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1 TriMark Publications January 2015 Volume: TMRIVD IN VITRO DIAGNOSTIC TESTING WORLD MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers

2 TABLE OF CONTENTS 1. IVD Market Overview Statement of Report About This Report Scope of the Report Objectives Methodology Executive Summary IVD Global Market Overview Total Global IVD Market International Sector and Country IVD Markets IVD Market Segments by Analyte High Growth Markets Summary Analysis of the Global IVD High-Growth Market by Geographic Region U.S.: Summary of IVD High-Growth Market Europe: Summary Analysis of the IVD High-Growth Market South-East Asia and Japan: Summary Analysis of the IVD High-Growth Market BRIC: Summary Analysis of the IVD High-Growth Market Brazil: Summary Analysis of the IVD High-Growth Market Russia: Summary Analysis of the IVD High-Growth Market Indian IVD High Growth Markets Summary of IVD High-Growth Market India China: Summary Analysis of the IVD High-Growth Market Summary of IVD High-Growth Market China Key Players Key Trends in the IVD Industry Acquisitions Market Drivers and Barriers Key Market Drivers Barriers to Growth Companion Diagnostics POCT POCT Market Overview Total Global POCT Market International Sector and Country POCT Markets POCT Market Segments by Analyte Key Players Acquisition, License Agreements, Internal Development and Partnerships Key Concepts for POCT Markets The Future of POCT The Biggest New Opportunities in POCT Molecular Diagnostics Market Overview Market Size and Growth Rate Key Players Market Segments Infectious Disease Key Segments of Molecular Diagnostic Markets for Infectious Disease Cancer Technology and Market Trends in Cancer Testing Cancer Testing Cancer Prognostic Assays TriMark Publications, LLC. All rights reserved. 2 trimarkpublications.com

3 Market Size Key Players Competitive Landscape Myriad Genetics (BRCA1 and BRCA2) Genomic Health (Oncotype DX) InterGenetics, Inc Clarient, Inc. (GE Healthcare) BioTheronostics Agendia B.V. (MammaPrint) LabCorp Quest Diagnostics Competitive Structure and Market Share Analysis Drivers and Restraints Molecular Diagnostics Cancer Market Drivers Ranked in Order of Impact Molecular Diagnostics Cancer Market Restraints Ranked in Order of Impact Business Factors Influencing Advanced Oncology Testing Services Market Trends in Cancer Testing Strategic Recommendations on Molecular Diagnostic Sector Business Functions Emerging Cancer Personalized Medicine Market Genetic Testing Genetic Testing Market Primary Competitors Prominent Issues in Genetic Prenatal Diagnosis Using Molecular Diagnostics Testing Snapshot of Molecular Diagnostics Industry Structure Technology and Market Trends Emerging Technologies Market Trends Molecular Diagnostics Testing Going Forward Key Sector Takeaways Clinical Chemistry Market Overview International Markets U.S. Market European Market Asian Market Key Players Market Segments Ultra-Large Throughput Chemistry Analyzers Large Throughput Analyzers Mid-Size Clinical Chemistry Analyzers Chemistry Analyzers for the Small-Volume Market Long-Term Changes Market Drivers The Limits to Growth Hot Sectors in the IVD Market Key Technologies Key Sector Takeaways Diabetes and Glucose Testing Market Overview Glucose Self-Testing Markets Key Players M&A Activity Important Deals in BGM Market Future of Patient Self-testing TriMark Publications, LLC. All rights reserved. 3 trimarkpublications.com

4 6.5 Lancet Market Market Size Strategic Recommendations in the Lancet Business Health and Safety Regulations Key Players in the Blood Lancet Market Lancet Distribution Networks Drivers of OTC and Self-testing Markets Factors Affecting OTC Medical Product Distribution Drugstores Critical to the Diabetic Care Category Important Elements of OTC Testing Strategic Recommendations for Self-Monitoring Blood Glucose Markets Future of Patient Self-Testing Immunochemistry Markets Market Overview Markets for Immunoanalyzer Testing Key Players Abbott Diagnostics Siemens Roche Beckman Coulter, Inc biomérieux Ortho-Clinical Diagnostics Long Term Changes Key Developments Market Drivers and Restraints Hot Sectors in the Immunoanalyzer Market Key Technologies Analyzer Integration Chemistry/Immunoassay Consolidated Workstations Key Sector Takeaways Hematology Market Overview International Markets U.S. Market European Market Asian Market Key Players Hematology Analyzers Large Throughput Analyzers Mid-Size Analyzers Analyzers for the Small Volume Market New Hematology Analyzers Profitability Market Drivers Key Sector Takeaways Coagulation Market Overview International Markets U.S. Market European Market Asian Market Rest of the World Markets Key Players TriMark Publications, LLC. All rights reserved. 4 trimarkpublications.com

