U.S. Lateral Flow Assay Market Size, Share & Trends Analysis Report By Product (Kits & Reagents, Lateral Flow Readers), By Application (Veterinary Diagnostics, Food Safety & Environment Testing), By Technique, By End use, And Segment Forecasts, 2025 - 2033

U.S. Lateral Flow Assay Market Trends

The U.S. lateral flow assay market size was valued at USD 2.82 billion in 2024 and is projected to reach USD 4.63 billion by 2033, growing at a CAGR of 6.08% from 2025 to 2033. The rising prevalence of infectious diseases places immense pressure on public health systems worldwide. With increasing urbanization, interconnectivity, antimicrobial resistance, and the rising impact of climate change, experts stress the urgent need for enhanced infectious disease surveillance, prevention, and diagnostic capabilities. The global rise in infectious diseases significantly drives the lateral flow assays (LFA) market by necessitating rapid diagnostic solutions. According to the Centers for Disease Control and Prevention (CDC), tuberculosis (TB) cases in the U.S. increased from 7,874 in 2022 to 10,347 in 2024, reflecting a notable public health challenge.

The mosquito-borne disease testing segment is projected to experience significant growth due to the rising prevalence of mosquito-borne infections, including West Nile virus (WNV), dengue, chikungunya, Zika virus, malaria, and yellow fever. The increasing incidence of these diseases has heightened the demand for rapid and efficient diagnostic solutions, particularly in regions prone to outbreaks. According to the Centers for Disease Control and Prevention (CDC), West Nile virus (WNV) has become endemic in the U.S., with cases reported in all 48 contiguous states and the District of Columbia, predominantly during the summer and fall months. As of November 2024, the CDC recorded 1,466 cases of WNV, while in 2022, 913 human cases were reported, with 70% classified as neuroinvasive and 30% as non-neuroinvasive. The increasing burden of mosquito-borne diseases, alongside ongoing health crises such as COVID-19 and monkeypox, underscores the urgent need for effective diagnostic and surveillance measures.

Public health initiatives also play a crucial role in market expansion. The CDC’s Influenza Division International Program focuses on surveillance, pandemic preparedness, research, and vaccination programs to combat influenza. Additionally, the National Association of County and City Health Officials supports local health departments in influenza prevention and control.

Estimated influenza disease burden by age group U.S., 2023-2024 influenza season:

Source: CDC

Innovations in lateral flow assays (LFAs) have significantly improved their accuracy, sensitivity, and versatility, making them indispensable for disease diagnostics. A standard LFA structure consists of a polymeric material layer connected to a sample collection pad, leading to the detection area where a specific analyte binds, triggering a visible color change. Due to their ease of use and cost-effective production, over 2 billion LFAs are manufactured annually, including nearly 400 million strips for malaria and HIV testing. As LFAs require minimal technical expertise and function as ideal point-of-care systems, continuous advancements in LFA technology have had a transformative impact.

The OraQuick HIV Self-Test, approved in December 2024, detects HIV-1 and HIV-2 antibodies in oral fluid, offering a discreet over-the-counter solution. In 2024, InBios International’s SCoV-2 Ag Detect Rapid Test, also FDA-cleared, provides a 20-minute COVID-19 testing option without equipment, supporting home use across North America. High rates of sexually transmitted infections (STIs) further underscore the need for accessible diagnostic tools in the U.S. In 2023, chlamydia rates reached 492.2 cases per 100,000 people, while gonorrhea stood at approximately 179.5 per 100,000. These persistent levels have fueled innovations such as LetsGetChecked’s Simple 2 test kit, which allows users to self-collect samples for chlamydia and gonorrhea, mail them for analysis, and receive results within 2-5 days, supported by virtual consultations.

List Of Few Of Benchtop And Digital Readers Available In The Market:

Source: CDC

The increasing demand for rapid, accurate, and cost-effective diagnostic solutions is accelerating the adoption of LFAs in homecare settings across the U.S. These tests offer several advantages, including ease of use, quick results, and suitability for various environments, ranging from clinical settings to remote and at-home testing. The expansion of self-testing kits has empowered individuals to monitor their health independently, reducing the burden on healthcare systems and promoting proactive healthcare management. In 2023, the BinaxNOW COVID-19 Antigen Self-Test, a lateral flow immunoassay, was approved by the U.S. Food and Drug Administration (USFDA) for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This self-test has played a crucial role in enabling individuals to detect infections quickly and conveniently at home.

