Lateral Flow Assays Market Size, Share & Trends Analysis Report By Product (Kits, Lateral Flow Readers), By Technique (Sandwich Assays, Competitive Assays), By Application, By Test, By End Use, By Region, And Segment Forecasts, 2025 - 2030

Lateral Flow Assays Market Size & Trends

The global lateral flow assays market size was estimated at USD 9.85 billion in 2024 and is projected to grow at a CAGR of 5.99% from 2025 to 2030. Lateral flow assays are used to detect the presence of a target component in the liquid sample without the need for expensive or specialized equipment. The rising prevalence of infectious diseases is anticipated to boost the market growth during the forecast period.

The high prevalence of infectious diseases worldwide has been a major driver for the growth of the LFA market. These diseases necessitate novel diagnostic techniques for efficient treatment to stop the rising mortality rate. The COVID-19 pandemic highlighted the need for rapid and accessible diagnostic tools, leading to a surge in demand for LFAs. Beyond COVID-19, other infectious threats have emerged. For instance, in 2025, a highly pathogenic avian influenza A (H5N1) virus infection resulted in a fatality in Louisiana, USA, despite the use of personal protective equipment that was deemed inadequate. According to the Centers for Disease Control and Prevention (CDC), while the general public faces a low risk, individuals working closely with infected animals-such as farmers, veterinarians, and wildlife facility staff-remain highly vulnerable. In 2024, 67 human cases of avian influenza were reported, with 40 linked to exposure to dairy cattle and 23 associated with poultry farms. In response, the UK proactively secured 5 million doses of the H5 vaccine to mitigate potential risks in 2025.

Advancements in LFA technology have significantly improved the sensitivity, specificity, and overall performance of these assays, thereby expanding their applications. In December 2021, Eurofins Technologies introduced the RapidScan ST5-W lateral flow reader, designed for field and in-process testing applications that require qualitative to semi-quantitative test results. Traditionally, commercial LFA test strips utilize the red coloration of gold nanoparticles (GNPs) or colored beads for detection. LFAs have proven highly sensitive in diagnosing diseases like HIV-AIDS, Hepatitis B, and C, and assessing immune responses against SARS-CoV-2. Advanced signal amplification techniques, including silver enhancement and GNP-enzyme conjugation (such as horseradish peroxidase), have significantly improved detection capabilities. Furthermore, integrating electrochemical sensing, Surface-Enhanced Raman Spectroscopy (SERS), fluorescence detection, and nanoparticles have enhanced the specificity of LFAs, allowing for multiplex detection and faster diagnostics. Future advancements, including next-generation chips, DNA amplification, and CRISPR-based technologies, hold the potential to improve LFA performance further. The use of quantum and nanomaterials is also being explored to boost sensitivity.

The convenience and accessibility of home-based testing have led to increased adoption of LFAs among consumers. In September 2024, InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, obtained 510(k) clearance from the USFDA for its SCoV-2 Ag Detect Rapid Test. Featuring a patent-pending design, this user-friendly rapid antigen test requires no additional equipment or mixing, can be stored at room temperature, and delivers results in just 20 minutes-offering a simple and accessible COVID-19 testing solution for home use. Beyond COVID-19, InBios International Inc. has secured a USD 16.5 million project aimed at enhancing the design of its Active Melioidosis Detect Plus (AMD Plus) device. The funding will support performance validation and regulatory approvals, demonstrating the growing investment in LFA-based diagnostics for infectious diseases beyond the pandemic. In December 2024, the USFDA approved the OraQuick HIV Self-Test, a qualitative immunoassay designed to detect antibodies to HIV-1 and HIV-2 in oral fluid samples. Intended for over-the-counter (OTC) use, this test offers individuals a discreet and reliable way to screen HIV at home, contributing to early diagnosis and timely medical intervention.

Market Concentration & Characteristics

Technological advancements have significantly enhanced the sensitivity, specificity, and usability of LFAs. Innovations such as multiplex LFAs, smartphone-compatible test readers, and improved signal amplification techniques have broadened diagnostic applications. For instance, in December 2021, Eurofins Technologies introduced the RapidScan ST5-W lateral flow reader, designed for field and in-process testing applications requiring qualitative to semi-quantitative results. This innovation has expanded the usability of LFAs beyond traditional laboratory environments. In addition, advanced signal amplification techniques, including silver enhancement and gold nanoparticle-enzyme conjugation, have significantly improved detection capabilities. Integrating electrochemical sensing, surface-enhanced Raman spectroscopy (SERS), fluorescence detection, and nanoparticles have enhanced LFA specificity, enabling multiplex detection and faster diagnostics. Future advancements, such as next-generation chips, DNA amplification, and CRISPR-based technologies, hold the potential to improve LFA performance further. The exploration of quantum and nanomaterials is also underway to boost sensitivity.

Several market players, such as Abbott Laboratories, Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche AG, and Merck KGaA, amongst others, are actively engaged in inorganic developments.

The LFA market has witnessed active mergers and acquisitions, with major players investing in innovative diagnostic solutions. In January 2025, bioMérieux announced the acquisition of SpinChip Diagnostics ASA, a Norwegian firm specializing in immunoassay platforms, to strengthen its point-of-care diagnostics capabilities. Similarly, in August 2023, QuidelOrtho Corporation received FDA De Novo authorization for its Sofia 2 SARS Antigen+ FIA, marking the first FDA-cleared rapid antigen test for COVID-19. These strategic moves enhance companies' technological capabilities and expand their market presence.

Regulatory approvals play a critical role in shaping the LFA market, ensuring test accuracy and reliability. For example, in December 2021, F. Hoffmann-La Roche launched its SARS-CoV-2 & Flu A/B Rapid Antigen Test, receiving CE Mark approval for European markets. Meanwhile, in October 2021, BD introduced the BD Veritor At-Home COVID-19 Test, one of the first smartphone-interpreted rapid tests. Regulatory bodies, including the USFDA and EMA, continue to influence market growth by setting stringent standards for diagnostic accuracy and consumer safety.

Leading companies are continuously expanding their LFA product portfolios to meet rising diagnostic demands. QuidelOrtho Corporation’s Sofia 2 SARS Antigen+ 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 lateral flow assay (LFA) industry is experiencing significant regional expansion, driven by factors such as technological advancements, increased prevalence of infectious diseases, and rising demand for point-of-care testing. In North America, robust healthcare infrastructure and a strong focus on research and development have solidified its market presence. Europe's supportive regulatory environment and strategic collaborations among industry players have fostered growth in the region. Meanwhile, the Asia Pacific region is witnessing rapid market expansion due to rising healthcare expenditures and the increasing adoption of rapid diagnostic tests in emerging economies.

Product Insights

The kits and reagents segment captured the largest market share of 35.43% in 2024 and is projected to register the fastest CAGR over the forecast period. Its growth is primarily driven by the increasing adoption of lateral flow assays, which underscores the segment’s expanding role. Strategic mergers and acquisitions are expected to further enhance the market share of kits and reagents while rising R&D activities are set to accelerate growth. For example, in September 2023, Gemina Laboratories Ltd. introduced an innovative lateral flow assay test design featuring its proprietary Gemina Bridge chemistry platform, an environmentally friendly technology.

Lateral flow readers are also poised for robust growth due to the critical need for precise and accurate result interpretation in R&D and sample testing applications. These devices fall into two categories: digital/mobile lateral flow readers and bench-top lateral flow readers. Digital/mobile readers are anticipated to witness exponential growth in the coming years as digital connectivity increasingly enhances their capabilities.

Application Insights

In 2024, the clinical testing segment led the market, driven by a surge in infectious diseases and heightened demand for rapid, accurate test kits. Enhanced R&D efforts are expected to further boost this segment through 2030. For instance, in August 2022, MIT researchers developed a wireless electronic lateral flow assay for biomarker monitoring-an innovation poised to impact growth positively.

Meanwhile, the drug development and quality testing segment is projected to grow at a CAGR of 6.82% over the forecast period. LFAs are increasingly used for therapeutic drug monitoring due to their ease of use, cost efficiency, and capability to detect multiple markers in one sample. These assays, which provide both fully and semi-quantitative results, are widely applied in regulated and less regulated industries. Key applications include the quantitative measurement of adalimumab in human serum for precision dosing and the authentication of piperaquine and dihydroartemisinin-essential components of artemisinin-based combination therapy. In addition, the growing geriatric and adult populations, coupled with ongoing drug development, are further fueling segment expansion.

Technique Insights

Sandwich assays dominated the global market in 2024 due to their high accuracy, cost-effectiveness, and ease of use. Their suitability for low-resource healthcare settings-where specialized personnel might not be available-further enhances their appeal. In addition, strong product availability is expected to drive segment growth over the forecast period. For example, Abcam’s Universal Lateral Flow Assay Kit enables the creation of custom sandwich assays by integrating GOLD conjugation with Ulfa-Tag kit technologies, offering flexibility to work with any pair of detection and capture antibodies.

