The U.S. lateral flow assay market was valued at USD 2.97 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2025 to 2034. By 2034, the market is expected to reach approximately USD 5.39 billion, driven by the growing focus on point-of-care diagnostics, rising prevalence of chronic and infectious diseases, and an increasing preference for rapid, user-friendly testing solutions.

Market Overview

Lateral flow assays are simple, paper-based diagnostic devices designed to detect the presence or absence of a target analyte in liquid samples, without the need for specialized laboratory equipment. Praised for their affordability, ease of use, and quick results, LFAs have become a crucial tool in point-of-care (POC) and at-home testing across the United States.

Initially popularized by pregnancy tests, LFAs have rapidly expanded into diverse areas such as infectious disease detection, cardiac markers, cancer screening, veterinary diagnostics, food safety, and drug abuse testing. With U.S. healthcare moving toward decentralization and early intervention, LFAs are increasingly recognized as an essential part of modern diagnostic strategies.

Key Market Growth Drivers

1️⃣ Rising Demand for Point-of-Care Testing (POCT)

LFAs are a vital component in POCT thanks to their simplicity, speed, and minimal requirement for technical expertise. The continued shift toward decentralized care—including telemedicine, home health services, and urgent care clinics—is boosting the adoption of LFAs, making them a preferred choice in a wide range of care settings.

2️⃣ High Burden of Chronic and Infectious Diseases

The U.S. continues to grapple with high prevalence rates of chronic conditions like diabetes and cardiovascular disease, as well as infectious diseases such as COVID-19, influenza, HIV, and sexually transmitted infections. LFAs play a critical role in early diagnosis and monitoring, providing timely results that enable rapid treatment decisions and effective disease control.

3️⃣ Technological Advancements and Digital Integration

Innovations in assay design have significantly improved sensitivity, specificity, and multiplexing capabilities. Integration with smartphone readers, AI-based analytics, and cloud-connected reporting systems is transforming LFAs into sophisticated diagnostic tools that not only provide quick results but also enable real-time data sharing and epidemiological tracking.

4️⃣ Strong Regulatory Support and Emergency Use Authorizations (EUAs)

The U.S. FDA’s proactive approach in granting EUAs—especially during health crises like the COVID-19 pandemic—has accelerated product approvals and market growth. This supportive regulatory landscape continues to encourage innovation and streamline pathways for new diagnostic technologies.

5️⃣ Growing Consumer Preference for At-Home Testing

Heightened health awareness and a strong desire for privacy and convenience have fueled demand for over-the-counter (OTC) lateral flow kits. These are widely used for pregnancy and fertility monitoring, glucose testing, infectious disease screening, and drug testing, empowering consumers to take charge of their own health.

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Market Segmentation

By Product Type

• Kits & Reagents (Dominant Segment)

• Lateral Flow Readers

Kits and reagents continue to lead the market, driven by high-volume usage in diverse applications. However, lateral flow readers are seeing increasing demand for their ability to deliver quantitative and automated results, which are critical for clinical accuracy and advanced monitoring.

By Application

• Clinical Testing

  • Infectious Diseases (COVID-19, HIV, influenza, etc.)

  • Cardiac Biomarkers

  • Pregnancy & Fertility

  • Others (e.g., cancer, kidney function)

• Veterinary Diagnostics

• Food Safety & Environmental Testing

• Drug of Abuse Testing

Clinical testing represents the largest market share, primarily fueled by infectious disease screening and chronic disease management needs. Veterinary diagnostics and food safety testing are also growing rapidly, supported by increasing zoonotic disease surveillance and stricter food safety standards.

By Technique

• Sandwich Assays (Widely used for large analytes like proteins)

• Competitive Assays (Used for small molecules such as hormones and drugs)

Sandwich assays dominate the market due to their higher sensitivity and widespread application in major diagnostic tests, including COVID-19 antigen detection and cardiac marker monitoring.

By End User

• Hospitals & Clinics

• Diagnostic Laboratories

• Homecare Settings

• Pharmaceutical & Biotechnology Companies

• Veterinary Clinics

Hospitals and clinics remain the primary end users because of their high patient volumes and broad diagnostic capabilities. However, homecare settings are the fastest-growing segment, driven by consumer demand for convenient and private self-testing solutions.

Regional Insights

The U.S. remains the leading market globally for LFAs, supported by:

• A highly developed healthcare infrastructure

• Significant investment in R&D

• A mature diagnostics ecosystem

• Active regulatory support from agencies such as the FDA, CDC, and NIH

Urban and suburban regions dominate demand due to strong consumer awareness and access to advanced healthcare services. Meanwhile, efforts to extend testing capabilities to rural and underserved communities are creating new opportunities for growth and market penetration.

Competitive Landscape

The U.S. LFA market is highly competitive and innovation-driven. Key players continue to focus on expanding their product portfolios, enhancing digital capabilities, and pursuing strategic partnerships to strengthen their market positions.

Key Companies:

• Abbott (Leader with comprehensive LFA offerings, including the widely used BinaxNOW COVID-19 test)

• BD (Becton, Dickinson and Company)

• BIOMÉRIEUX

• Bio-Rad Laboratories, Inc.

• DH Life Sciences, LLC

• F. Hoffmann-La Roche

• QIAGEN

• Quest Diagnostics

• QuidelOrtho Corporation

• Siemens Healthineers AG

Recent Strategic Developments

• Mergers & Acquisitions: Major players are acquiring innovative startups to expand their technology portfolios and market reach.

• New Product Launches: Introduction of multi-analyte panels and digital reader-enabled kits to improve diagnostic accuracy and broaden use cases.

• Public-Private Partnerships: Collaborations with government agencies to support pandemic response efforts and strengthen community-level diagnostics.

Conclusion

The U.S. lateral flow assay market is set to maintain strong growth momentum through 2034, underpinned by the rising emphasis on decentralized healthcare, advancements in rapid diagnostics, and growing consumer interest in at-home testing.

Continued technological innovation, supportive regulatory frameworks, and robust investments from public and private sectors will drive the evolution of LFAs into even more sophisticated, data-enabled diagnostic solutions. As demand for fast, reliable, and accessible testing continues to expand, LFAs are expected to play an increasingly critical role in the future of American healthcare.

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