Future expansion hinges on integrating digital connectivity with lab-quality sensitivity to solidify decentralized care. Domestic manufacturing initiatives and streamlined regulatory pathways will eventually secure global supply chains, transforming rapid diagnostics into primary healthcare infrastructure worldwide.
Chicago, Jan. 19, 2026 (GLOBE NEWSWIRE) — The global lateral flow assay market was valued at USD 10.84 billion in 2025 and is estimated to reach valuation of USD 17.66 billion by 2035 at a CAGR of 5.0% over the forecast period 2026-2035.
The Lateral flow assay market is witnessing an unprecedented surge in demand driven by post-pandemic healthcare shifts and rising infectious disease burdens. Data from 2024 reports 40 million estimated influenza cases in the US alone, resulting in 470,000 hospitalizations. Such high clinical volumes have necessitated rapid triage tools capable of immediate deployment. Furthermore, 28,000 deaths attributed to influenza underscore the critical need for early detection. The market’s responsiveness is evident in the maintenance of 150 million test capacities within government contracts. Emerging zoonotic threats also fuel this growth. Specifically, 67 human cases of Avian Influenza reported in 2024 triggered new procurement cycles. Consequently, the UK secured 5 million Avian Influenza vaccine doses for 2025, directly stimulating the need for associated diagnostic testing.
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Endemic viral management remains a core revenue driver for the Lateral flow assay market. North America is projected to reach a cumulative 124.5 million COVID-19 cases by June 2025, sustaining high-volume testing requirements. Global health initiatives further amplify these numbers. Reports from 2024 highlight 1.5 million new HIV infections and 10.6 million Tuberculosis cases globally, all requiring rapid screening solutions. Manufacturers are responding to these dual pressures of endemic management and emerging outbreaks. The sector effectively leverages these high infection rates to justify expanded production lines. Stakeholders see clear value in decentralized diagnostics that address these urgent public health statistics.
Key Market Findings
- By Product, lateral flow assay market is largely dominated by LFA kits and their market share exceeds 71.9%.
- By Indication, diagnose of infectious diseases leads the market by capturing the largest 72.2% market share.
- By technique, sandwich assay technique controls nearly 48% market share.
- By end users, hospitals and clinics dominates the market by accounting for over 38.8% market share.
By Product, Kits Command Massive 71.9% Share Through Multiplexing and Manufacturing Scalability
The lateral flow assay market is overwhelmingly driven by the sales of test kits, a segment capturing 71.9% of total revenue. This dominance is currently being reinforced by a significant industry shift toward multiplexing capabilities. Manufacturers are increasingly transitioning from single-target strips to combo-kits that detect multiple pathogens—such as Influenza A/B and COVID-19—on a single cassette. This innovation allows companies to increase the average selling price (ASP) of the consumable unit without requiring end-users to invest in new hardware, effectively expanding the revenue footprint of the “kit” segment.
Furthermore, the manufacturing economics of test kits solidify this market position. The “reel-to-reel” production process used for lateral flow strips is highly scalable, allowing major diagnostic players to maintain healthy profit margins even as volumes fluctuate. Unlike instrument sales, which are capital-intensive and slow-moving, the production agility of LFA kits allows the market to respond instantly to demand surges. This scalability ensures that kits remain the primary vehicle for revenue generation, as they can be deployed globally with minimal logistical friction compared to heavy diagnostic machinery.
By Indication, Infectious Diseases Control 72.2% Share Driven by Antimicrobial Stewardship Efforts
The Infectious Disease segment secures a commanding 72.2% share of the lateral flow assay market, driven largely by the global healthcare imperative of Antimicrobial Stewardship. As healthcare systems worldwide battle the rise of antibiotic-resistant bacteria, lateral flow assays have become the essential gatekeepers for prescription practices. By rapidly distinguishing between viral infections (which do not require antibiotics) and bacterial infections (like Group A Strep) at the point of care, these diagnostics prevent unnecessary medication use. This utility anchors the segment’s dominance far beyond simple screening; it integrates LFA technology into core treatment protocols and payer-mandated clinical guidelines.
