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Point of Care Diagnostic Testing World Markets

Publication Date June 2009
Publisher TriMark Publications
Product Type Report
Pages 379
ISBN Number not applicable
Product Code TRI00093
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Summary

This TriMark Publications report describes latest developments in the point of care diagnostic testing (POCT) market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. The current market condition of all clinical segments involving point of care testing is examined. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Also, parallel areas where rapid detection is important using hand held devices such as rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are discussed in detail.

The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S and worldwide, including China and India. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position.

The main objectives of this analysis are:

  • Identifying viable technology drivers through a comprehensive look at platform technologies for POCT.
  • Understanding the different sectors of POCT, looking at the hospital market segment and, separately, at a description of the instruments, reagents and supplies marketed by major companies in each segment.
  • Obtaining a complete understanding of the individual point of care tests from their basic principles to their clinical applications.
  • Discovering exciting 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 technology, as well as important country markets, including growth forecasts.
  • Presenting market figures regarding the current value of the POCT, five year market projections, market share, key players and sector growth rates. The source of this information is the most current data derived from the global diagnostic industry.

This study contains:

  • A 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 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.
  • An analysis of potential new point of care applications in the clinical sector.
  • Market predictions and trends analysis concerning U.S. expenditures on point of care solutions.
  • Projections of point of care market sizes for European and Asian markets.
  • 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 M&A developments in the point of care marketplace.
  • A comprehensive overview and insight into point of care business strategies.
  • An in-depth examination of the subsections of each market segment, including the physician office laboratories (POLs) and clinic testing.

Analysis includes over 100 charts and graphs measuring product growth and trends within the point of care marketplace. Company-specific information, including sales figures, product pipeline status and R&D trends, is provided.

This review will also:

  • Assess point of care market drivers and bottlenecks, from medical and scientific community perspectives.
  • Discuss the potential benefits of point of care for various sectors of the medical and scientific community.
  • Establish the current total market size and future growth of the point of care market and analyze the current size and growth of individual segments.
  • Provide current and forecasted market shares by company.
  • Discuss profit and business opportunities by segment.
  • Provide strategic recommendations for near-term business opportunities.
  • Assess current commercial uses of the point of care market.

The following questions will also be addressed in this analysis:

  • What are the near-term business opportunities in the point of care market?
  • What are the current and forecasted point of care market sizes in the U.S., European Union (E.U.) and Japan, as well as in other key country markets?
  • What are the business models currently used by companies in the point of care market?
  • How will manufacturers, researchers, physicians and patients influence this market?
  • What are the drivers and bottlenecks influencing the point of care market?
  • What are the technologies used in point of care?
  • Who holds the proprietary rights to the point of care market technology platforms?
  • In the U.S., Japan and the E.U., what regulatory processes apply to point of care technologies?
  • How will new point of care technologies change diagnostic screening testing paradigms?
  • How will new point of care technologies reduce healthcare expenditures and affect R&D spending?

The report contains:

  • A comprehensive overview of the several categories of point of care technology platforms that are, or will be, revolutionizing the use of diagnostic tests in hospitals.
  • A sector on each of the important point of care categories and applications.
  • Full descriptions of the technologies involved and how these differ from existing and emerging technologies.
  • Analysis of the technological approaches undertaken by various competitors, as well as industry and end-user responses to these products.
  • Regulatory issues and legislation affecting use and marketing of point of care products.
  • Market forecasts for each category of product, including profiles of selected competitors.

