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 is growing due to the spread of diagnostic services, the fast adoption of point-of-care testing (POCT), improvements in rapid testing technology, and a growing focus on self-testing. The rise in infectious diseases and increased awareness of rapid test kits during the COVID-19 pandemic have also helped expand the lateral flow assay market.

MARKET DEFINITION

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, the food industry, veterinary science, etc. It is also known as rapid test, lateral flow immunochromatographic assay, and lateral flow devices.

MARKET OPPORTUNITIES & DRIVERS

Attention Towards Development of LFAs Readers

The development of the LFAs platform is known across the global market, however, in recent years, the attention has grown towards readers. The reader is a most essential tool to complete the LFAs test and it creates high demand for development and technology advancement. Based on that, the recent commercialization of inexpensive, small-form, and mobile-centric readers has become popular and poised to transform the laboratory flow assay market as simple methods quantifying the output of laboratory flow assays without using stand-alone bench-top readers open up lucrative opportunities for home-use point-of-care diagnostics. For instance, in the recently developed reader with LFAs product from Lumos Diagnostics, where a strip is inserted into a cartridge, the signal intensity on the strip is analyzed with a photodiode, and results are sent back to a mobile phone to display the result outcomes. Lateral flow assay work in association with the reader and sample handling methodologies is the area that offers lucrative opportunities for assay development companies. Currently, the growing attention towards Integrated Reader Technologies for lateral flow immunoassay is creating significant space for market growth.

The Rising Acceptance of Home-based Diagnosis

Home tests (also called self-tests or home tests) are typically sold over the counter and allow users to test self-collected samples and obtain results without the assistance of a trained medical professional. However, home testing is now not a new phenomenon. FDA-approved home tests for detecting, diagnosing, or treating various health conditions have existed in the United States for many years. These home tests are designed to detect conditions that are treatable and possibly more benign than HIV or to monitor chronic diseases, but the key lesson of home HIV testing is that the untrained can learn from users' performance. The home-use lateral flow assay device plays an important role in the treatment of cardiovascular disease and infectious diseases. These devices could also be very useful for testing pregnancy and stigmatized diseases such as HIV, allowing patients to perform self-tests at home. More than 20 million pregnancy test kits are sold in the US. The pregnancy test kit is one of the best examples of a lateral flow assay-based POC test solution.

INDUSTRY RESTRAINTS

Available Alternative Solutions and Methods

With the continued development of clinical diagnostics methods and technology, there are several options available in the market. During the COVID-19 pandemic, several types of rapid tests were developed that worked on different principles. In addition, RT-PCR was becoming the gold standard for infectious disease diagnosis in clinical labs. The introduction of alternative technology, such as that used in infectious disease testing, cardiac marker testing, blood glucose monitoring, etc., can pose challenges to the growth of the lateral flow assay market. Many diagnostic tests in these application areas include PCR, enzyme-linked immunosorbent assay (ELISA), isothermal nucleic acid amplification technique (INAAT), dipsticks, microfluidics, molecular diagnostics, agglutination assays, flow-through, solid phase, and bio. It can be divided into sensors.

KEY TAKEAWAYS

• By Product: The kits & reagents accounted for the largest global lateral flow assay market share in 2024. These kits and reagents, including biomarkers, assay kits, substrates, enzymes, specific proteins, lipids, and other test kits, are crucial for fast and accurate diagnosis of acute and chronic diseases. The growth of this segment is mainly driven by continuous technological improvements, making lateral flow assay (LFA) kits more advanced with new technology. These innovations create strong opportunities for market growth. LFA kits are widely used for quick and early detection of conditions like pregnancy, infectious diseases, and blood glucose levels. The increasing number of infectious and chronic diseases, along with the growing use of LFAs in women's health, such as pregnancy and fertility testing, is further driving the segment's expansion.
• 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 common type of lateral flow assay used to detect larger analytes with multiple binding sites. It is the most widely used technique in LFAs, with key applications in pregnancy test kits and COVID-19 rapid tests. In the US, more than 20 million pregnancy test kits are sold each year, and in 2020, the World Health Organization helped distribute about 120 million COVID-19 rapid test kits worldwide. This assay is often used to detect antigens in biological fluids like saliva or harmful substances in food and genetically modified crops. Its broad applications in human and veterinary diagnostics, food safety, and agriculture are driving strong growth in this segment.
• By Application: Based on the applications, the clinical diagnostics segment dominates and holds the largest share of the global lateral flow assay market in 2024. Lateral flow assays (LFAs) are used more in clinical diagnostics than in other industries. With the rise in chronic and non-chronic diseases, the demand for LFA-based point-of-care testing is growing worldwide. LFAs were already widely used for infectious disease diagnosis before the pandemic, but the spread of COVID-19 made them one of the most important tools in clinical diagnostics. Rapid disease detection is now a key priority for many organizations. Groups like the Health and Human Services (HHS), National Institutes of Health (NIH), US Centers for Disease Control and Prevention (CDC), and US Department of Defense (DoD) see early and fast testing as essential for controlling infectious diseases.
• By End-Users: Based on the end-users, in 2024, the hospitals and clinics segment holds the largest market share. Hospitals and clinics use lateral flow assays (LFAs) for various purposes, including screening, diagnosis, monitoring, prognosis, and disease surveillance. The high number of communicable and non-communicable diseases worldwide has led to more hospital admissions and clinical visits, increasing the demand for LFAs in patient care. LFAs are affordable, versatile, and reliable, making them essential for disease diagnosis and patient monitoring. Hospitals and clinics play a major role in market growth by supporting clinical testing and research. Since hospitals are key locations for clinical research, LFAs are widely used in these settings. Additionally, hospital diagnostic and pathology labs generate strong demand for LFAs, as most hospitals have in-house labs that rely on these tests.

GEOGRAPHICAL ANALYSIS

In 2024, North America held the largest share of over 25% in the global lateral flow assay market. North America is a strong market for clinical diagnostics, environmental science, the food industry, and veterinary care, all of which drive market growth. Advanced clinical diagnostic services and the widespread use of point-of-care testing in healthcare increase the demand for lateral flow assays (LFAs). Self-diagnosis is also a common practice in the region.

Beyond healthcare, industries like environmental science, food production, and veterinary diagnostics play key roles. In Canada, veterinary care is in high demand, while in the US, the veterinary industry is growing due to more pet ownership and farm animals. The food industry is also expanding in both countries, and stricter food safety rules have increased the need for LFAs in food testing. As the food industry grows, regulations continue to tighten, further boosting demand for lateral flow assays.

COMPETITIVE LANDSCAPE

The global lateral flow assay market report consists of exclusive data on 36 vendors. Leading companies in the global lateral flow assays market include Abbott Laboratories, F. Hoffmann-La Roche, Siemens Healthineers, Thermo Fisher Scientific, QuidelOrtho Corporation, and PerkinElmer. These companies focus on expanding their products and services to meet customer needs and international standards while improving efficiency and strengthening their market position. Competition has increased as key players launch new products and develop advanced technologies. By adopting these strategies and expanding their capabilities, major companies have gained a larger share of the market.

RECENT VENDORS ACTIVITIES

In 2024, Gold Standard Diagnostics announced the launch of a new allergen PowerLine Test: SENSIStrip Gluten Powerline Lateral Flow Device for food safety applications.