Additionally, the expansion of testing menus to include tropical and climate-sensitive diseases is fueling growth in this segment. As climate change expands the geographical range of vectors for Dengue, Zika, and Chikungunya, the demand for rapid infectious disease testing is rising in regions previously unaffected. Governments and NGOs are increasingly stockpiling these specific infectious disease assays as part of biodefense and national health security strategies, ensuring that this indication remains the undisputed leader in market volume.
By Technique, Sandwich Technique Seizes 48% Share Due to Digital Readability and Quantitation
The Sandwich Assay technique holds a dominant 48% share of the lateral flow assay market because it is the only format capable of supporting the industry’s transition toward quantitative digital diagnostics. Unlike competitive inhibition assays, which show an inverse relationship between signal and antigen presence, the sandwich format produces a signal intensity directly proportional to the amount of analyte. This linear relationship is critical for modern optoelectronic readers and smartphone-based analyzers that aim to give patients a specific numerical value rather than a subjective “yes or no” result.
Moreover, this technique offers unparalleled robustness in reagent stability, a key factor for commercial success. The use of two distinct antibodies binding to different epitopes of the antigen creates a highly specific “match,” significantly reducing the risk of cross-reactivity with interfering substances found in complex clinical matrices like blood or saliva. For manufacturers seeking FDA clearance or CE marking, the sandwich format provides the most reliable path to meeting regulatory performance standards. This reliability makes it the default engineering choice for high-stakes product launches, cementing its technical leadership.
By End Users, Hospitals and Clinics Retain 38.8% Dominance Through Emergency Room Efficiency
Hospitals and clinics account for 38.8% of the lateral flow assay market, maintaining their leadership position by leveraging these tests to solve critical operational bottlenecks in Emergency Departments (EDs). In overcrowded hospital environments, the primary value of a lateral flow assay is not just diagnosis, but “throughput efficiency.” By utilizing rapid tests that deliver results in minutes rather than the hours required for central lab PCR, triage nurses can rapidly isolate infectious patients or discharge non-critical cases. This speed directly translates to improved bed management and reduced wait times, making LFAs a vital operational asset for hospital administrators.
Furthermore, the dominance of this segment is protected by the requirement for data connectivity and compliance. unlike over-the-counter home tests, professional LFA systems used in clinics are increasingly designed to integrate directly with Laboratory Information Systems (LIS) and Electronic Health Records (EHR). This connectivity ensures that test results are automatically logged for insurance reimbursement and public health reporting. As healthcare digitization accelerates, the demand for these connected, professional-grade systems ensures that hospitals and clinics remain the highest-value end-user segment in the market.
QuidelOrtho Financials Reveal Strong Infectious Disease Revenue Streams
QuidelOrtho Corporation serves as a prime benchmark for the Lateral flow assay market performance in the infectious disease sector. Financial reports for the quarter ending September 2024 reveal a robust Total Revenue of USD 727 million. Projections for Q4 2024 estimate revenue between USD 702 million and USD 707 million, signaling steady market demand. Specifically, the respiratory product segment, a key LFA driver, is estimated to generate between USD 141 million and USD 143 million in Q4 2024 alone. Non-respiratory diagnostics also show strength, with estimates reaching USD 561 million to USD 563 million for the same period. These figures validate the sector’s profitability and consistent cash generation capabilities.
Operational efficiency within the Lateral flow assay market is equally impressive. QuidelOrtho reported USD 1.74 billion in recurring revenue year-to-date for 2024. Adjusted EBITDA for Q3 2024 stood at USD 171 million, demonstrating strong margin management. Net cash provided by operating activities reached USD 118 million, while adjusted free cash flow hit USD 120 million. Strategic regulatory wins support these financials, notably the FDA 510(k) clearance for the QuickVue COVID-19 test in April 2024. Furthermore, the company successfully executed USD 100 million in annualized cost-saving initiatives by mid-2025. Such financial discipline and regulatory success position major players for sustained growth.
