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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.

The main objectives of this analysis are to:

• Identify viable technology drivers through a comprehensive look at platform technologies for point of care testing
• Obtain a complete understanding of the chief point of care tests from their basic principles to their applications
• Discover feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, focusing on the biggest and expanding markets
• Focus on global industry development through an in-depth analysis of the major world markets for point of care diagnostic testing technology, including growth forecasts
• Present market figures regarding the current value of the point of care market, projections and growth rates.

The source of this information is the most current data derived from the global diagnostic industry.

By purchasing this report, the reader will have:

• An understanding of the most exciting point of care market segments, current and future
• The latest information on leading products and research and development (R&D) initiatives
• Familiarity with recent developments and their effects on selected markets
• Knowledge of the point of care market as an area of growth, research and investment.

Key questions answered in this report:

• How can point of care tools and technologies facilitate other diagnostic tests?
• What are the main types of point of care technologies that are currently available?
• Who are the current key players in this marketplace?
• Which point of care market areas have the greatest potential for growth?
• What is the current state of the point of care market?
• Which biotechnology and diagnostic companies are investing in point of care solutions?
• What are the main point of care business strategies adopted by leading companies?
• What are the benefits of point of care technology platforms?

This report contains:

• Detailed analysis of recent trends in the point of care marketplace.
• In-depth profiles of the leading companies with point of care tools and technologies.
• A five-year forecast for the point of care market in the biotechnology and diagnostic industries.
• Views and principles on the point of care industry from leading industry experts.
• Analysis of potential point of care applications in the life science sector
• Market predictions and trends analysis concerning U.S. expenditure on point of care solutions
• Projections for future applications of molecular diagnostic tests in point of care related screening.
• Analysis of commercial point of care business strategies
• The latest news and developments in the point of care marketplace
• A comprehensive overview and insight into point of care business strategies.

Table of Contents

• 1.Overview6
  • 1.1Statement of Report6
  • 1.2Scope of the Report8
  • 1.3Objectives9
  • 1.4Methodology9
  • 1.5Executive Summary9
  
  
• 2.Overview of Diagnostic Point of Care Testing11
  • 2.1Key Issues in the Point of Care Diagnostic Testing Sector11
    • 2.1.1Current Market Trends and Drivers11
    • 2.1.2Effectiveness of POCT12
    • 2.1.3New Growth Areas for POCT13
    • 2.1.4Advantages of POCT in a Clinical Setting13
    • 2.1.5Pricing and Reimbursement Issues13
    • 2.1.6Key Customer Segments13
  • 2.2Global Point of Care Marketplace13
  • 2.3Shifts from Central-Lab Testing to POCT15
  • 2.4Geographical Distribution15
  • 2.5Emerging New Technologies16
  • 2.6Challenges of POCT17
  • 2.7Key Issues for POCT17
    • 2.7.1Locations of POCT17
    • 2.7.2Hospital Lab Rapid Tests18
    • 2.7.3Doctor's Office Laboratory18
    • 2.7.4Non-Hospital POCT18
    • 2.7.5Home Monitoring19
    • 2.7.6Milestones in Technology Development20
    • 2.7.7Drive for Decentralization from Lab to Patient20
    • 2.7.8Expanded Reimbursement20
    • 2.7.9Competitive Landscape for POCT23
  • 2.8The Future of POCT23
  
  
• 3.POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors24
  • 3.1Global POCT Market26
  • 3.2.U.S. Point of Care Markets27
  • 3.3.European POCT Market32
  • 3.4.Japanese POCT Market35
  
  
• 4.The Place of POCT in Critical Care36
  • 4.1Technological Diversity in POCT36
    • 4.1.1The Wide Range of Point of Care Assays36
    • 4.1.2Challenge of Testing on a Single Platform39
    • 4.1.3Connectivity with Testing Platforms40
    • 4.1.4Improvement in Clinical Outcomes with Use of POCT42
    • 4.1.5Future Developments42
  • 4.2Point of Care Addresses Critical Requirements43
    • 4.2.1Needs in Critical-Care Testing43
    • 4.2.2Point of Care Instrument Key Elements44
    • 4.2.3Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access44
    • 4.2.4Standardized System for All Testing Locations45
  • 4.3POCT Versus Central-Laboratory Testing47
    • 4.3.1The Financial Advantages of POCT47
    • 4.3.2Is the Shift Towards Point of Care Justified?47
    • 4.3.3Overall Cost Benefit48
    • 4.3.4More Available Time for Clinical Practitioners49
    • 4.3.5Future Policies49
    
    
• 5.POCT Sector Trends and Forecasts50


• 6.Business Trends in the Point of Care Sector52
  • 6.1Sector Consolidation52
  • 6.2Acquisition, License Agreements, Internal Development and Partnerships53
  • 6.3Product Breadth in POCT54
  • 6.4Companies Exiting from POCT54
  • 6.5Increased Market Penetration55
  • 6.6Costs of Doing Business in Europe56
  • 6.7Drivers of European Diagnostics Testing56
  • 6.8European Reimbursement Practices56
  • 6.9Cost Containment in Europe56
  • 6.10Significant Factors that Provide Competitive Advantage57
  • 6.11Sales and Marketing Strategies for POCT57
    • 6.11.1North American Market57
    • 6.11.2International Markets58
      • 6.11.2.1Europe59
      • 6.11.2.2Central and South America59
      • 6.11.2.3Asia/Pacific59
      
      
• 7.Biotechnology Industry Trends61
  • 7.1Pharmaceutical Industry Trends61
  • 7.2Acquisition, License Agreement and Partnerships62
  
  
• 8. Government Regulation65
  • 8.1Government Regulation65
    • 8.1.1U.S. Regulation65
      • 8.1.1.1Importing Medical Devices into the U.S.66
      • 8.1.1.2Exporting Medical Devices from the U.S.67
    • 8.1.2U.K. Regulations68
    • 8.1.3E.U. Regulations69
    • 8.1.4Japanese Regulations71
    • 8.1.5Korean Regulations71
  • 8.2Post-Filing Regulations for Point of Care Devices72
  • 8.3Exporting Unapproved POCTs73
  • 8.4Analyte Specific Reagents (Home-Brew Tests)73
  • 8.5Medical Device Registration73
  • 8.6Product Labeling74
  • 8.7Punitive FDA Actions74
  • 8.8Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws74
  • 8.9Impact of Regulations on the Industry75
  • 8.10Minimizing Regulatory Barriers76
  
  
• 9.Limited Reimbursements by Third-Party Payers Obstruct Sales79
  • 9.1Third-Party Reimbursement Impact on POCT Reagents and Devices Sales79
  • 9.2Reimbursement Codes Classification79
  • 9.3Point of Care Product Line Reimbursement Picture80
  
  
• 10.Barriers to Business81
  • 10.1Concentration of Customers81
  • 10.2Intense Competition from Other Companies81
  • 10.3Protection of Intellectual Property Rights81
  • 10.4Physician Acceptance82
  • 10.5Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth82
  • 10.6Additional Applications of Technology Platform83
  • 10.7Management of Growth83
  • 10.8Difficulty of Establishing a Marketing Infrastructure83
  
  
• 11.Acquisition Activity84
  • 11.1The Ideal Acquisition Profile84
  • 11.2Markets of Interest for Acquisition of POCT84
  • 11.3Key M&A Steps84
  
