The In Vitro Diagnostics World Market 2016-2026: Clinical Chemistry, Immunochemistry, Haematology, Microbiology, Genetic Testing, Point of Care Diagnostics, Blood Glucose Testing, Infectious Diseases Testing, Rapid Cardiac Market Testing, Cholesterol Testing, Pregnancy Testing report assesses the global market for IVDs. The market is first split and forecasted by submarket.
Six main submarkets are covered, these are the: • Point-of-care diagnostics (PoC) • Clinical chemistry • Immunochemistry • Haematology • Microbiology • Genetic testing
The leading submarket in the IVD industry at present and throughout the next decade will be point-of-care diagnostics. This submarket is further subdivided into more specific tests. Blood glucose testing accounted for over half of the revenue PoC testing made in 2015 due to the rise in prevalence of diabetes.
What are the prospects in the leading regions and countries? In our study you will find individual revenue forecasts to 2026 for the leading regional and national markets: • US • Japan • Germany • France • UK • Spain • Italy • China • India • Brazil • Russia • Rest of the World
The US, Japan and China were the 1st 2nd and 3rd leading national markets in 2015 and each will retain its place over the next 10 years. India will be the fastest growing national market from 2015-2026 with China close behind.
Our new report discusses issues and events affecting the IVD market. You will find discussions, including qualitative analyses on: • The global IVD market • The IVD market divided by submarket including; point-of-care, clinical chemistry, haematology, immunochemistry, microbiology and genetic testing • The challenges facing the market, such as the US excise tax on medical devices • The latest merger & acquisition activity amongst industry leaders • 11 different national markets including the ‘EU5’ and ‘BRIC’ nations
Visiongain predicts that the demand for IVDs will increase in line with the rise in both incidence and prevalence of chronic and infectious diseases. Health professionals will recognise that if these diseases can be diagnosed at the earliest stage possible, then damage to the individual can be minimised in addition to a reduction of later costs to healthcare systems. IVDs will be able to stem the economic and clinical costs of chronic and infectious disease.
The drive to provide patients with diagnostic testing options that are more accurate, easy-to-use and convenient will sustain growth in the IVD market during the forecast period of this report.
Our 166 page report provides 38 tables and 72 figures covering 6 different IVD submarkets. 11 individual national markets are covered in addition to coverage of the leading companies in the industry. Discover the most lucrative areas in the industry and the future market prospects. You will see financial results, a primary interview, industry trends, opportunities, and revenue predictions. The increasing prevalence of both chronic and infectious diseases will ensure that there is a great demand for use and innovation of IVDs over the next decade and beyond.
Visiongain is a trading partner with the US Federal Government CCR Ref number: KD4R6
1. Report Overview 1.1 Introduction to the IVD Industry and Market 1.2 Main Report Findings 1.3 This Study Provides the Following Knowledge 1.4 Why You Should Read This Report 1.5 How This Report Delivers 1.6 Main Questions Answered by This Study 1.7 Who is This Study For? 1.8 Research Methods and Analysis 1.9 Frequently Asked Questions (FAQ) 1.10 Associated Visiongain Reports 1.11 About Visiongain
2. Introduction 2.1 What are In Vitro Diagnostic (IVD) Tests? 2.2 Classifying In Vitro Diagnostics 2.2.1 The US Classification 2.2.2 The European Commision (EC) Classification 2.2.3 Regulatory Issues in the IVD Market 2.2.3.1 Regulation of IVD Tests 2.2.3.2 Lack of Clarity Can be Costly 2.3 What are the Different Types of IVD Tests? 2.3.1 Point of care Diagnostics – The Most Prominent Type of IVD 2.3.2 Clinical Chemistry is Increasing in Complexity 2.3.3 Microbiology 2.3.3.1 Regulatory Differences with IVD Microbiology Tests 2.3.4 Haematology 2.3.5 Immunochemistry 2.3.6 Genetic Testing