5 9.4 Recent Coagulation Testing Sector Activity Roche and Diagnostica Stago Parting Ways in Laboratory Coagulation Roche Acquires Verum Diagnostica GmbH and Expands Coagulation Testing Product Line Universal Biosensors and Siemens Collaborate on Advanced POC Coagulation Platform Instrumentation Laboratory and Beckman Coulter concluded their Cross-Distribution Agreement CoaguChek XS Personal Receives Reimbursement Approval for Self-Testing in Japan Diagnostica Stago Launches Products for Measurement of Rivaroxaban Diagnostic Stago Offers Three Factor VII Detection Methods Diagnostica Stago Offers Three Procoagulant Microparticle Detection Methods Diagnostica Stago S.A.S enters into Joint Research Agreement with Bristol-Myers Squibb Trinity Biotech Sold its Worldwide Coagulation Business to the Stago Group Alere aka Inverness Medical Innovations Acquired HemoSense, Inc Alere Announced Positive Results in Clinical Study Evaluating At-Home Coagulation Testing Anticoagulation Self-Testing and Self-Management Market Drivers and Restraints Market Drivers Market Restraints Impact of New Oral Anticoagulant Drugs on the Coagulation Testing Market Key Technologies Key Strategic Recommendations Pathology Overview Pathology Markets Market Size Pathology Markets Served Key Technologies Key Sector Players Ventana Medical Systems Inc. (part of Roche s Diagnostics Division) Dako (An Agilent Technologies Company) Aperio(Part of Leica Biosystems) Abbott Laboratories Omnyx, LLC (Part of GE Healthcare) Visiopharm Digital Pathology Markets Market Drivers in the Digital Pathology Markets Market Barriers in the Digital Pathology Markets Digital Pathology Takeaways Microbiology Overview Microbial Culture Biochemical Tests Microscopy Microbiology Reagent Market Size and Revenue Analysis Key Players Diagnostic Platforms for Infectious Diseases Culture Methods Molecular Diagnostics Mass Spectroscopy Market Drivers and Restraints in Infectious Disease Testing Markets Market Drivers Market Restraints Key Sector Takeaways Blood Banking and Screening TriMark Publications, LLC. All rights reserved. 5 trimarkpublications.com

6 12.1 Market Overview International Markets Key Players in Blood Screening Histology and Cytology Tests The Overall Market Market Size Market Drivers Market Restraints Cytology and Histology Technology Platforms HLA Typing Cytology Screening Procedures and Pap Smear Technology Cytology Pap Smears Pap Smear Market Share Detection of HPV Detection of HPV DNA Benefits of Pap Smear and HPV Co-Testing Human Papillomavirus Testing Market Structure HPV Testing Market Overview U.S. Market European Market Latin American Market Asian Market Histology IHC Staining ISH Staining Special Stains Staining Tissue Staining Market Major Players Data Management and Connectivity Wireless LANs Connectivity Platforms DataLink Data Management System DataLink Integrated with RALS -Plus and Quick Multi-Linc DataLink with RALS-Plus DataLink with QML RALS-Plus, RALS-Web3 and RALS-Freedom International Technidyne Corporation HEMOCHRON Signature Elite Siemens Diagnostics Rapidpoint Alere Connect Products Medical Implant Communications Service (MICS) Conworx Technology Alere Informatics Medasys NoemaLife Advantages of POCT Connectivity Cost-Benefit Analysis of Testing Devices and IT Connectivity Hospital Network Issues POCT Analyzer Connectivity Software Solutions Company Profiles A. Menarini Abaxis, Inc Abbott Laboratories TriMark Publications, LLC. All rights reserved. 6 trimarkpublications.com

7 15.4 Accriva Diagnostics, Inc Adaltis AdnaGen AdvanDx Affymetrix, Inc Agendia Agilent Technologies ALERE, INC Alfa Scientific Designs, Inc Alfa Wasserman, Inc ALPHELYS AMS Ambry Genetics ArcticDx, Inc Ariosa Diagnostics, Inc ARKRAY USA, Inc Asuragen, Inc Atlas Genetics Atonomics A/S AutoGenomics, Inc Awareness Technology Axxin Bayer BD Beckman Coulter Genomics, Inc Biocartis SA BioCytex Biodata (Microlink Engineering Systems) BioData Ltd Biodesix BioGenex Laboratories, Inc BioFire Diagnostics, Inc. (Part of biomérieux now) BioMedomics biomérieux Biophor Diagnostics Bio-Rad Biosensia Ltd Biosite Diagnostics (part of Alere) Biotage AB biotheranostics Cancer Genetics, Inc Caris Life Sciences Cepheid Celula, Inc Chembio Diagnostics, Inc Clarient Coagusense, Inc CombiMatrix Corporation Curetis AG Cyber Medical Ltd Dako A/S (Agilent Technologies) Debiotech DexCom Diagnostica Stago, Inc Diagnostica Stago S.A.S Diagnostics for All TriMark Publications, LLC. All rights reserved. 7 trimarkpublications.com

