U.S. And Europe Lateral Flow Assay Market Size, Share & Trends Analysis Report Product (Kits & Reagents, Lateral Flow Readers), By Application, By Technique, By Test Type, By End Use, By Country, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The U.S. and Europe lateral flow assay market size was estimated at USD 5.19 billion in 2024 and is projected to grow at a CAGR of 5.48% from 2025 to 2030. 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 emergence and resurgence of infectious diseases-such as COVID-19-have emphasized the importance of robust disease monitoring, early detection, and testing strategies. These diseases, caused by bacteria, viruses, parasites, and fungi, spread through direct and indirect human contact, vectors like mosquitoes, and contaminated food or water. While regional variations exist due to socioeconomic and healthcare disparities, the repercussions of these diseases are significant.

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 European market is witnessing rapid advancements and significant investments in LFA development. In April 2024, a breakthrough in food safety testing was achieved with the launch of the SENSIStrip Gluten PowerLine Lateral Flow Device. This state-of-the-art test offers highly accurate and sensitive gluten detection, meeting the growing demand for reliable screening in the food industry and among gluten-sensitive consumers. Using a monoclonal antibody-based detection system, the device can identify even trace amounts of gluten in food products, rinse water, and surface swabs, ensuring greater safety and compliance with gluten-free standards.

The increasing demand for rapid, accurate, and cost-effective diagnostic solutions is accelerating the adoption of LFAs in homecare settings across the U.S. and Europe. 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 U.S. and Europe lateral flow assay industry is experiencing continuous technological advancements, improving sensitivity, accuracy, and multiplex capabilities. The introduction of AI-driven lateral flow readers, quantitative LFA systems, and enhanced detection methods has expanded the application of LFAs beyond traditional diagnostic settings. In January 2025, bioMérieux announced the acquisition of SpinChip Diagnostics ASA, a Norwegian diagnostics company known for its innovative immunoassay platform, further strengthening its point-of-care diagnostics capabilities.

The U.S. and Europe lateral flow assay industry 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 U.S. and Europe lateral flow assay industry, influencing product adoption and market entry. In December 2021, F. Hoffmann-La Roche launched the SARS-CoV-2 & Flu A/B Rapid Antigen Test, targeting professional use in CE Mark-accepting markets to aid in differentiating respiratory infections. Similarly, QuidelOrtho Corporation’s Sofia 2 SARS + FIA, receiving FDA market clearance in August 2023, showcases the importance of regulatory pathways in ensuring widespread acceptance and commercialization of innovative LFA products.

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. and Europe lateral flow assay industry 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. and European 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 led the market with the largest revenue share of 68.48% in 2024, 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 its antibody response mirrors the R5 antibody, reinforcing accuracy. In addition, 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 is projected to experience at 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

Based on application, the clinical testing segment led the market with the largest revenue share of 77.18% in 2024. 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 expanded 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 is projected to grow at the fastest CAGR of 6.38% 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. In addition, 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

Based on technique, the sandwich assay segment led the market with the largest revenue 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.

Test Type Insights

Based on test type, the lateral flow immunoassay (LFIA) segment led the market with the largest revenue share of 65.10%in 2024, solidifying its position as a widely used platform for rapid diagnostics since its introduction in the mid-1980s. These tests are commonly employed in physician offices, hospitals, clinical laboratories, and clinics for both qualitative and quantitative detection of a diverse range of antibodies and antigens. Due to their ease of use, cost efficiency, and quick results, LFIA tests are highly adaptable, allowing for administration by healthcare professionals and patients at home. Home-based lateral flow devices play a crucial role in managing infectious diseases, cardiovascular conditions, and other medical concerns by accurately detecting biomarkers such as enzymes, hormones, cancer markers, microorganisms, vitamins, and viruses.

The nucleic acid lateral flow assay (NALFA) segment is projected to grow at a significant CAGR over the forecast period, emerging as a promising alternative to traditional antibody-based LFIAs by focusing on detecting amplicons. While the LFA market has historically been dominated by antibody-based detection, challenges such as high inter-batch variability, error margins, and stringent storage conditions have driven innovation in nucleic acid lateral flow technology. The increasing demand for highly sensitive and reliable point-of-care diagnostics has accelerated the development of nucleic acid-based tests, with aptamer technology playing a key role in enhancing assay accuracy and performance.

End Use Insights

Based on end use, the hospitals & clinics segment led the market with the largest revenue share of 35.99% in 2024. As primary diagnostic and treatment centers, hospitals and clinics play a crucial role in driving LFA adoption across the U.S. and Europe. 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. In addition, 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. In addition, regulatory approvals and partnerships between industry players and healthcare institutions are fostering further market growth.

