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Worldwide Point of Care Diagnostic Test Markets
December 1, 2010



Countries covered: Global

Diagnostic tests performed outside the central laboratory or decentralized testing is
generally known as point-of-care (POC). Over the years, the increasing introduction of
transportable, portable, and handheld instruments has resulted in the migration of POC
testing from the hospital environment to a range of medical environments including the
workplace, home, disaster care and most recently, convenience clinics.

Moreover POC test devices have contributed significantly to the growth of the overall
diagnostics market over the past 10 years. As more diagnostic manufacturers pursue
CLIA waiver status for their POC devices and CE Mark for POC or self use, more
decentralized test venues are investing in non-waived rapid tests and instruments. POC
testing appears to be headed for an even bigger role in diagnosis and monitoring patient
care and the world market for POC tests has shown consistent growth, a trend that is
expected to continue. This report, Worldwide Point of Care Testing Markets, includes
the following:

          Market Estimates and Forecasts for POC OTC
          Market Estimates and Forecasts for POC Professional Testing
          Product Information
          Products in Development
          Revenues (2009) of Leading Companies
          Trends in POC Testing
          Company Profiles
          Analyst Conclusions

The field for rapid test devices is crowded, worldwide, more than 100 companies market
rapid tests using the whole gamut of instruments, devices and technologies that reduce
test times to minutes or hours in some cases. Growth in POC testing is fueled by the
increasing number of diagnosed diabetics, by the globalization of infectious diseases
and the associated public health issues, and by the need to monitor an ever-growing
group of people with chronic diseases such as cardiovascular diseases, arthritis, cancer
and other chronic conditions.
Market analysis in this report covers world markets for point of care tests, however the
reader will find a bias toward the developed areas of the globe -- North America, Japan
and Western Europe. However public health and infectious disease are a growing
global problem and where possible the report covers POC products related to global
public health and healthcare delivery issues. The following specific POC testing
segments are included:

      Glucose Testing
      Critical Care
      Infectious Diseases
      Urinalysis
      Cholesterol
      HbA1c
      Coagulation
      Hematology,
      Chemistry/Immunoassays
      Infectious Diseases,
      Fecal Occult Blood
      Pregnancy,
      Cardiac Markers
      Oncology
      Urinalysis,
      Drugs of Abuse

All market data are based on factory sales to the end user and not retail pricing or
reimbursement payments. Data are presented in U.S. dollars and the market size for
categories of tests, and for specific analytes is provided where possible with certainty.
The dollar value of a market segment is directly proportional to the number of tests
performed, because the cost of the instrumentation is generally buried in the per test
price.
The information presented in this report is derived on publicly available information
sources such as company, government, and medical organization reports. The analysis
is based on the author's industry knowledge combined with literature searches and
interviews with industry professionals and experts in the areas of POC tests,
decentralized healthcare and healthcare economics.

TABLE OF CONTENTS

CHAPTER ONE: EXECUTIVE SUMMARY

      Scope and Methodology
      Size and Growth of the Market
      Market Trends

CHAPTER TWO: INTRODUCTION
Miniaturization, digitization and informatics
     The pros and cons of POC testing
     Point of View

CHAPTER THREE: ECONOMICS, EMR AND HEALTHCARE REFORM

     Healthcare Reform
     POC and Clinical Outcomes Management
     POC’s Unmet Need

CHAPTER FOUR: TECHNOLOGY AND INDUSTRY TRENDS

     Backgroun
     The search for non-invasive tools
     Saliva
     Breath
     Optical Techniques
     Patch Technology
     Wearable Sensors/Textiles
     The Wireless Revolution
     Connectivity Imperative
     Lab-on-a chip

CHAPTER FIVE: VENUES FOR POC TESTING

     POC Testing in the Hospital
     POL and Clinic Testing
     Retail Outlets
     Other Professional POC Venues - Workplace Testing and Home Visits
     Home Monitoring of Individuals with Chronic Diseases
     Self-Test Sector - OTC Tests

CHAPTER SIX: MARKET ANALYSIS

     Market Overview
     Prognosis for POC growth
     Technological Challenges
     Market and Forecasts
     Self Testing/OTC
     Breakout of Non-Glucose Testing
     Professional POC Testing
     POC in world markets
     Europe
     Asia
     Rest of World
     United States
Physician Office Labs
    United Kingdom
    HIV/AIDS
    Market for Rapid Flu Testing
    The Major Players
    Licenses and Distribution Agreements
    Struggling Competitors