Content

  • 1. Overview
    • 1.1 About this Report
    • 1.2 Scope of the Report
    • 1.3 Objectives
    • 1.4 Methodology
    • 1.5 Executive Summary
  • 2. Overview of Diagnostic Testing Point of Care
    • 2.1 Point of Care Testing Sites
    • 2.2 Point of Care Market Structure
  • 3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors
    • 3.1 Global POCT Market
    • 3.2 U.S. POCT Market
    • 3.3 European POCT Market
      • 3.3.1 German POCT Diagnostic Market
      • 3.3.2 U.K. POCT Diagnostic Market
        • 3.3.2.1 U.K. POCT Market Statistics
        • 3.3.2.2 U.K. Competitive Analysis
        • 3.3.2.3 U.K. Market Access
      • 3.3.3 French POCT Diagnostic Market
      • 3.3.4 Italian POCT Diagnostic Market
      • 3.3.5 Spanish POCT Diagnostic Market
      • 3.3.6 Scandinavian POCT Diagnostic Market
      • 3.3.7 Swedish POCT Diagnostic Market
      • 3.3.8 Finland POCT Diagnostic Market
      • 3.3.9 Norway POCT Diagnostic Market
      • 3.3.10 Swiss POCT Diagnostic Market
      • 3.3.11 Dutch POCT Diagnostic Market
      • 3.3.12 Belgian POCT Diagnostic Market
      • 3.3.13 Portugal POCT Diagnostic Market
      • 3.3.14 Austria POCT Diagnostic Market
      • 3.3.15 Greek POCT Diagnostic Market
      • 3.3.16 Poland POCT Diagnostic Market
      • 3.3.17 Czech Republic POCT Diagnostic Market
      • 3.3.18 Turkish POCT Diagnostic Market
    • 3.4 Asian POCT Markets
      • 3.4.1 Japanese POCT Diagnostic Market
      • 3.4.2 Indian POCT Diagnostic Market
      • 3.4.3 Chinese POCT Diagnostic Market
    • 3.5 Rest of the World POCT Market
      • 3.5.1 Canada POCT Diagnostic Market
      • 3.5.2 Brazil POCT Diagnostic Market
      • 3.5.3 Australia POCT Diagnostic Market
    • 3.6 Overview of Asian Healthcare Market
      • 3.6.1 Singapore
      • 3.6.2 Malaysia
      • 3.6.3 Thailand
      • 3.6.4 Indonesia
      • 3.6.5 Philippines
      • 3.6.6 South Korea
      • 3.6.7 Taiwan
  • 4. POCT Individual Markets
    • 4.1 Glucose Testing
    • 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors
      • 4.2.1 World Market
      • 4.2.2 U.S. Market
      • 4.2.3 European Market
      • 4.2.4 Alternate Glucose Monitoring Products
      • 4.2.5 HbA1c POCT
    • 4.3 Blood Gas and Electrolytes
      • 4.3.1 Whole Blood Lactate
    • 4.4 Rapid Coagulation Tests
      • 4.4.1 World POCT Coagulation Market
      • 4.4.2 U.S. Coagulation Market
      • 4.4.3 European Coagulation Market
      • 4.4.4 Trends in POCT Coagulation Testing
    • 4.5 Rapid Cardiac Markers
      • 4.5.1 U.S. Market
      • 4.5.2 European Market
    • 4.6 Drugs of Abuse Screening Testing
      • 4.6.1 Acetaminophen
      • 4.6.2 Tricyclic Antidepressants (TCAs)
      • 4.6.3 Other Toxic Drugs
      • 4.6.4 Drug Testing Selectivity
      • 4.6.5 Methaqualone and Phencyclidine (PCP)
      • 4.6.6 Tetrahydrocannabinol
      • 4.6.7 Drug Panels by Toxidromes
      • 4.6.8 Alcohol Testing
    • 4.7 Urine Strips
    • 4.8 Pregnancy Tests
    • 4.9 Fecal Occult Blood
    • 4.10 Hemoglobin Testing
    • 4.11 Miscellaneous Rapid Tests
      • 4.11.1 Estriol
      • 4.11.2 Fetal Fibronectin (fFN)
      • 4.11.3 H. pylori
      • 4.11.4 Vaginal pH and Vaginitis
      • 4.11.5 Bladder Cancer
      • 4.11.6 Fetal Status
      • 4.11.7 Heparin-Induced Thrombocytopenia
    • 4.12 Human Immunodeficiency Virus (HIV)
    • 4.13 Cholesterol
    • 4.14 Infectious Disease
      • 4.14.1 C. difficile
      • 4.14.2 Giardia
      • 4.14.3 Salmonella and Campylobacter
      • 4.14.4 Malaria Testing
      • 4.14.5 Influenza Testing
      • 4.14.6 Strep Testing
      • 4.14.7 Chlamydia
      • 4.14.8 Mononucleosis
      • 4.14.9 Rubella
      • 4.14.10 Methicillin-Resistant Staphylococcus Aureus (MRSA)
      • 4.14.11 Hepatitis
      • 4.14.12 Gonorrhea
      • 4.14.13 Tuberculosis (TB)
      • 4.14.14 Herpes Simplex Virus Type-2
    • 4.15 Infant Jaundice
    • 4.16 Anthrax
    • 4.17 Rupture of Fetal Membranes (ROM)
    • 4.18 Food Pathogens
    • 4.19 Typhoid
  • 5. POCT: Reagents and Equipment
    • 5.1 Blood Glucose Monitoring
      • 5.1.1 LifeScan
      • 5.1.2 Roche Accu-Chek
      • 5.1.3 Siemens Healthcare Diagnostics
      • 5.1.4 Cholestech (Acquired by Inverness Medical Innovations)
      • 5.1.5 Abbott Diabetes Care
      • 5.1.6 International Technidyne Corporation
      • 5.1.7 HemoCue
      • 5.1.8 Stanbio/GDS Technology
      • 5.1.9 Disetronic Medical Systems
      • 5.1.10 Medtronic MiniMed
      • 5.1.11 Abaxis
    • 5.2 Blood Gas and Electrolytes
      • 5.2.1 Roche Corporation
      • 5.2.2 TechnoMedica
      • 5.2.3 Siemens Healthcare Diagnostics
      • 5.2.4 Instrumentation Laboratory
      • 5.2.5 Nova Biomedical
      • 5.2.6 Radiometer
      • 5.2.7 Abbott Laboratories
      • 5.2.8 Span Diagnostics
      • 5.2.9 Avox Systems
      • 5.2.10 ITC
      • 5.2.11 OPTImedical
    • 5.3 Rapid Coagulation Tests
      • 5.3.1 POC Coagulation Instrument Description
        • 5.3.1.1 Roche Diagnostics Corp
        • 5.3.1.2 Abbott Laboratories
        • 5.3.1.3 International Technidyne Corp
        • 5.3.1.4 Medtronic
        • 5.3.1.5 HemoSense (Inverness)
        • 5.3.1.6 Helena Laboratories Point of Care
        • 5.3.1.7 Sienco, Inc
        • 5.3.1.8 Accumetrics
      • 5.3.2 Connectivity Issues
      • 5.3.3 Cost Benefits
      • 5.3.4 Quality Control Issues
      • 5.3.5 Certification for POC Coagulation Devices
    • 5.4 Rapid Cardiac Markers
      • 5.4.1 Nanogen
      • 5.4.2 Biosite Diagnostics (Inverness)
      • 5.4.3 Roche Diagnostics
      • 5.4.4 Ani Biotech
      • 5.4.5 Response Biomedical Corporation
      • 5.4.6 Siemens Healthcare Diagnostics
      • 5.4.7 Lab21 Limited
      • 5.4.8 Abbott Laboratories
      • 5.4.9 LifeSign (Princeton BioMediTech Corp)
      • 5.4.10 Mitsubishi Kagaku Iatron
    • 5.5 Rapid Drugs of Abuse
      • 5.5.1 Biosite Diagnostics (now a brand of Inverness Medical Innovations)
      • 5.5.2 Abbott Diagnostics
      • 5.5.3 Roche Diagnostics
      • 5.5.4 BioScan Screening Systems, Inc
      • 5.5.5 American Bio Medica Corp
      • 5.5.6 Phamatech, Inc
      • 5.5.7 Worldwide Medical
      • 5.5.8 OraSure
      • 5.5.9 LifePoint
      • 5.5.10 Avitar, Inc
      • 5.5.11 Cozart Biosciences
      • 5.5.12 Pathtech
      • 5.5.13 Alfa Scientific Designs, Inc
      • 5.5.14 TCPI, Inc
      • 5.5.15 Roche
      • 5.5.16 Siemens Corporation
      • 5.5.17 Diagnostic Chemical, Ltd
      • 5.5.18 Quidel
      • 5.5.19 HemoCue (Quest)
    • 5.6 Rapid Pregnancy and Fertility Tests
    • 5.7 Fecal Occult Blood
      • 5.7.1 Helena Laboratories
      • 5.7.2 Biomerica
      • 5.7.3 Beckman Coulter
      • 5.7.4 Worldwide Medical
      • 5.7.5 Aerscher Diagnostics
      • 5.7.6 Enterix
      • 5.7.7 Medix Biochemica
    • 5.8 Hemoglobin Testing
      • 5.8.1 Wampole Laboratories
      • 5.8.2 HemoCue, Inc
      • 5.8.3 Stanbio/GDS Technology
    • 5.9 Miscellaneous Rapid Tests
      • 5.9.1 Triage C. difficile Panel
      • 5.9.2 Ketoacids
      • 5.9.3 Acetaminophen
      • 5.9.4 Estriol
      • 5.9.5 H. pylori
      • 5.9.6 Vaginal Fluid pH and Vaginitis
      • 5.9.7 Prostate Specific Antigen (PSA)
      • 5.9.8 Bladder Cancer
      • 5.9.9 Other Rapid Cancer Tests
      • 5.9.10 Fetal Status (PROM)
      • 5.9.11 Osteoporosis
      • 5.9.12 Hemodynamic Monitoring
      • 5.9.13 Heparin-Induced Thrombocytopenia
    • 5.10 HIV
      • 5.10.1 Whole Blood, Serum or Plasma-Based HIV Tests
        • 5.10.1.1 Bio-Rad Laboratories
        • 5.10.1.2 Orgenics (wholly-owned by Inverness Medical Innovations)
        • 5.10.1.3 StatSure Diagnostic Systems
        • 5.10.1.4 Trinity Biotech
        • 5.10.1.5 Savyon Diagnostics
        • 5.10.1.6 MedPharm
        • 5.10.1.7 American Bio Medica Corp
        • 5.10.1.8 Chembio Diagnostics
        • 5.10.1.9 OraSure
        • 5.10.1.10 Inverness
      • 5.10.2 Saliva-Based HIV Tests
        • 5.10.2.1 OraSure Collection Device
        • 5.10.2.2 SureStat
      • 5.10.3 Urine-Based HIV Tests
        • 5.10.3.1 MedMira Laboratories, Inc
        • 5.10.3.2 Medical Services International, Inc
        • 5.10.3.3 Maxim Biomedical
        • 5.10.3.4 Wampole Laboratories
    • 5.11 Cholesterol
      • 5.11.1 Cholestech (Now a Brand of Inverness Medical Innovations)
      • 5.11.2 Actimed Laboratories
      • 5.11.3 StatSite Meter
      • 5.11.4 Polymer Technology Systems
      • 5.11.5 PreMD Inc. (f/k/a International Medical Innovations, Inc. (IMI))
