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Diagnostics


Point of Care Diagnostics


Publication Date   February 2006
Publisher   Business Communications Company
Product Type   Report
Pages   156
ISBN Number   not applicable
Product Code   BCC027
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Summary


The United States is the world's largest single market for diagnostic testing, and one of the most active segments within the diagnostic industry is pointof- care (POC) testing. POC testing is growing in both home use and POC near-patient applications. However, but the projected POC near-patient applications are forecasted to grow at a 15.5% average annual growth rate (AAGR) as opposed to 9.3% AAGR for the home use segment.

Over the last few decades, there has been a strong trend toward POC testing because of an increasing demand for near-patient testing that provides rapid results. More tests are being performed at the hospital patients' bedsides, in physicians' office laboratories, outpatient clinics, emergency rooms and intensive care units. Critical care instruments combining selected important chemistry, hematology and hemostasis parameters have entered the market for POC testing in the emergency and operating rooms. The trend toward greater POC testing is driven by the faster diagnostic benefits it provides.

This important report studies the flourishing near-patient testing business. It provides a complete review and analysis of the current POC markets and provides forecasts of market growth through 2010. In addition, it provides an overview of POC products, and descriptions of current and emerging technologies. The study also covers federal regulation of POC testing, international developments, and patents that will affect the future of the industry.

Scope Of Study

This comprehensive study:

  • Describes the point of care (POC) industry
  • Estimates the current and future market sizes
  • Discusses product segments
  • Analyzes market influences and predicts the future of POC
  • Reviews business activities of market leaders
  • Highlights emerging and leading technologies.

Report Highlights

  • POC testing revenue reached an estimated $5.05 billion in 2005 and is expected to grow at a 13.8% AAGR through 2010, yielding sales of nearly $9.65 billion.
  • A major force driving the growth of this industry is the effort to provide better patient care by improving the time to treatment (TAT) that POC testing offers. Other forces include cost containment, the aging population, the increased incidence of certain diseases, and technological advances.
  • Glucose testing meters and supplies accounted for 47.9% of POC sales in 2005 and are expected to grow at a 9.4% AAGR through 2010. The worldwide incidence of diabetes is predicted to double in the next 25 years.

