The World Market for Point of Care (POC) Diagnostics

Dec 6, 2012
200 Pages - Pub ID: KLI4891643
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 Point-of-care (POC) tests are diagnostic tests that are performed at or near the site where the patient is located. They are performed in decentralized settings, outside of central hospital laboratories or centralized reference laboratories. Growth in POC testing is being fueled by many factors including the growing number of people with diabetes, the globalization of infectious diseases and the associated public health issues, advances in therapies giving physicians more tools for treatment of patients if the doctor is able to rapidly diagnose the problem, the need to monitor an ever-growing group of people with chronic diseases such as cardiovascular diseases, arthritis, cancer and other chronic conditions, and many other factors.

Point of Care Testing (POCT) is attracting considerable investor and industry activity.  This Kalorama Information report, The World Market for Point of Care Diagnostics, the result of primary and secondary research into the point of care diagnostics market, presents the most current analysis of the POC Diagnostics industry and the role it plays in medical practice. This report takes an in depth look at the market, technologies, and trends in decentralized testing, looking at both self-testing by patients (also referred to as the over-the-counter (OTC) market, and at point-of-care testing by healthcare professionals.

As part of this report's coverage, the following data is included:

  • Molecular POC Test Products and the Future of Molecular POC
  • Self-Testing Point of Care Test Market by Category, Worldwide (Glucose, Infectious Diseases, Critical Care, Cardiac Markers, Hematology, Coagulation, Fecal Occult Blood, HbA1c, Cholesterol/Lipids, Drugs of Abuse, Pregnancy/Ovulation, Other)
  • Professional Point of Care Testing Market by Test Category, Worldwide, 2011 and 2016 (Glucose, Pregnancy/Ovulation, Fecal occult blood, Coagulation, Drugs of abuse, Cholesterol, HIV, Other)
  • Regional Breakout of POC Market (US, EU, Japan, ROW)
  • Blood Glucose Monitoring Markets
  • Small Footprint and POC Chemistry Systems
  • Small Footprint and POC Hematology Systems
  • Small Footprint and POC Immunoassay Systems
  • Non-Invasive Testing Innovations
  • Miniaturization and Microfluidics Innovations
  • POC Test Revenues of Selected IVD Companies
  • Selected Rapid HIV Tests on the Market
  • Comparative Effectiveness, Healthcare Reform and Other Trends in IVD
  • Hospital POCT, Physician Office POCT, Critical Care POCT
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 field for rapid test devices is crowded. This report profiles 140 companies that currently market POC, plus more than 40 additional companies that are developing POC technologies and products or that have just recently entered this market. Companies profiled in this report are using a wide range of different technologies to develop and market rapid tests for much of the range of in vitro diagnostic (IVD) tests that can be performed in centralized laboratories.

The report offers a quantitative assessment of specific markets, worldwide, in U.S. dollars for 2011 to 2016. Information is provided in order to set the status quo of tests and technologies, and to get a look at what is coming. The report also discusses how these tests will affect the economics of healthcare over the near term and longer when possible.

    As part of Kalorama Information's comprehensive coverage of Point of Care Diagnostics the following companies are discussed:

  • 1 Step Detect Associates
  • 3M
  • 3test
  • 77 Elektronika Kft.
  • A. Menarini Diagnostics
  • Abaxis, Inc.
  • Abbott Diagnostics
  • AccuBioTech Co., Ltd.
  • Accumetrics
  • Accutech
  • Acon Laboratories
  • Acrongenomics Inc.
  • Advanced Care Products
  • Advanced Microdevices Pvt. Ltd.
  • Aerscher Diagnostics
  • AgaMetrix, Inc.
  • Aimedics (Australia)
  • Akers Biomedical
  • Alere
  • Alfa Scientific Designs, Inc.
  • Alfa Wassermann Diagnostic Technologies, LLC
  • Alliance International Co., Ltd.
  • All Medicus
  • Amedica Biotech
  • American Bio Medica Corp
  • American Screening Corporation
  • AmeriTek
  • Ampcor
  • Analyticon Biotechnologies AG
  • Ani Biotech/Ani Laboratories
  • Apex Biotechnology Corp.
  • Applied Microarrays
  • ARJ Medical
  • ARKRAY, Inc.
  • Arlington Scientific, Inc.
  • Artron Laboratories
  • AspenBio Pharma, Inc.
  • Ativa Medical
  • Atlas Genetics
  • Atlas Link Biotech Co., Ltd.
  • Atonomics A/S
  • Audit Diagnostics
  • Autobio Diagnostics Co., Ltd.
  • Aventir Biotech
  • Axis-Shield plc
  • Axxin
  • AZOG, Inc.
