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.

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 AdvancementsMenu, 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 bioMrieux 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 Vsamed, 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