Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads

Date: November 23, 2009
Pages: 300
US$ 3,995.00
Publisher: Kalorama Information
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)

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Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads
As Kalorama Information's lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality are here. But is healthcare ready? The drive for wellness and the attention surrounding healthcare reform will surely focus attention on rapid diagnostics. However, according to Shara Rosen, RT, M.B.A., there are many challenges which must be overcome for point of care solutions to fit, and those companies willing to pivot strategies and best adjust to changes in the healthcare marketplace may be rewarded.

This report, Point of Care Diagnostics 2010: Rapid Testing at a Crossroads represents the most current analysis of the role of Point of Care Diagnostics in today's in vitro industry. Other reports have looked at products, companies and market forecasts, as this report does. But in her analysis Shara Rosen 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. The report includes:
  • Markets for POC Diagnostics (Diabetes, Cardiac markers, Clinical Chemistry/Critical Care, Hematology, Coagulation,
  • Drugs of Abuse/Therapeutic Drug Monitoring, Infectious Diseases, Pharmacodiagnostics, Sepsis, Oncology, Women’s health / Pregnancy/Fertility)
  • By Venue Revenue Estimates for Hospital POC, Physician POC and Other Venue
  • Review of Products in the Market
  • Forecasts to 2013
  • Markets and Forecasts for Self-Testing (OTC)
  • The role of EMR in the Point of Care Market
  • Possible Effects of Healthcare Reform
  • POLs, Home Monitoring, Alternate Samples and Other Trends
  • Successful Strategies of POC Companies
  • Profiles of Over 100 Companies Competing in this Market
There are many factors in the growth of POC testing- increasing numbers of diagnosed diabetics, people with cardiovascular disease, and other chronic conditions. It is also expected to play a role in 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. This is an especially relevant technology given the U.S. healthcare reform efforts.

All countries are feeling the brunt of aging populations and an increased burden of chronic disease management. Employers and insurance companies are interested in improving the health of customers, and there are some innovative tactics developing in this area. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.

The report offers a quantitative assessment of specific markets in US dollars for 2008 and forecasted out to 2013. 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.

