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1 TriMark Publications April 2016 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 Markets Key Issues in the POC Diagnostic Testing Sector Current Market Trends and Drivers Effectiveness of POCT New Growth Areas for POCT Advantages of POCT in a Clinical Setting Pricing and Reimbursement Issues Key Customer Segments Global Point of Care Marketplace Shifts from Central Lab Testing to POCT Geographical Distribution Challenges of POCT Key Issues for POCT Locations of POCT Milestones in Technology Development Drive for Decentralization from Lab to Patient Competitive Landscape for POCT The Future of POCT Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share Global POCT Market Global Market Revenues Analysis by Market Segment Global POC Blood Glucose Monitoring Systems Market Global POC Blood Gas and Electrolyte Analyzers Market Global POC Rapid Coagulation Analyzers Market Global POC Cardiac Markers Devices Market Global POC Substance Abuse Testing Device Market Global POC Infectious Disease Testing Device Market Global POC Urine Strip Testing Market Global POC Pregnancy Testing Device Market Global POC Fecal Occult Device Market Global POC Cholesterol Testing Market Global Market Share Analysis Global Market Size by Geographic Location Global Market Size by Analyte Market Segment Global POCT Testing by Location Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share U.S. Market Revenues Analysis by Market Segment U.S. POC Blood Glucose Monitoring Systems Market U.S. POC Blood Gas and Electrolyte Analyzers Market U.S. POC Rapid Coagulation Analyzers Market U.S. POC Cardiac Markers Devices Market U.S. POC Substance Abuse Testing Device Market U.S. POC Infectious Disease Testing Device Market U.S. POC Urine Strip Testing Market U.S. POC Pregnancy Testing Device Market TriMark Publications, LLC. All rights reserved 1

3 4.1.9 U.S. POC Fecal Occult Device Market U.S. POC Cholesterol Testing Market U.S. Market Share Analysis U.S. Market Size by Analyte Market Segment Analysis of the European POCT Market: Value, Growth Rates and Market Shares European Market Revenues Analysis European Market Revenues Analysis by Geographic Region French Revenues for POCT Systems German Revenues for POCT Systems Italian Revenues for POCT Systems Spanish Revenues for POCT Systems U.K. Revenues for POCT Systems Benelux Revenues for POCT Systems Scandinavian Revenues for POCT Systems Rest of Europe Revenues for POCT Systems European Market Revenues Analysis by Market Segment European POC Blood Glucose Monitoring Systems Market European POC Blood Gas and Electrolyte Analyzers Market European POC Rapid Coagulation Analyzers Market European POC Cardiac Marker Market European POC Substance Abuse Testing Device Market European POC Infectious Disease Testing Market European POC Urine Strip Testing Market European POC Pregnancy Testing Device Market European POC Fecal Occult Blood Testing Market European POC Cholesterol Testing Market European Market Share Analysis Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and Market Share Summary Analysis of Japanese, Chinese and Indian POCT Market Revenues Summary of Asian (Japanese, Chinese and Indian) Market Revenues by Market Segment Asian (Japanese, Chinese and Indian) POC Blood Glucose Monitoring Systems Market Asian (Japanese, Chinese and Indian) POC Blood Gas and Electrolyte Analyzers Market Asian (Japanese, Chinese and Indian) POC Rapid Coagulation Analyzers Market Asian (Japanese, Chinese and Indian) POC Cardiac Markers Devices Market Asian (Japanese, Chinese and Indian) POC Substance Abuse Testing Device Market Asian (Japanese, Chinese and Indian) POC Infectious Disease Testing Device Market Asian (Japanese, Chinese and Indian) POC Urine Strip Testing Market Asian (Japanese, Chinese and Indian) POC Pregnancy Testing Device Market Asian (Japanese, Chinese and Indian) POC Fecal Occult Device Market Asian (Japanese, Chinese and Indian) POC Cholesterol Testing Market Asian (Japanese, Chinese and Indian) Market Share Analysis Summary Analysis of the Japanese POCT Market Summary Analysis of the Indian POCT Market Summary Analysis of the Chinese POCT Market Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share Summary Analysis of the ROW POCT Market Revenues Summary of the ROW Market Revenues by Market Segment ROW POC Blood Glucose Monitoring Systems Market ROW POC Blood Gas and Electrolyte Analyzers Market ROW POC Rapid Coagulation Analyzers Market ROW POC Cardiac Markers Devices Market ROW POC Substance Abuse Testing Device Market TriMark Publications, LLC. All rights reserved 2