The multiplex detection assays segment is anticipated to grow at the fastest CAGR during the forecast period. This approach allows for the simultaneous detection of multiple targets within a single test, eliminating the need for multiple individual assays. A key advantage of multiplex techniques is their ability to analyze several targets using only small sample volumes, which is particularly beneficial for diagnosing conditions that require the detection of numerous markers and for verifying the presence of contaminants in high-volume feed and food testing.

Test Insights

The lateral flow immunoassay segment dominated the global market in 2024. Since their introduction in the mid-1980s, these rapid immunoassays have become a widely used platform for detecting a broad range of antibodies and antigens in physician offices, hospitals, clinical laboratories, and clinics. Their ease of use and low cost make them ideal for screening, monitoring, and diagnosing numerous diseases, allowing both healthcare professionals and patients to perform tests at home.

The nucleic acid lateral flow assay segment is expected to see the fastest CAGR during the forecast period. These assays focus on identifying amplicons, presenting an alternative to the antibody-dominated market. Limitations of traditional antibody-based tests-such as high inter-batch variability, error margins, and strict storage requirements-have spurred advancements in nucleic acid lateral flow technology. In recent years, nucleic acid-based diagnostics have attracted significant attention, with aptamer technology emerging as a promising tool to create highly efficient point-of-care devices through various aptamer-based assays and sensors.

End Use Insights

In 2024, the hospitals and clinics segment captured a significant market share, as these primary care settings remain essential for diagnosing, treating, and managing a wide range of medical conditions. With a growing reliance on these facilities, the continuous evolution in the healthcare industry has driven the demand for enhanced diagnostic services. In addition, the global rise in healthcare expenditure has played a pivotal role in fueling market growth.

Meanwhile, the pharmaceutical and biotechnology companies segment is expected to witness lucrative growth during the forecast period. These organizations are engaging in strategic initiatives such as product development, mergers and acquisitions, regulatory approvals, and new product launches to expand their global presence. Collaborations among emerging players are further enhancing lateral flow test offerings. For instance, in July 2022, Merck’s Life Science Business announced plans to open a new production facility in the U.S. focused on manufacturing lateral flow membranes.

Regional Insights

North America lateral flow assays industry held the largest global revenue share of 35.43% in 2024, driven by the widespread availability and affordability of state-of-the-art lateral flow assays. The region’s high incidence of respiratory infections-such as COVID-19, influenza, and RSV-further boosts the demand for effective detection and treatment. In addition, a robust healthcare infrastructure combined with substantial government research funding is expected to drive continued market growth.

U.S. Lateral Flow Assay Market Trends

The U.S. lateral flow assays industry is thriving, driven by ongoing product innovation, strategic investments, and robust government backing. Technological improvements have boosted test sensitivity and expanded applications, accelerating market growth. For example, in April 2024, Gold Standard Diagnostics launched the SENSIStrip Gluten Lateral Flow Device-its first allergen PowerLine test. This innovative, monoclonal antibody-based test accurately detects gluten residues in food matrices, rinse water, and swabs, enhancing food safety monitoring.

Europe Lateral Flow Assay Market Trends

The Europe lateral flow assays industry is witnessing robust expansion, driven by government initiatives and increased investments in rapid diagnostic testing. Enhanced public health programs and improved funding for accessible, point-of-care diagnostics have been pivotal in this growth. For instance, in September 2021, the Pharmacy Collect Service was launched to provide free rapid COVID-19 tests through selected community pharmacies. The Health Minister stressed that, alongside vaccination and contact tracing, extensive testing is crucial for controlling the virus. Lateral flow device tests have proven especially effective in detecting asymptomatic COVID-19 cases, reducing the risk of unnoticed transmission, while regular biweekly testing boosts early detection of highly infectious individuals.

The UK lateral flow assays industry has experienced significant growth, fueled by government-driven COVID-19 testing initiatives and the introduction of user-friendly diagnostic products. The widespread adoption of rapid testing solutions has strengthened the market and broadened its applications beyond infectious disease detection. A key contributor to this growth was the extensive rollout of COVID-19 lateral flow tests across the UK. In September 2021, the government introduced the Pharmacy Collect Service, enabling free access to rapid COVID-19 tests at community pharmacies. This initiative, which supports local manufacturing and innovation, has reinforced the UK's commitment to enhancing diagnostic accessibility while reducing reliance on imported test kits, ensuring a robust supply chain and sustained demand.