  • B.R.A.H.M.S. AG
  • Bayer Diabetes Care
  • Beckman Coulter Inc.
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories Inc.
  • EKF-diagnostic Gmb
  • Quest Diagnostics
  • Inverness Medical Innovations
  • Lifescan Inc.
  • Medtronic Inc.
  • Meridian Bioscience
  • Nanomix, Inc.
  • Nanosphere, Inc.
  • OraSure Technologies, Inc.
  • Qiagen N.V.
  • Quidel Corporation
  • Radiometer A/S
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex CorporationThermo Scientific
  • and many other POC Competitors...
CHAPTER ONE: EXECUTIVE SUMMARY
Overview
Scope and Methodology
Point-of-Care Testing Market Overview
Glucose Market and Rest of POC Market
Regional Markets
Competitive Market Share
CHAPTER TWO: INTRODUCTION
Definition
CLIA
Market Drivers for Point-of-Care Testing
Patent focused drivers
Medical/Healthcare related drivers
Technology drivers
Economic drivers
Other drivers
Advantages and Disadvantages of Point-of-Care Testing
Advantages:
Disadvantages:
Point of View
CHAPTER THREE: TECHNOLOGY INNOVATIONS IN POINT-OF-CARE TESTING
Non-Invasive Technologies
Companies Offering Alternative Sample POC Technology
Urine
Saliva
Breath
Optical Technologies
Wireless POC Devices
Connected Glucose Devices
IICC
Miniaturization and Microfluidics Technologies
Lab on a Chip
Companies Offering Microfluidica and Miniaturization Devices
Molecular Diagnostics
Development of Molecular Technologies
Companies Offering POC Molecular Test Products
CHAPTER FOUR: LOCATIONS FOR POINT-OF-CARE TESTING
Overview, Locations of Testing
POC Testing in Hospitals
Physicians’ Office Laboratories and Clinics
Growth and Growth Limiters for POLs
Retail Clinics
Other Professional POC Testing
Self Testing – Over-the-Counter (OTC) Tests
CHAPTER FIVE: POINT-OF-CARE TESTING MARKET ANALYSIS 􀀃
Market Overview
Prognosis for Growth of POC Market
Challenges for the POC Market
POC markets – Current Markets and Market Forecasts
Self Testing/OTC
Professional POC Testing
POC in World Markets
The United States
Europe
Rest of World
The Major Players
Consolidation
Emerging New POC Companies with Innovative Platforms
Biocartis:
Curetis
Integrated Genetics
CHAPTER SIX: POC TEST SEGMENTS 􀀃
Diabetes – Blood Glucose Monitoring
Pregnancy and Ovulation
Clinical Chemistry
Critical Care (Hospitals)
Clinical Chemistry in Other POL Settings
Infectious Disease
HIV POC Testing
Influenza
Tuberculosis
Hospital Acquired Infections
Hematology
Coagulation
Cardiovascular Diagnostics
Cardiac Markers for AMI and Heart Failure
Cholesterol Tests and Lipid Panels
CHAPTER SEVEN: HEALTHCARE ECONOMICS AND HEALTHCARE REFORM
Healthcare Reform
ACOs
Preventive
Increased Demand, Cost Reduction
Heathcare Economics and Outcomes Testing
Comparative Effectiveness Studies
Overall Effect of Reform on IVD?
CHAPTER EIGHT: COMPANY PROFILES
1 Step Detect Associates, LLC
Recent Revenue History:
Company Overview and POC Products:
77 Elektronika Kft.
Recent Revenue History:
Company Overview and POC Products:
A. Menarini Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Abaxis, Inc.
Recent Revenue History:
Company Overview and POC Products:
Abbott Diagnostics
Recent Revenue History:
Company Overview and POC Products:
AccuBioTech Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
Accumetrics
Recent Revenue History:
Company Overview and POC Products:
Accutech, LLC
Recent Revenue History:
Company Overview and POC Products:
ACON Laboratories
Recent Revenue History:
Company Overview and POC Products:
Aerscher Diagnostics LLC
Recent Revenue History:
Company Overview and POC Products:
AgaMatrix, Inc.
Recent Revenue History:
Company Overview and POC Products:
Akers Biosciences, Inc.
Recent Revenue History:
Company Overview and POC Products:
Alere Inc.
Recent Revenue History:
Company Overview and POC Products:
Alfa Wassermann, Inc.
Recent Revenue History:
Company Overview and POC Products:
Alfa Scientific Designs, Inc.
Recent Revenue History:
Company Overview and POC Products:
Alliance International Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
All Medicus Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
American Bio Medica Corporation
Recent Revenue History:
Company Overview and POC Products:
Analyticon Biotechnologies AG
Recent Revenue History:
Company Overview and POC Products:
Ani Biotech Oy
Recent Revenue History:
Company Overview and POC Products:
Apex Biotechnology Corp.
Recent Revenue History:
ArcDia International Oy Ltd
Recent Revenue History:
Company Overview and POC Products:
ARKRAY, Inc.
Recent Revenue History:
Company Overview and POC Products:
Arlington Scientific, Inc.
Recent Revenue History:
Company Overview and POC Products:
Artron Laboratories Inc.
Recent Revenue History:
Company Overview and POC Products:
Atlas Link Biotech Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
Audit Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Augurix SA/Augurix Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Autobio Diagnostics Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
Axis-Shield plc (Acquired by Alere)
Recent Revenue History:
Company Overview and POC Products:
Bayer Diabetes Care
Recent Revenue History:
Company Overview and POC Products:
BD (Becton Dickinson)
Recent Revenue History:
Company Overview and POC Products:
Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)
Recent Revenue History:
Company Overview and POC Products:
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Recent Revenue History:
Company Overview and POC Products:
BioCARE Corporation
Recent Revenue History:
Company Overview and POC Products:
Biohit HealthCare
Recent Revenue History:
Company Overview and POC Products:
BioLand Technology Ltd.
Recent Revenue History:
Company Overview and POC Products:
Biolytical Laboratories Inc.
Recent Revenue History:
Company Overview and POC Products:
Bio-Medical Products Corp.
Recent Revenue History:
Company Overview and POC Products:
Biomerica, Inc.
Recent Revenue History:
Company Overview and POC Products:
bioMérieux sa
Recent Revenue History:
Company Overview and POC Products:
Bionime Corporation
Recent Revenue History:
Company Overview and POC Products:
Bioptik Technology, Inc.
Recent Revenue History:
Company Overview and POC Products:
Bio-Rad Laboratories, Inc.
Recent Revenue History:
Company Overview and POC Products:
BioScan Screening Systems, Inc.
Recent Revenue History:
Company Overview and POC Products:
BioSence Medical Devices, LLC
Recent Revenue History:
Company Overview and POC Products:
BioSys Laboratories, Inc.
Recent Revenue History:
Company Overview and POC Products:
Biotech Atlantic, Inc.
Recent Revenue History:
Company Overview and POC Products:
BioVei Incorporated
Recent Revenue History:
Company Overview and POC Products:
BodyTel Europe GmbH
Recent Revenue History:
Company Overview and POC Products:
Calypte Biomedical Corporation
Recent Revenue History:
Company Overview and POC Products:
CARE Products, Inc.
Recent Revenue History:
Company Overview and POC Products:
Cepheid
Recent Revenue History:
Company Overview and POC Products:
Chembio Diagnostics, Inc.
Recent Revenue History:
Company Overview And POC Products:
Coagusense, Inc.
Recent Revenue History:
Company Overview And POC Products:
Common Sense
Recent Revenue History:
Company Overview And POC Products:
Confirm Biosciences
Recent Revenue History:
Company Overview And POC Products:
Contravac, Inc.
Recent Revenue History:
Company Overview And POC Products:
Devon Medical Products
Recent Revenue History:
Company Overview And POC Products:
Dexcom, Inc.
Recent Revenue History:
Company Overview And POC Products:
Diabetech, LP
Recent Revenue History:
Company Overview And POC Products:
Diabetes Sentry Products Inc.
Recent Revenue History:
Company Overview And POC Products:
Diaglobal Gmbh
Recent Revenue History:
Company Overview And POC Products:
Diagnostics For The Real World (DRW)
Recent Revenue History:
Company Overview And POC Products:
Diazyme Laboratories
Recent Revenue History:
Company Overview And POC Products:
Eiken Chemical Co., Ltd.
Recent Revenue History:
company overview and poc products:
EKF Diagnostics Holdings Plc
Recent Revenue History:
Embryotech Laboratories
Recent Revenue History:
Company Overview And POC Products:
Enterix Inc. (A Quest Diagnostics Company)
Recent Revenue History:
Company Overview And POC Products:
Entra Health Systems
Recent Revenue History:
Company Overview And POC Products:
Epocal, Inc.
Recent Revenue History:
Company Overview And POC Products:
Escreen, Inc. (Part Of Alere)
Recent Revenue History:
Company Overview And POC Products:
Eumed Biotechnology Co. Ltd.
Recent Revenue History:
Company Overview And POC Products:
Fora Care Inc.