3. The Global In Vitro Diagnostics Market, 2016-2026 3.1 In Vitro Diagnostics Market in 2015 3.2 Global IVD Market Forecast, 2016-2026: Three Submarkets Dominate 3.3 Expected IVD Industry Trends Over 2016-2026 3.3.1 Advances in Technology Driving the IVD Market 3.3.2 A Shift towards Decentralisation Healthcare 3.3.3 Increased Awareness of the Need for IVD Tests
4. In Vitro Diagnostics Submarkets, 2016-2026 4.1 The Global Point-of-Care IVD Market, 2016-2026: A Revolution in the Making 4.1.1 POC Diagnostics Market, 2015 4.1.2 POC Diagnostics: Market Forecast, 2016-2026 4.1.3 POC Diagnostics: Market Trends, 2016-2026 4.1.3.1 New Tests Targeting Biomarkers Will Be Crucial 4.1.3.2 Competition Driving Consolidation and Product Innovation 4.1.3.3 Infectious Diseases Prompting Growth of POC 4.1.3.4 Other Factors Influencing the POC Segment 4.2 The Global Clinical Chemistry IVD Market, 2016-2026 4.2.1 Clinical Chemistry Market Forecast, 2016-2026 4.2.2 Clinical Chemistry Market Trends, 2016-2026 4.3 The Global Immunochemistry IVD Market, 2016-2026 4.3.1 Immunochemistry Market Forecast, 2016-2026 4.3.2 Immunochemistry Market Trends, 2016-2026 4.3.2.1 Immunoassays and Automated Systems Prompting Market Growth 4.3.2.2 Emerging Markets Showing Strong Growth and Opportunities 4.4 The Global Haematology IVD Market, 2016-2026 4.4.1 Haematology Market Forecast, 2016-2026 4.4.2 Haematology Market Trends, 2016-2026 4.5 The Global Microbiology IVD Submarket, 2016-2026 4.5.1 Microbiology Market Forecast, 2016-2026 4.5.2 Microbiology Market Trends, 2016-2026 4.6 Genetic testing – The Future of the Industry 4.6.1 Genetic Testing Market Forecast, 2016-2026 4.6.2 Genetic Testing Market Trends, 2016-2026 4.6.2.1 Cytogenetic tests to Drive Market Growth 4.6.2.2 Direct-To-Consumer (DTC) Genetic Screening 4.6.2.3 Theranostics: Targeting Unmet Needs through DNA Tests
5. Leading National IVD Markets, 2016-2026 5.1 Regional Breakdown of the Global IVD Market, 2015 5.2 Leading National Markets for the Global IVD Market, 2016-2026 5.3 The US IVD Market Forecast, 2016-2026: Still the Global Leader 5.3.1 Increased Levels of Molecular Testing in the US 5.3.2 Increased Use of Mobile Applications 5.3.3 Obamacare and the Medical Device Excise Tax 5.4 The Japanese IVD Market 2016-2026 5.5 The EU5 Nations IVD Market, 2016-2026 5.5.1 Germany IVD Market, 2016-2026 5.5.2 The French IVD Market, 2012-2026 5.5.3 The UK IVD Market, 2016-2026 5.5.4 The Spanish IVD Market, 2016-2026 5.5.5 The Italian IVD Market, 2016-2026 5.6 The BRIC Nations 5.6.1 The Brazilian IVD Market, 2016-2026 5.6.2 The Russian IVD Market, 2016-2026 5.6.3 The Indian IVD Market, 2016-2026 5.6.4 The Chinese IVD Market, 2016-2026
6. Leading Companies in the IVD Market, 2016 6.1 A Fragmented Market with a Few Dominant Major Players 6.2 IVD Market Leaders Breakdown 6.3 Roche Continues to Dominate 6.3.1 Sales and Recent Performance Analysis, 2015 6.3.1.1 Roche Diagnostics - Driven by Immunodiagnostic Products 6.4 Danaher – A Strong Competitor in the IVD Market 6.4.1 Sales and Performance Analysis, 2015 6.4.1.1 Life sciences & Diagnostics – Danaher’s Main Source of Revenue 6.5 Siemens – A Highly Diversified Company 6.5.1 Sales and Recent Performance Analysis 6.5.1.1 Siemens Healthcare Sector 6.6 Abbott Laboratories Make a Prominent Contribution 6.6.1 Sales and Recent Performance Analysis, 2015 6.6.1.1 The Abbott Diagnostics Segment – Alere Acquisition Proving Troublesome 6.7 Thermo Fisher Scientific Acquires Life Technologies 6.8 Agilent Technologies Inc. 6.9 Smaller Companies in the IVD Market, 2016 6.9.1 Johnson & Johnson – The World’s Largest Med Tech Company 6.9.2 Myriad Genetics – Specialist Molecular Diagnostics 6.9.3 Horizon Discovery – A World Leader in Gene-Editing
