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Redding, California - December 4, 2023

U.S. Point-of-Care Diagnostics Market to be Worth $13.16 Billion by 2030

U.S. Point-of-Care Diagnostics Market by Application (Influenza, Pneumonia, TB, HAI, Salmonellosis, Hepatitis, HIV, COVID, Pregnancy, Glucose Monitoring, Hematology, Tumor Marker), Platform (LFA, Molecular), Sample (Blood, Urine), End User - Forecast to 2030


Meticulous Research®—a leading global market research company, published a research report titled, U.S. Point-of-Care Diagnostics Market by Application (Influenza, Pneumonia, TB, HAI, Salmonellosis, Hepatitis, HIV, COVID, Pregnancy, Glucose Monitoring, Hematology, Tumor Marker), Platform (LFA, Molecular), Sample (Blood, Urine), End User - Forecast to 2030.’

According to this latest publication from Meticulous Research®, the U.S. point-of-care diagnostics market is expected to register a CAGR of 4.3% from 2023 to reach $13.16 billion by 2030. The U.S. point-of-care diagnostics market is growing due to innovation in POC tests, growing commercialization of CLIA-waived POC tests, increasing funding for research and development, rising awareness regarding early disease diagnosis, and increasing prevalence of chronic diseases coupled with the aging population. However, stringent regulatory policies and pricing pressure due to fluctuations in reimbursements are restraining the growth of this market. Furthermore, growing investments in healthcare infrastructure and healthcare professionals' increasing preference for POC tests over other lab tests across the U.S. are expected to offer significant growth opportunities in the market.

Key Players

The key players operating in the U.S. point-of-care diagnostics market are Abbott Laboratories (U.S.), Siemens Healthineers AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Danaher Corporation (U.S.), Becton, Dickinson and Company (U.S.), Thermo Fisher Scientific Inc. (U.S.), bioMérieux S.A. (France), QuidelOrtho Corporation (U.S.), Sekisui Diagnostics, LLC. (U.S.), Chembio Diagnostics, Inc. (U.S.), EKF Diagnostics Holdings plc (U.K.), Trinity Biotech plc (Ireland), Werfen (Spain), and Nova Biomedical (U.S.). 

U.S. Point-of-Care Diagnostics Market: Future Outlook

The U.S. point-of-care diagnostics market is segmented by offering [{consumables, instruments, and software and services}; platform {lateral flow assays, molecular diagnostics, and other platform}; application {blood glucose monitoring, infectious disease testing (parasitic infections testing, blood-borne infections testing (Hepatitis, HIV, other blood-borne infections), respiratory infections testing (Influenza, Pneumonia, Tuberculosis (TB), COVID-19 testing, and other respiratory infections testing), healthcare-associated infection (HAI) testing, gastrointestinal infections testing (salmonellosis, E. Coli infections, other GI infections) other infectious diseases testing), tumor/cancer markers testing, pregnancy and fertility testing (pregnancy testing, fertility testing), cardiac marker/cardiac metabolism testing, cholesterol/lipid profile testing, coagulation testing (prothrombin time (PT/INR) testing, activated clotting time (ACT/APTT) testing, other coagulation testing), hematology, drugs of abuse testing, urinalysis, other POC testing}; sample type {blood sample, nasopharyngeal swab, urine sample, saliva sample, other sample types}; end user (home care/self-testing, hospitals, physician offices & ambulatory care settings, diagnostics laboratories, and other end users}] and country. The study also evaluates industry competitors and analyzes their market share at the country level.

Among all the offerings in the report, in 2023, the consumables segment is expected to account for the largest share of the U.S. point-of-care diagnostics market. Factors such as recurrent use of consumables in the detection of various diseases through diagnostics, rise in product approvals, increased use of kits in healthcare settings, and technological advancements in ELISpot assay kits, and direct-to-customer tests contribute to the large share of the segment’s growth.

Among all the platforms studied in the report, the molecular diagnostics segment is expected to register the highest CAGR during the forecast period. The high sensitivity and accuracy of molecular diagnostics tests, the growing need for advanced diagnostic techniques, the widening applications of molecular detection tests in various fields, and product launches are the major factors driving the market's growth.

Among all the applications studied in the report, in 2023, the blood glucose monitoring segment is expected to account for the largest share of the U.S. point-of-care diagnostics market. The large market share of this segment is attributed to the rising prevalence of diabetes, new product launches, and the growing need for blood glucose monitoring. The major factors responsible for such a high incidence of diabetes are the lack of awareness and knowledge, physical inactivity, and the growing prevalence of obesity. Therefore, it is important to periodically monitor the blood glucose levels to prevent further implications of diabetes.

Among all the sample types studied in the report, the blood sample type segment is expected to grow with the highest CAGR during the forecast period. The growth of this segment is attributed to the availability of a large variety of tests using blood samples, increasing prevalence of various chronic diseases, and increasing consumer awareness regarding the monitoring of chronic diseases.

Among all the end users studied in the report, in 2023, the hospital segment is expected to account for the largest share of the U.S. point-of-care diagnostics market. As hospitals perform various tests to diagnose several medical conditions, the increasing healthcare expenditure is expected to boost the point-of-care diagnostics market in the U.S. Point-of-care (PoC) devices are widely used in various areas of the hospital, including the emergency department (ED), intensive care unit (ICU), operating room/reanimation, delivery room/neonatal ward, CT scanning/invasive radiology, diabetic care ward, and dialysis unit. PoC testing is particularly prevalent in the ED, as it enables rapid confirmation of diagnoses, allowing for quick treatment initiation and reducing patient wait times.

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Key questions answered in the report:

  • What are the high-growth market segments regarding the offering, platform, applications, techniques, sample types, and end user?
  • What was the historical market for U.S. point-of-care diagnosis?
  • What are the market forecasts and estimates for 2023–2030?
  • What are the major drivers, restraints, challenges, and opportunities in the U.S. point-of-care diagnostics market?
  • Who are the major players in the U.S. point-of-care diagnostics market?

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