4 7.2.6 ROW POC Infectious Disease Testing Device Market ROW POC Urine Strip Testing Market ROW POC Pregnancy Testing Device Market ROW POC Fecal Occult Device Market ROW POC Cholesterol Testing Market ROW Market Share Analysis Summary Analysis of the ROW POCT Market Revenues Summary Analysis of the Argentinian POCT Market Summary Analysis of the Australian POCT Market Summary Analysis of the Brazilian POCT Market Summary Analysis of the Canadian POCT Market Summary Analysis of the Russian POCT Market Summary Analysis of the Middle East POCT Market Summary Analysis of the African POCT Market Summary Analysis of the Asia-Pacific POCT Market Review of the Market Segments, Reagents and Equipment Blood Glucose Monitoring Introduction to Blood Glucose Monitoring Types of Blood Glucose Testing Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) Two-Hour Postprandial Blood Sugar or Two-Hour PC Random Blood Sugar (RBS) Glucose Urine Test Blood Glucose Test Strip Glycosylated Hemoglobin (HbA1c) Intravenous Glucose Tolerance Test (IVGTT) Oral Glucose Tolerance Test (OGTT) Segmentation of POC Blood Glucose Testing Continuous Blood Glucose Monitoring (CBGM) Self-Monitoring Blood Glucose (SMBG) Testing Minimally-Invasive and Non-Invasive Blood Glucose Testing Emerging Glucose Monitoring Technologies Optical Transducer Technologies Transdermal Sensor Technologies Invasive Glucose Sensor Technologies Review of Professional POC Blood Glucose Monitoring Systems New Guidance: Use of Blood Glucose Monitoring Systems for Professional and Home POC Review of POC Blood Glucose Monitoring Products Abaxis, Inc Abbott Alere Apex Biotechnology ARKRAY, Inc DiaSys EKF Diagnostics Fora Care HemoCue (part of Radiometer) HMD BioMedical Infopia Instrumentation Laboratory Jant Pharmacal LifeHealth (formerly International Technidyne Corp.) Medtronic Nova Biomedical Polymer Technology Systems TriMark Publications, LLC. All rights reserved 3

5 Radiometer Randox Laboratories Roche Siemens Stanbio Laboratory Techno Medica Co., Ltd LifeScan Professional POC Hemoglobin A1c (HbA1c) Testing A. Menarini Diagnostics Alere Apex Biotechnology Convergent Technologies GmbH & Co DiaSys Diagnostic Systems Diazyme Laboratories EKF Diagnostics Eurolyser Green Cross Medis (formerly Ceragem Medisys) HemoCue (a division of Radiometer) Infopia Roche SD Biosensor Siemens Healthcare Diagnostics Erba Diagnostics Market Analysis Worldwide Professional Glucose Testing Market U.S. Professional Glucose Testing Market Competitive Analysis for the Glucose POCT Sector Market Share for Glucose Testing Competitive Analysis for the Glucose POCT Sector Market Analysis Market Drivers Market Restraints POC Glucose Testing Assay Market and Technology Trends POC Glucose Testing Assay Market Trends POC Glucose Testing Assay Technology Trends POC Glucose Testing Assay Strategic Recommendations Blood Gas and Electrolytes Background to POC Blood Gas and Electrolyte Testing Acid-Base Balance and the Lungs Respiratory Acidosis Respiratory Alkalosis Metabolic (or Non-Respiratory) Acidosis Metabolic (or Non-Respiratory) Alkalosis Increasing Popularity of POC Blood Gas and Electrolyte Testing Market Segmentation (Segmentation by Type of Blood Gas Monitoring Equipment) Intermittent Blood Gas Monitoring Equipment Continuous Blood Gas Monitoring Equipment EABG Monitors IABG Monitors Portable Blood Gas Analyzers Patient-Attached On-Demand Blood Gas Analyzers Applications for POCT Blood Gas and Electrolyte Analyzers Emerging Technologies Whole-Blood Lactate Creatinine Electrolytes Point of Care Analysis: Comparison of POCT and Central Lab Results TriMark Publications, LLC. All rights reserved 4

6 8.2.8 Review of Selected Blood Gas and Electrolyte Analyzers Review of Company Products Roche Corporation Siemens Healthcare Diagnostics Instrumentation Laboratory Nova Biomedical Radiometer Abbott Point of Care Accriva Diagnostics Alere Opti Medical Market Share for Blood Gas and Electrolyte Testing Market Analysis Market Drivers Market Restraints POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends POC Blood Gas and Electrolyte Testing Assay Market Trends POC Blood Gas and Electrolyte Testing Assay Technology Trends POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations Rapid Coagulation Tests Background to Rapid Coagulation Tests Review of Selected POC Rapid Coagulation Analyzers Review of Company Products Roche Diagnostics Corp Abbott Laboratories Accriva Medtronic Alere Helena Laboratories Point of Care Sienco, Inc Instrumentation Laboratory s GEM PCL Plus Connectivity Issues Cost Benefits Quality Control Issues Certification for POC Coagulation Devices D-Dimer Testing Market Analysis Market Share for POCT Coagulation Testing Competitive Analysis of Sector Companies Market Drivers Market Restraints POC Coagulation Testing Assay Market Trends POC Coagulation Testing Assay Technology Trends POC Coagulation Testing Assay Strategic Recommendations SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market POC Rapid Cardiac Markers Background to POC Rapid Cardiac Marker Testing Cardiac Marker Tests Creatine Kinase (CK) Myoglobin Cardiac Troponins T (TnT), I (TnI) and C (TnC) C-Reactive Protein (CRP) Homocysteine Emerging Markers B-Type Natriuretic Peptide (BNP) TriMark Publications, LLC. All rights reserved 5

