Lateral Flow Assay Market Gains Momentum & Attracts Investment in Rapid Testing Kits | Merck KGaA, F. Hoffmann-La Roche AG, Bio-Rad Laboratories, Inc.

"Lateral Flow Assay Market size was valued USD 8,924.03 million in 2022 and is estimated to reach USD 12,816.53 million by 2031, growing at a CAGR of 4.4% during the forecast period (2024-2031)." As per DataM intelligence research report

Market growth opportunities(2025-2031):

The lateral flow assay market is projected to grow rapidly across this period, driven by escalating demand for rapid diagnostics in clinical, home-use, food‐safety, and veterinary applications. Integration with AI‐enabled digital readers and smartphone apps is creating new adoption models and recurring data services. Expanding chronic and infectious disease detection, such as TB, HIV, and influenza, is fueling higher deployment in decentralized settings. Growth in home-use and self-testing segments including pregnancy, fertility, and wellness continues to expand the user base. Emerging markets with increasing healthcare investment offer strong opportunity for affordable decentralized testing.

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lateral flow assay Market: Recent Industry Developments

✅In June 2025 InBios secured FDA 510(k) clearance in June 2025 for its Active Melioidosis Detect Plus (AMD Plus) lateral flow assay, targeting detection of Burkholderia pseudomallei. Alongside the approval, InBios raised $16.5 million in funding to scale up production and expand diagnostic use in melioidosis-endemic regions. This marks an important diversification of LFAs beyond COVID and common infections.

✅In April 2025, Abingdon Health unveiled Eco-Flo, a sustainable, plastic-free LFA cassette design made from compostable materials. Eco-Flo reduces CO2 emissions by 80% compared to conventional LFA kits. It is targeted at healthcare systems and diagnostics firms aiming to reduce single-use plastic waste in diagnostics.

✅In March 2025 UpFront Diagnostics began piloting its LVO stroke detection lateral flow assay across ambulance services in Cambridgeshire, UK. The test uses a finger-prick blood sample to identify large vessel occlusion strokes in under 15 minutes with around 90% accuracy. This initiative, launched in March 2025, marks a major leap for LFA applications in neurology and emergency triage, addressing time-critical stroke care gaps.

lateral flow assay Market: Market Drivers

Rising global infectious disease burden and growing public awareness of early diagnosis boost demand for point‐of‐care tests. The simplicity, affordability, and quick result turnaround of LFAs make them ideal for resource‐limited and home-care settings. Technological progress such as AI‐based image interpretation, quantum‐dot and CRISPR-enhanced detection, and multiplex assays is improving performance and application scope. Growth of telehealth and remote patient monitoring drives adoption of integrated digital LFA platforms. Expansion in food safety, environmental monitoring, and veterinary diagnostics further widens the market reach.

Strategic Players Driving the lateral flow assay Market Forward:

✦ Merck KGaA
✦ F. Hoffmann-La Roche AG
✦ Bio-Rad Laboratories, Inc.
✦ ABBOTT Laboratories
✦ Siemens AG
✦ Danaher Corporation
✦ Becton, Dickinson and Company
✦ QIAGEN N.V.
✦ Thermo Fisher Scientific Inc.
✦ bioMérieux SA
✦ Hologic Inc.

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Segment Covered in the lateral flow assay Market:

➥By Product: Kits & Reagents, Lateral Flow Readers

➥By Application: Veterinary Diagnostics, Drug Development & Quality Testing, Food Safety & Environmental Safety, Clinical Testing, Pregnancy & Fertility Testing, Cardiac Markers, Infectious Diseases Testing, Drugs of Abuse Testing, Cholesterol/Lipid Testing, Other Clinical Tests

➥By Technique: Sandwich Assays, Competitive Assays, Multiplex Detection Assays

Why Purchase the Report for lateral flow assay Market?:

➠ Technology & Innovation: Tracks clinical trials and upcoming pharmaceutical advancements to stay ahead in product development.
➠ Market Positioning & Competitive Strategy: Analyzes product performance, market share, and competitor tactics for strategic decision-making.
➠ Real-World Evidence & Physician Insights: Incorporates patient data and physician behavior to align products with actual healthcare needs.
➠ Pricing & Market Access: Reviews reimbursement trends and access models to optimize product pricing and launch strategies.
➠ Regulatory & Industry Shifts: Covers policy changes, health system dynamics, and technology trends impacting market opportunities.
➠ Regional Growth & Expansion: Identifies high-growth markets and investment opportunities for geographic expansion.

Regional Analysis for lateral flow assay Market:

North America currently leads the LFA market, benefiting from advanced healthcare infrastructure, high diagnostics adoption, and strong R&D investment, capturing roughly one-third to 40% of global sales. Europe holds a significant share, supported by strong regulatory support for rapid diagnostics and wide deployment in hospitals and pharmacies. Asia‐Pacific is the fastest-growing region, driven by rising disease prevalence, expanding healthcare access in China, India, and Japan, and initiatives toward rural and home diagnostics.

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Conclusion:

The lateral flow assay market is set for strong expansion through 2031, driven by technological innovation, digital integration, and growing demand across clinical, home, and food/veterinary applications. North America and Europe remain major contributors today, but Asia‐Pacific is rapidly emerging as a high‐momentum region. Stakeholders should prioritize digital-enabled product development, partnerships for emerging markets, and regulatory alignment to unlock value. As trust and performance improve, LFAs are poised to become core to decentralized diagnostics and preventive care strategies.

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