Market Concentration & Characteristics

The LFA market in the U.S. is experiencing continuous technological advancements, improving sensitivity, accuracy, and multiplex capabilities. A notable development in this sector occurred in April 2024 when Gold Standard Diagnostics launched the SENSIStrip Gluten Lateral Flow Device. This introduction is part of their new allergen PowerLine tests, based on a monoclonal antibody detection system. The device boasts high sensitivity for detecting gluten residues in various food matrices, rinse water, and swabs. This innovative testing solution enhances food safety monitoring, showcasing the continuous evolution of the market through cutting-edge technologies.

The LFA market has seen notable M&A activity, with companies acquiring cutting-edge technologies to expand their portfolios. In January 2025, bioMérieux acquired SpinChip Diagnostics ASA to enhance its point-of-care diagnostics segment. Similarly, QuidelOrtho Corporation received De Novo FDA authorization in August 2023 for its Sofia 2 SARS + FIA, becoming the first FDA-cleared rapid antigen test for COVID-19. These strategic moves highlight the ongoing consolidation and investment in LFA technology for infectious disease detection.

Regulatory approvals play a crucial role in the LFA market, influencing product adoption and market entry. In April 2024, QuidelOrtho Corporation received FDA clearance for its QuickVue COVID-19 test, allowing its use in both home settings and medical facilities. This approval not only enhances diagnostic accessibility and accuracy but also solidifies QuidelOrtho’s position in the competitive landscape of the LFA market.

Leading companies are continuously expanding their LFA product portfolios to meet rising diagnostic demands. QuidelOrtho Corporation’s Sofia 2 SARS + FIA received FDA market clearance in 2023, setting a benchmark for rapid antigen tests. Similarly, F. Hoffmann-La Roche’s SARS-CoV-2 & Flu A/B Rapid Antigen Test addresses the need for dual viral detection in professional settings. These expansions enhance the usability and versatility of LFAs across healthcare environments, including clinical, homecare, and point-of-care diagnostics.

The U.S. markets are seeing increased investment and product availability for LFAs, driven by growing diagnostic needs. bioMérieux’s acquisition of SpinChip Diagnostics ASA strengthens its European market position. Meanwhile, BD’s Veritor At-Home COVID-19 Test and Roche’s CE-marked SARS-CoV-2 & Flu A/B test highlight strategic U.S. expansions. Companies continue to leverage regulatory approvals and partnerships to enhance market reach, ensuring wider access to rapid, reliable, and cost-effective diagnostic solutions.

Product Insights

The kits & reagents segment dominated the market in 2024, accounting for 68.50% of the revenue share, driven by technological advancements and rising demand for rapid diagnostics. Innovations in assay sensitivity, specificity, and ease of use have significantly contributed to market expansion. In March 2024, the launch of the SENSIStrip Gluten PowerLine Lateral Flow Device revolutionized allergen detection, offering a monoclonal antibody-based system to detect gluten residues in food, rinse water, and swabs. The device incorporates a hook line feature, preventing false negatives in highly contaminated samples. Validation studies confirm that its antibody response mirrors the R5 antibody, reinforcing accuracy. Additionally, investments in biomarker-based LFAs are expected to propel growth, particularly for Alzheimer’s disease diagnostics, addressing the urgent need for early detection.

The lateral flow readers segment in the U.S. is projected to experience the fastest CAGR over the forecast period, driven by technological advancements and the growing demand for real-time analysis. Innovations in portable, high-performance LFA readers are enhancing diagnostic accuracy and efficiency, particularly in field and point-of-care testing. These advancements support a broad range of applications, from infectious disease diagnostics to environmental and food safety monitoring, reinforcing the market’s expansion.

Application Insights

The clinical testing application segment dominated the market in 2024, capturing 77.20% of the market share. This growth is fueled by the increasing prevalence of infectious diseases and chronic conditions and the rising demand for rapid diagnostic solutions. LFAs have become essential in point-of-care testing (POCT) across hospitals, clinics, laboratories, and physician offices, offering a fast, cost-effective, and user-friendly diagnostic approach. The COVID-19 pandemic significantly accelerated LFA adoption for infectious disease detection, improving assay sensitivity, regulatory approvals, and expanding applications. Beyond COVID-19, these tests are widely used for influenza, HIV, tuberculosis, pregnancy and fertility testing, cardiac biomarker assessment, cholesterol/lipid monitoring, and drug abuse screening.

The drug development & quality testing segment in the U.S. LFA market is projected to grow at a CAGR of 6.52% over the forecast period. LFAs are increasingly utilized for therapeutic drug monitoring, offering ease of use, cost efficiency, and the ability to detect multiple markers in a single sample. These assays are applied across both regulated and less regulated industries, providing full and semi-quantitative results. A key application in the pharmaceutical sector includes the quantitative measurement of adalimumab levels in human serum, aiding in precision dosing. Additionally, developing LFAs for authenticating piperaquine and dihydroartemisinin crucial components of artemisinin-based combination therapy is expected to fuel market growth. The rising geriatric and adult populations, coupled with ongoing drug development, further contribute to the expansion of this segment.

