Point of Care Diagnostic Testing Sector Trends

Point of Care Diagnostic Testing Sector Trends
  • 1. Overview 6
  • 1.1 Statement of Report 6
  • 1.2 Scope of the Report 8
  • 1.3 Objectives 8
  • 1.4 Methodology 8
  • 1.5 Executive Summary 10
  • 2. Overview of Diagnostic Point of Care Testing 11
  • 2.1 Key Issues in the Point of Care Diagnostic Testing Sector 11
  • 2.1.1 Current Market Trends and Drivers 11
  • 2.1.2 Effectiveness of POCT 12
  • 2.1.3 New Growth Areas for POCT 13
  • 2.1.4 Advantages of POCT in a Clinical Setting 13
  • 2.1.5 Pricing and Reimbursement Issues 13
  • 2.1.6 Key Customer Segments 13
  • 2.2 Global Point of Care Marketplace 13
  • 2.3 Shifts from Central Lab Testing to POCT 15
  • 2.4 Geographical Distribution 15
  • 2.5 Emerging New Technologies 16
  • 2.6 Challenges of POCT 17
  • 2.7 Key Issues for POCT 17
  • 2.7.1 Locations of POCT 17
  • 2.7.2 Hospital Lab Rapid Tests 18
  • 2.7.3 Doctor's Office Laboratory 18
  • 2.7.4 Non-Hospital POCT 18
  • 2.7.5 Home Monitoring 18
  • 2.7.6 Milestones in Technology Development 19
  • 2.7.7 Drive for Decentralization from Lab to Patient 20
  • 2.7.8 Expanded Reimbursement 20
  • 2.7.9 Competitive Landscape for POCT 23
  • 2.8 The Future of POCT 23
  • 3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors 24
  • 3.1 Global POCT Market 27
  • 3.2 U.S. Point of Care Markets 28
  • 3.3 European POCT Market 33
  • 3.4 Japanese POCT Market 36
  • 4. The Place of POCT in Critical Care 37
  • 4.1 Technological Diversity in POCT 37
  • 4.1.1 The Wide Range of Point of Care Assays 37
  • 4.1.2 Challenge of Testing on a Single Platform 39
  • 4.1.3 Connectivity with Testing Platforms 41
  • 4.1.4 Improvement in Clinical Outcomes with Use of POCT 43
  • 4.1.5 Future Developments 43
  • 4.2 Point of Care Addresses Critical Requirements 44
  • 4.2.1 Needs in Critical Care Testing 44
  • 4.2.2 Point of Care Instrument Key Elements 45
  • 4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access 45
  • 4.2.4 Standardized System for All Testing Locations 46
  • 4.3 POCT versus Central Laboratory Testing 48
  • 4.3.1 The Financial Advantages of POCT 48
  • 4.3.2 Is the Shift Towards Point of Care Justified? 48
  • 4.3.3 Overall Cost Benefit 48
  • 4.3.4 More Available Time for Clinical Practitioners 49
  • 4.3.5 Future Policies 50
  • 5. POCT Sector Trends and Forecasts 51
  • 6. Business Trends in the Point of Care Sector 53
  • 6.1 Sector Consolidation 53
  • 6.2 Acquisition, License Agreements, Internal Development and Partnerships 54
  • 6.3 Product Breadth in POCT 56
  • 6.4 Companies Exiting From POCT 56
  • 6.5 Increased Market Penetration 56
  • 6.6 Costs of Doing Business in Europe 57
  • 6.7 Drivers of European Diagnostics Testing 57
  • 6.8 European Reimbursement Practices 58
  • 6.9 Cost Containment in Europe 58
  • 6.10 Significant Factors That Provide Competitive Advantage 58
  • 6.11 Sales and Marketing Strategies for POCT 58
  • 6.11.1 North American Market 59
  • 6.11.2 International Markets 60
  • 6.11.2.1 Europe 60
  • 6.11.2.2 Central and South America 60
  • 6.11.2.3 Asia/Pacific 61
  • 7. Biotechnology Industry Trends 62
  • 7.1 Pharmaceutical Industry Trends 62
  • 8. Government Regulation 63
  • 8.1 Government Regulation 63
  • 8.1.1 U.S. Regulation 63
  • 8.1.1.1 Importing Medical Devices into the U.S. 64
  • 8.1.1.2 Exporting Medical Devices from the U.S. 65
  • 8.1.2 U.K. Regulations 65
  • 8.1.3 E.U. Regulations 67
  • 8.1.4 Japanese Regulations 69
  • 8.1.5 Korean Regulations 69
  • 8.2 Post Filing Regulations for Point of Care Devices 70