Germany’s lateral flow assays industry is also experiencing notable growth, driven by strategic collaborations and innovative research in diagnostic technologies, particularly in cancer detection and infectious disease diagnostics. The focus on developing advanced, rapid, and non-invasive testing solutions is expected to propel market expansion in the coming years further.

Asia Pacific Lateral Flow Assay Market Trends

Asia Pacific lateral flow assays industry is anticipated to grow at the fastest CAGR over the forecast period. Rising demand due to the high prevalence of infectious and chronic diseases coupled with the emergence of new players in Asian countries are major driving factors for regional market growth. Moreover, a rise in product approval for various infectious disease tests is anticipated to boost market growth in the near future.

Japan lateral flow assays industry is experiencing steady growth driven by increasing demand for rapid diagnostic solutions and technological advancements. Government investments and supportive regulations have further spurred market expansion. Healthcare providers and research institutions are adopting innovative point-of-care tests for infectious disease management and routine diagnostics. The nation’s commitment to enhancing public health and embracing digital connectivity has accelerated LFA adoption, ensuring efficient, accurate, and cost-effective diagnostics across applications.

China lateral flow assays industry is rapidly expanding, driven by significant investments in healthcare infrastructure and technological innovation. Rising demand for rapid diagnostic testing in urban and rural areas fuels market growth, while strong government support and regulatory approvals further bolster progress. Leading companies are developing advanced LFAs for infectious disease detection and chronic condition management, enhancing diagnostic accuracy and affordability, solidifying China’s position as a major player globally today.

Latin America Lateral Flow Assay Market Trends

Latin America lateral flow assay industry is experiencing robust expansion due to rising demand for rapid, cost-effective diagnostics in healthcare and environmental testing. Government initiatives, increased investments, and expanding healthcare infrastructure are propelling market growth. Heightened awareness of infectious diseases and local-international collaborations further accelerate LFA adoption. Advanced technologies and supportive regulatory frameworks are improving diagnostic accuracy and accessibility, ultimately strengthening the market across the region globally.

Middle East and Africa Lateral Flow Assay Market Trends

The Middle East and Africa lateral flow assay industry is experiencing significant expansion due to improving healthcare infrastructure and growing investments in rapid diagnostic technologies. Government support and initiatives to enhance disease surveillance have boosted LFA adoption. Rising infectious and chronic diseases fuels demand for accessible, point-of-care testing. Collaborative efforts between local and international players, along with technological advancements, are expanding market opportunities across the region and ensuring improved outcomes.

Key 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, and among others 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.

Recent Developments

• In January 2025, The BIOMÉRIEUX announced an agreement to acquire SpinChip Diagnostics ASA, a Norwegian diagnostics company known for its innovative immunoassay platform. This acquisition aims to bolster bioMérieux's point-of-care diagnostics capabilities

• In February 2024, The BIOMÉRIEUX 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 March 2023, QuidelOrtho Corporation received De Novo authorization from the U.S. Food and Drug Administration (FDA) to market its Sofia 2 SARS + FIA, making it the first rapid antigen test for COVID-19 to achieve FDA market clearance.

Lateral Flow Assays Market Report Scope

Global Lateral Flow Assays Market Report Segmentation

This report forecasts revenue growth at global, 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 global lateral flow assays market report based on product, application, technique, end use, test, and region.

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

  • Kits & Reagents

  • Lateral Flow Readers

    • Digital/Mobile Readers

    • Benchtop Readers

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

  • Clinical Testing

    • Infectious Diseases Testing

      • COVID-19 Testing

      • Mosquito Borne Disease Testing

      • Influenza Testing

      • Sexually Transmitted Infection Testing

        • HIV Testing

        • HPV Testing

        • Chlamydia Testing

        • Gonorrhea Testing

        • Syphilis Testing

        • Others

      • Hepatitis

      • Tuberculosis

      • Others

    • Cardiac Marker Testing

      • Troponin I and T Testing

      • CK-MB Testing

      • BNP and NT-proBNP Testing

      • Myoglobin Testing

      • D-Dimer Testing

      • Others

    • Pregnancy & Fertility Testing

      • Pregnancy Testing

      • Fertility Testing

    • Cholesterol Testing/Lipid Profile Testing

    • Drugs of Abuse Testing

    • Others

  • Veterinary Diagnostics

  • Food safety & Environment Testing

  • Drug Development & Quality Testing

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

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

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

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others

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

  • Lateral Flow Immunoassay

  • Nucleic Acid Lateral Flow Assay

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

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait