As discussed in this report, The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 9th Edition, POC testing has skyrocketed in the last 20 years as demand for accurate and rapid testing has blossomed both inside and outside the hospital setting. 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.
POC tests are performed in a wide range of geographical locations such as:
Hospital departments such as emergency departments, operating rooms, intensive care units, and others
Physicians’ offices
Hospital clinics
Rural health clinics
Student health clinics
Retail clinics
Pharmacies
Homes – With testing performed by patients, visiting nurses, or other caregivers
Nursing homes
Prisons
POC testing may be performed by laboratory personnel, but often it is performed by non-laboratory personnel such as physicians, nurses, assistants in medical offices, emergency medical technicians (EMTs), medics, pharmacists, and the patients themselves (self-testing). Some POC tests are manual tests, often performed with technologies based on dipsticks or strips, lateral flow cassettes, or other manual tests. There are also many small, portable instruments that have been developed for use in POC settings. With the advances in miniaturization and microfluidics that have occurred in recent years, a growing number of small, handheld devices are reaching the POC market for a range of different testing applications.
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: HbA1c, 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. Rapid tests are beginning to fold into the point of care arena because they allow the physician to treat the patient before they leave the clinic or office.
This report breaks out point of care testing by segment.
Among the top and/or innovative competitors discussed within Corporate Profiles are:
1 Step Detect Associates
Abbott Laboratories
Abingdon Health
Access Bio
AccuBioTech Co
ACON Laboratories
Aerscher Diagnostics
Akers Biosciences
Alfa Scientific Designs
American Bio Medica
ARKRAY
Artron Laboratories
Ascensia Diabetes Care
Ativa Medical Corp
Atlas Link Biotech
Audit Diagnostics
Autobio Diagnostics
Beckman Coulter
Becton Dickinson
Beijing Wantai Biological Pharmaceuticals
Bhat Bio-Tech India Private Ltd.
Binx health
bioLytical Laboratories
BioMedomics
Biomeme
Biomerica
bioMérieux SA
Bio-Rad Laboratories
Biosensia
Biotron Diagnostics
Boditech Med
Boson Biotech
BTNX
Calypte Biomedical Corp
Cepheid
Chembio Diagnostics
Church & Dwight
Clarity Diagnostics
Confirm Biosciences
CTK Biotech
Danaher Corporation
Dexcom
DIALAB
DiaSys Diagnostic Systems
Diazyme Laboratories
DNA Electronics Ltd. (DNAe)
Dr Fooke-Achterrath
DxGen
Eiken Chemical
EKF Diagnostics
ELITechGroup, Inc
Enterix (Clinical Genomics)
Eurobio Scientific
Everlywell
Exact Sciences
EY Laboratories
First Check Diagnostics
GenBio
Genedrive
GenePOC
GeTein Biotech Inc.
GlysBy
Helena Labs
Hemosure
HORIBA
Immunosciences Lab
Immunostics
Mitra & Co Pvt
JAL Innovation
Jant Pharmacal
LamdaGen Corp
LifeScan
LifeSign
LightDeck Diagnostics
Macherey-Nagel
Medix Biochemica
MedMira
Medtronic
Menarini Diagnostics
Meridian BioScience
MiCo BioMed USA
Nano-Ditech Corporation
NG Biotech
Noble Medical
Nova Biomedical
NuGenerex Diagnostics
Oasis Diagnostics
Operon
OPKO Health
OraSure Technologies
Polymedco
Polymer Technologies (PTS Diagnostics)
Preventis
Princeton Biomeditech
QuantuMDx Group
Quidel
Radiometer Medical
Randox Labs
RENESA UG
Response Biomedical
Reszon Diagnostics
Rheonix
Roche Diagnostics
Savyon Diagnostics
Sekisui Diagnostics
Siemens Healthcare
Sysmex
TECHLAB
Trinity Biotech
Trividia Health
Tulip Diagnostics
VedaLab
Veredus Laboratories
Werfen
Scope and Methodology
The geographic scope of The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 9th Edition is global, with information for specific geographical regions, world demographics, and other general issues affecting the market. The market summary includes total market values, market analysis by product, test usage, technology, region, end-use and a competitive analysis of leading providers. Additionally, key company profiles are included.
All market data pertains to the world market at the manufacturers’ level. The market includes manufacturer tests excluding services. The base year for data was 2021, including updates and reexaminations stemming from the impact of the COVID-19 pandemic. Forecast data is provided for 2022 through 2026. Compound annual growth rates (CAGRs) are provided for 2021-2026 periods for each segment covered. Competitive analysis is provided for the year 2021 along with regional breakdowns. The forecasted market analysis for 2022-2026 was largely based on demographic trends, new developments, innovative technology and global expansion.
Table of Contents
Chapter 1: Executive Summary
Introduction
Scope and Methodology
Size and Growth of the Market
Table 1-1: Global POC Test Market, 2021-2026 (in millions $ at manufacturer level)
Trends Affecting the Market
POC COVID TESTING
Overview of POC COVID-19 Testing
Market Outlook
Figure 1-1: POC COVID-19 Testing Market by Method
Major Product Activity
Antigen (last six months)
Serology (last six months)
Molecular (last six months)
Setting Market
Figure 1-2: POC COVID-19 Sales by Test Setting, 2020 and 2021
Top Company Briefs
Abbott
Roche
Quidel
Becton Dickinson
Figure 1-3: Major Players in the POC COVID-19 Test Market, 2021
Competitive Outlook
Market Conclusions
Conclusion One – POC Market Transformed By Technological Progress
Conclusion Two –POC Molecular Diagnostics Continue Making Inroads
Conclusion Three – Prevention and Early Detection at Nexus of POC Development
Conclusion Four- Wearables Continue to Influence POC Market
Conclusion Four – Test Cost Will Continue to be an Issue Worldwide
Conclusion Five – Rising Demand Will Drive POC Market in RoW Markets
Conclusion Six– New venues – Urgent & Retail Care
Conclusion Seven – COVID-19’s Positive Effect
Conclusion Eight– Insurance Coverage for OTC COVID-19 Testing
Conclusion Nine – New Opportunities in POC Infectious Disease Testing
Conclusion Ten- Supply Chain Delays
Chapter 2: 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 Industry Challenges
POC Test Types
Blood
Urine
Saliva
Hair
Optical Technologies
Breath
Conditions Evaluated by POC Diagnostic Testing
Cancer
Colorectal Cancer
Prostate Cancer
Cardiovascular Disease
Diabetes
Drug Abuse
Infectious Disease
Herpes
HTLV
Respiratory Syncytial Virus
Hepatitis
Lyme Disease
Babesiosis
Gonorrhea, Syphilis and Chlamydia
Trichomonas Vaginalis
HIV/AIDS
Helicobacter Pylori
Influenza
Coronavirus
Mononucleosis
Streptococcus
Osteoporosis
Pregnancy and Fertility
Chapter 3: 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 3-1: Selected Glucose Self-Test Meter Innovations
Table 3-2: Selected Apps and Glucose Management IT
Continuous Self-Testing
Glycated Hemoglobin Tests
Table 3-3: Selected POC HbA1c Devices
Professional
Market Size and Growth
Table 3-4: Global POC Glucose (including CGM and HbA1c) Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
Table 3-5: Global POC Diabetes Sales by Test Category, 2021-2026 (Glucose, Self-test; Glucose, professional; Glucose, continuous; HbA1c, POC) (TOTAL; $ millions)
Table 4-3: Global POC Blood and Electrolytes Testing (Blood Gases/Electrolytes, Hemoglobin/Hematocrit, WBC, Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
Table 4-4: Global POC Blood & Electrolytes Revenues by Test Category, 2021-2026 ($ millions)
Regional Analysis
Figure 4-1: POC Blood and Electrolytes Testing Regional Market (US, Europe, Japan, Rest of World) Analysis 2021
POC Blood and Electrolyte Self-Testing
Table 4-5: Global POC Blood and Electrolyte Self Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
POC Blood and Electrolyte Professional Testing
Table 4-6: Global POC Blood and Electrolyte Professional Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
COVID-19 Impact
Competitive Analysis
Table 4-7: Global POC Blood and Electrolyte Testing Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions $)
Figure 4-2: Global POC Blood and Electrolyte Testing Market Manufacturers, by Percent, 2021
Chapter 5: POC Rapid Coagulation
Products
Table 5-1: Selected POC Coagulation Test Innovations
Platelet Testing
Table 5-2: Selected Platelet Activity Test Innovations
Market Size and Growth
Table 5-3: Global Rapid Coagulation Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
Table 6-2: Global POC Cardiac Markers Test Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions $)