CHAPTER SEVEN: POC TEST SEGMENTS

    Diabetes Testing - Blood Glucose Monitoring (BGM)
    Blood Glucose Self-Testing
    Blood Glucose Testing by Professionals
    Diabetes Testing - Glycated Hemoglobin
    Cardiovascular Diagnostics
    Cardiac Markers (AMI enzymes)
    Cholesterol/Lipid Panels
    Clinical Chemistry/Critical Care
    Hemoglobin Testing for Anemia
    Hematology
    Coagulation
    Decentralized Coagulation testing - Professional Use
    Decentralized Coagulation Testing - OTC
    Drugs of Abuse/Therapeutic Drug Monitoring
    Allergy
    Infectious Diseases
    OTC Tests for Infectious Diseases
    Professional POC Tests for Infectious Diseases
    Pharmacodiagnostics
    Sepsis
    Oncology
    Bladder Cancer
    Colon Cancer
    Prostate Cancer
    Cervical Cancer
    Women’s Health / Pregnancy/Fertility
    Emerging Tests and Technologies
    Commercial Outlook

CHAPTER EIGHT: COMPANY PROFILES MAJOR COMPANIES

    Abbott Diagnostics
      o Diabetes
      o Critical Care
      o Hematology
    ARKRAY, Inc.
o   Distribution News
       o   Product News
    Bayer Diabetes Care
    Beckman Coulter Inc.
    Becton, Dickinson and Company (BD)
    bioMerieux Inc.
    Bio-Rad Laboratories Inc.
    GE Healthcare
    Instrumentation Laboratory
    Inverness Medical Innovations
    Lifescan Inc.
    Nova Biomedical
    Ortho Clinical Diagnostics (OCD)
    Qiagen N.V.
    Quidel Corporation
    Radiometer A/S
    Roche Diagnostics
        o Diabetes
        o Cardiac Markers
        o Clinical Chemistry
        o Critical Care
    Siemens Healthcare Diagnostics
        o Cardiac Markers
        o Diabetes Care
        o Blood Gases
        o Urinalysis
    Sysmex Corporation
    TOSOH Corporation

CHAPTER NINE: NEW FRONTIER POC COMPANIES

    3M Health Care
    77 Elektronika Kft.
    Abaxis, Inc.
    A/C Diagnostics
    Accumetrics
    ACIST Medical Systems, Inc.
    AgaMetrix, Inc.
    Alfa Wassermann Diagnostic Technologies, LLC (AWDT)
    American Bio Medica Corp
    Audit Diagnostics
    Axis-Shield plc
    Biohit Oy
    BioIQ
    Biomerica, Inc.
    Biosite Incorporated
B.R.A.H.M.S. AG
    Calypte Biomedical Corporation
    Chembio Diagnostic Systems, Inc.
    Chempaq A/S
    Cholestech Corporation
    Concateno plc
    DexCom, Inc.
    Diabetech, LP
    Diazyme Laboratories
    EKF-diagnostic GmbH
    ESA Biosciences Inc.
    Hain Lifescience GmbH
    HandyLab, Inc.
    Helena Laboratories USA
    Hema Diagnostic Systems (HDS)
    HemoCue AB
    HemoSense, Inc.
    Home Diagnostics, Inc.
    Horiba ABX S.A.
    Insulet Corporation
    International Technidyne Corp (ITC)
    Masimo Corporation
    Matritech
    Medical Automation Systems, Inc.
    MedMira Inc.
    Medtronic Inc.
    A. Menarini Diagnostics
    Meridian Bioscience
    MP Biomedicals LLC
    Nanosphere, Inc.
    OPTI Medical Systems, Inc.
    OraSure Technologies, Inc.
    Phadia AB
    Philips Handheld Immunoassays
    Polymedco, Inc.
    QBC Diagnostics, Inc.
    Response Biomedical Corp.
    Serotec (AbD Serotec)
    Smiths Medical MD, Inc. (formerly Deltec, Inc.)
    Stanbio Laboratory
    Taidoc Technology Corp.
    Trinity Biotech plc
    Via Medical Corporation
    Vital Diagnostics

CHAPTER TEN: OTHER PLAYERS
Acrongenomics Inc.
Alfa Scientific Designs, Inc.
Amic AB
Astron Clinica
AspenBio Pharma, Inc.
AT First Diagnostic, LLC
bioLytical Laboratories Inc.
Biomagnetics Diagnostics Corporation
Bionime Corporation
BodyTel Scientific, Inc.
Burnet Institute
Celerus Diagnostics
Chelsea Technologies Group Ltd
Claros Diagnostics
CLX Medical, Inc.
ContraVac, Inc.
Decision Biomarkers Inc.
Diabetes Sentry Products Inc.
Diaglobal GmbH
Diagnostic Devices, Inc.
Diagnostics for All (DFA)
Diagnostics for the Real World (DRW)
Digital Bio Technology/ InCyto
Diversa Limited (formerly Ambri Ltd.)
DNAFORM
DxNA
Echo Therapeutics, Inc. (previously Sontra Medical)
Enigma Diagnostics Limited
Enterix Inc.
Entra Health Systems
Epocal, Inc.
EUMED Biotechnology Co. Ltd.
eScreen, Inc.
EyeMarker Systems, Inc.
Flexsite Diagnostics, Inc.
Fora Care
GenBio
Gene Smart Wellness
Gentag Inc.
Glucometrics, Inc.
Guided Therapeutics, Inc.
Hai Kang Life Corporation
HealthPia America
Heidelberger-Medical-Marketing GmbH (HMM GmbH)
Hema Metrics
Hoana Medical, Inc.
Idaho Technology, Inc.
Identa Corporation
Identigene
Innovative Biosensors, Inc.
Integrity Applications Ltd.
Intel Corporation
LifeAssays AB
LifeSign LLC
Lifestyle Choices Ltd
Luminous Medical, Inc.:
M-Biotech
Menssana Research, Inc.
Micromem Technologies Inc.
Micronics Inc.
MicroPhage, Inc.
Multilyte Limited
MycroLab Pty Ltd.
Nanomix, Inc.
National Jewish Health
Network Biosystems
Neuroptix Corporation
Noninvasive Medical Technologies, Inc.
OrSense Ltd.
OvumOptics, Inc.
Oxonica Diagnostics
PlaCor, Inc.
PointCare Technologies
Probe Scientific Ltd
Prometheus Laboratories Inc.
Q-linea
Quadraspec
QualSec, Inc
QuantRx Biomedical Corporation
Quotient Diagnostics
Rapid Pathogen Screening
Rennesens GmbH
Screening Devices Canada, Inc.
Sentinel Bioactive Paper Network
Sphere Medical Ltd.
SIENCO
Smiths Detection
Solei Systems, Inc.
Solianis Monitoring AG
SpheroSense Technologies Inc.
STD Test Express
Surface Enhanced Micro Optical Fluidic Systems
T2 Biosystems, Inc.
       TwistDx, Ltd.
       Veralight, Inc.
       Veredus Laboratories Pte
       VeriChip Corporation
       Vivacta Limited



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Worldwide Point of Care Diagnostic Test Markets

