Lateral Flow Assays Market Size, Share & Trends Analysis Report By Product (Kits & Reagents, Benchtop Readers), By Application (Clinical Testing, Veterinary Diagnostics), By Technique, By End-use, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global lateral flow assays market size was valued at USD 7.2 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 4.0% from 2021 to 2028. Lateral Flow Assays (LFAs) have been developed over half a century ago, facilitating diagnosis across several applications, such as healthcare, environmental testing, and food and beverage. The use of LFAs in point of care diagnostic settings has been gaining significant traction in the research community in turn, driving the growth of the market for lateral flow assays.

The use of POC devices reduces the need for laboratory testing eliminating the need for trained laboratory personnel and propelling self-testing. Although several technological advancements have been made in the recent past, several emerging economies are still facing the struggle to get timely medical intervention in times of need. This is one of the major factors propelling market growth as dipsticks or Lateral Flow Assays are increasingly being adopted to facilitate timely diagnosis and treatment.

Since the outbreak of the novel coronavirus (COVID-19), there has been an urgent demand for diagnostic solutions, including lateral flow assays, as it is a cornerstone for the management of the COVID-19 pandemic. The incidence of COVID-19 increased exponentially across the different countries over 2020, driving investment by key operating players in R&D for rapid tests. This has resulted in several launches of antibody/antigen tests. 

For instance, in June 2021, Novacyt introduced two COVID-19 antigen lateral flow tests, expanding its COVID-19 product portfolio, mainly in the point-of-care segment. The company introduced Pathflow COVID-19 rapid antigen and PathFlow COVID-19 rapid antigen pro tests. Similarly, in October 2021, Siemens introduced the Clinitest rapid COVID-19 antigen test in Europe, which can identify individuals infected with COVID-19 in 15 minutes.

The increasing use of lateral flow devices in-home care settings is one of the major factors facilitating the growth of the market for lateral flow assays. The use of dipsticks has increased rapidly since their inception owing to factors such as portability, compactness, and rapid interpretation of results without the need for external instrumentation and medical intervention. Thus, the availability of these tests without prescription is increasing their adoption, thereby facilitating the market growth. The use of lateral flow devices also eliminates the need to wait for deciphering test results as well as aids in the optimization of timely treatment decisions, improves the efficacy of care provided, and significantly reduces diagnosis costs, especially in resource-constrained settings where laboratory infrastructure is weak. Rising trends toward decentralized testing have been crucial in increasing the adoption of lateral flow devices globally.

Product Insights

The kits and reagents segment dominated the market for lateral flow assays and accounted for the largest revenue share of 67.8% in 2020. The launch of new kits by major players is anticipated to boost market growth during the forecast period. For instance, in June 2021, Abbott’s Panbio COVID-19 Antigen Self-Test received CE marking in Europe. This is expected to increase its business in Europe. In addition, in August 2021, Thermo Fisher Scientific updated TaqMan SARS-CoV-2 Mutation Panel for detection of Lambda and Delta variants of SARS-CoV-2. The panel was first introduced in March 2021. The updates include a customizable panel for the identification of mutations.

Lateral flow readers are anticipated to grow at a lucrative rate owing to their high demand to ensure precise and accurate interpretation of results for R&D and sample testing applications. There are two types of lateral flow readers, digital/mobile lateral flow readers, and benchtop lateral flow readers. Digital/mobile lateral flow assay readers are anticipated to witness exponential growth in the coming years due to a rise in the use of digital connectivity to enhance the capabilities of lateral readers.

Introducing a digital connectivity platform to lateral flow readers is expected to revolutionize single-use diagnostic tests as the test results will be available at any laboratory setting, thereby saving time. Therefore, advanced technology products offered by players are anticipated to positively impact market growth.

Application Insights

In 2020, the clinical testing segment dominated the market for lateral flow assays and accounted for the largest revenue share of 67.9%. This is owing to the increased incidence of infectious diseases, including the outbreak of COVID-19. Lateral flow-based tests are widely used in physicians’ offices, hospitals, and clinical laboratories for the quantitative and qualitative detection of specific antibodies, products of gene amplification, and antigens. Lateral flow assay testing facilitates disease testing due to the ease of use and portability.

These tests save time as they provide real-time results compared to other laboratory tests. Infectious diseases, pregnancy, and urine analysis strips tests are the most common tests that utilize lateral flow assays. Increased incidence of COVID-19 across several regions is driving mass screening programs by governments, boosting the market. For instance, in February 2021, The North Dakota Department of Health initiated a COVID-19 mass screening program using COVID-19 rapid antigen tests. The program was expected to increase the demand for lateral flow tests.

The drug development and quality testing segment are anticipated to register the fastest CAGR during the forecast period owing to the increase in the use of lateral flow assays for therapeutic drug monitoring. Complementary and companion lateral flow immunoassays are used across various less regulated and regulated industries for the rapid production of fully and semi-quantitative results. This technology offers benefits to this segment, such as ease of use, the ability to detect various markers in samples, and cost-effectiveness.

