(SAMPLE COPY, NOT FOR RESALE)

TriMark Publications July 2011 Volume: TMRPOC11-0701 POINT OF CARE DIAGNOSTIC TESTING WORLD MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers

TABLE OF CONTENTS 1. Overview 15 1.1 About this Report 15 1.2 Scope of the Report 16 1.3 Objectives 17 1.4 Methodology 17 1.5 Executive Summary 18 2. Overview of Diagnostic Testing Point of Care 22 2.1 Point of Care Testing Sites 22 2.2 Point of Care Market Structure 23 2.3 New Directions in Clinical IVD Testing 23 3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 26 3.1 Global POCT Market 33 3.2 U.S. POCT Market 36 3.3 European POCT Market 38 3.3.1 German POCT Diagnostic Market 45 3.3.2 U.K. POCT Diagnostic Market 47 3.3.2.1 U.K. POCT Market Statistics 47 3.3.2.2 U.K. Competitive Analysis 49 3.3.2.3 U.K. Market Access 50 3.3.3 French POCT Diagnostic Market 50 3.3.4 Italian POCT Diagnostic Market 51 3.3.5 Spanish POCT Diagnostic Market 53 3.3.6 Scandinavian POCT Diagnostic Market 54 3.3.7 Swedish POCT Diagnostic Market 55 3.3.8 Finnish POCT Diagnostic Market 56 3.3.9 Norwegian POCT Diagnostic Market 57 3.3.10 Swiss POCT Diagnostic Market 58 3.3.11 Dutch POCT Diagnostic Market 59 3.3.12 Belgian POCT Diagnostic Market 60 3.3.13 Portuguese POCT Diagnostic Market 61 3.3.14 Austrian POCT Diagnostic Market 62 3.3.15 Greek POCT Diagnostic Market 63 3.3.16 Polish POCT Diagnostic Market 64 3.3.17 Czech Republic POCT Diagnostic Market 65 3.3.18 Turkish POCT Diagnostic Market 66 3.4 Asian POCT Markets 66 3.4.1 Japanese POCT Diagnostic Market 66 3.4.2 Indian POCT Diagnostic Market 68 3.4.3 Chinese POCT Diagnostic Market 73 3.5 Rest of the World POCT Market 83 3.5.1 Canadian POCT Diagnostic Market 84 3.5.2 Brazilian POCT Diagnostic Market 84 3.5.3 Australian POCT Diagnostic Market 85 3.6 Overview of Asian Healthcare Market 85 3.6.1 Singapore 87 3.6.2 Malaysia 87 3.6.3 Thailand 88 3.6.4 Indonesia 88 3.6.5 Philippines 88 3.6.6 South Korea 89 3.6.7 Taiwan 89 2011 TriMark Publications, LLC. All rights reserved. 1 www.trimarkpublications.com

4. POCT Individual Markets 90 4.1 Glucose Testing 90 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 91 4.2.1 World Market Revenue and Forecasts 91 4.2.2 Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts during 2001-2012 92 4.2.3 European Market 93 4.2.4 Market Share 93 4.2.5 Alternate Glucose Monitoring Products 94 4.2.6 HbA1c POCT 95 4.2.7 Market Challenges and Strategic Recommendations 96 4.2.7.1 Market Drivers and Restraints 96 4.2.7.1.1 Market Drivers 96 4.2.7.1.2 Market Restraints 96 4.2.7.2 Point of Care Glucose Testing Assay Market and Technology Trends 97 4.2.7.2.1 Point of Care Glucose Testing Assay Market Trends 97 4.2.7.2.2 Point of Care Glucose Testing Assay Technology Trends 97 4.2.7.2.3 Point of Care Glucose Testing Assay Strategic Recommendations 97 4.3 Blood Gas and Electrolytes 98 4.3.1 Whole Blood Lactate 101 4.3.2 Creatinine 101 4.4 Rapid Coagulation Tests 102 4.4.1 World POCT Coagulation Market 104 4.4.2 U.S. Coagulation Market 105 4.4.3 European Coagulation Market 108 4.4.4 Trends in POCT Coagulation Testing 109 4.4.4.1 Self-testing Coagulation Market 109 4.4.4.2 D-Dimer Testing 110 4.4.5 Point of Care Coagulation Testing Assay Market and Technology Trends 110 4.4.5.1 Point of Care Coagulation Testing Assay Market Trends 110 4.4.5.2 Point of Care Coagulation Testing Assay Technology Trends 110 4.4.5.3 Point of Care Coagulation Testing Assay Strategic Recommendations 110 4.5 Rapid Cardiac Markers 111 4.5.1 U.S. Market 111 4.5.2 European Market 114 4.5.3 Market Drivers and Restraints 115 4.5.3.1 Market Drivers 115 4.5.3.2 Market Restraints 116 4.5.4 Point of Care Cardiac Marker Testing Assay Market and Technology Trends 116 4.5.4.1 Point of Care Cardiac Marker Testing Assay Market Trends 116 4.5.4.2 Point of Care Cardiac Marker Testing Assay Technology Trends 116 4.5.4.3 Point of Care Cardiac Marker Testing Assay Strategic Recommendations 116 4.6 Drugs of Abuse Screening Testing 117 4.6.1 Acetaminophen 124 4.6.2 Tricyclic Antidepressants (TCAs) 125 4.6.3 Other Toxic Drugs 125 4.6.4 Drug Testing Selectivity 125 4.6.5 Methaqualone and Phencyclidine (PCP) 125 4.6.6 Tetrahydrocannabinol 125 4.6.7 Drug Panels by Toxidromes 126 4.6.8 Alcohol Testing 126 4.7 Urine Strips 127 4.8 Pregnancy Tests 129 4.9 Fecal Occult Blood 131 4.10 Hemoglobin Testing 131 4.11 Miscellaneous Rapid Tests 132 2011 TriMark Publications, LLC. All rights reserved. 2 www.trimarkpublications.com