7. SWOT and STEP Analysis of the IVD Market, 2016 7.1 In Vitro Diagnostics: Industry Trends 7.2 Strengths of the IVD Market, 2016 7.2.1 Patient Demographics Will be a Major Driver 7.2.2 Innovation Will Continue 7.3 Weaknesses 7.3.1 Regulatory Board Approvals May be Problematic 7.3.2 Reimbursement Issues Could Restrain Growth 7.4 Opportunities 7.4.1 Globalisation Creates a Wealth of Opportunity in Emerging Economies 7.4.2 Molecular Diagnostics Will have Increased Prominence 7.5 Threats 7.5.1 Medical Device Excise Tax in the US 7.5.2 Convergence 7.6 STEP Analysis 7.6.1 Social Factors 7.6.2 Technological Factors 7.6.3 Economic Factors 7.6.4 Political Factors
8. Research Interviews 8.1 Interview with Horizon Discovery, a Gene-Editing Company 8.1.1 On Horizon Discovery and the IVD Products Which They Offer 8.1.2 On the Challenges of Developing IVDs 8.1.3 On IVDs in the Future
9. Conclusions from the Research 9.1 Overview of the IVD Market 9.2 Submarket Breakdown: Point of Care Testing Will be the Biggest Driver 9.3 National IVD Market Outlook, 2016-2026 9.4 Leading Companies in the Global IVD Market 9.5 Future Outlook and Concluding Remarks 9.6 Associated Visiongain Reports 9.7 Visiongain Report Sales Order Form 9.8 About Visiongain 9.9 Report Evaluation Form
List of Tables Table 1.1 Global IVD Market Forecasts, 2016-2026: Revenue ($bn), Market Share (%), Annual Growth Rate (%) and CAGR (%) Table 2.1 Advantages and Disadvantages of POC Diagnostics, 2016 Table 3.1 IVD Global Market Revenues ($bn) and Market Shares (%) by Sector, 2015 Table 3.2 Global IVD Market Forecasts, 2016-2026: Revenue ($bn), Market Share (%), Annual Growth Rate (%) and CAGR (%) Table 4.1 POC Diagnostics Market Shares (%) & Revenues ($bn) by Test, 2015 Table 4.2 Point-of-Care (POC) Diagnostics Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 4.3 Clinical Chemistry Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 4.4 Immunochemistry IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 4.5 Haematology IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 4.6 Microbiology IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 4.7 Genetic Testing IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.1 IVD Market Revenues ($bn) and Market Shares (%) by Country, 2015 Table 5.2 IVD Market Forecasts, 2016-2026: Revenue ($bn), Market Share (%), Annual Growth Rate (%) and CAGR (%) Table 5.3 The US IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.4 The Japanese IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.5 The EU5 IVD Market Forecast, 2016-2026: Revenue ($bn), EU5 Market Share (%), AGR (%) and CAGR (%) Table 5.6 The German IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.7 The French IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.8 The UK IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.9 The Spanish IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.10 The Italian IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.11 The BRIC IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.12 The Brazilian IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.13 The Russian IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.14 The Indian IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 5.15 The Chinese IVD Market Forecast, 2016-2026: Revenue ($bn), Market Share (%), AGR (%) and CAGR (%) Table 6.1 Leading Companies in the IVD Market, Revenues ($bn) and Market Shares (%), 2015 Table 6.2 Leading Companies in the IVD Market, Revenues ($bn) and Market Shares (%), 2015 Table 6.3 Roche Diagnostics Product Lines: Revenues ($bn), Revenue Share (%) and Growth (%), 2015 Table 6.4 Danaher Total Revenues ($bn) and Revenue Shares (%) by Business Segments, 2015 Table 6.5 Siemens Revenues ($bn) & Revenue Shares (%) by Business Sectors, 2015 Table 6.6 Abbott Segment Revenues ($bn) and Revenue Shares (%), 2015 Table 6.7 Thermo Fisher Scientific Historical Sales: Revenue ($bn), AGR (%), 2010-2015 Table 6.8 Thermo Fisher Scientific Segment Breakdown: Revenue ($bn) and Revenue Share (%), 2015 Table 6.9 Agilent Technologies Revenues ($bn) and Revenue Shares (%), by Business Group, 2015 Table 6.10 Johnson & Johnson Major Medical Device Divisions: Revenues ($bn) and Revenue Share (%), 2015 Table 6.11 Myriad Genetics Revenues ($m) and Revenue Shares (%), by Business Segment, 2015 Table 7.1 SWOT Analysis of the Global IVD Market, 2016-2026
List of Figures Figure 3.1 IVD Market Shares (%) by Submarket, 2015 Figure 3.2 IVD Market Shares (%) by Submarket, 2020 Figure 3.3 IVD Market Shares (%) by Submarket, 2026 Figure 3.4 Global IVD Market Revenue Forecast ($bn), 2016-2026 Figure 3.5 Global IVD Market AGR Forecast (%), 2016-2026 Figure 3.6 Global IVD Market: Drivers and Restraints, 2016-2026 Figure 4.1 POC Diagnostics Market Shares (%) by Test Type, 2015 Figure 4.2 Point-of-Care (POC) Diagnostics 2016-2026: Revenue Forecast ($bn) Figure 4.3 Point-of-Care (POC) Diagnostics 2016-2026: AGR Forecast (%) Figure 4.4 Point-of-Care (POC) Diagnostics Drivers and Restraints, 2016-2026 Figure 4.5 Clinical Chemistry Diagnostics 2016-2026: Revenue Forecast ($bn) Figure 4.6 Clinical Chemistry Diagnostics 2016-2026: AGR Forecast (%) Figure 4.7 Clinical Chemistry Drivers and Restraints, 2016-2026 Figure 4.8 Immunochemistry IVD 2016-2026: Revenue Forecast ($bn) Figure 4.9 Immunochemistry IVD 2016-2026: AGR Forecast (%) Figure 4.10 Immunochemistry Drivers and Restraints, 2016-2026 Figure 4.11 Haematology IVD 2016-2026: Revenue Forecast ($bn) Figure 4.12 Haematology IVD 2016-2026: AGR Forecast (%) Figure 4.13 Haematology Drivers and Restraints, 2016-2026 Figure 4.14 Microbiology IVD 2016-2026: Revenue Forecast ($bn) Figure 4.15 Microbiology IVD 2016-2026: AGR Forecast (%) Figure 4.16 Microbiology Drivers and Restraints, 2016-2026 Figure 4.17 Genetic Testing IVD 2016-2026: Revenue Forecast ($bn) Figure 4.18 Genetic Testing IVD 2016-2026: AGR Forecast (%) Figure 4.19 Genetic Testing Drivers and Restraints, 2016-2026 Figure 5.1 National IVD Market Shares (%), 2015 Figure 5.2 National IVD Market Shares (%), 2020 Figure 5.3 National IVD Market Shares (%), 2026 Figure 5.4 The US IVD Revenue Forecast ($bn), 2016-2026 Figure 5.5 The US IVD AGR Forecast (%), 2016-2026 Figure 5.6 US IVD Market Drivers and Restraints, 2016-2026 Figure 5.7 The Japanese IVD Revenue Forecast ($bn), 2016-2026 Figure 5.8 The Japanese IVD AGR Forecast (%), 2016-2026 Figure 5.9 Japanese IVD Market Drivers and Restraints, 2016-2026 Figure 5.10 EU5 IVD Market Shares (%) by Country, 2015 Figure 5.11 EU5 IVD Market Shares (%) by Country, 2020 Figure 5.12 EU5 IVD Market Shares (%) by Country, 2026 Figure 5.13 EU5 IVD Market Drivers and Restraints, 2016-2026 Figure 5.14 The German IVD Revenue Forecast ($bn), 2016-2026 Figure 5.15 The German IVD AGR Forecast (%), 2016-2026 Figure 5.16 The French IVD Revenue Forecast ($bn), 2016-2026 Figure 5.17 The French IVD AGR Forecast (%), 2016-2026 Figure 5.18 The UK IVD Revenue Forecast ($bn), 2016-2026 Figure 5.19 The UK IVD AGR Forecast (%), 2016-2026 Figure 5.20 The Spanish IVD Revenue Forecast ($bn), 2016-2026 Figure 5.21 The Spanish IVD AGR Forecast (%), 2016-2026 Figure 5.22 The Italian IVD Revenue Forecast ($bn), 2016-2026 Figure 5.23 The Italian IVD AGR Forecast (%), 2016-2026 Figure 5.24 The BRIC Nations IVD Market Shares (%) by Country, 2015 Figure 5.25 The BRIC Nations IVD Market Shares (%) by Country, 2020 Figure 5.26 The BRIC Nations IVD Market Shares (%) by Country, 2026 Figure 5.27 BRIC Nations IVD Market Drivers and Restraints, 2016-2026 Figure 5.28 The Brazilian IVD Revenue Forecast ($bn), 2016-2026 Figure 5.29 The Brazilian IVD AGR Forecast (%), 2016-2026 Figure 5.30 