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Table of Contents:
1. Overview 6
1.1 Statement of Report 6
1.2 Scope of the Report 8
1.3 Objectives 9
1.4 Methodology 9
1.5 Executive Summary 9
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 19
2.7.6 Milestones in Technology Development 20
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 26
3.2. U.S. Point of Care Markets 27
3.3. European POCT Market 32
3.4. Japanese POCT Market 35
4. The Place of POCT in Critical Care 36
4.1 Technological Diversity in POCT 36
4.1.1 The Wide Range of Point of Care Assays 36
4.1.2 Challenge of Testing on a Single Platform 39
4.1.3 Connectivity with Testing Platforms 40
4.1.4 Improvement in Clinical Outcomes with Use of POCT 42
4.1.5 Future Developments 42
4.2 Point of Care Addresses Critical Requirements 43
4.2.1 Needs in Critical-Care Testing 43
4.2.2 Point of Care Instrument Key Elements 44
4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access 44
4.2.4 Standardized System for All Testing Locations 45
4.3 POCT Versus Central-Laboratory Testing 47
4.3.1 The Financial Advantages of POCT 47
4.3.2 Is the Shift Towards Point of Care Justified? 47
4.3.3 Overall Cost Benefit 48
4.3.4 More Available Time for Clinical Practitioners 49
4.3.5 Future Policies 49
5. POCT Sector Trends and Forecasts 50
6. Business Trends in the Point of Care Sector 52
6.1 Sector Consolidation 52
6.2 Acquisition, License Agreements, Internal Development and Partnerships 53
6.3 Product Breadth in POCT 54
6.4 Companies Exiting from POCT 54
6.5 Increased Market Penetration 55
6.6 Costs of Doing Business in Europe 56
6.7 Drivers of European Diagnostics Testing 56
6.8 European Reimbursement Practices 56
6.9 Cost Containment in Europe 56
6.10 Significant Factors that Provide Competitive Advantage 57
6.11 Sales and Marketing Strategies for POCT 57
6.11.1 North American Market 57
6.11.2 International Markets 58
6.11.2.1 Europe 59
6.11.2.2 Central and South America 59
6.11.2.3 Asia/Pacific 59
7. Biotechnology Industry Trends 61
7.1 Pharmaceutical Industry Trends 61
7.2 Acquisition, License Agreement and Partnerships 62
8. Government Regulation 65
8.1 Government Regulation 65
8.1.1 U.S. Regulation 65
8.1.1.1 Importing Medical Devices into the U.S. 66
8.1.1.2 Exporting Medical Devices from the U.S. 67
8.1.2 U.K. Regulations 68
8.1.3 E.U. Regulations 69
8.1.4 Japanese Regulations 71
8.1.5 Korean Regulations 71
8.2 Post-Filing Regulations for Point of Care Devices 72
8.3 Exporting Unapproved POCTs 73
8.4 Analyte Specific Reagents (Home-Brew Tests) 73
8.5 Medical Device Registration 73
8.6 Product Labeling 74
8.7 Punitive FDA Actions 74
8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 74
8.9 Impact of Regulations on the Industry 75
8.10 Minimizing Regulatory Barriers 76
9. Limited Reimbursements by Third-Party Payers Obstruct Sales 79
9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 79
9.2 Reimbursement Codes Classification 79
9.3 Point of Care Product Line Reimbursement Picture 80
10. Barriers to Business 81
10.1 Concentration of Customers 81
10.2 Intense Competition from Other Companies 81
10.3 Protection of Intellectual Property Rights 81
10.4 Physician Acceptance 82
10.5 Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth 82
10.6 Additional Applications of Technology Platform 83
10.7 Management of Growth 83
10.8 Difficulty of Establishing a Marketing Infrastructure 83
11. Acquisition Activity 84
11.1 The Ideal Acquisition Profile 84
11.2 Markets of Interest for Acquisition of POCT 84
11.3 Key M&A Steps 84
12. POCT Manufacturers' Corporate Profiles 85
12.1 Abaxis, Inc. 85
12.2 Abbott Diagnostics 86
12.3 Accumetrics, Inc. 89
12.4 Accurex Biomedical, Pvt., Ltd. 90
12.5 ActiMed Diagnostics 90
12.6 Adeza Biomedical Corporation 90
12.7 Akers Bioscience 90
12.8 Ambri, Ltd. 90
12.9 American Biogenetic Sciences, Inc. 91
12.10 American Bio Medica Corp. 91
12.11 Ani Biotech 92
12.12 Apogent Technologies 93
12.13 Ark Therapeutics 94
12.14 Array Medical 94
12.15 Avitar, Inc. 94
12.16 Avox Systems 95
12.17 Axis-Shield 95
12.18 Bayer Corp. 96
12.19 Beacon Diagnostics 98
12.20 Beckman Coulter 99
12.21 Biex, Inc. 102
12.22 Binax Corporation 103
12.23 Biomerica 103
12.24 BioMérieux Vitek, Inc. 103
12.25 BioScan Screening Systems, Inc. 103
12.26 Biosite Diagnostics 103
12.27 BioStar 107
12.28 Bio-Warm Corporation 107
12.29 Caliper Life Sciences 108
12.30 Calypte Biomedical 108
12.31 Cardiovascular Diagnostics 109
12.32 Chembio Diagnostics 110
12.33 ChemTrak 110
12.34 Cholestech 110
12.35 Chongqing Sungene Pharmaceutical Co., Ltd. 111
12.36 CompuCyte Corporation 111