8 15.60 DiaSorin S.p.A DxNA, LLC Echo Therapeutics Eiken Chemical Company Limited Enigma Diagnostics Limited Epigenomics Exact Sciences Corporation Exagen Diagnostics, Inc Exiqon Exosome Diagnostics FIFTY50 Medical, Inc Fluidigm Corporation Fujirebio Inc GE Healthcare Genera Biosystems GenMark Diagnostics, Inc Genomica S.A.U Genomic Health, Inc Genomix Biotech Genoptix, Inc Gentag, Inc Great Basin Corporation Grifols Haemonetics Corporation Hologic Gen-Probe Hutman Diagnostics, AG Hy Laboratories Ltd HYPHEN BioMed Ikonisys Inc Illumina, Inc Immunexpress Group Infopia Co., Ltd Innovative Biosensors, Inc Integrity Applications InterGenetics, Inc Integrated Diagnostics International Technidyne Corp (THORATEC CORP Instrumentation Laboratory IQuum, Inc.(acquired by Roche) isense Corporation (subsidiary of BayerAG) JEOL Ltd Johnson & Johnson Kommanditgesellschaft Behnk Elektronik GmbH & Co Kyowa Medex LabCorp Labor BioMedical Technologies GmbH (LABiTec) Leica Biosystems Life Technologies Corporation Luminex Corporation Lumora Ltd M-Biotech MBio Diagnostics, Inc MDxHealth Medica Corporation, Inc Medtronic Menssana Research, Inc TriMark Publications, LLC. All rights reserved. 8 trimarkpublications.com

9 Meridian Biosciences Metaara Medical Technologies Inc Miraculins Inc Mobidiag Myriad Genetics, Inc Nanosphere Nanostring Natera Inc Neogenomics Nipro Diagnostics Nova Biomedical Corporation Novartis Novo Nordisk Nuvera Biosciences OraSure Ortho Clinical Diagnostics (Formerly a Johnson & Johnson Company) Pfizer, Inc Phamatech, Inc Pharma Supply, Inc Polymedco Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) Qiagen NV Quidel Corporation Radient Pharmaceuticals Corporation Randox Roche AG Rosetta Genomics Ltd Sanofi Seegene Sekisui Diagnostics Sensors for Medicine and Science Sequenom, Inc Shimadzu Corporation Siemens AG Siemens Healthcare Diagnostics Sienco Inc Simple Diagnostics SIRS-Lab Smiths Medical Source MDx Spartan Bioscience Spectrum Laboratories, Inc Sysmex America, Inc Technoclone Gmbh Telcare Thermo Fisher Scientific, Inc TrimGen TrovaGene Trinity Biotech plc U.S. Diagnostics Universal Biosensors, Inc Ventana VeraLight Veredus Laboratories Veridex (a Johnson & Johnson company) Visiopharm TriMark Publications, LLC. All rights reserved. 9 trimarkpublications.com