  
• 12.POCT Manufacturers' Corporate Profiles85
  • 12.1Abaxis, Inc.85
  • 12.2Abbott Diagnostics86
  • 12.3Accumetrics, Inc.89
  • 12.4Accurex Biomedical, Pvt., Ltd.90
  • 12.5ActiMed Diagnostics90
  • 12.6Adeza Biomedical Corporation90
  • 12.7Akers Bioscience90
  • 12.8Ambri, Ltd.90
  • 12.9American Biogenetic Sciences, Inc.91
  • 12.10American Bio Medica Corp.91
  • 12.11Ani Biotech92
  • 12.12Apogent Technologies93
  • 12.13Ark Therapeutics94
  • 12.14Array Medical94
  • 12.15Avitar, Inc.94
  • 12.16Avox Systems95
  • 12.17Axis-Shield95
  • 12.18Bayer Corp.96
  • 12.19Beacon Diagnostics98
  • 12.20Beckman Coulter99
  • 12.21Biex, Inc.102
  • 12.22Binax Corporation103
  • 12.23Biomerica103
  • 12.24BioMérieux Vitek, Inc.103
  • 12.25BioScan Screening Systems, Inc.103
  • 12.26Biosite Diagnostics103
  • 12.27BioStar107
  • 12.28Bio-Warm Corporation107
  • 12.29Caliper Life Sciences108
  • 12.30Calypte Biomedical108
  • 12.31Cardiovascular Diagnostics109
  • 12.32Chembio Diagnostics110
  • 12.33ChemTrak110
  • 12.34Cholestech110
  • 12.35Chongqing Sungene Pharmaceutical Co., Ltd.111
  • 12.36CompuCyte Corporation111
  • 12.37Cortech, Ltd.111
  • 12.38Cozart Bioscience113
  • 12.39Cygnus Therapeutic Systems113
  • 12.40Cytogen115
  • 12.41Dade Behring115
  • 12.42Daiichi Co., Ltd.115
  • 12.43Denka Seiken Co., Ltd.115
  • 12.44Diagnology, Inc.116
  • 12.45Diametrics Medical, Inc.116
  • 12.46EY Laboratories, Inc.116
  • 12.47Enterix, Inc.116
  • 12.48First Medical, Inc.117
  • 12.49GDS Technology117
  • 12.50GenBio117
  • 12.51Genzyme Diagnostics117
  • 12.52Grant Life Sciences, Inc.119
  • 12.53Gryphus Diagnostics, LLC120
  • 12.54Helena Laboratories120
  • 12.55Hema Diagnostic Systems120
  • 12.56HemoCue, Inc.121
  • 12.57Home Access Health Corp.121
  • 12.58i-STAT Corporation121
  • 12.59ImmunoScience, Inc.122
  • 12.60Instrumentation Laboratory122
  • 12.61International Medical Innovations123
  • 12.62Inverness Medical Innovations123
  • 12.63Jiangnan Biotech126
  • 12.64Johnson & Johnson126
  • 12.65Kyowa Medex Co., Ltd.127
  • 12.66LifeAssays127
  • 12.67LifePoint, Inc.127
  • 12.68Lifestream Technologies130
  • 12.69LXN Corp. (Inverness Medical Technologies)130
  • 12.70Matritech130
  • 12.71Medical Services International, Inc.130
  • 12.72MediSense131
  • 12.73Medisys131
  • 12.74Medix Biochemica131
  • 12.75MedMira Laboratories131
  • 12.76Meretek Corporation132
  • 12.77Meridian Bioscience133
  • 12.78MiniMed134
  • 12.79Mitsubishi Kagaku Iatron135
  • 12.80Nanogen135
  • 12.81New Horizons Diagnostics136
  • 12.82Nova Diagnostics136
  • 12.83Optical Sensors, Inc.138
  • 12.84OraSure139
  • 12.85Orgenics140
  • 12.86Orion Diagnostica140
  • 12.87PanBio Corp.141
  • 12.88PharmaNetics, Inc.141
  • 12.89Pharmatech Corporation141
  • 12.90Phillips Medical Systems141
  • 12.91Point of Care Technologies142
  • 12.92Polymedco142
  • 12.93Polymer Technology Systems143
  • 12.94Princeton BioMeditech Corporation144
  • 12.95Quidel144
  • 12.96Radiometer146
  • 12.97Response Biomedical Corp.147
  • 12.98Roche Diagnostics148
  • 12.99Royal Philips Electronics152
  • 12.100Saliva Diagnostics152
  • 12.101Savyon Diagnostics152
  • 12.102Selfcare, Inc.153
  • 12.103Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)153
  • 12.104Shionogi & Co., Ltd.153
  • 12.105SpectRx, Inc.153
  • 12.106Spectral Diagnostics154
  • 12.107STC Technologies155
  • 12.108Sun Biomedical Laboratories155
  • 12.109Sybron International Corporation155
  • 12.110Taiwan Diagnostic155
  • 12.111TCPI155
  • 12.112TheraSense, Inc.157
  • 12.113Thermo BioStar157
  • 12.114Thoratec/International Technidyne Corp.157
  • 12.115Transmedica158
  • 12.116Trinity Biotech, PLC158
  • 12.117Wampole Laboratories159
  • 12.118Worldwide Medical Corporation159
  
  
• 13. FDA Currently-Waived Tests160

INDEX OF TABLES

Table 2.1: POCT Frequency in Hospitals14

Table 2.2: Worldwide Distribution of IVD Testing16

Table 2.3: Top-Dozen Country IVD Testing Markets16

Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing23

Table 3.1: Number of Emergency Room Visits in U.S. Hospitals, 2000-200824

Table 3.2: Number of POCTs in U.S., 2000-200824

Table 3.3: The Overall IVD Testing Market Worldwide, 200425

Table 3.4: Ten-Largest Diagnostic Companies Worldwide26

Table 3.5: Global Point of Care Market Size, 1998-200827

Table 3.6: Worldwide Distribution of POCT, 200427

Table 3.7: U.S. POCT Market, 2000-201128

Table 3.8: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 200428

Table 3.9: U.S. POCT by Distribution Location, 200428

Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 200429

Table 3.11: U.S. POCT Glucose-Testing Market Size, 2003-201129

Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-201130

Table 3.13: U.S. POCT Coagulation Market Size, 2003-201130

Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-201130

Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-201131

Table 3.16: U.S. POCT Urinalysis Market Size, 2003-201131

Table 3.17: Manufacturer Market Share U.S. POCT Market, 200531

Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 200531

Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 200532

Table 3.20: Manufacturer Market Share U.S. POCT Coagulation Market, 200532

Table 3.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 200532

Table 3.22: Regional Comparison of GDP, Healthcare and IVD for Eastern Europe33

Table 3.23: European POCT Market, 2000-200834

Table 3.24: European POCT Diagnostics Market, 200434

Table 3.25: Top-Dozen Country IVD Testing Markets and Point of Care Share, 200434

Table 3.26: Japan POCT Market, 2000-200835

Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements41

Table 12.1: Products Marketed by Abbott in the Diagnostic Market, 200388

Table 12.2: Quidel Product Sales Distribution, 2003145

Table 12.3: Key Products150

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