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Lateral Flow Assays Market worth $13.52 billion by 2031 - Exclusive Report by MarketsandMarkets™

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ABT Abbott Laboratories is mentioned as a leading player in the lateral flow assays market, indicating its significant presence and established portfolio in this growing sector. The article highlights the company's competitive position due to its broad diagnostics portfolio and manufacturing capabilities. AMGN Amgen is not mentioned in the article. The article discusses the lateral flow assays market and lists several key players, but Amgen is not among them. BDX Becton, Dickinson and Company is identified as a leading player in the lateral flow assays market, benefiting from its established rapid diagnostics portfolio and manufacturing capabilities. Its inclusion suggests a strong position in the market. BIIB Biogen is not mentioned in the article. The article focuses on the lateral flow assays market and lists several key companies, but Biogen is not one of them. DHR Danaher Corporation is listed as a leading player in the lateral flow assays market, indicating its significant role and competitive strength in this sector due to its established diagnostics portfolio and manufacturing capabilities. HOLX Hologic Inc. is mentioned as a key player in the lateral flow assays market. Its inclusion among leading companies suggests a significant presence and contribution to the market's growth and innovation. ORGO Oragenics, Inc. is not mentioned in the article. The article discusses the lateral flow assays market and lists several key companies, but Oragenics is not among them. QDEL QuidelOrtho Corporation is identified as one of the top five players in the global lateral flow assays market, underscoring its significant market share and established presence in rapid diagnostics. REGN Regeneron Pharmaceuticals, Inc. is not mentioned in the article. The article focuses on the lateral flow assays market and lists several key companies, but Regeneron is not among them. TMO Thermo Fisher Scientific, Inc. is listed as a key player in the lateral flow assays market. Its inclusion suggests a significant role and established presence in the diagnostics sector. XRAY DENTSPLY SIRONA Inc. is not mentioned in the article. The article focuses on the lateral flow assays market and lists several key companies, but DENTSPLY SIRONA is not among them.

Lateral Flow Assays Market worth $13.52 billion by 2031 - Exclusive Report by MarketsandMarkets™ DELRAY BEACH, Fla., Oct. 14, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Lateral Flow Assays Market is projected to reach USD 13.52 billion by 2031 from USD 9.14 billion in 2026, at a CAGR of 8.1% during the forecast period.

Browse 608 market data Tables and 57 Figures spread through 436 Pages and in-depth TOC on "Lateral Flow Assays Market - Global Forecast to 2031"

Lateral Flow Assays Market Size & Forecast:

Lateral Flow Assays Market Trends & Insights:

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The widespread impact of infectious diseases remains the primary driver of the LFA market. In recent years, outbreaks and endemic conditions like influenza, HIV, tuberculosis, and emerging zoonoses have elevated the demand for fast, point-of-care or in-home diagnostic tools. In addition, the aging global population, especially in developed regions, creates higher demand for regular health monitoring, particularly for chronic and cardiac markers, fueling the use of lateral flow assays in both clinical and home settings. The market is also being propelled by the rise of home-based testing solutions and user centric diagnostic technologies that empower patients to self-test for infections, fertility, cardiovascular biomarkers, and other conditions.

The increasing adoption of advanced antibodies, nanomaterial-based labels, signal-amplification technologies, and improved membrane systems is enhancing the sensitivity, specificity, and reliability of lateral flow assays. In parallel, advances in nanotechnology, assay engineering, and biorecognition technologies are enabling higher-performance LFA platforms that can detect lower-abundance targets and support multiplex testing. These innovations are improving analytical performance, reducing interpretation variability, and expanding LFA applicability beyond conventional qualitative rapid tests toward quantitative and digitally enabled diagnostics.

By technique, the sandwich assays segment is expected to grow at the fastest rate in the lateral flow assay kits & reagents market across the forecast period.

Based on 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 2025. This segment's large share is attributed to the better assay sensitivity and specificity of sandwich assays and their extensive use in measuring critical analytes (such as cardiac and hepatitis markers).

By sample type, blood samples held the largest share in the lateral flow assays market in 2025.

Based on 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 2025. The extensive use of blood samples in lateral flow tests and the easy detection of disease antibodies in blood samples are key factors driving growth in this market segment.

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North America dominated the global lateral flow assays market in 2025.

