Worldwide Point of Care Diagnostic Test Markets

Date: December 22, 2010
Pages: 390
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US$ 2,800.00
Publisher: Kalorama Information
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: W347FBA9C77EN
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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. At the same time more decentralized test venues invest in non-waived rapid tests and instruments POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care.

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.
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
  Diabetes
  Critical Care
  Hematology
ARKRAY, Inc.
  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
  Diabetes
  Cardiac Markers
  Clinical Chemistry
  Critical Care
Siemens Healthcare Diagnostics
  Cardiac Markers
  Diabetes Care
  Blood Gases
  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

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Exchange Rate Fluctuations, 2005-200
Table 1-2: POC Sales by Test Category (OTC and POC), Worldwide 2008-2011

CHAPTER FOUR: TECHNOLOGY AND INDUSTRY TRENDS

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

CHAPTER FIVE: VENUES FOR POC TESTING

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

CHAPTER SIX: MARKET ANALYSIS

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

CHAPTER SEVEN: POC TEST SEGMENTS

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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