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

2 TABLE OF CONTENTS 1. Overview About this Report Scope of the Report Objectives Methodology Executive Summary Overview of Diagnostic Testing Point of Care Point of Care Testing Sites Point of Care Market Structure New Directions in Clinical IVD Testing POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors Global POCT Market U.S. POCT Market European POCT Market German POCT Diagnostic Market U.K. POCT Diagnostic Market U.K. POCT Market Statistics U.K. Competitive Analysis U.K. Market Access French POCT Diagnostic Market Italian POCT Diagnostic Market Spanish POCT Diagnostic Market Scandinavian POCT Diagnostic Market Swedish POCT Diagnostic Market Finnish POCT Diagnostic Market Norwegian POCT Diagnostic Market Swiss POCT Diagnostic Market Dutch POCT Diagnostic Market Belgian POCT Diagnostic Market Portuguese POCT Diagnostic Market Austrian POCT Diagnostic Market Greek POCT Diagnostic Market Polish POCT Diagnostic Market Czech Republic POCT Diagnostic Market Turkish POCT Diagnostic Market Asian POCT Markets Japanese POCT Diagnostic Market Indian POCT Diagnostic Market Chinese POCT Diagnostic Market Rest of the World POCT Market Canadian POCT Diagnostic Market Brazilian POCT Diagnostic Market Australian POCT Diagnostic Market Overview of Asian Healthcare Market Singapore Malaysia Thailand Indonesia Philippines South Korea Taiwan TriMark Publications, LLC. All rights reserved. 1

3 4. POCT Individual Markets Glucose Testing POCT Individual Market Sectors, Size, Growth Rates and Competitors World Market Revenue and Forecasts Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts during European Market Market Share Alternate Glucose Monitoring Products HbA1c POCT Market Challenges and Strategic Recommendations Market Drivers and Restraints Market Drivers Market Restraints Point of Care Glucose Testing Assay Market and Technology Trends Point of Care Glucose Testing Assay Market Trends Point of Care Glucose Testing Assay Technology Trends Point of Care Glucose Testing Assay Strategic Recommendations Blood Gas and Electrolytes Whole Blood Lactate Creatinine Rapid Coagulation Tests World POCT Coagulation Market U.S. Coagulation Market European Coagulation Market Trends in POCT Coagulation Testing Self-testing Coagulation Market D-Dimer Testing Point of Care Coagulation Testing Assay Market and Technology Trends Point of Care Coagulation Testing Assay Market Trends Point of Care Coagulation Testing Assay Technology Trends Point of Care Coagulation Testing Assay Strategic Recommendations Rapid Cardiac Markers U.S. Market European Market Market Drivers and Restraints Market Drivers Market Restraints Point of Care Cardiac Marker Testing Assay Market and Technology Trends Point of Care Cardiac Marker Testing Assay Market Trends Point of Care Cardiac Marker Testing Assay Technology Trends Point of Care Cardiac Marker Testing Assay Strategic Recommendations Drugs of Abuse Screening Testing Acetaminophen Tricyclic Antidepressants (TCAs) Other Toxic Drugs Drug Testing Selectivity Methaqualone and Phencyclidine (PCP) Tetrahydrocannabinol Drug Panels by Toxidromes Alcohol Testing Urine Strips Pregnancy Tests Fecal Occult Blood Hemoglobin Testing Miscellaneous Rapid Tests TriMark Publications, LLC. All rights reserved. 2

4 Estriol Fetal Fibronectin (ffn) H. pylori Vaginal ph and Vaginitis Bladder Cancer Fetal Status Heparin-induced Thrombocytopenia Human Immunodeficiency Virus (HIV) Cholesterol Infectious Disease Clostridium difficile Giardia Salmonella and Campylobacter Malaria Testing Influenza Testing Strep Testing Chlamydia Mononucleosis Rubella Methicillin-resistant Staphylococcus aureus (MRSA) Hepatitis Gonorrhea Tuberculosis (TB) Herpes Simplex Virus Type Legionella RSV Market Drivers and Restraints Market Drivers Market Restraints Point of Care Infectious Disease Testing Assay Market and Technology Trends Point of Care Infectious Disease Testing Assay Market Trends Point of Care Infectious Disease Testing Assay Technology Trends Point of Care Infectious Disease Testing Assay Strategic Recommendations Infant Jaundice Anthrax Rupture of Fetal Membranes (ROM) Food Pathogens Typhoid POCT: Reagents and Equipment Blood Glucose Monitoring LifeScan Roche Accu-Chek Abbott Diabetes Care HemoCue Stanbio/GDS Technology Abaxis, Inc Arkray (Japan) Accurex (India) Home Diagnostics, Inc Nova Biomedical Bayer Hemoglobin A1c Measurements Biosite (now part of Alere) Siemens Healthcare Diagnostics Infopia TriMark Publications, LLC. All rights reserved. 3

5 Diasys Quotient Dx Cholestech (Acquired by Inverness Medical Innovations, now named Alere) Bio-Rad Axis-Shield Blood Gas and Electrolytes Roche Corporation TechnoMedica Siemens Healthcare Diagnostics Instrumentation Laboratory Nova Biomedical Radiometer Abbott Laboratories Span Diagnostics Nexus Dx Avoximeter Systems for Co-oximetry ITC (Nexus Dx) Alere Abaxis, Inc Rapid Coagulation Tests POC Coagulation Instrument Description Roche Diagnostics Corp Abbott Laboratories International Technidyne Corporation Nexus DX Medtronic HemoSense (Inverness) Helena Laboratories Point of Care Sienco, Inc Accumetrics Alere ITC Connectivity Issues Cost Benefits Quality Control Issues Certification for Point of Care Coagulation Devices Rapid Cardiac Markers Biosite Diagnostics (Inverness, now called Alere) Roche Diagnostics Ani Biotech Response Biomedical Corporation Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring) Lab21 Ltd Abbott Laboratories LifeSign (Princeton BioMediTech Corp.) Mitsubishi Kagaku Iatron Alpha Scientific Rapid Drugs of Abuse Biosite Diagnostics (Inverness, now called Alere) Abbott Diagnostics Roche Diagnostics BioScan Screening Systems, Inc American Bio Medica Corp Phamatech, Inc First Check Medical OraSure Avitar, Inc TriMark Publications, LLC. All rights reserved. 4

6 Concateno Pathtech Alfa Scientific Designs, Inc TCPI, Inc Roche Biophor Diagnostics Rapid Pregnancy and Fertility Tests Fecal Occult Blood Helena Laboratories Biomerica Beckman Coulter Worldwide Medical Aerscher Diagnostics Enterix Medix Biochemica Orion Diagnostica Hemoglobin Testing Wampole Laboratories HemoCue, Inc Stanbio Miscellaneous Rapid Tests Triage C. difficile Panel Ketoacids Acetaminophen Estriol H. pylori Vaginal Fluid ph and Vaginitis Prostate-specific Antigen (PSA) Bladder Cancer Other Rapid Cancer Tests Fetal Status (PROM) Osteoporosis Hemodynamic Monitoring Heparin-induced Thrombocytopenia HIV Whole Blood, Serum or Plasma-based HIV Tests Bio-Rad Laboratories Orgenics (Inverness, now called Alere) StatSure Diagnostic Systems Trinity Biotech Savyon Diagnostics MedPharm American Bio Medica Corp Chembio Diagnostics OraSure Technologies Inverness (Alere) Saliva-based HIV Tests OraSure Collection Device SureStat Urine-based HIV Tests MedMira Laboratories, Inc Medical Services International, Inc Maxim Biomedical Wampole Laboratories Cholesterol Cholestech (now a brand of Inverness Medical Innovations) TriMark Publications, LLC. All rights reserved. 5

7 Actimed Laboratories StatSite Meter Polymer Technology Systems PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) Abaxis, Inc Infectious Disease C. difficile Giardia Dengue Fever Malaria Testing Rapid Influenza Testing Streptococcus Testing Chlamydia Mononucleosis Rubella Staphylococcus aureus and MRSA Hepatitis E. Coli O Gonorrhea Testing Smallpox SARS Rabies Tuberculosis Avian Flu West Nile Virus Herpes Simplex Virus Type Legionella RSV Infant Jaundice Anthrax Homeland Defense (Plague and Tularemia) BSE (Mad Cow Disease) Tuberculosis Typhoid Avian Flu Food Pathogens (Salmonella, Listeria, Campylobacter) Ruptured Fetal Membranes (ROM) POCT: Growth Regulators Moderators of Growth Personnel Acceptance Key People for POCT Information Management Issues Elements of Information Management for POCT: Information Processing Capabilities Data Mining Middleware Web Portals POCT-1A Standard Key Elements for POCT POCT and Reimbursement Effectiveness of Clinical Outcomes Rapid Near-Patient Testing in Hospitals Satellite Facilities Regionalization of Laboratory Care Requirements for POCT Locations of Point of Care for Patient Care TriMark Publications, LLC. All rights reserved. 6