7 Myeloperoxidase (MPO) Ischemia-Modified Albumin (IMA) Glycogen Phosphorylase Isoenzyme BB (GPBB) Fatty Acid-Binding Proteins (FABPs) Review of Selected POC Cardiac Biomarker Analyzers Review of Company Products Abbott s i-stat System Alere s Triage System Alpha Scientific Boditech Med s i-chroma System BTNX Homemed LSI Medience (formerly Mitsubishi Chemical Medience Corp.) Nano-Ditech Princeton BioMeditech Radiometer (part of Danaher) Response Biomedical Corporation Roche Diagnostics cobas h 232 POC System Roche s CARDIAC TROP T Sensitive Test (Visual) Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation and Dade Behring) Trinity Biotech Trivitron Healthcare (formerly Ani Biotech) biomérieux Market Share and Sales for Cardiac Marker Testing Market Drivers Market Restraints POC Cardiac Marker Testing Assay Market and Technology Trends POC Cardiac Marker Testing Assay Market Trends POC Cardiac Marker Testing Assay Technology Trends POC Cardiac Marker Testing Assay Strategic Recommendations POCT Substance Abuse Testing Background to POC Substance Abuse Testing Substance Abuse Test Types Urine Substance/Drug Screening Hair Tests for Substance Abuse and Screening Blood Tests for Substance Abuse and Screening Saliva Tests for Substance Abuse and Screening Sweat Tests for Substance Abuse and Screening Alcohol Abuse and Screening Saliva Testing Qualitative Analysis Market Drivers Market Restraints Review of Selected POC Substance Abuse Analyzers Review of Company Products Alere Abbott Diagnostics BTNX, Inc BioScan Screening Systems, Inc American Bio Medica Corp Phamatech, Inc First Check Diagnostics Corp. (Alere, Inc.) OraSure Noble Medical, Inc Guangzhou Wondfo Biotech Co., Ltd TriMark Publications, LLC. All rights reserved 6

8 Pathtech Alfa Scientific Designs, Inc American Bio Medica Biophor Diagnostics Randox Laboratories Branan Medical Concateno LifeSign POC Pregnancy and Fertility Tests Background to POC Pregnancy and Fertility Tests Review of Selected POC Pregnancy Testing Devices Review of Company Products Quidel Abbott Diagnostics Alere Sutherland Health Group Ltd Sekisui Diagnostics, LLC Siemens Diagnostics Orgenics (A subsidiary of Alere) LifeSign Other Companies in this Sector Market Analysis Competitive Sector Analysis Fecal Occult Blood Background to POC Fecal Occult Blood Testing Review of Selected POC Fecal Occult Testing Devices Review of Company Products Helena Laboratories Biomerica Beckman Coulter Worldwide Medical Aerscher Diagnostics Enterix Medix Biochemica Orion Diagnostica ACON Laboratories Mission FOB Reagent Strips Alere s Products Immunostics Hema-Screen Princeton BioMeditech s BioSign ifobtest Quest Diagnostics InSure FIT Quidel s QuickVue ifob Exact Sciences Cologuard Epigenomics CTK Biotech Market Share for Fecal Occult Blood Testing Company Analysis for the Fecal Occult Blood POCT Sector Market Analysis Market Drivers Market Restraints POC Fecal Occult Blood Testing Assay Market and Technology Trends POC Fecal Occult Blood Testing Assay Market Trends Fecal Occult Blood Testing Assay Technology Trends POC Fecal Occult Blood Testing Assay Strategic Recommendations POC Infectious Disease Testing Background to POC Infectious Disease Testing Types of Diagnosis for Infectious Diseases TriMark Publications, LLC. All rights reserved 7