  • 8.3 Exporting Unapproved POCTs 71
  • 8.4 Analyte Specific Reagents (Home Brew Tests) 71
  • 8.5 Medical Device Registration 71
  • 8.6 Product Labeling 72
  • 8.7 Punitive FDA Actions 72
  • 8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 72
  • 8.9 Impact of Regulations on the Industry 73
  • 8.10 Minimizing Regulatory Barriers 74
  • 8.11 Waived Testing 76
  • 9. Limited Reimbursements by Third-Party Payers Obstruct Sales 77
  • 9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 77
  • 9.2 Reimbursement Codes Classification 77
  • 9.3 Point of Care Product Line Reimbursement Picture 78
  • 10. Barriers to Business 79
  • 10.1 Concentration of Customers 79
  • 10.2 Intense Competition from Other Companies 79
  • 10.3 Protection of Intellectual Property Rights 79
  • 10.4 Physician Acceptance 80
  • 10.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth 80
  • 10.6 Additional Applications of Technology Platform 80
  • 10.7 Management of Growth 81
  • 10.8 Difficulty of Establishing a Marketing Infrastructure 81
  • 11. Acquisition Activity 82
  • 11.1 The Ideal Acquisition Profile 82
  • 11.2 Markets of Interest for Acquisition of POCT 82
  • 11.3 Key M&A Steps 82
  • 12. Company Profiles 83
  • 12.1 Abaxis, Inc. 83
  • 12.2 Abbott Diagnostics 85
  • 12.3 Accumetrics, Inc. 87
  • 12.4 Accurex Biomedical Pvt., Ltd. 88
  • 12.5 Akers Bioscience (ABI) 88
  • 12.6 Alfa Scientific Design, Inc. 89
  • 12.7 Ambri, Ltd. 89
  • 12.8 American Bio Medica Corp. 89
  • 12.9 Ani Biotech 90
  • 12.10 Apogent Technologies 91
  • 12.11 Ark Therapeutics 91
  • 12.12 ARKRAY 91
  • 12.13 Atlas Genetics 92
  • 12.14 Atonomics 92
  • 12.15 Avox Systems 92
  • 12.16 Axis-Shield 92
  • 12.17 Bayer Corp. 93
  • 12.18 Beacon Diagnostics 95
  • 12.19 Beckman Coulter 95
  • 12.20 Binax Corporation 100
  • 12.21 Biomerica 100
  • 12.22 bioMérieux Vitek, Inc. 100
  • 12.23 BioScan Screening Systems, Inc. 100
  • 12.24 Biosite Diagnostics 101
  • 12.25 BioStar 101
  • 12.26 British Biocell Holdings 101
  • 12.27 Caliper Life Sciences 101
  • 12.28 Calypte Biomedical 102
  • 12.29 Cardiovascular Diagnostics 103
  • 12.30 Chembio Diagnostics 103
  • 12.31 Cholestech 104
  • 12.32 CompuCyte Corporation 104
  • 12.33 Cozart Bioscience 104
  • 12.34 Cygnus Therapeutic Systems 104
  • 12.35 Cytogen 104
  • 12.36 Dade Behring 105
  • 12.37 Daiichi Sankyo Group 105
  • 12.38 Denka Seiken Co., Ltd. 105
  • 12.39 Diagnostic Chemicals, Ltd. 105
  • 12.40 EY Laboratories, Inc. 106
  • 12.41 Enterix, Inc. 106
  • 12.42 Focus Diagnostic, Inc. 106
  • 12.43 GDS Technology 106
  • 12.44 GenBio 107
  • 12.45 Genzyme Diagnostics 107
  • 12.46 Grant Life Sciences, Inc. 109
  • 12.47 Gryphus Diagnostics, LLC 109
  • 12.48 Guided Therapeutics, Inc 110
  • 12.49 Helena Laboratories 111
  • 12.50 Hema Diagnostic Systems 111
  • 12.51 HemoCue, Inc. 112
  • 12.52 Home Access Health Corp. 112
  • 12.53 i-STAT Corporation 112
  • 12.54 ImmunoScience, Inc. 113
  • 12.55 Instrumentation Laboratory 114
  • 12.56 International Medical Innovations 114
  • 12.57 Inverness Medical Innovations 114
  • 12.58 Johnson & Johnson 118
  • 12.59 LifeAssays 120
  • 12.60 LifePoint, Inc. 121
  • 12.61 Lifestream Technologies 121
  • 12.62 LXN Corp. (Inverness Medical Technologies) 121
  • 12.63 Matritech 121
  • 12.64 Medical Services International, Inc. 122
  • 12.65 MediSense 122
  • 12.66 Medisys 122
  • 12.67 Medix Biochemica 122
  • 12.68 MedMira Laboratories 123
  • 12.69 Meretek Diagnostics Group 124
  • 12.70 Meridian Bioscience 124
  • 12.71 MiniMed 126