Content


  • Introduction
    • Study Goals And Objectives
    • Reasons For Doing This Study
    • Scope And Format
    • Contributions Of The Study And Audience
    • Methodology And Information Sources
    • Related BCC Work Credentials
    • BCC Online Services
    • Disclaimer
  • Executive Summary
    • Overview
    • Major Findings
    • Summary Table: Forecast Of The U.S. Poc Market By Application, Through 2010 ($ Billions)
    • Summary Figure: Forecast Of The U.S. Poc Market By Application, 2005 And 2010 ($ Billions)
  • Point Of Care Testing
    • What Is Point Of Care Testing?
    • Overview Of Point Of Care (POC) Market
    • Poc As Part Of Clinical Diagnostics Industry Structure
      • Medical Benefits Derived From Immediate Diagnostic Testing
    • Poc Testing Sites
      • Home Use/ Self Care
      • Emergency Rooms (ER)
      • Critical Care Units (CCU)
      • Bedside Testing
      • Operating Rooms (OR)/ Procedure Rooms (PR)
      • Physicians Offices/ Clinics/ Treatment Centers/Other Non-Critical Care Sites
    • Poc Product Segments
      • Poc Clinical Assay Categories
        • Blood Gases And Electrolytes
        • Clinical Chemistry
        • Glucose Testing
        • Hematology And Hemostasis
        • Urinalysis
        • Immunoassay/Microbiology
    • Commonly Performed Poc Tests
    • Significance Of Clia
    • Other Regulatory Agencies
      • Fda (Food And Drug Administration)
        • Good Manufacturing Practice (GMP)
    • Driving Forces Of The Poc Market
      • Cost Containment
      • Technological Advancement
        • Availability - Ease Of Use Devices
        • New Technologies
        • Biosensors
      • Changes In Incidence Of Disease
        • Diabetes
        • Asthma
        • Cardiovascular Disease
        • Pulmonary Disease
      • Aging Population
  • The Point Of Care (POC) Market
    • The Point Of Care (POC) Market
    • Market Share
    • Market Structure
      • Distribution
      • Promotion
      • Strategic Alliances And Mergers
    • Market Components
      • Glucose Testing
        • Market Size
        • Meters
        • Market Size Type 1 Diabetics
        • Market Size Type 2 Diabetes
        • Related Supplies (Test Strips, Lancets, Controls)
        • Test Strips
        • Lancets
        • Automatic Lancing Devices
        • Laser Skin Perforators
        • Control (CALIBRATION) Solutions
        • Market Dynamics
        • Market Participants
        • Bayer Health Care
        • Ascensia Breeze Glucometer
        • Ascensia Contour Glucometer
        • Ascensia Elite Glucometer
        • Ascencia Dex 2 Diabetes Care System
        • Abbott Diabetes Care
        • Freestyle Blood Glucose Monitoring System
        • Freestyle Flash Glucose Monitoring System
        • Freestyle Cozmonitor
        • Precision Xtra
        • I-Stat 1
        • Johnson And Johnson
        • Lifescan - One Touch® Ultra® Meter
        • Lifescan Onetouch Ultrasmart Meter
        • Lifescan One Touch Induo
        • Lifescan Onetouch Basic Meter
        • Lifescan Onetouch Surestep Meter
        • Lifescan Onetouch Diabetes Management Software
        • Roche Diagnostic Systems
        • Accu-Chek Advantage System
        • Accu-Chek Aviva System
        • Accu-Chek Active Meter
        • Accu-Chek Compact Meter
        • Accu-Chek Complete Meter
        • Accu-Chek Go System
        • Accu-Chek Inform System
        • Accu-Chek Voicemate System
        • Accu-Chek Multiclix Lancet Device
        • Accu-Chek Softclixiclix Lancet Device
        • Home Diagnostics Inc.
        • Sidekick Testing System
        • Truetrack Smart System
        • Trackease Smart System
        • Prestige Iq Blood Glucose Monitor
        • Hypoguard Usa
        • At Home Use Glucose Meters
        • Reli-On Newtek
        • Advance Micro-Draw Blood Glucose Monitoring System
        • Advance Intuition Blood Glucose Monitoring System
        • Quicktek Blood Glucose System
        • Professional Use
        • Assure 3 Blood Glucose Monitoring System
        • Assure Ii Blood Glucose Monitoring System
        • Supreme Ii Blood Glucose Monitoring System
        • Haemolance And Hemolance Plus Safety Lancets
        • Becton Dickinson & Co.
        • Bd Logic
        • Queststar
        • Focus
        • Data Management Systems
      • Blood Gases And Electrolyte Testing
        • Blood Gas Parameters
        • Electrolytes
        • Connectivity
        • Market Size
        • Market Share
        • Blood Gas And Electrolyte Poc Products
        • Clia Quality Control (QC) Requirements For Blood Gas Analysis
        • Radiometer America, Inc.
        • Abl 77
        • Npt7
        • Nova Biomedical
        • Stat Profile Phox Product Line
        • Point-Of-Care Manager (PDM)
        • Bayer Diagnostics
        • Rapidpoint 440/405
        • Abbott Diagnostics
        • I-Stat
        • Instrumentation Laboratory
        • Gem® Premier 3000
        • Gem Opl
        • Roche Diagnostics
        • Omni S
        • Osmetech
        • Opti Cca Blood Gas Analyzer
        • Technidyne Corporation (ITC)
        • Irma Trupoint
      • Cardiac Markers
        • Market Size
        • Market Participants And Market Shares
        • Biosite Diagnostics
        • Triage Meter Plus
        • Dade Behring
        • Stratus Cs Acute Care Diagnostic System
        • Abbott
        • Istat 1
        • Roche
        • Cardiac Reader System
        • Spectral Diagnostics Inc
        • Cardiac Status
        • I-Lynx
        • Response Biomedical
        • Ramp System
      • Rapid Tests
        • Market Size
        • Market Participants
        • Rapid Test Products
        • Professional Use Rapid Test Products
        • Strep A
        • Market Size And Participants
        • H. Pylori
        • Market Size And Participants
        • Respiratory Syncytial Virus (RSV)
        • Market Size And Participants
        • Influenza
        • Market Size And Participants
        • Infectious Mononucleosis
        • Market Size And Participants
        • Chlamydia/Trichomonas
        • Market Size And Participants
        • Hematology And Hemostasis
        • Hemostasis (COAGULATION)
        • Urinalysis
        • Market Size And Participants
      • Hiv Testing
        • Orasure
        • Trinity Botech Plc
        • Professional And Home Use Rapid Tests
        • Pregnancy/Fertility
        • Drug Testing
        • Market Size And Participants
        • Fecal And Gastric Occult Blood
        • Market Share And Participants
        • Cholesterol
        • Market Size And Participants
      • Connectivity - Data Management
        • Connectivity Industry Consortium (CIC)
        • Requirements For Integrating Poc Data To His/Lis
        • Issues Relating To Implementing Poc Connectivity
        • Currently Market Poc Vendor Data Management Systems
        • Medisense Precision Net
        • Rapidlink
        • Impact
        • Datalink
        • Radiance Data Management System (DMS)
        • Nova Patient Management System
        • Diametrics Idms-Irma Data Management System
        • Cobas It 1000 Solution
        • Wireless Communication
        • Cost Analysis Poc Testing Connectivity System
        • Potential Market Size
        • Market Participants Poc Data Management Systems
        • Misys Healthcare Systems
        • Data Innovations
        • Scc Soft Computer
        • Labsoft Inc.
        • Schuyler House
        • Clinlab Inc.
        • Clinlab Inc.
  • Technology
    • Biosensors
      • What Are Biosensors?
        • Catalytic Sensors
        • Affinity Sensors
      • Amperometric Measurement
      • Coulometry
    • Electrodes
      • What Are Electrodes?
    • Immunoassay Analytical Methods
      • Enzyme Immunoassay (EIA)/Rapid Enzyme Immunoassay
      • Latex Agglutination Inhibition Immunoassay
      • Monoclonal Antibodies
  • Patents
    • Number Of Recently Issued Patents
      • Analysis Of Patent By Subject
      • Patent Assignees
  • Worldwide Point Of Care Market
    • Market Size
    • Global Market Shares
      • Presence Of U.S. Manufacturers In The Worldwide Market
  • Profiles Of Major Market Participants
    • Market Participants
    • Abbott Laboratories
    • Bayer Corporation.
    • Beckman Coulter Inc.
    • Biosite Incorporated
    • Dade Behring, Inc.
    • Hypoguard Usa
    • Instrumentation Laboratories (IL)
    • International Technidyne Corp.
    • Inverness Medical Innovatons
    • Johnson And Johnson
    • Nova Biomedical
    • Quidel Corporation
    • Response Biomedical
    • Roche Diagnostics
  • Appendix
    • Recently Issued Patents
      • Blood Gas Testing
      • Rapid Testing Kits
      • Near Patient Testing
      • Poc Testing
      • Glucose Meters
      • Hematology
      • Coagulation
      • Immunoassay Kits
    • Summary Table:
  • Forecast Of The U.S. Poc Market By Application, Through 2010 ($ Billions)
    • Table 1 Selected Key Statistics Poc Testing Sites
    • Table 2 Selected Poc Tests - Clia Waived
    • Table 3 Pertinent Parameters Of Gmp Regulations Affecting In Vitro Diagnostics
    • Table 4 U.S. Population Projections Of Those Aged 55+, 2000 And 2010 (MILLIONS)
    • Table 5 Forecast For The U.S. Poc Market By Volume And Value, Through 2010 (MILLIONS)
    • Table 6 Market Share Poc Market Participants (%)
    • Table 7 Forecast For The U.S. Glucose Meters And Related Supplies Market, Through 2010 (MILLIONS)
    • Table 8 Home Use Glucose Meter Sales By Type Of Diabetes, Through 2010 (MILLIONS)
    • Table 9 Forecast Of U.S. Glucose Meter Related Sales, Through 2010 (MILLIONS)
    • Table 10 Recently Approved Clia Poc Blood Glucose Meters,* 2005
    • Table 11 Relative Market Share Glucose Meters And Supplies, 2005 (%)
    • Table 12 Bayer Glucose Meter Prices
    • Table 13 Abbott Glucose Meter Prices
    • Table 14 Lifescan (J&j) Glucose Meter Prices
    • Table 15 Roche Glucose Meter Prices
    • Table 16 Selected Listing Of Retailers Selling Home Diagnostic's Meters Under Their Name
    • Table 17 Home Diagnostics Glucose Meter Prices
    • Table 18 Hypoguard Usa Glucose Meter Prices
    • Table 19 Selected Listing Of Blood Glucose Monitors Capable Of Interacting With Computer Software
    • Table 20 Forecast Of The U.S. Blood Gas/Electrolyte Testing Market, Through 2010 (MILLIONS)
    • Table 21 Relative Market Share Blood Gas Analyzer Manufacturers (%)
    • Table 22 Clia Approved Poc Blood Gas Analyzers
    • Table 23 Nova Biochemical Poc Stat Profile Phox Series By Available Tests
    • Table 24 Forecast For The U.S. Cardiac Marker Testing Market, Through 2010
    • Table 25 Cardiac Market Tests By Company
    • Table 26 Relative Share Poc Cardiac Marker Manufacturers (%)
    • Table 27 Forecast For The U.S. Poc Rapid Test Market, Through 2010 (MILLIONS)
    • Table 28 Forecast For The U.S. Strep A Rapid Test, Through 2010 (MILLIONS)
    • Table 29 Market Share Strep A Rapid Test Manufacturers (%)
    • Table 30 Selected Listing Clia Approved Strep A Rapid Tests
    • Table 31 Forecast For The U.S. H. Pylori Rapid Tests, -Through 2010 (MILLIONS)
    • Table 32 Relative Market Share H. Pylori Poc Rapid Test Manufacturers (%)
    • Table 33 Selected List Clia Approved H. Pylori Rapid Tests
    • Table 34 Forecast For The U.S. Rsv Rapid Tests, Through 2010 (MILLIONS)
    • Table 35 Selected Listing Clia Approved Rsv Tests
    • Table 36 Forecast For The U.S. Influenza Rapid Tests, Through 2010 (MILLIONS)
    • Table 37 Relative Market Share Influenza Poc Rapid Test Manufacturers (%)
    • Table 38 Selected Listing Clia Approved Influenza Rapid Tests
    • Table 39 Forecast For The U.S. Infectious Mononucleos Rapid Tests, -Through 2010 (MILLIONS)
    • Table 40 Market Share Poc Infectious Mononucleosis Rapid Tests (%)
    • Table 41 Selected Interest Clia Approved Infectious Mononucleosis Rapid Tests
    • Table 42 Forecast For The U.S. Chlamydia/Trichomonas Rapid Tests, Through 2010 (MILLIONS)
    • Table 43 Relative Market Share Chlamydia/Trichomonas Rapid Test Manufacturers (%)
    • Table 44 Selected Listing Clia Approved Chlamydia/Trichomonas Rapid Tests
    • Table 45 Forecast For The U.S. Hemoglobin/Hemostasis Rapid Test, Through 2010 (MILLIONS)
    • Table 46 Relative Market Share Hematology/Hemostasis Poc Rapid Test Manufacturers (%)
    • Table 47 Selected Listing Clia Approved Hematology/Hemostasis Rapid Tests
    • Table 48 Forecast For The U.S. Urinalysis Rapid Tests, Through 2010 (MILLIONS)
    • Table49 Relative Market Share Poc Urine Test Manufacturers (%)
    • Table 50 Selected Testing Clia Approved Urinalysis Rapid Tests
    • Table 51 Forecast For The U.S. Rapid Poc Hiv Testing Market, Through 2010 ($ Million)
    • Table 52 Poc Hiv Company's Relative Market Share (%)
    • Table 53 Pregnancy/Fertility Rapid Tests, Through 2010 (MILLIONS)
    • Table 54 Relative Market Share Pregnancy Test Manufacturers (%)
    • Table 55 Recent (2005) Clia Approved Pregnancy Rapid Tests
    • Table 56 Forecast For The U.S. Drug Rapid Tests, Through 2010 (MILLIONS)
    • Table 57 Relative Market Size Drug Screening Rapid Test Manufacturers (%)
    • Table 58 Selected Listing Clia Approved Drug Screening Rapid Tests
    • Table 59 Forecast For The U.S. Fecal And Gastric Occult Blood Rapid Tests, Through 2010 (MILLIONS)
    • Table 60 Relative Market Share Poc Occult Blood Testing Manufacturers (%)
    • Table 61 Clia Approved Fecal And Gastric Occult Blood Rapid Tests
    • Table 62 Forecast For The U.S. Cholesterol Rapid Tests, Through 2010 (MILLIONS)
    • Table 63 Relative Market Share Cholesterol Poc Rapid Test Manufacturers (%)
    • Table 64 Selected Listing Clia Approved Cholesterol Rapid Tests
    • Table 65 Selected Listing Of Poc Device Linked Data Management Products
    • Table 66 Theoretical Component Cost Analysis ($)
    • Table 67 Results Of Patent Search For Poc Categories, September 2004 - November 2005
    • Table 68 Patents By Subject Area
    • Table 69 Listing Of Patent Assigness
    • Table 70 Global Forecast For The Poc Market, Through 2010 ($ Billions)
    • Table 71 Global Market Share By Country Poc Market (%)
  • List Of Figures
    • Summary Figure: Forecast Of The U.S. Poc Market By Application, 2005 And 2010 ($ Billions)
    • Figure 1 U.S. Population Projections Of Those Aged 55+, 2000 And 2010 (MILLIONS)
    • Figure 2 Forecast Value For The U.S. Poc Market, 2005 And 2010 ($ Millions)
    • Figure 3 Market Share Poc Market Participants (%)
    • Figure 4 Distribution Channels: Poc Diagnostic Devices
    • Figure 5 Forecast For The U.S. Glucose Meters And Related Supplies Market, 2005 And 2010 ($ Millions)
    • Figure 6 Home Use Glucose Meter Sales By Type Of Diabetes, 2005 And 2010 ($ Millions)
    • Figure 7 Relative Market Share Glucose Meters And Supplies, 2005 (%)
    • Figure 8 Relative Market Share Blood Gas Analyzer Manufacturers (%)
    • Figure 9 Forecast For The U.S. Poc Rapid Test Market, 2005 And 2010 ($ Millions)
    • Figure 10 Pregnancy/Fertility Rapid Tests, 2005 And 2010 ($ Millions)
    • Figure 11 Schematic Poc And His/Lis Connectivity System