8 6.13 Benefits of POCT Cost Elements of POCT Necessary Functions in POCT TAT for POCT Clinical Laboratory Improvement Amendments (CLIA) Sexually-transmitted Diseases in Underdeveloped Countries Sources of Error in Point of Care Testing Business Trends in the Point of Care Sector Sector Consolidation Diagnostic Testing Growth Trends Opportunities for Healthcare Stakeholders Acquisition, License Agreements, Internal Development and Partnerships Product Testing Depth in POCT Government Regulation U.S. Regulation Importing Medical Devices into the U.S Exporting Medical Devices from the U.S U.K. Regulation E.U. Regulation French Regulation Japanese Regulation Korean Regulation Increased Market Penetration Costs of doing Business in Europe Drivers of European Diagnostics Testing European Reimbursement Practices Cost Containment in Europe Technology Platform Innovations in POCT Sensor Systems for Diagnostic Applications Glucose Measurements Continuous Glucose Monitoring Systems Glucose Test Methods Cholesterol Testing The New Paradigm Consolidated Workstations and Modularity Automation and Robotics in the Clinical Laboratory Laboratory Information Systems (LIS) NOVIUS Lab Biosensor Technology Nanogen Third Generation Point of Care Analyzer Quidel MChip Data Management and Connectivity Wireless LANs Connectivity Platforms DataLink Data Management System RALS-Plus International Technidyne Corporation HEMOCHRON Signature Elite Siemens Diagnostics Rapidpoint Coag Radiometer HemoCue s DM Hemoglobin Roche Diagnostics BD.id Medical Implant Communications Service (MICS) TriMark Publications, LLC. All rights reserved. 7

9 9.3 Advantages of POCT Connectivity Cost Benefit of POCT and IT Connectivity Hospital Network Issues Corporate Profiles Abaxis, Inc Abbott Laboratories Accumetrics, Inc AccuTech, LLC ACON Laboratories Acrongenomics Aerscher Diagnostics Akers Biosciences, Inc Alere Alfa Scientific Designs, Inc American Bio Medica Corporation Amic AB Ani Biotech Oy Ltd Arkray, Inc Atonomics A/S Audit Diagnostics Augurix Diagnostics Ltd Axis-Shield Axxin Bayer Beckman Coulter BioLytical Laboratories Biomerica, Inc BiOracle Bio-Rad Laboratories, Inc BioScan Screening Systems, Inc BioSite Calmark Sweden AB Calypte Biomedical Corporation Chembio Diagnostic Systems Chempaq A/S Cholestech Claros Diagnostics Concateno Plc Dexcom Enigma Diagnostics Ltd Epinex Diagnostics Eurotrol Exalenz Bioscience GenBio Genzyme Helena Laboratories HemoCue AB HemoSense Home Diagnostics (Nipro Diagnostics) IND Diagnostic Instrumentation Laboratory Company ITC (International Technidyne Corporation) Jant Pharmacal Corporation Johnson & Johnson Lein Applied Diagnostics TriMark Publications, LLC. All rights reserved. 8

10 10.52 LifeAssays AB LifeSign Medica Medical Automation Systems Mediwatch Medix Biochemica MedMira MELA Sciences (formerly Electro-Optical Sciences) Meretek Diagnostics Group Meridian Bioscience Micronics M New Horizons Diagnostics Nexus DX/ITC Nova Biomedical OraSure Technologies Orion Diagnostica Polymer Technology Systems Prima Biomedical Company QBC Diagnostics Qualigen Quidel Radiometer Medical Response Biomedical Roche Telcor SA Scientific Siemens AG Stanbio Laboratory POCT Sector Trends and Forecasts Home Care Analysis as Part of Near-Patient Testing Non-Traditional Collection for POCT New Systems for Critical Care and Near-Patient Testing Utility of Near-Patient Testing in Critical Care Settings Physician s Office Market Information Management Advances Test-Ordering Patterns and Demand for POCT Demand for Emergency Department Services Move Away from Central Laboratory Healthcare Cost Controls M&A in POCT Competition for Services Drivers of POCT Confluence of New Technology Difficulties of Design for Point of Care Products European Hospital Structure The Biggest New Opportunities in POCT 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, TriMark Publications, LLC. All rights reserved. 9

11 Figure 3.3: Global Point of Care Revenues, Figure 3.4: Global Growth of Point of Care Testing Volume, Figure 3.5: Global POCT Share of Total IVD Testing Market, Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 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, February 12, Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary, Figure 5.1: Global POCT Share of HIV Testing Market, 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, Table 3.2: Number of Point of Care Tests in the U.S., Table 3.3: Global Clinical Laboratory Market Sales, Table 3.4: Overall IVD Testing Market Worldwide, Table 3.5: Worldwide Distribution of IVD Testing, Table 3.6: Top 12 Country IVD Testing Markets, Table 3.7: Global Point of Care Revenues, Table 3.8: Worldwide POCT Market Size by Geographic Location, Table 3.9: Worldwide Distribution of POCT, Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, Table 3.11: Worldwide POCT by Performance Location, Table 3.12: Largest POCT Diagnostic Companies Worldwide, Table 3.13: U.S. Clinical Laboratory Testing Market, Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, Table 3.15: U.S. POCT Market, Table 3.16: U.S. POCT by Performance Location, Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Dollars, Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Euros, Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, Table 3.21: European Rapid POCT by Country Market Estimates, Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 44 Table 3.23: European POCT Market, Table 3.24: Top 12 POCT Country Markets, Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market Sales, Table 3.26: German POCT Diagnostics Products Market Sales, Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales, Table 3.29: U.K. POCT Diagnostics Products Market Sales, Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 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 TriMark Publications, LLC. All rights reserved. 10