10 Wako WILEX AG ZS Genetics 341 INDEX OF FIGURES Figure 2.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2013 and Figure 2.2: Worldwide Geographic Distribution of Total IVD Testing Markets by Country, Figure 2.3: Global IVD Market Share by Specialty, Figure 2.4: Indian Diagnostics Market Segments, Figure 2.5: Company Market Share for IVD Testing Markets, Figure 3.1: Percentage Uptake by Analyte in Hospitals Performing POC Testing 46 Figure 3.2: Total Global POCT Market, Figure 3.3: Worldwide Distribution of POCT, Figure 3.4: Summary of Global POCT Markets by Market Segment, Figure 4.1: Global Market for Molecular Diagnostics, Figure 4.2: Market Share by Region for Molecular Diagnostics Testing, Figure 4.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets, Figure 4.4: Share of Molecular Diagnostics Testing by Application, Figure 4.5: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, Figure 4.6: Total Global Infectious Disease Molecular Diagnostics Markets, 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, Figure 4.9: Molecular Diagnostic Markets for Cancer Testing U.S., Figure 5.1: Global Clinical Chemistry Revenues, Figure 5.2: Worldwide Geographical Distribution of Clinical Chemistry Testing, Figure 6.1: Geographic Segments of the Worldwide Glucose Self-Testing Market, 2012 and Figure 6.2: Worldwide Glucose Self-Testing Market by Region, Figure 6.3: Personal Lancet Unit Sales Market Share by Geographic Region, Figure 7.1: Market Share for Key Players in Immunoassay Testing Markets, Figure 9.1: Global Revenue Forecasts for Coagulation Testing, Figure 9.2: U.S. Revenue Forecasts for Coagulation Testing, Figure 9.3: European Revenue Forecasts for Coagulation Testing, Figure 9.4: Japanese Revenue Forecasts for Coagulation Testing, Figure 9.5: ROW Revenue Forecasts for Coagulation Testing, Figure 10.1: Market Shares in Pathology Diagnostics, by Company 166 Figure 10.2: The Global Laboratory Digital Pathology Market, 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 INDEX OF TABLES Table 2.1: Global Distribution of IVD Testing by Key Geographic Regions, 2013 and Table 2.2: Global GDP Growth Rates, 2011 to Table 2.3: Top 15 Country Markets for IVD Testing, Table 2.4: Global Distribution of IVD Testing by Market Segments, Table 2.5: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing, Table 2.6: Global IVD High-Growth Markets Percentage of Revenues by Geographic Region, Table 2.7: Summary of IVD High-Growth Market U.S., Table 2.8: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing U.S., Table 2.9: U.S. Individual IVD High-Growth Markets Revenue Forecast Table 2.10: Europe: Individual IVD High-Growth Markets Revenue Forecast, TriMark Publications, LLC. All rights reserved. 10 trimarkpublications.com

11 Table 2.11: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Asia, Table 2.12: Asia: Individual IVD High-Growth Markets Revenue Forecast, Table 2.13: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Brazil, Table 2.14: Brazil: Individual IVD High-Growth Markets Revenue Forecast, Table 2.15: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Russia, Table 2.16: Russia: Individual IVD High-Growth Markets Revenue Forecast, Table 2.17: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing India, Table 2.18: India: Individual IVD High-Growth Markets Revenue Forecast, Table 2.19: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing China, Table 2.20: China: Individual IVD High-Growth Markets Revenue Forecast, Table 2.21: Company Market Share for IVD Testing Markets, Table 2.22: Market Trends in the Diagnostics Space 38 Table 3.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2013 and Table 3.2: Global Company Market Share POCT Analysis, Table 3.3: Main Drivers for the Point of Care Market 53 Table 4.1: Applications of Molecular Diagnostics Technology Platforms 56 Table 4.2: Global Distribution of Molecular Diagnostics Testing by Geographic Region, Table 4.3: Key Players and Market Share in the Global Molecular Diagnostics Testing Market, Table 4.4: Share of Molecular Diagnostics Testing by Application, Table 4.5: Future Areas of Growth in Molecular Diagnostics 60 Table 4.6: Molecular Diagnostics Infectious Disease Market Drivers Ranked in Order of Impact 63 Table 4.7: Molecular Diagnostics Infectious Disease Market Restraints Ranked in Order of Impact 63 Table 4.8: Molecular Diagnostics Infectious Disease Sector: Strategic Recommendations on Business Functions 63 Table 4.9: Nucleic Acid Testing Reagents for HIV Testing 65 Table 4.10: Nucleic Acid Testing Reagents for HBV Testing 65 Table 4.11: Nucleic Acid Testing Reagents for HCV Testing 65 Table 4.12: Molecular Diagnostic Markets for Cancer Testing, Table 4.13: Specific Diagnostic Products Categories Comprising the General Cancer Diagnostic Market 71 Table 4.14: Highlights of the Cancer Molecular Diagnostic Testing Segment 71 Table 4.15: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 71 Table 4.16: U.S. Market for Molecular Diagnostics Cancer Testing, Table 4.17: Key Diagnostic Company Players and Market Share in Global Molecular Diagnostics Cancer Testing Market 74 Table 4.18: Key Players in the Breast Cancer Molecular Diagnostic Space 74 Table 4.19: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 75 Table 4.20: Oncotype DX Overview 77 Table 4.21: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 77 Table 4.22: Clarient s Offerings in Breast Cancer Testing 78 Table 4.23: Trends in Cancer Personalized Medicine 84 Table 4.24: Commercial Labs Performing Genetic Testing 86 Table 4.25: Technology Trends in Cancer Testing 89 Table 4.26: Trends in Theranostics 90 Table 4.27: Market Trends in Cancer Testing 90 Table 4.28: Molecular Diagnostics Cancer Market Drivers Ranked in Order of Impact 91 Table 4.29: Molecular Diagnostics Cancer Market Restraints Ranked in Order of Impact 91 Table 5.1: Global Distribution of General Chemistry Testing by Geographic Region, Table 5.2: Leading Marketers of Automated Clinical Chemistry Instruments 97 Table 5.3: Ultra-Large Clinical Chemistry Analyzers 99 Table 5.4: Large Clinical Chemistry Analyzers TriMark Publications, LLC. All rights reserved. 11 trimarkpublications.com

12 Table 5.5: Mid-Size Clinical Chemistry Analyzers 102 Table 5.6: Small Clinical Laboratory Analyzers 103 Table 5.7: Clinical Chemistry Analyzer Market Drivers Ranked in Order of Impact 105 Table 5.8: Clinical Chemistry Analyzer Market Restraints Ranked in Order of Impact 106 Table 6.1: Worldwide Comprehensive Glucose Testing Market (Includes Reagents and Supplies in both the Self- Testing and Professional Markets in $ Billions), Table 6.2: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), Table 6.3: Global Revenues for Professional Point of Care Blood Glucose Monitoring Systems (within Hospitals and Physician s Offices), Table 6.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets), Table 6.5: Revenues and Market Shares in the SMBG Market in 2013, by Company 114 Table 6.6: Unit Sales of Homecare Lancets in the U.S., Table 6.7: Unit Sales of Homecare Lancets in the E.U., Table 6.8: Dollar Sales of Homecare Lancets in the U.S., Table 6.9: Dollar Sales of Homecare Lancets in the E.U., Table 6.10: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., Table 6.11: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., Table 6.12: Competition in the Lancet Market Segment 121 Table 7.1: Global Revenue Forecasts for Immunoanalyzer Testing, Table 7.2: Immunoanalyzer Market Drivers Ranked in Order of Impact 135 Table 7.3: Immunoanalyzer Market Restraints Ranked in Order of Impact 135 Table 8.1: Global Clinical Hematology Analyzer and Reagent Revenues, Table 8.2: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, Table 8.3 Key Players in Worldwide Hematology Analyzers and Reagent Market 144 Table 8.4: Hematology Analyzers Currently in Market, Table 9.1: Key Players in Anticoagulation Sector 153 Table 9.2: Benefits of Anticoagulation Self-Testing 158 Table 9.3: Barriers to Anticoagulation Self-Testing and Self-Management 160 Table 9.4: Key Market Drivers for Coagulation Testing 162 Table 9.5 Market Drivers for Point of Care Anticoagulation Testing Market 162 Table 9.6 Key Market Restraints for Coagulation Testing 162 Table 9.7: Market Restraints for Point of Care Anticoagulation Testing Market 162 Table 10.1: Global Distribution of Pathology Equipment and Reagents by Geographic Region, Table 10.2: Anatomical Laboratory Computer Systems Manufactures 169 Table 10.3: Digital Pathology Market Drivers Ranked in Order of Impact 171 Table 10.4: Digital Pathology Market Restraints Ranked in Order of Impact 171 Table 11.1: Global Microbiology Reagent Sales Table 11.2: Clinical Microbiology Market Drivers Ranked in Order of Impact 178 Table 11.3: Clinical Microbiology Market Restraints Ranked in Order of Impact 178 Table 12.1: Global Distribution of Blood Banking Reagents Sales by Geographic Region, Table 12.2: Key Players in Blood Banking and Transfusion Markets 181 Table 12.3: Roche s cobas s 201 system: Competitive Advantages 183 Table 12.4: Blood Bank information Systems 184 Table 13.1: Global Histology and Cytology Sales by Segment, Table 13.2: Cytology and Histology Market Drivers Ranked in Order of Impact 186 Table 13.3: Cytology and Histology Market Restraints Ranked in Order of Impact 187 Table 13.4: Estimated Number of Pap Smears Performed by Country, Table 13.5: Global Market for HPV Molecular Diagnostic Testing, Table 13.6: U.S. Market for HPV Diagnostic Testing, Table 13.7: Tissue Diagnostics Market Segments 199 Table 14.1: Applications for Wireless LAN Technology 200 Table 14.2: Customized Reports Must Support CAP and JCAHO Requirements 203 Table 14.3: Applications of RALS Connectivity with POCT Devices 205 Table 15.1: Drugs of Abuse Cut-off Levels for the TOX/See Test by Bio-Rad 240 Table 15.2: OraSure Portfolio of Drugs of Abuse Detection Methodologies TriMark Publications, LLC. All rights reserved. 12 trimarkpublications.com