9 Microbial Culture Microscopy Biochemical Tests Immunologic Tests Molecular Diagnostics Testing Diagnostic Platforms for Infectious Diseases Centralized Laboratory Testing for Infectious Diseases POC Testing for Infectious Diseases Emerging Technologies Market Analysis Market Drivers Market Restraints Review of Selected POC Infectious Disease Testing Devices POC Infectious Disease Testing Devices and Assays in Development Cepheid s GeneXpert Omni Alere q Quidel Roche s cobas Liat System QuantuMDx s Q-POC SRI International Atlas Genetics io System Overview of POC Assays for Detection of Infectious Disease Anthrax and Other Bio-threats Campylobacter Clostridium difficile E. coli Gastrointestinal Infectious Agents Giardia and Cryptosporidium Entamoeba histolytica Rotavirus & Adenovirus Norovirus Hepatitis Herpes Simplex Virus Type Influenza Legionella Malaria Testing Meningitis Mononucleosis Procalcitonin (Detects Sepsis) Respiratory Tract Infections C-Reactive Proteins Pneumonia Respiratory Tract Panels RSV Streptococcus Rubella Sexually-Transmitted Diseases Chlamydia Gonorrhea Testing Syphilis Staphylococcus aureus and MRSA Streptococcus A Testing Tropical Diseases Chagas Disease Dengue Fever Ebola TriMark Publications, LLC. All rights reserved 8

10 Filariasis Onchocerciasis Zika Virus Tuberculosis Typhoid POC Urine Strip Testing Background to POC Urine Strip Testing Emerging Technologies Review of Selected POC Urine Strip Testing Devices POC Cholesterol Testing POC Cholesterol Testing Market Size and Development Background to POC Cholesterol Testing POC Cholesterol Testing Devices Review of Selected POC Cholesterol Testing Devices Review of Company Products Cholestech (Now Alere) Polymer Technology Systems Miraculins Abaxis, Inc Product Comparison of Leading Suppliers Launch Dates of Leading Products Worldwide Miscellaneous POC Tests Estriol POC H. pylori Testing Bacterial Contamination of Platelet Units POC Vaginal Fluid ph and Vaginitis Testing POC Cancer Testing Prostate-Specific Antigen (PSA) Bladder Cancer Other Rapid Cancer Tests Fetal Status (PROM) Hemodynamic Monitoring Heparin-Induced Thrombocytopenia Ruptured Fetal Membranes Alcohol Microalbumin Testing Prenatal, Labor and Delivery Testing Alere Triage PLGF Medix Biochemica Sperm Fertility Surgical Coagulation and Hemostasis Management Respiratory Tests C-Reactive Protein HIV FDA-Approved Rapid HIV Assays Alere biolytical Laboratories, Inc Bio-Rad Laboratories Chembio Diagnostics MedMira Laboratories, Inc OraSure Technologies Trinity Biotech Rapid HIV Assays Not Approved by the FDA (not commercially available in the U.S.) Alere biomérieux Bio-Rad TriMark Publications, LLC. All rights reserved 9

11 Core Diagnostics CTK Biotech EY Laboratories Hema Diagnostics Systems ImmunoScience InTec Products JAL Innovation J Mitra & Co Premier Medical Corporation Princeton BioMeditech Savyon Diagnostics Shanghai Kehua Span Diagnostics Tulip Group YD Diagnostics AIDScan POC Viral Load Technologies of the Future Cepheid Roche Wave 80 Biosciences 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 POC for Patient Care Benefits of POCT Cost Elements of POCT Necessary Functions in POCT Turnaround Time (TAT) for POCT Clinical Laboratory Improvement Amendments (CLIA) Sexually-Transmitted Diseases in Underdeveloped Countries Sources of Error in POC Testing Business Trends in the POC 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 TriMark Publications, LLC. All rights reserved 10

12 E.U. Regulation Japanese Regulation Post-Filing Regulations for POC Devices Exporting Unapproved POCTs Analyte-Specific Reagents ( Home-Brew Tests) Medical Device Registration Product Labeling Punitive FDA Actions CLIA 88 and State Laboratory Laws Impact of Regulations on the Industry Minimizing Regulatory Barriers Waived Testing Technology Platform Innovations in POCT Latest POCT Technological Platforms Device Miniaturization and Microfluidic Technologies Minimally-Invasive and Non-Invasive POCT Technologies Libre Flash Glucose Monitor and OneTouch Verio Sync Meter Echo Therapeutics Advances in Wireless Technologies Automation of POCT Developments in New Genomic Technologies (Genotyping, Haplotyping and Sequencing Technologies) Advances in Informatics Technologies Pharmacogenetic Testing Multi-Assay Technologies in POCT Molecular Diagnostic Technology in POCT for Infectious Disease Smart Phone Technology Aquila Diagnostic Systems, Inc AgaMatrix Quick HIV and Syphilis Screening Accu-Check Connect System QuantuMDx Handheld, Portable Low Cost Rapid Devices Data Management and Connectivity Wireless LANs Connectivity Platforms Data Management Systems Alere RALS System International Technidyne Corporation HEMOCHRON Signature Elite Siemens Diagnostics Rapidpoint Radiometer HemoCue s DM Hemoglobin Roche Diagnostics Cobas IT Accriva BD.id Medical Implant Communications Service (MICS) Conworx Technology Telcor QML Medasys NoemaLife Telcare Advantages of POCT Connectivity Cost-Benefit Analysis of POCT and IT Connectivity Hospital Network Issues TriMark Publications, LLC. All rights reserved 11