The Russian IVD Revenue Forecast ($bn), 2016-2026 Figure 5.31 The Russian IVD AGR Forecast (%), 2016-2026 Figure 5.32 The Indian IVD Revenue Forecast ($bn), 2016-2026 Figure 5.33 The Indian IVD AGR Forecast (%), 2016-2026 Figure 5.34 The Chinese IVD Revenue Forecast ($bn), 2016-2026 Figure 5.35 The Chinese IVD AGR Forecast (%), 2016-2026 Figure 6.1 Leading Companies in the IVD Market by Market Shares (%), 2015 Figure 6.2 Roche Revenue Shares (%) by Business Segment, 2015 Figure 6.3 Roche Diagnostics Product Lines: Revenue Shares (%), 2015 Figure 6.4 Danaher Revenue Shares (%) by Business Segment, 2015 Figure 6.5 Siemens Revenue Share (%), by Business Sectors, 2015 Figure 6.6 Abbott Revenue Shares (%), by Segment, 2015 Figure 6.7 Thermo Fishers Scientific Segment Revenue Shares (%), 2015 Figure 6.8 Agilent Technologies Revenue Shares (%), by Business Group, 2015 Figure 6.9 Johnson & Johnson Major Medical Device Divisions Revenue Share (%), Figure 6.10 Myriad Genetics Revenue Shares (%) by Business Segment, 2015 Figure 9.1 The Global IVD Submarket Forecast Breakdown: Revenue ($bn), 2016-2026 Figure 9.2 National IVD Market Shares (%), 2015
3M Abbott Laboratories AbbVie Adaltis AdnaGen AG Affymetrix Agendia Agilent Akonni Biosystems Alere Amgen Arkay AssuraGen Astute Medical Atlas Genetics Bayer Beckman Coulter Binding Site Biohit HealthCare bioMérieux Bio-Rad BioSystems Bristol Myers-Squibb CardioGenics Celerus Diagnostics Center for Devices and Radiological Health (CDRH) [part of US FDA] Cepheid Claros Diagnostics Cognex Compendia Bioscience Corgenix Crescendo Bioscience Dako Danaher Daxor Corporation Devicor Medical Products DiaGenic DiaSorin Diaxonhit Diazyme Laboratories European Commission (EC) European Diagnostic Manufacturers Association (EDMA) European Medicines Agency (EMA) Expression Diagnostics Foundation for Innovative and New Diagnostics (FIND) Fujirebio Diagnostics Inc. Gene Chip Research Centre, Tianjin, China Genentech GenMark Diagnostics Genomic Health Gen-Probe Gifu University Glycominds Hai Kang Life Corporation Haplogen Genomics GmbH HemoCue Hoffman-La Roche Hologic Human Genetics Commission Immucell Immucor Innogenetics Innova Biotechnology Co. Instrumentation Laboratory Ipsogen Janssen Biotech Janssen Pharmaceuticals Japanese Ministry of Health and Welfare Johnson & Johnson Kreatech Diagnostics Lab-21 LabIndia Launch Diagnostics Leica Microsystems Life Technologies LifeScan Luminex Med BioGene Melanoma Diagnostics Meridian Bioscience Milagen Mindray Miraca Life Sciences Myriad Genetics Nanosphere National Institute of Clinical Excellence (UK NICE) Novartis Onconome Orion Genomics Ortho Clinical Diagnostics PathWorks Diagnostics PerkinElmer Pharmaceutical and Medical Devices Agency, Japan (PMDA) Phillips Polymedco Qiagen Quest Diagnostics Radiometer Medical Randox Laboratories Response Biomedical Roche Rules-Based Medicine Saladax Biomedical Sanofi SDIX Sekisui Diagnostics Sera Prognostics SeraCare Life Sciences Siemens Span Diagnostics St Jude Medical Stago STARLIMS Technologies SterilMed Suzhou Ribo Life Sciences Synthes Sysmex Target Discovery Targeted Diagnostics & Therapeutics Tethys Bioscience The Carlyle Group Tocagen Tosoh Bioscience Transasia Bio Medicals Trinity Biotech United Nations (UN) UroSens US Food and Drug Administration (FDA) VentriPoint Verax Biomedical Vermillion ViiV Healthcare World Health Organization (WHO)
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Visiongain’s reports are based on comprehensive primary and secondary research. Those studies provide global market forecasts (sales by drug and class, with sub-markets and leading nations covered) and analyses of market drivers and restraints (including SWOT analysis) and current pipeline developments. To find out more about our reports methodology, please email sara.peerun@visiongain.com
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