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

The U.S. Point-of-Care Diagnostics Market is expected to reach $13.16 billion by 2030, at a CAGR of 4.3% during the forecast period 2024–2030. Point-of-care diagnostics, or bedside tests, are diagnostic tests performed on-site by healthcare professionals. These tests provide quick and accurate results without requiring samples to be sent to a laboratory. Point-of-care diagnostics products quickly determine a marker responsible for a certain disease. These tests can be used in various point-of-care settings such as physician offices, urgent care facilities, long-term care facilities, and nursing homes. Also, these devices can be categorized as handheld, transportable, and portable based on format.

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 and infectious diseases. 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. In addition, a lack of awareness regarding the use of POC devices is a major challenge to the market’s growth.

Development of CLIA-waived PoC Tests Drive the U.S. Point-of-Care Diagnostics Market

In efforts to deliver effective diagnostic products, key market players are focused on simplifying and automating disease diagnosis and detection steps, revolutionizing disease diagnosis processes. For instance, manufacturers have started developing automated platforms that require minimal hands-on time by trained laboratory personnel; this has driven a shift in diagnostic testing from centralized laboratories to near-patient settings, such as hospital labs, physicians’ offices, hospital outpatient departments, and home healthcare facilities. CLIA-waived tests enable testing in point-of-care settings. These tests are simple procedures with an insignificant risk of erroneous results. Such tests can be used in several settings, including pharmacy-based clinics, urgent care centers, and hospitals. Waived tests that can be performed in physician offices include streptococcus testing, HIV testing, INR (coagulation) testing for Coumadin, and pregnancy testing. CLIA-waived tests speed up diagnosis and treatment, improving patients’ clinical outcomes.

Furthermore, CLIA-waived PoC tests bring high diagnostic sensitivity and specificity to point-of-care testing. If a test is CLIA-waived, the site or facility performing the assay does not need to document personnel qualifications and training, perform quality control procedures (unless specified in the test instructions), or conduct proficiency testing or routine quality assessment related to that assay. Thus, by securing CLIA grants, vendors can help customers by reducing the documentation burden.

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Healthcare Professionals’ Increasing Preference for PoC Tests Over Other Lab Tests Creates an Opportunity for Market Growth

Many healthcare professionals in hospitals and clinical laboratories prefer using point-of-care diagnostics to diagnose several health conditions promptly. Healthcare professionals are replacing established diagnostic methods (microscopy, pathogen culturing, biochemical testing, conventional polymerase chain reaction (PCR), enzyme-linked immunoassay (ELISA), and other time-consuming diagnostic methods) with new point-of-care diagnostic techniques that provide higher levels of efficiency and reproducibility. The advantages of point-of-care diagnostics include faster turnaround times, convenience, cost-effectiveness, improved patient outcomes, and patient satisfaction. Point-of-care diagnostic tests deliver rapid results, whereas traditional lab tests can take days to provide results. This speed can be crucial for time-sensitive medical conditions, allowing healthcare providers to make timely decisions about patient care.

Further, PoC tests are performed on-site, eliminating the need to send samples to a laboratory. This saves time and resources and can be particularly useful for patients who live in remote or rural areas. These tests are less expensive than traditional lab tests, requiring less equipment and personnel, making them a more affordable option for healthcare providers, particularly in resource-constrained settings. PoC tests help healthcare providers make faster and more accurate diagnoses, which can lead to improved patient outcomes. For example, PoC tests for infectious diseases can help healthcare providers quickly identify and treat patients, preventing the spread of diseases. Thus, the inclination towards point-of-care methods and medical practices among physicians drives the growth of the U.S. point-of-care diagnostics market.

Key Findings of U.S. Point-of-Care Diagnostics Market Study:

The Consumables Segment is Expected to Dominate the U.S. Point-of-Care Diagnostics Market in 2024

Among all the offerings, in 2024, the consumables segment is expected to account for the largest share of the market. Factors such as the growing demand for rapid diagnosis, the commercial availability of a diverse range of consumables, several product launches and approvals from the key players, increasing demand for POC diagnostics kits owing to their benefits such as ease of use, portability, and accuracy are contributing to the large share of this segment. PoC diagnostic kits are pre-packaged sets of materials and reagents for performing tests. These diagnostic kits are user-friendly, with clear instructions for use, and require minimal training, making them ideal for use in settings with limited access to trained laboratory personnel, such as rural or remote areas.