      • 5.11.6 Abaxis, Inc
    • 5.12 Infectious Disease
      • 5.12.1 C. difficile
      • 5.12.2 Giardia
      • 5.12.3 Dengue Fever
      • 5.12.4 Malaria Testing
      • 5.12.5 Rapid Influenza Testing
      • 5.12.6 Streptococcus Testing
      • 5.12.7 Chlamydia
      • 5.12.8 Mononucleosis
      • 5.12.9 Rubella
      • 5.12.10 Staphylococcus Aureus and MRSA
      • 5.12.11 Hepatitis
      • 5.12.12 E. Coli O157
      • 5.12.13 Gonorrhea Testing
      • 5.12.14 Smallpox
      • 5.12.15 SARS
      • 5.12.16 Rabies
      • 5.12.17 Tuberculosis
      • 5.12.18 Avian Flu
      • 5.12.19 West Nile Virus
      • 5.12.20 Herpes Simplex Virus Type-2
    • 5.13 Infant Jaundice
    • 5.14 Anthrax
    • 5.15 Homeland Defense (Plague and Tularemia)
    • 5.16 BSE (Mad Cow Disease)
    • 5.17 Tuberculosis
    • 5.18 Typhoid
    • 5.19 Avian Flu
    • 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter)
    • 5.21 Ruptured Fetal Membranes (ROM)
  • 6. POCT: Growth Regulators
    • 6.1 Moderators of Growth
    • 6.2 Personnel Acceptance
    • 6.3 Key People for POCT
    • 6.4 Information Management Issues
      • 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities
      • 6.4.2 Data Mining
      • 6.4.3 Middleware
      • 6.4.4 Web Portals
      • 6.4.5 POCT-1A Standard
    • 6.5 Key Elements for POCT
    • 6.6 POCT and Reimbursement
    • 6.7 Effectiveness of Clinical Outcomes
    • 6.8 Rapid Near-Patient Testing in Hospitals
    • 6.9 Satellite Facilities
    • 6.10 Regionalization of Laboratory Care
    • 6.11 Requirements for POCT
    • 6.12 Locations of Point of Care for Patient Care
    • 6.13 Benefits of POCT
    • 6.14 Cost Elements of POCT
    • 6.15 Necessary Functions in POCT
    • 6.16 TAT for POCT
    • 6.17 Clinical Laboratory Improvement Amendments (CLIA)
    • 6.18 Sexually-Transmitted Diseases in Underdeveloped Countries
  • 7. Business Trends in the Point of Care Sector
    • 7.1 Sector Consolidation
    • 7.2 Diagnostic Testing Growth Trends
    • 7.3 Acquisition, License Agreements, Internal Development and Partnerships
    • 7.4 Product Testing Depth in POCT
    • 7.5 Government Regulation
      • 7.5.1 U.S. Regulation
        • 7.5.1.1 Importing Medical Devices into the U.S
        • 7.5.1.2 Exporting Medical Devices from the U.S
      • 7.5.2 U.K. Regulation
      • 7.5.3 E.U. Regulation
        • 7.5.3.1 French Regulation
      • 7.5.4 Japanese Regulation
      • 7.5.5 Korean Regulation
    • 7.6 Increased Market Penetration
    • 7.7 Costs of Doing Business in Europe
    • 7.8 Drivers of European Diagnostics Testing
    • 7.9 European Reimbursement Practices
    • 7.10 Cost Containment in Europe
  • 8. Technology Platform Innovations in POCT
    • 8.1 Sensor Systems for Diagnostic Applications
    • 8.2 Glucose Measurements
    • 8.3 Glucose Test Methods
    • 8.4 Cholesterol Testing
    • 8.5 The New Paradigm
    • 8.6 Consolidated Workstations and Modularity
    • 8.7 Automation and Robotics in the Clinical Laboratory
    • 8.8 Laboratory Information Systems (LIS)
      • 8.8.1 NOVIUS Lab
    • 8.9 Biosensor Technology
    • 8.10 Nanogen Third Generation POC Analyzer
    • 8.11 Quidel MChip
  • 9. Data Management and Connectivity
    • 9.1 Wireless LANs
    • 9.2 Connectivity Platforms
      • 9.2.1 DataLink Data Management System
      • 9.2.2 RALS-Plus
        • 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite
        • 9.2.2.2 Siemens Diagnostics Rapidpoint? Coag
        • 9.2.2.3 Radiometer
        • 9.2.2.4 HemoCue?s DM Hemoglobin
        • 9.2.2.5 Roche Diagnostics
      • 9.2.3 BD.id
      • 9.2.4 Medical Implant Communications Service (MICS)
    • 9.3 Advantages of POCT Connectivity
      • 9.3.1 Cost Benefit of POCT and IT Connectivity
      • 9.3.2 Hospital Network Issues
  • 10. Corporate Profiles
    • 10.1 Abaxis, Inc
    • 10.2 Abbott Diagnostics
    • 10.3 Accumetrics, Inc
    • 10.4 Accurex Biomedical, Pvt., Ltd
    • 10.5 Akers Biosciences
    • 10.6 Alfa Scientific Design, Inc
    • 10.7 Ambri, Ltd
    • 10.8 American Bio Medica Corp
    • 10.9 Ani Biotech
    • 10.10 Apogent Technologies
    • 10.11 Ark Therapeutics
    • 10.12 ARKRAY
    • 10.13 Atlas Genetics
