Global IVD Market

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1 Global IVD Market

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 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.

3 US$ Billion 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 IVD Market by Technology Type (2013) Immunoassay Conventional chemistry Molecular diagnostic Anatomic pathology Blood work Conventional microbiology Flow cytometry HBGM Others 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 The industry recorded an impressive CAGR of % during the period 2009 to Laboratory tests make up about % of the total IVD market. The Near-Patient Tests worth US$... billion, also referred as point-ofcare (POC), that make up about % of the total IVD market are performed in hospitals as well as physician offices and other decentralized sites such as retail and community clinics. Lastly, Self-Test worth US$... billion, either physician directed or Over- The-Counter (OTC), represent % of the IVD market. Global IVD Market ( ) IVD Market by Test Location (2013) Laborartory Tests Near-Patient Tests Self-Tests

4 Million 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 ( ) Global ageing population (over 65) was recorded to be million in 2013, compared to that of million in This depicts an increase of about % in 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 Disease Area (2013) IVD Market by Product (2013) Infectious Disease Cancer Cardio Vascular Others Reagents Instrumentation Instrument Services

5 US$ Billion US$ Billion Molecular diagnostic segment plays a significant role in global IVD industry Molecular Diagnostics Market Size ( ) MDx and Immunoassays Taking Over Food Safety Testing Market ( E) The US$... billion molecular diagnostic market (MDx) is the fastestgrowing 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 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) E Culture-based Testing Method Molecular Diagnostics and Immunoassays Roche Siemens Abbott Danaher J&J OCD Alere biomerieux Others

6 F 2015F 2016F 2017F US$ Billion US$ Billion 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 IVD Market of China ( ) Global In Vitro Diagnostics Market ( F) Chinese IVD market is growing at a staggering CAGR of %, to reach US$... billion (CNY billion), in revenues, in China is expected to witness further growth in IVD industry as immunochemistry market is blossoming because of their favorable demographics and large underpenetrated populations. Growth of IVD industry in China will further be driven by self-monitoring blood glucose market owing to the large diabetes population in the country with more individuals with diabetes seeking treatment and usage of glucose monitors outside of clinics. The demand for disease screening diagnostics is further expected to expand due to shift from reactive testing to proactive testing. The growth of the IVD industry in the developing economies is being propelled by an increase in general affluence, and as a consequence rising spending on healthcare. The global IVD market is forecasted to grow by % to reach US$... billion by the end of 2014, compared to US$... billion in The same is forecasted to reach US$... billion by the end of 2017 marking the growth of the IVD industry at a CAGR of % during the period spanning 2013 to 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 Furthermore, it was also estimated that the total global diabetic population will reach approximately 592 million by the end of 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

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