US Lateral Flow Assays Market 2025 – 2034

Reports Description

As per the US Lateral Flow Assays Market 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

The manufacturers are benefiting from the US FDA’s phased regulation of tests developed in the laboratory. The basic objective is that of improving product reliability and fostering confidence in clinicians. Technological advancements such as digital readers and multiplex detection do open white-space opportunities across veterinary, food safety, and clinical domains. Additionally, pressures regarding sustainability are incentivizing research into circular-economy manufacturing and biodegradable substrates, thereby creating extra sources for revenue.

Traditional immunoassays are likely to detect close to 30% of influenza A cases, that too, relative to PCR benchmarks. This gap cuts down on adoption regarding critical diagnoses. However, plasmatic scattering improvements and DNA-origami amplification are now able to reduce detection limits by around 4,400-fold, thereby narrowing this gap.

Key Trends & Drivers

• Increasing Incidences of Infectious Diseases

Though non-communicable diseases do continue being the leading causes of fatalities, infectious diseases do pose a serious threat to public health in the US As per the WHO, tuberculosis emerged as the top infectious disease in 2023, surpassing even Covid-19. It further states that by April 2024, the US alone had witnessed more than 7 million cases of dengue, which had increased threefold as compared to April-end 2023. This higher prevalence of infectious diseases does create a noticeable demand for advanced assays such as lateral flow assays.

What’s trending in the US Lateral Flow Assays Market?

The government’s biodefense budgets imply channeling funding to field-deployable, rapid diagnostics. In other words, programs that explore bioagent-agnostic signatures need multiplex immunoassays that can detect pathogen DNA along with host-response biomarkers. The US Department of Health and Human services does prioritize manufacturing capacity on the domestic front, thereby encouraging onshore manufacturing partnerships. These investments do generate consistent demand for new lateral flow formats with metagenomic integration capable of handling engineered or new threats.

Key Threats

• Inconsistency in Results of Lateral Flow Assay Tests

Lateral flow assays prove to be less competent than PCR or ELISA due to their variable reliability and precision, especially where concentrations of the analytes are somewhere near to the detection limit of the assays. Besides, variations with respect to sample handling procedures could compromise the results’ accuracy. They may, in turn, result in false negatives, wherein an analyte does not get detected in spite of being present, or false positives, wherein the assay falsely identifies the analyte’s presence. Such mistakes could substantially affect clinical decision-making, thereby leading to inappropriate patient care with suboptimal health outcomes. For instance – certain antigen-based lateral flow assay tests, as a part of tuberculosis screening, have shown reduced sensitivity in the HIV-positive patients due to lower bacterial loads, thereby contributing toward missed diagnoses.

Opportunities

Lateral flow assays are transitioning from conventional applications with regard to infectious disease detection to a broad range of uses in POC as well as diagnostic settings. Such innovative assays are crucial in non-invasive saliva-based diagnostics as well as behavioral health screenings, thereby paving the way for quick evaluations for both mental and physical health.

In agriculture there is a significant opportunity for lateral flow assays to detect the GMOs (genetically modified organisms) and assess the quality of crops, thereby promoting food safety. They also play an important role in the detection of biowarfare agents such as anthrax, thereby improving security measures against the biological threats. Plus, they could be used in environmental monitoring for identifying contaminating enzymes in production facilities, thereby ascertaining product safety. In food microbiology they are important in order to detect harmful pathogens such as Listeria, Salmonella, and E. coli, thereby providing protection to public health and helping in the prevention of foodborne diseases.

OraSure Technologies is amongst the prominent players in salivary lateral flow assay (LFA) testing. It usually finds application in drug abuse detection. Many such systems have been given a green signal for marketing by the US FDA.

Category Wise Insights

By Product

• Kits & Reagents: Lateral flow assays, in combination with pre-packaged kits & reagents, do offer a satisfactory testing experience. The ease of use on their part is vital for POC and at-home testing, wherein there could be limitations regarding specialized training. Continual advancements pertaining to the development of reagents may result in more specific and sensitive LFAs, thereby enhancing the precision of results. This is important for reliable monitoring and diagnosis of several health conditions. As such, growing adoption of LFAs in various clinical settings inclusive of diagnostic laboratories, clinics, and hospitals drives the demand for kits & reagents further.

• Lateral Flow Readers: Lateral flow readers could be categorized into digital/mobile readers and benchtop readers. Digital ones provide consistent and objective results, thereby doing away with faint lines’ subjective interpretation by the human eye. benchtop readers offer accurate quantification of results, which are important for clinical settings and research wherein precision is paramount. Quick results provided by LFAs in conjunction with benchtop or digital readers do encourage increased accessibility to and broader adoption of diagnostic tools.

By Application

• Clinical Testing: Clinical testing comprises Covid-19 testing, mosquito borne disease testing, influenza testing, sexually transmitted infection testing, Hepatitis testing, tuberculosis testing, cardiac marker testing, pregnancy & fertility testing, cholesterol testing/lipid profile testing, drugs of abuse testing, and the like. Speed and convenience provided by lateral flow assays, especially in the POC settings, have resulted in their widespread adoption regarding the diagnosis of infectious diseases, routine health screenings, and monitoring chronic conditions. Also, ongoing advancements in lateral flow assay technology, such as enhanced specificity and sensitivity, are accelerating its adoption in clinical settings.

• Veterinary Diagnostics: Lateral flow assays provide a cost-effective, rapid, and convenient method for detection of diseases in animals. This is important regarding the management of infectious diseases in companion and livestock animals, thereby driving the demand for LFA-based tests. Rise in pet ownership in the US has resulted in an increase in spending on animal healthcare, inclusive of diagnostics. Lateral flow assays are user-friendly. In other words, they do not need specialized equipment, which makes them suitable for usage in several settings encompassing farms, veterinary clinics, and at-home testing as well.

• Food Safety & Environment Testing: Lateral flow assays are used for detecting a broad range of contaminants in food, inclusive of pathogens, biotoxins, allergens, pesticide residues, illegal additives, and veterinary drug residues. Rise in awareness regarding foodborne ailments coupled with the importance of safeguarding the environment is accelerating the demand for reliable and rapid testing methods. Also, the development of AI-powered analysis tools and smartphone-based lateral flow assay readers is improving precision, remote monitoring capabilities, and data integration.

• Drug Development & Quality Testing: Lateral flow assays are being used at a large scale for monitoring the intake of drugs in patients, thereby facilitating personalized dosing. LFAs help in identifying and quantifying specified biomarkers in the development of drugs, thereby helping in efficacy studies and target validation. They could also be used effectively for validating the performance of the novel drug candidates and optimizing assay conditions. Potential drug to drug interactions could also be assessed by monitoring different drugs’ levels in a sample.

By Technique

• Sandwich Assays: Sandwich assays are known for their cost-effectiveness, precision, and simplicity of use. Their conduciveness to low-resource healthcare settings, wherein specialized individuals may be unavailable, further improves their appeal. Abcam’s Universal Lateral Flow Assay Kit facilitates creating custom sandwich assays by integration of GOLD conjugation with the Ulfa-Tag kit, thereby proffering flexibility to operate with any of the pairs of capture and detection antibodies.

• Competitive Assays: Competitive assays foster innovation, thereby enhancing product offerings and raising market penetration. The competition does encourage the US lateral flow assays market players to come up with more specific, sensitive, and user-friendly assays, thereby resulting in broader adoption across several healthcare settings. Abbott has expanded the product line pertaining to rapid tests for infectious diseases. This is credited to the competitive environment. Quidel’s concentration on fast diagnostics is also an outcome of the competitive landscape.

• Multiplex Detection Assays: Multiplex detection assays, as the name suggests, allow for simultaneously detecting multiple targets in a single test, thereby doing away with the need for multiple individual assays. The major advantage is their ability to analyze numerous targets using small sample volumes, which is especially advantageous in order to diagnose conditions needing detection of several markers and verify the presence of contaminants in the high-volume food and feed testing.