13 13. Corporate Profiles Abaxis, Inc Abbott Laboratories AccuBioTech Co., Ltd Accriva Diagnostics ACON Laboratories, Inc Acrongenomics AgaMatrix Aerscher Diagnostics, LLC Akers Biosciences, Inc Alere Alfa Scientific Designs, Inc American Bio Medica Corporation Arkray, Inc Atlas Genetics Ltd Atonomics A/S Audit Diagnostics Augurix Diagnostics Ltd Axxin Beckman Coulter (Danaher Corporation) biolytical Laboratories Biomerica, Inc biomérieux BiOracle Bio-Rad Laboratories, Inc BioScan Screening Systems, Inc Calypte Biomedical Corporation Chembio Diagnostic, Inc Cholestech Claros Diagnostics (OPKO Healthcare) ERBA Diagnostics, Inc Daktari Diagnostics Dexcom Diagnostics for All Enigma Diagnostics Ltd EY Laboratoires, Inc Eurotrol Exalenz Bioscience GenBio Guided Therapeutics, Inc Helena Laboratories Hema Diagnostic Systems, LLC Instrumentation Laboratory (IL)/Werfen Group Jant Pharmacal Corporation Lein Applied Diagnostics LifeSign, LLC Medica Corporation Medix Biochemica MedMira Laboratories A. Menarini Diagnostics Micronics New Horizons Diagnostics Nova Biomedical OraSure Technologies, Inc Orion Diagnostica Polymedco, Inc TriMark Publications, LLC. All rights reserved 12

14 13.56 Polymer Technology Systems, Inc Prima Biomedical Company Qualigen Quest Diagnostics, Inc Quidel Corporation Radiometer Medical Response Biomedical Corp Roche Diagnostics Savyon Diagnostics Seegene Sekisui Diagnostics, LLC Shanghai Ruicare Medical Co., Ltd Shenzhen Fitconn Technology Co., Ltd Shionogi & Co., Ltd Siemens AG Siloam Biosciences, Inc Spectral Diagnostics, Inc StatSure Diagnostic Systems, Inc One Step Detect Associates, LLC Senseonics Telcare Trinity Biotech Plc Väsamed, Inc 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 the Central Laboratory Healthcare Cost Controls Mergers & Acquisitions Competition for Services Drivers of POCT Confluence of New Technology Difficulties of Design for POC Products Point of Care Compliance The Biggest New Opportunities in POCT New Entrants to the Point of Care Market Alliance International Co., Ltd Analyticon Biotechnologies AG Ativa Medical Corporation Aquila Diagnostic Systems, Inc ArcDia International Oyo Ltd Artron Laboratories, Inc Atlas Link Biotech Co., Ltd Audit Diagnostics Autobio Diagnostics Co., Ltd Biocartis SA BioFire Diagnostics, Inc BioMedomics TriMark Publications, LLC. All rights reserved 13

15 15.13 Biosensia Ltd Curetis AG DxNA, LLC Echo Therapeutics, Inc Gentag, Inc Great Basin Corporation Immunexpress Group Integrated Diagnostics Integrity Applications MBio Diagnostics, Inc Menssana Research, Inc Metaara Medical Technologies, Inc QuantuMDx Group Venaxis, Inc Philips Business Group EBA Wave 80 Biosciences Veredus Laboratories Pte Ltd. 449 INDEX OF FIGURES Figure 2.1: Worldwide Distribution of IVD Testing, Figure 2.2: Top 13 Country IVD Testing Markets, Figure 2.3: Market Share for IVD Testing by Company, Figure 3.1: Total Global POCT Market, Figure 3.2: Worldwide Distribution of POCT, Figure 3.3: Summary of Global POCT Markets by Market Segment, Figure 4.1: U.S. Revenues for POCT Market, Figure 4.2: Summary of U.S. POCT Markets by Market Segment, Figure 5.1: European Revenues for POCT Market, Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, Figure 6.2: Japanese Revenues for POCT Market, Figure 6.3: Indian Revenues for POCT Market, Figure 6.4: Chinese Revenues for POCT Market, Figure 7.1: Summary Analysis of ROW POCT Market, Figure 7.2: Summary Analysis of Russian Revenues for POCT Products Market, Figure 7.3: Summary Analysis of Middle East Revenues for POCT Products Market, Figure 7.4: Summary Analysis of African Revenues for POCT Products Market, Figure 7.5: Summary Analysis of Latin America Revenues for POCT Products Market, Figure 8.1: Global Share of Glucose Testing Market by Company, Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, Figure 8.3: Global POCT Share of Coagulation Testing Market, Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, Figure 8.5: Distribution of Infectious Diseases Tested at the Point of Care 259 Figure 8.6: Global POCT Share of HIV Testing Market, Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 342 Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category 360 Figure 12.1: The Alere RALS Data Management System Connects to Most of the Major Instruments Used in Point of Care 385 INDEX OF TABLES Table 2.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2015 and Table 2.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2015 and TriMark Publications, LLC. All rights reserved 14

16 Table 2.3: Summary of European POCT Markets by Major Market Sub-Segment, 2015 and Table 2.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2015 and Table 2.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2015 and Table 2.6: Worldwide Distribution of IVD Testing, Table 2.7: Top 13 Country IVD Testing Markets, Table 2.8: Company Market Share for IVD Testing Markets, Table 2.9: Competitive Landscape for POC Diagnostic Testing 42 Table 3.1: Total Global POCT Market, Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers, Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, Table 3.5: Global Revenues for POC Cardiac Marker Devices, Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market, Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market, Table 3.8: Global Revenues for POC Urine Strip Testing Products Market, Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market, Table 3.11: Global Revenues for POC Cholesterol Testing Products Market, Table 3.12: Global POCT Market Share Analysis, Table 3.13: Worldwide POCT Market Size by Geographic Location, Table 3.14: Worldwide Distribution of POCT, Table 3.15: Summary of Global POCT Markets by Market Segment, Table 3.16: Worldwide POCT by Performance Location, Table 4.1: U.S. Revenues for POCT Market, Table 4.2: U.S Revenues for POC Blood Glucose Monitoring Systems, Table 4.3: U.S. Revenues for POC Blood Gas and Electrolyte Analyzers, Table 4.4: U.S. Revenues for POC Rapid Coagulation Analyzer Systems, Table 4.5: U.S. Revenues for POC Cardiac Marker Devices, Table 4.6: Market Share of U.S. POCT Cardiac Marker Market, Table 4.7: U.S. Revenues for POC Substance/Drug Abuse Testing Device Market, Table 4.8: U.S. Revenues for POC Infectious Disease Testing Devices Market, Table 4.9: U.S. Revenues for POC Urine Strip Testing Products Market, Table 4.10: U.S. Revenues for POC Pregnancy Testing Devices Market, Table 4.11: U.S. Revenues for POC Fecal Occult Testing Devices Market, Table 4.12: U.S. Revenues for POC Cholesterol Testing Products Market, Table 4.13: U.S. POCT Market Share Analysis, Table 4.14: Summary of U.S. POCT Markets by Market Segment, Table 5.1: Models of Public-Private Partnership in Hospital Provision 67 Table 5.2: European Revenues for POCT Market, Table 5.3: French Revenues for POCT Systems, Table 5.4: German Revenues for POCT Systems, Table 5.5: Italian Revenues for POCT Systems, Table 5.6: Spanish Revenues for POCT Systems, Table 5.7: U.K. Revenues for POCT Systems, Table 5.8: Benelux Revenues for POCT Systems, Table 5.9: Scandinavian Revenues for POCT Systems, Table 5.10: Rest-of-Europe Revenues for POCT Systems, Table 5.11: European Revenues for POC Blood Glucose Monitoring Systems, Table 5.12: European Revenues for POC Blood Gas and Electrolyte Analyzers, Table 5.13: European Revenues for POC Rapid Coagulation Analyzer Systems, Table 5.14: European Revenues for POC Cardiac Markers, Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Market, Table 5.16: European Revenues for POC Infectious Disease Testing Market, Table 5.17: European Revenues for POC Urine Strip Testing Products Market, Table 5.18: European Revenues for POC Pregnancy Testing Market, Table 5.19: European Revenues for POC Fecal Occult Blood Testing Market, TriMark Publications, LLC. All rights reserved 15

