Welcome to BioSeeker Group!

Point of Care Diagnostic Testing Sector Trends

Additional Information

Published Date Nov 1, 2011
Pages 189
PDF Fact Sheet View TOC for the report Point of Care Diagnostic Testing Sector Trends in PDF
Format PDF
Publisher TriMark Publications LLC

Availability: In stock

€0.00

Quick Overview

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...
Request free sample pages from 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.
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


Request free sample pages from Point of Care Diagnostic Testing Sector Trends

Other selected research from the 'Point-of-Care Diagnostics' category:


Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads
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


European Point of Care Diagnostic Testing Markets
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