Description
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.
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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/
Table of Contents
TABLE OF CONTENTS
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
