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Worldwide Point of Care (POC): Are Decentralized Clinical Diagnostics a Cost Drain or Revenue Driver?


Attention: There is an updated edition available for this report.

This report takes a bold look into the markets, technologies, and trends in decentralized testing with a special focus on the economics of rapid test use in critical care and emergency medicine. There is also an emphasis on early disease detection via rapid test use in clinics and public venues. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.

The field for rapid test devices is crowded; worldwide, more than 100 companies market rapid tests using the whole gamut of instruments and technologies that reduce test times to hours or minutes in some cases. Growth in POC testing is fueled by the increasing numbers of diagnosed diabetics, people with cardiovascular disease, and other chronic conditions. It is also part of a trend in health care to evaluate provider organizations for quality in care delivery. While this quality imperative is most apparent in pay-for-performance systems, it also provides a framework by which public funds can be used more rationally. All countries are feeling the brunt of aging populations and an increased burden of chronic disease management.

The report offers a quantitative assessment of specific markets in US dollars for 2005 to 2015. These data are provided in order to set the status quo of tests and technologies. However the report concentrates on how these will impact the economics of healthcare over the near term and longer when possible.


Chapter One: Executive Summary

  • Introduction
  • Scope and Methodology
  • Size and Growth of the Market
  • Market Trends

Chapter Two: Introduction

  • Background
  • Miniaturization, digitization and informatics
  • The pros and cons of POC testing
  • Point of View

Chapter Three: Market and Technological Dynamics

  • Background
  • The emergence of non-invasive technologies
  • Pharmacogenomics (PGx) on Demand
  • Lab-on-a-Chip
  • The Wireless Revolution
  • Connectivity Imperative
  • Non-Invasive Sampling
  • Regulatory environment

Chapter Four: The Economics of POC Testing: Revenue Opportunity

  • Background
  • POC and Clinical Outcomes Management
  • POC and Organization Culture Change
  • POC in the Management of Critical Care Patients
  • Reimbursement Trends
  • Migration of POC to the Core Lab: The Lab Fights Back
  • More than Device Installation: Training and QC

Chapter Five: Market Analysis

  • Market Overview
  • POC in World Markets
  • The Major Players
  • Over-the-Counter (OTC) Tests
  • Physician Office Labs (POLs) and Clinic Testing for Early Disease Detection
  • POC Testing in the Hospital
  • Home Monitoring of Individuals with Chronic Diseases
  • POC Test Segments
    • Blood Glucose
    • Cardiac markers
    • Clinical Chemistry/Hematology
    • Coagulation
    • Critical care analytes - Blood Gas/Electrolytes
    • Drugs of Abuse
    • Infectious Diseases
    • Pharmacogenetics
    • Pregnancy/Fertility
    • Sepsis
    • Oncology
    • Women’s health
    • Urinalysis

  • Emerging Tests and Technologies
  • Commercial Outlook

Chapter Six: Company Briefs

  • The Top IVD Companies and Their POC Offerings
    • Abbott Laboratories
    • Bayer Corporation / Siemens
    • Beckman-Coulter Diagnostics
    • bioMerieux Inc.
    • Dade Behring Inc.
    • Daiichi Pure Chemicals Co., Ltd.
    • Instrumentation Laboratory (IL)
    • Roche Diagnostics

  • POC Companies and New Frontiers
    • Abaxis Inc.
    • Abbott Diagnostics
    • Accumetrics, Inc.
    • Accurex Biomedical, Pvt., Ltd
    • Actimed Diagnostics
    • Adeza Biomedical Corporation
    • Aerscher Diagnostics
    • Akers Bioscience
    • Ambri Ltd
    • American Bio Medica Corp.
    • American Biogenetic Sciences, Inc
    • Ani Biotech
    • Ark Therapeutics
    • Array Medical
    • Avitar, Inc.
    • Avox Systems
    • Axis-Shield
    • Bayer Corporation
    • Beacon Diagnostics
    • Biex Inc.
    • Binax Corporation
    • Biomerica
    • BioMérieux Vitek, Inc.
    • BioScan Screening Systems, Inc.
    • Biosite Diagnostics
    • Biostar
    • Caliper Technologies
    • Calypte Biomedical
    • Cardiovascular Diagnostics (Pharmanetics)
    • Cholestech
    • Chongqing Sungene Pharmaceutical Co., Ltd
    • Compucyte Corporation
    • Cortech Ltd.
    • Cozart Biosciences
    • Cygnus Therapeutic Systems
    • Cytogen
    • Dade Behring
    • Denka Seiken Co., Ltd.
    • Diagnology, Inc.
    • Diametrics Medical, Inc.
    • Disetronic Medical Systems
    • Dynagen
    • Ely Labs
    • Enterix, Inc.
    • GDS Technology GenBio
    • Genzyme Diagnostics
    • Gryphus Diagnostics
    • Helena Laboratories
    • Hemocue, Inc.
    • Home Access Health Corp
    • Iatron
    • Immunoscience, Inc.
    • Instrumentation Laboratory
    • International Medical Innovations
    • Inverness
    • i-Stat Corporation
    • Jiangnan Biotech
    • Johnson & Johnson
    • Kyowa Medex Co., Ltd.
    • LifeAssays
    • LifePoint, Inc.
    • LifeScan Corporation
    • Lifestream Technologies 266
    • LXN Corp (Inverness Medical Technologies)
    • Matritech
    • Medical Services International Inc.
    • Medisense
    • Medix Biochemica
    • MedMira Laboratories
    • Medtronic Cardiac Surgery (ACT)
    • Medtronic
    • Meretek Corporation
    • Meridian Diagnostic
    • Micro Diagnostics Corp
    • MiniMed
    • New Horizons Diagnostics
    • Nova Biomedical
    • Optical Sensors Inc.
    • Orasure
    • Orgenics
    • Orion Diagnostica
    • PanBio Corp
    • Pharmanetics, Inc.
    • Pharmatech Corporation
    • Point of Care Technologies
    • Polymedco
    • Polymer Technology Systems
    • PreMD
    • Princeton BioMeditech Corporation
    • Quidel
    • Radiometer
    • Rapid Bio Tests Corporation
    • Response Biomedical Corp.
    • Roche Diagnostics
    • Royal Philips Electronics
    • Phillips Medical Systems
    • Saliva Diagnostics
    • Savyon Diagnostics
    • Selfcare, Inc.
    • Seradyn Clinical Diagnostics/Apogent Technologies
    • Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)
    • Sienco
    • Simplex Medical Systems
    • SmithKline/Beckman Diagnostics
    • Spectral Diagnostics
    • SpectRx, Inc.
    • Stat Site Meter
    • STC Technologies
    • Sun Biomedical Laboratories
    • Sybron International Corporation
    • Taiwan Diagnostic
    • Therasense, Inc.
    • Thoratec/International Technidyne Corp
    • Transmedica
    • Trinity Biotech
    • Wampole Laboratories
    • Worldwide Medical Corporation
    • Wyntek Diagnostics

