Global In-Vitro Diagnostics Market Size 2017-2023

1. GLOBAL IN-VITRO DIAGNOSTICS (IVD) MARKET: ANALYSIS & FORECASTS, 2017-2023 (Focus on Product Type, Test Type, Application, and Competitive Landscape) 1 The Research Scope and Methodology 1.1 Scope of the Report The report constitutes of an in-depth study of the global In-Vitro Diagnostics (IVD) market, including a thorough analysis of the product across different countries. The study also presents a detailed analysis of the market dynamics and the estimation for market size over the forecast period, 2017 to 2023. The purpose of the study is to gain a holistic view of the global In-Vitro Diagnostics (IVD) market in terms of various factors influencing it like recent trends, technological advancements, and regulatory aspects of automation systems. In addition, the study also comprises of exhaustive information on the product shortcomings, unmet needs, perception on the new products, preferences, competitive landscape, restraints and opportunities and the other vital information with respect to IVD products. The scope of this report is centred upon conducting a detailed study of the solutions allied with the global IVD market. The market has been segmented into ‘Product’, ‘Application’, ‘Test’, ‘End Users’ and ‘Region’. Moreover, the global IVD market report deliberates in detail, the analysis of all the macro & micro factors. It also evaluate the opportunities in the market for stakeholders and provide details of a competitive landscape for market leaders. The IVD market report is an exertion to provide the clear picture of the state of the market and sub markets over the next seven years. The report also sheds light on a very interesting market figure: Although, new tests and technologies have come to market in recent years but the very same major companies generate about 90% of product sales. 1 www.bisresearch.com  sales@bisresearch.com

2. Report coverage of the global IVD market includes key elements considered for the detailed analysis of the market: An in-depth analysis of the different product divisions across various countries consists of valuable insights into the trend followed in the market Valuation of the top investment areas in IVD space and captivating strategies will aid in channelizing investments in the precise directions to harvest better outcomes Geographical fragmentation and forecasts of the entire market; providing valuable insights on the major countries/regions in which this industry is flourishing and also identifies highly untapped regions Segment-level analysis in terms of products, end users, and pricing along with market size forecasts and estimations to detect key areas of industry growth Revisiting various micro environment factors that regulate the overall success of an Industry, using Porter’s Five Force analysis for estimating the level of competition and formulation of business strategies A comprehensive list comprising of key market players in conjunction with their product portfolio, current strategic interests, financial information, legal status, and SWOT analysis • • • • • • Figure 1 Key Elements Considered In-Depth Market Dynamics Analysis Exhaustive Product Segmentation Comprehensive Competitive Insights Detailed Market Share Analysis Extensive Coverage of Market Players Thorough Analysis of Business Opportunities BIS Research Analysis 2 www.bisresearch.com  sales@bisresearch.com

3. The global IVD market is further segmented as below: Figure 2 Global IVD Market Segmentation • Instruments • Consumables • Data Management Software/Hardware • Services • Others By Product Type • Immunoassays • Whole Blood Glucose Monitoring • Clinical Chemistry • Molecular Diagnostics • Microbiology • Anatomic Pathology • Hematology • Coagulation • Others By Test Type • Diabetes • Infectious Diseases • Oncology/Cancer • Cardiology • Nephrology • Autoimmune Diseases • Drug Testing • Infectious Diseases • Others Global IVD Market Segmentation By Applicati on Type • Central Lab • Point-of-care (POC) • General Practitioner (GP) and Clinics • Home Based • Academic Institutes By End User • North America • Europe • Asia Pacific (APAC) • Rest of the World (RoW) By Region BIS Research Analysis 1.2 BIS Research Market Research Methodology The research methodology design adopted for this specific study includes a mix of data collected from primary and secondary sources. Both primary sources (in-house experts, industry leaders and market players) and secondary sources (a host of paid and unpaid databases) along with analytical tools have been used exhaustively to build the forecast and predictive models. 3 www.bisresearch.com  sales@bisresearch.com

