What is the Size of the Point of Care Diagnostic Testing Market?
This report provides an in-depth look at the global POC testing market yielded several interesting facts that are explored in this study. Emerging technological innovations in smartphones, biosensors, lab-on-a-chip and wearable devices are influencing the POC landscape. The driving force behind these innovations in the health arena is to provide expedited diagnosis where the patient is seen or in the patient’s home. The POC diagnostic industry will be part of a paradigm shift from curative medicine to predictive, personalized and preemptive medicine.
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.
POC Glucose Testing
POC Infectious Disease Testing, (including Hepatitis, HIV, Respiratory and Others)
POC Cancer Tumor Marker Testing
POC Colon Cancer Testing
POC Electrolytes and Blood Testing
POC Substance Abuse Testing
POC Pregnancy and Fertility Testing
POC Cardiac Markers
POC Urine Testing
Other POC Testing
Products on the Market
Company Profiles
An in-depth look at the global POC testing market yielded several interesting facts that are explored in this study. Emerging technological innovations in smartphones, biosensors, lab-on-a-chip and wearable devices are influencing the POC landscape. The driving force behind these innovations in the health arena is to provide expedited diagnosis where the patient is seen or in the patient’s home. The POC diagnostic industry will be part of a paradigm shift from curative medicine to predictive, personalized and preemptive medicine.
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.
The menu for point-of-care testing continues to expand. The traditional set of POC tests includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, hemoglobin diagnostics, infectious disease testing and cholesterol screening.
In the past 5-10 years the following tests were added: HgA1c, B-Type Natriuretic Peptide (BNP), whole-blood lactate, D-Dimer, C-Reactive Protein (CRP).
Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued 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. New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation or an electronic medical record.
Where are Point of Care Tests Winning?
Molecular POC tests in physician office are already available for respiratory infections and more. The capacity to provide precise answers for time sensitive tests such as sexually transmissible diseases and other infections will drive the market for POC molecular test devices. Ease of use is a plus for hospital labs. Worldwide, lab budgets are being cut for test send-outs and there are not enough trained technologists to run molecular tests in their present configuration.
A major factor in achieving this goal of more precise and personalized therapeutic options is the use of advanced algorithm driven information technologies that can turn test data into actionable medical decision-making information. This trend is driven by the involvement of major information technology companies and payers that are tired of paying for drugs that often have limited positive patient outcome.
Information about diseases, therapies and tests is readily available via the Internet and a growing number of apps on personal digital assistants (PDAs) including all sorts of smart phones. Wearable devices participate in this area by collecting vital sign data that are then analyzed by IT tools to provide health care improvement instructions.
These are among the companies covered in The Worldwide Market for Point of Care (POC) Testing Technologies
Who's Competing in the Market for Point of Care Diagnostics?
Large and small companies are involved in the development and/or marketing of POC testing. The market is considered evolving with growth opportunity. Developing and developed markets alike have room to grow due to an aging population worldwide. Key companies such as Roche, LifeScan, Abbott /Alere and Siemens Healthineers will likely maintain leading positions in the market through continued product innovation and strategic alliances and mergers.
Among the top and/or innovative competitors discussed within Corporate Profiles are:
1 Step Detect Associates
Abaxis
Abbott Labs
Abingdon Health
Access Bio
AccuBioTech Co
Accutech
Accriva Diagnostics
ACON Laboratories
Aerscher Diagnostics
Akers Biosciences
Alere
Alfa Scientific Designs
American Bio Medica
AmniSure
Aquila Diagnostic System
Arlington Scientific
Arkray
Artron Laboratories
Atlas Genetics
Atlas Link Biotech
Ativa Medical Corp
Audit Diagnostics
Autobio Diagnostics
Augurix Diagnostic
Axxin
Beckman Coulter
Becton Dickinson
Beijing Wantai Biological Pharmaceuticals
Bhat Bio-Tech India Private Ltd.
bioLytical Laboratories
Biomerica
biOracle Limited
BioMedomics
Biomeme
bioMerieux SA
Biophor Diagnostics
Bio-Rad Laboratories
Bioscan Screening Systems
Biotron Diagnostics
Biosensia
Boditech Med
Boson Biotech
BTNX
Calypte Biomedical Corp
CARE Products
Cepheid
Chembio Diagnostic Systems
Church & Dwight
Clarity Diagnostics
Confirm Biosciences
CTK Biotech
Daktari Diagnostics
Danaher Corporation
Dexcom
DIALAB
DiaSys Diagnostic Systems
Diaxohit
Diazyme Laboratories
DNA Electonics Ltd.