List of Exhibits

  • Exhibit 1: Market Summary: Worldwide POC Sales 2005-2010
  • Exhibit 2: Selected New Biochip Products (Company, Product, Target)
  • Exhibit 3: U.S. Lab Reimbursement by Recipient (Quest, LabCorp, Other Reference Lab, Hospital Lab, Physician Office Lab), 2005
  • Exhibit 4: World POC OTC Sales by Test Category (Glucose, Pregnancy/Ovulation, Coagulation/PT, Fecal Occult Blood, Drugs Of Abuse, H. Pylori, HIV, Cholesterol, Other) 2005-2010
  • Exhibit 5 World POC Professional Sales by Test Category (Glucose, Critical Care, Pregnancy, Infectious Diseases, Cardiac Markers, Cholesterol/Lipids, Coagulation/PT/ACT, HbA1c, Hemoglobin, Fecal Occult Blood, Drugs of Abuse, Bilirubin, Other) 2005-2010
  • Exhibit 6: POC Test Revenues of Selected IVD Companies (Top 40 Competitors), 2005
  • Exhibit 7: Selected Direct-to-Consumer Tests on the Market
  • Exhibit 8: Selected OTC Test Devices on the Market (Company, Device, Target)
  • Exhibit 9: Selected Professional POC Tests on the Market and in Development (Company, Device, Target, Development Status)
  • Exhibit 10: World Glucose Monitoring Sales and Market Share by Company and Segment (Professional vs OTC), 2005
  • Exhibit 11: Selected Blood Glucose Test Devices on the Market (Company, Product, Development Status)
  • Exhibit 12: HgbA1c Test Market by Setting (Lab vs POC) and Region (United States, Europe, ROW), Revenues, Average Cost per Test, Number of Tests 2005
  • Exhibit 13: Worldwide Sales of Selected Lab Based Cardiac IVDs (Cholesterol/Lipid Markers, CRP/Inflammation Markers, AMI Enzymes, BNP, Homocysteine, D-Dimer), 2005-2010
  • Exhibit 14: Worldwide Sales of Selected Professional POC Cardiac IVDs (Cholesterol/Lipid Markers, AMI Enzymes, BNP, D-Dimer), 2005-2010
  • Exhibit 15: Worldwide Sales of OTC Cholesterol/Lipid Tests, 2005-2010
  • Exhibit 16: Cardiac IVD Testing Volumes by Region (United States, Europe, ROW) and Test (6 Lab-Based Tests, 4 Professional POC Tests, OTC Cholesterol [see Exhibits 13, 14, and 15 for specific tests]), 2005
  • Exhibit 17: PT Testing Volume by Region (United States, Europe, ROW) and Type (Lab, Professional POC, OTC), 2005
  • Exhibit 18: Infectious Disease Testing Volumes by Region (United States, Europe, ROW) and Test (Strep A, Influenza, HIV, Vaginitis, Chlamydia, H. pylori, Meningitis, Mononucleosis, Strep B, Strep. Pneum, Others), 2005
  • Exhibit 19: Selected SNP-Drug Interactions
  • Exhibit 20: Fecal Occult Blood (FOB) Testing Volumes by Region (United States, Europe, ROW) and Type (POC Professional Guaiac, POC Professional Immunochemical, OTC Guaiac/immuno, OTC Flushable), 2005
  • Exhibit 21: Women’s Health Testing Volumes by Region (United States, Europe, ROW) and Type (Professional Pregnancy, OTC Pregnancy, OTC LH/Ovulation), 2005
  • Exhibit 22: Selected OTC Non-Pregnancy Women’s Health and Fertility Tests on the Market

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