Lateral Flow Assays Market Size, Share & Trends Analysis Report By Product (Kits & Reagents, Lateral Flow Readers), By Application, 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 5.40 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 5.9% 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 particularly to develop products that evaluate body fluids, such as urine and saliva. The use of these 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 faced with the struggle to get timely medical intervention in times of need. This is one of the major factors propelling market growth as dipsticks or LFAs 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. Rapid testing allows the quick detection of viruses and helps stop further transmission by isolating patients. The COVID-19 pandemic has caused large-scale loss of life and severe human suffering. Countries including the U.S., the U.K., Spain, Italy, Germany, India, and France have reported a large number of COVID-19 cases and mass testing is a potential way to confront this pandemic. Thus, in response to this pandemic, several government agencies are focused on mass COVID-19 testing and are taking a series of initiatives to boost the testing rate in their countries. For instance, in May 2020, Luxembourg initiated a mass COVID-19 testing, intending to cover 600,000 patients rapidly and stop the second wave of the infection.

The increasing use of lateral flow devices in home care settings is one of the major factors facilitating market growth. 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 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.

Moreover, the applications of lateral flow assays are significantly increasing globally. Public awareness campaigns aimed at identifying the symptoms of infectious diseases and ways to prevent them play an important role in controlling the disease epidemic. Thus, increased patient awareness has led to the high demand for lateral flow assays. For instance, the advocacy program by the International Society for Infectious Diseases focuses on collaborating with clinicians, public health practitioners, and researchers globally as well as supporting the exchange of scientific knowledge and the application of public health practices and evidence-based medicine. In addition, in 2018, World Hepatitis Alliance launched “Find the Missing Millions” campaign to raise awareness about hepatitis and remove barriers in rapid diagnosis.

However, with the advent of advanced technologies, such as PCR and molecular diagnostics, the demand for lateral flow assays is witnessing sluggish growth. Although lateral flow assays have high sensitivity and specificity for detecting malaria, PCR and molecular diagnostic technologies have proved to be more sensitive. Studies have shown high accuracy in detecting P. falciparum by real-time PCR assays. Thus, infectious disease diagnosis has been revolutionized through advanced molecular techniques, such as PCR. The introduction of various quantitative and qualitative molecular assays, such as real-time PCR, LAMP-PCR, multiplex PCR, and digital PCR, is expected to limit the demand for lateral flow assays. PCR-based diagnostics provide rapid results and are comparatively less prone to cross-contamination because these tests are performed in automated thermal cyclers.

Product Insights

The kits and reagents segment accounted for the largest share of over 65.0% in 2020. The launch of new kits by major players is anticipated to boost the market growth during the forecast period. For instance, in February 2020, Shenzen Bioeasy Biotechnology announced that the company received CE marking for its COVID-19 LFA immunoassay kits. In addition, in March 2019, Abbott introduced its rapid influenza diagnostic test, BinaxNOW Influenza A & B Card 2. This test has also received a CLIA waiver in order to be used with the company’s diagnostic reader DIGIVAL.

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 bench top 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.

Application Insights

In 2020, the clinical testing segment accounted for the largest share of over 55.0% 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.

The drug development and quality testing segment is 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. One of the applications of lateral flow assays in the pharmaceutical industry is the quantitative determination of adalimumab levels in human serum samples. The development of lateral flow immunoassays to authenticate piperaquine and dihydroartemisinin - used during an artemisinin-based combination therapy - is anticipated to propel the lateral flow assays market growth.

Technology Insights

Sandwich assays held the largest share of over 35.0% 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 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. The technique offers cost-saving benefits to end users in the field or laboratory settings by testing for multiple targets simultaneously. In agricultural and remote areas, where there are limited resources, this technique can help save time and money.

End-use Insights

The hospitals and clinics segment held the largest share of over 35.0% in 2020. Hospitals and clinics are primary care settings for the diagnosis and treatment of medical conditions. The majority 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 & acquisitions, product approval and launches, and the expansion of global presence. New players tend to collaborate to enhance their offerings in lateral flow tests. For instance, in January 2019, Sona Nanotech, Inc. collaborated with Anteo Diagnostics to enhance the speed and performance of its lateral flow tests. 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 with a share of more than 35.0% 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 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.

Europe accounted for the second-largest market share in 2020.  A rise in the prevalence of respiratory diseases and the growing investments for the development of advanced diagnostics solutions are expected to drive the market in this region. In 2020, the COVID-19 pandemic created high demand for effective lateral flow solutions in key European countries, such as Italy, the U.K., France, Spain, and Germany, to conduct mass testing for controlling the pandemic.

Key Companies & Market Share Insights

A rise in product approvals is anticipated to fuel the market growth during the forecast period. For instance, in May 2017, Quidel announced that its Sofia Influenza A+B immunoassay received 510(k) clearance and CLIA waiver from the FDA. This assay employs advanced immunofluorescence and lateral flow technologies in order to provide clinical sensitivity for influenza infections. Some prominent players in the global lateral flow assays market include:

• Abbott Laboratories

• 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 the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 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, 2016 - 2028)

  • Kits & Reagents  

  • Lateral Flow Readers    

    • Digital/Mobile Readers

    • Benchtop Readers

• Application Outlook (Revenue, USD Million, 2016 - 2028)

  • Clinical Testing

    • Infectious Diseases 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, 2016 - 2028)

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

• End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 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