US Point of Care Diagnostics Market

The US point of care diagnostics market is projected to reach USD 10.6 billion by 2031 from USD 6.8 billion in 2026, at a CAGR of 9.2%.

The high prevalence of communicable diseases and the rising number of cancer cases in the US are key factors driving the growth of the US point of care diagnostics market. Additionally, government initiatives to improve the country's healthcare infrastructure are contributing to this market expansion.

In December 2025, Roche received FDA 510(k) clearance and a CLIA waiver for its first molecular point-of-care assay designed to identify Bordetella infections, including whooping cough. This test is performed on the cobas Liat system and delivers results in approximately 15 minutes. The launch of this assay enhances Roche's point-of-care portfolio by enabling rapid on-site diagnosis in US healthcare settings.

In June 2024, Abbott announced that it had received FDA approval for an over-the-counter (OTC) version of two new continuous glucose monitoring systems: Lingo and Libre Rio. These systems are based on Libre technology and offer glucose management solutions through OTC options. Lingo targets general wellness, while Libre Rio is designed for adults with Type 2 diabetes who do not require insulin therapy.

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The US point of care diagnostics market is primarily dominated by major companies such as Siemens (Germany), Abbott (US), Danaher (US), QuidelOrtho (US), Thermo Fisher Scientific Inc. (US), Roche (Switzerland), BD (US), BIOSYNEX SA (France), EKF Diagnostics Holdings Plc (UK), bioMérieux (France), Nova Biomedical (US), Trinity Biotech (Ireland), Werfen (US), Boditech Med Inc. (South Korea), and SEKISUI Diagnostics (US), among others. These leading companies are also expanding their market presence through various strategies aimed at business growth. These strategies include offering technologically advanced point-of-care devices, forming strategic partnerships, pursuing expansions, and engaging in diverse business combinations, all while introducing innovative testing devices.

Abbott is a leading player in the US point of care diagnostics industry, offering a wide range of diagnostic systems, including blood screening, immunoassays, and clinical chemistry systems. Its extensive geographic reach has enabled the company to provide a diverse array of point-of-care solutions nationwide. Abbott maintains its competitive advantage through continuous investment in research & development (R&D) and a strong focus on innovation. Additionally, the company supports its market position with regular product launches and timely regulatory approvals.

F. Hoffmann-La Roche Ltd. is well known for its strong position in the US marketplace, particularly in the point-of-care diagnostics sector. The company has maintained its leadership in the overall diagnostics market for a considerable time. Its diversified product offerings and established presence have contributed to its competitive advantage in the US market. Roche's access to well-developed direct and indirect distribution channels enables it to achieve high levels of efficiency in responding to changing market demands. Additionally, Roche successfully balances organic growth strategies, such as innovation, with inorganic growth strategies, thereby helping the firm maintain its prominent position in the US point of care diagnostics market.

Market Ranking

The key players in the US point of care diagnostics market are recognized for their comprehensive portfolios and ongoing technological innovations. These include Siemens Healthineers AG (Germany), Abbott (US), Danaher (US), QuidelOrtho Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), and BD (US).

Abbott and QuidelOrtho have established strong reputations for delivering comprehensive rapid immunoassay and near-patient testing solutions suitable for point-of-care settings. Siemens Healthineers and F. Hoffmann-La Roche hold a competitive advantage through their extensive point-of-care solutions, which deliver fast, accurate results for both critical and routine testing.

Danaher is committed to providing comprehensive diagnostic solutions and demonstrates expertise in meeting the demands for rapid testing at the point of care. Additionally, BD offers point-of-care solutions to enhance workflow efficiency and patient safety in these environments.

All these companies have significantly contributed to the growth of the US point of care diagnostics market.

Related Reports:

US Point of Care Diagnostics Market by Product [Glucose, Infectious Disease (TB, HAI, STD), Pregnancy], Purchase Mode (Rx, OTC), Technology [Biochemistry, MDx (RT-PCR, INAAT)], Sample (Blood, Urine), End User (Home Care, Hospitals) - Forecast to 2031

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