Technique Insights

The sandwich assay segment held a significant market share of 39.66% in 2024, driven by its accuracy, affordability, and ease of use. These assays are particularly valuable in low-resource healthcare settings, as they do not require trained personnel. Sandwich assays are commonly used to detect larger analytes that contain two epitopes or binding sites. One epitope is linked to a nanoparticle-bound antibody, while the other binds to a capture antibody on the test line. When the analyte is present, it forms a sandwich complex between the capture and detection antibodies, generating a positive signal. If the analyte is absent, the nanoparticle conjugate does not bind to the capture antibody, resulting in a negative outcome.

The multiplex detection assays segment is expected to grow at the fastest CAGR during the forecast period, driven by its ability to detect multiple targets simultaneously. These assays incorporate a control line and multiple test lines, eliminating the need for separate tests and improving efficiency in both laboratory and field applications. A major advantage of multiplex LFAs is their ability to detect various biomarkers or contaminants using minimal sample volumes, making them ideal for disease diagnostics and high-volume food and feed testing. This approach is particularly beneficial in resource-limited agricultural and remote settings, where it helps reduce costs, save time, and optimize resource utilization.

End Use Insights

The hospitals & clinics segment dominated the lateral flow assay (LFA) market in 2024, capturing 35.99% of the market share. As primary diagnostic and treatment centers, hospitals and clinics play a crucial role in driving LFA adoption across the U.S. With continuous advancements in healthcare infrastructure, there is a rising demand for enhanced diagnostic capabilities, leading to the widespread use of lateral flow assays for rapid and efficient disease detection. Additionally, increasing healthcare expenditure has significantly contributed to market expansion, allowing hospitals to integrate innovative point-of-care testing solutions into routine clinical workflows, improving patient outcomes and operational efficiency.

The pharmaceutical & biotechnology companies segment is expected to grow at the fastest CAGR during the forecast period, driven by rising investments in research and development, strategic collaborations, and advancements in LFA technology. Companies in this sector are actively pursuing mergers, acquisitions, product launches, and market expansion to strengthen their diagnostic portfolios. The increasing demand for rapid point-of-care diagnostic solutions has encouraged pharmaceutical and biotech firms to enhance their LFA capabilities, focusing on innovative tests for infectious diseases, chronic conditions, and biomarker detection. Additionally, regulatory approvals and partnerships between industry players and healthcare institutions are fostering further market growth.

Key U.S. Lateral Flow Assay Companies Insights

Key players operating in the U.S. lateral flow assay market are undertaking various initiatives to strengthen their presence and increase the reach of their products and services. Strategies such as expansion activities and partnerships are key in propelling the market growth.

Recent Developments

• In December 2024, the BIOFIRE Tropical Fever Panel, targeting causes of tropical fever infections, received U.S. FDA Special 510(k) clearance, enhancing bioMérieux's syndromic PCR test portfolio.

•  In August 2023, QuidelOrtho Corporation received De Novo FDA authorization in August 2023 for its Sofia 2 SARS + FIA, becoming the first FDA-cleared rapid antigen test for COVID-19. These strategic moves highlight the ongoing consolidation and investment in LFA technology for infectious disease detection.

U.S. Lateral Flow Assay Market Report Scope

U.S. Lateral Flow Assay Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. lateral flow assay market report based on product, application, technique, and end use:

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Kits & Reagents

  • Lateral Flow Readers

  • Benchtop Readers

  • Digital Readers

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Clinical Testing

    • Infectious Disease Testing

      • COVID-19

      • Mosquito Borne Disease Testing

        • Malaria Testing

        • Dengue Testing

        • Zika Testing

        • Chikungunya Testing

        • Others

      • Influenza Testing

      • Sexually Transmitted Infection Testing

        • HIV Testing

        • HPV Testing

        • Chlamydia Testing

        • Gonorrhea Testing

        • Syphilis Testing

        • Other STI Testing

      • Hepatitis

      • Tuberculosis

      • Other Infectious Diseases

    • Cardiac Marker Testing

      • Troponin I and T Testing

      • CK-MB Testing

      • BNP and NT-Probnp Testing

      • Myoglobin Testing

      • D-Dimer Testing

      • Other Cardiac Marker Tests

    • Pregnancy & Fertility Testing

      • Pregnancy Testing

      • Fertility Testing

    • Cholesterol Testing/Lipid Profile

    • Drugs of Abuse Testing

    • Other Clinical Tests

  • Veterinary Diagnostics

  • Food Safety & Environment Testing

  • Drug Development & Quality Testing

• Technique Outlook (Revenue, USD Million, 2021 - 2033)

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others