Point of Care Diagnostic Testing Sector Trends

Product Code TRI00030
Publication Date November 2011
Publisher TriMark Publications
Product Type Report
Pages 189
ISBN Number not applicable
Change currency
PDF £2,150.00 €2,589 $3,400 BUY >
Order by fax
Ask a question about this product > Receive product alerts > Call now +44 20 7060 7474

Point of Care Diagnostic Testing Sector Trends

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.

Contents

  • 1. Overview
    • 1.1 Statement of Report
    • 1.2 Scope of the Report
    • 1.3 Objectives
    • 1.4 Methodology
    • 1.5 Executive Summary
  • 2. Overview of Diagnostic Point of Care Testing
    • 2.1 Key Issues in the Point of Care Diagnostic Testing Sector
      • 2.1.1 Current Market Trends and Drivers
      • 2.1.2 Effectiveness of POCT
      • 2.1.3 New Growth Areas for POCT
      • 2.1.4 Advantages of POCT in a Clinical Setting
      • 2.1.5 Pricing and Reimbursement Issues
      • 2.1.6 Key Customer Segments
    • 2.2 Global Point of Care Marketplace
    • 2.3 Shifts from Central Lab Testing to POCT
    • 2.4 Geographical Distribution
    • 2.5 Emerging New Technologies
    • 2.6 Challenges of POCT
    • 2.7 Key Issues for POCT
      • 2.7.1 Locations of POCT
      • 2.7.2 Hospital Lab Rapid Tests
      • 2.7.3 Doctor's Office Laboratory
      • 2.7.4 Non-Hospital POCT
      • 2.7.5 Home Monitoring
      • 2.7.6 Milestones in Technology Development
      • 2.7.7 Drive for Decentralization from Lab to Patient
      • 2.7.8 Expanded Reimbursement
      • 2.7.9 Competitive Landscape for POCT
    • 2.8 The Future of POCT
  • 3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors
    • 3.1 Global POCT Market
    • 3.2 U.S. Point of Care Markets
    • 3.3 European POCT Market
    • 3.4 Japanese POCT Market
  • 4. The Place of POCT in Critical Care
    • 4.1 Technological Diversity in POCT
      • 4.1.1 The Wide Range of Point of Care Assays
      • 4.1.2 Challenge of Testing on a Single Platform
      • 4.1.3 Connectivity with Testing Platforms
      • 4.1.4 Improvement in Clinical Outcomes with Use of POCT
      • 4.1.5 Future Developments
    • 4.2 Point of Care Addresses Critical Requirements
      • 4.2.1 Needs in Critical Care Testing
      • 4.2.2 Point of Care Instrument Key Elements
      • 4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access
      • 4.2.4 Standardized System for All Testing Locations
    • 4.3 POCT versus Central Laboratory Testing
      • 4.3.1 The Financial Advantages of POCT
      • 4.3.2 Is the Shift Towards Point of Care Justified?
      • 4.3.3 Overall Cost Benefit
      • 4.3.4 More Available Time for Clinical Practitioners
      • 4.3.5 Future Policies
  • 5. POCT Sector Trends and Forecasts
  • 6. Business Trends in the Point of Care Sector
    • 6.1 Sector Consolidation
    • 6.2 Acquisition, License Agreements, Internal Development and Partnerships
    • 6.3 Product Breadth in POCT
    • 6.4 Companies Exiting From POCT
    • 6.5 Increased Market Penetration
    • 6.6 Costs of Doing Business in Europe
    • 6.7 Drivers of European Diagnostics Testing
    • 6.8 European Reimbursement Practices
    • 6.9 Cost Containment in Europe
    • 6.10 Significant Factors That Provide Competitive Advantage
    • 6.11 Sales and Marketing Strategies for POCT
      • 6.11.1 North American Market
      • 6.11.2 International Markets
        • 6.11.2.1 Europe
        • 6.11.2.2 Central and South America
        • 6.11.2.3 Asia/Pacific
  • 7. Biotechnology Industry Trends
    • 7.1 Pharmaceutical Industry Trends
  • 8. Government Regulation
    • 8.1 Government Regulation
