US Point of Care Diagnostics Market Outlook to 2028

US Point of Care Diagnostics Market Overview

The US Point of Care Diagnostics (POC) market is valued at USD 11 billion, driven by the growing need for rapid diagnostic results and increasing cases of chronic and infectious diseases such as diabetes and cardiovascular diseases. The market benefits from the healthcare sector's push for decentralized diagnostics, especially in homecare settings and retail clinics, which has led to more investments in POC technologies. The strong focus on patient-centered care and the rise in self-testing due to consumer demand for convenience are further pushing market expansion.

Key regions like New York, California, and Texas dominate the market due to their large healthcare infrastructure and high patient demand for decentralized testing solutions. These states benefit from a dense population, progressive healthcare regulations, and significant investments in health technologies, which accelerate the adoption of POC diagnostics. Cities within these regions act as hubs for healthcare innovation, attracting manufacturers, healthcare providers, and funding, giving them a dominant position in the US market.

In 2024, the FDA continues to offer fast-track approvals for POC diagnostics that address urgent healthcare needs, particularly for infectious diseases and chronic conditions. This is expected to accelerate the launch of over 50 new diagnostic devices focused on rapid testing for diseases like sepsis and influenza.

US Point of Care Diagnostics Market Segmentation

By Technology

The US Point of Care Diagnostics market is segmented by technology into lateral flow assays, biosensors, molecular diagnostics, and immunoassays. Among these, lateral flow assays hold a dominant market share due to their widespread use in rapid diagnostic tests for infectious diseases, including COVID-19, and the ease of use without requiring complex laboratory equipment. The simplicity of these devices, their relatively low cost, and their capability for mass production contribute to their prevalence in both healthcare and homecare settings.

By Application

The market is also segmented by application into cardiology, oncology, infectious diseases, diabetes management, and pregnancy and fertility testing. Diabetes management is the leading segment in terms of market share, largely due to the high prevalence of diabetes in the US and the increasing demand for continuous glucose monitoring (CGM) devices. These devices enable real-time monitoring, allowing for better disease management and improved patient outcomes, which is crucial in managing chronic conditions like diabetes.

Competitive Landscape

The US Point of Care Diagnostics market is dominated by major players that have established a strong presence through product innovation and strategic partnerships. These companies focus on expanding their technological capabilities to maintain competitiveness in the growing market.

Company Name

Established

Headquarters

Product Portfolio

R&D Investment

Revenue Growth

Testing Platforms

Market Presence

Partnerships

Competitive Edge

Abbott Laboratories

1888

Abbott Park, Illinois

Roche Diagnostics

1896

Basel, Switzerland

Siemens Healthineers

1847

Erlangen, Germany

Thermo Fisher Scientific

1956

Waltham, Massachusetts

Quidel Corporation

1979

San Diego, California

US Point of Care Diagnostics Market Analysis

3.1. Growth Drivers

Regulatory Incentives: The U.S. government has introduced several incentives to encourage the adoption of point-of-care diagnostics (POC), including expedited FDA approvals and tax benefits for manufacturers developing rapid diagnostic devices. In 2024, over 200 new POC diagnostic devices are expected to gain fast-track approvals, fueling market expansion. This is driven by the increasing demand for real-time diagnostic tools that reduce the need for centralized labs.

Shift to Home-based Diagnostics: By 2024, home-based diagnostics are seeing significant adoption, particularly driven by the need for self-monitoring tools for chronic diseases such as diabetes. The demand for glucose monitoring kits alone is projected to increase by 15 million units annually, with home diagnostics becoming a standard for managing chronic conditions.

Chronic Disease Prevalence: The rising incidence of chronic diseases, including cardiovascular diseases and diabetes, has created a surge in demand for POC diagnostics in the U.S. By the end of 2024, over 37 million Americans are managing diabetes, and the need for real-time glucose monitoring devices is projected to result in a market demand increase of 4.5 million units.

Market Challenges

Reimbursement Complexities: Navigating reimbursement models for POC diagnostics remains a significant hurdle. As of 2024, nearly 35% of healthcare providers have reported delays or complications in receiving reimbursements for POC tests, resulting in slower adoption among smaller healthcare facilities.

Data Security Concerns: As POC diagnostics become more integrated with digital health platforms, ensuring the security of patient data is increasingly challenging. By 2024, it is estimated that over 2 million POC devices will be connected to cloud platforms, making cybersecurity a critical concern for healthcare providers and patients alike.

Future Outlook

Over the next five years, the US Point of Care Diagnostics market is expected to experience robust growth driven by the increasing demand for rapid diagnostic solutions, technological advancements in molecular and biosensor-based diagnostics, and the expansion of telemedicine services. As healthcare shifts toward personalized care and early diagnosis, point-of-care testing will play a critical role in improving patient outcomes and reducing the burden on traditional healthcare facilities.

Opportunities

Emerging Technologies: Emerging technologies like nanotechnology and AI-based diagnostics are expected to open new opportunities for POC applications. By 2024, around 5,000 new AI-driven diagnostic devices will enter the U.S. market, offering enhanced diagnostic speed and accuracy for multiple diseases.

Personalized Medicine: The growing focus on personalized medicine is creating opportunities for customized POC diagnostics. As of 2024, the demand for personalized diagnostic tools is set to rise, with over 10 million POC devices tailored to individual genetic profiles expected to be utilized in personalized care strategies.
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