4. Figure 3 BIS Research Market Research Methodology RESEARCH APPROACH PRIMARY RESEARCH SECONDARY RESEARCH 1. DATABASE FOR KEY INDUSTRY PARTICIPANTS (DKIP) PREPARATION STUDYING THE MARKET STRUCTURE The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing directors, technology and innovation directors, and related key executives from various vendors providing technology solutions, associated service providers, and system integrators operatingin the targetedregions. E.g. CIO’s, VP, DirectorNew ProductDevelopment,Director–operations Mainly used to obtain key information about the industry’s value chain, the total pool of key players IDENTIFY MARKET, TECHNOLOGY AND COMPETITOR TRENDS 2. DISCUSSION GUIDE PREPARATION Understand market classification, and segmentation according to industry trends to the bottom-most level, regional markets, and key developments from both market- and technology-oriented perspectives A detailed questionnaire is shared with the primary respondent covering all the aspects related to the report topic 3. SCHEDULING AN APPOINTMENT Appointments are scheduled with CIO’s, VP – healthcare companies, Director with prior appointmentsand the discussionguide is shared with the primary respondentprior to the call INTEGRATE INFORMATION Integrate information within relevant documents to form launch pad for primary research 4. CALL EXECUTION A roundtable discussion is held with the KIP with the aim to gather first hand information about the technology,recent developmentsin the technologyand future outlook/ growthor decline VENDORS CONSULTANT RESELLERS 5. DOCUMENTATION POTENTIAL RESPONDENTS The interview is recorded and the information gathered in put on the drawing board with the informationcollectedthroughsecondary research. END USER MSP’s BIS Research Analysis Primary Data Sources The key data points taken from Primary Sources includes: • Validation and Triangulation of all the numbers and graphs • Validation of report segmentation and key qualitative findings • Understanding the competitive landscape • Understanding and considering the market dynamics factors for various market segment and sub-segment • Validation of impact analysis of macro and micro factors in different countries • Percentage split of individual markets for geographical analysis Secondary Data Sources The research study involves the usage of extensive secondary sources such as databases, company websites, and annual reports, among others. 4 www.bisresearch.com  sales@bisresearch.com

5. The following figure exhibits key secondary data sources considered in this report: Figure 4 Secondary Data Sources STOCK ANALYST WEBSITES COMPANY SOURCES Seeking Alpha Yahoo Finance Wiki finance The Wall Street Journal Annual Reports Press Releases SEC Filings Investor Presentations Financial Disclosures SECONDARY DATA SOURCES GOVERNMENT AND REGULATORY SOURCES PUBLIC AND PRIVATE DATABASES Medline PubMed National Library of Medicine ProQuest Thin Database CMS Datasets Medicare Beneficiaries Database Oxon Epidemiology The Centre for Disease Control (CDC) The World Health Organization (WHO) The National Health Services (NHS) The National Center for Biotechnology Information (NCBI) The Food & Drug Administration of United States (U.S. FDA) BIS Research Analysis The key data points taken from secondary sources include: • Segmentation breakups, split-ups, and percentage shares • Data for market value • Key industry trends of the top players of the market • Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation • Quantitative data for mathematical and statistical calculations The following figure exhibits the methodology adopted for estimating the global IVD market: 5 www.bisresearch.com  sales@bisresearch.com

6. Figure 5 Top Down and Bottom Up Approach Total global IVD market size ($million) Market value of global IVD market Percent split for the product type and sub-types of global IVD market Summation of x & y Geographical split Average selling price (ASP) for each type of product (Y) Regional and country-wise market for each sub- segment Products into number of units (X) Analysis of macro & micro factors BIS Research Analysis Note: The above approach has been followed for the market estimation of all the product segments related to IVD market Having estimated the global market size, the forecast employs a set of macro factors such as the population, disease prevalence rate, population, healthcare expenditure, disposable income, and Gross Domestic Product (GDP), among others. Assumptions and Limitations The following figure exhibits the standard assumptions and limitations which have been followed throughout the research study of the global IVD market: 6 www.bisresearch.com  sales@bisresearch.com