Figure 6-2: Global POC Cardiac Test Manufacturers by Percent, 2021
Chapter 7: POC Substance Abuse
Overview
Products
Urine
Oral
Blood
Hair
Market Size and Growth
Table 7-1: Global POC Drugs of Abuse Testing (critical care, employment and criminal) Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
Table 7-2: Global POC Drugs of Abuse Self Testing Market, 2021-2026 (in millions of dollars)
POC Drugs of Abuse Professional Testing
Table 7-3: Global POC Drugs of Abuse Professional Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
COVID-19 Impact
Competitive Analysis
Table 7-4: Global POC Drugs of Abuse Testing Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions$)
Figure 7-2: Global POC Drug of Abuse Testing Manufacturers by Percent, 2021
Chapter 8: POC Pregnancy and Fertility Testing
Products
Table 8-1: Selected Pregnancy and Fertility CLIA Waivers (Manufacturer and Instrument / Assay), Manufacturer’s Instrument / Device / Assay
Market Size and Growth
Table 8-2: Global POC Pregnancy and Fertility Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
Regional Analysis
Figure 8-1: POC Pregnancy and Fertility Testing Regional (US, Europe, Japan, Rest of World) Market Analysis, 2021
POC Pregnancy and Fertility Self-Testing
Table 8-3: POC Pregnancy and Fertility Self-Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
POC Pregnancy and Fertility Professional Testing
Table 8-4: POC Pregnancy and Fertility Professional Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
COVID-19 Impact
Competitive Analysis
Table 8-5: Global POC Pregnancy and Fertility Testing Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions $)
Figure 8-2 Global POC Pregnancy and Fertility Testing Manufacturers by Percent, 2021
Chapter 9: POC Colon Cancer Screening/Fecal Occult Blood Testing
Products
Table 9-1: Selected POC Colon Cancer Tests
Market Size and Growth
Table 9-2: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis: 2021-2026 (in millions of dollars at the manufacturer’s level)
Regional Analysis
Figure 9-1: POC Colon Cancer Screening/FOB Testing Regional (US, Europe, Japan, Rest of World) Market Analysis, 2021
POC Colon Cancer Screening/Fecal Occult Blood Self-Testing
Table 9-3: POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
POC Colon Cancer Screening/ Fecal Occult Blood Professional Testing
Table 9-4: POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
COVID-19 Impact
Competitive Analysis
Table 9-5: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions $)
Figure 9-2: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Manufacturers by Percent, 2021
Chapter 10: POC Infectious Disease Testing
Products
HIV and Hepatitis
Respiratory
STD
Tropical Diseases
Lyme Disease
TB
Zika
Hospital Acquired Infections and Sepsis
Sepsis
C.Diff
Table 10-1: Selected Innovations in POC Infectious Disease Diagnostics
COVID-19
Antigen
Serology
Molecular
Market Size and Growth
Table 10-2: Global POC Infectious Disease (including COVID-19) Testing Market Analysis: 2021-2026(in millions of dollars at the manufacturer’s level)
Table 10-3: POC Infectious Disease Self-Testing (including COVID-19) Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
POC Infectious Disease Professional Testing
Table 10-4: POC Infectious Disease (including COVID-19) Professional Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
POC Infectious Disease Testing by Disease Type
Table 10-5: Global POC Infectious Disease Revenues and Percent of Infectious Disease Market by Disease Type, 2021 (in millions $)
Figure 10-2 : Global POC Infectious Disease (COVID-19, Influenza, HIV, STD, Hepatitis, Malaria, C. Diff, E. coli, H. pylori, Home, Others) Percent by Disease Type 2021
Figure 10-3: Global Selected POC Infectious Disease (COVID-19, Respiratory, HIV, STD, Hepatitis, C. Diff) Percent by End-user (Hospital including reference labs, physician office labs (POL) and nursing homes, pharmacy, home use and others) in 2021
Competitive Analysis
Table 10-6: Global POC Infectious Disease including COVID-19 Testing Market, Revenues and Market Share of Leading Suppliers, 2021 (in millions $)
Figure 10-4: Global POC Infectious Disease Test Manufacturers by Percent, 2021
Chapter 11: POC Lipid Testing
Products
Market Size and Growth
Table 11-1: Global POC Lipid Testing Market Analysis, 2021-2026 (in millions of dollars at the manufacturer’s level)