  • 1. Get more info on this report! Worldwide Point of Care Diagnostic Test Markets December 1, 2010 Countries covered: Global Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as point-of-care (POC). Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments including the workplace, home, disaster care and most recently, convenience clinics. Moreover POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. As more diagnostic manufacturers pursue CLIA waiver status for their POC devices and CE Mark for POC or self use, more decentralized test venues are investing in non-waived rapid tests and instruments. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care and the world market for POC tests has shown consistent growth, a trend that is expected to continue. This report, Worldwide Point of Care Testing Markets, includes the following: Market Estimates and Forecasts for POC OTC Market Estimates and Forecasts for POC Professional Testing Product Information Products in Development Revenues (2009) of Leading Companies Trends in POC Testing Company Profiles Analyst Conclusions The field for rapid test devices is crowded, worldwide, more than 100 companies market rapid tests using the whole gamut of instruments, devices and technologies that reduce test times to minutes or hours in some cases. Growth in POC testing is fueled by the increasing number of diagnosed diabetics, by the globalization of infectious diseases and the associated public health issues, and by the need to monitor an ever-growing group of people with chronic diseases such as cardiovascular diseases, arthritis, cancer and other chronic conditions.
  • 2. Market analysis in this report covers world markets for point of care tests, however the reader will find a bias toward the developed areas of the globe -- North America, Japan and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers POC products related to global public health and healthcare delivery issues. The following specific POC testing segments are included: Glucose Testing Critical Care Infectious Diseases Urinalysis Cholesterol HbA1c Coagulation Hematology, Chemistry/Immunoassays Infectious Diseases, Fecal Occult Blood Pregnancy, Cardiac Markers Oncology Urinalysis, Drugs of Abuse All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data are presented in U.S. dollars and the market size for categories of tests, and for specific analytes is provided where possible with certainty. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price. The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of POC tests, decentralized healthcare and healthcare economics. TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY Scope and Methodology Size and Growth of the Market Market Trends CHAPTER TWO: INTRODUCTION
  • 3. Miniaturization, digitization and informatics The pros and cons of POC testing Point of View CHAPTER THREE: ECONOMICS, EMR AND HEALTHCARE REFORM Healthcare Reform POC and Clinical Outcomes Management POC’s Unmet Need CHAPTER FOUR: TECHNOLOGY AND INDUSTRY TRENDS Backgroun The search for non-invasive tools Saliva Breath Optical Techniques Patch Technology Wearable Sensors/Textiles The Wireless Revolution Connectivity Imperative Lab-on-a chip CHAPTER FIVE: VENUES FOR POC TESTING POC Testing in the Hospital POL and Clinic Testing Retail Outlets Other Professional POC Venues - Workplace Testing and Home Visits Home Monitoring of Individuals with Chronic Diseases Self-Test Sector - OTC Tests CHAPTER SIX: MARKET ANALYSIS Market Overview Prognosis for POC growth Technological Challenges Market and Forecasts Self Testing/OTC Breakout of Non-Glucose Testing Professional POC Testing POC in world markets Europe Asia Rest of World United States
  • 4. Physician Office Labs United Kingdom HIV/AIDS Market for Rapid Flu Testing The Major Players Licenses and Distribution Agreements Struggling Competitors CHAPTER SEVEN: POC TEST SEGMENTS Diabetes Testing - Blood Glucose Monitoring (BGM) Blood Glucose Self-Testing Blood Glucose Testing by Professionals Diabetes Testing - Glycated Hemoglobin Cardiovascular Diagnostics Cardiac Markers (AMI enzymes) Cholesterol/Lipid Panels Clinical Chemistry/Critical Care Hemoglobin Testing for Anemia Hematology Coagulation Decentralized Coagulation testing - Professional Use Decentralized Coagulation Testing - OTC Drugs of Abuse/Therapeutic Drug Monitoring Allergy Infectious Diseases OTC Tests for Infectious Diseases Professional POC Tests for Infectious Diseases Pharmacodiagnostics Sepsis Oncology Bladder Cancer Colon Cancer Prostate Cancer Cervical Cancer Women’s Health / Pregnancy/Fertility Emerging Tests and Technologies Commercial Outlook CHAPTER EIGHT: COMPANY PROFILES MAJOR COMPANIES Abbott Diagnostics o Diabetes o Critical Care o Hematology ARKRAY, Inc.
