Lateral Flow Assays Market Size will Hit US$ 15.68 Billion by 2033, Driven by Infectious Disease Testing and AI-Powered Diagnostics | DataM Intelligence

AUSTIN, Texas and TOKYO, Sept. 9, 2025 /PRNewswire/ -- "The Lateral Flow Assays Market Size was US$ 7.51 billion in 2024, with a rise of US$ 7.50 billion in 2024, and is expected to reach US$ 15.68 billion by 2033, growing at a CAGR of 8.6% by 2025–2033", according to latest report published by DataM Intelligence. This strong trajectory is fueled by the rising prevalence of infectious diseases, increased demand for point-of-care testing, and expanding applications across clinical, veterinary, food safety, and environmental diagnostics.

Lateral flow assays (LFAs) have become indispensable tools for rapid and cost-effective testing. Their adoption surged globally during the COVID-19 pandemic, and the momentum has continued with innovations in sandwich assays, multiplex detection formats, and portable lateral flow readers. The ability to deliver near-instant results without sophisticated lab infrastructure is driving their widespread use in both developed and emerging economies.

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Industry Trends and Recent Developments

• AI-powered diagnostics: Startups are embedding machine learning into smartphone-compatible readers, enhancing accuracy and enabling telemedicine integration.
• Multiplex testing on the rise: Demand for multiplex assays capable of detecting multiple pathogens in one test has accelerated, particularly in hospital and emergency settings.
• Mergers & acquisitions: In the last quarter, several global diagnostic players expanded their portfolios by acquiring niche LFA companies focused on veterinary and food safety applications.
• Regulatory focus: The U.S. FDA and Japan's PMDA have streamlined pathways for lateral flow assay approvals, especially for infectious disease and cardiac markers, expediting market access.

Segmentation Analysis

By Product

In 2024, kits and reagents dominated the market, contributing more than 70% of global revenues, valued at approximately US$ 5.25 billion. Their dominance reflects widespread adoption across hospitals, diagnostic centers, and home testing kits for conditions ranging from infectious diseases to fertility monitoring. Lateral flow readers, valued at around US$ 2.25 billion, are witnessing rapid growth due to technological advances that integrate smartphone connectivity, AI-powered image recognition, and quantitative readouts, making them indispensable for precision diagnostics.

By Application

Clinical testing remained the leading application segment in 2024, generating over US$ 3.1 billion in revenue. Within this, infectious disease testing accounted for the largest share, underscored by growing incidences of influenza, tuberculosis, HIV, and emerging viral infections. Pregnancy and fertility testing maintained its strong foothold, supported by consumer familiarity and widespread availability of home-use kits. Cardiac marker testing emerged as a fast-growing segment, reflecting rising cardiovascular disease prevalence globally.

Veterinary diagnostics, estimated at US$ 0.6 billion in 2024, continue to gain relevance due to zoonotic disease surveillance and livestock health monitoring. Food safety and environmental testing also demonstrated steady demand, valued at over US$ 0.7 billion, as governments and regulatory agencies prioritize contamination prevention and ecosystem protection. Drug development and quality testing applications are expanding, particularly in pharmaceutical manufacturing where LFAs are used to ensure compliance and safety.

By Technique

The sandwich assay format led the market in 2024, valued US$ 3.9 billion, owing to its accuracy and versatility across infectious disease, pregnancy, and chronic condition testing. Competitive assays, valued at US$ 2.2 billion, held a significant share due to their utility in small molecule detection such as drugs of abuse and hormone assays. Multiplex detection assays, though comparatively smaller at US$ 1.4 billion, represent the fastest-growing technique with a CAGR above 10%, as they allow simultaneous detection of multiple analytes in a single test, reducing costs and improving efficiency.

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Regional Analysis:

United States Market Insights

The U.S. accounted for the largest share of the lateral flow assay market in 2024, was US$ 2.9 billion, reflecting more than one-third of global revenues. The dominance is attributed to a robust diagnostic infrastructure, high prevalence of infectious and chronic diseases, and growing adoption of home-based testing solutions. In the past three months, the U.S. witnessed significant regulatory approvals for next-generation multiplex assays targeting respiratory viruses, alongside rising investments in AI-enabled lateral flow readers by biotech startups. Strategic acquisitions have also shaped the market, with diagnostic giants acquiring smaller firms specializing in digital assay interpretation and microfluidic integration.

Japan Market Insights

Japan, with a 2024 market size was US$ 0.65 billion, is emerging as one of Asia's key innovation hubs in lateral flow assays. Recent industry developments in Japan highlight the integration of digital health ecosystems with point-of-care testing devices, particularly in infectious disease surveillance and geriatric care. In the last three months, Japanese diagnostic companies have partnered with hospitals to roll out multiplex assays for influenza and COVID-19 co-detection. Furthermore, government-backed initiatives to enhance domestic production of diagnostic kits are strengthening Japan's competitive positioning in the global market.

Competitive Landscape:

Getinge

Getinge, headquartered in Sweden, is a global leader in healthcare and life sciences solutions, with a strong presence in infection control and diagnostics. In 2024, the company reported revenues exceeding US$ 3.2 billion, investing significantly in R&D to integrate rapid diagnostic tools into its clinical portfolio. Getinge is actively collaborating with diagnostic startups to expand its lateral flow assay applications, particularly in hospital infection monitoring. Its strategy combines acquisitions with organic innovation, ensuring long-term competitiveness in the global market.

STERIS

STERIS, a U.S.-based healthcare company, generated over US$ 5.4 billion in revenue in 2024, with a diversified portfolio spanning sterilization, infection prevention, and diagnostics. Within the lateral flow assay space, STERIS leverages its expertise in infection control to develop integrated diagnostic and sterilization solutions, targeting hospital-acquired infections and surgical site monitoring. In the last three months, the company strengthened its presence in Japan through a strategic partnership with a diagnostic technology provider. STERIS's growth strategy emphasizes regulatory compliance, quality manufacturing, and innovation in digital-enabled diagnostics.

Hill-Rom Holdings, Inc.

Hill-Rom, now part of Baxter International following a high-value acquisition, reported over US$ 3.1 billion in revenue in 2024 across its healthcare platforms. Its lateral flow assay initiatives are embedded within patient monitoring and diagnostic solutions, focusing on point-of-care applications. In 2025, Hill-Rom is expanding its digital health integration, enabling clinicians to access LFA results directly through electronic health records (EHR). The company's leadership is reinforced by its deep penetration in U.S. hospitals and growing international footprint, especially in Asia-Pacific.

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The lateral flow assay market is poised to more than double by 2033, reaching US$ 15.68 billion, propelled by technological innovation, growing consumer demand for rapid diagnostics, and integration into digital health ecosystems. The U.S. will maintain its leadership through innovation and regulatory strength, while Japan emerges as a critical hub for advanced multiplex testing and digital health integration.

For industry stakeholders, the opportunities lie in embracing multiplex assay development, investing in AI-powered readers, and targeting non-traditional applications such as veterinary diagnostics and environmental safety. Companies that prioritize innovation, strategic partnerships, and regulatory compliance will capture outsized value in this rapidly evolving market.

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