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The World Market for Point of Care (POC) Diagnostics

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SKU: KLI4891643 Categories: Clinical Chemistry, Diagnostics Market Research, Point-of-Care Diagnostics Pages: 200
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Description

The World Market for Point of Care (POC) Diagnostics

Visit our ‘Point of Care Testing’ curated page for complete industry coverage.

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.

Point of Care Testing Market Data Including:

  • 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.

Point of Care Diagnostics Companies 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…

Table of Contents

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:

  1. 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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