Nanoparticle Integration Achieves Unprecedented Sensitivity In Rapid Diagnostics
Technological advancements are redefining performance boundaries within the Lateral flow assay market. New nanoparticle-enhanced assays published in 2024 reviews have achieved a Limit of Detection (LoD) of 0.01 pg/mL. Similarly, CRISPR-based LFAs for SARS-CoV-2 reached a sensitivity threshold of 0.25 copy/μL in 2024 clinical studies. Optimized Quantum Dot-based assays now detect Hepatitis B surface antigen at 15.6 ng/mL. Researchers also achieved an LoD of 48.84 ng/mL for SARS-CoV-2 IgG antibodies using ZnCdSe/ZnS quantum dot probes. Such precision allows these rapid tests to rival traditional laboratory PCR methods in specific use cases.
Further innovations in the Lateral flow assay market focus on material science and dual-functionality. Dual-functional strips can now detect Influenza A virus at 1 ng/mL. Material improvements are yielding tangible results; a 2024 study observed a 10-fold increase in sensitivity using cellulose binding domain linkers compared to nitrocellulose. Validation protocols are becoming increasingly rigorous to support these claims. Recent 2025 clinical evaluations utilized 244 serum samples to validate new Quantum Dot LFAs, aiming for a 98% Negative Predictive Value (NPV). Additionally, 54 clinical samples validated portable SERS-based devices in 2024. These metrics confirm that rapid diagnostics are moving toward high-sensitivity applications.
FDA Approvals and Clearances Accelerate Through Streamlined Regulatory Pathways
Regulatory bodies are processing submissions at record speeds, boosting the Lateral flow assay market trajectory. In the first half of 2024 alone, the FDA issued 1,507 510(k) clearances. The average decision time for these submissions was remarkably efficient at 168.9 days. Looking ahead, the statutory review cycle target for 2025 remains fixed at 180 days. Estimates suggest the FDA will approve 31 Premarket Approval (PMA) applications in full-year 2024. Additionally, 28 Panel Track supplement approvals are projected for the same timeframe. These metrics demonstrate a regulatory environment committed to facilitating market access for diagnostic innovations.
The transition from emergency use to full approval defines the current Lateral flow assay market landscape. By June 2024, the FDA had approved 13 original PMAs and granted 24 De Novo classification requests. However, the De Novo pathway remains rigorous, with an average wait time of 420 days in 2024. Ongoing updates to viral strains necessitate continuous regulatory engagement. Two major COVID-19 vaccine formulas (KP.2 and JN.1) drove companion diagnostic re-authorizations in August 2024. Furthermore, over 430 distinct COVID-19 tests with EUA status were reviewed for transition to full approval by late 2024.
Federal Funding and Strategic Contracts Catalyze Diagnostic Innovation
Substantial government investment is actively de-risking R&D in the Lateral flow assay market. BARDA awarded a base contract of USD 22.5 million to Pattern Bioscience in November 2024 for rapid ID/AST testing. With options exercised, this contract holds a total potential value of USD 40.9 million. Similarly, Selux Diagnostics secured a USD 45 million BARDA contract for infectious disease testing. These awards highlight a shift toward funding next-generation technologies. Private sector performance mirrors this scale, with Abbott reporting USD 10 billion in total sales in Q1 2024, providing massive capital for internal R&D.
Innovation prizes further stimulate the Lateral flow assay market ecosystem. The NIH awarded USD 8 million in cash prizes for maternal health point-of-care technologies in 2024. Additionally, a USD 50 million prize purse for Project NextGen vaccine innovation was established, directly spurring demand for companion diagnostics. Revenue baselines remain healthy across the sector. Major players like Abbott referenced a quarterly COVID-19 testing revenue baseline of USD 263 million in 2024 analysis. These financial inflows from both public and private sources ensure a continuous pipeline of breakthrough diagnostic solutions.
Manufacturing Capacity and Infrastructure Investments Secure Global Supply in Later Flow Assay Market
Supply chain resilience is a top priority for the Lateral flow assay market. USPTO received 700,000 total patent applications in 2024, reflecting broad innovation in manufacturing inputs. Additionally, 326,921 patents were issued in FY 2024, covering essential processes and devices. To support the digital transformation of diagnostics, 170 new semiconductor and technology facility investments were tracked in 2025. These facilities are crucial for the production of digital reader components. Furthermore, the EU Chips Act funded 5 new regional manufacturing hubs in 2025, directly strengthening the component supply chain for European markets.
Strategic capital is flowing into domestic production to secure the Lateral flow assay market future. Investment targets for supply chain onshoring initiatives reached USD 100 million in 2024/2025. This funding aims to reduce dependency on volatile international logistics. The intellectual property landscape supports these physical investments. Companies are protecting their manufacturing innovations aggressively. Strong patent portfolios combined with localized manufacturing hubs create a formidable barrier to entry. These infrastructure developments ensure that the industry can meet the 150 million test capacity requirements demanded by government contracts.
Patent Filings and IP Activity Signal Intense Market Competition
The intellectual property landscape of the Lateral flow assay market is experiencing explosive growth. In Q3 2024 alone, the medical industry filed 30,461 patent applications. The USPTO published a staggering 147,164 total patent filings in FY 2024. Key players are aggressively fencing their technologies. Samsung, a major supplier for digital reader components, filed 6,660 patents in 2024. Medical device giants followed suit; Johnson & Johnson filed 717 patents, Becton Dickinson (BD) filed 547, and Medtronic filed 542 in Q3 2024. This density of filings indicates a fierce battle for technological dominance.
mRNA technologies are creating new intersections with the Lateral flow assay market. BioNTech filed 36 new patent families in 2024, while Moderna filed 34. These filings influence the development of companion diagnostics for mRNA therapeutics. Furthermore, 200 patent families related to mRNA and diagnostic technologies were published in Q3 2024 alone. This surge in IP generation suggests a rapid evolution of diagnostic modalities. Companies are securing rights not just for current devices but for next-generation platforms. The sheer volume of patents confirms that stakeholders view this market as a long-term growth engine.
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Lateral Flow Assay Market Key Players:
- Abbott Laboratories
- bioMerieux S.A
- Bio-Rad Laboratories Inc.
- Danaher Corporation
- F. Hoffmann-La Roche Ltd.
- Hologic Inc.
- Merck KGaA
- PerkinElmer Inc.
- Qiagen N.V.
- Quidel Corporation
- Siemens Healthineers
- Thermo Fisher Scientific, Inc.,
- Other Prominent Players
Key Market Segmentation:
By Product & Services:
- Readers
- Bench-top Readers
- Hand-held Readers
- LFA Kits
- Test Strips
- Dipsticks
- Cassettes
- Lancets
By Indications:
- Infectious Diseases
- Mosquito-borne Diseases
- Streptococcus Infections
- Sexually Transmitted Diseases
- Hepatitis
- Tuberculosis
- Asthma
- Pneumonia
- Sepsis
- Gastrointestinal Infections
- Others
- Pregnancy Test
- Drug of Abuse Testing
By Technique:
- Sandwich Assays
- Competitive Assays
- Multiplex Detection Assays
By End User:
- Hospitals & Clinics
- Diagnostics Laboratories
- Home Care Settings
- Pharmaceuticals & Biotechnology Companies
- Other
By Distribution Channel:
- Hospital Pharmacies
- Retail Pharmacies
- Supermarkets/ Hypermarkets
- e-Commerce
By Region:
- North America
- Europe
- Asia Pacific
- Middle East & Africa (MEA)
- South America
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