Regional Insights

U.S. Lateral Flow Assay Market Trends

The lateral flow assays market in the U.S. is experiencing robust growth, driven by continuous product innovation, strategic investments, and strong government support. Advances in LFA technology have significantly enhanced sensitivity and broadened applications, fueling market expansion. A notable development occurred in April 2024, when Gold Standard Diagnostics introduced the SENSIStrip Gluten Lateral Flow Device, marking the debut of its allergen PowerLine tests. Utilizing a monoclonal antibody detection system, this highly sensitive test detects gluten residues in food matrices, rinse water, and swabs, improving food safety monitoring. The launch of such specialized lateral flow tests highlights the market’s continuous evolution through cutting-edge innovations.

Europe Lateral Flow Assay Market Trends

The lateral flow assay market in Europe is witnessing strong growth, driven by government-led initiatives and increased investments in rapid diagnostic testing. The expansion of public health programs and funding for accessible, point-of-care diagnostics has been instrumental in strengthening the market. A major factor fueling market growth is the implementation of government-backed testing programs aimed at enhancing early disease detection. In September 2021, the Pharmacy Collect Service was introduced, offering free rapid COVID-19 tests through selected community pharmacies. The Health Minister emphasized that, along with vaccination and contact tracing, widespread testing is critical in controlling the virus. Lateral Flow Device (LFD) tests have been particularly effective in identifying asymptomatic COVID-19 cases, minimizing the risk of unintentional transmission. Regular biweekly testing increases detection rates, allowing for early identification of highly infectious individuals and preventing further spread.

The UK lateral flow assay market has experienced notable growth, driven by government-led COVID-19 testing initiatives and the introduction of user-friendly diagnostic products. The widespread adoption of rapid, accessible testing solutions has significantly strengthened the market and expanded its applications beyond infectious disease detection. A key factor contributing to this growth was the extensive distribution of COVID-19 lateral flow tests across the UK. In September 2021, the government launched the Pharmacy Collect Service, enabling individuals to obtain free rapid COVID-19 tests from participating community pharmacies. This initiative aimed to detect asymptomatic COVID-19 cases and interrupt transmission chains. By supporting local manufacturing and innovation, the UK government reinforced its commitment to enhancing diagnostic accessibility while reducing reliance on imported test kits. This large-scale distribution of LFDs significantly boosted the UK market, ensuring a robust supply chain and sustained demand for rapid diagnostics

The lateral flow assay market in Germany is experiencing notable growth, propelled by strategic collaborations and innovative research in diagnostic technologies, especially in cancer detection and infectious disease diagnostics. The emphasis on developing advanced, rapid, and non-invasive testing solutions is anticipated to drive market expansion in the forthcoming years further.

The France lateral flow assay market is witnessing notable growth, propelled by the escalating demand for rapid, cost-effective diagnostic solutions across sectors such as healthcare, food safety, and environmental monitoring. This surge is further bolstered by government initiatives and heightened public awareness regarding infectious disease diagnostics, leading to increased adoption of lateral flow assays (LFAs).

Key U.S. And Europe Lateral Flow Assay Company Insights

Leading players in the market, such as Abbott Laboratories, Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche AG, Bio-Rad Laboratories, Inc., bioMérieux SA, Quidel Corporation, Hologic, Inc., PerkinElmer, Inc., Merck KGaA, BD, Siemens Healthineers, Danaher Corporation, and QIAGEN N.V. are actively developing innovative products and kits. For instance, in July 2021, Abbott announced the launch of the Panbio COVID-19 Antigen Self-Test, designed for detecting the SARS-CoV-2 virus in both adults and children, regardless of symptom presence. In line with the latest ICMR advisory on self-testing, these kits will be made available to enhance testing efforts for symptomatic and asymptomatic individuals, as well as close contacts of confirmed COVID-19 cases.

Key U.S. And Europe Lateral Flow Assay Companies:

Recent Developments

• In February 2024, The company entered into a strategic research collaboration with the U.S. Food and Drug Administration (FDA) to develop advanced tools for detecting food-borne pathogens, including Shiga-toxin producing E. coli, Cyclospora cayetanensis, Salmonella spp., and Listeria monocytogenes.

• 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 October 2024, BIOMÉRIEUX received CE-marking for the VIDAS VITAMIN B12 TOTAL test, an automated assay designed to measure total Vitamin B12 concentrations in human serum or plasma, expanding its diagnostic offerings.

U.S. And Europe Lateral Flow Assay Market Report Scope

U.S. And Europe Lateral Flow Assay Market Report Segmentation

This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. and Europe lateral flow assay market report based on product, application, technique, test type, end use, and region.

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Kits & Reagents

  • Lateral Flow Readers

    • Benchtop Readers

    • Digital Readers

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Clinical Testing

    • Infectious Disease Testing

      • COVID-19

      • Mosquito Borne Disease Testing

      • 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, 2018 - 2030)

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Lateral Flow Immunoassay

  • Nucleic Acid Lateral Flow Assay

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • U.S.

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway