Point of Care Diagnostic Testing Sector Trends

Table of 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

INDEX 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