13 1. IVD Market Overview 1.1 Statement of 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 microarrays are enabling greater sensitivity and precision in nucleic acid measurements, further expanding manufacturers offerings. This TriMark Publications 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. 1.2 About This Report This report includes the following features for each major IVD market segment: It examines the generally accepted clinical analytical activities in use today in the diagnostics (IVD) sector for diagnosis and management of disease. It includes the prevalent clinical-measurement devices and the accompanying reagents and supplies as utilized in hospitals and large reference and specialty Clinical Laboratory Improvements Act (CLIA) licensed laboratories, as well as physicians offices and point of care testing. It discusses the potential benefits of the diagnostics techniques for various sectors of the medical and scientific communities in serving patients and managing disease, and it assesses the market drivers and bottlenecks for IVD tests from the perspective of these communities. It establishes the current total IVD market size and future growth of the diagnostics market for disease management, and analyzes the current size and growth of key segments. It assesses various business models in diagnostics, including CLIA-licensed specialty labs, general reference labs and reagent kit marketing and provides strategic recommendations for near-term business opportunities. It examines the roles played by companies that have invested significantly in this market, and it provides current and forecasted market shares by these companies. 1.3 Scope of the Report The goal of this study is to review the market for IVD diagnostics testing equipment and supplies using reagents and instruments for analysis of individual components in body tissues and fluids. Toward this goal, this review: Identifies the major segments in IVD markets. Estimates the current and future U.S. and global markets for in vitro diagnostics for various disease sectors. Examines market drivers that have resulted in the global race for new in vitro diagnostics. Reviews the impact of current products and the future of the diagnostics industry. Provides insight into the diagnostics products in the pipeline and the companies that strive to bring these products to the market in the immediate future TriMark Publications, LLC. All rights reserved. 13 trimarkpublications.com

14 Evaluates global activity of IVD with specific contributions from the top-ranking five country markets: U.S., Japan, Europe, China and ROW. Key questions answered in this study are: What products are included in the phrase in vitro diagnostics? What disease conditions offer the greatest potential for diagnostics technology platforms? What is the current global market for in vitro diagnostics? What regulatory and technical challenges are being confronted by the diagnostics industry? What are the current promising developments in each major diagnostics sector? This examination surveys most of the biotech companies known to be currently marketing, manufacturing or developing instruments and reagents for the diagnostics market for disease diagnosis and management, in both the U.S. and the world. Each company is discussed in depth, with sections on its history, product line, business and marketing analysis, and a subjective commentary of the company s market position. Market size, growth rates and market components for instruments, reagents, controls and consumables used in this area are also analyzed. 1.4 Objectives The reader should consult other TriMark Publications reports for detailed discussions of important individual market segments related to the molecular diagnostics market or routine testing. In addition to this report, TriMark Publications offers a complete suite of market reports aimed at the molecular diagnostic space including: Molecular Diagnostics Markets, Molecular Diagnostics in Infectious Disease Testing, Molecular Diagnostics in Cancer Testing and Molecular Diagnostics in Genetic Testing. 1.5 Methodology The principal author of this report holds a Ph.D. in biochemistry from the University of Minnesota, and had his postdoctoral studies at the University Of Connecticut School of Medicine. He has taught at Quinnipiac University, the Tufts School of Medicine and New York Institute of Technology. He has been a senior scientist at DuPont and Pfizer Pharmaceutical Laboratories in drug development and diagnostic testing. He was a leader in the formation and development of Dianon Laboratories, now part of LabCorp. He also has many decades of experience in science writing and as a medical industry analyst and consultant. He has over 40 years of experience in laboratory testing and instrument and reagent development technology as a licensed clinical laboratory director, as well as extensive experience in senior level management positions in biotech and medical service companies. The editor holds a Ph.D. in life sciences from Jawaharlal Nehru University, with post-doctoral training from the University of Manitoba and Saskatoon Cancer Centre, respectively. She has authored several peer-reviewed articles on signaling pathways involved in cancer progression, and has over six years experience as a scientific editor. Company-specific information is obtained mainly from industry trade publications, academic journals, news and research articles, press releases and corporate websites, as well as annual reports for publicly-held firms. Additional sources of information include non-governmental organizations (NGOs) such as the World Health Organization (WHO) and governmental entities such as the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Where possible and practicable, the most recent data available have been used. Some of the statistical information was taken from Biotechnology Associates databases and from TriMark s private data stores. The information in this study was obtained from sources that we believe to be reliable, but we do not guarantee the accuracy, adequacy or completeness of any information or omission or for the results obtained by the use of such information. Key information from the business literature was used as a basis to conduct dialogue with and obtain expert opinion from market professionals regarding commercial potential and market sizes. Senior managers from major company players were interviewed for part of the information in this report TriMark Publications, LLC. All rights reserved. 14 trimarkpublications.com