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 2025. North America leads the lateral flow assays market due to its advanced healthcare infrastructure and significant investments in medical technology innovation. Major medical device manufacturers and the growing evolution of LFA are driving growth, with advances in smartphone-enabled readers, AI-powered result interpretation, and multiplex testing formats.

Key Players

Leading players in the Lateral Flow Assays companies include Abbott Laboratories (US), F. Hoffmann-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), among others.

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Lateral Flow Assays Market - Investment & funding +Merger & Acquisition

Investment Funding Context

The lateral flow assays market has continued to attract investment toward rapid-test development, digital and quantitative LFA platforms, advanced signal-amplification technologies, and scalable manufacturing during 2024–2026. In January 2024, OraSure invested USD 30 million in Sapphiros to lead its Series B round, with the strategic relationship covering visual and digital lateral flow diagnostics and co-development opportunities. Abingdon Health raised approximately USD 7.5 million in August 2024 to support product development, analytical laboratory expansion, and working capital, and later received approximately USD 1.1 million through a UKRI-supported program for lateral flow malaria-test development. Amplifold raised approximately USD 5.7 million in December 2025 to industrialize its DNA-origami signal-amplification platform for ultrasensitive LFAs and advance its first IVD product toward IVDR approval. These investments indicate increasing funding interest in technologies that can improve LFA sensitivity, digitalization, scalability, and commercialization.

Revenue Shift Context

The lateral flow assays market is gradually shifting from predominantly conventional qualitative, single-analyte rapid tests toward higher-value applications incorporating multiplex detection, quantitative interpretation, digital connectivity, advanced signal amplification, and application-specific testing. Investment activity reflects this transition, with companies developing smartphone-enabled quantitative testing, ultrasensitive signal-amplification technologies, and scalable manufacturing platforms. Sapphiros' manufacturing infrastructure, for example, has a capacity of up to 5 billion diagnostic units annually, while its strategic agreement with Roche provides Roche access to at least 1 billion LFA tests annually from this capacity. These developments are supporting expansion into broader infectious-disease, women's health, chronic-disease, veterinary, food-safety, and other decentralized testing applications. Global lateral flow assays revenue is projected to grow from USD 9.14 billion in 2026 to USD 13.52 billion by 2031 with a CAGR of 8.1%.

Mergers and Acquisitions

M&A activity in the lateral flow assays market is increasingly focused on expanding diagnostic portfolios, strengthening regulatory and development capabilities, and adding complementary technologies and commercial channels.

LATERAL FLOW ASSAYS MARKET: MERGERS AND ACQUISITIONS, JANUARY 2024–AUGUST 2026

Month & Year

Deal Type

Company 1

Company 2

Description

November 2025

Agreement

F. Hoffmann-La Roche Ltd. (Switzerland)

Sapphiros (UK)

Roche entered into a strategic supply and manufacturing option agreement with Sapphiros, giving Roche exclusive rights to at least 1 billion lateral-flow tests annually from Sapphiros' UK extreme-volume manufacturing process. Sapphiros' reel-to-reel facility has a stated capacity of up to 5 billion diagnostic tests annually. The agreement also provides Roche access to Sapphiros' future instrument-free multiplex molecular POC technology.

January 2025

Acquisition

bioMérieux SA (France)

SpinChip Diagnostics (Norway)

bioMérieux agreed to acquire SpinChip, a Norwegian immunoassay company developing a compact POC platform that delivers results from a small blood sample in about 10 minutes. The initial menu includes high-sensitivity cardiac troponin I, with NT-proBNP and D-dimer planned. bioMérieux stated that the acquisition would leverage its immunoassay R&D and manufacturing capabilities and strengthen its POC presence.

Company Revenue Share Details

The top five players in the global lateral flow assays market include Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation (US), Becton, Dickinson and Company (US), and QuidelOrtho Corporation (US), supported by established rapid-diagnostics portfolios, broad geographic reach, and strong relationships across healthcare and decentralized testing settings. These companies' competitive positions are supported by broad rapid diagnostics portfolios, established manufacturing capabilities, technology development, digital and automated testing platforms, and strategic access to scalable LFA production. Competition is increasingly focused on improving analytical performance, expanding decentralized testing applications, enabling quantitative and automated interpretation, and developing scalable manufacturing models for rapid diagnostic products.

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