Point Of Care Diagnostics Market Size, Share & Trends Analysis Report By Product (Infectious Diseases, Glucose Testing, Cardiac Markers), By End-use (Clinics, Home, Hospitals), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global point of care diagnostics market size was valued at USD 40.61 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 6.50% from 2023 to 2030. The market is set to gain momentum in the coming years on account of the increase in funding from multiple sources, the rising prevalence of target diseases, and the need to address the recent outbreak of coronavirus. The ongoing COVID-19 pandemic had an enormous impact on the global industry in 2021 and the COVID-19 effect is anticipated to reflect in the projected tenure. For instance, in September 2021, the South Korean Department of Defense awarded USD 626 million to Celltrion as a part of the procurement contract for DiaTrust COVID-19 Ag Rapid Test. 

However, the pandemic disrupted the supply chain and restricted the manufacturers to receive substantial raw material from across borders. An increase in funding by multiple sources, including the U.S. Department of Defense (DOD), the NIH, and private foundations like the Bill & Melinda Gates Foundation, is expected to drive the POCT market. For instance, Grand Challenges Canada and the Bill & Melinda Gates Foundation have launched a joint initiative for POC diagnostics. These organizations are involved in the development and integration of different diagnostic components into interoperable POC platforms with a “plug-and-play” characteristic feature and the capability of running diverse tests from various developers. Research is carried out to incorporate each test on a common platform with a single interface, enabling analysis of different sample specimens, with various approaches for analysis. 

The integration of digital technologies is expected to exhibit a powerful impact on the expansion of POC solutions in limited resource settings. Increasing usage of telehealth as new normal is a critical go-to-market strategy for POCT players. As per the U.S. Centers for Disease Control and Prevention, approximately 95% of health centers in the U.S. provided telehealth services during the pandemic. Therefore, the expansion of remote patient monitoring systems such as PixCell Medical, a POC technology for CBC tests, is expected to positively impact the market growth.

The increasing importance of POC diagnostics in environmental monitoring and public health also demands the integration of technologies that facilitate easy networking, further making it convenient for healthcare professionals to interpret test results accurately. Companies are developing affordable POC with high specificity and sensitivity. For instance, in March 2022, Everything Genetic received approval from the U.K. regulatory bodies for selling COVID-19 Antigen Tests in the U.K. market. The company sells lateral flow devices at GBP 2 for single kits, this is expected to surge the POC diagnostics market growth, especially in developing economies.

Product Insights

The infectious diseases segment held the largest revenue share of over 24.4% in 2022. Infectious disease testing has shifted from centralized to decentralized POC testing, resulting in better patient care. The market is being driven by increased demand for quick tests, which has prompted industry players to deliver POC solutions to decentralized regions. For instance, Abbott has introduced ID NOW, the world's quickest molecular POC test, which provides COVID-19 findings in 13 minutes and is usable in a variety of decentralized healthcare settings such as doctors' offices and urgent care clinics.

The glucose testing segment captured the second-largest revenue share in 2022. The high prevalence of diabetes, coupled with the requirement of constant monitoring of blood sugar levels, is contributing to the segment growth. According to statistics published by the International Diabetes Federation, the global prevalence of diabetes will increase from 382 million in 2013 to 592 million in 2035.

The growing prevalence of diabetes and the introduction of portable diagnostic equipment are expected to boost the segment growth from 2022 to 2030. For instance, in March 2022, research on the assessment of glucose levels in hospitalized patients with community-acquired pneumonia required recording everyday glucose data from February to June 2021. The researchers employed POC capillary blood glucose testing for monitoring the glucose in patients.

The cancer markers segment is expected to witness significant growth of 9.6% during the forecast period. Annually, millions of patients report to the emergency room with symptoms of a heart attack. Approximately, 31% of all deaths are due to cardiovascular disease. Players are assessing the upcoming demand and initiating product development strategies accordingly. For instance, in April 2021, Siemens Healthineers obtained CE marking for Atellica VTLi Patient-Side Immunoassay Analyzer. It is one of the first technologies in the industry that aims to enhance the patient care paradigm and offers hs-cTnI results that assist in the diagnosis and treatment of heart attacks.

High accuracy rates associated with these markers and the growing prevalence of target diseases are some primary drivers of this segment. Moreover, the segment is expected to witness a rapid rise in the penetration rates in the developed markets of North America and Europe. The growing geriatric population and the prevalence of disease-inducing lifestyle habits in these countries are expected to fuel market growth over the forecast years.

End-use Insights

The clinics segment accounted for the largest revenue share of over 37.91% in 2022. Pharmacy and retail clinics are the major contributors to the revenue generated by this segment. Growing access to novel diagnostic technologies, improving healthcare coverage, and affordability are the key factors that are expanding the applications of POC diagnostics.

Thus, community pharmacies and retail clinics have emerged as potential medical setups that perform such lab tests, especially regarding cholesterol and glycosylated hemoglobin (A1C) testing. Improved healthcare accessibility for the older population, increased prevalence of communicable diseases, and growing strain on traditional clinics are key factors contributing to global market growth.

As the adoption of POCT increases in hospitals, regulatory bodies have toughened the validation/verification setting for POC devices. For instance, in January 2022, an article published in Clinical Laboratory News stated that the employment of hospital POC glucose meters needs to be verified and validated by the institutions. For on-label POCT devices, a formal validation is not required, however, needs to verify the precision, accuracy, and analytical measurement range, among other core parameters defined under CLIA.

The home end-use segment is expected to register the fastest growth rate of 7.2% from 2023 to 2030. Home care is a lucrative segment owing to the cost-effectiveness and comfort level of POCT provided to patients at home. POC in the home healthcare sector also empowers patients to address healthcare challenges at home and take decisions instantly. As the emphasis of healthcare is shifting toward early detection and prevention of diseases, the POC diagnostics-based home healthcare market is expected to witness lucrative growth during the forecast period. 

Regional Insights

North America held the largest revenue share of over 43.2% in 2022. The region will maintain its dominant position throughout the forecast years on account of the rapidly increasing COVID-19 cases along with the presence of key players in the U.S. and Canada. For instance, in March 2022, Canada-based Company, bioLytical Laboratories Inc. received CE marking for the iStatis COVID-19 Antigen Home Test. This will enable the company to enter the European market.

The Asia Pacific is estimated to be the fastest-growing regional market with a CAGR of 8.1% from 2023 to 2030. The point-of-care market in the Asia Pacific is expected to be driven by a rising pool of local diagnostic kits and reagents manufacturers in this region to offer a wide range of testing solutions for the diagnosis of coronavirus infection. The countries are constantly ramping up their capacities to boost COVID-19 testing. For instance, in April 2020, the Ministry of Health of Malaysia approved the usage of antigen rapid testing kits exported from South Korea to increase the country’s COVID-19 testing to reach the capacity of 16,500 tests per day.

Key Companies & Market Share Insights

Point-of-care diagnostics has witnessed considerable progress in the past years. Integration of molecular diagnostics in POC testing is one of the significant advancements in this segment. Despite the fact that major players have limited the opportunities for new entrants, some companies were able to mark their entry into the market. Furthermore, key companies are engaged in the development of more sophisticated bench-top and portable testing solutions to maintain a competitive edge in the market. For instance, in March 2022, Una Health announced to partner with Siemens Healthineers for expanding the distribution channel of Atellica VTLi Patient-side Immunoassay Analyser in the U.K. 

This product launch demo exhibited the company's commitment to POC diagnostics and critical care. In March 2022, Visby Medical announced to receive funding of USD 25.5 million from the U.S. Biomedical Advanced Research and Development Authority in order to develop a rapid flu-COVID-19 PCR test for home use. At present, the test is in the under-developing phase and the design is ready as a PCR device that can detect COVID-19, influenza A, and B from a single sample. Some prominent companies in the global point of care diagnostics market include:

• F. Hoffmann-La Roche Ltd.

• Danaher

• BD

• Qiagen

• Abbott

• Siemens Healthcare AG

• bioMerieux SA

• Zoetis, Inc.

• Instrumentation Laboratory

• Nova Biomedical

• Quidel Corp.

• Trividia Health, Inc.

• Sekisui Diagnostics

• Nipro Corp.

• Trinity Biotech

• Orasure Technologies, Inc.

• Spectral Medical, Inc. 

Recent Developments

• In February 2023, bioMérieux received CLIA-waiver and US FDA 510(k) Clearance for the innovative BIOFIRE® SPOTFIRE® System and its Respiratory (R) Panel. CLIA-waiver allows its usage by appointed non-lab personnel at the point of care.

• In January 2023, Trinity Biotech and imaware™ entered into a partnership to develop at-home and remote point-of-care rapid testing solutions, leveraging Trinity Biotech’s advanced manufacturing capabilities for point-of-care product development. The collaboration aimed at providing integrated white-label and private solutions designed to cater to the digital health channel partner requirements with industry-leading quick turnaround and integration of a patient-centric ecosystem.

• In March 2022, Nova Biomedical launched the kidney function screening tool: CE-Marked Nova Max Pro Creatinine/eGFR Meter. The launch was intended to improve kidney care outcomes in point-of-care settings through the early detection of kidney diseases.

• In May 2022, Trinity Biotech declared that its 10-minute Covid-19 antigen test received the CE mark.

• In January 2022, Roche introduced a new cloud-based platform Cobas infinity edge, an open digital ecosystem that connects patient medical records, test results, and third-party applications for point-of-care professionals, facilitating operational efficiencies in healthcare and enhanced patient outcomes.

• In January 2022, Zoetis expanded its digital portfolio of precision animal health and introduced BLOCKYARD™ and Performance Ranch™. The innovative blockchain technology provides information on cattle health, remotely accessible from digital devices.

Point Of Care Diagnostics Market Report Scope 

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global point of care diagnostics market report on the basis of product, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Glucose Testing

  • Hb1Ac Testing

  • Coagulation Testing

  • Fertility/Pregnancy

  • Infectious Disease

    • HIV POC

    • Clostridium Difficile POC

    • HBV POC

    • Pneumonia or Streptococcus Associated Infections

    • Respiratory Syncytial Virus (RSV) POC

    • HPV POC

    • Influenza/Flu POC

    • HCV POC

    • MRSA POC

    • TB and Drug-resistant TB POC

    • HSV POC

    • COVID-19

    • Other Infectious Diseases

  • Cardiac Markers

  • Thyroid Stimulating Hormone

  • Hematology

  • Primary Care Systems

  • Decentralized Clinical Chemistry

  • Feces

  • Lipid Testing

  • Cancer Marker

  • Blood Gas/Electrolytes

  • Ambulatory Chemistry

  • Drug of Abuse (DOA) Testing

  • Urinalysis/Nephrology

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Clinics

    • Pharmacy & Retail Clinics

    • Physician Office

    • Urgent Care Clinics

    • Non-practice Clinics

  • Hospitals

  • Home

  • Assisted Living Healthcare Facilities

  • Laboratory

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia