beckman Coulter

Worldwide PlayersBeckman 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 PlayersBeckman 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.


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.


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.

A handle is attached for easy lifting of the rotor.

Source: https://www.beckmancoulter.com/wsrportal/techdocs?docname=LXLA-TB-003

Worldwide PlayersFor 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 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

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Worldwide Players

AKSA Medical

Worldwide Players

AKSA MedicalLocated 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

◦ Infectious Diseases

◦ Life Sciences

◦ Point of care Testing (POCT)

◦ Quality Control

◦ QC software

◦ Laboratory Instruments

◦ Reagents

◦ Special products

◦ Lipoprint

◦ HPLC

◦ LC-MS/MS Applications

◦ Happy Cell / 3D Cell Culture in HCS & HTS

◦ Toxicologie


Worldwide Players

AKSA has 19 suppliers, all of which are displayed below

1. Randox2. Quantimetrix Corporation3. CisBiotech4. IVD Technologies5. LTA S.R.L6. RECIPE Chemical + Instruments GmbH 7. Sentinel Diagnostics8. DiaMetra9. Express Diagnostics10. HIMedia Laboratories11. BioGroup Medical System 12. Pilots Point13. BIOCRATES14. Biocroi Ltd.15. Boditech16. Princeton BioMitech Corporation17. IVD Research Inc. 18. ACCESS BIO, Inc.19. LifeSign


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Future prospects and growth2013 Market Analysis- European market

European SectorIt 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

Germany Italy0

5

10

15

20

25

30

market sharerevenue growth

• 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 Glucose-

4,209◦Haematology- 1,253◦Blood Grouping/Typing

Source: http://www.researchandmarkets.com/reports/35139/the_top_100_in_vitro_diagnostics_manufacturing

European SectorThe 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.

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Future prospects and growth2013 Market Analysis- China and India

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-comparing-two-fast-growing-ivd-markets

China and India

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


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%


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%


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Future Prospects and Growth2013 Market Analysis- US Market

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/press-releases/us-vitro-diagnostics-market-grow-nearly-86-billion-2017#ixzz2M4meCZXp


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/press-releases/us-vitro-diagnostics-market-grow-nearly-86-billion-2017#ixzz2M4of25cl

Future Prospects and GrowthHigh 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/press-releases/us-vitro-diagnostics-market-grow-nearly-86-billion-2017#ixzz2M4qaxKgI


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/press-releases/us-vitro-diagnostics-market-grow-nearly-86-billion-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.



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



However, the increase in test volumes will outweigh these negative effects, and the US IVD market will see steady growth.


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/press-releases/us-vitro-diagnostics-market-grow-nearly-86-billion-2017:

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Conclusions 2013 In Vitro Market Analysis

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ConclusionsThe In Vitro diagnostic market is growing

rapidly worldwideRapid 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.

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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.

in vitro market 2013 market analysis. historical trends 2013 market analysis

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