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Worldwide Point of Care Diagnostic Test Markets

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.

All Kalorama reports advertise the single user price. Use is limited to one user. We also feature department and global pricing for reports that we be utilized by more than one user at your company. Please consult ask your sales representative or select the correct license on our website.

For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/


  • Executive Summary
    • SCOPE AND METHODOLOGY
      • Table Historic Exchange Rate Data, 2005-2010
    • SIZE AND GROWTH OF THE MARKET
      • Table POC Sales by Test Category (OTC and POC), Worldwide 2009-2014 ($ million)
      • MARKET TRENDS
  • Introduction
    • MINIATURIZATION, DIGITIZATION AND INFORMATICS
    • THE PROS AND CONS OF POC TESTING
    • POINT OF VIEW
  • Economics, EMR and Healthcare Reform
    • BACKGROUND
      • HEALTHCARE REFORM
      • POC AND CLINICAL OUTCOMES MANAGEMENT
      • POC'S UNMET NEED
  • Technology and Industry Trends
    • BACKGROUND
    • THE SEARCH FOR NON-INVASIVE TOOLS
      • Table Selected Non-Invasive Testing Innovations
      • Saliva
      • Breath
        • Table Selected disease markers in exhaled breath
      • Optical Techniques
      • Patch Technology
      • Wearable Sensors/Textiles
    • THE WIRELESS REVOLUTION
      • Table Selected POC Wireless Innovations, 2010
      • CONNECTIVITY IMPERATIVE
        • Table Selected RALS connected POC systems, 2009
    • LAB-ON-A CHIP
      • Table Selected biochip and biosensor innovations, 2010
  • VENUES FOR POC TESTING
    • POC TESTING IN THE HOSPITAL
      • Table POC Test Sales in the Hospital Sector, WW, 2009
    • POL AND CLINIC TESTING
      • Table POC Test Sales in the POL Sector, WW, 2009
      • Table Selected Small Footprint Chemistry Systems, 2010
      • Table Selected Small Footprint Hematology Systems, 2010
      • Table Selected New Small Footprint Immunoassay Systems, 2010
      • RETAIL OUTLETS
      • OTHER PROFESSIONAL POC VENUES
        • Table POC Test Sales in Other Care Venues, 2009
      • HOME MONITORING OF INDIVIDUALS WITH CHRONIC DISEASES
      • SELF-TEST SECTOR - OTC TESTS
        • Table Selected self-test innovations, 2010
  • Market Analysis
    • MARKET OVERVIEW
    • PROGNOSIS FOR POC GROWTH
    • TECHNOLOGICAL CHALLENGES
    • MARKET AND FORECASTS
      • Self Testing/OTC
        • Table OTC/Self Test Sales by Test Category (Glucose, Pregnancy, Coagulation, Fecal Occult Blood, Drugs of Abuse, HbA1c, HIV, Cholesterol, Other) Worldwide 2009 and 2014 (Sales $ MM)
      • Professional POC Testing
        • Table Professional Point of Care Testing Market by Test Category (Glucose, Critical Care, Cardiac Markers, Infectious Diseases, Cholesterol/Lipids, Coagulation, Hematology, HbA1c, Chemistry/Immunoassays, Fecal Occult Blood, Drugs of Abuse, Pregnancy, Urinalysis, Onocology, Other) 2009 and 2014 (Sales $ MM)
    • POC IN WORLD MARKETS
      • Table POC Test Sales by Region (US, Europe, Japan, ROW), 2009-2014 ($ million)
      • Europe
      • Rest of the World
    • THEMAJOR PLAYERS
      • Table POC Test Revenues of Selected IVD Companies, $ million, estimated
    • LICENSES AND DISTRIBUTION AGREEMENTS
      • Table Selected Market Expansion Deals in POC testing, 2008-2010
      • Struggling Competitors
  • POC Test Segments
    • DIABETES TESTING - BLOOD GLUCOSEMONITORING (BGM)
      • Table World Glucose Monitoring Sales, by Company, 2007 - 2009 ($MM, estimated)
      • Blood Glucose Self-Testing
        • Table Selected glucose meter innovations
        • Table Selected wireless enabled BGMs
        • Table Selected Continuous BGM Sales, 2009
        • Table Selected continuous blood glucose systems, 2010
      • Blood Glucose Testing by Professionals
      • Diabetes Testing - Glycated Hemoglobin
        • Table Selected POC HbA1c Devices, 2010
    • CARDIOVASCULAR DIAGNOSTICS
      • Table Worldwide Sales, POC CVD markers, 2009-2014 $ millions
      • Cardiac Markers (AMI enzymes)
      • Cholesterol/Lipid Panels
    • CLINICAL CHEMISTRY/CRITICAL CARE
      • Continuous Testing
      • Clinical Chemistry
    • HEMATOLOGY
      • Table Selected POC Hematology Systems, 2010
    • COAGULATION
      • Table World POC Coagulation Sales, 2009 ($ million)
      • Decentralized Coagulation Testing - Professional Use
        • Table Selected CLIA Waived PT Devices
      • Decentralized Coagulation Testing - OTC
      • Platelet Testing
    • DRUGS OF ABUSE/THERAPEUTIC DRUG MONITORING
    • ALLERGY
    • INFECTIOUS DISEASES
      • OTC Tests for Infectious Diseases
        • Table Selected rapid HIV tests on the market
      • Professional POC Tests for Infectious Diseases
        • Table Selected rapid infectious disease test innovations
    • PHARMACODIAGNOSTICS
    • SEPSIS
    • ONCOLOGY
      • Bladder Cancer
      • Colon Cancer
      • Prostate Cancer
      • Cervical Cancer
    • WOMEN'S HEALTH / PREGNANCY/FERTILITY
      • Table Selected Women's Health OTC Tests
    • EMERGING TESTS AND TECHNOLOGIES
      • Table Selected POC Platform Innovations, 2010
    • COMMERCIAL OUTLOOK
  • Company Profiles
    • MAJOR COMPANIES
      • ABBOTT DIAGNOSTICS
        • Table Recent Revenue History
      • ALERE (FORMERLY INVERNESS MEDICAL INNOVATIONS)
        • Table Recent Revenue History: $ million
      • BAYER DIABETES CARE
        • Table Recent Revenue History: (million)
      • BECKMAN COULTER INC.
        • Table Recent Revenue History: ($ million)
      • BECTON, DICKINSON AND COMPANY (BD)
        • Table Recent Revenue History
        • Table Recent Revenue History
      • BIO-RAD LABORATORIES INC.
        • Table Recent Revenue History: ($ million)
      • GE HEALTHCARE
      • HORIBA MEDICAL
      • INSTRUMENTATION LABORATORY
        • Table Recent Revenue History: ($ millions, estimated)
      • LIFESCAN INC.
        • Table Recent Revenue History: (in millions)
      • NOVA BIOMEDICAL
      • ORTHO CLINICAL DIAGNOSTICS (OCD)
        • Table Recent Revenue History: (in millions)
      • PHADIA AB
        • Table Recent Revenue History
      • QIAGEN N.V.
        • Table Recent Revenue History: ($ million)
      • QUIDEL CORPORATION
        • Table Recent Revenue History
        • Table Breakdown Of Quidel's POC Product Revenue
      • RADIOMETER A/S
      • ROCHE DIAGNOSTICS
        • Table Recent Revenue History (in millions)
        • Table Breakdown Of Roche's Revenue
      • SIEMENS HEALTHCARE DIAGNOSTICS
        • Table Recent Revenue History: $ million (1 Euro = $1.37)
        • Table Breakdown Of Siemens' IVD Product
      • SYSMEX CORPORATION
        • Table Recent Revenue History: ($ million, 1yen = $0.0090)
        • Table Breakdown Of Sysmex's Product
      • TOSOH CORPORATION
        • Table Recent Revenue History: (estimated, million, 1 yen = $0.009)
    • New Frontier Companies
      • 3M HEALTH CARE
      • 77 ELEKTRONIKA KFT.
      • ABAXIS, INC.
        • Table Recent Revenue History
      • A/C DIAGNOSTICS
      • ACCUMETRICS
        • Table Recent Revenue History
      • ACISTMEDICAL SYSTEMS, INC.
      • ACON LABORATORIES, INC.
      • AGAMETRIX, INC.
      • AKERS BIOSCIENCES, INC.
      • ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC (AWDT)
      • AMERICAN BIO MEDICA CORP (ABMC)
      • AMIC AB
      • ANI BIOTECH OY
      • AUDIT DIAGNOSTICS
      • AXIS-SHIELD PLC
        • Table Recent Revenue History (in millions, 1£ = $1.50)
      • BIOIQ
      • BIOMERICA, INC.
        • Table Recent Revenue History: (estimated)
      • BIOSITE INCORPORATED
      • BIOVEI INCORPORATED
      • CAROLINA LIQUID CHEMISTRIES CORP.
