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.
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.
- 1. Overview
- 1.1 Statement of Report
- 1.2 Scope of This Report
- 1.3 Objectives
- 1.4 Methodology
- 1.5 Executive Summary
- 2. Overview of Point of Care Diagnostic 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 Milestones in Technology Development
- 2.7.3 Drive for Decentralization from Lab to Patient
- 2.7.4 Expanded Reimbursement
- 2.7.5 Competitive Landscape for POCT
- 2.8 The Future of POCT
- 3. POC and Rapid Testing Market: Summary of Market Analysis: Size, Background, Growth, Share and Competitors
- 3.1 Global POCT Market
- 4. U.S. POCT Market
- 5. European POCT Market
- 6. Japanese POCT Market Sector Trends
- 7. Chinese POCT Market Sector Trends
- 8. Indian POCT Market Sector Trends
- 9. The Rest of the World (ROW) POCT Market
- 10. The Role of POCT in Critical Care
- 10.1 Technological Diversity in POCT
- 10.1.1 The Wide Range of Point of Care Assays
- 10.1.2 Challenge of Testing on a Single Platform
- 10.1.3 Connectivity with Testing Platforms
- 10.1.4 Improvement in Clinical Outcomes with Use of POCT
- 10.1.5 Future Developments
- 10.2 Point of Care Addresses Critical Requirements
- 10.2.1 Needs in Critical Care Testing
- 10.2.2 Point of Care Instrument Key Elements
- 10.2.3 Key Advancements--Menu, Quality Assurance (QA), Connectivity, Internet Access
- 10.2.4 Standardized System for All Testing Locations
- 10.3 POCT versus Central Laboratory Testing
- 10.3.1 The Financial Advantages of POCT
- 10.3.2 Is the Shift Towards Point of Care Justified?
- 10.3.3 Overall Cost Benefit
- 10.3.4 More Available Time for Clinical Practitioners
- 10.3.5 Future Policies
- 11. POCT Sector Trends and Market Predictions
- 12. Business Trends in the Point of Care Sector
- 12.1 Sector Consolidation
- 12.2 Acquisition, License Agreements, Internal Development and Partnerships
- 12.3 The Ideal Acquisition Profile
- 12.3.1 Markets of Interest for Acquisition of POCT
- 12.3.2 Key M&A Steps
- 12.4 Product Breadth in POCT
- 12.5 Companies Exiting From POCT
- 12.6 Increased Market Penetration
- 12.7 Costs of Doing Business in Europe
- 12.8 Drivers of European Diagnostics Testing
- 12.9 European Reimbursement Practices
- 12.10 Cost Containment in Europe
- 12.11 Significant Factors that Provide Competitive Advantage
- 12.12 Sales and Marketing Strategies for POCT
- 12.12.1 North American Market
- 12.12.2 International Markets
- 12.12.2.1 Europe
- 12.12.2.2 Central and South America
- 12.12.2.3 Asia-Pacific
- 13. Biotechnology Industry Trends
- 13.1 Pharmaceutical Industry Trends
- 14. Government Regulation
- 14.1 Government Regulation
- 14.1.1 U.S. Regulation
- 14.1.1.1 Importing Medical Devices into the U.S.
- 14.1.1.2 Exporting Medical Devices from the U.S.
- 14.1.2 E.U. Regulations
- 14.1.3 Japanese Regulations
- 14.1.4 Korean Regulations
- 14.2 Post Filing Regulations for Point of Care Devices
- 14.3 Exporting Unapproved POCTs
- 14.4 Analyte Specific Reagents (Home Brew Tests)
- 14.5 Medical Device Registration
- 14.6 Product Labeling
- 14.7 Punitive FDA Actions
- 14.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
- 14.9 Impact of Regulations on the Industry
- 14.10 Minimizing Regulatory Barriers
- 14.11 Waived Testing
- 15. Limited Reimbursements by Third-Party Payers Obstruct Sales
- 15.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales
- 15.2 Reimbursement Codes Classification
- 15.3 Point of Care Product Line Reimbursement Picture
- 16. Barriers to Business
- 16.1 Concentration of Customers
- 16.2 Intense Competition from Other Companies
- 16.3 Protection of Intellectual Property Rights
- 16.4 Physician Acceptance
- 16.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth
- 16.6 Additional Applications of Technology Platform
- 16.7 Management of Growth
- 16.8 Difficulty of Establishing a Marketing Infrastructure
- 17. Company Profiles
- 17.1 Abaxis, Inc.
- 17.2 Abbott Diagnostics
- 17.3 Accumetrics, Inc.
- 17.4 Accurex Biomedical Pvt. Ltd.
- 17.5 AgaMatrix
- 17.6 Akers Bioscience, Inc. (ABI)
- 17.7 Alfa Scientific Design, Inc.
- 17.8 Alere Health, LLC
- 17.9 Ambri Ltd.
