The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition

The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 8th Edition

By the middle of the decade, point of care testing is expected to reach 45 billion dollars annually. This should not be surprising. Globally, millions of dollars are spent annually on POC diagnostic testing, both professional testing and self-testing. In 2020, sales of POC testing reached $29,316 million. COVID-19 was a significant game changer in 2020. The number of new tests for POC COVID-19 was stunning.

Updated for COVID-19 Impacts

In some segments, COVID-19 caused a contraction of the segment due to lockdown, closures, limited physician visits and a reduction in elective and outpatient surgery. The market is expected to resume pre-pandemic growth in all segments of the POC market. Certain segments will continue to advance significantly from 2021-2025. In 2025, the total global POC diagnostic testing market is expected to reach almost $45 billion, displaying growth of 8.9% over the forecast period 2020-2025.

• Global POC Test Market, 2020-2025 (in millions $ at manufacturer level)
• Global POC Testing Market Analysis by Product Category, 2020 (in millions $) (Self-Testing, Professional Testing, Total)
• Global POC Self-Testing Market Analysis by Product Category, 2020 (in millions$) (Glucose [includes CGM], Pregnancy & Fertility, Fecal Occult Blood, Rapid Coagulation, Drugs of Abuse, Urine, Infectious Disease, Lipid, Total)
• Global POC Self-Testing Market Analysis by Product Category, 2020 (by %) (Infectious Disease, Urine, DOA, Coagulation, FOB, Pregnancy, Glucose)
• Global POC Professional Testing Market Analysis by Product Subcategory, 2020 (in millions$) (Drugs of Abuse, Glucose includes HbA1c, Blood & Electrolytes, Infectious Disease, Rapid Coagulation, Fecal Occult Blood, Cardiac Markers, Lipid, Pregnancy & Fertility, Miscellaneous, Urine, Cancer Tumor Markers, Total)
• Global POC Professional Testing Market Analysis by Product Subcategory, 2020 (by %) (Tumor Markers, Urine, Misc, Pregnancy, Lipid, Cardiac Markers, Rapid Coag, FOB, Infectious Disease, Blood/ Electrolytes, Glucose/ HbA1c, DOA)
• POC Testing by End-user, 2020 (%) (Hospitals, Others)
• Global POC Market by Technology by Sales, 2020 (%) (LFA, Biosensors, Analyzers, Strips)
• Regional Market Analysis

The POC market is also broken out by geographic region:

• Global POC Testing Analysis by Region/Country, 2020 (in millions $) (United States, Europe, Japan, ROW, Total)
• Global POC Testing Market Analysis by European Region, 2020 (in millions $) (W. Europe, E. Europe, Total)
• Europe POC Testing Percentage Participation, by Country, 2020 (Germany, UK, France, Italy, Switzerland/ Sweden, Spain, Other)
• Global POC Testing Market Analysis by Rest of World Region/Country, 2020 (in millions $) (Latin America and Mexico, China, Australia, South Korea, India, Other, Total)
• POC Blood Glucose Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Blood and Electrolytes Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Rapid Coagulation Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Rapid Cardiac Markers Testing Regional Market Analysis, 2020 (US; Europe; Japan; Latin America, India, Asia Pacific and the Middle East; RoW)
• POC Substance Abuse Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Pregnancy and Fertility Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Colon Cancer Screening/FOB Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Infectious Disease Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Lipid Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Cancer Tumor Marker Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Urine Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• POC Miscellaneous Testing Regional Market Analysis, 2020 (US, Europe, Japan, RoW)
• Segment Size and Growth

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. As the menu for point-of-care testing continues to expand, the report looks in-depth at the following market segments:

