(SAMPLE COPY, NOT FOR RESALE)

TriMark Publications January 2015 Volume: TMRIVD15-0101 IN VITRO DIAGNOSTIC TESTING WORLD MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers

TABLE OF CONTENTS 1. IVD Market Overview 14 1.1 Statement of Report 14 1.2 About This Report 14 1.3 Scope of the Report 14 1.4 Objectives 15 1.5 Methodology 15 1.6 Executive Summary 16 2. IVD Global Market Overview 19 2.1 Total Global IVD Market 19 2.2 International Sector and Country IVD Markets 20 2.3 IVD Market Segments by Analyte 23 2.4 High Growth Markets 24 2.4.1 Summary Analysis of the Global IVD High-Growth Market by Geographic Region 24 2.4.1.1 U.S.: Summary of IVD High-Growth Market 25 2.4.1.2 Europe: Summary Analysis of the IVD High-Growth Market 26 2.4.1.3 South-East Asia and Japan: Summary Analysis of the IVD High-Growth Market 28 2.4.1.4 BRIC: Summary Analysis of the IVD High-Growth Market 29 2.4.1.4.1 Brazil: Summary Analysis of the IVD High-Growth Market 29 2.4.1.4.2 Russia: Summary Analysis of the IVD High-Growth Market 30 2.4.1.4.3 Indian IVD High Growth Markets 31 2.4.1.4.4 Summary of IVD High-Growth Market India 33 2.4.1.4.5 China: Summary Analysis of the IVD High-Growth Market 34 2.4.1.4.6 Summary of IVD High-Growth Market China 36 2.5 Key Players 37 2.6 Key Trends in the IVD Industry 38 2.7 Acquisitions 38 2.8 Market Drivers and Barriers 42 2.8.1 Key Market Drivers 42 2.8.2 Barriers to Growth 43 2.9 Companion Diagnostics 43 3. POCT 46 3.1 POCT Market Overview 46 3.1.1 Total Global POCT Market 47 3.1.2 International Sector and Country POCT Markets 47 3.2 POCT Market Segments by Analyte 48 3.3 Key Players 50 3.3.1 Acquisition, License Agreements, Internal Development and Partnerships 51 3.4 Key Concepts for POCT Markets 52 3.5 The Future of POCT 54 3.6 The Biggest New Opportunities in POCT 55 4. Molecular Diagnostics 56 4.1 Market Overview 56 4.2 Market Size and Growth Rate 57 4.3 Key Players 58 4.4 Market Segments 59 4.4.1 Infectious Disease 60 4.4.1.1 Key Segments of Molecular Diagnostic Markets for Infectious Disease 61 4.4.2 Cancer 66 4.4.2.1 Technology and Market Trends in Cancer Testing 67 4.4.2.2 Cancer Testing 69 4.4.2.3 Cancer Prognostic Assays 72 2015 TriMark Publications, LLC. All rights reserved. 2 trimarkpublications.com

4.4.2.4 Market Size 72 4.4.2.5 Key Players 74 4.4.2.6 Competitive Landscape 74 4.4.2.6.1 Myriad Genetics (BRCA1 and BRCA2) 75 4.4.2.6.2 Genomic Health (Oncotype DX) 76 4.4.2.6.3 InterGenetics, Inc. 77 4.4.2.6.4 Clarient, Inc. (GE Healthcare) 78 4.4.2.6.5 BioTheronostics 78 4.4.2.6.6 Agendia B.V. (MammaPrint) 79 4.4.2.6.7 LabCorp 80 4.4.2.6.8 Quest Diagnostics 81 4.4.2.7 Competitive Structure and Market Share Analysis 81 4.4.2.8 Drivers and Restraints 82 4.4.2.8.1 Molecular Diagnostics Cancer Market Drivers Ranked in Order of Impact 82 4.4.2.8.2 Molecular Diagnostics Cancer Market Restraints Ranked in Order of Impact 82 4.4.2.9 Business Factors Influencing Advanced Oncology Testing Services 82 4.4.2.10 Market Trends in Cancer Testing 83 4.4.2.11 Strategic Recommendations on Molecular Diagnostic Sector Business Functions 83 4.4.2.12 Emerging Cancer Personalized Medicine Market 83 4.4.3 Genetic Testing 84 4.4.3.1 Genetic Testing Market 84 4.4.3.2 Primary Competitors 86 4.4.3.3 Prominent Issues in Genetic Prenatal Diagnosis Using Molecular Diagnostics Testing 86 4.5 Snapshot of Molecular Diagnostics Industry Structure 87 4.5.1 Technology and Market Trends 88 4.5.2 Emerging Technologies 89 4.5.3 Market Trends 89 4.6 Molecular Diagnostics Testing Going Forward 91 4.7 Key Sector Takeaways 93 5. Clinical Chemistry 94 5.1 Market Overview 94 5.2 International Markets 95 5.2.1 U.S. Market 95 5.2.2 European Market 95 5.2.3 Asian Market 96 5.3 Key Players 97 5.4 Market Segments 97 5.4.1 Ultra-Large Throughput Chemistry Analyzers 99 5.4.2 Large Throughput Analyzers 100 5.4.3 Mid-Size Clinical Chemistry Analyzers 101 5.4.4 Chemistry Analyzers for the Small-Volume Market 103 5.5 Long-Term Changes 104 5.6 Market Drivers 105 5.7 The Limits to Growth 106 5.8 Hot Sectors in the IVD Market 107 5.9 Key Technologies 107 5.10 Key Sector Takeaways 108 6. Diabetes and Glucose Testing 109 6.1 Market Overview 109 6.2 Glucose Self-Testing Markets 111 6.3 Key Players 114 6.3.1 M&A Activity 115 6.3.2 Important Deals in BGM Market 115 6.4 Future of Patient Self-testing 116 2015 TriMark Publications, LLC. All rights reserved. 3 trimarkpublications.com

6.5 Lancet Market 117 6.5.1 Market Size 117 6.5.2 Strategic Recommendations in the Lancet Business 119 6.5.3 Health and Safety Regulations 120 6.5.4 Key Players in the Blood Lancet Market 121 6.5.5 Lancet Distribution Networks 122 6.6 Drivers of OTC and Self-testing Markets 122 6.6.1 Factors Affecting OTC Medical Product Distribution 122 6.6.2 Drugstores Critical to the Diabetic Care Category 124 6.7 Important Elements of OTC Testing 124 6.8 Strategic Recommendations for Self-Monitoring Blood Glucose Markets 125 6.9 Future of Patient Self-Testing 125 7. Immunochemistry Markets 126 7.1 Market Overview 126 7.2 Markets for Immunoanalyzer Testing 126 7.3 Key Players 127 7.3.1 Abbott Diagnostics 127 7.3.2 Siemens 128 7.3.3 Roche 129 7.3.4 Beckman Coulter, Inc. 130 7.3.5 biomérieux 131 7.3.6 Ortho-Clinical Diagnostics 132 7.4 Long Term Changes 133 7.4.1 Key Developments 133 7.5 Market Drivers and Restraints 134 7.6 Hot Sectors in the Immunoanalyzer Market 136 7.7 Key Technologies 137 7.7.1 Analyzer Integration Chemistry/Immunoassay 138 7.7.2 Consolidated Workstations 139 7.8 Key Sector Takeaways 140 8. Hematology 142 8.1 Market Overview 142 8.2 International Markets 142 8.2.1 U.S. Market 143 8.2.2 European Market 143 8.2.3 Asian Market 143 8.3 Key Players 143 8.4 Hematology Analyzers 144 8.4.1 Large Throughput Analyzers 145 8.4.2 Mid-Size Analyzers 145 8.4.3 Analyzers for the Small Volume Market 146 8.4.4 New Hematology Analyzers 147 8.5 Profitability 147 8.6 Market Drivers 147 8.7 Key Sector Takeaways 148 9. Coagulation 149 9.1 Market Overview 149 9.2 International Markets 150 9.2.1 U.S. Market 150 9.2.2 European Market 151 9.2.3 Asian Market 151 9.2.4 Rest of the World Markets 152 9.3 Key Players 153 2015 TriMark Publications, LLC. All rights reserved. 4 trimarkpublications.com

9.4 Recent Coagulation Testing Sector Activity 155 9.4.1 Roche and Diagnostica Stago Parting Ways in Laboratory Coagulation 155 9.4.2 Roche Acquires Verum Diagnostica GmbH and Expands Coagulation Testing Product Line 155 9.4.3 Universal Biosensors and Siemens Collaborate on Advanced POC Coagulation Platform 155 9.4.4 Instrumentation Laboratory and Beckman Coulter concluded their Cross-Distribution Agreement 156 9.4.5 CoaguChek XS Personal Receives Reimbursement Approval for Self-Testing in Japan 156 9.4.6 Diagnostica Stago Launches Products for Measurement of Rivaroxaban 156 9.4.7 Diagnostic Stago Offers Three Factor VII Detection Methods 156 9.4.8 Diagnostica Stago Offers Three Procoagulant Microparticle Detection Methods 157 9.4.9 Diagnostica Stago S.A.S enters into Joint Research Agreement with Bristol-Myers Squibb 157 9.4.10 Trinity Biotech Sold its Worldwide Coagulation Business to the Stago Group 157 9.4.11 Alere aka Inverness Medical Innovations Acquired HemoSense, Inc. 158 9.4.12 Alere Announced Positive Results in Clinical Study Evaluating At-Home Coagulation Testing 158 9.5 Anticoagulation Self-Testing and Self-Management 158 9.6 Market Drivers and Restraints 161 9.6.1 Market Drivers 161 9.6.2 Market Restraints162 9.7 Impact of New Oral Anticoagulant Drugs on the Coagulation Testing Market 162 9.8 Key Technologies 164 9.9 Key Strategic Recommendations 164 10. Pathology 165 10.1 Overview 165 10.2 Pathology Markets 165 10.2.1 Market Size 165 10.2.2 Pathology Markets Served 165 10.2.3 Key Technologies 166 10.3 Key Sector Players 166 10.3.1 Ventana Medical Systems Inc. (part of Roche s Diagnostics Division) 166 10.3.2 Dako (An Agilent Technologies Company) 167 10.3.3 Aperio(Part of Leica Biosystems) 167 10.3.4 Abbott Laboratories 167 10.3.5 Omnyx, LLC (Part of GE Healthcare) 168 10.3.6 Visiopharm 168 10.4 Digital Pathology Markets 169 10.4.1 Market Drivers in the Digital Pathology Markets 171 10.4.2 Market Barriers in the Digital Pathology Markets 171 10.4.3 Digital Pathology Takeaways 171 11. Microbiology 172 11.1 Overview 172 11.1.1 Microbial Culture172 11.1.2 Biochemical Tests 173 11.2 Microscopy 173 11.3 Microbiology Reagent Market Size and Revenue Analysis 174 11.4 Key Players 175 11.5 Diagnostic Platforms for Infectious Diseases 175 11.5.1 Culture Methods 175 11.5.2 Molecular Diagnostics 175 11.5.3 Mass Spectroscopy 177 11.6 Market Drivers and Restraints in Infectious Disease Testing Markets 178 11.6.1 Market Drivers 178 11.6.2 Market Restraints 178 11.7 Key Sector Takeaways 179 12. Blood Banking and Screening 180 2015 TriMark Publications, LLC. All rights reserved. 5 trimarkpublications.com

12.1 Market Overview 180 12.2 International Markets 180 12.3 Key Players in Blood Screening 181 13. Histology and Cytology Tests 185 13.1 The Overall Market 185 13.1.1 Market Size 186 13.2 Market Drivers 186 13.3 Market Restraints 186 13.4 Cytology and Histology Technology Platforms 187 13.4.1 HLA Typing 187 13.5 Cytology Screening Procedures and Pap Smear Technology 187 13.5.1 Cytology 187 13.5.2 Pap Smears 188 13.5.2.1 Pap Smear Market Share 191 13.5.3 Detection of HPV 191 13.5.3.1 Detection of HPV DNA 191 13.5.3.2 Benefits of Pap Smear and HPV Co-Testing 192 13.5.3.3 Human Papillomavirus Testing Market Structure 193 13.5.3.3.1HPV Testing Market Overview 193 13.5.3.3.2U.S. Market 193 13.5.3.3.3European Market 194 13.5.3.3.4Latin American Market 195 13.5.3.3.5Asian Market 195 13.6 Histology 196 13.6.1 IHC Staining 197 13.6.2 ISH Staining 198 13.6.3 Special Stains Staining 198 13.6.4 Tissue Staining Market 198 13.6.7 Major Players 199 14. Data Management and Connectivity 200 14.1 Wireless LANs 200 14.2 Connectivity Platforms 202 14.2.1 DataLink Data Management System 203 14.2.1.1 DataLink Integrated with RALS -Plus and Quick Multi-Linc 204 14.2.1.2 DataLink with RALS-Plus 204 14.2.1.3 DataLink with QML 205 14.2.2 RALS-Plus, RALS-Web3 and RALS-Freedom 205 14.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 206 14.2.2.2 Siemens Diagnostics Rapidpoint 500 206 14.2.2.3 Alere Connect Products 207 14.2.3 Medical Implant Communications Service (MICS) 207 14.2.4 Conworx Technology 207 14.2.5 Alere Informatics 208 14.2.6 Medasys 208 14.2.7 NoemaLife 208 14.3 Advantages of POCT Connectivity 208 14.3.1 Cost-Benefit Analysis of Testing Devices and IT Connectivity 209 14.3.2 Hospital Network Issues 209 14.4 POCT Analyzer Connectivity Software Solutions 210 15. Company Profiles 212 15.1 A. Menarini 212 15.2 Abaxis, Inc. 212 15.3 Abbott Laboratories 213 2015 TriMark Publications, LLC. All rights reserved. 6 trimarkpublications.com

15.4 Accriva Diagnostics, Inc. 216 15.5 Adaltis 217 15.6 AdnaGen 217 15.7 AdvanDx 217 15.8 Affymetrix, Inc. 218 15.9 Agendia 220 15.10 Agilent Technologies 221 15.11 ALERE, INC. 222 15.12 Alfa Scientific Designs, Inc. 226 15.13 Alfa Wasserman, Inc. 226 15.14 ALPHELYS 227 15.15 AMS 227 15.16 Ambry Genetics 227 15.17 ArcticDx, Inc. 227 15.18 Ariosa Diagnostics, Inc. 228 15.19 ARKRAY USA, Inc. 228 15.20 Asuragen, Inc. 228 15.21 Atlas Genetics 229 15.22 Atonomics A/S 229 15.23 AutoGenomics, Inc. 230 15.24 Awareness Technology 231 15.25 Axxin 232 15.26 Bayer 232 15.27 BD 233 15.28 Beckman Coulter Genomics, Inc. 235 15.29 Biocartis SA 235 15.30 BioCytex 236 15.31 Biodata (Microlink Engineering Systems) 236 15.32 BioData Ltd. 236 15.33 Biodesix236 15.34 BioGenex Laboratories, Inc. 237 15.35 BioFire Diagnostics, Inc. (Part of biomérieux now) 237 15.36 BioMedomics 237 15.37 biomérieux 238 15.38 Biophor Diagnostics 239 15.39 Bio-Rad 240 15.40 Biosensia Ltd. 240 15.41 Biosite Diagnostics (part of Alere) 241 15.42 Biotage AB 242 15.43 biotheranostics 242 15.44 Cancer Genetics, Inc. 242 15.45 Caris Life Sciences 243 15.46 Cepheid 243 15.47 Celula, Inc. 244 15.48 Chembio Diagnostics, Inc. 244 15.49 Clarient 245 15.50 Coagusense, Inc. 245 15.51 CombiMatrix Corporation 245 15.52 Curetis AG 246 15.53 Cyber Medical Ltd. 246 15.54 Dako A/S (Agilent Technologies) 246 15.55 Debiotech 247 15.56 DexCom 247 15.57 Diagnostica Stago, Inc. 248 15.58 Diagnostica Stago S.A.S 248 15.59 Diagnostics for All 249 2015 TriMark Publications, LLC. All rights reserved. 7 trimarkpublications.com

