U.S. Point of Care Diagnostics Market Size, Share & Industry Analysis, By Product (Blood Glucose Monitoring, Infectious Disease Testing, Cardiometabolic Disease Testing, Pregnancy & Fertility Testing, Hematology Testing, and Others), By Sample (Blood, Nasal and Oropharyngeal Swabs, Urine, and Others), By End-user (Hospital Bedside, Physician’s Office Lab, Urgent Care & Retail Clinics, and Homecare/Self-Testing), and Country Forecast, 2024-2032

The U.S. point of care diagnostics market size was worth USD 9.45 billion in 2023 and is anticipated to grow at a CAGR of 6.9% during the forecast period. 

Point of care diagnostics refers to medical tests performed at or near the patient's care site. These tests produce rapid results, enabling healthcare professionals to make quick treatment decisions. Factors such as the rising prevalence of chronic diseases, rising technological advancement, and growing consumer demand for home care testing are anticipated to boost the demand for point of care diagnostics kits in the U.S.

• According to a report published by the Centers for Disease Control and Prevention (CDC), in 2021, 37.3 million people had diabetes, constituting about 11.3% of the U.S. population. Among these 37.7 million diabetic populations, around 28.7 million were diagnosed with diabetes. However, around 8.5 million people had undiagnosed diabetes.

Moreover, an increasing shift towards personalized medicine further influences the demand for point of care diagnostics. The COVID-19 pandemic significantly propelled the market growth in the country and impacted the market positively, owing to the development and launch of several new POC tests for COVID-19 diagnosis.

LATEST TRENDS

Growing Focus on Multiplex Testing Products to Expand POC Testing Applications

Multiplexing is the ability to test for multiple analyses in a single assay simultaneously. There is a growing trend towards point of care diagnostics that offer multiplexing capabilities as these tests enable the detection of multiple diseases in a single sample providing comprehensive diagnostic information in a shorter time frame. This growing trend gained the attention of many market players and encouraged them to develop new products.

• For instance, in July 2022, BioGX, a molecular diagnostics company, announced the launch of a three-gene multiplex COVID-19 test, a CE-IVD marked POC test. The multiplex test targets the N1, RdRp, and M gene regions for greater redundancy in detecting SARS-CoV-2 emerging variants.

DRIVING FACTORS

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Rising Incidence of Infectious Diseases to Boost the Demand for the Product 

The highly contagious nature of the infectious disease is continuously increasing the burden on the healthcare system of the U.S. The list of key infectious diseases includes influenza, HIV, pneumonia, hepatitis, and tuberculosis, among others. The rising incidence of infectious diseases is leading to increasing demand for point-of-care diagnostics, driving the market growth during the forecast period.

• According to the Pan American Health Organization (PAHO), around 23,000 deaths yearly and approximately 10,000 newly diagnosed cases of hepatitis B are reported. Also, the World Health Organization (WHO) estimates of hepatitis C indicate 67,000 new infections annually and 84,000 deaths.

Moreover, the increasing incidence of tuberculosis in the U.S. further boosts the demand for point of care diagnostics in the U.S., driving the market growth during the forecast period.

RESTRAINING FACTORS

Increasing Product Recalls due to Comparatively Lower Accuracy to limit the Market Growth

The stringent guidelines enable regulatory agencies to rigorously investigate the product quality and issue cause. Increased scrutiny of products has led to multiple product recalls in recent years, impacting product adoption.

• For instance, in September 2021, Magellan Diagnostics, a Meridian Bioscience, Inc. subsidiary, announced the Class I recall of LeadCare II, a point-of-care (CLIA-waived) blood lead testing system. The recall was initiated due to the significant risk of falsely low results that may risk the health of special populations such as pregnant individuals and young children.

Thus, such product recalls negatively impact the U.S. point of care diagnostics market growth.

SEGMENTATION

By Product Analysis

Based on the product, the market is categorized into infectious disease testing, blood glucose monitoring, pregnancy & fertility testing, cardiometabolic disease testing, and hematology testing.                                                                                   

The blood glucose monitoring segment accounted for the largest U.S. point of care diagnostics market share in 2022 due to the rising prevalence of diabetes in the country, leading to increased demand for diabetes rapid test kits. The segment’s growth is further attributed to increasing product launches and rising adoption of blood glucose monitoring systems.

• For instance, in March 2021, Diabetomics, Inc., a U.S.-based company, announced the launch of Insudex. Insudex is a rapid, simple-to-use POC test for C-peptide that aims to facilitate the staging of presymptomatic T1D and differential diagnosis of late-onset type 1 diabetes.

By Sample Analysis

Based on the sample segment, the market is categorized into nasal and oropharyngeal swabs, urine, blood, and others.

The blood segment held a larger share in 2022 as it contains numerous biomarkers indicating a disease's presence, progression, or severity. Blood acts as a core sample that offers diagnostic versatility as blood can be stored and preserved for a more extended period without degradation of required analytes.

• In July 2023, Lumos Diagnostics, a rapid point of care diagnostic developer, received USFDA approval for FebriDx, a rapid POC test for bacterial acute respiratory infection diagnosis. The test involves an immunoassay on a fingerstick blood sample to measure C-reactive protein (CRP) and myxovirus resistance protein A (MxA).

By End User Analysis

Based on end user segment, the market is categorized into urgent care & retail clinics, hospital bedside, homecare/self-testing, and physician's office lab.

The hospital bedside segment held a larger share in 2022 due to the increased accessibility of technologically advanced, compact, and portable devices leading to improved patient outcomes and better treatment decisions.  Also, the rising expenditure on healthcare infrastructure further boosts the adoption of these products contributing to the segment’s growth during the forecast period.

• For instance, according to a report published in June 2023 by the U.S. Centers for Medicare & Medicaid Services, hospital expenditures grew around 4.4% to USD 1,323.9 billion in 2021.

KEY INDUSTRY PLAYERS

The competitive landscape of the market is semi-consolidated. Some key players include Abbott, F. Hoffman-La Roche AG, and Danaher (Cepheid Inc.), which accounted for a significant market share in 2022. The factors attributed to the growth of these companies are broad product portfolio, technological advancement, and huge R&D investment leading to the introduction of new products in the market.

Moreover, key strategies followed by these companies and increasing funding opportunities for new entrants further contribute to market growth during the forecast period. For instance, in June 2022, Visby Medical, a U.S.-based diagnostics company, received an additional USD 35 million fund in a Series E round, totaling over USD 135 million raised in the same round. Thus, rising funding opportunities, a wide product portfolio, and increasing strategic alliances are expected to enable companies further to strengthen their market presence.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• Abbott Laboratories (U.S.)


• Quest Diagnostics Incorporated (U.S.)


• BD (U.S.)


• bioMérieux SA (France)


• Cardinal Health, Inc. (U.S.)


• Cepheid (U.S.)


• Trinity Biotech (Ireland)


• Quidel Corporation (U.S.)


• Bio-Rad Laboratories Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• July 2023 – New Day Diagnostics, LLC and EDP Biotech announced the merger of their asset and formed a vertically integrated force. Under the merger, New Day Diagnostics LLC brought a diversified pipeline of physician Point-of-Care (POC) and physician Mediated-Direct-to-Consumer (DTC) tests to the combined entity.


• June 2023 – Cue Health Inc. received de novo authorization form USFDA approval for the Cue Covid-19 molecular test, a point of care molecular nucleic acid amplification test.


• March 2023 – InBios International, Inc. received the marketing rights from USFDA for Active Anthrax Detect Plus Rapid Test, a POC diagnostic test for Anthrax. The approval was granted through the FDA’s De Novo process for new medical devices or technology with no comparable device.

REPORT COVERAGE

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The U.S. point of care diagnostics market report provides a detailed market analysis. It focuses on key aspects such as the prevalence of key indications, technological advancements, reimbursement scenarios, and emerging trends in the U.S. point of care diagnostic market. Additionally, it includes new product launches, key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also highlights key industry dynamics.

Report Scope & Segmentation