Point of Care Diagnostic Testing Sector Trends

Point of Care Diagnostic Testing Sector Trends

The purpose of this TriMark Publications report is to describe the sector trends within the point of care testing (POCT) diagnostic market. It examines those measurement devices and their reagents and supplies that are utilized in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the purpose of diagnosis and monitoring of disease. This study includes all of the generally-accepted clinical analytical activities that are currently in use today. Additionally, an analysis of business and technology trends and developing areas of point of care and HPV testing is provided, along with a review of the market for point of care testing equipment and supplies in the clinical and research market segments, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. This report defines U.S. and global market dollar sales volume and analyzes factors that influence the size and growth of market segments.

- Abaxis, Inc.
- Abbott Diagnostics
- Accumetrics, Inc.
- Accurex Biomedical, Pvt., Ltd.
- Akers Bioscience (ABI)
- Alfa Scientific Design, Inc.
- Ambri, Ltd.
- American Bio Medica Corp.
- Ani Biotech
- Apogent Technologies
- Ark Therapeutics
- ARKRAY
- Atlas Genetics
- Atonomics
- Avox Systems
- Axis-Shield
- Bayer Corp.
- Beacon Diagnostics
- Beckman Coulter
- Binax Corporation
- Biomerica
- BioMérieux Vitek, Inc.
- BioScan Screening Systems, Inc.
- Biosite Diagnostics
- BioStar
- British Biocell Holdings
- Caliper Life Sciences
- Calypte Biomedical
- Cardiovascular Diagnostics
- Chembio Diagnostics
- Cholestech
- CompuCyte Corporation
- Cozart Bioscience
- Cygnus Therapeutic Systems
- Cytogen
- Dade Behring
- Daiichi Sankyo Group
- Denka Seiken Co., Ltd.
- Diagnostic Chemicals, Ltd.
- EY Laboratories, Inc.
- Enterix, Inc.
- Focus Diagnostic, Inc.
- GDS Technology
- GenBio
- Genzyme Diagnostics
- Grant Life Sciences, Inc.
- Gryphus Diagnostics, LLC
- Guided Therapeutics, Inc
- Helena Laboratories
- Hema Diagnostic Systems
- HemoCue, Inc.
- Home Access Health Corp.
- i-STAT Corporation
- ImmunoScience, Inc.
- Instrumentation Laboratory
- International Medical Innovations
- Inverness Medical Innovations
- Johnson & Johnson
- LifeAssays
- LifePoint, Inc.
- Lifestream Technologies
- LXN Corp. (Inverness Medical Technologies)
- Matritech
- Medical Services International, Inc.
- MediSense
- Medisys
- Medix Biochemica
- MedMira Laboratories
- Meretek Diganostics Group
- Meridian Bioscience
- MiniMed
- Mitsubishi Chemical USA, Inc.
- Mitsubishi Kagaku Iatron
- Nanogen
- New Horizons Diagnostics
- Nova Biomedical
- OraSure
- Orgenics
- Orion Diagnostica
- PanBio, Ltd.
- Phamatech Corporation
- PharmaNetics, Inc.
- Phillips Medical Systems
- Polymedco
- Polymer Technology Systems
- Princeton BioMeditech Corporation
- Quest Diagnostics
- Quidel
- Radiometer
- Response Biomedical Corp.
- Roche Diagnostics
- Royal Philips Electronics
- Saliva Diagnostics
- Savyon Diagnostics
- Selfcare, Inc.
- Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
- Shionogi & Co., Ltd.
- Siemens Corporation
- SpectRx, Inc.
- Spectral Diagnostics
- StatSure Diagnostics
- STC Technologies
- Strategic Diagnostics
- Sun Biomedical Laboratories
- Sybron International Corporation
- TheraSense, Inc.
- Thermo BioStar
- Thoratec/International Technidyne Corp.
- Trinity Biotech, PLC
- Väsamed, Inc.
- Venkateshwara Hatcheries Pvt., Ltd.
- Wampole Laboratories
- Worldwide Medical Corporation

1. Overview 6
1.1 Statement of Report 6
1.2 Scope of the Report 8
1.3 Objectives 8
1.4 Methodology 9
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 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 33
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 55
6.4 Companies Exiting from POCT 55
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 57
6.9 Cost Containment in Europe 57
6.10 Significant Factors that Provide Competitive Advantage 57
6.11 Sales and Marketing Strategies for POCT 58
6.11.1 North American Market 58
6.11.2 International Markets 59
6.11.2.1 Europe 59
6.11.2.2 Central and South America 60
6.11.2.3 Asia/Pacific 60

7. Biotechnology Industry Trends 61
7.1 Pharmaceutical Industry Trends 61
7.2 Acquisition, License Agreement and Partnerships 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 66
8.1.3 E.U. Regulations 67
8.1.4 Japanese Regulations 69
8.1.5 Korean Regulations 70
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 72
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