    • 10.14 Atonomics
    • 10.15 Avitar, Inc
    • 10.16 Avox Systems
    • 10.17 Axis-Shield
    • 10.18 Beckman Coulter
    • 10.19 Binax Corporation
    • 10.20 Biomerica
    • 10.21 BioM?rieux Vitek, Inc
    • 10.22 BioScan Screening Systems, Inc
    • 10.23 Biosite Diagnostics
    • 10.24 BioStar
    • 10.25 British Biocell Holdings
    • 10.26 Caliper Life Sciences
    • 10.27 Calypte Biomedical
    • 10.28 Chembio Diagnostics
    • 10.29 Cholestech
    • 10.30 Chongqing Sungene Pharmaceutical Co., Ltd
    • 10.31 CompuCyte Corporation
    • 10.32 Cortech Diagnostics Ltd. (Now Called Kent International Holdings)
    • 10.33 Cozart Biosciences
    • 10.34 Cygnus Therapeutic Systems
    • 10.35 Cytogen
    • 10.36 DexCom
    • 10.37 Daiichi Sankyo Group
    • 10.38 Denka Seiken Co., Ltd
    • 10.39 Diagnostic Chemicals, Ltd
    • 10.40 Enterix, Inc
    • 10.41 Focus Diagnostics, Inc
    • 10.42 GDS Technology
    • 10.43 GenBio
    • 10.44 Genzyme Diagnostics
    • 10.45 Grant Life Sciences
    • 10.46 Gryphus Diagnostics
    • 10.47 Helena Laboratories
    • 10.48 Hema Diagnostic Systems
    • 10.49 Hemocue, Inc
    • 10.50 Home Access Health Corp
    • 10.51 Immunoscience, Inc
    • 10.52 Instrumentation Laboratory
    • 10.53 International Medical Innovations
    • 10.54 Inverness Medical Innovations
    • 10.55 Johnson & Johnson
    • 10.56 Kyowa Medex Co., Ltd
    • 10.57 LifeAssays
    • 10.58 LifePoint, Inc
    • 10.59 LifeScan Corporation
    • 10.60 Lifestream Technologies
    • 10.61 LXN Corp. (Inverness Medical Technologies)
    • 10.62 Matritech
    • 10.63 Medical Services International, Inc
    • 10.64 MediSense
    • 10.65 Medisys
    • 10.66 Medix Biochemica
    • 10.67 MedMira Laboratories
    • 10.68 Meretek Corporation
    • 10.69 Meridian Bioscience
    • 10.70 MiniMed
    • 10.71 Mitsubishi Chemical U.S.A, Inc
    • 10.72 Mitsubishi Kagaku Iatron
    • 10.73 Nanogen
    • 10.74 New Horizons Diagnostics
    • 10.75 Nova Biomedical
    • 10.76 OraSure
    • 10.77 Orgenics
    • 10.78 Orion Diagnostica
    • 10.79 PanBio, Ltd
    • 10.80 Phamatech, Inc
    • 10.81 PharmaNetics, Inc
    • 10.82 Polymedco
    • 10.83 Polymer Technology Systems
    • 10.84 Princeton BioMeditech Corporation
    • 10.85 Quest Diagnostics
    • 10.86 Quidel
    • 10.87 Radiometer
    • 10.88 Response Biomedical Corp
    • 10.89 Roche Diagnostics
    • 10.90 Royal Philips Electronics
    • 10.91 Savyon Diagnostics
    • 10.92 Selfcare, Inc
    • 10.93 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
    • 10.94 Shionogi & Co., Ltd
    • 10.95 Siemens Corporation
    • 10.96 SpectRx, Inc
    • 10.97 Spectral Diagnostics
    • 10.98 StatSure Diagnostic Systems
    • 10.99 Strategic Diagnostics
    • 10.100 Sun Biomedical Laboratories
    • 10.101 Thoratec/International Technidyne Corp
    • 10.102 Transmedica
    • 10.103 Trinity Biotech
    • 10.104 Vasamed, Inc
    • 10.105 Venkateshwara Hatcheries Pvt., Ltd
  • 11. POCT Sector Trends and Forecasts
    • 11.1 Home Care Analysis as Part of Near-Patient Testing
    • 11.2 Non-Traditional Collection for POCT
    • 11.3 New Systems for Critical Care and Near-Patient Testing
    • 11.4 Utility of Near-Patient Testing in Critical Care Settings
    • 11.5 Physician?s Office Market
    • 11.6 Information Management Advances
    • 11.7 Test-Ordering Patterns and Demand for POCT
    • 11.8 Demand for Emergency Department Services
    • 11.9 Move Away From Central Laboratory
    • 11.10 Healthcare Cost Controls
    • 11.11 M&A in POCT
    • 11.12 Competition for Services
    • 11.13 Drivers of POCT
    • 11.14 Confluence of New Technology
    • 11.15 Difficulties of Design for POC Products
    • 11.16 European Hospital Structure
    • 11.17 The Biggest New Opportunities in Point of Care Testing
  • 12. Corporate Directory
  • List of Tables
    • Table 2.1: Percentage of Point of Care Testing Performed in Selected Hospitals
    • Table 2.2: Point of Care Testing Procedural Advantages for Hospital Testing
    • Table 2.3: Point of Care Testing Trends
    • Table 2.4: Professional Point of Care Testing Compared to Home Testing
    • Table 2.5: Drivers for Integrating Point of Care Testing into Hospital Routines
    • Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008
    • Table 3.2: Number of Point of Care Tests in U.S., 2000-2012
    • Table 3.3: Global Clinical Laboratory Market Sales, 1998-2010
    • Table 3.4: Overall In Vitro Diagnostic Testing Market Worldwide, 2007
    • Table 3.5: Worldwide Distribution of IVD Testing, 2008
    • Table 3.6: Top Twelve Country IVD Testing Markets, 2007
    • Table 3.7: Thirteen Largest Diagnostic Companies Worldwide, 2007
    • Table 3.8: Global Point of Care Revenues, 2005-2012
    • Table 3.9: Worldwide POCT Market Size by Geographic Location, 2005-2012
    • Table 3.10: Worldwide Distribution of POCT, 2008
    • Table 3.11: Worldwide POCT by Performance Location, 2008
    • Table 3.12: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
    • Table 3.13: Largest POCT Diagnostic Companies Worldwide, 2007
    • Table 3.14: U.S. Clinical Laboratory Testing Market, 2003-2012
    • Table 3.15: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2008
    • Table 3.16: U.S. POCT Market, 2000-2012
    • Table 3.17: U.S. POCT by Performance Location, 2008
    • Table 3.18: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
    • Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market ($), 2000-2012
    • Table 3.20: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012
    • Table 3.21: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007
    • Table 3.22: European Rapid Point of Care Testing by Country Market Estimates, 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: Top Twelve Country IVD and POC Testing Markets, 2007
    • Table 3.26: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012
    • Table 3.27: German POCT Diagnostics Products Market Sales, 2003-2012
    • Table 3.28: German Clinical Diagnostic Rapid Test Market Segments, 2007
    • Table 3.29: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.30: U.K. POCT Diagnostics Products Market Sales, 2006-2012
    • Table 3.31: U.K. Clinical Diagnostic Rapid Test Market Segments, 2007
    • Table 3.32: Major U.K. IVD Manufacturers
    • Table 3.33: U.S. IVD Manufacturers Doing Business in the U.K
    • Table 3.34: Other European Companies that Manufacture IVD Products in the U.K
    • Table 3.35: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012
    • Table 3.36: French POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.37: French Clinical Diagnostic Rapid Test Market Segments, 2007
    • Table 3.38: Italian Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.39: Italian POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.40: Italian Clinical Diagnostic Rapid Test Market Segments, 2007
    • Table 3.41: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.42: Spanish Clinical Diagnostic Rapid Test Market Segments, 2007
    • Table 3.43: Spanish POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.44: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012
    • Table 3.45: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.46: Swedish POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.47: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.48: Finnish POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.50: Norwegian POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.51: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.52: Swiss POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.53: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.54: Dutch POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.55: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.56: Belgium POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.57: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.58: Portuguese POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.59: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.60: Austrian POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.61: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.62: Greek POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.63: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012
    • Table 3.64: Polish POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.65: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012