      • CHEMBIO DIAGNOSTIC SYSTEMS, INC.
        • Table Recent Revenue History
      • CHEMPAQ A/S
      • CHOLESTECH CORPORATION
        • Table Recent Revenue History: ($ million)
      • CLAROS DIAGNOSTICS, INC.
      • COAGUSENSE, INC.
      • CONCATENO PLC
        • Table Recent Revenue History
      • CONTRAVAC, INC.
      • DEXCOM, INC.
        • Table Recent Revenue History
      • DIABETECH, LP
      • DIADEXUS, INC.
      • DIAZYME LABORATORIES
      • EIKEN CHEMICAL CO., LTD
        • Table Recent Revenue History
        • Table Breakdown Of Eiken's Product Sales
      • EKF-DIAGNOSTIC GMBH
      • ESA BIOSCIENCES INC.
      • HAIN LIFESCIENCE GMBH
      • HANDYLAB, INC.
      • HELENA LABORATORIES USA
      • HEMA DIAGNOSTIC SYSTEMS (HDS)
      • HEMOCUEAB
      • HEMOSENSE, INC.
      • HOME DIAGNOSTICS, INC. (NOW NIPRO DIAGNOSTICS)
        • Table Recent Revenue History: ($ million)
      • HORIBA ABX S.A.
      • INSULET CORPORATION
        • Table Recent Revenue History
      • INTERNATIONAL TECHNIDYNE CORP (ITC)
      • MACHEREY-NAGELGMBH&CO.
      • MASIMO CORPORATION
      • MATRITECH
      • MEDICAL AUTOMATION SYSTEMS, INC.
        • Table RALS connected POC systems, 2009
      • MEDMIRA INC.
      • MEDTRONIC INC.
        • Table Recent Revenue History: ($ million)
      • A. MENARINI DIAGNOSTICS
      • MERIDIAN BIOSCIENCE
        • Table Recent Revenue History
      • MP BIOMEDICALS LLC
      • NANOSPHERE, INC.
        • Table Recent Revenue History
      • OPTI MEDICAL SYSTEMS, INC.
        • Table Recent Revenue History
      • ORASURE TECHNOLOGIES, INC.
        • Table Recent Revenue History: (million)
      • PHILIPS HANDHELD IMMUNOASSAYS
      • POLYMEDCO, INC.
      • QBC DIAGNOSTICS, INC.
      • RANDOX
      • RESPONSE BIOMEDICAL CORP.
        • Table Recent Revenue History
      • SEROTEC (ABDSEROTEC)
      • TRINITY BIOTECH PLC
        • Table Recent Revenue History: (million)
      • VIA MEDICAL CORPORATION
      • VITAL DIAGNOSTICS
    • Other Players
      • Acrongenomics Inc.
      • Astron Clinica
      • AspenBio Pharma, Inc.
      • AT First Diagnostic, LLC
      • bioLytical Laboratories Inc.
      • Biomagnetics Diagnostics Corporation
      • Bionime Corporation
      • BodyTel Scientific, Inc.
      • Burnet Institute
      • Chelsea Technologies Group Ltd
      • Common Sense, Ltd.
      • Diabetes Sentry Products Inc.
      • Diaglobal GmbH
      • Diagnostic Devices, Inc.
      • Diagnostics for the Real World (DRW)
      • DNAFORM
      • DxNA
      • Enigma Diagnostics Limited
      • Enterix Inc.
      • Entra Health Systems
      • Epocal, Inc.
      • EUMED Biotechnology Co. Ltd.
      • eScreen, Inc.
      • Flexsite Diagnostics, Inc.
      • Fora Care
      • GenBio
      • Gene Smart Wellness
      • Gentag Inc.
      • Hai Kang Life Corporation
      • Hema Metrics
      • Idaho Technology, Inc.
      • Identa Corporation
      • Innovative Biosensors, Inc.
      • Integrity Applications Ltd.
      • Intel Corporation
      • LifeAssays AB
      • LifeSign LLC
      • Lifestyle Choices Ltd
      • Luminous Medical, Inc.
      • M-Biotech
      • Menssana Research, Inc.
      • Micronics Inc.
      • MycroLab Pty Ltd.
      • OrSense Ltd.
      • Oxonica Diagnostics
      • PlaCor, Inc.
      • PointCare Technologies
      • Probe Scientific Ltd
      • Rheonix Inc.
      • Tyrian Diagnostics Limited
      • Q-linea
      • QuantRx Biomedical Corporation
      • Quotient Diagnostics
      • Rapid Pathogen Screening
      • rennesens GmbH
      • Screening Devices Canada, Inc.
      • Sentinel Bioactive Paper Network
      • Sphere Medical Ltd.
      • SIENCO
      • Solianis Monitoring AG
      • STD Test Express
      • T2 Biosystems, Inc.
      • TwistDx, Ltd.
      • Veredus Laboratories Pte

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