7. Figure 6 Assumptions and Limitations CURRENCY CONVERSION LIMITATIONS • The base currency considered for this study is U.S. $ • In the Company Profiles section, for the companies having revenues in any other currencies, is converted in to U.S. $ • The currencies other than U.S. $ are converted to U.S. $ for all statistical calculations considering the average conversion rate for the particular year • The currency conversion rate is taken from historical exchange rate of Oanda website • Technologies currently used are expected to persist through the forecast with no major breakthrough in technology • The economic downturn in future was not taken under consideration for market estimation and forecast AVERAGE SELLING PRICE (ASP) ASSUMPTION FOR MARKET ESTIMATION • The ASP is calculated for the year 2015 & 2016 and the currency considered is U.S. $ • For calculating the ASP of the market products, the weighted average of the list price of products has been considered • The base year considered for the calculation of market size was 2015. Instances where the market size for the FY 2015 were not available from primary or secondary sources, at such instances the values were estimated based on the Delphi method. • The historical year analysis was done from the FY 2010 to FY 2014 and the market size was estimated for the FY 2016 and projected from the year 2016 to 2023 BIS Research Analysis 7 www.bisresearch.com  sales@bisresearch.com

8. TABLE OF CONTENTS 1 Research Scope and Methodology 1.1 Scope of the Report Executive Summary 2 Market Overview 2.1 1.2 Global IVD Market Research Methodology Global IVD Market Overview (Addressable Market Size and Growth Potential), 2015-2023 2.1.1 North America 2.1.2 Europe 2.1.3 Asia Pacific 2.1.4 Latin America 2.1.5 Middle East and Africa 2.2 Historical Trends 2.3 World Economic Outlook of IVD Market, 2016 2.3.1 Global Diagnostics Expenditures 2.3.2 Global Laboratory Expenditure 2.3.3 Pricing Patterns for Diagnostics (IVD) 2.4 Technology Trends 2.4.1 An Era of Point of Care Testing 2.4.2 Exome Sequencing 2.4.3 Importance of Metabolomics profiling 2.4.4 Upsurge in the Adoption of Liquid Biopsy/Cell Free DNA Solutions 2.4.5 Emergence of Multigene Panels 2.5 Legal & Regulatory Environment 2.5.1 FDA Regulation 2.5.1.1 Key Aspect of IVD Regulation 2.5.2 European Commission Regulation 3 Market Dynamics 3.1 2.5.2.1 Key Changes in EU IVD Regulation Market Drivers 3.1.1 Demand for Rapid, Minimally Invasive and Non-Invasive Diagnostics Tools & Techniques 3.1.2 Upsurge in the Number of Patients with Infectious and Chronic Diseases 3.1.3 Increasing Global Healthcare Expenditure 3.1.4 Demand of POC Testing 3.2 Market Challenges 3.2.1 Reimbursement Challenges 3.2.2 Uncertain and Ambiguous Regulatory Environment Restraints IVD market 3.2.3 Ethical Issues 3.3 Market Opportunities 3.3.1 Upsurge in the Demand of Molecular Diagnostics 4 IVD Market Demand and Supply Analysis 3.3.2 Epigenomics Based Diagnostics Expected to be an Emerging Segment 8 www.bisresearch.com  sales@bisresearch.com

9. 4.1 Demand and Supply 4.2 Demand Determinant 5 Competitive Insights 5.1 Key Market Developments & Strategies 4.3 End-User Demand and Supply 5.1.1 Patent, Approvals and Certifications 5.1.2 Product Launch and Development 5.1.3 Collaborations, Joint Ventures & Partnerships 5.1.4 Mergers and Acquisitions 5.1.5 Business Expansion and Contracts 5.2 Porter’s Five Forces Analysis 6 Global IVD Market by Product Type, 2016-2023 6.1 Overview 5.3 Market Attractiveness Analysis of the IVD Market, by Geography 6.2 Instruments 6.2.1 Different Types of IVD Instruments 6.2.2 Clinical Chemistry Analyzers 6.2.2.1 Manual Photometer and Spectrophotometer 6.2.2.2 Glucose Monitoring Systems 6.2.2.3 Dedicated Glycated Hemoglobin/HbA1 Systems 6.2.2.4 Semi/Fully Automated Analyzers 6.2.2.5 Dedicated Multi-Parameter Clinical Chemistry Systems 6.2.2.6 Small Manual and Semi-Automated CC Systems 6.2.2.7 Semi-Automated CC Analyser 6.2.2.8 Medium Automated Clinical Chemistry Analyzer 6.2.2.9 Large Automated CC Analyser 6.2.2.10 Electrolyte- Flame Photometer 6.2.2.11 Electrolyte/ISE Only 6.2.2.12 Biogas Analyzer 6.2.2.13 Urine Analyzer 6.2.3 Immunochemistry Instruments 6.2.3.1 Immunoassay Analyzer 6.2.3.2 Nucleic Acid Processors 6.2.4 Haematology Instruments 6.2.4.1 Hemoglobin Analyser 6.2.5 Coagulation Systems 6.2.6 Microbiology Instruments 6.3 Reagents & Consumables 6.4 Data Management Software/Hardware 7 Global IVD Market by Test Type, 2016-2023 7.1 Overview 6.5 Global IVD Services Market 7.2 Clinical Chemistry 7.3 Immunoassays 9 www.bisresearch.com  sales@bisresearch.com

