Global Lateral Flow Assays Market - Focused Insights 2025-2030

MARKET INSIGHTS

The global lateral flow assay market was valued at USD 9.65 billion in 2024 and is expected to reach USD 11.66 billion by 2030, growing at a CAGR of 3.20% during the forecast period. The market's growth is driven by the increasing decentralization of diagnostic services, rapid adoption of point-of-care testing (POCT), advancements in rapid testing technologies, and the positive shift toward self-testing strategies. Additionally, the rising prevalence of infectious diseases and heightened awareness of rapid test kits during the COVID-19 pandemic have created favorable conditions for the lateral flow assay market's expansion.

Lateral Flow Assay (LFA) is a simple, cheap, and quick/rapid assay that helps to detect the presence of a target antibody or antigen in a liquid sample. It is a paper-based platform that detects & counts the number of molecules in a fluid mixture. It is used in several industries including clinical care, environmental science, food industry, veterinary science, etc. It is also known as rapid test, lateral flow immunochromatographic assay, and lateral flow devices.  

KEY TAKEAWAYS

1. Market Growth: The global lateral flow assay market was valued at USD 9.65 billion in 2024 and is expected to reach USD 11.66 billion by 2030, growing at a CAGR of 3.20% during the forecast period.
2. By Product: In 2024, the kits & reagents market segment accounted for the largest market share. The segmental growth is mainly attributed to the technology development and continued advancement.
3. By Technique: The sandwich assay segment shows the highest growth of 3.56% as they help to detect larger analytes with multiple binding sites.
4. By Application: The clinical diagnostics segment holds the largest market share of 45%. The application of lateral flow assays in clinical diagnostics is significantly high compared to other industries due to the growing prevalence of chronic and non-chronic diseases.
5. By End-Users: The hospitals and clinics segment holds the largest market share. In hospitals and clinics, the LFA technique is used in a range of applications, including screening, diagnosis, monitoring, prognosis, and surveillance, thus helping segmental growth.
6. By Geography: In 2024, North America held the largest share of over 25% in the global lateral flow assays market. The region's well-established markets in clinical diagnostics, environmental science, the food industry, and veterinary care are key drivers of this growth.
7. Growth Factor: The global lateral flow assays market is set to grow due to attention toward the development of LFAs readers and the integration of smartphones and AI in LFAs.

MARKET OPPORTUNITIES & DRIVERS

Next-generation Lateral Flow Assay

Lateral flow assay (LFA) is a widely used point-of-care platform in clinical diagnostic and environmental applications from several decades ago. The adoption of advanced nanomaterials in LFAs is driving the industry forward by significantly enhancing their performance, making them more reliable for detecting substances in diverse applications. The integration of nanoparticles (NPs) in LAFs helps to address several challenges of point-of-care diagnostics, such as lowering the detection limits, sensitivity enhancement, multiplexing, and quantification of analytes. Currently, the efficiency and convenience of LFA diagnosis have been improved using some optical metal nanoparticles, such as carbon NPs, gold NPs (Au NPs), quantum dots (QD), and up-conversion NPs. Of these, owing to excellent optical properties and chemical stability, gold NPs (Au NPs) have now become the most popular and one of the most used optical nanometers in LFA.

Advancement in Lateral Flow Assay Solutions and Reagents

New technologies and reagents in LFAs are continuously advancing and improving accuracy and sensitivity by vendors. In addition, some new technologies have recently emerged in the market, such as photoacoustic techniques, Surface-enhanced Raman Spectroscopy (SERS), integration of smartphones and digital thermal readers, and fluorescence resonance energy transfer (FRET) have become promising and popular technologies in LFAs industry. These technologies are enabling more accuracy and increasing sensitivity of LFAs. During the COVID-19 pandemic, the increasing demand for high-sensitivity LFAs created lucrative opportunities for SERS technology. With high specificity in the serum sample, SERS becomes an effective medical device for diagnosing infectious diseases. Furthermore, this new technology offers more portability, digital analysis, rapid result delivery within 30 minutes, and versatility in use across several industrial applications.

Rising Acceptance of Point-of-care (POC) Testing

The point-of-care-testing (POCT) approach has expanded itself as having remarkable values in the diagnosis of infectious diseases as well as non-communicable diseases. Where, POCT has succeeded in meeting the current need for diagnostic strategies that can offer reliable, sensitive, fast, and highly accurate test results without incorporating complex procedures. This increasing demand has been accomplished by developing rapid bioanalytical sensors or tools such as Lateral Flow Assays (LFAs). The application of POCT in infectious disease diagnosis is well-known across the healthcare industry. However, its growing application in chronic diseases, such as cancer, stroke, diabetes, and Alzheimer's fuels significant market growth. The growing mortality of these non-communicable diseases drives the significant demand for POCT.

INDUSTRY RESTRAINTS

Limitations of Lateral Flow Assays

Lateral flow assay is a widely used solution across healthcare and other industries, and it gained high momentum in recent years. However, it also has some limitations, such as low resolution, they are unable to control the flow rate, and demand for large volumes of reagents creating huge imitations in their usage. Many LFIAs are designed for point-of-care/as-needed use, providing inexpensive, quick, and easy testing that is desirable in many industries. However, regulators often need to confirm results using independent methods. Therefore, LFIA is only suitable for primary point-of-care/as-needed screening. With a long shelf life and no refrigeration required for storage, these tests are well-suited for use in developing countries. Lateral flow (antigen) testing is widely used to enroll children in schools and kindergartens for SARS-CoV-2, the virus that causes COVID-19 infection. The accuracy of these tests in adults varies widely and is often much lower than specified by the manufacturer.