Technique Insights

The sandwich assays dominated the market for lateral flow assays and accounted for the largest revenue share of 39.5% in 2020 owing to their accuracy, affordability, and ease of use. In this technique, a positive test is mostly represented by a colored line at the test line position. The test can also be used in any low-resource healthcare or field setting and does not require training. The growing number of research activities undertaken by various research institutes is expected to boost the market growth.

A research study published in the Asian Pacific Journal of Tropical Biomedicine, in July 2019, aimed at developing a lateral flow that is a sandwich-based immunochromatographic strip used for rapidly detecting circulating Schistosoma mansoni antigens in urine and serum samples of patients diagnosed with active schistosomiasis.

The multiplex detection assays segment is anticipated to witness the fastest growth over the forecast period. This technique is used for the detection of multiple targets in a single test, rather than using various individual tests. One of the key advantages of the technique is that it can help detect various targets using small sample volumes. It helps assist diagnosis when detecting a high number of markers and in confirming the presence of various contaminants in high volume feed and food testing.

End-use Insights

The hospitals and clinics segment dominated the lateral flow assays market and accounted for the largest revenue share of 39.5% in 2020. Hospitals and clinics are primary care settings for the diagnosis and treatment of medical conditions. Most of the population relies on these long-term facilities for the diagnosis, treatment, and management of diseases. Constant changes in the healthcare industry have led to an increase in the need for hospitals with enhanced diagnostic services. An increase in healthcare expenditure globally has significantly contributed to the growth of the market.

The pharmaceutical and biotechnology companies’ segment is anticipated to witness lucrative growth during the forecast period. These companies are involved in strategic initiatives, such as product development, mergers and acquisitions, product approval and launches, and the expansion of global presence. New players tend to collaborate to enhance their offerings in lateral flow tests. In November 2020, Cytiva announced its plans to support various startups for the development of point-of-care tests. For instance, Hutano Diagnostics was supported by Cytiva for the development of its lateral flow device. An increase in such strategic collaborations is expected to enhance the development of lateral flow assays during the forecast period.

Regional Insights

North America dominated the market for lateral flow assays and accounted for the largest revenue share of 36.3% in 2020. This can be attributed to the easy availability and the high affordability of technologically advanced lateral flow assays. In addition, the high incidence of respiratory infections, such as COVID-19, influenza, and RSV, is boosting the demand for detection and treatment in the region. Furthermore, the presence of well-established healthcare infrastructure and the availability of government funding for research is anticipated to augment the growth of the market for lateral flow assays in this region. In July 2020, the NIH invested USD 248.7 million in the development of new technologies to address challenges that are associated with the testing of COVID-19.

Asia Pacific is anticipated to witness the fastest CAGR over the forecast period. Rising demand due to the high prevalence of infectious and chronic diseases coupled with the emergence of new players in Asian countries are major driving factors for the regional market growth. Moreover, a Rise in product approval for various infectious disease tests is anticipated to boost the market growth in the near future.

Key Companies & Market Share Insights

The market for lateral flow assays is highly competitive with the presence of a large number of key players as well as emerging players in it. The advent of new strategic plans to maintain competitiveness stimulates market growth. The COVID-19 pandemic has resulted in an increasing number of new market entrants, in turn intensifying the market competition. For instance, in September 2021, ANP Technologies Inc. was approved emergency use authorization by the U.S. FDA for its NIDS COVID-19 Antigen Rapid Test Kit. This test is based on lateral flow immunoassay and uses ANP’s Nano-Intelligent Detection System (NIDS) platform technology. Some of the prominent players in the lateral flow assays market include:

• Abbott

• Thermo Fisher Scientific, Inc.

• F. Hoffmann-La Roche AG

• Bio-rad Laboratories, Inc.

• Biomérieux SA

• Quidel Corporation

• Hologic, Inc.

• Perkinelmer, Inc.

• Merck KGAA

• Becton, Dickinson and Company

• Siemens Healthineers

• Danaher Corporation

• Qiagen N.V.

Lateral Flow Assays Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global lateral flow assays market report on the basis of product, application, technique, end use, and region: 

• Product Outlook (Revenue, USD Million, 2017 - 2028)

  • Kits & Reagents

  • Lateral Flow Readers

    • Digital/Mobile Readers

    • Benchtop Readers

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • 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

          • Others

        • Hepatitis

        • Tuberculosis

        • Others

    • Cardiac Marker Testing

      • Troponin I and T Testing

      • CK-MB Testing

      • BNP and NT-proBNP Testing

      • Myoglobin Testing

      • D-Dimer Testing

      • Others

    • Pregnancy & Fertility Testing

      • Pregnancy Testing

      • Fertility Testing

    • Cholesterol Testing/Lipid Profile Testing

    • Drugs of Abuse Testing

    • Others

  • Veterinary Diagnostics

  • Food safety & Environment Testing

  • Drug Development & Quality Testing

• Technique Outlook (Revenue, USD Million, 2017 - 2028)

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

• End-use Outlook (Revenue, USD Million, 2017 - 2028)

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE