---

Market Overview

---

The global market for lateral flow assays had a valuation of USD 9.53 billion in 2022 and is projected to reach USD 11.30 billion by 2028, growing at a compound annual growth rate (CAGR) of 2.89%. This market is a significant segment within the global point-of-care and rapid diagnostics market, and it is experiencing steady growth that is expected to continue throughout the forecast period. The increasing prevalence and incidence of infectious and chronic diseases are contributing factors to the market’s growth. Notably, malaria remains a leading cause of death in some regions, such as the Middle East & Africa, according to the World Health Organization (WHO).

The general population, particularly the elderly and children, requires periodic health checkups for seasonal flu during the monsoon and winter seasons. This demand, along with the COVID-19 pandemic, has positively impacted the rapid diagnostics market. There has been a surge in demand for rapid COVID-19 tests, prompting countries like the UK, Germany, France, Russia, and the USA to perform mass testing in order to screen their populations and take necessary preventive measures. These factors have significantly increased the global demand for rapid test kits, which play a crucial role in monitoring the pandemic situation. Furthermore, the increased utilization of diagnostic tests for routine health checkups, infectious diseases, seasonal flu, blood donation, blood preservation, and blood transfusion further drives the lateral flow assay market.

The use of smartphones as biosensors through various optical-based methods, including absorption, reflection, and fluorescence, holds great potential for improving diagnostics, healthcare, medical services, food monitoring, and environmental monitoring. It offers a portable, low-cost point-of-care platform that can provide treatment in remote low-income areas. Recently, the Cambridge-based startup PocDoc received CE mark approval for a digital reader powered by artificial intelligence (AI) for lateral flow testing. This cloud-based system can turn any smartphone or tablet into a universal digital reader, enabling healthcare organizations to conduct large-scale lateral flow testing for any disease or marker. Another AI-driven innovation that allows COVID-19 lateral flow tests to be read using a user’s smartphone has received special use approval from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Lateral flow testing has been widely used for infectious disease diagnosis, heart disease diagnosis, and veterinary applications, but its use has expanded in recent years to include several new applications. These include saliva diagnostics, behavioral health, agriculture (detection of genetically modified organisms and quality control of plants), biological warfare (detection of Bacillus anthracis), environmental testing (detection of contaminating enzymes in production facilities), and food microbiology (detection of E. coli O157, Salmonella, Listeria, and other food spoilage bacteria). Saliva has gained recognition as a new biological fluid with numerous studies and clinical applications. OraSure Technologies, a US-based company, is one of the prominent vendors of lateral flow saliva testing. Salivary LFAs have also made their mark in substance abuse testing, among other applications, and several systems have been cleared for sale by the FDA. However, these tests remain predominantly qualitative.

Home tests, also known as self-tests or at-home tests, are sold over the counter and allow users to perform tests on self-collected samples and obtain results without the assistance of a trained medical professional. Home-use lateral flow assay devices play a crucial role in the treatment of cardiovascular diseases and infectious diseases. They can also be highly useful for pregnancy testing and for diagnosing stigmatized diseases such as HIV, empowering patients to perform self-tests in the comfort of their own homes. Consequently, the increasing incidence of these diseases and the growing adoption of lateral flow assay testing in home healthcare settings are expected to drive the growth of the lateral flow assays market. During the COVID-19 pandemic, many companies introduced at-home lateral flow assays for COVID-19 testing. This was in response to people’s reluctance to visit diagnostic labs or hospitals for testing, creating a demand for at-home testing options. Some of the tests introduced for home use included the BinaxNOW COVID-19 Ag Card and Panbio rapid COVID-19 test in August 2020, the Roche SARS-CoV-2 Rapid Antigen test in September 2020, the Quidel Sofia 2 Flu+ SARS Antigen FIA during the COVID-19 pandemic, the Siemens Healthineers CLINITEST Rapid COVID-19 Antigen test in June 2022, and the BD Veritor SARS CoV-2 Test by BD.

---

Market Segmentation

---

The market is segmented based on various factors, including product, application, technique, end-users, and geography.

