IVD (In Vitro Diagnostic) Testing Market Size, Share and Research Report

In vitro diagnostic (IVD) testing is experiencing a revival fueled by a combination of technological improvements, cost pressures, reimbursement changes, rapid growth in molecular diagnostics and increasing interest in the genomics testing. Recent advances in molecular diagnostics technologies–including sequencing, PCR and microarray–are enabling greater sensitivity and precision in nucleic acid measurements, further expanding manufacturers’ offerings. This report is an overview of each major in vitro diagnostic testing segment, including: point of care testing (POCT), molecular diagnostics, chemistry, diabetes and glucose, immunoassay, hematology, coagulation, pathology, microbiology, histology and cytology, and blood banking. For each segment, this study examines the generally accepted clinical analytical activities in use today.

Moreover, the analysis here discusses the potential benefits of the diagnostics techniques, as well as provides market size and future growth potential. Additionally, this report assesses the various business models, including CLIA-licensed specialty labs, general reference labs and reagent kit marketing. This study also examines hundreds of companies that are actively developing and marketing IVD testing products around the world. This report analyzes the size and growth of the important sectors of the diagnostics market, including the drivers and restraints that influence the various market segments, as well as the dollar volume of sales and market growth rates, both in the U.S. and worldwide.

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Table of Contents

1. IVD Market Overview 14

2. IVD Global Market Overview 19

3. POCT 46

4. Molecular Diagnostics 56

5. Clinical Chemistry 94

6. Diabetes and Glucose Testing 109

7. Immunochemistry Markets 126

8. Hematology 142

9. Coagulation 149

10. Pathology 165

11. Microbiology 172

12. Blood Banking and Screening 180

13. Histology and Cytology Tests 185

14. Data Management and Connectivity 200

15. Company Profiles 212

List of Figures

Figure 2.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2013 and 2018 19

Figure 2.2: Worldwide Geographic Distribution of Total IVD Testing Markets by Country, 2013 21

Figure 2.3: Global IVD Market Share by Specialty, 2013 23

Figure 2.4: Indian Diagnostics Market Segments, 2011 32

Figure 2.5: Company Market Share for IVD Testing Markets, 2013 37

Figure 3.1: Percentage Uptake by Analyte in Hospitals Performing POC Testing 46

Figure 3.2: Total Global POCT Market, 2008-2018 47

Figure 3.3: Worldwide Distribution of POCT, 2013 48

Figure 3.4: Summary of Global POCT Markets by Market Segment, 2013 49

Figure 4.1: Global Market for Molecular Diagnostics, 2002-2019 57

Figure 4.2: Market Share by Region for Molecular Diagnostics Testing, 2013 58

Figure 4.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets, 2013 59

Figure 4.4: Share of Molecular Diagnostics Testing by Application, 2013 60

Figure 4.5: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018 61

Figure 4.6: Total Global Infectious Disease Molecular Diagnostics Markets, 2013 64

Figure 4.7: Key Players Market Share in Global Molecular Diagnostics Cancer Testing Markets 67

Figure 4.8: Molecular Diagnostic Markets for Cancer Testing Globally, 2013 73

Figure 4.9: Molecular Diagnostic Markets for Cancer Testing U.S., 2013 73

Figure 5.1: Global Clinical Chemistry Revenues, 2000-2018 94

Figure 5.2: Worldwide Geographical Distribution of Clinical Chemistry Testing, 2013 95

Figure 6.1: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and 2018 113

Figure 6.2: Worldwide Glucose Self-Testing Market by Region, 2018 113

Figure 6.3: Personal Lancet Unit Sales Market Share by Geographic Region, 2013 122

Figure 7.1: Market Share for Key Players in Immunoassay Testing Markets, 2013 127

Figure 9.1: Global Revenue Forecasts for Coagulation Testing, 2010-2018 150

Figure 9.2: U.S. Revenue Forecasts for Coagulation Testing, 2010-2018 150

Figure 9.3: European Revenue Forecasts for Coagulation Testing, 2010-2018 151

Figure 9.4: Japanese Revenue Forecasts for Coagulation Testing, 2010-2018 152

Figure 9.5: ROW Revenue Forecasts for Coagulation Testing, 2010-2018 152

Figure 10.1: Market Shares in Pathology Diagnostics, by Company 166

Figure 10.2: The Global Laboratory Digital Pathology Market, 2012-2018 170

Figure 13.1: Liquid-Based Pap Test Market Share 191

Figure 14.1: The RALS Data Management System Connects to Most of the Major Instruments Used in

Point of Care 204

Figure 14.2: AegisPOC Point of Care and Critical Care Connectivity and Information Management System 210

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