2. Executive Summary
An in-vitro diagnostic test is performed outside of a human body in an artificial environment (e.g. laboratory). IVD is considered as an
essential part of today’s healthcare. The IVD products are broadly divided into three categories: reagents, analytical instruments and
accessory products. IVD is widely used for diagnosis, monitoring of prescribed treatments and assessment of medical intervention,
apart from others thereby contributing to availability of medical information regarding a patient. Furthermore, IVD allows earlier and
more targeted treatment which in turn leads to reduced hospital stays and convalescences resulting in a healthier population and
economic growth in the long run.
A constant growth has been observed in the global IVD industry since 2009. In IVD by technology, immunoassay and conventional
chemistry strongly dominates the market. Laboratory test lead the IVD market by test location followed by self-test. Infectious disease
is the largest segment covering the IVD market. On the basis of IVD products, reagent has the maximum market share.
The key factors which are anticipated to drive market growth include rising global healthcare expense, increasing global ageing
population, accelerating global diabetic population apart from rising incidences of chronic and infectious diseases and increasing
global gross national income. Some of the noteworthy developments of this industry include food safety testing market being taken
over, development in patient monitoring and telemedicine, continued expansion of POC testing apart from mergers and acquisitions.
However, the industry remains threatened by certain challenges which include lack of economies of scale and scope, increase in
investment demands apart from usual regulatory, reimbursement and intellectual property issues.
This report offers a comprehensive analysis of the global in-vitro diagnostic market, along with an in-depth study of the IVD segments
and the regional markets of Europe and China. The global IVD industry is consolidated with the top players, Abbott, Siemens, Roche
and Johnson and Johnson which operate in a highly competitive environment. The above mentioned companies are being profiled
along with their key financials and strategies for growth.
By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of
the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSS
Base to determine the future direction of the industry. Before deploying the regression model, the relationship between several
independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and
tests.
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3. The process of performing a diagnostic test outside of a living organism in an artificial environment,
usually a laboratory, is called an in-vitro diagnostic
•Immunoassays and Conventional Chemistry together represent
the largest market with …% market share. Also the Anatomic
Pathology and Blood Work markets represents market share of
…% and …% respectively. Diagnostics represents a market share
of …% whereas HBGM (Home Blood Glucose Monitoring) and
Flow Cytometry have a market share of …% and …% respectively.
•The global IVD market was worth US$... billion at the end of 2013,
up by notable …%, compared to US$... billion in 2012. The industry
recorded an impressive CAGR of …% during the period 2009 to
2013.
•Laboratory tests make up about …% of the total IVD market. The
Near-Patient Tests worth US$... billion, also referred as point-of-
care (POC), that make up about …% of the total IVD market are
performed in hospitals as well as physician offices and other
decentralized sites such as retail and community clinics. Lastly,
Self-Test worth US$... billion, either physician directed or Over-
The-Counter (OTC), represent …% of the IVD market.
IVD Market by Test Location (2013)Global IVD Market (2009-2013)
IVD Market by Technology Type (2013)
2009 2010 2011 2012 2013
US$Billion
Laborartory Tests Near-Patient Tests Self-Tests
Immunoassay Conventional chemistry Molecular diagnostic
Anatomic pathology Blood work Conventional microbiology
Flow cytometry HBGM Others
4. Some of the noteworthy developments of this industry include rising global healthcare expenditure,
increasing global ageing population, and accelerating global diabetic population, among others
•Global ageing population (over 65) was recorded to be … million
in 2013, compared to that of … million in 2012. This depicts an
increase of about …% in 2013. However, until now the overall
increase since 2009 is …%.
•Within the IVD market, infectious disease represents …% of the
market by disease area followed by cancer that makes up about
…% of it. Cardio vascular diseases represent …% of the market
and remaining …% of market making up for other types of
diseases.
• By product type, IVD industry is classified into three categories
among which Reagents makes up majority of the market of about
…%. It is a result of development of large variety of reagents and
analytical techniques, and inexpensive automated testing known as
point-of-care (POC) are driving the growth of reagents market.
Instrumentation and Instrument Services holds …% and …% of
the market respectively.
IVD Market by Product (2013)IVD Market by Disease Area (2013)
Global Ageing Population (2009-2013)
2009 2010 2011 2012 2013
Million
Reagents Instrumentation Instrument Services
Infectious Disease Cancer Cardio Vascular Others
5. Molecular diagnostic segment plays a significant role in global IVD industry
• The US$... billion molecular diagnostic market (MDx) is the fastest-
growing segment of the IVD industry. Since 2011, there is an overall
growth of …% in this segment. The market is expected to experience a
…% growth in next two years. Growth in this segment is driven by
higher sensitivity, faster turnaround times, easier workflow, and lower
costs (in some cases) than other techniques, such as immunoassays or
conventional microbiology. The maturation of technologies, such as
next generation sequencing, and increased automation are also
responsible for the same.
• Molecular Diagnostics and Immunoassays market size is estimated to
grow at a CAGR of …% and Culture-based Testing method for food
safety testing to decline by CAGR of …% by 2015.
•Siemens holds a very powerful number two position with …% market
share in the professional diagnostics submarket, just below Roche with
…%.Immunoassay business is the primary growth driver of Roche
Professional Diagnostics. Abbott has a market share of …% in
professional diagnostic segment.
Professional Diagnostics Market Share by Company (2013)
MDx and Immunoassays Taking Over
Food Safety Testing Market (2010–2015E)
Molecular Diagnostics Market Size (2011-2013)
2010 2015E
US$Billion
Molecular Diagnostics and Immunoassays
Culture-based Testing Method
2011 2012 2013
US$Billion
Roche Siemens Abbott Danaher J&J OCD Alere bioMerieux Others
6. The growth of respective industry is hindered by the barrier for regulatory, reimbursement, and
intellectual property arenas, and lack of economies of scale and scope, among others
Chinese IVD market is growing at a staggering CAGR of …%, to reach US$... billion (CNY… billion), in revenues, in 2013. China is expected
to witness further growth in IVD industry as immunochemistry market is blossoming because of their favorable demographics and large
underpenetrated populations. Growth of IVD industry in China will further be driven by self-monitoring blood glucose market owing to the large
diabetes population in the country with more individuals with diabetes seeking treatment and usage of glucose monitors outside of clinics.
The demand for disease screening diagnostics is further expected to expand due to shift from reactive testing to proactive testing. The growth
of the IVD industry in the developing economies is being propelled by an increase in general affluence, and as a consequence rising spending
on healthcare. The global IVD market is forecasted to grow by …% to reach US$... billion by the end of 2014, compared to US$... billion in
2013. The same is forecasted to reach US$... billion by the end of 2017 marking the growth of the IVD industry at a CAGR of …% during the
period spanning 2013 to 2017.
The increase in the diabetic cases recorded worldwide can be attributed to the ever changing lifestyle of the people in the present era. It is
found that there is an increase of … million diabetic cases to reach … million cases in 2013, compared to … million cases recorded in 2012.
Furthermore, it was also estimated that the total global diabetic population will reach approximately 592 million by the end of 2035. Therefore, it
is expected that global IVD market will be pumped up in the near future due to increasing diabetes patients worldwide coupled with the
increasing awareness amongst the people regarding health.
Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa
2009
2010
2011
2012
2013
US$Billion
IVD Market of China (2009-2013)
2013
2014F
2015F
2016F
2017F
US$Billion
Global In Vitro Diagnostics Market (2013-2017F)
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