12.37 Cortech, Ltd. 111
12.38 Cozart Bioscience 113
12.39 Cygnus Therapeutic Systems 113
12.40 Cytogen 115
12.41 Dade Behring 115
12.42 Daiichi Co., Ltd. 115
12.43 Denka Seiken Co., Ltd. 115
12.44 Diagnology, Inc. 116
12.45 Diametrics Medical, Inc. 116
12.46 EY Laboratories, Inc. 116
12.47 Enterix, Inc. 116
12.48 First Medical, Inc. 117
12.49 GDS Technology 117
12.50 GenBio 117
12.51 Genzyme Diagnostics 117
12.52 Grant Life Sciences, Inc. 119
12.53 Gryphus Diagnostics, LLC 120
12.54 Helena Laboratories 120
12.55 Hema Diagnostic Systems 120
12.56 HemoCue, Inc. 121
12.57 Home Access Health Corp. 121
12.58 i-STAT Corporation 121
12.59 ImmunoScience, Inc. 122
12.60 Instrumentation Laboratory 122
12.61 International Medical Innovations 123
12.62 Inverness Medical Innovations 123
12.63 Jiangnan Biotech 126
12.64 Johnson & Johnson 126
12.65 Kyowa Medex Co., Ltd. 127
12.66 LifeAssays 127
12.67 LifePoint, Inc. 127
12.68 Lifestream Technologies 130
12.69 LXN Corp. (Inverness Medical Technologies) 130
12.70 Matritech 130
12.71 Medical Services International, Inc. 130
12.72 MediSense 131
12.73 Medisys 131
12.74 Medix Biochemica 131
12.75 MedMira Laboratories 131
12.76 Meretek Corporation 132
12.77 Meridian Bioscience 133
12.78 MiniMed 134
12.79 Mitsubishi Kagaku Iatron 135
12.80 Nanogen 135
12.81 New Horizons Diagnostics 136
12.82 Nova Diagnostics 136
12.83 Optical Sensors, Inc. 138
12.84 OraSure 139
12.85 Orgenics 140
12.86 Orion Diagnostica 140
12.87 PanBio Corp. 141
12.88 PharmaNetics, Inc. 141
12.89 Pharmatech Corporation 141
12.90 Phillips Medical Systems 141
12.91 Point of Care Technologies 142
12.92 Polymedco 142
12.93 Polymer Technology Systems 143
12.94 Princeton BioMeditech Corporation 144
12.95 Quidel 144
12.96 Radiometer 146
12.97 Response Biomedical Corp. 147
12.98 Roche Diagnostics 148
12.99 Royal Philips Electronics 152
12.100 Saliva Diagnostics 152
12.101 Savyon Diagnostics 152
12.102 Selfcare, Inc. 153
12.103 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 153
12.104 Shionogi & Co., Ltd. 153
12.105 SpectRx, Inc. 153
12.106 Spectral Diagnostics 154
12.107 STC Technologies 155
12.108 Sun Biomedical Laboratories 155
12.109 Sybron International Corporation 155
12.110 Taiwan Diagnostic 155
12.111 TCPI 155
12.112 TheraSense, Inc. 157
12.113 Thermo BioStar 157
12.114 Thoratec/International Technidyne Corp. 157
12.115 Transmedica 158
12.116 Trinity Biotech, PLC 158
12.117 Wampole Laboratories 159
12.118 Worldwide Medical Corporation 159
13. FDA Currently-Waived Tests 160
List of Table :
Table 2.1: POCT Frequency in Hospitals 14
Table 2.2: Worldwide Distribution of IVD Testing 16
Table 2.3: Top-Dozen Country IVD Testing Markets 16
Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23
Table 3.1: Number of Emergency Room Visits in U.S. Hospitals, 2000-2008 24
Table 3.2: Number of POCTs in U.S., 2000-2008 24
Table 3.3: The Overall IVD Testing Market Worldwide, 2004 25
Table 3.4: Ten-Largest Diagnostic Companies Worldwide 26
Table 3.5: Global Point of Care Market Size, 1998-2008 27
Table 3.6: Worldwide Distribution of POCT, 2004 27
Table 3.7: U.S. POCT Market, 2000-2011 28
Table 3.8: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2004 28
Table 3.9: U.S. POCT by Distribution Location, 2004 28
Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2004 29
Table 3.11: U.S. POCT Glucose-Testing Market Size, 2003-2011 29
Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2011 30
Table 3.13: U.S. POCT Coagulation Market Size, 2003-2011 30
Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-2011 30
Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2011 31
Table 3.16: U.S. POCT Urinalysis Market Size, 2003-2011 31
Table 3.17: Manufacturer Market Share U.S. POCT Market, 2005 31
Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2005 31
Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2005 32
Table 3.20: Manufacturer Market Share U.S. POCT Coagulation Market, 2005 32
Table 3.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2005 32
Table 3.22: Regional Comparison of GDP, Healthcare and IVD for Eastern Europe 33
Table 3.23: European POCT Market, 2000-2008 34
Table 3.24: European POCT Diagnostics Market, 2004 34
Table 3.25: Top-Dozen Country IVD Testing Markets and Point of Care Share, 2004 34
Table 3.26: Japan POCT Market, 2000-2008 35
Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 41
Table 12.1: Products Marketed by Abbott in the Diagnostic Market, 2003 88
Table 12.2: Quidel Product Sales Distribution, 2003 145
Table 12.3: Key Products 150
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