10. 7.4 Whole Blood Glucose Monitoring 7.5 Molecular Diagnostics 7.6 Microbiology 7.7 Anatomic Pathology 7.8 Haematology 7.9 Coagulation 7.10 Critical Care 7.11 Urinalysis 8 Global IVD Market by Application Type, 2016-2023 8.1 Diabetes 7.12 Others 8.2 Infectious diseases 8.3 Oncology/Cancer 8.4 Cardiology 8.5 Nephrology 8.6 Autoimmune Diseases 8.7 Drug Testing/Pharmacogenomics 8.8 HIV/AIDS 8.9 Women Health 9 Global IVD Market by End User Type, 2016-2023 9.1 Central Laboratories 8.10 Other IVD Application 9.2 Point-of Care (POC) 9.3 General Practitioner (GP) and Clinics 9.4 Academic Institutions 9.5 Hospitals 10 Global IVD Market by Geography, 2016-2023 10.1 North America 9.6 Others 10.1.1 U.S. 10.1.2 Canada 10.2 Europe 10.2.1 Germany 10.2.2 U.K. 10.2.3 France 10.2.4 Italy 10.2.5 Spain 10.2.6 Sweden 10.2.7 Norway 10.2.8 Switzerland 10.2.9 Austria 10.2.10 Denmark 10.2.11 Belgium 10 www.bisresearch.com  sales@bisresearch.com

11. 10.2.12 Portugal 10.2.13 Netherlands 10.2.14 Finland 10.2.15 Turkey 10.2.16 Rest of Europe 10.3 APAC 10.3.1 China 10.3.2 Japan 10.3.3 Australia 10.3.4 India 10.3.5 Singapore 10.3.6 Malaysia 10.3.7 Indonesia 10.3.8 South Korea 10.3.9 Vietnam 10.3.10 Rest of Asia Pacific (RoAPAC) 10.4 Latin America 10.4.1 Brazil 10.4.2 Mexico 10.4.3 Rest of Latin America 10.5 Middle East 10.5.1 Saudi Arabia 10.5.2 Israel 10.5.3 U.A.E. 10.5.4 Qatar 10.5.5 Oman 10.5.6 Bahrain 10.5.7 Kuwait 10.5.8 Rest of Middle East 11 End User Perception About IVD 11.1 Key Factors Influencing Decision About IVD Market 10.6 Rest of the World 11.2 Influence of GPs, labs and KOLs on Decision Making 11.3 Innovation Trends in IVD 11.4 Level of Competition Among Players 11.5 Perception About Pricing 11.6 Technology Preferences 11.7 Brand Perception 11.8 Selection Criteria for IVD 11.9 Information Required to Purchase a New Product 11.10 Preferred Channel for Purchasing 12 Market Analytics & Recommendations 11.11 Reason for Preferences 11 www.bisresearch.com  sales@bisresearch.com

12. 12.1 Product Benchmarking 12.1.1 Instruments 12.1.2 Consumables 12.1.2.1 Pregnancy Kits 12.1.3 IVD Reagents 12.2 Competitor Benchmarking 12.2.1 Clinical Chemistry Products 12.2.2 HIV Simple Assays/Rapid Diagnostics Tests (RDTs) 12.2.3 HIV Enzyme Immunoassays (EIAs) 12.2.4 HCV Enzyme Immunoassays (EIA) 12.2.5 CD4 Enumeration Technologies 12.2.6 HIV Quantitative Nucleic Acid Testing Technologies 12.2.7 HIV Qualitative Nucleic Acid Testing Technologies for HIV Diagnosis, Including Early Infant Diagnosis 13 Competitive Landscape 13.1 Market Share Analysis 12.2.8 Haematology Analyzers 13.2 Growth Share Matrix 13.3 Comprehensive Competitive Index 13.4 Supply Chain 14 Company Profile 14.1 13.5 Value Chain F. Hoffmann-La Roche AG 14.1.1 Overview 14.1.2 Financials 14.1.2.1 Financial Summary 14.1.3 SWOT Analysis 14.2 Danaher Corporation 14.2.1 Overview 14.2.2 Financials 14.2.2.1 Financial Summary 14.2.3 SWOT Analysis 14.3 Agilent Technologies 14.3.1 Overview 14.3.2 Financials 14.3.2.1 Financial Summary 14.3.3 SWOT Analysis 14.4 Novartis International AG 14.4.1 Overview 14.4.2 Financial 14.4.2.1 Financial Summary 14.4.3 SWOT Analysis 14.5 Illumina, Inc. 12 www.bisresearch.com  sales@bisresearch.com