      • 8.1.1 U.S. Regulation
        • 8.1.1.1 Importing Medical Devices into the U.S.
        • 8.1.1.2 Exporting Medical Devices from the U.S.
      • 8.1.2 U.K. Regulations
      • 8.1.3 E.U. Regulations
      • 8.1.4 Japanese Regulations
      • 8.1.5 Korean Regulations
    • 8.2 Post Filing Regulations for Point of Care Devices
    • 8.3 Exporting Unapproved POCTs
    • 8.4 Analyte Specific Reagents (Home Brew Tests)
    • 8.5 Medical Device Registration
    • 8.6 Product Labeling
    • 8.7 Punitive FDA Actions
    • 8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
    • 8.9 Impact of Regulations on the Industry
    • 8.10 Minimizing Regulatory Barriers
    • 8.11 Waived Testing
  • 9. Limited Reimbursements by Third-Party Payers Obstruct Sales
    • 9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales
    • 9.2 Reimbursement Codes Classification
    • 9.3 Point of Care Product Line Reimbursement Picture
  • 10. Barriers to Business
    • 10.1 Concentration of Customers
    • 10.2 Intense Competition from Other Companies
    • 10.3 Protection of Intellectual Property Rights
    • 10.4 Physician Acceptance
    • 10.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth
    • 10.6 Additional Applications of Technology Platform
    • 10.7 Management of Growth
    • 10.8 Difficulty of Establishing a Marketing Infrastructure
  • 11. Acquisition Activity
    • 11.1 The Ideal Acquisition Profile
    • 11.2 Markets of Interest for Acquisition of POCT
    • 11.3 Key M&A Steps
  • 12. Company Profiles
    • 12.1 Abaxis, Inc.
    • 12.2 Abbott Diagnostics
    • 12.3 Accumetrics, Inc.
    • 12.4 Accurex Biomedical Pvt., Ltd.
    • 12.5 Akers Bioscience (ABI)
    • 12.6 Alfa Scientific Design, Inc.
    • 12.7 Ambri, Ltd.
    • 12.8 American Bio Medica Corp.
    • 12.9 Ani Biotech
    • 12.10 Apogent Technologies
    • 12.11 Ark Therapeutics
    • 12.12 ARKRAY
    • 12.13 Atlas Genetics
    • 12.14 Atonomics
    • 12.15 Avox Systems
    • 12.16 Axis-Shield
    • 12.17 Bayer Corp.
    • 12.18 Beacon Diagnostics
    • 12.19 Beckman Coulter
    • 12.20 Binax Corporation
    • 12.21 Biomerica
    • 12.22 bioMerieux Vitek, Inc.
    • 12.23 BioScan Screening Systems, Inc.
    • 12.24 Biosite Diagnostics
    • 12.25 BioStar
    • 12.26 British Biocell Holdings
    • 12.27 Caliper Life Sciences
    • 12.28 Calypte Biomedical
    • 12.29 Cardiovascular Diagnostics
    • 12.30 Chembio Diagnostics
    • 12.31 Cholestech
    • 12.32 CompuCyte Corporation
    • 12.33 Cozart Bioscience
    • 12.34 Cygnus Therapeutic Systems
    • 12.35 Cytogen
    • 12.36 Dade Behring
    • 12.37 Daiichi Sankyo Group
    • 12.38 Denka Seiken Co., Ltd.
    • 12.39 Diagnostic Chemicals, Ltd.
    • 12.40 EY Laboratories, Inc.
    • 12.41 Enterix, Inc.
    • 12.42 Focus Diagnostic, Inc.
    • 12.43 GDS Technology
    • 12.44 GenBio
    • 12.45 Genzyme Diagnostics
    • 12.46 Grant Life Sciences, Inc.
    • 12.47 Gryphus Diagnostics, LLC
    • 12.48 Guided Therapeutics, Inc
    • 12.49 Helena Laboratories
    • 12.50 Hema Diagnostic Systems
    • 12.51 HemoCue, Inc.
    • 12.52 Home Access Health Corp.
    • 12.53 i-STAT Corporation
    • 12.54 ImmunoScience, Inc.
    • 12.55 Instrumentation Laboratory
    • 12.56 International Medical Innovations
    • 12.57 Inverness Medical Innovations
    • 12.58 Johnson & Johnson
    • 12.59 LifeAssays
    • 12.60 LifePoint, Inc.
    • 12.61 Lifestream Technologies
    • 12.62 LXN Corp. (Inverness Medical Technologies)
    • 12.63 Matritech
    • 12.64 Medical Services International, Inc.
    • 12.65 MediSense
    • 12.66 Medisys
    • 12.67 Medix Biochemica
    • 12.68 MedMira Laboratories
    • 12.69 Meretek Diagnostics Group
    • 12.70 Meridian Bioscience
    • 12.71 MiniMed
    • 12.72 Mitsubishi Chemical USA, Inc.
    • 12.73 Mitsubishi Kagaku Iatron
    • 12.74 Nanogen
    • 12.75 New Horizons Diagnostics
    • 12.76 Nova Biomedical
    • 12.77 OraSure
    • 12.78 Orgenics
    • 12.79 Orion Diagnostica
    • 12.80 PanBio, Ltd.
    • 12.81 Phamatech Corporation
    • 12.82 PharmaNetics, Inc.
    • 12.83 Phillips Medical Systems
    • 12.84 Polymedco
    • 12.85 Polymer Technology Systems
    • 12.86 Princeton BioMeditech Corporation
    • 12.87 Quest Diagnostics
    • 12.88 Quidel
    • 12.89 Radiometer
    • 12.90 Response Biomedical Corp.
    • 12.91 Roche Diagnostics
    • 12.92 Royal Philips Electronics
    • 12.93 StatSure Diagnostic Systems (Saliva Diagnostics)
    • 12.94 Savyon Diagnostics
    • 12.95 Selfcare, Inc.
    • 12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
    • 12.97 Shionogi & Co., Ltd.
    • 12.98 Siemens Corporation
    • 12.99 Guided Therapeutics (SpectRx, Inc.)
    • 12.100 Spectral Diagnostics
    • 12.101 StatSure Diagnostics
    • 12.102 Strategic Diagnostics
    • 12.103 Sun Biomedical Laboratories
    • 12.104 Thoratec/International Technidyne Corp.
    • 12.105 Trinity Biotech, Plc
    • 12.106 Vasamed, Inc.
    • 12.107 Venkateshwara Hatcheries Pvt., Ltd.
  • 13. FDA Currently Waived Tests
  • List of Tables
    • Table 2.1: POCT Frequency in Hospitals
    • Table 2.2: Worldwide Distribution of IVD Testing in 2008
    • Table 2.3: Top Twelve Country IVD Testing Markets, 2007
    • Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing
    • Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008
    • Table 3.2: Number of POCTs in U.S., 2004-2012
    • Table 3.3: Overall In Vitro Diagnostic Testing Market Worldwide, 2007
    • Table 3.4: Largest Diagnostic Companies Worldwide, 2007
    • Table 3.5: Global Point of Care Revenues, 2005-2012
    • Table 3.6: Worldwide Distribution of POCT, 2008
    • Table 3.7: Professional Glucose Testing Market for POCT Worldwide, 2001-2012
    • Table 3.8: U.S. POCT Market, 2000-2012
    • Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008
    • Table 3.10: U.S. POCT by Performance Location, 2008
    • Table 3.11: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
    • Table 3.12: U.S. POCT Glucose Testing Market, 2003-2012
    • Table 3.13: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012
    • Table 3.14: U.S. POCT Coagulation Market Size, 2003-2012
    • Table 3.15: U.S. POCT Cardiac Markers Market Size, 2003-2012
    • Table 3.16: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012
    • Table 3.17: U.S. POCT Urinalysis Market Size, 2003-2012
    • Table 3.18: Manufacturer Market Share U.S. POCT Market, 2008
    • Table 3.19: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2008
    • Table 3.20: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2008
    • Table 3.21: Manufacturer Market Share U.S. POCT Coagulation Market, 2008
    • Table 3.22: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2008
    • Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern Europe
    • Table 3.24: European POCT Market, 2005-2012
    • Table 3.25: European POCT Diagnostics Market, 2007
    • Table 3.26: Top Twelve Country IVD and POC Testing Markets, 2007
    • Table 3.27: Japan POCT Market, 2005-2012
    • Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements
    • Table 12.1: Products Marketed by Abbott in the Diagnostic Market
    • Table 12.2: Quidel Product Sales Distribution and Sales, 2006-2008
    • Table 12.3: Key Products