The Molecular Diagnostics Platform Segment is Expected to Register the Highest CAGR During the Forecast Period

Among all the platforms, the molecular diagnostics segment is projected to register the highest CAGR during the forecast period. Molecular diagnostics is a sensitive method that enables the detection of lower amounts of infectious agents. Molecular tests are designed to detect the genetic material of a virus, bacteria, or other pathogens in a patient's sample, such as blood or saliva. Factors such as relative ease of use, high sensitivity, specificity, and accuracy of molecular tests, ability to perform rapid analysis, the widening applications of molecular detection tests in various fields, and high popularity and awareness regarding RT-PCR diagnostics tests are driving the segment’s growth.

The Blood Glucose Monitoring Segment is Expected to Dominate the U.S. Point-of-Care Diagnostics Market in 2024

Among all the applications, in 2024, the blood glucose monitoring segment is expected to account for the largest share of the market. The large market share of this segment is mainly attributed to the increased prevalence of diabetes and the need for glucose monitoring devices. For instance, as per data from the International Diabetes Federation’s (IDF) Diabetes Atlas, nearly 32,215.3 adults in the U.S. survived with diabetes in 2021. This number is expected to reach 34,755.3 by 2030 and 36,289.9 by 2045.

The Blood Sample Type Segment is Expected to Dominate the U.S. Point-of-Care Diagnostics Market in 2024

Among all the sample types, in 2024, the blood sample type segment is expected to account for the largest share of the market. The large share of this segment is attributed to the availability of a wide range of tests that can be conducted using blood samples and an increasing awareness among consumers about the importance of self-monitoring. Blood samples are ideal for multiple point-of-care testing for diagnosing chronic diseases. Owing to the increasing prevalence of chronic and infectious diseases, early diagnosis is critical for successful treatment and prevention. For instance, in 2021, an estimated 32,100 new HIV infections occurred in the U.S.

The Home Care/Self-Testing Segment is Expected to Account for the Largest Share of the U.S. Point-of-Care Diagnostics Market

Among all the end users, in 2024, the home care/self-testing segment is expected to account for the largest share of the U.S. point-of-care diagnostics market. The largest share of the segment is attributed to the increasing prevalence of chronic diseases requiring long-term care and frequent monitoring, increasing home healthcare spending, growing awareness about home care, and the increasing availability of user-friendly and advanced POC diagnostic products. Also, the elderly population is more likely to have comorbidities and prefer staying in their home surroundings, leading to increasing demand for home care settings across the U.S.

Key Players

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presence, and key strategic developments adopted by leading market players in the industry over the years. The key players profiled 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.).

Report Summary:

Scope of the Report:

U.S. Point-of-Care Diagnostics Market Assessment, by Offering

• Consumables
• Instruments
• Software and Services

U.S. Point-of-Care Diagnostics Market Assessment, by Platform

• Lateral Flow Assays
• Molecular Diagnostics
• Other Platforms
  (Note: Other platforms include coagulation tests, dipsticks, cholesterol and glucose monitoring systems, and other point-of-care diagnostic platforms).

U.S. Point-of-Care Diagnostics Market Assessment, by Applications

• Blood Glucose Monitoring
• Infectious Disease Testing
  • Parasitic Infection Testing
  • Blood-borne Infection Testing
    • Hepatitis
    • HIV
    • Other Blood-borne Infections
  • Respiratory Infections Testing
    • Influenza
    • Pneumonia
    • Tuberculosis (TB)
    • COVID-19 Testing
    • Other Respiratory Infections Testing
  • Healthcare-associated Infection (HAI) Testing
  • Gastrointestinal (GI) Infection Testing
    • Salmonellosis
    • E. Coli Infections
    • Other GI Infections
  • Other Infectious Disease Testing
• Tumors/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
  (Note 1: Other respiratory infections testing include strep infections and respiratory syncytial virus (RSV). Other GI infections include cholera, Helicobacter pylori (H. pylori), and campylobacteriosis)
  (Note 2: Other blood-borne diseases include syphilis and brucellosis. Other infectious disease testing includes meningitis, hand, foot, and mouth disease (HFMD), and mononucleosis)
  (Note 3: Other coagulation testing segment includes fibrinogen level and platelet count. Other PoC testing includes tropical diseases and sexually transmitted diseases)

U.S. Point-of-Care Diagnostics Market Assessment, by Sample Type

• Blood Sample
• Nasopharyngeal Swab
• Urine Sample
• Saliva Sample
• Other Sample Types
  (Note: Other sample types of segment include stool, cervical swab, buccal swab, hair, vaginal swab, and semen)

U.S. Point-of-Care Diagnostics Market Assessment, by End User

• Hospitals
• Home care/self-testing
• Physician Offices & Ambulatory Care Settings
• Diagnostics Laboratories
• Other End Users
  (Note: Other end users include nursing homes, long-term care centers, pharmacies, urgent care facilities, schools, airports, hotels, and workplaces.)

Key questions answered in the report: