DELRAY BEACH, Fla., Aug. 14, 2025 /PRNewswire/ -- The global Lateral Flow Assays Market, valued at US$7.93 billion in 2024, stood at US$8.51 billion in 2025 and is projected to advance at a resilient CAGR of 8.0% from 2025 to 2030, culminating in a forecasted valuation of US$12.52 billion by the end of the period. The persistent rise in infectious diseases worldwide demands fast, accessible diagnostics, boosting the adoption of LFAs in diverse environments from hospitals and clinics to homes and remote clinics. Moreover, an aging global demographic is increasing the need for routine monitoring of chronic and cardiac conditions, encouraging broader use of home-based and point-of-care LFA solutions. Innovations such as smartphone-compatible readers, AI-powered analysis, and multiplex-capable assays further support this shift, improving usability, connectivity, and diagnostic precision. At the same time, extensive deployment of home testing kits, including pregnancy, fertility, and infectious markers self-tests, has boosted consumer acceptance and comfort with LFA devices, while regulatory approvals for POC and home-based LFAs reinforce market expansion.
Adoption is tempered by notable constraints. LFAs often exhibit lower sensitivity and specificity than molecular or lab-based tests, leading to false-positive or false-negative outcomes and hindering widespread clinical acceptance.
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By technique, the lateral flow assay kits and reagents market is segmented into competitive, sandwich, and multiplex detection assays. Sandwich assays dominated the market, with a share in 2024. The large share of this segment can be attributed to the better assay sensitivity and specificity associated with sandwich assays and their extensive application in the measurement of critical analytes (such as cardiac and hepatitis markers).
By sample type, the lateral flow assays market is segmented into blood, urine, saliva, and other samples (nasal swabs, throat swabs, and vaginal fluid). Blood samples accounted for the largest market share in 2024. Technological advancements in testing methods have also improved accuracy and reduced turnaround times, making these tests more appealing for both healthcare providers and patients. The extensive use of blood samples in lateral flow tests and the easy detection of disease antibodies from blood samples are the key factors driving the growth of this market segment.
By geography, the lateral flow assays market is segmented into six major segments, namely, North America, Europe, Asia Pacific, Latin America, Middle East & Africa, and GCC Countries. North America accounts for the largest market share in the lateral flow assays market in 2024. North America is the leading region in the lateral flow assays market due to its advanced healthcare infrastructure and significant investments in medical technology innovation. The presence of major medical device manufacturers and growing LFA evolution, leading in smartphone-enabled readers, AI-powered result interpretation, and multiplex testing formats.
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Prominent players in the lateral flow assays market include Abbott Laboratories (US), F. Hoffman-La Roche Ltd. (Switzerland), Danaher Corporation (US), Becton, Dickinson and Company (US), QuidelOrtho Corporation (US), Siemens AG (Germany), bioMérieux SA (France), Thermo Fisher Scientific, Inc. (US), Revvity, Inc. (US), Hologic Inc. (US), QIAGEN N.V. (Netherlands), Merck KGaA (Germany), Surmodics, Inc. (US), and OraSure Technologies Inc. (US).
Abbott Laboratories (US):
Abbott is the leading player in the global lateral flow assay market, accounting for the largest share of the global LFA market in 2024. Its dominance stems from a diverse LFA portfolio encompassing infectious disease, cardiac, and consumer-based diagnostics, backed by robust continuous innovation. Abbott's strategic investments in reader-enabled and multiplex LFA formats, along with a strong global manufacturing footprint and R&D pipeline, reinforce its leadership position. The company's focus on benchtop reader integration and pharma/biotech QC applications signals its intent to stay ahead in high-value LFA segments, ensuring sustained competitive advantage.
F. Hoffman-La Roche Ltd. (Switzerland)
Roche is a key leader in the lateral flow assay space, accounting for the second-largest share of the global market. Known for its high-sensitivity LFA products, Roche has made strides in digital-read capabilities and advanced sandwich assays targeting infectious diseases and oncology screening. Its regular product refreshes and R&D expansion, including enhanced multiplex LFA formats, reflect its ongoing commitment to innovation. Roche's established global footprint and investment in smart diagnostic technologies position it as a formidable force in premium LFA segments, strengthening its presence during market transitions.
Danaher Corporation (US)
Danaher commands a significant share of the LFA market. Beyond components, its Life Sciences portfolio, bolstered by acquisitions like Pall and Cytiva, equips Danaher to influence next-generation LFA platforms for process development and QC in biopharma. In 2023, Danaher further solidified its position by acquiring Abcam, enhancing capabilities in research-stage diagnostics. With a strong operational backbone, strategic M&A strategy, and growing role in supplying membranes, conjugates, and benchtop instruments, Danaher is a key enabler of LFA innovation, powering the ecosystem behind major LFA brands.
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