Recent Revenue History:
Company Overview And POC Products:
Fresenius Medical Care
Recent Revenue History:
Company Overview And POC Products:
GE Healthcare
Recent Revenue History:
Company Overview And POC Products:
Genbio
Recent Revenue History:
Company Overview And POC Products:
Gene Smart Wellness
Recent Revenue History:
Company Overview And POC Products:
Hain Lifescience Gmbh
Recent Revenue History:
Company Overview And POC Products:
Heidelberger-Medical-Marketing Gmbh (HMM Gmbh)
Recent Revenue History:
Company Overview and POC Products:
Helena Laboratories
Recent Revenue History:
Company Overview and POC Products:
Hema Diagnostic Systems, LLC (HDS)
Recent Revenue History:
Company Overview and POC Products:
HemoCue, Inc. (A Quest Diagnostic Company)
Recent Revenue History:
Company Overview and POC Products:
Hemosure, Inc.
Recent Revenue History:
Company Overview and POC Products:
IDenta Corporation
Recent Revenue History:
Company Overview and POC Products:
i-Health, Inc. (Division of DSM Nutritional Products)
Recent Revenue History:
Company Overview and POC Products:
Insulet Corporation
Recent Revenue History:
Company Overview and POC Products:
International Technidyne Corporation (ITC)
Recent Revenue History:
Company Overview and POC Products:
Instrumentation Laboratory
Recent Revenue History:
Company Overview and POC Products:
LifeAssays AB
Recent Revenue History:
Company Overview and POC Products:
LifeSign LLC
Recent Revenue History:
Company Overview and POC Products:
Lifescan, Inc.
Recent Revenue History:
Company Overview and POC Products:
Macherey-Nagel GmbH & Co.
Recent Revenue History:
Company Overview and POC Products:
Major Biosystem Corporation
Recent Revenue History:
Company Overview and POC Products:
MedMira Inc.
Recent Revenue History:
Company Overview and POC Products:
Medtronic, Inc.
Recent Revenue History:
Company Overview and POC Products:
Meridian Bioscience, Inc.
Recent Revenue History:
Company Overview and POC Products:
MP Biomedicals, LLC
Recent Revenue History:
Company Overview and POC Products:
Nanosphere, Inc.
Recent Revenue History:
Company Overview and POC Products:
Nipro Diagnostics, Inc.
Recent Revenue History:
Company Overview and POC Products:
Nova Biomedical
Recent Revenue History:
Company Overview and POC Products:
Oasis Diagnostics Corporation
Recent Revenue History:
Company Overview and POC Products:
Omega Diagnostics Group PLC
Recent Revenue History:
Company Overview and POC Products:
OPTI Medical Systems, Inc.
Recent Revenue History:
Company Overview and POC Products:
OraSure Technologies, Inc.
Recent Revenue History:
Company Overview and POC Products:
OrSense Ltd.
Recent Revenue History:
Company Overview and POC Products:
Ortho-Clinical Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Philips Healthcare/Philips Handheld Diagnostics
Revneue
Company Overview and POC Products:
PointCare Technologies, Inc.
Recent Revenue History:
Company Overview and POC Products:
Polymedco, Inc.
Recent Revenue History:
Company Overview and POC Products:
Precheck Bio, Inc.
Recent Revenue History:
Company Overview and POC Products:
Prestige Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Princeton Biomeditech Corporation
Recent Revenue History:
Company Overview and POC Products:
Prodigy Diabetes Care LLC
Recent Revenue History:
Company Overview and POC Products:
QBC Diagnostics, Inc.
Recent Revenue History:
Company Overview and POC Products:
QIAGEN N.V
Recent Revenue History:
Company Overview and POC Products:
Quidel Corporation
Recent Revenue History:
Company Overview and POC Products:
Radiometer Medical ApS (Subsidiary of Danaher Corporation)
Recent Revenue History:
Company Overview and POC Products:
Randox Laboratories Ltd
Recent Revenue History:
Company Overview and POC Products:
Rapid Pathogen Screening, Inc.
Recent Revenue History:
Company Overview and POC Products:
Real World Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Renese UG
Recent Revenue History:
Company Overview and POC Products:
Response Biomedical Corporation
Recent Revenue History:
Company Overview and POC Products:
Roche Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Screening Devices Canada, Inc.
Recent Revenue History:
Company Overview and POC Products:
Siemens Healthcare Diagnostics
Recent Revenue History:
Company Overview and POC Products:
Sienco, Inc.
Recent Revenue History:
Company Overview and POC Products:
Sphere Medical Ltd.
Recent Revenue History:
Company Overview and POC Products:
Sysmex Corporation
Recent Revenue History:
Company Overview and POC Products:
Systagenix Wound Management
Recent Revenue History:
Company Overview and POC Products:
Telcare
Recent Revenue History:
Company Overview and POC Products:
Tosoh Corporation
Recent Revenue History:
Company Overview and POC Products:
Trinity Biotech plc
Company Overview and POC Products:
VeraLight, Inc.
Recent Revenue History:
Company Overview and POC Products:
Veredus Laboratories Pte Ltd
Recent Revenue History:
Company Overview and POC Products:
Via Medical Corporation
Recent Revenue History:
Company Overview and POC Products:
Vital Diagnostics, Inc.
Recent Revenue History:
Company Overview and POC Products:
CHAPTER NINE: NEW ENTRANTS TO THE POC MARKET
Alverix, Inc.
AspenBio Pharma, Inc.
Aptiva Medical Inc.
Atlas Genetics Ltd
Atonomics A/S
Axxin
Biocartis SA
BioFire Diagnostics, Inc.
BioHelix Corporation
BioMedomics
Biosensia Ltd.
Curetis AG
Diagnostics for All (DFA)
DxNA, LLC
Echo Therapeutics, Inc.
Enigma Diagnostics Limited
Gentag, Inc.
Great Basin Corporation
Hai Kang Life Corporation Limited
Immunexpress Group
Innovative Biosensors, Inc.
Integrity Applications Ltd.
Investigen, Inc
Integrated Diagnostics
Ionian Technologies Inc.
IQuum, Inc.
Lumora Ltd
MBio Diagnostics, Inc.
Menssana Research, Inc.
Metaara Medical Technologies Inc.
Micronics Inc. (A Sony Group Company)
MycroLab Diagnostics Pty Ltd.
Nanomix, Inc.
NetBio, Inc.
Nexus Dx, Inc. (Subsidiary of Samsung Electronics Co.)
OPKU Health, Inc./OPKU Diagnostics
Positive ID Corporation
Probe Scientific Ltd
Q-linea AB
QuantuMDx Group
Rheonix Inc.
Spartan Bioscience Inc.
Supernova Diagnostics, Inc
T2 Biosystems, Inc.
TwistDx, Ltd.
Vivacta Limited
Wave 80 Biosciences
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: POC Sales by Test Category (OTC and POC), Worldwide, 2011-2016
Figure 1-1: POC Sales by Test Category (OTC and POC), Worldwide, 2011-2016
Figure 1-2: POC Sales by Test Category (OTC and POC), Worldwide, 2011-2016
Figure 1-3: Regional Breakout of POC Market (US, EU, Japan, ROW)
CHAPTER THREE: TECHNOLOGY INNOVATIONS IN POINT-OF-CARE TESTING
Table 3-1: Selected Non-Invasive Testing Innovations
Table 3-2: Selected Disease Markers in Inhaled Breath
Table 3-3: Selected Miniaturization and Microfluidics Innovations
Table 3-4: Selected Molecular Diagnostic Companies Developing and/or Marketing Rapid or Near-Patient Tests
Table 3-5: Selected Molecular Diagnostic Companies with Molecular Diagnostic Products Categorized as Moderate Complexity Under CLIA
CHAPTER FOUR: LOCATIONS FOR POINT-OF-CARE TESTING
Table 4-1: Selected Small Footprint and POC Chemistry Systems
Table 4-2: Selected Small Footprint and POC Hematology Systems
Table 4-3: Selected Small Footprint and POC Immunoassay Systems
CHAPTER FIVE: POINT-OF-CARE TESTING MARKET ANALYSIS
Table 5-1: OTC/Self Test Sales by Test Category, Worldwide, 2011 and 2016 (Glucose, Infectious Diseases, Critical Care, Cardiac Markers, Hematology, Coagulation, Fecal Occult Blood, HbA1c, Cholesterol/Lipids, Drugs of Abuse, Pregnancy/Ovulation, Other)
Table 5-2: Professional Point of Care Testing Market by Test Category, Worldwide, 2011 and 2016 (Glucose, Pregnancy/Ovulation, Fecal occult blood, Coagulation, Drugs of abuse, Cholesterol, HIV, Other)
Table 5-3: POC Test Sales by Region (U.S., Europe, Japan, ROW), 2011 and 2016
Table 5-4: POC Test Revenues of Selected IVD Companies,
CHAPTER SIX: POC TEST SEGMENTS􀀃
Table 6-1:World Glucose Monitoring Sales, by Company, 2009-2011
Table 6-2: Selected Blood Glucose Meters
Table 6-3: Selected Examples of Companies in Developing Countries with Blood Glucose Meters
Table 6-4: Selected Rapid HIV Tests on the Market

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