Sheridan, Wyoming – – September 22, 2026 -- The global lateral flow assay market is set to expand from $11.04 billion in 2026 to $16.37 billion by 2031, a compound annual growth rate of 8.2%, according to a new study by Wissen Research.
Multiplex and CRISPR platforms are replacing single-analyte strips
The sector's core technology shift is moving away from single-target qualitative strips toward multiplex assays that confirm several markers from one sample in a single step, particularly in combined respiratory panels for influenza, RSV and COVID-19, and in cardiac biomarker testing. CRISPR-enhanced nucleic acid lateral flow assays using Cas12a and Cas13 enzymes are enabling low-cost nucleic acid detection with minimal lab infrastructure, with recent research addressing false-positive issues while allowing simultaneous testing for multiple pathogens on one strip. The same CRISPR-plus-magnetic-bead approach is extending into food safety screening for multiple pathogens.
Home testing habits from the pandemic are expanding into chronic disease
Sustained consumption of home-based diagnostic kits, reinforced during COVID-19, is now extending into pregnancy, fertility and chronic-disease self-monitoring. Hospitals and clinics are increasingly favoring point-of-care lateral flow testing over centralized lab work to avoid delays in clinical decisions, while expanding diagnostic infrastructure in developing economies is broadening the addressable market.
Accuracy doubts and post-pandemic regulatory gaps constrain adoption
Concerns about sensitivity and specificity relative to PCR continue to limit lateral flow adoption for high-risk clinical decisions, with hospitals often reluctant to shift from established workflows. Regulatory frameworks for infectious disease testing remain unsettled in several markets as authorities transition from pandemic-era emergency authorizations back to standard licensing, creating approval-timeline uncertainty for manufacturers.
Roche locks in one billion tests annually from Sapphiros
In November 2025, F. Hoffmann-La Roche Ltd signed a supply and manufacturing agreement with Sapphiros, securing exclusive rights to at least one billion lateral flow tests annually from Sapphiros' UK reel-to-reel production line, plus access to an upcoming instrument-free multiplex molecular platform for point-of-care and home use. In December 2025, BBI Solutions allied with Lateral Dx to pair assay-development capability with BBI's ISO 13485-certified manufacturing, aiming to cut time-to-market for assay developers. Abingdon Health plc partnered with Okos Diagnostics in June 2025 to co-develop a rapid H5N1 avian influenza lateral flow kit for bovine and human use, while VolitionRx Limited reported in August 2026 that its point-of-care nucleosome device correlated closely with its lab-based Nu.Q NETs platform for identifying at-risk patients from finger-prick samples.
North America leads share while Asia-Pacific grows fastest
Kits and reagents generated the largest product revenue share in 2025 as a recurring consumable requiring no capital investment at the point of use, while multiplex detection assays are projected to post the highest growth by technique through 2031. North America held the largest regional share in 2025 on the strength of advanced healthcare infrastructure, high testing volumes and retail pharmacy distribution, with ACON and Thermo Fisher Scientific contributing to the region's kit and reader ecosystem. Asia-Pacific is the fastest-growing region, driven by rising medical infrastructure investment and expanding local-international research partnerships across China, India and Japan.