Segmentation by Product
Kits & Reagents
Readers

Segmentation by Application
Clinical Diagnostics
Food Safety
Veterinary Diagnostics
Others

Segmentation by Technique
Sandwich Assays
Competitive Assays

Segmentation by End-Users
Hospitals & Clinics
Individuals
Diagnostic Laboratories
Food & Beverage Companies
Pharma & Biotech Companies
Others

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain, Russia
APAC – China, Japan, India, South Korea, Australia, Philippines
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey

In 2022, the largest product segment in the global lateral flow assays market is expected to be kits & reagents, accounting for a share of 82.24%. These kits & reagents primarily include biomarkers, assay kits, and various reagents such as substrates, enzymes, specific proteins, lipids, and other test kits. The demand for rapid testing is driven by the awareness of rapid and POC (point-of-care) testing for infectious diseases. The consumables nature of these kits & reagents also contributes to their large market share, as they generate continuous revenue for vendors. Consequently, many renowned vendors are manufacturing consumables required for analyzers. This growth can be attributed to the increasing use of rapid tests in various POC sites, including emergency care, physician offices, ambulatory settings, nursing homes, and self-diagnosis for diseases like infectious diseases, diabetes, cancer, and metabolic diseases.

The global lateral flow assays market is segmented into clinical diagnostics, food safety, veterinary diagnostics, and others. Clinical application accounted for the highest share, 46.50%, of the global market in 2022. Rapid infectious disease diagnostic tests play a critical role in early detection, biosurveillance, and improving global health. Government entities such as 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 in reducing the impact of diseases on the population. POC testing offers multiple advantages over other diagnostics, especially for rapid testing scenarios. For instance, a leading company in the lateral flow assay market, Chembio, offers FDA-approved LFA HIV tests called SURE CHECK HIV 1/2 Assay, which utilizes a patented plastic barrel device to house the lateral flow strip.

The global lateral flow assays market for food safety is expected to reach USD 3.83 billion by 2028. Lateral flow tests are convenient immunoassays for detecting foodborne pathogens. These tests cover the most important pathogens, function as mini-labs, and come with built-in control reactions for optimized pathogen testing. Several leading and local players, including Sigma-Aldrich, a subsidiary of Merck kGaA, Perkinelmer, R-Biopharma, Abingdon Health, and creative diagnostics, offer LFA testing for food safety.

Among the technique segments, sandwich assays held the largest share of 61.36% in the global lateral flow assays market in 2022. Sandwich assays are used for macromolecular analytes that have two antigen-binding sites, one binding to the target and the other to a binder that does not interfere. If the target is present in the sample, the signal at the test line increases. Vendors in the LFA market often use the sandwich technique to market their products, and well-known examples of this format include over-the-counter pregnancy tests. Sandwich assays have a larger share in the technique segment and are experiencing high growth at a rate of 3.39%. The competitive segment accounted for 38.64% of the global lateral flow assays market.

In terms of end-users, hospitals & clinics held the largest market share of 25.32% in 2022. Hospitals perform a significant number of rapid tests and serve as the first point of contact for infections and diseases. Rapid testing is used for initial patient screening, contributing to its extensive use in hospitals. Moreover, hospitals establish contracts with multiple vendors to procure rapid test kits, POC analyzers, and related consumables. Hospital laboratories, which are unique entities within hospitals, operate in around 92% of hospitals. Hospitals are one of the largest end-users of infectious disease diagnosis and conduct a wide range of diagnostics as per the requirement.

The market for lateral flow assays by individuals was valued at USD 1.87 billion in 2022. Home care settings were initially introduced to reduce hospital resource utilization over longer periods, and they have become popular with high demand, primarily in developed countries. The aging population globally has increased the usage of blood glucose monitoring and other tests in the home care segment. Rapid testing provides several advantages to home health care providers, including rapid turnaround times, improved decision times, and cost savings between 8-20% of laboratory costs.

North America accounted for the highest share of 28.57% in the global lateral flow assays market in 2022. The region dominates due to factors such as the prevalence of infectious diseases like COVID-19, influenza, and HIV, as well as chronic conditions and lifestyle diseases. The easy availability and affordability of technologically advanced LFAs, along with the presence of key vendors in the market, contribute to North America’s dominance. The region’s advanced healthcare infrastructure and government funding for research further support the growth of the LFA market, as evidenced by the NIH’s investment of USD 248.7 million in new technologies for dealing with COVID-19 testing challenges.

