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Worldwide Point of Care Diagnostic Test Markets
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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.
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
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