4.11.1 Estriol 132 4.11.2 Fetal Fibronectin (ffn) 133 4.11.3 H. pylori 133 4.11.4 Vaginal ph and Vaginitis 133 4.11.5 Bladder Cancer 134 4.11.6 Fetal Status 135 4.11.7 Heparin-induced Thrombocytopenia 136 4.12 Human Immunodeficiency Virus (HIV) 136 4.13 Cholesterol 142 4.14 Infectious Disease 143 4.14.1 Clostridium difficile 144 4.14.2 Giardia 144 4.14.3 Salmonella and Campylobacter 145 4.14.4 Malaria Testing 146 4.14.5 Influenza Testing 147 4.14.6 Strep Testing 150 4.14.7 Chlamydia 152 4.14.8 Mononucleosis 153 4.14.9 Rubella 153 4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 153 4.14.11 Hepatitis 158 4.14.12 Gonorrhea 160 4.14.13 Tuberculosis (TB) 161 4.14.14 Herpes Simplex Virus Type-2 163 4.14.15 Legionella 163 4.14.16 RSV 163 4.14.16.1 Market Drivers and Restraints 166 4.14.16.1.1 Market Drivers 166 4.14.16.1.2 Market Restraints 166 4.14.16.2 Point of Care Infectious Disease Testing Assay Market and Technology Trends 166 4.14.16.2.1 Point of Care Infectious Disease Testing Assay Market Trends 166 4.14.16.2.2 Point of Care Infectious Disease Testing Assay Technology Trends 167 4.14.16.2.3 Point of Care Infectious Disease Testing Assay Strategic Recommendations 167 4.15 Infant Jaundice 167 4.16 Anthrax 167 4.17 Rupture of Fetal Membranes (ROM) 169 4.18 Food Pathogens 170 4.19 Typhoid 170 5. POCT: Reagents and Equipment 171 5.1 Blood Glucose Monitoring 171 5.1.1 LifeScan 172 5.1.2 Roche Accu-Chek 175 5.1.3 Abbott Diabetes Care 177 5.1.4 HemoCue 178 5.1.5 Stanbio/GDS Technology 178 5.1.6 Abaxis, Inc. 179 5.1.7 Arkray (Japan) 180 5.1.8 Accurex (India) 180 5.1.9 Home Diagnostics, Inc. 180 5.1.10 Nova Biomedical 180 5.1.11 Bayer 181 5.1.11.1 Hemoglobin A1c Measurements 182 5.1.12 Biosite (now part of Alere) 182 5.1.13 Siemens Healthcare Diagnostics 182 5.1.14 Infopia 183 2011 TriMark Publications, LLC. All rights reserved. 3 www.trimarkpublications.com

5.1.15 Diasys 183 5.1.16 Quotient Dx 183 5.1.17 Cholestech (Acquired by Inverness Medical Innovations, now named Alere) 183 5.1.18 Bio-Rad 183 5.1.19 Axis-Shield 183 5.2 Blood Gas and Electrolytes 184 5.2.1 Roche Corporation 184 5.2.2 TechnoMedica 184 5.2.3 Siemens Healthcare Diagnostics 184 5.2.4 Instrumentation Laboratory 185 5.2.5 Nova Biomedical 185 5.2.6 Radiometer 185 5.2.7 Abbott Laboratories 186 5.2.8 Span Diagnostics 186 5.2.9 Nexus Dx Avoximeter Systems for Co-oximetry 186 5.2.10 ITC (Nexus Dx) 188 5.2.11 Alere 188 5.2.12 Abaxis, Inc. 188 5.3 Rapid Coagulation Tests 188 5.3.1 POC Coagulation Instrument Description 193 5.3.1.1 Roche Diagnostics Corp. 194 5.3.1.2 Abbott Laboratories 196 5.3.1.3 International Technidyne Corporation Nexus DX 196 5.3.1.4 Medtronic 198 5.3.1.5 HemoSense (Inverness) 198 5.3.1.6 Helena Laboratories Point of Care 199 5.3.1.7 Sienco, Inc. 201 5.3.1.8 Accumetrics 201 5.3.1.9 Alere 201 5.3.1.10 ITC 202 5.3.2 Connectivity Issues 202 5.3.3 Cost Benefits 202 5.3.4 Quality Control Issues 203 5.3.5 Certification for Point of Care Coagulation Devices 203 5.4 Rapid Cardiac Markers 204 5.4.1 Biosite Diagnostics (Inverness, now called Alere) 204 5.4.2 Roche Diagnostics 205 5.4.3 Ani Biotech 206 5.4.4 Response Biomedical Corporation 206 5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring) 207 5.4.6 Lab21 Ltd. 207 5.4.7 Abbott Laboratories 208 5.4.8 LifeSign (Princeton BioMediTech Corp.) 208 5.4.9 Mitsubishi Kagaku Iatron 208 5.4.10 Alpha Scientific 208 5.5 Rapid Drugs of Abuse 208 5.5.1 Biosite Diagnostics (Inverness, now called Alere) 210 5.5.2 Abbott Diagnostics 211 5.5.3 Roche Diagnostics 211 5.5.4 BioScan Screening Systems, Inc. 212 5.5.5 American Bio Medica Corp. 212 5.5.6 Phamatech, Inc. 215 5.5.7 First Check Medical 216 5.5.8 OraSure 216 5.5.9 Avitar, Inc. 217 2011 TriMark Publications, LLC. All rights reserved. 4 www.trimarkpublications.com

