Lateral Flow Assay Market Size, Share & Trends Analysis Report By Product (Kits & Reagents, Lateral Flow Readers), By Application, By Technique, By Test Type, By End-user, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global lateral flow assay market size was valued at USD 12.14 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 3.05% from 2022 to 2030. Lateral flow assays are used to detect the presence of a target component in the liquid sample without the need for expensive or specialized equipment. The rising prevalence of infectious diseases is anticipated to boost the growth of the lateral flow assay industry during the forecast period. For instance, according to WHO, about 10 million people worldwide suffered from tuberculosis in 2020.

Furthermore, new product approvals and increasing revenue due to the sales of COVID-19 rapid tests are driving the growth of the industry. As of January 2022, the U.S. FDA had approved at least 12 rapid antigen at-home tests for the detection of COVID-19, with companies such as Abbott Laboratories and Quidel Corporation being among the key players involved.

The COVID-19 pandemic has propelled the adoption of lateral flow assays due to a sharp rise in the demand for rapid, point-of-care testing of the deadly disease. As lateral flow assays represent a cost-effective, and easy-to-use testing solution for the mitigation of the COVID-19 outbreak, these assays are expected to witness significant demand for disease surveillance during the pandemic period.

Furthermore, international organizations, such as WHO and the European Commission, as well as governments around the world have focused on mass population testing, followed by contact tracing, for curbing the spread of COVID-19. Lateral flow assays have enabled frequent testing and decentralization of healthcare for supporting large-scale testing efforts without the need for complex and extensive infrastructure.

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 disease epidemics. Thus, increased patient awareness has led to high demand for lateral flow assays. Furthermore, new product approvals and increasing revenue due to the sales of COVID-19 rapid tests are driving the lateral flow assay market growth.

For instance, Abbott had shipped more than 1 billion COVID-19 tests since the beginning of the pandemic up to the end of the third quarter of 2021, and its sales for the quarter increased by 23.4% to USD 10.9 billion, including USD 1.9 billion revenue from sales of the tests. Similarly, in 2021, COVID-19 tests accounted for USD 510 million of Quidel’s fourth-quarter revenue of around USD 635 million.

Rapid detection of chronic diseases, especially infectious diseases, is necessary and should be accurate & affordable. It helps minimize the need for multiple patient visits and facilitates timely treatment & control of infectious disease outbreaks. The WHO has recommended prompt parasite-based diagnosis in all malaria-suspected patients before proper administration of treatment.

Thus, there is a growing need for rapid diagnostic test kits, facilitating prompt diagnosis and treatment. According to WHO, rapid diagnostic tests are capable of significantly improving the quality of diagnosis and management of infectious diseases, especially in areas with restricted access to advanced technologies.

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 areas with resource-constrained settings and insufficient laboratory infrastructure. The rising trend of decentralized testing has been crucial in increasing the adoption of lateral flow devices globally. The role of these devices has also been observed in controlling major infectious diseases such as malaria and influenza.

According to WHO, rapid diagnostic tests are used in diagnosis by healthcare professionals distant from microscopy services; remote diagnosis by professionals in malaria-endemic countries; and outbreak investigation & survey of parasite prevalence. Thus, various benefits offered by lateral flow devices are among the key factors responsible for increasing the adoption of lateral flow devices globally.

Moreover, the rising prevalence of infectious diseases, including malaria, tuberculosis, HIV/AIDS, hepatitis, pneumonia, and influenza, is one of the major factors boosting the growth of the lateral flow assays industry. According to the World Malaria Report 2020, around 241 million malaria cases were reported in 2021, leading to over 627 thousand malaria-related deaths globally.

As per the data from the IDF Diabetes Atlas, there were about 537 million adults living with diabetes in 2021, and this number is anticipated to increase to 643 million by 2030. The disease is estimated to have caused 6.7 million deaths in 2021. Thus, with the rising incidence of chronic diseases, the demand for lateral flow assays is likely to increase in the coming years.

Product Insights

Based on product, the kits and reagents segment held a larger revenue share in 2021 as these lateral flow kits enable greater adaptability to capture and detect any type of analyte without the requirement to spray the captured antibodies on the test strip. Due to their versatility, these kits are also used in pharmaceuticals, animal health, environmental testing, feed & food testing, and crop & plant testing. The launch of new kits by major players is anticipated to boost market growth during the forecast period. For instance, in July 2021, Abbott Launched its Panbio COVID-19 Antigen Self-Test in India. Similarly, in January 2022, Roche Diagnostics India also launched its COVID-19 At-Home Test.