    • Table 3.66: Czech POCT Diagnostics Products Market Sales, 2005-2012
    • Table 3.67: Turkish POCT Market, 2000-2012
    • Table 3.68: Japan POCT Market, 2000-2012
    • Table 3.69: Japanese Population and Aging Demographics Forecast, 2000-2050
    • Table 3.70: Indian IVD Market for Instruments and Reagents, 2004-2012
    • Table 3.71: Number of Automated Clinical Labs in India, 2004-2012
    • Table 3.72: Indian IVD Market, 2007
    • Table 3.73: Indian POCT Diagnostics Products Market Sales, 2000-2008
    • Table 3.74: Chinese IVD Market, 2006-2012
    • Table 3.75: Number of Automated Clinical Labs in China, 2004-2012
    • Table 3.76: Chinese IVD Market, 2007
    • Table 3.77: Chinese POCT Diagnostics Products Market Sales, 2000-2012
    • Table 3.78: Rest of the World POCT Market, 2000-2012
    • Table 3.79: Canadian POCT Market, 2000-2012
    • Table 3.80: Brazilian POCT Market, 2000-2012
    • Table 3.81: Australian POCT Market, 2000-2012
    • Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers
    • Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025
    • Table 4.3: Professional Glucose Testing Market for POCT Worldwide, 2001-2012
    • Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012
    • Table 4.5: Manufacturer Market Share U.S. POCT Market, 2008
    • Table 4.6: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment
    • Table 4.7: HbA1c Testing Market for POCT Worldwide, 2006-2012
    • Table 4.8: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012
    • Table 4.9: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012
    • Table 4.10: Location Market Share of Critical Care Blood Gas Testing
    • Table 4.11: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2007
    • Table 4.12: Hospital Locations of Point of Care Coagulation Testing
    • Table 4.13: Drivers for Point of Care Coagulation Testing
    • Table 4.14: Barriers for Point of Care Coagulation Testing
    • Table 4.15: Coagulation Testing Market for POCT Worldwide, 2006-2012
    • Table 4.16: Hand-held Coagulation Testing Market for POCT Worldwide, 2006-2012
    • Table 4.17: Coagulation Market for POCT in the U.S., 2001-2012
    • Table 4.18: POC Prothrombin Market for POCT in the U.S., 2000-2007
    • Table 4.19: Cardiac Marker Market for POCT in the U.S., 2001-2012
    • Table 4.20: Cardiac Marker Market for POCT Worldwide, 2001-2012
    • Table 4.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007
    • Table 4.22: Cardiac Marker Market for POCT in Europe, 2001-2011
    • Table 4.23: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2012
    • Table 4.24: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2012
    • Table 4.25: Drug Testing Needs Tier I for Rapid Serum Point of Care Testing in the Emergency Department
    • Table 4.26: Stat Urine Testing Drug Recommendations
    • Table 4.27: Device Specifications for POCT Breath Alcohol Analysis
    • Table 4.28: Global Point of Care Urine Test Strip Testing Market, 2001-2007
    • Table 4.29: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012
    • Table 4.30: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011
    • Table 4.31: U.S. Point of Care Urine Test Strip Testing Market Share
    • Table 4.32: Medicare Fee Schedule for Urine Chemistry Testing
    • Table 4.33: Pregnancy Testing Market for POCT Worldwide, 2006-2012
    • Table 4.34: U.S. Point of Care Pregnancy Testing Market, 2001-2012
    • Table 4.35: International Point of Care Pregnancy Testing Markets, 2001-2007
    • Table 4.36: U.S. Market Share for Rapid Point of Care Pregnancy Tests
    • Table 4.37: Hemoglobin Testing Market for POCT Worldwide, 2006-2012
    • Table 4.38: Drivers of Demand for HIV Testing
    • Table 4.39: Worldwide POCT Market for HIV, 2001-2012
    • Table 4.40: U.S. POCT Market for HIV, 2001-2012
    • Table 4.41: Countries with the Highest Prevalence of HIV/AIDS
    • Table 4.42: FDA-Approved Rapid HIV Antibody Screening Tests
    • Table 4.43: OraSure OraQuick Rapid HIV Test Revenues, 2008
    • Table 4.44: Cholesterol Testing Market for POCT Worldwide, 2006-2012
    • Table 4.45: Infectious Disease Testing Market for POCT Worldwide, 2006-2012