5.5.10 Concateno 217 5.5.11 Pathtech 217 5.5.12 Alfa Scientific Designs, Inc. 218 5.5.13 TCPI, Inc. 218 5.5.14 Roche 219 5.5.15 Biophor Diagnostics 219 5.6 Rapid Pregnancy and Fertility Tests 219 5.7 Fecal Occult Blood 221 5.7.1 Helena Laboratories 222 5.7.2 Biomerica 222 5.7.3 Beckman Coulter 222 5.7.4 Worldwide Medical 222 5.7.5 Aerscher Diagnostics 222 5.7.6 Enterix 223 5.7.7 Medix Biochemica 223 5.7.8 Orion Diagnostica 223 5.8 Hemoglobin Testing 223 5.8.1 Wampole Laboratories 223 5.8.2 HemoCue, Inc. 224 5.8.3 Stanbio 224 5.9 Miscellaneous Rapid Tests 224 5.9.1 Triage C. difficile Panel 224 5.9.2 Ketoacids 224 5.9.3 Acetaminophen 224 5.9.4 Estriol 225 5.9.5 H. pylori 225 5.9.6 Vaginal Fluid ph and Vaginitis 227 5.9.7 Prostate-specific Antigen (PSA) 228 5.9.8 Bladder Cancer 228 5.9.9 Other Rapid Cancer Tests 232 5.9.10 Fetal Status (PROM) 232 5.9.11 Osteoporosis 233 5.9.12 Hemodynamic Monitoring 233 5.9.13 Heparin-induced Thrombocytopenia 233 5.10 HIV 233 5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 236 5.10.1.1 Bio-Rad Laboratories 236 5.10.1.2 Orgenics (Inverness, now called Alere) 236 5.10.1.3 StatSure Diagnostic Systems 236 5.10.1.4 Trinity Biotech 236 5.10.1.5 Savyon Diagnostics 237 5.10.1.6 MedPharm 237 5.10.1.7 American Bio Medica Corp. 237 5.10.1.8 Chembio Diagnostics 237 5.10.1.9 OraSure Technologies 238 5.10.1.10 Inverness (Alere) 239 5.10.2 Saliva-based HIV Tests 239 5.10.2.1 OraSure Collection Device 240 5.10.2.2 SureStat 241 5.10.3 Urine-based HIV Tests 241 5.10.3.1 MedMira Laboratories, Inc. 241 5.10.3.2 Medical Services International, Inc. 242 5.10.3.3 Maxim Biomedical 242 5.10.3.4 Wampole Laboratories 242 5.11 Cholesterol 242 5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 243 2011 TriMark Publications, LLC. All rights reserved. 5 www.trimarkpublications.com

5.11.2 Actimed Laboratories 244 5.11.3 StatSite Meter 244 5.11.4 Polymer Technology Systems 244 5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 245 5.11.6 Abaxis, Inc. 245 5.12 Infectious Disease 245 5.12.1 C. difficile 245 5.12.2 Giardia 246 5.12.3 Dengue Fever 246 5.12.4 Malaria Testing 247 5.12.5 Rapid Influenza Testing 249 5.12.6 Streptococcus Testing 252 5.12.7 Chlamydia 254 5.12.8 Mononucleosis 254 5.12.9 Rubella 255 5.12.10 Staphylococcus aureus and MRSA 255 5.12.11 Hepatitis 256 5.12.12 E. Coli O157 259 5.12.13 Gonorrhea Testing 259 5.12.14 Smallpox 259 5.12.15 SARS 259 5.12.16 Rabies 259 5.12.17 Tuberculosis 259 5.12.18 Avian Flu 260 5.12.19 West Nile Virus 260 5.12.20 Herpes Simplex Virus Type-2 260 5.12.21 Legionella 260 5.12.22 RSV 261 5.13 Infant Jaundice 262 5.14 Anthrax 262 5.15 Homeland Defense (Plague and Tularemia) 264 5.16 BSE (Mad Cow Disease) 264 5.17 Tuberculosis 265 5.18 Typhoid 265 5.19 Avian Flu 265 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 266 5.21 Ruptured Fetal Membranes (ROM) 267 6. POCT: Growth Regulators 268 6.1 Moderators of Growth 268 6.2 Personnel Acceptance 268 6.3 Key People for POCT 269 6.4 Information Management Issues 269 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 271 6.4.2 Data Mining 271 6.4.3 Middleware 271 6.4.4 Web Portals 272 6.4.5 POCT-1A Standard 272 6.5 Key Elements for POCT 273 6.6 POCT and Reimbursement 273 6.7 Effectiveness of Clinical Outcomes 275 6.8 Rapid Near-Patient Testing in Hospitals 276 6.9 Satellite Facilities 276 6.10 Regionalization of Laboratory Care 277 6.11 Requirements for POCT 278 6.12 Locations of Point of Care for Patient Care 279 2011 TriMark Publications, LLC. All rights reserved. 6 www.trimarkpublications.com

6.13 Benefits of POCT 280 6.14 Cost Elements of POCT 281 6.15 Necessary Functions in POCT 281 6.16 TAT for POCT 281 6.17 Clinical Laboratory Improvement Amendments (CLIA) 282 6.18 Sexually-transmitted Diseases in Underdeveloped Countries 284 6.19 Sources of Error in Point of Care Testing 284 7. Business Trends in the Point of Care Sector 287 7.1 Sector Consolidation 287 7.2 Diagnostic Testing Growth Trends 288 7.2.1 Opportunities for Healthcare Stakeholders 289 7.3 Acquisition, License Agreements, Internal Development and Partnerships 289 7.4 Product Testing Depth in POCT 292 7.5 Government Regulation 292 7.5.1 U.S. Regulation 293 7.5.1.1 Importing Medical Devices into the U.S. 294 7.5.1.2 Exporting Medical Devices from the U.S. 295 7.5.2 U.K. Regulation 295 7.5.3 E.U. Regulation 296 7.5.3.1 French Regulation 298 7.5.4 Japanese Regulation 298 7.5.5 Korean Regulation 299 7.6 Increased Market Penetration 299 7.7 Costs of doing Business in Europe 300 7.8 Drivers of European Diagnostics Testing 300 7.9 European Reimbursement Practices 300 7.10 Cost Containment in Europe 301 8. Technology Platform Innovations in POCT 304 8.1 Sensor Systems for Diagnostic Applications 304 8.2 Glucose Measurements 307 8.2.1 Continuous Glucose Monitoring Systems 309 8.3 Glucose Test Methods 311 8.4 Cholesterol Testing 312 8.5 The New Paradigm 312 8.6 Consolidated Workstations and Modularity 313 8.7 Automation and Robotics in the Clinical Laboratory 313 8.8 Laboratory Information Systems (LIS) 314 8.8.1 NOVIUS Lab 314 8.9 Biosensor Technology 314 8.10 Nanogen Third Generation Point of Care Analyzer 316 8.11 Quidel MChip 317 9. Data Management and Connectivity 318 9.1 Wireless LANs 318 9.2 Connectivity Platforms 321 9.2.1 DataLink Data Management System 321 9.2.2 RALS-Plus 322 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 324 9.2.2.2 Siemens Diagnostics Rapidpoint Coag 324 9.2.2.3 Radiometer 324 9.2.2.4 HemoCue s DM Hemoglobin 324 9.2.2.5 Roche Diagnostics 324 9.2.3 BD.id 325 9.2.4 Medical Implant Communications Service (MICS) 325 2011 TriMark Publications, LLC. All rights reserved. 7 www.trimarkpublications.com

9.3 Advantages of POCT Connectivity 325 9.3.1 Cost Benefit of POCT and IT Connectivity 326 9.3.2 Hospital Network Issues 326 10. Corporate Profiles 327 10.1 Abaxis, Inc. 327 10.2 Abbott Laboratories 330 10.3 Accumetrics, Inc. 332 10.4 AccuTech, LLC 332 10.5 ACON Laboratories 332 10.6 Acrongenomics 332 10.7 Aerscher Diagnostics 333 10.8 Akers Biosciences, Inc. 333 10.9 Alere 333 10.10 Alfa Scientific Designs, Inc. 336 10.11 American Bio Medica Corporation 337 10.12 Amic AB 338 10.13 Ani Biotech Oy Ltd. 338 10.14 Arkray, Inc. 338 10.15 Atonomics A/S 338 10.16 Audit Diagnostics 339 10.17 Augurix Diagnostics Ltd. 339 10.18 Axis-Shield 339 10.19 Axxin 340 10.20 Bayer 340 10.21 Beckman Coulter 340 10.22 BioLytical Laboratories 342 10.23 Biomerica, Inc. 342 10.24 BiOracle 343 10.25 Bio-Rad Laboratories, Inc. 343 10.26 BioScan Screening Systems, Inc. 343 10.27 BioSite 343 10.28 Calmark Sweden AB 344 10.29 Calypte Biomedical Corporation 344 10.30 Chembio Diagnostic Systems 345 10.31 Chempaq A/S 345 10.32 Cholestech 345 10.33 Claros Diagnostics 345 10.34 Concateno Plc 345 10.35 Dexcom 345 10.36 Enigma Diagnostics Ltd. 346 10.37 Epinex Diagnostics 346 10.38 Eurotrol 346 10.39 Exalenz Bioscience 347 10.40 GenBio 347 10.41 Genzyme 347 10.42 Helena Laboratories 347 10.43 HemoCue AB 348 10.44 HemoSense 348 10.45 Home Diagnostics (Nipro Diagnostics) 348 10.46 IND Diagnostic 348 10.47 Instrumentation Laboratory Company 348 10.48 ITC (International Technidyne Corporation) 348 10.49 Jant Pharmacal Corporation 349 10.50 Johnson & Johnson 349 10.51 Lein Applied Diagnostics 350 2011 TriMark Publications, LLC. All rights reserved. 8 www.trimarkpublications.com

10.52 LifeAssays AB 350 10.53 LifeSign 350 10.54 Medica 350 10.55 Medical Automation Systems 350 10.56 Mediwatch 350 10.57 Medix Biochemica 351 10.58 MedMira 351 10.59 MELA Sciences (formerly Electro-Optical Sciences) 351 10.60 Meretek Diagnostics Group 351 10.61 Meridian Bioscience 351 10.62 Micronics 352 10.63 3M 352 10.64 New Horizons Diagnostics 353 10.65 Nexus DX/ITC 353 10.66 Nova Biomedical 353 10.67 OraSure Technologies 354 10.68 Orion Diagnostica 355 10.69 Polymer Technology Systems 355 10.70 Prima Biomedical Company 355 10.71 QBC Diagnostics 355 10.72 Qualigen 355 10.73 Quidel 356 10.74 Radiometer Medical 358 10.75 Response Biomedical 359 10.76 Roche 359 10.77 Telcor 360 10.78 SA Scientific 360 10.79 Siemens AG 361 10.80 Stanbio Laboratory 361 11. POCT Sector Trends and Forecasts 363 11.1 Home Care Analysis as Part of Near-Patient Testing 363 11.2 Non-Traditional Collection for POCT 363 11.3 New Systems for Critical Care and Near-Patient Testing 363 11.4 Utility of Near-Patient Testing in Critical Care Settings 364 11.5 Physician s Office Market 364 11.6 Information Management Advances 365 11.7 Test-Ordering Patterns and Demand for POCT 365 11.8 Demand for Emergency Department Services 365 11.9 Move Away from Central Laboratory 366 11.10 Healthcare Cost Controls 367 11.11 M&A in POCT 367 11.12 Competition for Services 368 11.13 Drivers of POCT 368 11.14 Confluence of New Technology 369 11.15 Difficulties of Design for Point of Care Products 369 11.16 European Hospital Structure 369 11.17 The Biggest New Opportunities in POCT 369 12. Corporate Directory 370 INDEX OF FIGURES Figure 3.1: Blood Tests Ordered in Emergency Department Visits 27 Figure 3.2: Worldwide Distribution of IVD Testing, 2010 31 2011 TriMark Publications, LLC. All rights reserved. 9 www.trimarkpublications.com

Figure 3.3: Global Point of Care Revenues, 2005-2012 33 Figure 3.4: Global Growth of Point of Care Testing Volume, 2000-2012 34 Figure 3.5: Global POCT Share of Total IVD Testing Market, 2010 35 Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 95 Figure 4.2: Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) and Weekly National Summary, September 30, 2007- February 12, 2011 148 Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary, 2010-2011 149 Figure 5.1: Global POCT Share of HIV Testing Market, 2008 235 Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 275 Figure 6.2: CLIA Laboratories by Certificate Types 282 INDEX OF TABLES Table 2.1: Percentage of POCT Performed in Selected Hospitals 22 Table 2.2: POCT Procedural Advantages for Hospital Testing 24 Table 2.3: POCT Trends 25 Table 2.4: Professional POCT Compared to Home Testing 25 Table 2.5: Drivers for Integrating POCT into Hospital Routines 25 Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 26 Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 27 Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 30 Table 3.4: Overall IVD Testing Market Worldwide, 2010 31 Table 3.5: Worldwide Distribution of IVD Testing, 2010 31 Table 3.6: Top 12 Country IVD Testing Markets, 2010 32 Table 3.7: Global Point of Care Revenues, 2005-2012 33 Table 3.8: Worldwide POCT Market Size by Geographic Location, 2005-2012 34 Table 3.9: Worldwide Distribution of POCT, 2010 34 Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 35 Table 3.11: Worldwide POCT by Performance Location, 2010 35 Table 3.12: Largest POCT Diagnostic Companies Worldwide, 2010 36 Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 36 Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2010 37 Table 3.15: U.S. POCT Market, 2000-2012 37 Table 3.16: U.S. POCT by Performance Location, 2010 38 Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 38 Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Dollars, 2000-2012 39 Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Euros, 2000-2012 39 Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2010 40 Table 3.21: European Rapid POCT by Country Market Estimates, 2010 41 Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 44 Table 3.23: European POCT Market, 2005-2012 44 Table 3.24: Top 12 POCT Country Markets, 2010 44 Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 45 Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 45 Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2010 46 Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 47 Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 48 Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2010 48 Table 3.31: Major U.K. IVD Manufacturers 49 Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 49 Table 3.33: Other European Companies that Manufacture IVD Products in the U.K. 49 2011 TriMark Publications, LLC. All rights reserved. 10 www.trimarkpublications.com

Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 50 Table 3.35: French POCT Diagnostics Products Market Sales, 2005-2012 51 Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2010 51 Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 52 Table 3.38: Italian POCT Diagnostics Products Market Sales, 2005-2012 52 Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2010 52 Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 53 Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2010 54 Table 3.42: Spanish POCT Diagnostics Products Market Sales, 2005-2012 54 Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 55 Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55 Table 3.45: Swedish POCT Diagnostics Products Market Sales, 2005-2012 56 Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 56 Table 3.47: Finnish POCT Diagnostics Products Market Sales, 2005-2012 57 Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 57 Table 3.49: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 58 Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 58 Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 59 Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 59 Table 3.53: Dutch POCT Diagnostics Products Market Sales, 2005-2012 60 Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 60 Table 3.55: Belgian POCT Diagnostics Products Market Sales, 2005-2012 61 Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 61 Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 62 Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 62 Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 63 Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 63 Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 64 Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 64 Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 65 Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 65 Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 66 Table 3.66: Turkish POCT Market, 2000-2012 66 Table 3.67: Japanese POCT Market, 2000-2012 67 Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 67 Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 68 Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 69 Table 3.71: Indian IVD Market, 2010 69 Table 3.72: Indian POCT Diagnostics Products Market Sales, 2000-2012 73 Table 3.73: Chinese IVD Market, 2006-2012 74 Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 75 Table 3.75: Chinese IVD Market, 2010 75 Table 3.76: Chinese POCT Diagnostics Products Market Sales, 2000-2012 81 Table 3.77: Rest of the World POCT Market, 2000-2012 83 Table 3.78: Canadian POCT Market, 2000-2012 84 Table 3.79: Brazilian POCT Market, 2000-2012 84 Table 3.80: Australian POCT Market, 2000-2012 85 Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 90 Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 91 Table 4.3: Professional Glucose Testing Market for POCT Worldwide Revenue and Forecasts, 2001-2012 92 Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 92 Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 94 Table 4.6: HbA1c Testing Market for POCT Worldwide, 2006-2012 95 Table 4.7: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 96 Table 4.8: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 96 2011 TriMark Publications, LLC. All rights reserved. 11 www.trimarkpublications.com

Table 4.9: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 98 Table 4.10: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 99 Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 99 Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and 2010 99 Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2010 101 Table 4.14: Hospital Locations of Point of Care Coagulation Testing 103 Table 4.15: Drivers for Point of Care Coagulation Testing 104 Table 4.16: Barriers for Point of Care Coagulation Testing 104 Table 4.17: Coagulation Testing Market for POCT Worldwide, 2006-2012 104 Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012 105 Table 4.19: Coagulation Market for POCT in the U.S., 2001-2015 106 Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 2000-2010 106 Table 4.21: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Coagulation Point of Care Market 111 Table 4.22: Cardiac Marker Market for POCT in the U.S., 2001-2016 113 Table 4.23: Cardiac Marker Market for POCT Worldwide, 2001-2016 113 Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2010 114 Table 4.25: Cardiac Marker Market for POCT in Europe, 2008-2016 114 Table 4.26: Point of Care Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 115 Table 4.27: Point of Care Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 116 Table 4.28: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Cardiac Marker Point of Care Market 117 Table 4.29: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 122 Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 122 Table 4.31: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 124 Table 4.32: Stat Urine Testing Drug Recommendations 124 Table 4.33: Device Specifications for POCT Breath Alcohol Analysis 126 Table 4.34: Global Point of Care Urine Test Strip Testing Market, 2001-2010 127 Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 127 Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 127 Table 4.37: U.S. Point of Care Urine Test Strip Testing Market Share 128 Table 4.38: Medicare Fee Schedule for Urine Chemistry Testing, 129 Table 4.39: Pregnancy Testing Market for POCT Worldwide, 2006-2012 130 Table 4.40: U.S. Point of Care Pregnancy Testing Market, 2001-2012 130 Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 131 Table 4.42: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 132 Table 4.43: Drivers of Demand for HIV Testing 136 Table 4.44: Worldwide POCT Market for HIV, 2001-2012 137 Table 4.45: U.S. POCT Market for HIV, 2001-2012 138 Table 4.46: Countries with the Highest Prevalence of HIV/AIDS 139 Table 4.47: FDA-approved Rapid HIV Antibody Screening Tests 141 Table 4.48: Cholesterol Testing Market for POCT Worldwide, 2006-2012 143 Table 4.49: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 143 Table 4.50: Worldwide Point of Care Influenza Testing Market, 2002-2010 149 Table 4.51: U.S. Point of Care Influenza Testing Market, 2002-2010 150 Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, 2010 150 Table 4.53: Worldwide Point of Care Strep A Testing Market, 2002-2010 151 Table 4.54: U.S. Point of Care Strep A Testing Market, 2002-2010 151 Table 4.55: U.S. Market Share for Rapid Point of Care for Group A Strep Tests 151 Table 4.56: Global Market for Chlamydia Diagnostic Testing, 2000-2010 152 Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, 2000-2010 152 Table 4.58: U.S. Market for MRSA Rapid Testing, 2006-2013 157 Table 4.59: Global Market for Gonorrhea Diagnostic Testing, 2000-2010 161 Table 4.60: Global Market for TB Diagnostic Testing, 2000-2010 163 Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers Ranked in Order of Impact 166 2011 TriMark Publications, LLC. All rights reserved. 12 www.trimarkpublications.com

Table 4.62: Point of Care Infectious Disease Testing Market: Market Restraints Ranked in Order of Impact 166 Table 4.63: U.S. Anthrax Test Market 169 Table 5.1: Roche Diagnostics Glucose Testing Products 176 Table 5.2: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2010 193 Table 5.3: Actalyke XL 200 Table 5.4: Actalyke Mini 200 Table 5.5: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse 209 Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 209 Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 209 Table 5.8: ColoCARE Fecal Occult Blood Test 222 Table 5.9: Competitive Factors Related to HIV Tests 234 Table 5.10: Largest POCT Diagnostic Companies Worldwide, 2008 235 Table 5.11: Influenza Diagnostic Rapid Tests 250 Table 5.12: Type of Hepatitis Test: Lateral Flow 257 Table 5.13: Flow-through 258 Table 5.14: Agglutination 258 Table 5.15: Immunoblot 258 Table 5.16: AmniSure 267 Table 6.1: Access Points 270 Table 6.2: Desktop Adapters Four Computers 270 Table 6.3: Desktop Adapters One Computer 270 Table 6.4: PCMCIA Adapters 270 Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 273 Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 275 Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 276 Table 6.8: POCT in Three Hospitals Cost Analysis with Labor Included 278 Table 6.9: POCT versus Central Lab Cost Analysis for Glucose Testing 279 Table 6.10: CLIA Laboratories by Type of Facility 280 Table 6.11: Financial Comparison for Moderate and Waived CLIA Labs 283 Table 6.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories 286 Table 7.1: Key Changes in IVD Business Structure 292 Table 7.2: Business Trends in POCT 301 Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic Testing 301 Table 7.4: Emerging Trends in Point of Care Testing 301 Table 7.5: Future Developments in Point of Care Testing 302 Table 7.6: The Confluence of the New Technology 302 Table 7.7: Professional Continuous Glucose Monitoring (CGM) ICD-9 Codes 302 Table 7.8: Professional CGM 303 Table 8.1: Normal Glucose Values Fasting State 308 Table 9.1: Applications for Wireless LAN Technology 318 Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 322 Table 9.3: RALS-Plus Point of Care Market Share 323 Table 9.4: Applications of RALS Connectivity with POCT Devices 323 Table 10.1: Abaxis Blood Analysis Diagnostic Tests 328 Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 329 Table 10.3: Products Marketed by Abbott in the Diagnostic Market 331 Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 364 Table 11.2: Test Menu and TAT for ED 365 Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented in the ED 365 Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 366 Table 11.5: Estimates of Patient Costs by DRG 367 2011 TriMark Publications, LLC. All rights reserved. 13 www.trimarkpublications.com

1. Overview The purpose of this report is to describe the specific market segment of the in vitro diagnostics (IVD) market called point of care testing (POCT). It examines these clinical measurement devices and their reagents and supplies as utilized in near-patient environments like hospitals, clinics and doctor s offices. An analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient is addressed. Moreover, the study defines the dollar volume of sales both worldwide and in the United States and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including the research, hospital and commercial laboratories. This report analyzes in detail the important sections of the point of care diagnostics sector including: glucose, blood gases, coagulation, cardiac marker, drugs of abuse, infectious disease, and many others. Additionally, rapid detection of food pathogens and infectious pathogens (methicillin-resistant Staphylococcus aureus [MRSA], herpes simplex, avian flu, West Nile virus [WNV] and typhoid) are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company s market position. 1.1 About this Report A review of analytes that are related to the chemical and cellular constituents of blood, plasma or serum at the point of care of the patient is addressed in this study. The two most important areas where such tests are measured are in the hospital and the clinic environments (emergency department and the critical care section). Another important place where these tests are measured is in physician s office labs (POLs). Newer areas of testing interest for these analytes are satellite labs, corporate facilities, law enforcement agencies and home testing locations. Emphasis is on those companies and products that are actively developing and marketing clinical laboratory instrumentation, reagents and supplies for performing clinical diagnostic tests in the near-patient environment. The main objectives of this analysis are: Identifying viable technology drivers through a comprehensive look at platform technologies for POCT. Understanding the different sectors of POCT, looking at the hospital market segment and, separately, at a description of the instruments, reagents and supplies marketed by major companies in each segment. Obtaining a complete understanding of the individual point of care tests from their basic principles to their clinical applications. Discovering feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, focusing on the biggest and expanding markets. Focusing on global industry development through an in-depth analysis of the major world markets for point of care technology, including growth forecasts. Presenting market figures regarding the current value of the POCT, market projections, market share, key players and sector growth rates. The source of this information is the most current data derived from the global diagnostic industry. This study contains: A detailed analysis of recent trends in the point of care marketplace. In-depth profiles of the leading companies with point of care tools and technologies. A forecast for the point of care market in the biotechnology and diagnostic industries. Views and principles on the point of care industry from leading industry experts. An analysis of potential new point of care applications in the clinical sector. Market predictions and trends analysis concerning U.S. expenditures on point of care solutions. Projections of point of care market sizes for European and Asian markets. Projections for future applications of molecular diagnostic tests in point of care-related screening. Analysis of commercial point of care business strategies. The latest news and mergers and acquisitions (M&As) developments in the point of care marketplace. A comprehensive overview and insight into point of care business strategies. An in-depth examination of the subsections of each market segment, including the POLs and clinic testing. 2011 TriMark Publications, LLC. All rights reserved. 14 www.trimarkpublications.com

Analysis includes charts and graphs measuring product growth and trends within the marketplace. Company-specific information, including sales figures, product pipeline status and research and development (R&D) trends, is provided. This review will also: Assess point of care market drivers and bottlenecks, from medical and scientific community perspectives. Discuss the potential benefits of point of care for various sectors of the medical and scientific community. Establish the current total market size and future growth of the point of care market and analyze the current size and growth of individual segments. Provide current and forecasted market shares by company. Discuss profit and business opportunities by segment. Provide strategic recommendations for near-term business opportunities. Assess current commercial uses of the point of care market. The following questions will also be addressed in this analysis: What are the near-term business opportunities in the point of care market? What are the current and forecasted point of care market sizes in the U.S., European Union (E.U.) and Japan, as well as in other key country markets? What are the business models currently used by companies in the point of care market? How will manufacturers, researchers, physicians and patients influence this market? What are the drivers and bottlenecks influencing the point of care market? What are the technologies used in point of care? Who holds the proprietary rights to the point of care market technology platforms? In the U.S., Japan and the E.U., what regulatory processes apply to point of care technologies? How will new point of care technologies change diagnostic screening testing paradigms? How will new point of care technologies reduce healthcare expenditures and affect R&D spending? The report contains: A comprehensive overview of the several categories of point of care technology platforms that are, or will be, revolutionizing the use of diagnostic tests in hospitals. A chapter on each of the important point of care categories and applications. Full descriptions of the technologies involved and how these differ from existing and emerging technologies. Analysis of the technological approaches undertaken by various competitors, as well as industry and enduser responses to these products. Regulatory issues and legislation affecting use and marketing of point of care products. Market forecasts for each category of product, including profiles of selected competitors. 1.2 Scope of the Report The POCT diagnostic products market in the U.S., Japan and Europe the world s three largest analytical markets are the focus of this study. A number of other smaller country markets are included for analysis of their diagnostic and point of care activity. Primary attention is paid to the clinical market segment, and, separately, to the instruments, reagents and supplies marketed by major companies in this segment. Market size, growth rates and market components for instruments, reagents, controls and consumables used in this area are also analyzed. In general, the non-professional (home care) market for self testing is considered an entirely different market than professional (hospital, clinic and doctor s office) testing, and is not considered in this report in any detailed way. Other related areas like infant jaundice evaluation, anthrax detection, homeland defense testing, BSE (mad cow disease), tuberculosis and food pathogens are discussed. The reader should consult other TriMark Publications reports at http://www.trimarkpublications.com for detailed discussions of important individual market segments related to the POCT market. 2011 TriMark Publications, LLC. All rights reserved. 15 www.trimarkpublications.com

1.3 Objectives The goal of this study is to review the market for POCT equipment and supplies, using screening reagents and instruments for analysis of individual components in tissue samples, blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including the research labs, hospital labs and commercial laboratories. Additionally, the numbers of institutions using this type of POCT and the factors that influence purchases are discussed. 1.4 Methodology The author of this report holds a Ph.D. in biochemistry from the University of Minnesota and has had post-doctoral experience at the University of Connecticut School of Medicine. He has taught at Quinnipiac University and the Tufts School of Medicine, and has been a senior scientist at Pfizer Pharmaceutical Laboratories in drug development. He also has many decades of experience in science writing and as a medical industry analyst. He has over thirty 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 of the report has a Ph.D. in anatomy and degrees in molecular biology and has worked as a research assistant professor. 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. Primary Sources TriMark collects information from hundreds of Database Tables and many comprehensive multi-client 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. 2011 TriMark Publications, LLC. All rights reserved. 16 www.trimarkpublications.com

TriMark Publications Report Research and Data Acquisition Structure The general sequence of research and analysis activity prior to the publication of every report 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 databases, proprietary databases, direct meetings and personal interviews with key personnel. Formulating a study outline with the assigned writer, including important items: 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. Launching a combination of primary research activities including two levels of questionnaires, executivedirect focused, company-specific, and region-specific communications to qualified and experienced senior executives worldwide. Completing a confirmatory primary research assessment of the report s findings with the assistance of Expert Panel Partners from the industry being analyzed. 1.5 Executive Summary During 2010, 950 million point of care tests were carried out within hospitals in the U.S. This figure is expected to grow to 1.5 billion tests per annum by 2012 with an estimated compounded annual growth rate (CAGR) of 12.5%. In the U.S., there were an estimated 130 million visits to emergency departments in 2010. The overall worldwide in vitro medical diagnostic testing market was $45.1 billion in 2010. Typically, the market is segmented by the underlying technology involved in performing the diagnostic test. For example, the largest market segments of the IVD testing industry are clinical chemistry, with approximately 21% of the market, and immunodiagnostics, with approximately 31% of the market size. The global point of care market has reached $7.7 billion in 2010 and is growing at approximately 7% per year. In the U.S., POCT from all sources (hospitals, clinics, doctor s offices, but not home testing) now represents 15% of the $15.8 billion U.S. market for clinical diagnostic testing reagents, controls and equipment, or $2.7 billion in 2010. It is projected to grow at an annual rate of 7% in the U.S. through 2012 to a total of $3.1 billion. The professional point of care diagnostic testing market is composed of two general segments: hospital testing and decentralized testing. Hospital POCT is usually an extension of the central lab testing, and performed under the laboratory license. For example, immediate turnaround of blood gases and electrolytes is very helpful in the operating room or the emergency room (ER). Pregnancy tests or cardiac monitoring tests in the ER can be very helpful to manage critically-ill patients. This market segment in the U.S. was estimated at $2.0 billion in sales in the U.S. in 2010. The second component of the decentralized market testing segment consists of POLs, nursing homes, pharmacies and other non-institutional settings in which healthcare providers perform diagnostic tests. This market segment in the U.S. was estimated at $700 million in sales in the U.S. in 2010. In the IVD industry, the European segment accounted for 33% of the world market for IVD products in 2010, or approximately $17.5 billion for the European estimate of 27 surveyed. With an expected real growth at a CAGR of 2011 TriMark Publications, LLC. All rights reserved. 17 www.trimarkpublications.com

6% to 7% through 2012, estimates suggest that the market for IVDs in the E.U. will reach $20 billion by 2012. The E.U. (38.6%) is second only to North America s (39.2%) market share of IVD products. The major segments of the point of care diagnostic testing market highlighted in this study are: Blood glucose monitoring. Blood gas and electrolytes (critical care testing). Rapid coagulation tests. Rapid cardiac markers. Rapid drugs of abuse. Urine strips. Urine pregnancy tests. Fecal occult blood. Hemoglobin testing. Miscellaneous rapid tests. Human immunodeficiency virus (HIV). Cholesterol. Infectious disease. Infant Jaundice. Anthrax. Fetal membranes. Food pathogens. The professional POCT blood glucose monitoring segment is by far the largest of the point of care market segments. Virtually all U.S. hospitals now perform point of care glucose monitoring. The market is very mature, with annual global sales at $1.6 billion in 2010. The global market is projected to grow to $1.7 billion by 2012, a CAGR of 4%. U.S. sales in 2008 reached $482 million and are growing at a rate of 5% per year. The market is projected to grow to $537 million by 2012, with a CAGR of 5%. Roche is still the market leader in point of care glucose testing. Critical care diagnostic testing includes routine and time-sensitive testing for critically-ill patients in a variety of areas including ph/blood gases, electrolytes, metabolites and CO-oximetry. TriMark estimates the total worldwide sales in this segment in 2010 was $1,049 million, growing at a rate of about 4% per year. The total U.S. market for critical care blood gas supplies in 2010, for POCT, was $277 million. The electrolyte segment was a $103 million market in the U.S. in 2010 and growing at a rate of about 6% per year. The market for rapid, point of care-type coagulation tests in the U.S. was approximately $227 million in 2010, and growing at a rate of 14% per year, attaining sales of $342 million by 2012. This is the highest growth rate of all of the segments in the rapid test area save cardiac tests but moves from a much higher base of sales than the latter. In 2010, the global market for rapid cardiac markers was $837 million. This market is projected to grow to $1.9 billion in 2016. Rapid growth rates of 16% to 30% are expected in this segment. In 2010, the market in the U.S. for rapid cardiac markers was $413 million. This market is projected to grow to $795 million in 2016. Rapid growth rates of 16% to 30% are expected in this segment. Most of the cardiac marker tests are still performed in the hospital central lab rather than in the ER. This trend is expected by TriMark to continue. The principal markets for rapid drugs of abuse testing are law enforcement, medical emergency, drug courts and the industrial workplace. The U.S. hospital market alone is estimated to total $350 million for drugs of abuse screening products. The on-site point of care (non-laboratory) testing/screening was at $97 million in 2010 and scheduled to grow at annual rates in excess of 12% through 2012 to reach $110 million. The U.S. market for abused drug testing from all sources is approximately $600 million annually, including hospital, central lab, corporate, criminal justice and POCT. The worldwide market for routine urinary analysis performed in laboratories is approximately $450 million per year, with 79% of that business ($398 million in 2010) represented by test strip sales. More than $70 million in testing is 2011 TriMark Publications, LLC. All rights reserved. 18 www.trimarkpublications.com