By Test

• Lateral Flow Immunoassay: Lateral flow immunoassay does provide results in no time, thereby rendering it ideal for POC testing and emergency situations, which is important for diagnosis as well as treatment on time. Furthermore, it is a cost-effective option, particularly for limited resources and large-scale screening. The application areas include clinics, hospitals, and at-home, and need minimal technical expertise. The technology detects a broad spectrum of pathogens, biomarkers, and various other analytes, inclusive of the ones related to cardiovascular diseases, infectious diseases, and cancer.

• Nucleic Acid Lateral Flow Assay: Nucleic acid lateral flow assays combine the power of speed and simplicity of lateral flow technology with nucleic acid amplification techniques, thereby allowing for precise detection of pathogens as well as other genetic material. They also offer a more accessible and quicker alternative to conventional molecular methods such as PCR, particularly POC testing.

By End-use

• Hospitals & Clinics: Hospitals & clinics use lateral flow assays for a broad range of applications that include pregnancy testing, cardiac marker detection, and infectious disease diagnosis. The ongoing trend in the direction of decentralized healthcare and the requirement for quick diagnostic solutions are drawing integration of lateral flow assays into the clinical workflows. Growing adoption of lateral flow assays in outpatient and emergency departments does contribute to the growth of the US lateral flow assays market further.

• Diagnostic Laboratories: Diagnostic laboratories rely on rapid results and simplicity of lateral flow assays for routine POC applications and testing. LFAs are increasingly used in detecting a broad range of diseases such as urinary tract infections, HIV, and Covid-19. The laboratories are into the adoption of new technological advancements in antibody development, nanomaterials, and the integration of ML and app connectivity for improved performance of lateral flow assays.

• Home Care: Lateral flow assays have been designed for user-friendly operation, thereby making them ideal for monitoring at home. Their fast results and portability do away with the need for multiple visits to the hospital. Ease of use of LFAs is especially attractive to those who manage chronic conditions, the ones with mobility issues, and the ones preferring self-reliance in healthcare. Also, innovations such as AI-powered analysis and smartphone-compatible readers improve usability, diagnostic accuracy, and connectivity.

• Pharmaceutical & Biotechnology Companies: Pharmaceutical & biotechnology companies are increasingly involved in the development of improved and new lateral flow assays. Research & development activities are resulting in the creation of sophisticated assays that could be used in several settings, right from clinical labs to home testing. On these grounds, the companies may enter into partnership with research institutions for developing new diagnostic tests for specified diseases in order to integrate lateral flow assays into clinical workflows. Competitive Landscape.

How are Hospitals & Clinics Shaping the US Lateral Flow Assays Market?

Hospitals & clinics are accounting for the largest market share. This could be credited to the fact that lateral flow assays play an important role in providing rapid POC diagnostics for a broader range of applications inclusive of monitoring of cardiac markers, detection of infectious diseases, conduction of fertility and pregnancy tests, and enabling drug screening. Also, ongoing advancements regarding assay performance are accelerating the adoption of lateral flow assays by hospitals & clinics, as such enhancements improve sensitivity and reliability.

Report Scope

Key Developments

The US lateral flow assays market is witnessing a significant organic and inorganic expansion. Some of the key developments include –

• In March 2023, QuidelOrtho Corporation announced that it had received De Novo authorization from the US FDA for marketing its Sofia 2 SARS + FIA, thereby making it the very first rapid antigen test for Covid-19 to obtain this clearance.

Leading Players

The US lateral flow assays market is highly competitive, with a large number of service providers globally. Some of the key players in the market include:

• 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

These firms apply a plethora of strategies to enter the market, including innovations, mergers and acquisitions, as well as collaboration.

The US lateral flow assays market is shaped by the presence of diversified players that compete based on product innovation, vertical integration, and cost efficiency.

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