    • Table 4.46: Salmonella Testing Market, 2002-2007
    • Table 4.47: Worldwide Point of Care Influenza Testing Market, 2002-2007
    • Table 4.48: U.S. Point of Care Influenza Testing Market, 2002-2007
    • Table 4.49: International Point of Care Influenza Testing Markets, 2002-2007
    • Table 4.50: U.S. Market for Rapid Point of Care Influenza Tests, 2007
    • Table 4.51: Worldwide Point of Care Strep A Testing Market, 2002-2007
    • Table 4.52: U.S. Point of Care Strep A Testing Market, 2002-2007
    • Table 4.53: International Point of Care Strep A Testing Markets, 2002-2007
    • Table 4.54: U.S. Market for Rapid Point of Care for Group A Strep Tests
    • Table 4.55: Global Market for Chlamydia Diagnostic Testing, 2000-2009
    • Table 4.56: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009
    • Table 4.57: U.S. Market for MRSA Rapid Testing, 2006-2013
    • Table 4.58: Global Market for Gonorrhea Diagnostic Testing, 2000-2009
    • Table 4.59: Global Market for TB Diagnostic Testing, 2000-2008
    • Table 4.60: U.S. Anthrax Test Market
    • Table 5.1: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2008
    • Table 5.2: Actalyke XL
    • Table 5.3: Actalyke Mini
    • Table 5.4: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse
    • Table 5.5: Major Competitors in the Drugs of Abuse Testing Market Segment
    • Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment
    • Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment
    • Table 5.8: Major Competitors in the Drugs of Abuse Saliva Testing Market Segment
    • Table 5.9 : Siemens Urinalysis Near-Patient Devices
    • Table 5.10: ColoCARE Fecal Occult Blood Test
    • Table 5.11: Competitive Factors Related to HIV Tests
    • Table 5.12: Largest POCT Diagnostic Companies Worldwide, 2008
    • Table 5.13: Type of Hepatitis Test: Lateral Flow
    • Table 5.14: Flow-Through
    • Table 5.15: Agglutination
    • Table 5.16: Immunoblot
    • Table 5.17: AmniSure
    • Table 6.1: Access Points
    • Table 6.2: Desktop Adapters?One Computer
    • Table 6.3: Desktop Adapters
    • Four Computers
  • List of Tables
    • Table 6.4: PCMCIA Adapters
    • Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments
    • Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis
    • Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements
    • Table 6.8: POCT in Three Hospitals. Cost Analysis with Labor Included
    • Table 6.9: Cost Analysis for Glucose Testing: POCT vs. Central Lab
    • Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs
    • Table 9.1: Applications for Wireless LAN Technology
    • Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements
    • Table 9.3: RALS-Plus Point of Care Market Share
    • Table 9.4: Applications of RALS Connectivity with POCT Devices
    • Table 10.1: Abaxis Blood Analysis Diagnostic Tests
    • Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers
    • Table 10.3: Products Marketed by Abbott in the Diagnostic Market
    • Table 10.4: Inverness Brands
    • Table 10.5: Orasure?s Products
    • Table 10.6: Quidel Product Sales Distribution and Sales, 2008
    • Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT
    • Table 11.2: Test Menu and TAT for ED
    • Table 11.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED
    • Table 11.4: Key Areas and Metrics That Hospitals Measure To Assess Efficiency of ED
    • Table 11.5: Estimates of Patient Costs by DRG
  • LIST OF FIGURES
    • Figure 3.1: Blood Tests Ordered in Emergency Department Visits
    • Figure 3.2: Worldwide Distribution of IVD Testing, 2008
    • Figure 3.3: Global Point of Care Testing Share of Total In Vitro Diagnostic Testing Market, 2007
    • Figure 4.1: U.S. Point of Care Testing Share of Glucose Testing Market, 2008
    • Figure 4.2: Number of HbA1c Tests Performed Globally as POCT, 1991-2006
    • Figure 4.3: Total Spending on Healthcare in the U.S., 1960-2007
    • Figure 4.4: International Per Capita Healthcare Spending Per Country, 2006
    • Figure 5.1: Global Point of Care Testing Share of HIV Testing Market, 2008
    • Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment

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