Lateral Flow Assay Market: Biomarker Detection, Early Disease Screening & Growth Outlook

According to IMARC Group's latest research publication, global lateral flow assay market size reached USD 10.8 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 15.7 Billion by 2033, exhibiting a growth rate (CAGR) of 4.2% during 2025-2033.

How AI is Reshaping the Future of Lateral Flow Assay Market

• Automated Image Analysis and Quantitative Interpretation: AI algorithms reduce interpretation errors by 40% in low-contrast conditions, enabling precise quantitative readouts.
• Smartphone-Integrated Diagnostic Platforms: AI-powered smartphone readers enable semi-quantitative and fully quantitative results from traditionally qualitative assays.
• Multiplexing Optimization and Signal Enhancement: Deep learning algorithms process complex signal outputs from advanced formats including nanozyme-based, fluorescence, and electrochemical assays.

Discover Updated 2026 Market Dynamics & Forecasts

Lateral Flow Assay Industry Overview:

The lateral flow assay market experienced transformative growth following the COVID-19 pandemic, with over 3 billion antigen tests deployed globally demonstrating 98% specificity in real-world surveillance. Post-pandemic momentum continues as healthcare systems prioritize decentralized testing infrastructure for emerging infectious threats. In Louisiana, 67 human cases of avian influenza were reported with 40 linked to dairy cattle exposure, prompting the UK to secure 5 million H5 vaccine doses for preparedness.

Lateral Flow Assay Market Trends & Drivers

Rising infectious disease burden is driving unprecedented demand for rapid diagnostic solutions across clinical, veterinary, and environmental applications. Global health organizations reported 1.5 million new HIV infections and 10.6 million tuberculosis cases requiring rapid screening capabilities. The CDC noted sexually transmitted infection cases increased 13% over ten years despite recent declines, with congenital syphilis approaching 4,000 cases representing a 700% increase over the past decade.

Technological integration with digital health platforms is revolutionizing diagnostic capabilities and expanding market accessibility beyond traditional laboratory settings. Technology companies including Apple and Google partnered with manufacturers like Abbott and QuidelOrtho to integrate smartphone readers into consumer health platforms for cardiac biomarkers and infectious diseases.

Government investment and regulatory streamlining are de-risking innovation while accelerating market commercialization across developed and emerging economies. The U.S. Biomedical Advanced Research and Development Authority awarded Pattern Bioscience a contract with USD 40.9 million total potential value for rapid identification testing, while Selux Diagnostics secured USD 45 million for infectious disease applications.

Leading Companies Operating in the Global Lateral Flow Assay Industry:

• Abbott Laboratories
• Becton Dickinson and Company
• Biomérieux SA
• Bio-Rad Laboratories Inc.
• Danaher Corporation
• F. Hoffmann-La Roche AG
• Hologic Inc.
• Merck KGAA
• Perkinelmer Inc.
• Qiagen N.V.
• Quidel Corporation
• Siemens Healthineers AG (Siemens AG)
• Thermo Fisher Scientific Inc.

Lateral Flow Assay Market Report Segmentation:

By Technique:

• Sandwich Assays
• Competitive Assays
• Multiplex Detection Assays

Sandwich assays represent the largest segment due to superior sensitivity and specificity for detecting critical analytes including cardiac and hepatitis markers.

By Product:

• Kits and Reagents
• Lateral Flow Readers
• Digital/Mobile Readers
• Benchtop Readers

Kits and reagents dominate the market as essential consumable components required for every diagnostic test across point-of-care, home, and veterinary applications.

By Application:

• Clinical Testing
• Infectious Disease Testing

• Cardiac Marker Testing
• Pregnancy and Fertility Testing
• Cholesterol Testing/Lipid Profile
• Drug Abuse Testing
• Others
• Veterinary Diagnostics
• Food Safety and Environment Testing
• Drug Development and Quality Testing

Clinical testing accounts for the largest share driven by rising infectious disease prevalence, aging populations, and expanding point-of-care testing adoption.

By End User:

• Hospitals and Clinics
• Diagnostic Laboratories
• Home Care
• Pharmaceutical and Biotechnology Companies
• Others

Hospitals and clinics hold the largest market share due to widespread adoption of point-of-care testing and growing demand for rapid diagnosis in emergency and primary care settings.

Regional Insights:

• North America (United States, Canada)

Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)

Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)

Latin America (Brazil, Mexico, Others)

Middle East and Africa

North America dominates the market with advanced diagnostic infrastructure, high infectious disease prevalence, and strong adoption of home-based testing solutions.

Recent News and Developments in Lateral Flow Assay Market

• January 2025: bioMérieux acquired SpinChip Diagnostics ASA, a Norwegian company specializing in high-sensitivity immunoassay platforms, strengthening its point-of-care testing leadership and expanding advanced diagnostic capabilities across global markets.
• June 2025: Abingdon Health PLC entered a co-development, manufacturing, and commercialization agreement with Okos Diagnostics B.V. to adapt Okos' prototype avian flu lateral flow test for specific applications in both animal and human health diagnostics.

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