Global In-Vitro Diagnostics (IVD) Market Report

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1 Global In-Vitro Diagnostics (IVD) Market Report

2 Executive Summary The diagnostic industry is widely classified into two types: In-vitro diagnostics and In-vivo diagnostics. In-vitro tests are executed in glass test tubes, while In-vivo diagnostics tests are executed inside a patient s body. IVD products are indeed designed and produced for collecting samples derived from the patient s body and scrutinizing them outside, which are commonly conducted in hospitals, clinics and labs and in personal settings. Apart from the application of IVDs in medical diagnosis and health screening such as checking blood of signs for infections, or urine for the presence of glucose, they are also used in genetic testing, genomics, veterinary diagnostics, food testing, environmental testing, and research. As per the Global IVD market report, market segments such as blood glucose monitoring and clinical chemistry are relatively mature and stable. However, with growing personalized medical treatment trend, molecular diagnostics market is expected to grow significantly with strict regulatory measures. The key factors driving the market growth apart from generic macro-economic factors include accelerating diabetic population, increasing sales of medical technological devices, increasing complexity of diseases, and development of cardiac troponin assays. Some of the noteworthy trends observed in the industry are newly growing vitamin D testing market, genome sequencing market, usage of companion diagnostics in oncology, and increased importance of diagnostics. However, the industry remains exposed to certain challenges such as narrow economic moats in diagnostic market, reimbursement issues in clinical laboratory services, laboratory-developed tests waning IVD profits, and government regulation for IVD tests and stringent in genetic based tests. The report provides a comprehensive study of global in-vitro diagnostic market covering regional markets and major segments. The competition in the global in-vitro diagnostic market is highly amalgamated with large players like Abbott, Siemens, Roche and Johnson and Johnson. All these companies have been profiled in the present report highlighting their key financials and business strategies for their long term 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 Illumina has the largest market share in the genome sequencing market Global IVD Market by Geography (214) North America EMEA Asia-Pacific Japan Latin America Global In-Vitro Diagnostic Device Sales ( ) By region, North America is the largest market which accounted for..% of total IVD market, followed by EMEA (Europe/Middle East/Africa) with % of market share in 214. Asia-Pacific, Japan and Latin America accounted for..%,..% and % of the market share respectively. In 214, the global sales of in-vitro diagnostic medical technology amounted to US$... billion, up by..% from US$... billion in 213. In-vitro diagnostic devices have remained to be one of the most important and strongest segments of medical technology sales for past many years. The top three IVD segments by Technology type, i.e. selfmonitoring blood glucose, clinical chemistry and immunodiagnostics, collectively account for more than % of the total IVD market in 214. Molecular diagnostics accounts for..% of the IVD market. Moreover, point-of-care, hematology and microbiology account for..% of IVD market share each. Global IVD Market Share by Technology Type (214) Self-Monitoring Blood Glucose Clinical Chemistry 1 Immunodiagnostics Point-of-Care Molecular Diagnostics Hematology Microbiology Others

4 US$ Billion For Vitamin D testing, two laboratory tests for vitamin D are available - 25-hydroxy vitamin D and 1,25- dihydroxyvitamin D. Global Clinical and Industrial In-Vitro Market Value ( ) Clinical Industrial Global in-vitro diagnostic market has been broadly segmented into clinical and industrial in-vitro market segment, of which clinical in-vitro market is valued at US$... billion while industrial in-vitro market is valued at US$... billion in 214. Laboratory tests made up about..% of the total IVD market in 214. Most of the IVD testing worth is performed in laboratories defined as hospital labs and independent labs such as private reference labs and blood bank labs. By product type, IVD industry is classified into three categories among which Reagents/Chemistry makes up majority of the market of about..%. Instrumentation and Instrument Services holds..% and..% of the market in 214, respectively. Global IVD Market by Test Location (214) Global IVD Market Share by Product Type (214) Hospital Labs Independent Labs Consumer (Self-Test) Point-of-Care Reagents/Chemistry Instrumentation Instrument Services

5 Billion US$ Million US$ Billion The Chinese government gives priority to healthcare reforms and healthcare investments. Global Molecular Diagnostic Market Value (29-218E) E 215E 216E 217E 218E The estimated US$... billion molecular diagnostic market (MDx) is the fastest-growing segment of the IVD industry. Since 29, there is an overall growth of % in this segment, which is further estimated to become a US$.. billion market by 218. Except the UK, in 214, in terms of USD, European IVD market witnessed a growth of %, to reach US$... billion (EUR billion) as compared to US$... billion (EUR billion) in 213. Chinese IVD market is growing at a staggering CAGR of %, to reach US$... million by 218 from current market value of US$... million in 214. China is expected to witness growth in IVD industry as immunochemistry market is blossoming because of their favorable demographics and large underpenetrated population. IVD Market Value in EU27+ EFTA (29-214) IVD Market Value in China (29-218E) 16 7, 14 6, USD EUR 5, 4, 3, 2, 1, E 215E 216E 217E 218E Market Value CAGR (%)

6 US$ Billion In-vitro diagnostics is one of the strongest and largest segment within medical technology. Global In Vitro Diagnostics Market Value Forecast (213-22F) F 216F 217F 218F 219F 22F Market Value Growth (%) 6% 5% 4% 3% 2% 1% % The in-vitro diagnostics (IVD) industry is one of the strongest segments within the healthcare industry. The global IVD market is forecasted to grow by % to reach US$... billion in 215, compared to US$... billion in 214. The market is forecasted to reach US$... billion by the end of 22 at a CAGR of % from 214 to 22. Increasing complexity of diseases and need for better diagnosis for effective treatment has led to the growth of IVD market within healthcare industry. Some IVD market segments such as blood glucose monitoring and clinical chemistry are relatively mature, while molecular diagnostics market growth is likely to improve ease of access to personalized medical treatments. In particular, new companion diagnostic tests demand is expected to emerge as pharmaceutical and biotech companies are inclined to shift their pipelines toward such beset therapies. Along with genome sequencing this segment seems to be a disruptive and high-growth area that comprises greater genetic screening within cancer diagnosis and treatments, prenatal and newborn screening, and rare diseases.

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