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Point of Care Diagnostic Testing Sector Trends

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Price:
$2,500.00
Publication Date:
November 2011; Pages: 189
File Type:
Downloadable PDF


Description


Point of Care Sector Trends Sample

Point of care testing enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing 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, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. 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.

 

TABLE OF CONTENTS

1. Overview 8
1.1 Statement of Report 8
1.2 Scope of This Report 9
1.3 Objectives 10
1.4 Methodology 10
1.5 Executive Summary 11

2. Overview of Point of Care Diagnostic Testing 14
2.1 Key Issues in the Point of Care Diagnostic Testing Sector 14
2.1.1 Current Market Trends and Drivers 14
2.1.2 Effectiveness of POCT 15
2.1.3 New Growth Areas for POCT 16
2.1.4 Advantages of POCT in a Clinical Setting 16
2.1.5 Pricing and Reimbursement Issues 17
2.1.6 Key Customer Segments 17
2.2 Global Point of Care Marketplace 17
2.3 Shifts from Central Lab Testing to POCT 19
2.4 Geographical Distribution 19
2.5 Emerging New Technologies 20
2.6 Challenges of POCT 25
2.7 Key Issues for POCT 25
2.7.1 Locations of POCT 25
2.7.2 Milestones in Technology Development 28
2.7.3 Drive for Decentralization from Lab to Patient 29
2.7.4 Expanded Reimbursement 29
2.7.5 Competitive Landscape for POCT 33
2.8 The Future of POCT 34

3. POC and Rapid Testing Market: Summary of Market Analysis: Size, Background, Growth, Share and Competitors 36
3.1 Global POCT Market 36

4. U.S. POCT Market 43

5. European POCT Market 49

6. Japanese POCT Market Sector Trends 62

7. Chinese POCT Market Sector Trends 69

8. Indian POCT Market Sector Trends 70

9. The Rest of the World (ROW) POCT Market 71

10. The Role of POCT in Critical Care 77
10.1 Technological Diversity in POCT 77
10.1.1 The Wide Range of Point of Care Assays 77
10.1.2 Challenge of Testing on a Single Platform 80
10.1.3 Connectivity with Testing Platforms 81
10.1.4 Improvement in Clinical Outcomes with Use of POCT 83
10.1.5 Future Developments 83
10.2 Point of Care Addresses Critical Requirements 84
10.2.1 Needs in Critical Care Testing 84
10.2.2 Point of Care Instrument Key Elements 85
10.2.3 Key Advancements--Menu, Quality Assurance (QA), Connectivity, Internet Access 85
10.2.4 Standardized System for All Testing Locations 87
10.3 POCT versus Central Laboratory Testing 88
10.3.1 The Financial Advantages of POCT 88
10.3.2 Is the Shift Towards Point of Care Justified? 88
10.3.3 Overall Cost Benefit 89
10.3.4 More Available Time for Clinical Practitioners 90
10.3.5 Future Policies 90

11. POCT Sector Trends and Market Predictions 91

12. Business Trends in the Point of Care Sector 93
12.1 Sector Consolidation 93
12.2 Acquisition, License Agreements, Internal Development and Partnerships 94
12.3 The Ideal Acquisition Profile 96
12.3.1 Markets of Interest for Acquisition of POCT 96
12.3.2 Key M&A Steps 96
12.4 Product Breadth in POCT 96
12.5 Companies Exiting From POCT 97
12.6 Increased Market Penetration 97
12.7 Costs of Doing Business in Europe 98
12.8 Drivers of European Diagnostics Testing 98
12.9 European Reimbursement Practices 99
12.10 Cost Containment in Europe 99
12.11 Significant Factors that Provide Competitive Advantage 99
12.12 Sales and Marketing Strategies for POCT 99
12.12.1 North American Market 100
12.12.2 International Markets 101
12.12.2.1 Europe 101
12.12.2.2 Central and South America 101
12.12.2.3 Asia-Pacific 102

13. Biotechnology Industry Trends 103
13.1 Pharmaceutical Industry Trends 103

14. Government Regulation 105
14.1 Government Regulation 105
14.1.1 U.S. Regulation 105
14.1.1.1 Importing Medical Devices into the U.S. 106
14.1.1.2 Exporting Medical Devices from the U.S. 107
14.1.2 E.U. Regulations 107
14.1.3 Japanese Regulations 111
14.1.4 Korean Regulations 111
14.2 Post Filing Regulations for Point of Care Devices 112
14.3 Exporting Unapproved POCTs 113
14.4 Analyte Specific Reagents (Home Brew Tests) 113
14.5 Medical Device Registration 113
14.6 Product Labeling 114
14.7 Punitive FDA Actions 114
14.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 114
14.9 Impact of Regulations on the Industry 115
14.10 Minimizing Regulatory Barriers 116
14.11 Waived Testing 118