Dragerwerk AG
Dr Fooke-Achterrath
DRG International
Eiken Chemical
EKF Diagnostics
ELITechGroup, Inc
Enterix
Entopsis
Eurolyser Diagnostica
EY Laboratories
Exalenz Bioscience
FABPulous B.V.
Fio Corp
First Check Diagnostics
GenBio
Genedrive
GeTein BioMedical
GlysBy
Helena Labs
Hema Diagnostic System
Hemosure
HORBIA
Immunosciences Lab
InSilixa
Instrumentation Laboratory
JAL Innovations
Jant Pharmacal
J. Mitra & Co Pvt
LamdaGen Corp
LifeScan
LifeSign
Macherey-Nagel
Magnasense Technologies
Mbio Diagnostics
Medix Biochemica
MedMira
Medtronic
Menarini Diagnostics
Meridian BioScience
Metaara Medical Technologies
Micronics
Nano-Ditech Corporation
Noble Medical
Nova Biomedical
Oasis Diagnostics
Operon
OPKO Health
OPTI Medical Systems
OraSure Technologies
Ortho Clinical Diagnostics
Polymed Therapeutics
Polymedco
Polymer Technologies
Preventis
Princeton Biomeditech
QuantuMDx Group
Quidel
Radiometer Medical
RENESA UG
Response Biomedical
Reszon Diagnostics
Rheonix
Roche Diagnostics
Samsung Healthcare
Savyon Diagnostics
Sekisui Diagnostics
Siemens Healthcare
Siloam Biosciences
Spectral Medical
Sysmex
TECHLAB
Teco Diagnostics
Tosoh
Trinity Biotech
Trividia Health
Tulip Diagnostics
Veredus Laboratories
Vircell
WAMA Diagnostica
Wave 80 Biosciences
Werfen
Xagenic
FROM THE REPORT - Major Conclusions
Conclusion One – Paradigm shift toward prevention and early detection of disease
The development of smaller devices and Bluetooth communication has dramatically changed the patient/physician roles. Patients are more interested in playing a bigger role in their own healthcare. This will lead to more personalized healthcare with interventions tailored to specific patients.
Conclusion Two –POC Molecular Diagnostics continue to make inroads
Molecular POC diagnostics is at the nexus of low-complexity rapid testing performed near the patient and high-technology clinical molecular diagnostics. The emergent molecular POC test space seeks to leverage the key strengths of both segments – rapid results with ease of use operation and high sensitivity and specificity results – to address critical testing areas relating to emergency care, rapid clinical intervention, effective field screening, and the control of high-burden diseases in the developing world.
Conclusion Three- Technological progress is expanding the POC test market
Technological progress is expanding the domain of rapid and point-of-care tests. Led by the U.S. population, the global client base for POC products and tests (including physician offices and other primary care settings such as clinics and mobile labs) is significant – accounting for $19.5 billion in sales in 2017 – and will endure through episodes of healthcare expansion and reform found worldwide. However, the role of POC tests remains contentious due to questions regarding quality control or accuracy and added costs. In the United States, recent results of the GPA Waived Project have vindicated regulatory concerns regarding the quality of CLIA-waived testing that have also stalled the introduction of additional test waivers. Skepticism regarding POC test accuracy is significantly stronger abroad, with much more limited test menus for reimbursement or outright bans on testing at unaudited or uncertified office labs.
Executive Summary
Introduction
Scope and Methodology
Size and Growth of the Market
Table Global POC Test Market, 2015-2022 (in millions $ at manufacturer level)
Trends Affecting the Market
Competitive Outlook
Market Conclusions
Conclusion One – Paradigm shift toward prevention and early detection of disease
Conclusion Two –POC Molecular Diagnostics continue to make inroads
Conclusion Three- Technological progress is expanding the POC test market
Conclusion Four – Test cost will continue to be an issue worldwide
Conclusion Five– Reimbursement and economic conditions will continue to be an issue
Conclusion Six – Rising demand will drive POC market in RoW markets
Introduction and Overview
Point-of-Care Diagnostics Testing
Industry Regulations
POC Industry Drivers
Patient focused drivers
Medical/Healthcare related drivers
Technology drivers
Economic drivers
Other drivers
POC Test Types
Blood
Urine
Saliva
Hair
Optical Technologies
Breath
Conditions Evaluated by POC Diagnostic Testing
Cancer
Cardiovascular Disease
Diabetes
Drug Abuse
Central Nervous System Stimulants
Prevalence and Number of Illicit Drug Users
Table Estimated Number and Prevalence of Drug Users by Region and Age (15-64)
Infectious Disease
Osteoporosis
Pregnancy and Fertility
POC Blood Glucose Tests
Types of Blood Glucose Testing
Fasting Blood Sugar (FBS)
2-Hour Postprandial Blood Sugar (PPBS)
Random Blood Sugar
Glucose Tolerance Test
Glucose Urine Test
Glycated Hemoglobin (HbA1c)
Products
Blood Glucose Self-Testing
Table Selected Glucose Self-Test Meter Innovations
Table Selected Apps and Glucose Management IT
Continuous Self-Testing
Glycated Hemoglobin Tests
Professional
Market Size and Growth
Table Global POC Glucose Testing Market Analysis, 2015-2022 (in millions of dollars at the manufacturer's level)
Table Global POC Drugs of Abuse Self Testing Market, 2017-2022 (includes continuous glucose devices)
POC Drugs of Abuse Professional Testing
Table Global POC Drugs of Abuse Professional Testing Market Analysis, 2017-2022 (in millions of dollars at the manufacturer's level)
Competitive Analysis
Table Global POC Drugs of Abuse Testing Market, Revenues and Market Share of Leading Suppliers, 2017
Table Global POC Drug of Abuse Testing Manufacturers by Percent, 2017
POC Pregnancy and Fertility Testing
Products
Table 2016 Pregnancy and Fertility CLIA Waivers (Manufacturer and Instrument / Assay), Manufacturer's Instrument / Device / Assay
Market Size and Growth
Table Global POC Pregnancy and Fertility Testing Market Analysis, 2015-2022 (in millions of dollars at the manufacturer's level)
Regional Analysis
Table POC Pregnancy and Fertility Testing Regional Market Analysis, 2017
POC Pregnancy and Fertility Self-Testing
Table POC Pregnancy and Fertility Self-Testing Market Analysis, 2017-2022 (in millions of dollars at the manufacturer's level)
POC Pregnancy and Fertility Professional Testing
Table POC Pregnancy and Fertility Professional Testing Market Analysis, 2017-2022 (in millions of dollars at the manufacturer's level)
Competitive Analysis
Table Global POC Pregnancy and Fertility Testing Market, Revenues and Market Share of Leading Suppliers, 2017 (in millions $)
Table Global POC Pregnancy and Fertility Testing Manufacturers by Percent, 2017
POC Colon Cancer Screening/Fecal Occult Blood Testing
Products
Table Selected POC Colon Cancer Tests
Market Size and Growth
Table Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis: 2015-2022 (in millions of dollars at the manufacturer's level)
Regional Analysis
Table POC Colon Cancer Screening/FOB Testing Regional Market Analysis, 2017
POC Colon Cancer Screening/Fecal Occult Blood Self-Testing
Table POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis, 2017-2022 (in millions of dollars at the manufacturer's level)
POC Colon Cancer Screening/ Fecal Occult Blood Professional Testing
Table POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2017- 2022 (in millions of dollars at the manufacturer's level)
Competitive Analysis
Table Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market, Revenues and Market Share of Leading Suppliers, 2017 (in millions $)
Table Global POC Colon Cancer Screening/Fecal Occult Blood Testing Manufacturers by Percent, 2017
POC Infectious Disease Testing
Products
Market Size and Growth
Table Global POC Infectious Disease Testing Market Analysis: 2015-2022 (in millions of dollars at the manufacturer's level)