Lateral Flow Assays Market breakthroughs drive faster infectious screening

The global lateral flow assays market was valued at USD 9.85 billion in 2024 and is projected to reach USD 17.44 billion by 2033, reflecting a compound annual growth rate (CAGR) of 6.98% between 2025 and 2033. This growth is driven by the rising incidence of infectious diseases, ongoing technological improvements in assay design and manufacturing, and the greater adoption of rapid diagnostics in home-care and point-of-care testing.

Key Market Trends & Insights

In 2024, North America dominated the global lateral flow assays market, accounting for a 35.44% revenue share, with the U.S. being the leading national market. Within the product breakdown, kits and reagents led the field in 2024 with a 66.50% share of revenue. From the application standpoint, clinical testing held a dominant share of 74.33% in the same year. Regarding technique, sandwich assays accounted for 38.75% of revenue in 2024, while by end-use, hospitals and clinics claimed the largest portion at 34.90%.

A major factor in market growth is the face of persistent infectious diseases; for example, the World Health Organization (WHO) noted approximately 263 million malaria cases worldwide in 2023, underscoring the demand for rapid and affordable diagnostics. Innovations in lateral flow assay (LFA) technology have significantly enhanced performance — improvements in sensitivity, specificity, multiplexing, and connectivity via smartphones and cloud platforms are now broadening applications beyond infectious disease to pregnancy testing, cardiovascular monitoring, veterinary diagnostics, food safety and environmental testing.

Market Size & Forecast

As stated, the market size in 2024 was USD 9.85 billion, with a projection to USD 17.44 billion by 2033. The estimated CAGR from 2025 through 2033 stands at 6.98%. In terms of regional outlook, North America held the largest share in 2024, backed by advanced healthcare infrastructure, strong R&D investment, and a high prevalence of respiratory and other infectious diseases. Europe is also expanding, driven by government initiatives and rapid test programs; for example, community pharmacies in the UK provided free lateral flow device kits to eligible patients in 2023. The Asia Pacific region is seeing rapid growth, supported by large populations, rising healthcare investment and increasing adoption of point-of-care diagnostics in emerging economies such as India and China. Latin America and Middle East & Africa are similarly rising, driven by improving diagnostic infrastructure, governmental support and a growing burden of infectious and chronic diseases across those regions.

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Key Companies & Market Share Insight

The lateral flow assays market is moderately concentrated, with major players investing heavily in innovation, strategic partnerships, acquisitions and product launches. Sensitivity and specificity have improved markedly, and adoption of digital/mobile lateral-flow readers is accelerating. For example, one firm introduced a lateral flow reader in December 2021 designed for field and in-process testing applications. Market dynamics also include major M&A moves: in January 2025 a leading diagnostics company acquired a Norwegian firm specializing in immunoassay platforms to enhance its point-of-care diagnostics capability; similarly, another received regulatory clearance for a rapid antigen test in August 2023, reinforcing the trend toward stronger market consolidation and innovation.

Regulatory pathways remain key—companies continue to launch tests cleared by regulatory bodies in the U.S. and Europe, while product portfolios continue expanding into home-care and non-traditional settings. Accordingly, the market players listed below collectively hold the largest market share and steer the industry’s direction.

Key Companies List

• Abbott
• Bio-Rad Laboratories, Inc.
• Siemens Healthineers AG
• bioMérieux
• Becton, Dickinson and Company (BD)
• QIAGEN
• QuidelOrtho Corporation
• Hoffmann-La Roche AG
• DH Life Sciences, LLC
• Quest Diagnostics

Conclusion

Overall, the lateral flow assays market is poised for strong growth over the coming decade, propelled by a combination of rising infectious disease burden, expanding point-of-care and home-testing demand, and rapid technological advancements. The dominance of kits and reagents, the prevalence of clinical-testing applications, and the leadership of North America underscore the current structure of the market. As innovation continues — including multiplexing, nanomaterials and smartphone connectivity — and companies execute strategic moves to expand in emerging regions, the market landscape is likely to evolve significantly. With key companies driving innovation and global adoption expanding, the industry appears well-positioned to meet evolving diagnostic needs across clinical, veterinary, food-safety and environmental applications.

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