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 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.

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

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Point of Care Diagnostic Testing Sector Trends

Introduction

Abstract

The main objectives of this analysis are:

By purchasing this report, the reader will have:

Key questions answered in this report:

This report contains:

Table of Contents