17 Table 5.20: European Revenues for POC Cholesterol Testing Products Market, Table 5.21: European Market Share Analysis, Table 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, Table 6.2: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Glucose Monitoring Systems, Table 6.3: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Gas and Electrolyte Analyzers, Table 6.4: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Rapid Coagulation Analyzer Systems, Table 6.5: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cardiac Marker Devices, Table 6.6: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Substance/Drug Abuse Testing Device Market, Table 6.7: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Infectious Disease Testing Devices Market, Table 6.8: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Urine Strip Testing Products Market, Table 6.9: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Pregnancy Testing Devices Market, Table 6.10: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Fecal Occult Testing Devices Market, Table 6.11: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cholesterol Testing Products Market, Table 6.12: Summary Analysis of Japanese, Chinese and Indian Market Shares, Table 6.13: Japanese Population and Aging Demographics Forecast, Table 6.14: Japanese Revenues for POCT Market, Table 6.15: Indian Revenues for POCT Market, Table 6.16: Chinese Revenues for POCT Market, Table 7.1: Summary Analysis of ROW POCT Market, Table 7.2: Summary Analysis of ROW Revenues for POC Blood Glucose Monitoring Systems, Table 7.3: Summary Analysis of ROW Revenues for POC Blood Gas and Electrolyte Analyzers, Table 7.4: Summary Analysis of ROW Revenues for POC Rapid Coagulation Analyzer Systems, Table 7.5: Summary Analysis of ROW Revenues for POC Cardiac Marker Devices, Table 7.6: Summary Analysis of ROW Revenues for POC Substance/Drug Abuse Testing Device Market, Table 7.7: Summary Analysis of ROW Revenues for POC Infectious Disease Testing Devices Market, Table 7.8: Summary Analysis of ROW Revenues for POC Urine Strip Testing Products Market, Table 7.9: Summary Analysis of ROW Revenues for POC Pregnancy Testing Devices Market, Table 7.10: Summary Analysis of ROW Revenues for POC Fecal Occult Testing Devices Market, Table 7.11: Summary Analysis of ROW Revenues for POC Cholesterol Testing Products Market, Table 7.12: Summary Analysis of ROW Market Shares, Table 7.13: Summary Analysis of Argentinian Revenues for POCT Products Market, Table 7.14: Summary Analysis of Australian Revenues for POCT Products Market, Table 7.15: Summary Analysis of Brazilian Revenues for POCT Products Market, Table 7.16: Summary Analysis of Canadian Revenues for POCT Products Market, Table 7.17: Summary Analysis of Russian Revenues for POCT Products Market, Table 7.18: Summary Analysis of Middle East Revenues for POCT Products Market, Table 7.19: Summary Analysis of African Revenues for POCT Products Market, TriMark Publications, LLC. All rights reserved 16

18 Table 7.20: Summary Analysis of Asia (Other) Revenues for POCT Products Market, Table 7.21: Summary Analysis of Latin America (Other) Revenues for POCT Products Market, Table 8.1: Selected POC Blood Glucose and Blood Gas Meters Marketed for Professional Use, Table 8.2: POC HbA1c Testing Devices and Assays on the Market 143 Table 8.3: Global Revenues for Total Professional Blood Glucose Monitoring (Central Laboratory Testing and Hospital POC and POL), Table 8.4: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 150 Table 8.5: Global Share of Glucose Testing Market by Company, Table 8.6: Selected POC Blood Gas and Electrolyte Analyzers, Table 8.7: Market Share of Blood Gas and Electrolyte POCT Diagnostic Testing Companies Worldwide, Table 8.8: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Blood Gas and Electrolyte POC Market 170 Table 8.9: Hospital Locations of Point of Care Coagulation Testing 172 Table 8.10: Selected POC Rapid Coagulation Analyzers, Table 8.11: Actalyke XL 185 Table 8.12: Actalyke Mini 185 Table 8.13: Connectivity Modes for Leading Coagulation POCT Analyzers 187 Table 8.14: Market Share for Coagulation POCT Diagnostic Testing Companies, Table 8.15: Drivers for Point of Care Coagulation Testing 192 Table 8.16: Barriers for Point of Care Coagulation Testing 192 Table 8.17: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 193 Table 8.18: Selected POC Cardiac Biomarkers, Table 8.19: Market Share of Cardiac Marker POCT Diagnostic Testing Companies Worldwide, Table 8.20: POC Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 214 Table 8.21: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 215 Table 8.22: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Cardiac Marker POC Market 216 Table 8.23: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 223 Table 8.24: Stat Urine Testing Drug Recommendations 223 Table 8.25: Selected POC Substance/Drug Abuse Testing Devices, Table 8.26: Selected POC Pregnancy Testing Devices, Table 8.27: Selected POC Fecal Occult Testing Devices, Table 8.28: ColoCARE Fecal Occult Blood Test 249 Table 8.29: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Fecal Occult Blood POC Market 254 Table 8.30: Selected POC Infectious Disease Testing Devices and Assays, Table 8.31: Influenza Diagnostic Rapid Tests 274 Table 8.32: Selected POC Urine Strip Testing, Table 8.33: Selected POC Cholesterol Testing Devices, Table 8.34: AmniSure 318 Table 8.35: Competitive Factors Related to HIV Tests 321 Table 8.36: Global POCT Market for Rapid HIV Testing, Table 8.37: Global POCT Share of HIV Testing Market, Table 8.38: Rapid HIV Immunoassay Tests 324 Table 9.1: POCT1-Compliant Connectivity POC Instruments 340 Table 9.2: POCT Clinical Outcomes in Diabetic Ketoacidosis 342 Table 9.3: POCT Clinical Outcomes in Arterial Blood-Gas Measurements 342 Table 9.4: POCT in Three Hospitals Cost Analysis with Labor Included 345 Table 9.5: POCT versus Central Lab Cost Analysis for Glucose Testing 345 Table 11.1: Common Genotype Techniques 375 Table 12.1: Applications for Wireless LAN Technology 381 Table 12.2: Customized Reports Must Support CAP and JCAHO Requirements TriMark Publications, LLC. All rights reserved 17