As part of Kalorama Information's comprehensive coverage, the following companies are discussed:
  • 23andMe
  • 3M Health Care
  • 77 Elektronika
  • A. Menarini
  • A/C Diagnostics
  • Abaxis, Inc.
  • Abbott Diagnostics
  • ABTECH Scientific
  • Accumetrics
  • ACIST Medical
  • Acrongenomics Inc.
  • Adeza Biomedical
  • Aerscher Diagnostics
  • AgaMetrix, Inc.
  • Alfa Scientific
  • Alfa Wassermann
  • Alverix Inc.
  • American Bio Medica
  • Amic/Ortho
  • Amnisure International
  • Animas/J&J
  • ANP Technologies
  • Antigen Discovery Inc.
  • Apollo Hospitals
  • Arkray
  • Arrayit Diagnostics
  • AspenBio Pharma
  • Astron Clinica
  • AT First Diagnostic
  • Audit Diagnostics
  • Axis-Shield plc
  • Bayer Diabetes Care
  • Beckman Coulter
  • Becton Dickinson
  • Bedfont Scientific
  • Biohit Oy
  • BioIQ
  • bioLytical Labs
  • Biomagnetics Diagnostics
  • Biomerica, Inc.
  • bioMérieux
  • Bionime Corp.
  • Bio-Rad Laboratories
  • BIOSAFE Medical Technologies
  • Biosite/Inverness
  • Boditech Med
  • BodyTel Scientific
  • Branan Medical Corp
  • Burnet Institute
  • Calypte Biomedical
  • Careside Medical
  • Carolina Liquid Chemistries
  • Celerus Diagnostics
  • Chelsea Technologies
  • Chembio Diagnostic
  • Chempaq A/S
  • Chemtron Biotech
  • Cholestech Corp.
  • Claros Diagnostics
  • CLX Medical, Inc.
  • Combimatrix
  • Common Sense, Ltd.
  • Commonwealth Labs
  • Connectyx Technologies
  • ContraVac, Inc.
  • Decision Biomarkers
  • DexCom, Inc.
  • Diabetech, LP
  • Diabetes Sentry
  • Diaglobal GmbH
  • Diagnostic Devices
  • Diagnostics for All
  • Diagnostics for the Real World
  • Diazyme Laboratories
  • Digital Bio Tech
  • Diversa Limited
  • DNA Direct, Inc.
  • DxNA
  • Echo Therapeutics
  • EKF-diagnostic GmbH
  • Enfora
  • Enigma Diagnostics
  • Enterix Inc.
  • Entra Health
  • Epocal, Inc.
  • EPS Bio Technology
  • ESA Biosciences
  • eScreen, Inc.
  • ExpressMD Solutions
  • EyeMarker Systems
  • Flexsite Diagnostics
  • Focus Diagnostics
  • Fora Care
  • GE Healthcare
  • GenBio
  • Gene Smart Wellness
  • Genexel-Sein Inc.
  • Gentag Inc.
  • Genzyme Diagnostics
  • Global Detection & Reporting
  • Glucometrics, Inc.
  • Google, Inc.
  • Guided Therapeutics
  • Hai Kang Life Corp.
  • Hain Lifescience GmbH
  • HandyLab, Inc.
  • HealthPia America
  • HealthPort
  • Helena Laboratories
  • Hema Diagnostic Systems
  • Hema Metrics
  • HemoCue AB
  • Hero Network Network
  • HMM GmbH
  • Hoana Medical
  • Home Access Health
  • Home Diagnostics
  • Horiba ABX
  • Idaho Technology
  • IDenta Corp
  • Identigene
  • IDEXX Laboratories
  • incentaHEALTH LLC
  • Innovative Biosensors
  • Instrumentation Laboratory
  • Insulet Corporation
  • Integrity Applications
  • Intel Corporation
  • International Technidyne
  • Inverness Medical Innovations
  • Knome
  • Lab Express
  • LifeAssays AB
  • Lifescan
  • LifeSign LLC
  • LifeStat
  • Lifestream Technologies, Inc.
  • Lifestyle Choices
  • Luminex
  • Luminous Medical
  • Masimo Corp
  • Matritech
  • M-Biotech
  • Medical Automation Systems
  • MedMira Inc.
  • Medtronic Inc.
  • Menssana Research, Inc.
  • Meretek Diagnostics Inc.
  • Meridian Bioscience
  • Micromem Technologies
  • Micronics Inc.
  • MicroPhage, Inc.
  • MinuteClinic
  • Mitsubishi Kagaku Iatron
  • MP Biomedicals
  • Multilyte Limited
  • MycroLab Pty
  • Nanogen
  • Nanomix, Inc.
  • Nanosphere, Inc.
  • National Jewish Health
  • Navigenics, Inc.
  • Network Biosystems
  • Neuroptix Corp
  • Nihon Kohden
  • Noninvasive Medical Tech
  • Nova Biomedical
  • OPTI Medical Systems
  • OraSure Technologies
  • Orion Diagnostica
  • OrSense Ltd.
  • Ortho Clinical Diagnostics
  • OvumOptics, Inc.
  • Oxford Biosensors
  • Oxonica Diagnostics
  • Phadia AB
  • Philips Handheld Immunoassays
  • PlaCor, Inc.
  • PointCare Technologies
  • Polymedco
  • Practice Fusion
  • PreMD Inc.
  • PrimeraDx
  • Probe Scientific Ltd
  • Prometheus Laboratories
  • Psynomics
  • QBC Diagnostics
  • Qiagen
  • Q-linea
  • Quadraspec
  • QualSec, Inc
  • QuantRx Biomedical Corporation
  • Quidel Corp
  • Quotient Diagnostics
  • Radiometer A/S
  • Raman spectroscopy
  • Rapid Pathogen Screening
  • Rennesens GmbH
  • Response Biomedical
  • Rite Aid
  • Roche Diagnostics
  • Royal Philips Electronics
  • Safeway, Inc.
  • Screening Devices Canada
  • Sentinel Bioactive Paper Network
  • SeraCare Life Sciences
  • Serotec
  • Siemens Healthcare Diagnostics
  • Smiths Detection
  • Smiths Medical MD
  • Soar BioDynamics
  • Solei Systems, Inc
  • Solianis Monitoring
  • SpectraScience, Inc.
  • Sphere Medical Ltd.
  • SpheroSense Technologies
  • Stanbio Laboratory
  • StatSure Diagnostic Systems
  • STD Test Express
  • STMicroelectronics
  • Synova Healthcare
  • Sysmex Corp
  • T2 Biosystems
  • Taidoc Technology
  • TelCare
  • Telus Corporation
  • Textronics, Inc.
  • Thermo Fisher Scientific
  • Tosoh Corp
  • Trinity Biotech
  • TwistDx, Ltd.
  • Tyrian Diagnostics
  • UnitedHealth Group
  • Veralight, Inc.
  • Veredus Laboratories
  • VeriChip Corporation
  • Via Medical Corp
  • Vital Diagnostics
  • Vivacta Limited
  • Walgreens
  • Wal-Mart Stores
  • Webahn Inc.
  • Ypsomed

Scope and Methodology
Size and Growth of the Market
Market Trends


Miniaturization, Digitization and Informatics
The pros and cons of POC testing
Point of View


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


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


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


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


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
Decentralized Coagulation testing - Professional Use
Decentralized Coagulation Testing - OTC
Drugs of Abuse/Therapeutic Drug Monitoring
Infectious Diseases
OTC Tests for Infectious Diseases
Professional POC Tests for Infectious Diseases
Bladder Cancer
Colon Cancer
Prostate Cancer
Cervical Cancer
Women’s Health / Pregnancy/Fertility
Emerging Tests and Technologies
Commercial Outlook