Europe’s lateral flow assays market was valued at USD 2.58 billion in 2022. The region boasts developed healthcare infrastructure with advanced lateral flow assay devices, along with a high prevalence of infectious and chronic diseases. This combination has significantly contributed to the overall growth of the lateral flow assay market in Europe. Additionally, the region is experiencing an increasing prevalence of infectious diseases such as HIV, Haemophilus influenzae, Meningococcal disease, Streptococcus pneumoniae, etc., which further drives market growth.

The APAC lateral flow assays market is expected to register the fastest growth rate in the global market, with a CAGR of 3.90% during the forecast period. Developing countries account for 84% of the world’s population, with Asia alone representing approximately 60%. These regions experience a faster increase in the incidence of communicable and non-communicable diseases like diabetes, obesity, cardiovascular disease, and cancer compared to developed countries. Developing countries face challenges in dealing with preventable and treatable diseases, with millions of deaths occurring each year from diseases that are manageable in developed nations.

---

Competitive Landscape

---

The market for lateral flow assays is characterized by its dynamic nature, with a plethora of global and local players offering a wide range of instruments/analyzers and reagents for various applications such as clinical testing, food safety, veterinary diagnostics, and drug testing. The industry is primarily consolidated, with prominent global players holding significant market shares. Leading players in the global lateral flow assays market include Abbott, Danaher, F. Hoffmann-La Roche, Quidel, and Siemens Healthineers.

These global players prioritize the development of technologically advanced diagnostic solutions and the expansion of their product portfolios to maintain their competitiveness in the market. Considerable investments are made by these companies in research and development (R&D) as well as product development activities to enhance their product offerings. Manufacturers like Abbott, F. Hoffmann-La Roche, Danaher, Quidel, and Siemens Healthineers consistently focus on product development and introduce diagnostics with cutting-edge technology to expand their market presence.

Merck, a prominent science and technology company, has recently initiated the construction of its first lateral flow membrane manufacturing facility in Sheboygan, Wisconsin, representing its entrance into the field in the United States. This facility will produce lateral flow membranes, a crucial component of rapid diagnostic test kits utilized in various applications, including Covid-19 testing. The establishment of this facility is supported by a USD 128 million contract awarded by the US Department of Defense (DoD) on behalf of the US Department of Health and Human Services.

Key companies profiled in this report include Abbott, F. Hoffmann-La Roche, Siemens Healthineers, Thermo Fisher Scientific, Quidel, BD, Abaxis, Abingdon Health, Access BIO, Arbor Vita, Assure Tech, Atomo Diagnostics, AccuBioTech, BIOMÉRIEUX, bioLytical Laboratories, BIO-RAD Laboratories, Biosynex, Cupid, DIALAB, HUMAN Gesellschaft für Biochemica und Diagnostica mbH, INTEC, J. Mitra & Co. Pvt. Ltd., Meril Life Sciences, MP Biomedicals, Medsource Ozone Biomedicals, Nanjing Synthgene Medical Technology, OraSure Technologies, Premier Medical, QIAGEN, SD Biosensor, Rega Biotechnology, KHB, Türklab A.S., Trinity Biotech, Wondfo, PerkinElmer, Merck KGaA.

---

Key Questions Answered

---

How large is the global market for lateral flow assays?

The lateral flow assays market had a valuation of USD 9.53 billion in 2022 and is projected to reach USD 11.30 billion by 2028.

What is the projected growth rate of the lateral flow assays market?

The global lateral flow assays market is expected to grow at a compound annual growth rate (CAGR) of 2.89% from 2022 to 2028.

Which companies are considered key players in the global lateral flow assays market?

Abbott, F. Hoffmann-La Roche, Danaher, Siemens Healthineers, and Danaher are the key vendors in the global lateral flow assays market.

Which region dominates the global lateral flow assays market in terms of market share?

North America holds the largest market share in the global lateral flow assays market, accounting for 28.57% of the total market.

What are the emerging trends in the lateral flow assays market?

The integration of smartphones and artificial intelligence (AI) into lateral flow immunoassays, the exploration of new applications for lateral flow assays, and the increasing demand for these assays in the food and beverage industry are some of the rising trends in the global lateral flow assays market.