Market Size and Growth
As per the US Lateral Flow Assays Market size analysis conducted by the CMI team, the US lateral flow assays market is expected to record a CAGR of 6.57% from 2025 to 2034. In 2025, the market size was USD 5.72 Billion. By 2034, the valuation is anticipated to reach USD 10.09 Billion.
Overview
As per the industry experts at TMR, the U.S. lateral flow assays market is expected to witness linear progression during the forecast period. This could be attributed to the rise in incidence of infectious diseases, growing demand for POC testing, rise in adoption of home-based testing, and technological advancements such as multiplexing capacities and improvements in signal amplification. Also, efforts are being made on the creation of lateral flow assays capable of detecting specific biomarkers linked with several diseases, thereby facilitating earlier monitoring as well as diagnosis. These assays are also being integrated with data analysis tools and digital readers, thereby enhancing the precision and speed of results.
Key Trends & Drivers
- Multiplexing to Determine Growth: Multiplexing fosters detecting multiple biomarkers/analytes in one go, thereby saving on resources, time, and sample volume, thereby rendering it more cost-effective and efficient in comparison with existing multiple individual assays. Multiplex lateral flow assays, by facilitating the detection of multiple targets on a simultaneous note, provide more comprehensible results as well. The government is also encouraging public health initiatives, thereby catalyzing the market.
- Integration with Digital Technologies to Catalyze the U.S. Lateral Flow Assays Market: Digital readers, encompassing the ones compatible with smartphones, make provisions for more consistent and precise interpretations of test results than visual assessment, thereby cutting down on errors and enhancing reliability. AI-powered analysis is capable of further refining interpretation of results and even quantifying them. Digitalization allows seamless collection, transfer, and storage of test results, thereby creating a precious dataset for the healthcare providers. This data could later be used for monitoring the patients, analyzing the trends, and for research purposes.
Report Scope
| Feature of the Report | Details |
| Market Size in 2025 | USD 5.72 Billion |
| Projected Market Size in 2034 | USD 10.09 Billion |
| Market Size in 2024 | USD 5.37 Billion |
| CAGR Growth Rate | 6.57% CAGR |
| Base Year | 2024 |
| Forecast Period | 2025-2034 |
| Key Segment | By Product, Application, Technique, Test, End-use and Region |
| Report Coverage | Revenue Estimation and Forecast, Company Profile, Competitive Landscape, Growth Factors and Recent Trends |
| Country Scope | US |
| Buying Options | Request tailored purchasing options to fulfil your requirements for research. |
SWOT Analysis
- Strengths: Lateral flow assays need minimal expertise on the technical front, are user-friendly, and readily available for at-home testing and POC. They offer faster turnaround times, which is important for timely diagnosis as well as treatment. Apart from infectious disease diagnostics, lateral flow assays are finding increasing applications in environmental and veterinary testing.
- Weaknesses: Procedural limitations could, at times, result in variations in the test results, thereby affecting reliability. Also, lateral flow assays, in comparison with certain molecular diagnostic methods, are likely to have lower specificity and sensitivity, especially for low-abundance analytes. Furthermore, various lateral flow assays heavily rely on visual interpretation, which could be subject to errors.
- Opportunities: The market has opportunities to grow based on new applications in fields such as saliva-based diagnostics, behavioral health, and food safety. Innovations such as multiplexing capabilities, enhanced sensitivity, and digital integration could accelerate the growth further. Also, a rise in preference for at-home testing and POC creates a visible opportunity for lateral flow assays.
- Threats: Molecular diagnostic methods may offer superior specificity and sensitivity in some applications, thereby posing as one of the competitive threats. Moreover, sailing through the regulatory landscape, especially for new lateral flow assay technologies, could be time-consuming and challenging. In certain settings, lack of or limited reimbursement for lateral flow assay testing may hamper market growth.
List of the prominent players in the US Lateral Flow Assays Market:
- Abbott Laboratories
- Danaher Corporation
- Siemens AG
- Becton Dickinson and Company
- Thermo Fisher Scientific Inc.
- Revvity Inc.
- Hologic Inc.
- QuidelOrtho Corporation
- Surmodics Inc.
- OreSure Technologies Inc.
- Chembio Diagnostics Inc.
- DCN Diagnostics
- Polysciences Inc.
- Oranoxis Inc.
- Others
The US Lateral Flow Assays Market is segmented as follows:
By Product
- Kits & Reagents
- Lateral Flow Readers
- Digital/Mobile Readers
- Benchtop Readers
By Application
- Clinical Testing
- Infectious Diseases Testing
- Covid-19 Testing
- Mosquito Borne Disease Testing
- Influenza Testing
- Sexually Transmitted Infection Testing
- HIV Testing
- HPV Testing
- Chlamydia Testing
- Gonorrhea Testing
- Syphilis Testing
- Hepatitis
- Tuberculosis
- Cardiac Marker Testing
- Troponin I and T Testing
- CK-MB Testing
- BNP and NT-proBNP Testing
- Myoglobin Testing
- D-Dimer Testing
- Pregnancy & Fertility Testing
- Pregnancy Testing
- Fertility Testing
- Cholesterol Testing/Lipid Profile Testing
- Drugs of Abuse Testing
- Veterinary Diagnostics
- Food Safety & Environment Testing
- Drug Development & Quality Testing
By Technique
- Sandwich Assays
- Competitive Assays
- Multiplex Detection Assays
By Test
- Lateral Flow Immunoassay
- Nucleic Acid Lateral Flow Assay
By End-use
- Hospitals & Clinics
- Diagnostic Laboratories
- Home Care
- Pharmaceutical & Biotechnology Companies