SAN FRANCISCO, Nov. 27, 2025 /PRNewswire/ — The global lateral flow assays market size is expected to reach USD 17.44 billion by 2033, registering a CAGR of 6.98% from 2025 to 2033, according to a new report by Grand View Research, Inc. The market is primarily driven by the rising incidence of infectious diseases, continuous technological advancements in assay design and manufacturing, and the growing adoption of rapid diagnostic tests in home care and point-of-care settings.
The COVID-19 pandemic highlighted the importance of timely detection and self-testing, leading to widespread adoption of LFAs across homecare and clinical settings. Beyond COVID-19, the emergence of infectious threats such as the highly pathogenic avian influenza A (H5N1) virus has reinforced the need for efficient diagnostics, particularly among high-risk groups including farmers, veterinarians, and wildlife professionals. For instance, in 2025, a case of H5N1 in Louisiana, USA, led to a fatality despite the reported use of inadequate protective equipment, underscoring the ongoing demand for reliable point-of-care testing solutions.
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Technological innovation is another key growth driver for the market. Advancements in assay design, signal amplification, and digital integration have enhanced the sensitivity, specificity, and functionality of LFAs. The introduction of smartphone-compatible devices, cloud connectivity, and multiplexing technologies has enabled real-time data analysis and broadened diagnostic applications. A notable example is Abingdon Health plc’s launch of Boots’ own-brand saliva-based pregnancy self-test in 2024, which marked a shift from conventional urine-based formats to non-invasive, saliva-based diagnostics. This innovation demonstrates how improved assay design is enhancing user convenience, accessibility, and accuracy in home-based testing.
While the LFA market continues to advance rapidly, it faces manageable challenges related to regulatory compliance, performance consistency, and manufacturing efficiency. Regulatory authorities such as the USFDA and EMA uphold stringent standards to ensure diagnostic accuracy and consumer safety, which in turn encourage continuous product improvement and innovation. Although variations in sensitivity and specificity may arise depending on assay design and sample type, ongoing research and the adoption of advanced detection technologies are helping minimize these issues. As a result, these challenges are driving companies to enhance assay reliability, accelerate approval timelines, and strengthen trust in point-of-care diagnostics.
Lateral Flow Assays Market Report Highlights:
- Based on product, the kits and reagents segment held the largest revenue share of 66.50% in 2024, due to the growing adoption of LFAs and rising R&D activities.
- Based on application, the clinical testing segment held the largest revenue share of 74.33% in 2024, driven by the rising incidence of infectious diseases, increased government initiatives, and advancements in rapid diagnostic technologies.
- Based on technique, the sandwich assays segment held the largest revenue share of 38.75% in 2024, due to their high accuracy, cost-effectiveness, and ease of use.
- Based on end use, the hospitals and clinics segment dominated the market with the largest revenue share in 2024. The growth is driven by the critical role of primary care settings in diagnosing and managing a wide range of medical conditions, which fuels the demand for advanced diagnostic solutions.
- North America lateral flow assays market held the largest revenue share of 35.44% in 2024, driven by the widespread availability and affordability of state-of-the-art lateral flow assays.
Read full market research report on Lateral Flow Assays Market with TOC – Lateral Flow Assays Market Size, Share & Trends Analysis Report By Product (Kits, Lateral Flow Readers), By Application (Clinical Testing, Veterinary Diagnostics), By Technique, By End-use, By Region, And Segment Forecasts, 2025 – 2033
Lateral Flow Assays Market Segmentation
Grand View Research has segmented the global lateral flow assays market based on product, application, technique, end use, and region:
Lateral Flow Assays Market – Product Outlook (Volume, Thousands; Revenue, USD Million, 2021 – 2033)
- Kits & Reagents
- Lateral Flow Readers
- Digital/Mobile Readers
- Benchtop Readers
Lateral Flow Assays Market – Application Outlook (Volume, Thousands; Revenue, USD Million, 2021 – 2033)
- 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
Lateral Flow Assays Market – Technique Outlook (Volume, Thousands; Revenue, USD Million, 2021 – 2033)
- Sandwich Assays
- Competitive Assays
- Multiplex Detection Assays
Lateral Flow Assays Market – End Use Outlook (Volume, Thousands; Revenue, USD Million, 2021 – 2033)
- Hospitals & Clinics
- Diagnostic Laboratories
- Home Care
- Pharmaceutical & Biotechnology Companies
- Others
Lateral Flow Assays Market – Regional Outlook (Volume, Thousands; Revenue, USD Million, 2021 – 2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
- Asia Pacific
- Japan
- China
- India
- South Korea
- Australia
- Thailand
- Latin America
- Brazil
- Argentina
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
List of Key Players in the Lateral Flow Assays Market
- Abbott
- Bio-Rad Laboratories, Inc
- Siemens Healthineers AG
- BIOMÉRIEUX
- BD
- QIAGEN
- QuidelOrtho Corporation
- F. Hoffmann-La Roche
- DH Life Sciences, LLC.
- Quest Diagnostics
- Qiagen N.V.
Check out more related studies published by Grand View Research:
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• Oxidative Stress Assay Market – The global oxidative stress assay market size is anticipated to reach USD 2.09 billion by 2030 and is projected to grow at a CAGR of 9.43% from 2024 to 2030, according to a new report by Grand View Research, Inc. The increasing prevalence of oxidative stress-associated diseases such as cardiovascular diseases, respiratory diseases, diabetes, and others and research & development activities related to these diseases are major factors contributing to the market growth. For instance, according to the U.S. Department of Health and Human Services, in 2021, the global prevalence of diabetes among 20- to 79-year-old people was estimated at around 536.6 million, and it is expected to reach 783.2 million by 2045.
• Immunofluorescence Assay Market – The global immunofluorescence assay market size is anticipated to reach USD 4.95 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to reach at a CAGR of 5.29% from 2023 to 2030. Immunofluorescence is a traditional technique used for getting insight into cellular processes and structures using microscopy. For instance, specific proteins can be assessed for their location and expression. Increasing prevalence of chronic and infectious diseases, significant applications of immunofluorescence assay (IFA) in several areas and technological advancements in techniques and associated instruments are key factors driving the market growth.
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