  • 5. o Distribution News o Product News Bayer Diabetes Care Beckman Coulter Inc. Becton, Dickinson and Company (BD) bioMerieux Inc. Bio-Rad Laboratories Inc. GE Healthcare Instrumentation Laboratory Inverness Medical Innovations Lifescan Inc. Nova Biomedical Ortho Clinical Diagnostics (OCD) Qiagen N.V. Quidel Corporation Radiometer A/S Roche Diagnostics o Diabetes o Cardiac Markers o Clinical Chemistry o Critical Care Siemens Healthcare Diagnostics o Cardiac Markers o Diabetes Care o Blood Gases o Urinalysis Sysmex Corporation TOSOH Corporation CHAPTER NINE: NEW FRONTIER POC COMPANIES 3M Health Care 77 Elektronika Kft. Abaxis, Inc. A/C Diagnostics Accumetrics ACIST Medical Systems, Inc. AgaMetrix, Inc. Alfa Wassermann Diagnostic Technologies, LLC (AWDT) American Bio Medica Corp Audit Diagnostics Axis-Shield plc Biohit Oy BioIQ Biomerica, Inc. Biosite Incorporated
  • 6. B.R.A.H.M.S. AG Calypte Biomedical Corporation Chembio Diagnostic Systems, Inc. Chempaq A/S Cholestech Corporation Concateno plc DexCom, Inc. Diabetech, LP Diazyme Laboratories EKF-diagnostic GmbH ESA Biosciences Inc. Hain Lifescience GmbH HandyLab, Inc. Helena Laboratories USA Hema Diagnostic Systems (HDS) HemoCue AB HemoSense, Inc. Home Diagnostics, Inc. Horiba ABX S.A. Insulet Corporation International Technidyne Corp (ITC) Masimo Corporation Matritech Medical Automation Systems, Inc. MedMira Inc. Medtronic Inc. A. Menarini Diagnostics Meridian Bioscience MP Biomedicals LLC Nanosphere, Inc. OPTI Medical Systems, Inc. OraSure Technologies, Inc. Phadia AB Philips Handheld Immunoassays Polymedco, Inc. QBC Diagnostics, Inc. Response Biomedical Corp. Serotec (AbD Serotec) Smiths Medical MD, Inc. (formerly Deltec, Inc.) Stanbio Laboratory Taidoc Technology Corp. Trinity Biotech plc Via Medical Corporation Vital Diagnostics CHAPTER TEN: OTHER PLAYERS
  • 7. Acrongenomics Inc. Alfa Scientific Designs, Inc. Amic AB Astron Clinica AspenBio Pharma, Inc. AT First Diagnostic, LLC bioLytical Laboratories Inc. Biomagnetics Diagnostics Corporation Bionime Corporation BodyTel Scientific, Inc. Burnet Institute Celerus Diagnostics Chelsea Technologies Group Ltd Claros Diagnostics CLX Medical, Inc. ContraVac, Inc. Decision Biomarkers Inc. Diabetes Sentry Products Inc. Diaglobal GmbH Diagnostic Devices, Inc. Diagnostics for All (DFA) Diagnostics for the Real World (DRW) Digital Bio Technology/ InCyto Diversa Limited (formerly Ambri Ltd.) DNAFORM DxNA Echo Therapeutics, Inc. (previously Sontra Medical) Enigma Diagnostics Limited Enterix Inc. Entra Health Systems Epocal, Inc. EUMED Biotechnology Co. Ltd. eScreen, Inc. EyeMarker Systems, Inc. Flexsite Diagnostics, Inc. Fora Care GenBio Gene Smart Wellness Gentag Inc. Glucometrics, Inc. Guided Therapeutics, Inc. Hai Kang Life Corporation HealthPia America Heidelberger-Medical-Marketing GmbH (HMM GmbH) Hema Metrics Hoana Medical, Inc.
  • 8. Idaho Technology, Inc. Identa Corporation Identigene Innovative Biosensors, Inc. Integrity Applications Ltd. Intel Corporation LifeAssays AB LifeSign LLC Lifestyle Choices Ltd Luminous Medical, Inc.: M-Biotech Menssana Research, Inc. Micromem Technologies Inc. Micronics Inc. MicroPhage, Inc. Multilyte Limited MycroLab Pty Ltd. Nanomix, Inc. National Jewish Health Network Biosystems Neuroptix Corporation Noninvasive Medical Technologies, Inc. OrSense Ltd. OvumOptics, Inc. Oxonica Diagnostics PlaCor, Inc. PointCare Technologies Probe Scientific Ltd Prometheus Laboratories Inc. Q-linea Quadraspec QualSec, Inc QuantRx Biomedical Corporation Quotient Diagnostics Rapid Pathogen Screening Rennesens GmbH Screening Devices Canada, Inc. Sentinel Bioactive Paper Network Sphere Medical Ltd. SIENCO Smiths Detection Solei Systems, Inc. Solianis Monitoring AG SpheroSense Technologies Inc. STD Test Express Surface Enhanced Micro Optical Fluidic Systems
  • 9. T2 Biosystems, Inc. TwistDx, Ltd. Veralight, Inc. Veredus Laboratories Pte VeriChip Corporation Vivacta Limited Available immediately for Online Download at http://www.marketresearch.com/product/display.asp?productid=2828762 US: 800.298.5699 UK +44.207.256.3920 Int'l: +1.240.747.3093 Fax: 240.747.3004