15 Primary Sources TriMark collects information from full market reports, hundreds of Database Tables and many comprehensive multiclient research projects, as well as Sector Snapshots that it publishes annually. TriMark extracts relevant data and analytics from its research as part of this data collection. Secondary Sources TriMark uses research publications, journals, magazines, newspapers, newsletters, industry reports, investment research reports, trade and industry association reports, government-affiliated trade releases and other published information as part of its secondary research materials. The information is then analyzed and translated by the Industry Research Group into a TriMark study. The Editorial Group reviews the complete package with product and market forecasts, critical industry trends, threats and opportunities, competitive strategies and market share determinations. TriMark Publications Report, Research and Data Acquisition Structure The general sequence of research and analysis activity prior to the publication of every report in TriMark Publications includes the following items: Completing an extensive secondary research effort on an important market sector, including gathering all relevant information from corporate reporting, publicly-available data and proprietary databases. Formulating a study outline with the assigned writer, including important items, as follows: Market and product segment grouping, and evaluating their relative significance. Key competitors evaluations, including their relative positions in the business and other relevant facts to prioritize diligence levels and assist in designing a primary research strategy. End-user research to evaluate analytical significance in market estimation. Supply chain research and analysis to identify any factors affecting the market. New technology platforms and cutting-edge applications. Identifying the key technology and market trends that drive or affect these markets. Assessing the regional significance for each product and market segment for proper emphasis of further regional/national primary and secondary research. Completing a confirmatory primary research assessment of the report s findings with the assistance of expert panel partners from the industry being analyzed. For projection for the future values and growth rates of specific markets our analysts use a proprietary forecast spreadsheet, which takes into account a wide variety of market indices such as inflation rates and anticipated increases and decreases in funding of specific markets. Then, other factors such as new market introductions, acquisitions, and other factors are manually incorporated into the spreadsheet. 1.6 Executive Summary The total IVD market was $58.1 billion in Growing at a CAGR of 5%, it is on track to reach $74 billion by North America accounted for an estimated 38% of the IVD testing hospital market in 2013, Europe for 32%, Asia Pacific for 19% and the rest of the world for 11%. Total IVD revenues are growing at a rate of 5% to 6% per year worldwide, The U.S. and Western Europe are the largest IVD markets. Asia Pacific and Eastern Europe are projected to be the fastest growing. Revenue for the global the IVD market is forecasted to reach $74 billion by TriMark Publications, LLC. All rights reserved. 15 trimarkpublications.com