SEGMENTATION INSIGHTS

INSIGHTS BY PRODUCT

The global lateral flow assay market by product is segmented into kits & reagents and readers. The kits & reagents accounted for the largest market share in 2024. These kits and reagents, including biomarkers, assay kits, substrates, enzymes, specific proteins, lipids, and other test kits, are essential for obtaining quick and accurate results in diagnosing acute and chronic diseases. Segmental growth is primarily driven by continuous technological advancements, with lateral flow assay (LFA) kits becoming increasingly sophisticated through the integration of new technologies. These advancements create significant opportunities for market expansion. LFA kits are widely used for rapid and early detection of health conditions such as pregnancy, infectious diseases, blood glucose levels, and more. The rising prevalence of infectious and chronic diseases, coupled with the growing use of LFAs in women's health such as pregnancy and fertility testing contributes to the segment's robust growth.

INSIGHTS BY TECHNIQUE

The global lateral flow assay market by technique is categorized into sandwich assays and competitive assays. The sandwich assays show significant growth, with the fastest-growing CAGR of 3.56% during the forecast period. A sandwich assay is a non-competitive lateral flow assay commonly used to detect larger analytes with multiple binding sites. It is the most widely used assay technique in LFA. Some of its key applications include pregnancy test kits and COVID-19 rapid test kits. In the US, over 20 million pregnancy test kits are sold annually. In 2020, the World Health Organization facilitated the distribution of approximately 120 million COVID-19 rapid test kits globally. Furthermore, the sandwich assay is typically used to detect antigens from biological fluids, such as saliva, or pathogenic substances in food samples or genetically modified crops. Its wide range of applications spans human and veterinary clinical diagnostics, food safety, and the agriculture sector, driving significant growth in this segment.

INSIGHTS BY APPLICATIONS

Based on the applications, the clinical diagnostics segment dominates and holds the largest share of the global lateral flow assay market in 2024. The application of lateral flow assays (LFAs) in clinical diagnostics is significantly higher compared to other industries. With the growing prevalence of chronic and non-chronic diseases, the demand for LFA-based point-of-care testing is continuously increasing across the global healthcare industry.

The use of LFAs for infectious disease diagnosis was well-established before the pandemic. However, the surge in COVID-19 infections has made LFAs one of the most critical tools in clinical diagnostics worldwide. The ability to rapidly diagnose infectious diseases has been identified as a strategic priority by various organizations. For instance, the Health and Human Services (HHS), the National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), and the US Department of Defense (DoD) consider rapid and early detection essential to mitigating the impact of infectious diseases on populations.

INSIGHTS BY END-USERS

Based on the end-users, in 2024, the hospitals and clinics segment holds the largest market share. In hospitals and clinics, the lateral flow assay (LFA) technique is used in a wide range of applications, including screening, diagnosis, monitoring, prognosis, and surveillance. Globally, the significant prevalence of various communicable and non-communicable diseases has led to an increasing demand for hospital admissions and clinical visits. From disease diagnosis to patient monitoring, LFAs play a vital role in supporting these operations. As an affordable, versatile, and reliable technique, LFAs are driving substantial market growth, with hospitals and clinics contributing significantly. Moreover, these facilities support clinical testing and research activities. Since hospitals are ideal settings for conducting clinical research, LFAs are commonly utilized in such environments. Additionally, hospital-associated diagnostics and pathology labs contribute significantly to market revenue growth. Nearly all hospitals have their clinical diagnostic labs, which generate a substantial demand for LFAs.

GEOGRAPHICAL ANALYSIS

In 2024, North America held the largest share of over 25% in the global lateral flow assay market. North America is a well-developed market for clinical diagnostics, environmental science, the food industry, and veterinary care, all of which significantly drive market growth in the region. The availability of advanced clinical diagnostic services and the widespread adoption of point-of-care testing strategies in the healthcare industry fuel the demand for LFAs. Self-diagnosis is a widely adopted approach in North America's healthcare sector. Beyond healthcare, industries such as environmental science, food production, and veterinary diagnostics also play major roles in driving market growth. In Canada, veterinary care is in high demand, while in the US, the veterinary industry is rapidly expanding due to increasing pet ownership and a growing population of farm animals. The food industry is also experiencing significant growth in both the US and Canada. This growth, coupled with stringent food safety regulations, has created a substantial demand for LFAs in food safety testing. As the food industry expands, regulatory norms continue to tighten to ensure food safety, further boosting the need for lateral flow assays.

COMPETITIVE LANDSCAPE

The global lateral flow assays market report consists of exclusive data on 36 vendors. Abbott Laboratories, F. Hoffmann-La Roche, Siemens Healthineers, Thermo Fisher Scientific, QuidelOrtho Corporation, and PerkinElmer are some of the leading companies accounting for the largest share of the global lateral flow assays market. These vendors are continuously focusing on expanding their lateral flow assay solutions and services that meet customers’ requirements and international regulations, as well as increasing the efficiency of their products and strengthening their market position. Also, the adoption of various strategies, such as product launches, and new product development with advanced technologies, by key and other prominent players intensified the competition in the market. The adoption of such strategies by the major market players and their focus on expanding their capabilities have enabled them to gain a higher revenue share in the market. In 2024, Gold Standard Diagnostics announced the launch of a new allergen PowerLine Test: SENSIStrip Gluten Powerline Lateral Flow Device for food safety applications.