15.60 DiaSorin S.p.A. 249 15.61 DxNA, LLC. 249 15.62 Echo Therapeutics 250 15.63 Eiken Chemical Company Limited 251 15.64 Enigma Diagnostics Limited 251 15.65 Epigenomics 251 15.66 Exact Sciences Corporation 252 15.67 Exagen Diagnostics, Inc. 253 15.68 Exiqon 253 15.69 Exosome Diagnostics 253 15.70 FIFTY50 Medical, Inc. 254 15.71 Fluidigm Corporation 254 15.72 Fujirebio Inc. 256 15.73 GE Healthcare 257 15.74 Genera Biosystems 258 15.75 GenMark Diagnostics, Inc. 258 15.76 Genomica S.A.U. 259 15.77 Genomic Health, Inc. 260 15.78 Genomix Biotech261 15.79 Genoptix, Inc. 261 15.80 Gentag, Inc. 262 15.81 Great Basin Corporation 262 15.82 Grifols 262 15.83 Haemonetics Corporation 262 15.84 Hologic Gen-Probe 263 15.85 Hutman Diagnostics, AG 269 15.86 Hy Laboratories Ltd. 269 15.87 HYPHEN BioMed 270 15.88 Ikonisys Inc. 270 15.89 Illumina, Inc. 270 15.90 Immunexpress Group 273 15.91 Infopia Co., Ltd. 273 15.92 Innovative Biosensors, Inc. 273 15.93 Integrity Applications 273 15.94 InterGenetics, Inc. 274 15.95 Integrated Diagnostics 274 15.96 International Technidyne Corp (THORATEC CORP 274 15.97 Instrumentation Laboratory 275 15.98 IQuum, Inc.(acquired by Roche) 275 15.99 isense Corporation (subsidiary of BayerAG) 275 15.100 JEOL Ltd. 275 15.101 Johnson & Johnson 276 15.102 Kommanditgesellschaft Behnk Elektronik GmbH & Co. 277 15.103 Kyowa Medex 277 15.104 LabCorp 277 15.105 Labor BioMedical Technologies GmbH (LABiTec) 278 15.106 Leica Biosystems278 15.107 Life Technologies Corporation 279 15.108 Luminex Corporation 281 15.109 Lumora Ltd. 285 15.110 M-Biotech 286 15.111 MBio Diagnostics, Inc. 286 15.112 MDxHealth 286 15.113 Medica Corporation, Inc. 286 15.114 Medtronic 287 15.115 Menssana Research, Inc. 288 2015 TriMark Publications, LLC. All rights reserved. 8 trimarkpublications.com

15.116 Meridian Biosciences 288 15.117 Metaara Medical Technologies Inc. 289 15.118 Miraculins Inc. 289 15.119 Mobidiag 290 15.120 Myriad Genetics, Inc 290 15.121 Nanosphere 298 15.122 Nanostring 299 15.123 Natera Inc. 299 15.124 Neogenomics 300 15.125 Nipro Diagnostics 300 15.126 Nova Biomedical Corporation 300 15.127 Novartis 301 15.128 Novo Nordisk 301 15.129 Nuvera Biosciences 302 15.130 OraSure 303 15.131 Ortho Clinical Diagnostics (Formerly a Johnson & Johnson Company) 304 15.132 Pfizer, Inc. 306 15.133 Phamatech, Inc. 307 15.134 Pharma Supply, Inc. 307 15.135 Polymedco 308 15.136 Prodigy Diabetes Care, LLC (formerly Diagnostic Devices, Inc.) 309 15.137 Qiagen NV 309 15.138 Quidel Corporation 313 15.139 Radient Pharmaceuticals Corporation 317 15.140 Randox 317 15.141 Roche AG 319 15.142 Rosetta Genomics Ltd. 322 15.143 Sanofi 326 15.144 Seegene 326 15.145 Sekisui Diagnostics 326 15.146 Sensors for Medicine and Science 327 15.147 Sequenom, Inc. 327 15.148 Shimadzu Corporation 328 15.149 Siemens AG 328 15.150 Siemens Healthcare Diagnostics 329 15.151 Sienco Inc. 330 15.152 Simple Diagnostics 330 15.153 SIRS-Lab 330 15.154 Smiths Medical 331 15.155 Source MDx 331 15.156 Spartan Bioscience 332 15.157 Spectrum Laboratories, Inc. 332 15.158 Sysmex America, Inc. 333 15.159 Technoclone Gmbh 333 15.160 Telcare 333 15.161 Thermo Fisher Scientific, Inc. 334 15.162 TrimGen 336 15.163 TrovaGene 336 15.164 Trinity Biotech plc 337 15.165 U.S. Diagnostics 337 15.166 Universal Biosensors, Inc. 337 15.167 Ventana 338 15.168 VeraLight 338 15.169 Veredus Laboratories 339 15.170 Veridex (a Johnson & Johnson company) 339 15.171 Visiopharm 340 2015 TriMark Publications, LLC. All rights reserved. 9 trimarkpublications.com