  • 12.72 Mitsubishi Chemical USA, Inc. 127
  • 12.73 Mitsubishi Kagaku Iatron 127
  • 12.74 Nanogen 127
  • 12.75 New Horizons Diagnostics 128
  • 12.76 Nova Biomedical 129
  • 12.77 OraSure 131
  • 12.78 Orgenics 133
  • 12.79 Orion Diagnostica 133
  • 12.80 PanBio, Ltd. 134
  • 12.81 Phamatech Corporation 134
  • 12.82 PharmaNetics, Inc. 134
  • 12.83 Phillips Medical Systems 134
  • 12.84 Polymedco 135
  • 12.85 Polymer Technology Systems 137
  • 12.86 Princeton BioMeditech Corporation 137
  • 12.87 Quest Diagnostics 137
  • 12.88 Quidel 138
  • 12.89 Radiometer 141
  • 12.90 Response Biomedical Corp. 143
  • 12.91 Roche Diagnostics 144
  • 12.92 Royal Philips Electronics 147
  • 12.93 StatSure Diagnostic Systems (Saliva Diagnostics) 148
  • 12.94 Savyon Diagnostics 148
  • 12.95 Selfcare, Inc. 149
  • 12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 149
  • 12.97 Shionogi & Co., Ltd. 149
  • 12.98 Siemens Corporation 150
  • 12.99 Guided Therapeutics (SpectRx, Inc.) 150
  • 12.100 Spectral Diagnostics 151
  • 12.101 StatSure Diagnostics 151
  • 12.102 Strategic Diagnostics 151
  • 12.103 Sun Biomedical Laboratories 152
  • 12.104 Thoratec/International Technidyne Corp. 152
  • 12.105 Trinity Biotech, Plc 153
  • 12.106 Väsamed, Inc. 155
  • 12.107 Venkateshwara Hatcheries Pvt., Ltd. 156
  • 13. FDA Currently Waived Tests 157
  • INDEX OF TABLES
  • Table 2.1: POCT Frequency in Hospitals 14
  • Table 2.2: Worldwide Distribution of IVD Testing in 2008 16
  • Table 2.3: Top Twelve Country IVD Testing Markets, 2007 16
  • Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23
  • Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 24
  • Table 3.2: Number of POCTs in U.S., 2004-2012 25
  • Table 3.3: Overall In Vitro Diagnostic Testing Market Worldwide, 2007 26
  • Table 3.4: Largest Diagnostic Companies Worldwide, 2007 26
  • Table 3.5: Global Point of Care Revenues, 2005-2012 27
  • Table 3.6: Worldwide Distribution of POCT, 2008 27
  • Table 3.7: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 28
  • Table 3.8: U.S. POCT Market, 2000-2012 28
  • Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008 29
  • Table 3.10: U.S. POCT by Performance Location, 2008 29
  • Table 3.11: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 30
  • Table 3.12: U.S. POCT Glucose Testing Market, 2003-2012 30
  • Table 3.13: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012 30
  • Table 3.14: U.S. POCT Coagulation Market Size, 2003-2012 31
  • Table 3.15: U.S. POCT Cardiac Markers Market Size, 2003-2012 31
  • Table 3.16: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012 31
  • Table 3.17: U.S. POCT Urinalysis Market Size, 2003-2012 32
  • Table 3.18: Manufacturer Market Share U.S. POCT Market, 2008 32
  • Table 3.19: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2008 32
  • Table 3.20: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2008 33
  • Table 3.21: Manufacturer Market Share U.S. POCT Coagulation Market, 2008 33
  • Table 3.22: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2008 33
  • Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 34
  • Table 3.24: European POCT Market, 2005-2012 35
  • Table 3.25: European POCT Diagnostics Market, 2007 35
  • Table 3.26: Top Twelve Country IVD and POC Testing Markets, 2007 36
  • Table 3.27: Japan POCT Market, 2005-2012 36
  • Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 42
  • Table 12.1: Products Marketed by Abbott in the Diagnostic Market 86
  • Table 12.2: Quidel Product Sales Distribution and Sales, 2006-2008 139
  • Table 12.3: Key Products 146