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Point of Care Diagnostic Testing Sector Trends

The purpose of this 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:

• Identifying viable technology drivers through a comprehensive look at platform technologies for point of care testing
• Obtaining a complete understanding of the chief point of care tests from their basic principles to their applications
• Discovering feasible market opportunities by identifying high-growth applications in different analytical diagnostic areas, focusing on the biggest and expanding markets
• Focusing 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
  • 1.3Objectives8
  • 1.4Methodology9
  • 1.5Executive Summary10
  
  
• 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 Drivers 11
    • 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 Distribution 15
  • 2.5Emerging New Technologies16
  • 2.6Challenges of POCT17
  • 2.7Key Issues for POCT17
    • 2.7.1Locations of POCT17
    • 2.7.2Hospital Lab Rapid Tests 18
    • 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 Reimbursement 20
    • 2.7.9Competitive Landscape for POCT 23
  • 2.8The Future of POCT23
  
  
• 3.POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors24
  • 3.1Global POCT Market26
  • 3.2U.S. Point of Care Markets27
  • 3.3European POCT Market33
  • 3.4Japanese POCT Market35
  
  
• 4.The Place of POCT in Critical Care 36
  • 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 Forecasts 50


• 6.Business Trends in the Point of Care Sector 52
  • 6.1Sector Consolidation52
  • 6.2Acquisition, License Agreements, Internal Development and Partnerships53
  • 6.3Product Breadth in POCT 55
  • 6.4Companies Exiting from POCT55
  • 6.5Increased Market Penetration56
  • 6.6Costs of Doing Business in Europe 57
  • 6.7Drivers of European Diagnostics Testing57
  • 6.8European Reimbursement Practices 57
  • 6.9Cost Containment in Europe57
  • 6.10Significant Factors that Provide Competitive Advantage57
  • 6.11Sales and Marketing Strategies for POCT58
    • 6.11.1North American Market58
    • 6.11.2International Markets59
      • 6.11.2.1Europe 59
      • 6.11.2.2Central and South America60
      • 6.11.2.3Asia/Pacific60
      
      
• 7.Biotechnology Industry Trends61
  • 7.1Pharmaceutical Industry Trends61
  • 7.2Acquisition, License Agreement and Partnerships62
  
  
• 8. Government Regulation63
  • 8.1Government Regulation63
    • 8.1.1U.S. Regulation 63
      • 8.1.1.1Importing Medical Devices into the U.S.64
      • 8.1.1.2Exporting Medical Devices from the U.S.65
    • 8.1.2U.K. Regulations 66
    • 8.1.3E.U. Regulations 67
    • 8.1.4Japanese Regulations69
    • 8.1.5Korean Regulations70
  • 8.2Post-Filing Regulations for Point of Care Devices70
  • 8.3Exporting Unapproved POCTs71
  • 8.4Analyte Specific Reagents (Home-Brew Tests)71
  • 8.5Medical Device Registration72
  • 8.6Product Labeling 72
  • 8.7Punitive FDA Actions72
  • 8.8Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws72
  • 8.9Impact of Regulations on the Industry73
  • 8.10Minimizing Regulatory Barriers74
  
  
• 9.Limited Reimbursements by Third-Party Payers Obstruct Sales77
  • 9.1Third-Party Reimbursement Impact on POCT Reagents and Devices Sales77
  • 9.2Reimbursement Codes Classification77
  • 9.3Point of Care Product Line Reimbursement Picture78
  
  
• 10.Barriers to Business79
  • 10.1Concentration of Customers79
  • 10.2Intense Competition from Other Companies 79
  • 10.3Protection of Intellectual Property Rights79
  • 10.4Physician Acceptance80
  • 10.5Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth80
  • 10.6Additional Applications of Technology Platform81
  • 10.7Management of Growth81
  • 10.8Difficulty of Establishing a Marketing Infrastructure81
  
  
• 11.Acquisition Activity82
  • 11.1The Ideal Acquisition Profile82
  • 11.2Markets of Interest for Acquisition of POCT 82
  • 11.3Key M&A Steps 82
  
  
• 12.Company Profiles83
  • 12.1Abaxis, Inc.83
  • 12.2Abbott Diagnostics85
  • 12.3Accumetrics, Inc. 88
  • 12.4Accurex Biomedical, Pvt., Ltd.88
  • 12.5Akers Bioscience (ABI)88
  • 12.6Alfa Scientific Design, Inc.89
  • 12.7Ambri, Ltd.89
  • 12.8American Bio Medica Corp.89
  • 12.9Ani Biotech91
  • 12.10Apogent Technologies91
  • 12.11Ark Therapeutics 91
  • 12.12ARKRAY92
  • 12.13Atlas Genetics92
  • 12.14Atonomics92
  • 12.15Avox Systems92
  • 12.16Axis-Shield92
  • 12.17Bayer Corp.93
  • 12.18Beacon Diagnostics95
  • 12.19Beckman Coulter 95
  • 12.20Binax Corporation100
  • 12.21Biomerica100
  • 12.22BioMérieux Vitek, Inc.101
  • 12.23BioScan Screening Systems, Inc.101
  • 12.24Biosite Diagnostics101
  • 12.25BioStar 101
  • 12.26British Biocell Holdings101
  • 12.27Caliper Life Sciences102
  • 12.28Calypte Biomedical103
  • 12.29Cardiovascular Diagnostics104
  • 12.30Chembio Diagnostics104
  • 12.31Cholestech104
  • 12.32CompuCyte Corporation104
  • 12.33Cozart Bioscience104
  • 12.34Cygnus Therapeutic Systems105
  • 12.35Cytogen105
  • 12.36Dade Behring105
  • 12.37Daiichi Sankyo Group105
  • 12.38Denka Seiken Co., Ltd.106
  • 12.39Diagnostic Chemicals, Ltd.106
  • 12.40EY Laboratories, Inc.106
  • 12.41Enterix, Inc.107
  • 12.42Focus Diagnostic, Inc.107
  • 12.43GDS Technology 107
  • 12.44GenBio 107
  • 12.45Genzyme Diagnostics107
  • 12.46Grant Life Sciences, Inc.110
  • 12.47Gryphus Diagnostics, LLC110
  • 12.48Guided Therapeutics, Inc110
  • 12.49Helena Laboratories111
  • 12.50Hema Diagnostic Systems 112
  • 12.51HemoCue, Inc.112
  • 12.52Home Access Health Corp.113
  • 12.53i-STAT Corporation113
  • 12.54ImmunoScience, Inc.114
  • 12.55Instrumentation Laboratory115
  • 12.56International Medical Innovations115
  • 12.57Inverness Medical Innovations115
  • 12.58Johnson & Johnson120
  • 12.59LifeAssays122
  • 12.60LifePoint, Inc.122
  • 12.61Lifestream Technologies122
  • 12.62LXN Corp. (Inverness Medical Technologies)122
  • 12.63Matritech122
  • 12.64Medical Services International, Inc. 123
  • 12.65MediSense123
  • 12.66Medisys124
  • 12.67Medix Biochemica124
  • 12.68MedMira Laboratories124
  • 12.69Meretek Diganostics Group126
  • 12.70Meridian Bioscience126
  • 12.71MiniMed128
  • 12.72Mitsubishi Chemical USA, Inc.128
  • 12.73Mitsubishi Kagaku Iatron 129
  • 12.74Nanogen129
  • 12.75New Horizons Diagnostics 131
  • 12.76Nova Biomedical 132
  • 12.77OraSure 134
  • 12.78Orgenics136
  • 12.79Orion Diagnostica137
  • 12.80PanBio, Ltd.137
  • 12.81Phamatech Corporation137
  • 12.82PharmaNetics, Inc.137
  • 12.83Phillips Medical Systems 138
  • 12.84Polymedco139
  • 12.85Polymer Technology Systems140
  • 12.86Princeton BioMeditech Corporation 140
  • 12.87Quest Diagnostics140
  • 12.88Quidel141
  • 12.89Radiometer145
  • 12.90Response Biomedical Corp.147
  • 12.91Roche Diagnostics148
  • 12.92Royal Philips Electronics150
  • 12.93Saliva Diagnostics151
  • 12.94Savyon Diagnostics151
  • 12.95Selfcare, Inc.152
  • 12.96Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)152
  • 12.97Shionogi & Co., Ltd.152
  • 12.98Siemens Corporation152
  • 12.99SpectRx, Inc.153
  • 12.100Spectral Diagnostics154
  • 12.101StatSure Diagnostics154
  • 12.102STC Technologies155
  • 12.103Strategic Diagnostics155
  • 12.104Sun Biomedical Laboratories155
  • 12.105Sybron International Corporation155
  • 12.106TheraSense, Inc.155
  • 12.107Thermo BioStar155
  • 12.108Thoratec/International Technidyne Corp.156
  • 12.109Trinity Biotech, PLC157
  • 12.110Väsamed, Inc.159
  • 12.111Venkateshwara Hatcheries Pvt., Ltd.160
  • 12.112Wampole Laboratories160
  • 12.113Worldwide Medical Corporation160
  
  
• 13. FDA Currently-Waived Tests161

 

INDEX OF TABLES

Table 2.1: POCT Frequency in Hospitals14

Table 2.2: Worldwide Distribution of IVD Testing in 200716

Table 2.3: Top Twelve Country IVD Testing Markets, 200716

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, 1997-200524

Table 3.2: Number of POCTs in U.S., 2004-201224

Table 3.3: The Overall IVD Testing Market Worldwide, 2007 25

Table 3.4: Largest Diagnostic Companies Worldwide, 200726

Table 3.5: Global Point of Care Revenues, 2005-2012 27

Table 3.6: Worldwide Distribution of POCT, 200727

Table 3.7: U.S. POCT Market, 2000-201228

Table 3.8: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 200728

Table 3.9: U.S. POCT by Performance Location, 200728

Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 200729

Table 3.11: U.S. POCT Glucose Testing Market, 2003-201229

Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-201230

Table 3.13: U.S. POCT Coagulation Market Size, 2003-2012 30

Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-201230

Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-201231

Table 3.16: U.S. POCT Urinalysis Market Size, 2003-201231

Table 3.17: Manufacturer Market Share U.S. POCT Market, 200731

Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 200732

Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 200732

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, 200732

Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe34

Table 3.23: European POCT Market, 2005-2001234

Table 3.24: European POCT Diagnostics Market, 200734

Table 3.25: Top Twelve Country IVD and POC Testing Markets, 2007 35

Table 3.26: Japan POCT Market, 2005-2001235

Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements41

Table 12.1: Products Marketed by Abbott in the Diagnostic Market86

Table 12.2: Quidel Product Sales Distribution and Sales, 2007 142

Table 12.3: Key Products 149

 

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