Abbott Diagnostics
Critical Care
Distribution News
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
Cardiac Markers
Clinical Chemistry
Critical Care
Siemens Healthcare Diagnostics
Cardiac Markers
Diabetes Care
Blood Gases
Sysmex Corporation
TOSOH Corporation

‘New Frontier’ POC COMPANIES

3M Health Care
77 Elektronika Kft.
Abaxis, Inc.
A/C Diagnostics
ACIST Medical Systems, Inc.
AgaMetrix, Inc.
Alfa Wassermann Diagnostic Technologies, LLC (AWDT)
American Bio Medica Corp
Audit Diagnostics
Axis-Shield plc
Biohit Oy
Biomerica, Inc.
Biosite Incorporated
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
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 Serot
Smiths Medical MD, Inc. (formerly Deltec, Inc.)
Stanbio Laboratory
Taidoc Technology Corp.
Trinity Biotech plc
Via Medical Corporation
Vital Diagnostics

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.)
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
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
Innovative Biosensors, Inc.
Integrity Applications Ltd.
Intel Corporation
LifeAssays AB
LifeSign LLC
Lifestyle Choices Ltd
Luminous Medical, Inc.:
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.
QualSec, Inc
QuantRx Biomedical Corporation
Quotient Diagnostics
Rapid Pathogen Screening
Rennesens GmbH
Screening Devices Canada, Inc.
Sentinel Bioactive Paper Network
Sphere Medical Ltd.
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



Table 1-1: Exchange Rate Fluctuations, 2005-2008
Table 1-2: POC Sales by Test Category (OTC and POC), Worldwide 2008-2013


Table 4-1: Selected Non-Invasive Testing Innovations
Table 4-2: Selected disease markers in exhaled breath
Table 4-3: Selected POC Wireless Innovations, 2008-2009
Table 4-4: RALS connected POC systems, 2009
Table 4-5: Selected biochip and biosensor innovations, 2009


Figure 5-1: Venues for POC Testing (Hospital, Physician, Other)
Table 5-1: POC Test Sales in the Hospital Sector (Critical Care, Glucose, Cardiac Markers, Infectious Diseases, Coagulation, Hematology, Drugs of Abuse, Cholesterol, Pregnancy, Urinalysis), 2008
Table 5-2: POC Test Sales in the POL Sector (Glucose, Cholesterol, HbA1c, Coagulation, Hematology, Chemistry/Immunoassays, Infectious Diseases, Fecal Occult Blood, Pregnancy, Cardiac Markers, Oncology, Urinalysis, Drugs of Abuse), 2008
Table 5-3: Selected Small Footprint Chemistry Systems, 2009
Table 5-4: Selected Small Footprint Hematology Systems, 2009
Table 5-5: Selected New Small Footprint Immunoassay Systems, 2009
Table 5-6: POC Test Sales in Other Care Venues (Glucose, Cholesterol, Drugs of Abuse, Fecal Occult Blood, Infectious Diseases, Urinalysis, Coagulation), 2008
Table 5-7: Selected self-test innovations, 2008-2009


Table 6-1: OTC/Self Test Sales by Test Category (Glucose, Pregnancy, Coagulation, Fecal Occult Blood, Drugs of Abuse, HbA1c, HIV, Cholesterol, Other) Worldwide 2008 and 2013
Figure 6-1: Breakout of Non-Glucose Self-Testing
Figure 6-2: Professional POC Testing Market by Test Category
Table 6-2: 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) 2008 and 2013
Figure 6-3: Professional POC Testing Market by Test Category
Table 6-3: POC Test Sales by Region (US, Europe, Asia, ROW), 2008-2013
Table 6-4: POC Test Revenues of Selected IVD Companies, $ million, estimated
Table 6-5: Selected Market Expansion Deals in POC testing, 2008-2009


Table 7-1: World Glucose Monitoring Sales, by Company, 2005 - 2008
Table 7-2: Selected Glucose Meter Innovations, 2008-2009
Table 7-3: Selected Wireless Enabled Blood Glucose Monitors, 2009
Table 7-4: Selected Continuous BGM Sales by Company, 2008
Table 7-5: Selected Continuous Blood Glucose Systems, 2009
Table 7-6: Glucose Meters that use GDH-PQQ technology
Table 7-7: Selected POC HbA1c Devices, 2009
Table 7-8: Worldwide Sales, POC CVD markers (Cholesterol -Professional, Cholesterol OTC, AMI Enzymes), 2008-2013
Table 7-9: Selected POC Hematology Systems, 2009
Table 7-10: World POC Coagulation Sales(PT-Professional, PT OTC, ACT), 2008 (million)
Table 7-11: Selected CLIA Waived PT Devices
Table 7-12: Selected Rapid HIV Tests on the Market
Table 7-13: Selected Rapid Infectious Disease Test Innovations
Table 7-14: Selected Women’s Health OTC Tests
Table 7-15: Selected POC Platform Innovations, 2008/2009
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