• Global POC Glucose (including CGM and HbA1c) Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Diabetes Sales by Test Category, 2020-2025 (Glucose, Self-test; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; $ millions)
• Global POC Glucose Self-Testing Market (excludes continuous glucose devices) 2020-2025 (in millions $ at manufacturer level)
• Global POC Continuous Glucose Self-Testing Market 2020-2025 (in millions $ at manufacturer level)
• Global POC Glucose Professional Testing Market (excludes HbA1c testing) 2020-2025 (in millions $ at manufacturer level)
• Global POC Glucose HbA1c Professional Testing Market 2020-2025 (in millions $ at manufacturer level)
• Global POC Blood and Electrolytes Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Blood & Electrolytes Revenues by Test Category, 2020-2025 ($ millions) (Blood Gases & Electrolytes [inc critical care], Hematocrit/Hemoglobin, WBC other routine)
• Global POC Blood & Electrolytes Sales by Test Category, 2020-2025 ($ millions) (Blood Gases & Electrolytes [inc critical care], Hematocrit/Hemoglobin, WBC other routine)
• Global Rapid Coagulation Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Total Rapid Cardiac Markers Tests Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Drugs of Abuse Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Drugs of Abuse Self Testing Market, 2020-2025 (includes continuous glucose devices)
• Global POC Drugs of Abuse Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Pregnancy and Fertility Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Pregnancy and Fertility Self-Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Pregnancy and Fertility Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis: 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Testing Market Analysis: 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Revenues and Percent of Infectious Disease Market by Disease Type, 2020 (in millions $) (Influenza, HIV, STD, Hepatitis, Malaria, C. difficile, E. coli, H. pylori, Home Test/OTC, Others, Total)
• POC Infectious Disease Self-Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Infectious Disease Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Revenues and Percent of Infectious Disease Market by Disease Type, 2018 (in millions $) (Influenza, HIV, STD, Hepatitis, Malaria, C. difficile, E. coli, H. pylori, Home Test/OTC, Others, Total)
• Global POC Lipid Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Lipid Self-Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Lipid Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Cancer Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Urine Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Urine Self-Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• POC Urine Professional Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global Miscellaneous POC Testing Market Analysis, 2020-2025 (in millions of dollars at the manufacturer’s level)
• Global POC Miscellaneous Sales by Test Category, 2020-2025 (Microbiology, TSH, Allergy, Autoimmune, Others TOTAL; $ millions) (Microbiology, TSH, Allergy, Autoimmune, Others, Total)

Consumers increasingly want to use wearable devices that not only track their health and fitness but also track self-monitored health data directly into clinical data repositories. As these wearable devices are cleared to use the same biomarkers involved in clinical laboratory tests to monitor the wearer’s health condition, then these devices will stream that data into the electronic health records (EHR) of patients with chronic diseases.

It’s not all upside – test cost will continue to weigh more heavily upon the trajectory of POC testing in many markets. In Europe, fee schedules have significantly dampened or led to the contraction of national POC markets; Switzerland is an exception through its preserved (though repeatedly contested) premiums paid to POC tests over scheduled base fees. In the United States, future changes to Medicare’s CLFS will place significant pressure on some POC tests performed in large volumes on automated systems in centralized and commercial labs. These challenges and expected forecasts given their presence are discussed in the report.

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 clinic. Other terms used to describe POC testing include near-patient testing, physician’s office laboratory (POL) testing, rapid testing, patient self-testing or patient self-management, bedside testing, remote testing, or satellite testing. Some of these alternate terms actually describe segments of the POC testing market. 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). The future holds even more advancement of POC tests and devices including tests for cancer, molecular assays and phone enabled tests of all kinds.

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. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care; especially since 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.

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
• Abaxis
• Abbott Labs
• Abingdon Health
• Access Bio
• ACON Laboratories
• Aerscher Diagnostics
• Akers Biosciences
• Alfa Scientific Designs
• American Bio Medica
• Arkray
• Arlington Scientific
• Artron Laboratories
• Ascensia Diabetes Care
• Ativa Medical Corp
• Atlas Link Biotech
• Audit Diagnostics
• Augurix Diagnostic
• Autobio Diagnostics
• Axxin
• Beckman Coulter
• Becton Dickinson
• Beijing Wantai Biological Pharmaceuticals
• Bhat Bio-Tech India Private Ltd.
• Binx health
• bioLytical Laboratories
• BioMedomics
• Biomeme
• Biomerica
• And Scores of Other Companies