12 Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales, Table 3.35: French POCT Diagnostics Products Market Sales, Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, Table 3.37: Italian Laboratory Diagnostics Products Market Sales, Table 3.38: Italian POCT Diagnostics Products Market Sales, Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales, Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, Table 3.42: Spanish POCT Diagnostics Products Market Sales, Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales, Table 3.45: Swedish POCT Diagnostics Products Market Sales, Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales, Table 3.47: Finnish POCT Diagnostics Products Market Sales, Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, Table 3.49: Norwegian POCT Diagnostics Products Market Sales, Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales, Table 3.51: Swiss POCT Diagnostics Products Market Sales, Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales, Table 3.53: Dutch POCT Diagnostics Products Market Sales, Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales, Table 3.55: Belgian POCT Diagnostics Products Market Sales, Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales, Table 3.57: Portuguese POCT Diagnostics Products Market Sales, Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales, Table 3.59: Austrian POCT Diagnostics Products Market Sales, Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales, Table 3.61: Greek POCT Diagnostics Products Market Sales, Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales, Table 3.63: Polish POCT Diagnostics Products Market Sales, Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales, Table 3.65: Czech POCT Diagnostics Products Market Sales, Table 3.66: Turkish POCT Market, Table 3.67: Japanese POCT Market, Table 3.68: Japanese Population and Aging Demographics Forecast, Table 3.69: Indian IVD Market for Instruments and Reagents, Table 3.70: Number of Automated Clinical Labs in India, Table 3.71: Indian IVD Market, Table 3.72: Indian POCT Diagnostics Products Market Sales, Table 3.73: Chinese IVD Market, Table 3.74: Number of Automated Clinical Labs in China, Table 3.75: Chinese IVD Market, Table 3.76: Chinese POCT Diagnostics Products Market Sales, Table 3.77: Rest of the World POCT Market, Table 3.78: Canadian POCT Market, Table 3.79: Brazilian POCT Market, Table 3.80: Australian POCT Market, 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 Table 4.3: Professional Glucose Testing Market for POCT Worldwide Revenue and Forecasts, Table 4.4: U.S. Point of Care Glucose Testing Market, Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 94 Table 4.6: HbA1c Testing Market for POCT Worldwide, 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 TriMark Publications, LLC. All rights reserved. 11

13 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, Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 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, Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, Table 4.19: Coagulation Market for POCT in the U.S., Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 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., Table 4.23: Cardiac Marker Market for POCT Worldwide, Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, Table 4.25: Cardiac Marker Market for POCT in Europe, 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, Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 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, Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 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, Table 4.40: U.S. Point of Care Pregnancy Testing Market, Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 131 Table 4.42: Hemoglobin Testing Market for POCT Worldwide, Table 4.43: Drivers of Demand for HIV Testing 136 Table 4.44: Worldwide POCT Market for HIV, Table 4.45: U.S. POCT Market for HIV, 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, Table 4.49: Infectious Disease Testing Market for POCT Worldwide, Table 4.50: Worldwide Point of Care Influenza Testing Market, Table 4.51: U.S. Point of Care Influenza Testing Market, Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, Table 4.53: Worldwide Point of Care Strep A Testing Market, Table 4.54: U.S. Point of Care Strep A Testing Market, 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, Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, Table 4.58: U.S. Market for MRSA Rapid Testing, Table 4.59: Global Market for Gonorrhea Diagnostic Testing, Table 4.60: Global Market for TB Diagnostic Testing, Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers Ranked in Order of Impact TriMark Publications, LLC. All rights reserved. 12

14 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, 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, 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 TriMark Publications, LLC. All rights reserved. 13

15 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 TriMark Publications, LLC. All rights reserved. 14

16 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 for detailed discussions of important individual market segments related to the POCT market TriMark Publications, LLC. All rights reserved. 15

17 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 TriMark Publications, LLC. All rights reserved. 16

18 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 The overall worldwide in vitro medical diagnostic testing market was $45.1 billion in 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 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 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 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

19 6% to 7% through 2012, estimates suggest that the market for IVDs in the E.U. will reach $20 billion by 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 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 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 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 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

20 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 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 The market for doctor s offices was approximately $25 million in 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 TriMark Publications, LLC. All rights reserved. 19

21 So far, Roche and Siemens are best positioned in this space, with a market share of 68% of glucose testing in 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 TriMark Publications, LLC. All rights reserved. 20