16 The Asia Pacific area, which is led by the Chinese and Indian national markets (once Japan is excluded), is expected to be the fastest growing region for IVD market applications during the period 2013 to 2018 with a CAGR of 13%. The market for IVD testing in Asia (including Japan) is estimated to be $11 billion in The Asia Pacific region will account for 28% of the world IVD market by IVD sales in China have grown more than 30% per year for the past four to five years and now stand at more than $4.5 billion. The IVD markets of China and India, two countries that account for approximately one-third of the world s population, have demonstrated remarkable growth in the past decade. The IVD markets in these two countries have seen steady growth rates of 10% to 20% per year over the past 15 years TriMark estimates that the global POCT market was valued at $10.86 billion in 2013, equivalent to 18.6% of the global IVD market. It is estimated that the global POCT market will exhibit a compound annual growth rate (CAGR) of ~8% between 2012 and 2018 to $15.87 billion. Within the POCT markets, glucose testing remains the leading global segment, projected to account for 40.5% of global near-patient testing by Excluding glucose testing, in the point-of-care (near-patient) segment, only rapid cardiac markers rises above $2 billion in POCT testing by 2018, accounting for an estimated 18.1% of total testing by TriMark is publishing a report with more detail called Point of Care Diagnostic Testing World Markets. Worldwide, approximately $7.7 billion was spent on molecular diagnostics tools, assays and other products in 2013, corresponding to a CAGR of more than 12%. The CAGR is projected to be around 11.6% through 2018, reaching $13.4 billion by that year. Of this amount, approximately 55% was spent on assays used for testing infectious diseases. The remaining 45% was spent for other products, such as those used in cancer markers and genetic testing. A summary review of the global IVD high-growth markets as a percentage of revenues by geographic region is provided in the next table in the form of a five-year revenue forecast. Whilst the U.S. will obtain a higher proportion of the global market between 2012 and 2014, it is expected that it will decline between 2014 and It is anticipated that this will be as a direct result of the increase share of the global market by the emerging markets and, in particular, the effect of the increase in the market for IVD products in the BRIC countries. The value of the IVD high-growth diagnostic testing market in the U.S. in 2013 was $15.8 billion. By the end of the forecast period in 2018, it is predicted that the market will have increased in value to $28.01 billion (CAGR 12.2%). TriMark is publishing a report with more detail called High-Growth Diagnostic Testing Markets. Many of the new high-growth IVD products and services are specifically targeted at markets outside of the traditional hospital or clinical laboratory such as the point of care setting or genetic screening. Competition in the development and marketing of high-growth diagnostic products is intense, and diagnostic technologies have been subject to rapid change. TriMark estimates that the competitive factors determining success in the diagnostic market include convenience, privacy, price and product performance as well as the distribution, advertising, promotion and brand name recognition of the marketer. As more and more targeted drugs come onto the market in the next decade, there will be a growing need for diagnostics that can help predict and match patients with drugs which will serve them best. With a broad portfolio of genetic and proteomic analysis platforms, large diagnostic companies will be able to give a pharmaceutical company a flexible, cost-effective means to manage the evolution of the companion diagnostic assay through the drug development process. Leading clinical diagnostics companies, with the tools and technologies to help define the future of patient care, are looking forward to opportunities for collaborating with pharmaceutical companies and extending their position in specialty areas to take advantage of opportunities, particularly for early disease diagnosis and improved treatment regimens in the emerging companion diagnostic market. Over the past few years, there has been a dramatic shift in diagnostic testing which is steadily moving away from the centralized laboratory setting to the operating room, bedside, clinic and home points of care. Factors such as rapid technological advancements, expanded test menus, user-friendly instrumentation, and improved connectivity and data management, are the main drivers of growth in the IVD markets. IVD in near-patient settings serve to improve patient outcomes and lower overall healthcare costs by reducing diagnosis times, resulting in shorter timeframes to therapeutic intervention. Accelerated adoption of POCT devices is evident in the global shift toward POCT from centralized laboratory testing. Forces shaping the landscape include evolution of innovative technologies, an aging population, increased incidence of chronic disease such as diabetes, development of personalized medicine and promising new opportunities in emerging markets TriMark Publications, LLC. All rights reserved. 16 trimarkpublications.com

17 The major drivers of the IVD markets include molecular methodologies such as nucleic acid amplification (in particular PCR), sequencing, microarrays and in situ hybridization (ISH). IVD manufacturers are constantly improving on and expanding their product offerings to keep pace with ever-evolving end-user needs. While major players in the IVD industry attempt to increase market share by intensifying product development efforts in POCT for example, Abbott and Alere the industry remains highly fragmented, and there is room for smaller players to enter and compete with innovative platforms and expansive test menus. As the IVD markets continue to grow and evolve shaped by growing demand for IVD products and services the industry is also experiencing escalating deal activity in many sectors. Within these rapidly growing areas of the diagnostics market, strategic acquisitions allow companies to expand existing portfolios with complementary products and capabilities. Market drivers: Tests based upon molecular diagnostic (nucleic acid) technology platforms. Move toward marketing rapid point of care test kits. Tests developed as CLIA-waived tests. Cost per test less of an issue with high demand diagnostic tests. Coupling the diagnostic test with high profile diseases, e.g., ovarian or breast cancer. Move toward bringing complicated tests into a single expert lab. Move for CLIA regulatory oversight using expert labs, rather than FDA using diagnostic kits. Move away from central lab big iron chemistry analyzers. Focus on improving patient outcomes with diagnostic tests using so called personalized medicine. Move to reduce expertise needed to run tests because of shortage of trained personnel. More diagnostic start-ups to develop tests with high growth potential. Increased M&As as larger players acquire exciting new test technology. Improving profit margins through improved product pricing and operational efficiencies. Securing a stronger new product pipeline from internal research and development. Pursuing licensing and acquisitions opportunities, when financially and strategically attractive. Launching diagnostic test business under a brand by leveraging marketing and distributing strength in the U.S., maximizing worldwide sales through current and newly identified sales channels in Europe and the rest of world. Launching a new and improved CLIA-waived test worldwide. Launching rapid diagnostic tests on a worldwide basis in conjunction with a development partner such as a pharmaceutical company, i.e., companion diagnostic testing. Expanding development and marketing collaborations with large pharmaceutical and other healthcare companies. Identifying business development opportunities in the form of product or company acquisitions to enhance product portfolio and further leverage distribution channels worldwide. Expanding international sales through external alliances, collaborations and sales focus. Consolidation remains an attractive option in the IVD industry, which has been experiencing high rates of M&A activity over the past few years, and TriMark expects this trend to continue TriMark Publications, LLC. All rights reserved. 17 trimarkpublications.com