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 Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth 80
10.6 Additional Applications of Technology Platform 81
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. 88
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 91
12.10 Apogent Technologies 91
12.11 Ark Therapeutics 91
12.12 ARKRAY 92
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. 101
12.23 BioScan Screening Systems, Inc. 101
12.24 Biosite Diagnostics 101
12.25 BioStar 101
12.26 British Biocell Holdings 101
12.27 Caliper Life Sciences 102
12.28 Calypte Biomedical 103
12.29 Cardiovascular Diagnostics 104
12.30 Chembio Diagnostics 104
12.31 Cholestech 104
12.32 CompuCyte Corporation 104
12.33 Cozart Bioscience 104
12.34 Cygnus Therapeutic Systems 105
12.35 Cytogen 105
12.36 Dade Behring 105
12.37 Daiichi Sankyo Group 105
12.38 Denka Seiken Co., Ltd. 106
12.39 Diagnostic Chemicals, Ltd. 106
12.40 EY Laboratories, Inc. 106
12.41 Enterix, Inc. 107
12.42 Focus Diagnostic, Inc. 107
12.43 GDS Technology 107
12.44 GenBio 107
12.45 Genzyme Diagnostics 107
12.46 Grant Life Sciences, Inc. 110
12.47 Gryphus Diagnostics, LLC 110
12.48 Guided Therapeutics, Inc 110
12.49 Helena Laboratories 111
12.50 Hema Diagnostic Systems 112
12.51 HemoCue, Inc. 112
12.52 Home Access Health Corp. 113
12.53 i-STAT Corporation 113
12.54 ImmunoScience, Inc. 114
12.55 Instrumentation Laboratory 115
12.56 International Medical Innovations 115
12.57 Inverness Medical Innovations 115
12.58 Johnson & Johnson 120
12.59 LifeAssays 122
12.60 LifePoint, Inc. 122
12.61 Lifestream Technologies 122
12.62 LXN Corp. (Inverness Medical Technologies) 122
12.63 Matritech 122
12.64 Medical Services International, Inc. 123
12.65 MediSense 123
12.66 Medisys 124
12.67 Medix Biochemica 124
12.68 MedMira Laboratories 124
12.69 Meretek Diganostics Group 126
12.70 Meridian Bioscience 126
12.71 MiniMed 128
12.72 Mitsubishi Chemical USA, Inc. 128
12.73 Mitsubishi Kagaku Iatron 129
12.74 Nanogen 129
12.75 New Horizons Diagnostics 131
12.76 Nova Biomedical 132
12.77 OraSure 134
12.78 Orgenics 136
12.79 Orion Diagnostica 137
12.80 PanBio, Ltd. 137
12.81 Phamatech Corporation 137
12.82 PharmaNetics, Inc. 137
12.83 Phillips Medical Systems 138
12.84 Polymedco 139
12.85 Polymer Technology Systems 140
12.86 Princeton BioMeditech Corporation 140
12.87 Quest Diagnostics 140
12.88 Quidel 141
12.89 Radiometer 145
12.90 Response Biomedical Corp. 147
12.91 Roche Diagnostics 148
12.92 Royal Philips Electronics 150
12.93 Saliva Diagnostics 151
12.94 Savyon Diagnostics 151
12.95 Selfcare, Inc. 152
12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 152
12.97 Shionogi & Co., Ltd. 152
12.98 Siemens Corporation 152
12.99 SpectRx, Inc. 153
12.100 Spectral Diagnostics 154
12.101 StatSure Diagnostics 154
12.102 STC Technologies 155
12.103 Strategic Diagnostics 155
12.104 Sun Biomedical Laboratories 155
12.105 Sybron International Corporation 155
12.106 TheraSense, Inc. 155
12.107 Thermo BioStar 155
12.108 Thoratec/International Technidyne Corp. 156
12.109 Trinity Biotech, PLC 157
12.110 Väsamed, Inc. 159
12.111 Venkateshwara Hatcheries Pvt., Ltd. 160
12.112 Wampole Laboratories 160
12.113 Worldwide Medical Corporation 160

13. FDA Currently-Waived Tests 161

INDEX OF TABLES

Table 2.1: POCT Frequency in Hospitals 14
Table 2.2: Worldwide Distribution of IVD Testing in 2007 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 Emergency Room Visits in U.S. Hospitals, 1997-2005 24
Table 3.2: Number of POCTs in U.S., 2004-2012 24
Table 3.3: The Overall IVD Testing Market Worldwide, 2007 25
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, 2007 27
Table 3.7: U.S. POCT Market, 2000-2012 28
Table 3.8: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2007 28
Table 3.9: U.S. POCT by Performance Location, 2007 28
Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 29
Table 3.11: U.S. POCT Glucose Testing Market, 2003-2012 29
Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012 30
Table 3.13: U.S. POCT Coagulation Market Size, 2003-2012 30
Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-2012 30
Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012 31
Table 3.16: U.S. POCT Urinalysis Market Size, 2003-2012 31
Table 3.17: Manufacturer Market Share U.S. POCT Market, 2007 31
Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2007 32
Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2007 32
Table 3.20: Manufacturer Market Share U.S. POCT Coagulation Market, 2007 32
Table 3.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007 32
Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 34
Table 3.23: European POCT Market, 2005-20012 34
Table 3.24: European POCT Diagnostics Market, 2007 34
Table 3.25: Top Twelve Country IVD and POC Testing Markets, 2007 35
Table 3.26: Japan POCT Market, 2005-20012 35
Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 41
Table 12.1: Products Marketed by Abbott in the Diagnostic Market 86
Table 12.2: Quidel Product Sales Distribution and Sales, 2007 142
Table 12.3: Key Products 149