Grand View Research, Inc. (PRNewsfoto/Grand View Research, Inc.)
The global lateral flow assays (LFA) market is poised for significant growth, with projections indicating a rise to USD 17.44 billion by 2033. This anticipated expansion reflects a compound annual growth rate (CAGR) of 6.98% from 2025 to 2033, according to a report by Grand View Research, Inc. The surge is primarily attributed to the increasing prevalence of infectious diseases, technological innovations in assay design, and the rising acceptance of rapid diagnostic tests in both home care and point-of-care environments.
The COVID-19 pandemic has underscored the necessity for timely diagnostics and self-testing capabilities, which has driven the adoption of LFAs in various settings. Following the pandemic, new health threats, including the highly pathogenic avian influenza A (H5N1), have highlighted the urgent need for effective diagnostic solutions. A case reported in 2025 in Louisiana, USA, where H5N1 led to a fatality despite inadequate protective measures, further emphasizes the demand for reliable point-of-care testing among vulnerable populations.
Technological Advances Fuel Market Growth
Technological advancements are another significant factor propelling the LFA market forward. Innovations in assay design, signal amplification, and digital integration have greatly improved the sensitivity, specificity, and overall functionality of LFAs. The introduction of smartphone-compatible devices, alongside cloud connectivity and multiplexing technologies, allows for real-time data analysis, thereby broadening the applications of these diagnostics.
A noteworthy example of this innovation is the launch by Abingdon Health plc of a saliva-based pregnancy self-test under the Boots brand in 2024. This shift from conventional urine-based tests to non-invasive, saliva-based diagnostics demonstrates how improved assay design enhances user convenience, accessibility, and accuracy in home testing scenarios.
Despite the rapid advancement of the LFA market, challenges remain related to regulatory compliance, performance consistency, and manufacturing efficiency. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce strict standards to ensure diagnostic accuracy and consumer safety. These regulations promote continuous product enhancement and innovation.
Variations in sensitivity and specificity can occur based on assay design and sample type. Nevertheless, ongoing research and the integration of advanced detection technologies are essential in addressing these issues. Companies are focusing on improving assay reliability and expediting approval processes to strengthen trust in point-of-care diagnostics.
Market Segmentation and Key Players
The lateral flow assays market has been segmented based on product type, application, technique, end use, and region. In 2024, the kits and reagents segment accounted for the largest revenue share at 66.50%, driven by the rising adoption of LFAs and increased research and development activities. The clinical testing segment also held a significant share at 74.33%, propelled by the increasing incidence of infectious diseases and government initiatives aimed at enhancing rapid diagnostic capabilities.
Among techniques, sandwich assays dominated with a revenue share of 38.75% due to their superior accuracy and ease of use. The hospitals and clinics segment led the end-use category, reflecting the critical role of primary care settings in diagnosing and managing various medical conditions.
Regionally, North America held the largest market share at 35.44% in 2024, benefiting from the widespread availability and affordability of advanced lateral flow assays.
Key players in the lateral flow assays market include major companies such as Abbott, Bio-Rad Laboratories, Inc., Siemens Healthineers AG, BIOMÉRIEUX, BD, QIAGEN, and QuidelOrtho Corporation. These companies are instrumental in driving innovation and expanding the market’s reach.
As the demand for rapid and reliable diagnostic solutions continues to grow, the lateral flow assays market is set to play a crucial role in public health, enabling timely detection and improved patient outcomes worldwide.