13. 14.5.1 Overview 14.5.2 Financials 14.5.2.1 Financial Summary 14.5.3 SWOT Analysis 14.6 Myriad Genetics, Inc. 14.6.1 Overview 14.6.2 Financials 14.6.2.1 Financial Summary 14.6.3 SWOT Analysis 14.7 GE Healthcare 14.7.1 Overview 14.7.2 Financials 14.7.2.1 Financial Summary 14.7.3 SWOT Analysis 14.8 Qiagen, Inc. 14.8.1 Overview 14.8.2 Financials 14.8.2.1 Financial Summary 14.8.3 SWOT Analysis 14.9 Abbott Laboratories 14.9.1 Overview 14.9.2 Financials 14.9.2.1 Financial Summary 14.9.3 SWOT Analysis 14.10 Becton, Dickinson and Company 14.10.1 Overview 14.10.2 Financials 14.10.2.1 Financial Summary 14.10.2 SWOT Analysis 14.11 GlaxoSmithKline PLC (GSK) 14.11.1 Overview 14.11.2 Financials 14.11.2.1 Financial Summary 14.11.3 SWOT Analysis 14.12 Laboratory Corporation of America Holdings 14.12.1 Overview 14.12.2 Financials 14.12.2.1 Financial Summary 14.12.3 SWOT Analysis 14.13 Thermo Fisher Scientific 14.13.1 Overview 14.13.2 Financials 14.13.2.1 Financial Summary 13 www.bisresearch.com  sales@bisresearch.com

14. 14.13.3 SWOT Analysis 14.14 Johnson & Johnson 14.14.1 Overview 14.14.2 Financials 14.14.2.1 Financial Summary 14.14.3 SWOT Analysis 14.15 Siemens Healthineers 14.15.1 Overview 14.15.2 Financials 14.15.2.1 Financial Summary 14.15.3 SWOT Analysis 14.16 Quest Diagnostics Incorporated 14.16.1 Overview 14.16.2 Financials 14.16.2.1 Financial Summary 14.16.3 SWOT Analysis 14.17 Bio-Rad Laboratories, Inc. 14.17.1 Overview 14.17.2 Financials 14.17.2.1 Financial Summary 14.17.3 SWOT Analysis 14.18 Ortho Clinical Diagnostics 14.18.1 Overview 14.18.2 SWOT Analysis 14 www.bisresearch.com  sales@bisresearch.com

15. DISCLAIMER BIS Research provides valuable market intelligence to an exclusive group of customers in response to orders. The report is licensed for the customer’s internal use only and is subject to restrictions set henceforth. This document and its contents are confidential and may not be further distributed, published or reproduced, in whole or in part, by any medium or in any form for any purpose, without the express written consent of BIS Research. Customer will not disclose the contents of the report, whether directly in any media or indirectly through incorporation in a database, marketing list, report or otherwise, or use or permit the use of Information to generate any statistical or other information that is or will be provided to third parties; or voluntarily produce Information in legal proceedings. Market reports are based on expectations, estimates and projections as of the date such information is available. Any recommendation contained in this report may not be suitable for all investors or businesses. The market conclusions drawn are necessarily based upon a number of estimates and assumptions that, while considered reasonable by BIS Research as of the date of such statements, are inherently subject to market fluctuations and business, economic and competitive uncertainties and contingencies For more details regarding permission, please contact us: Email: sales@bisresearch.com  Tel: +1 650 228 0182 16 15 www.bisresearch.com  sales@bisresearch.com