15. Limited Reimbursements by Third-Party Payers Obstruct Sales 120
15.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 120
15.2 Reimbursement Codes Classification 121
15.3 Point of Care Product Line Reimbursement Picture 121

16. Barriers to Business 122
16.1 Concentration of Customers 122
16.2 Intense Competition from Other Companies 122
16.3 Protection of Intellectual Property Rights 122
16.4 Physician Acceptance 123
16.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth 123
16.6 Additional Applications of Technology Platform 124
16.7 Management of Growth 124
16.8 Difficulty of Establishing a Marketing Infrastructure 124

17. Company Profiles 125
17.1 Abaxis, Inc. 125
17.2 Abbott Diagnostics 127
17.3 Accumetrics, Inc. 129
17.4 Accurex Biomedical Pvt. Ltd. 129
17.5 AgaMatrix 129
17.6 Akers Bioscience, Inc. (ABI) 130
17.7 Alfa Scientific Design, Inc. 131
17.8 Alere Health, LLC 131
17.9 Ambri Ltd. 132
17.10 American Bio Medica Corporation 133
17.11 Ani Biotech 134
17.12 Apogent Technologies 135
17.13 Ark Therapeutics 135
17.14 ARKRAY, Inc. 135
17.15 Atlas Genetics 135
17.16 Atonomics A/S 136
17.17 Avox Systems 136
17.18 Axis-Shield 136
17.19 Bayer Corp. 137
17.20 Beacon Diagnostics, Inc. 138
17.21 Beckman Coulter 138
17.22 Binax Corporation 141
17.23 Biomerica, Inc. 141
17.24 bioMerieux 142
17.25 BioScan Screening Systems, Inc. 142
17.26 Biosite Diagnostics 143
17.27 British Biocell Holdings 143
17.28 Caliper Life Sciences 143
17.29 Calypte Biomedical Corporation 144
17.30 Chembio Diagnostics, Inc. 145
17.31 Cholestech 145
17.32 CompuCyte Corporation 145
17.33 Cozart Bioscience 146
17.34 Cygnus Therapeutic Systems 146
17.35 Cytogen Corporation 146
17.36 Dade Behring 146
17.37 Daiichi Sankyo Group 146
17.38 Denka Seiken Co., Ltd. 147
17.39 Diagnostic Chemicals Ltd. 147
17.40 EY Laboratories, Inc. 147
17.41 Enterix, Inc. 148
17.42 Focus Diagnostic, Inc. 148
17.43 GDS Technology 148
17.44 GenBio 148
17.45 Genzyme Diagnostics 148
17.46 Grant Life Sciences, Inc. 149
17.47 Gryphus Diagnostics, LLC 149
17.48 Guided Therapeutics, Inc. 150
17.49 Harring Group Ltd. (HGR) 150
17.50 Helena Laboratories 150
17.51 Hema Diagnostic Systems, LLC 151
17.52 HemoCue, Inc. 151
17.53 Home Access Health Corp. 152
17.54 i-STAT Corporation 152
17.55 ImmunoScience, Inc. 152
17.56 Instrumentation Laboratory 152
17.57 International Medical Innovations 153
17.58 Johnson & Johnson 154
17.59 LifeAssays AB 155
17.60 MediSense 155
17.61 Medisys 155
17.62 Medix Biochemica 155
17.63 MedMira Laboratories 156
17.64 Medtronic 157
17.65 A Menarini Diagnostics 158
17.66 Meretek Diagnostics Group 159
17.67 Meridian Bioscience 159
17.68 MiniMed 161
17.69 Mitsubishi Chemical USA, Inc. 162
17.70 Mitsubishi Kagaku Iatron 162
17.71 Nanogen (ELITech Group) 162
17.72 New Horizons Diagnostics 163
17.73 Nova Biomedical 163
17.74 OraSure Technologies, Inc. 164
17.75 Orgenics 166
17.76 Orion Diagnostica 166
17.77 PanBio Ltd. 167
17.78 Phamatech, Inc. 167
17.79 PharmaNetics, Inc. 167
17.80 Polymedco, Inc. 167
17.81 Polymer Technology Systems, Inc. 169
17.82 Princeton BioMeditech Corporation 169
17.83 Quest Diagnostics, Inc. 169
17.84 Quidel Corporation 170
17.85 Radiometer 174
17.86 Response Biomedical Corp. 177
17.87 Roche Diagnostics 178
17.88 Savyon Diagnostics 179
17.89 Selfcare, Inc. 181
17.90 Shionogi & Co., Ltd. 181
17.91 Siemens Corporation 181
17.92 Guided Therapeutics (SpectRx, Inc.) 182
17.93 Spectral Diagnostics 182
17.94 StatSure Diagnostic Systems, Inc. 182
17.95 Strategic Diagnostics 183
17.96 Trinity Biotech, Plc 183
17.97 Vasamed, Inc. 186

18. FDA Currently Waived Tests 187


INDEX OF FIGURES

Figure 14.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
Category 108


INDEX OF TABLES

Table 2.1: POCT Frequency in Hospitals 18
Table 2.2: Worldwide Distribution of IVD Testing, 2010 19
Table 2.3: Top Thirteen Country IVD Testing Markets, 2010 20
Table 2.4: Common Genotype Techniques 22
Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing 33
Table 3.1: Total Global POCT Market, 2007-2017 36
Table 3.2: Global Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 37
Table 3.3: Global Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 37
Table 3.4: Global Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 38
Table 3.5: Global Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 38
Table 3.6: Global Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017 39
Table 3.7: Global Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 39
Table 3.8: Global Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 40
Table 3.9: Global Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 40
Table 3.10: Global Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 41
Table 3.11: Global Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 41
Table 3.12: Global Market Share Analysis, 2010 42
Table 4.1: Total U.S. POCT Market for Blood Glucose Monitoring Systems, 2007-2017 43
Table 4.2: U.S Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 43
Table 4.3: U.S Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 44
Table 4.4: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 44
Table 4.5: U.S. Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 45
Table 4.6: U.S. Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017 45
Table 4.7: U.S. Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 46
Table 4.8: U.S. Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 46
Table 4.9: U.S. Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 47
Table 4.10: U.S. Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 47
Table 4.11: U.S. Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 48
Table 4.12: U.S. Market Share Analysis, 2010 48
Table 5.1: Models of Public-Private Partnership in Hospital Provision 50
Table 5.2: European Revenue Forecasts for POCT Market, 2007-2017 53
Table 5.3: European Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 54
Table 5.4: European Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017 54
Table 5.5: European Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 55
Table 5.6: European Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 56
Table 5.7: European Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
2007-2017 57
Table 5.8: European Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 58
Table 5.9: European Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 58
Table 5.10: European Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 59
Table 5.11: European Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 60
Table 5.12: European Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 60
Table 5.13: European Market Share Analysis, 2010 61
Table 6.1: Total Japanese POCT Market, 2007-2017 62
Table 6.2: Japanese Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 63
Table 6.3: Japanese Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017 63
Table 6.4: Japanese Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 64
Table 6.5: Japanese Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017 64
Table 6.6: Japanese Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
2007-2017 65
Table 6.7: Japanese Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 65
Table 6.8: Japanese Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 66
Table 6.9: Japanese Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 66
Table 6.10: Japanese Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 67
Table 6.11: Japanese Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 67
Table 6.12: Japanese Market Share Analysis, 2010 68
Table 9.1: ROW Revenue Forecasts for POC Market, 2007-2017 71
Table 9.2: ROW Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017 71
Table 9.3: ROW Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017 72
Table 9.4: ROW Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017 72
Table 9.5: ROW Revenue Forecasts for POC Cardiac Marker Devices Market, 2007-2017 73
Table 9.6: ROW Revenue Forecasts for POC Substance/Drug Abuse Testing Devices Market, 2007-2017 73
Table 9.7: ROW Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017 74
Table 9.8: ROW Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017 74
Table 9.9: ROW Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017 75
Table 9.10: ROW Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017 75
Table 9.11: ROW Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017 76
Table 9.12: ROW Market Share Analysis, 2010 76
Table 10.1: Customized Reports Must Support CAP and JCAHO Requirements 82
Table 17.1: Abaxis, Inc. Financial Figures--Net Sales by Business Sector, 2008-2010 126
Table 17.2: Abaxis, Inc. Financial Figures--Net Sales by Geographic Region, 2008-2010 127
Table 17.3: Abbott Laboratories Financial Figures--Net Sales by Business Sector, 2008-2010 128
Table 17.4: Abbott Laboratories Financial Figures--Net Sales by Geographic Region, 2008-2010 128
Table 17.5: Bayer AG Financial Figures--Net Sales by Business Sector, 2008-2010 137
Table 17.6: Bayer AG Financial Figures--Net Sales by Geographic Region, 2008-2010 138
Table 17.7: Johnson & Johnson Financial Figures--Net Sales by Major Medical and Diagnostics Businesses,
2008-2010 154
Table 17.8: Medtronic Financial Figures--Net Sales by Segment, 2008-2010 158
Table 17.9: Quidel Product Sales Distribution and Sales, 2009 and 2010 171
Table 17.10: Danaher Corporation Financial Figures--Net Sales by Business Sector, 2008-2010 175
Table 17.11: Danaher Corporation Financial Figures--Net Sales by Geographic Region, 2008-2010 175
Table 17.12: Roche Group Financial Figures--Net Sales by Business Sector, 2008-2010 179
Table 17.13: Roche Group Financial Figures--Net Sales by Geographic Region, 2009 and 2010 179
Table 17.14: Roche Group Financial Figures--Net Sales by Sub-Division, 2008-2010 179

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

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