- 17.10 American Bio Medica Corporation
- 17.11 Ani Biotech
- 17.12 Apogent Technologies
- 17.13 Ark Therapeutics
- 17.14 ARKRAY, Inc.
- 17.15 Atlas Genetics
- 17.16 Atonomics A/S
- 17.17 Avox Systems
- 17.18 Axis-Shield
- 17.19 Bayer Corp.
- 17.20 Beacon Diagnostics, Inc.
- 17.21 Beckman Coulter
- 17.22 Binax Corporation
- 17.23 Biomerica, Inc.
- 17.24 bioMerieux
- 17.25 BioScan Screening Systems, Inc.
- 17.26 Biosite Diagnostics
- 17.27 British Biocell Holdings
- 17.28 Caliper Life Sciences
- 17.29 Calypte Biomedical Corporation
- 17.30 Chembio Diagnostics, Inc.
- 17.31 Cholestech
- 17.32 CompuCyte Corporation
- 17.33 Cozart Bioscience
- 17.34 Cygnus Therapeutic Systems
- 17.35 Cytogen Corporation
- 17.36 Dade Behring
- 17.37 Daiichi Sankyo Group
- 17.38 Denka Seiken Co., Ltd.
- 17.39 Diagnostic Chemicals Ltd.
- 17.40 EY Laboratories, Inc.
- 17.41 Enterix, Inc.
- 17.42 Focus Diagnostic, Inc.
- 17.43 GDS Technology
- 17.44 GenBio
- 17.45 Genzyme Diagnostics
- 17.46 Grant Life Sciences, Inc.
- 17.47 Gryphus Diagnostics, LLC
- 17.48 Guided Therapeutics, Inc.
- 17.49 Harring Group Ltd. (HGR)
- 17.50 Helena Laboratories
- 17.51 Hema Diagnostic Systems, LLC
- 17.52 HemoCue, Inc.
- 17.53 Home Access Health Corp.
- 17.54 i-STAT Corporation
- 17.55 ImmunoScience, Inc.
- 17.56 Instrumentation Laboratory
- 17.57 International Medical Innovations
- 17.58 Johnson & Johnson
- 17.59 LifeAssays AB
- 17.60 MediSense
- 17.61 Medisys
- 17.62 Medix Biochemica
- 17.63 MedMira Laboratories
- 17.64 Medtronic
- 17.65 A Menarini Diagnostics
- 17.66 Meretek Diagnostics Group
- 17.67 Meridian Bioscience
- 17.68 MiniMed
- 17.69 Mitsubishi Chemical USA, Inc.
- 17.70 Mitsubishi Kagaku Iatron
- 17.71 Nanogen (ELITech Group)
- 17.72 New Horizons Diagnostics
- 17.73 Nova Biomedical
- 17.74 OraSure Technologies, Inc.
- 17.75 Orgenics
- 17.76 Orion Diagnostica
- 17.77 PanBio Ltd.
- 17.78 Phamatech, Inc.
- 17.79 PharmaNetics, Inc.
- 17.80 Polymedco, Inc.
- 17.81 Polymer Technology Systems, Inc.
- 17.82 Princeton BioMeditech Corporation
- 17.83 Quest Diagnostics, Inc.
- 17.84 Quidel Corporation
- 17.85 Radiometer
- 17.86 Response Biomedical Corp.
- 17.87 Roche Diagnostics
- 17.88 Savyon Diagnostics
- 17.89 Selfcare, Inc.
- 17.90 Shionogi & Co., Ltd.
- 17.91 Siemens Corporation
- 17.92 Guided Therapeutics (SpectRx, Inc.)
- 17.93 Spectral Diagnostics
- 17.94 StatSure Diagnostic Systems, Inc.
- 17.95 Strategic Diagnostics
- 17.96 Trinity Biotech, Plc
- 17.97 Vasamed, Inc.
- 18. FDA Currently Waived Tests
- INDEX OF FIGURES
- Figure 14.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
- Category
- INDEX OF TABLES
- Table 2.1: POCT Frequency in Hospitals
- Table 2.2: Worldwide Distribution of IVD Testing, 2010
- Table 2.3: Top Thirteen Country IVD Testing Markets, 2010
- Table 2.4: Common Genotype Techniques
- Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing
- Table 3.1: Total Global POCT Market, 2007-2017
- Table 3.2: Global Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017
- Table 3.3: Global Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017
- Table 3.4: Global Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017
- Table 3.5: Global Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017
- Table 3.6: Global Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017
- Table 3.7: Global Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017
- Table 3.8: Global Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017
- Table 3.9: Global Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017
- Table 3.10: Global Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017
- Table 3.11: Global Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017
- Table 3.12: Global Market Share Analysis, 2010
- Table 4.1: Total U.S. POCT Market for Blood Glucose Monitoring Systems, 2007-2017
- Table 4.2: U.S Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017
- Table 4.3: U.S Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017
- Table 4.4: U.S. Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017
- Table 4.5: U.S. Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017
- Table 4.6: U.S. Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market, 2007-2017
- Table 4.7: U.S. Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017
- Table 4.8: U.S. Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017
- Table 4.9: U.S. Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017
- Table 4.10: U.S. Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017
- Table 4.11: U.S. Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017
- Table 4.12: U.S. Market Share Analysis, 2010
- Table 5.1: Models of Public-Private Partnership in Hospital Provision
- Table 5.2: European Revenue Forecasts for POCT Market, 2007-2017
- Table 5.3: European Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017
- Table 5.4: European Revenue Forecasts for POC Blood Gas and Electrolyte Analyzers, 2007-2017
- Table 5.5: European Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017
- Table 5.6: European Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017
- Table 5.7: European Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
- 2007-2017
- Table 5.8: European Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017
- Table 5.9: European Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017
- Table 5.10: European Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017
- Table 5.11: European Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017
- Table 5.12: European Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017
- Table 5.13: European Market Share Analysis, 2010
- Table 6.1: Total Japanese POCT Market, 2007-2017
- Table 6.2: Japanese Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017
- Table 6.3: Japanese Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017
- Table 6.4: Japanese Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017
- Table 6.5: Japanese Revenue Forecasts for POC Cardiac Marker Devices, 2007-2017
- Table 6.6: Japanese Revenue Forecasts for POC Substance/Drug Abuse Testing Device Market,
- 2007-2017
- Table 6.7: Japanese Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017
- Table 6.8: Japanese Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017
- Table 6.9: Japanese Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017
- Table 6.10: Japanese Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017
- Table 6.11: Japanese Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017
- Table 6.12: Japanese Market Share Analysis, 2010
- Table 9.1: ROW Revenue Forecasts for POC Market, 2007-2017
- Table 9.2: ROW Revenue Forecasts for POC Blood Glucose Monitoring Systems, 2007-2017
- Table 9.3: ROW Revenue Forecasts for POC Blood Gas and Electrolytes Systems Analysis, 2007-2017
- Table 9.4: ROW Revenue Forecasts for POC Rapid Coagulation Analyzer Systems, 2007-2017
- Table 9.5: ROW Revenue Forecasts for POC Cardiac Marker Devices Market, 2007-2017
- Table 9.6: ROW Revenue Forecasts for POC Substance/Drug Abuse Testing Devices Market, 2007-2017
- Table 9.7: ROW Revenue Forecasts for POC Infectious Disease Testing Devices Market, 2007-2017
- Table 9.8: ROW Revenue Forecasts for POC Urine Strip Testing Products Market, 2007-2017
- Table 9.9: ROW Revenue Forecasts for POC Pregnancy Testing Devices Market, 2007-2017
- Table 9.10: ROW Revenue Forecasts for POC Fecal Occult Testing Devices Market, 2007-2017
- Table 9.11: ROW Revenue Forecasts for POC Cholesterol Testing Products Market, 2007-2017
- Table 9.12: ROW Market Share Analysis, 2010
- Table 10.1: Customized Reports Must Support CAP and JCAHO Requirements
- Table 17.1: Abaxis, Inc. Financial Figures--Net Sales by Business Sector, 2008-2010
- Table 17.2: Abaxis, Inc. Financial Figures--Net Sales by Geographic Region, 2008-2010
- Table 17.3: Abbott Laboratories Financial Figures--Net Sales by Business Sector, 2008-2010
- Table 17.4: Abbott Laboratories Financial Figures--Net Sales by Geographic Region, 2008-2010
- Table 17.5: Bayer AG Financial Figures--Net Sales by Business Sector, 2008-2010
- Table 17.6: Bayer AG Financial Figures--Net Sales by Geographic Region, 2008-2010
- Table 17.7: Johnson & Johnson Financial Figures--Net Sales by Major Medical and Diagnostics Businesses,
- 2008-2010
- Table 17.8: Medtronic Financial Figures--Net Sales by Segment, 2008-2010
- Table 17.9: Quidel Product Sales Distribution and Sales, 2009 and 2010
- Table 17.10: Danaher Corporation Financial Figures--Net Sales by Business Sector, 2008-2010
- Table 17.11: Danaher Corporation Financial Figures--Net Sales by Geographic Region, 2008-2010
- Table 17.12: Roche Group Financial Figures--Net Sales by Business Sector, 2008-2010
- Table 17.13: Roche Group Financial Figures--Net Sales by Geographic Region, 2009 and 2010
- Table 17.14: Roche Group Financial Figures--Net Sales by Sub-Division, 2008-2010
- 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
Other selected research from the 'Point-of-Care Diagnostics' category:
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As Kalorama Information’s lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality are here. But is healthcare... Learn More
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Point of care testing (POCT) enables diagnostic tests to be performed rapidly while the patient remains at the point of care facility, such as a hospital, health clinic, doctor’s office... Learn More