19 Table 14.1: Improvements in Achieving ED Operational Efficiency Using POCT 433 Table 14.2: Test Menu and TAT for ED 434 Table 14.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 434 Table 14.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 435 Table 14.5: Estimates of Patient Costs by DRG TriMark Publications, LLC. All rights reserved 18

20 1. Overview Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care (POC) facility where results can be obtained immediately rather than waiting hours or even days for outside lab results to arrive. POCT covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes the POC testing segment of the diagnostic market. An analysis of analytes that are related to the common chemical constituents of blood, plasma/serum, urine and other body fluids at the point of care of the patient are addressed. The two most important areas where such tests are measured for immediate results in a POC setting are hospital emergency rooms and critical-care clinics. The third place where these tests are frequently measured in what is characterized as a near-patient setting is in physician s office labs (POLs). Other testing areas of interest for these analytes are satellite labs, critical-care units, neonatal intensive-care units (NICUs), intensive-care units (ICUs) and home testing locations. Home testing is not directly covered in this report except in cases when the products and companies in this market segment are also actively used in the hospital and physician s office POC settings. This report also examines the subsections of each POC market segment, including: glucose, blood gases, coagulation, cardiac markers, drugs of abuse, infectious disease and many others. Additionally, rapid detection of infectious pathogens (methicillin-resistant Staphylococcus aureus [MRSA], herpes simplex, avian flu, West Nile virus [WNV] and typhoid) is discussed. This examination of POCT focuses on the POC segments in important worldwide markets, such as the U.S., Japanese, European, Asian and Rest-of-the-World (ROW) markets. An extensive review of POCT in this report includes the market for clinical equipment and supplies as well as the market for screening reagents and instruments for analysis of individual components in blood, serum, urine and other body fluids. This report defines the dollar volume of sales, for both worldwide and U.S. markets, and it analyzes the factors that influence the size and the growth of the individual market segments. Most of the companies known to be developing instruments and reagents for the clinical POC market are examined in this study. Each company is discussed in depth with a section on the history of the company, the product line, a business and marketing analysis and a subjective commentary of the position of the company in its market. 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 (the emergency department and the critical-care section). Another important place where these tests are measured is in POLs. Newer testing areas of interest for these analytes are satellite labs, corporate facilities, law enforcement agencies and home testing locations. This report s emphasis is on companies 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: For the general point of care testing market: The size of the market and distribution between different market segments. The expected growth over the next five years within each market segment. A comprehensive overview of the main POCT players. What kind of instruments do they have and what is range of analysis? Which analysis in POCT is expected to experience exceptional growth going forward? 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 POC tests, from their basic principles to their clinical applications TriMark Publications, LLC. All rights reserved 19

21 Discovering feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, emphasizing the biggest and expanding markets. Focusing on global industry development through an in-depth analysis of the major world markets for POC technology, including growth forecasts. Presenting POCT market figures regarding the market s current value, market projections, market share, key players and sector growth rates. This information is the most currently available data derived from the global diagnostic industry. This study contains: A detailed analysis of recent trends in the POC marketplace. In-depth profiles of the leading companies with POC tools and technologies. A forecast for the POC market and diagnostic segments thereof. Views and predictions on the POC industry from leading industry experts. An analysis of potential new POC applications in the clinical sector. Market predictions and trends analysis concerning U.S. expenditures on POC solutions. Projections of POC market sizes for European and Asian markets. Projections for future applications of molecular diagnostic tests in POC-related screening. Analysis of commercial POC business strategies. The latest news and mergers and acquisitions (M&As) developments in the POC marketplace. A comprehensive overview of and insight into POC business strategies. An in-depth examination of the subsections of each market segment, including the POLs and clinic testing. 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 POC market drivers and bottlenecks from medical and scientific community perspectives. Discuss the potential benefits of POC for various sectors of the medical and scientific community. Establish the current total market size and future growth of the POC 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 POC market. The following questions will also be addressed in this analysis: What are the near-term business opportunities in the POCT market? What are the current and forecasted POCT market sizes in the U.S., the European Union (E.U.), Japan and other key country markets? What are the business models currently used by companies in the POCT market? How will stakeholders like manufacturers, regulators, physicians and patients influence this market? What are the drivers and restraints influencing the POCT market? What are the important technologies used in POCT? Who holds the proprietary rights to the POCT market technology platforms? In the U.S., Japan and the E.U., what regulatory processes apply to POCT technologies? How will new POC technologies change diagnostic screening testing paradigms? How will new POC technologies reduce healthcare expenditures and affect R&D spending? The report contains: A comprehensive overview of the several categories of POC technology platforms that are or will be revolutionizing the use of diagnostic tests in hospitals TriMark Publications, LLC. All rights reserved 20