generated in the U.S. alone. TriMark estimates the total worldwide sales in this segment for POCT in 2010 of $228 million, growing at a rate of about 4% per year. Over 70 million tests for human chorionic gonadotropin (hcg), or pregnancy testing, are performed each year in U.S. doctor s offices, with clinics and ERs generating a market estimated at $71 million annually in 2010. The world market for point of care pregnancy testing is estimated to be $209 million. Quidel is the leader in the U.S. professional market; rapid, non-instrument-based pregnancy testing in doctor s offices holds a 49% share of the $34 million market with 11 generic competitors. Abbott dominates the U.S. hospital lab market for pregnancy tests. TriMark estimates the total worldwide sales in the fecal occult blood testing (FOBT) segment in 2010 of $400 million, growing at a rate of about 2% per year. The U.S. hospital market for FOBT was $30 million in 2010. The market for doctor s offices was approximately $25 million in 2010. The market leader, Beckman Coulter, has been the dominant company with its Hemoccult product. There are a number of miscellaneous products in the POCT area for analytes, such as HIV, estriol, fetal fibronectin and Helicobacter pylori, which are covered in this report. The area of infectious disease is growing rapidly in the point of care segment. This report discusses rapid testing for giardia, salmonella, mononucleosis, chlamydia and other infectious diseases. The global market for the point of care HIV/AIDS tests are substantially more than $283 million and predicted to grow at a rapid rate for the next decade. TriMark estimates that this market niche will grow worldwide to well over $300 million within the next five years, particularly as rapid urine-based tests become available to the large third world markets, and cheaper therapeutic agents become available to poor populations. The latter, of course, would make HIV/AIDS testing much more relevant. In the U.S., the estimate for 2010 was $172 million, growing 15% per year. TriMark estimates that this market niche will grow worldwide to over $300 million within the next five years, particularly as rapid urine-based tests become available to the large third world markets, and cheaper therapeutic agents become available to poor populations. Infectious disease is the largest illness category in the world. In the U.S., over 76 million cases of infectious diseases are diagnosed by physicians annually. This segment is projected to increase at a growth rate of over 20% for the next five years. Testing needs range from routine, pre-conception immune status screening to the progressive battle against opportunistic pathogens associated with the AIDS virus. The following are some key concepts to consider: The diagnostic POCT segment still has good growth potential, with multiple opportunities for entry and growth, as well as competition and change. Several segments such as cardiac testing, coagulation, and infectious disease testing are exhibiting double-digit growth. Advances in technology are propelling both new and old companies forward with fresh capabilities. The glucose and pregnancy segments account for the bulk of sales, at >70%. Growth from these segments, however, is expected to slow due to market saturation. Although the other segments are small today, it is an extremely fast-growing component of the market. Geographically, the U.S. constitutes almost 50% of sales. Significant opportunities exist in the rest of the world, especially in the BRIC countries, such as India and China, with burgeoning population and increasing healthcare awareness. This attractive growth marketplace, however, has high barriers to entry, particularly with regard to intellectual property, technical intensity, physician education, FDA regulation and obtaining reimbursement. 2011 TriMark Publications, LLC. All rights reserved. 19 www.trimarkpublications.com

So far, Roche and Siemens are best positioned in this space, with a market share of 68% of glucose testing in 2010. Recently, these companies started looking at new areas, such as cardiac and sepsis testing, to foster future growth as their market share in glucose is eroding. Although other companies, such as Abbott, LifeScan and Alere (formerly Inverness), are becoming increasingly focused on POCT, doubling their product expansion and collaboration efforts to gain market share, the market remains extremely fragmented. Alere seems to be improving its position through its acquisitions of companies like Biosite, and collaborations with SureStat and Chembio. Alere s HIV market share, on the other hand, could erode with the entry of Roche and Orasure and the advent of oral HIV tests. Nova Biomedical is becoming reliable player with its new POCT platform. POCT dynamics are changing rapidly, and smaller players, including Cepheid, Tm Bioscience, Chembio, Response Biomedical, Orasure and Nova, are poised to deliver value with their innovative platforms and growing test menu. The market has been driven by transition to fully-automated systems, real-time amplification, connectivity platforms and growing test development for point of care platforms. TriMark estimates that future growth will stem from emerging applications like genotyping for identifying drug resistant strains; bioterrorism; testing applications within infectious disease like influenza and HIV; disease diagnostics and prognostic assays for disease applications like sepsis, cardiovascular disease (CHF) and coagulation testing. The industry consolidation is here with a vengeance, as larger players like Alere want to move into fastergrowing markets to expand their product offerings and/or geographical reach. Larger, established diagnostic players and therapeutic companies like Roche are eager to build and extend their molecular diagnostic franchises and are willing to pay premium prices for good technology. 2011 TriMark Publications, LLC. All rights reserved. 20 www.trimarkpublications.com