15.172 Wako 340 15.173 WILEX AG 340 15.174 ZS Genetics 341 INDEX 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 INDEX OF TABLES Table 2.1: Global Distribution of IVD Testing by Key Geographic Regions, 2013 and 2018 19 Table 2.2: Global GDP Growth Rates, 2011 to 2015 20 Table 2.3: Top 15 Country Markets for IVD Testing, 2013 22 Table 2.4: Global Distribution of IVD Testing by Market Segments, 2013-2018 23 Table 2.5: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing, 2008-2018 24 Table 2.6: Global IVD High-Growth Markets Percentage of Revenues by Geographic Region, 2008-2018 25 Table 2.7: Summary of IVD High-Growth Market U.S., 2013 25 Table 2.8: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing U.S., 2008-2018 26 Table 2.9: U.S. Individual IVD High-Growth Markets Revenue Forecast 2008-2018 26 Table 2.10: Europe: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 28 2015 TriMark Publications, LLC. All rights reserved. 10 trimarkpublications.com

Table 2.11: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Asia, 2008-2018 28 Table 2.12: Asia: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 29 Table 2.13: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Brazil, 2008-2018 29 Table 2.14: Brazil: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 30 Table 2.15: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing Russia, 2008-2018 30 Table 2.16: Russia: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 31 Table 2.17: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing India, 2008-2018 33 Table 2.18: India: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 34 Table 2.19: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic Testing China, 2008-2018 36 Table 2.20: China: Individual IVD High-Growth Markets Revenue Forecast, 2008-2018 36 Table 2.21: Company Market Share for IVD Testing Markets, 2013 37 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 2018 50 Table 3.2: Global Company Market Share POCT Analysis, 2013 50 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, 2013 57 Table 4.3: Key Players and Market Share in the Global Molecular Diagnostics Testing Market, 2013 59 Table 4.4: Share of Molecular Diagnostics Testing by Application, 2013 60 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, 2012 66 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, 2008-2018 72 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, 2013-2018 95 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 101 2015 TriMark Publications, LLC. All rights reserved. 11 trimarkpublications.com

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), 2012-2018 110 Table 6.2: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), 2012-2018 111 Table 6.3: Global Revenues for Professional Point of Care Blood Glucose Monitoring Systems (within Hospitals and Physician s Offices), 2012-2018 111 Table 6.4: Worldwide Glucose Self-Testing Market Sales (Meters, Strips, and Lancets), 2012-2018 112 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., 2012-2017 118 Table 6.7: Unit Sales of Homecare Lancets in the E.U., 2012-2017 118 Table 6.8: Dollar Sales of Homecare Lancets in the U.S., 2012-2017 119 Table 6.9: Dollar Sales of Homecare Lancets in the E.U., 2012-2017 119 Table 6.10: Unit Sales of Homecare Glucose Self-Testing Lancets in the U.S., 2012-2017 119 Table 6.11: Unit Sales of Homecare Glucose Self-Testing Lancets in the E.U., 2012-2017 119 Table 6.12: Competition in the Lancet Market Segment 121 Table 7.1: Global Revenue Forecasts for Immunoanalyzer Testing, 2012-2018 126 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, 2008-2018 142 Table 8.2: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2013 143 Table 8.3 Key Players in Worldwide Hematology Analyzers and Reagent Market 144 Table 8.4: Hematology Analyzers Currently in Market, 2014 146 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, 2013-2018 165 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 2013-2018 175 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, 2013-2018 180 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, 2013-2018 185 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, 2013 189 Table 13.5: Global Market for HPV Molecular Diagnostic Testing, 2009-2017 193 Table 13.6: U.S. Market for HPV Diagnostic Testing, 2009-2017 194 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 304 2015 TriMark Publications, LLC. All rights reserved. 12 trimarkpublications.com

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. 2015 TriMark Publications, LLC. All rights reserved. 13 trimarkpublications.com

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. 2015 TriMark Publications, LLC. All rights reserved. 14 trimarkpublications.com

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 2013. Growing at a CAGR of 5%, it is on track to reach $74 billion by 2018. 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 2018. 2015 TriMark Publications, LLC. All rights reserved. 15 trimarkpublications.com

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 2013. The Asia Pacific region will account for 28% of the world IVD market by 2018. 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 2018. 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 2018. 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 2018. 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. 2015 TriMark Publications, LLC. All rights reserved. 16 trimarkpublications.com

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. 2015 TriMark Publications, LLC. All rights reserved. 17 trimarkpublications.com