Lateral flow assays are cheap & easy to use and provide accurate results within a few minutes. These tests detect both immunoglobulin G and immunoglobulin M antibodies against SARS-CoV-2, which causes diseases such as COVID-19. In March 2020, Ozo Life launched OZO COVID-19 Rapid Test Kits, which offer a latex-enhanced, high-sensitivity lateral flow immunoassay solution for the detection of COVID-19 at its early stages. Therefore, a rise in strategic initiatives undertaken by market players is expected to boost the industry’s growth during the forecast period.

Application Insights

The clinical testing segment held the largest share of 76.97% in 2021 owing to an increase in the incidence of infectious diseases. Based on clinical testing, the market is sub-segmented into infectious diseases, cardiac marker testing, cholesterol/lipid testing, pregnancy & fertility testing, drugs of abuse testing, and other clinical testing. The demand for rapid diagnostic kits such as lateral flow assays is increasing due to the rising risk of pathogen diseases and their exposure.

Lateral flow assay testing is used in clinical testing scenarios and multiple diagnostic industries due to ease of use & portability. These tests provide rapid results and are most commonly used for testing infectious diseases, pregnancy, and urine analysis. In addition, as oral fluid-based testing is gradually developing, the use of lateral flow assays is becoming convenient because of the noninvasive nature of collecting specimens.

The drug development & quality testing segment is expected to grow at the fastest CAGR. Lateral flow assays are being increasingly used for therapeutic drug monitoring due to their ease of use, cost-effectiveness, and capacity to detect several markers in samples. Such assays find applications for attaining fully & semi-quantitative results in several less regulated and regulated industries.

Moreover, the widespread availability of antibiotic tests is another factor driving the market growth during the forecast period. Charm Sciences Inc. offers Charm ROSA lateral flow assay, for the detection of aflatoxin M1 and some common antibiotics used for the treatment of dairy cows. These tests utilize patented technology to target drug sensitivities at safe & regulated levels, thereby, preventing unnecessary rejection of milk caused by extremely sensitive screening tests.

Technique Insights

Sandwich assays are expected to hold the largest revenue share, owing to their accuracy, affordability, and ease of use. The test can also be used in low-resource healthcare settings, without the need for trained personnel. The format of sandwich assays is typically used for the detection of larger analytes, which have about two epitopes or binding sites.

For Instance, Abcam offers a Universal Lateral Flow Assay Kit that enables the development of custom sandwich assays by combining GOLD conjugation and Ulfa-Tag kit technologies. One of the advantages offered by such a kit is its flexibility to work with any pair of detection and capture antibodies. Thus, an increase in the availability of technologically advanced sandwich assays is expected to propel the industry’s growth.

The multiplex detection assay segment is expected to grow at the fastest CAGR during the study period. Increasing development of various multiplex lateral flow assays by research & academic centers is a major factor anticipated to influence market growth. For instance, recent development published in the ACS Omega journal in August 2021, involves the creation of a novel multiplex spot array named Blind Spot.

The assay is a six-plex assay consisting of test spots printed in 6 positions, along with a MACAW (Modular Automated Colorimetric Analysis Widget) sensor for analysis and interpretation of test result images. It overcomes the challenges encountered in capillary flow dynamics and design limitations involved in the development of assays with several horizontal test lines. Such advancements in the development of multiplex lateral flow assays are expected to boost their usage in the near future, thereby driving segment growth.

Test Type Insights

The lateral flow immunoassay segment held the largest revenue share in 2021. In physician offices, hospitals, clinical laboratories, & clinics, lateral flow-based tests are used for the quantitative and qualitative detection of a wide variety of antibodies & antigens. It is an easy-to-perform and low-cost analytical method used for screening, monitoring, & diagnosis of numerous diseases. Owing to such factors, the applicability of lateral flow immunoassays is very high; these can be used by any health staff and/or patients at home.

Nucleic acid lateral flow assay is set to grow at a significant pace over the forecast years. Currently, the industry is dominated by antibodies. However, several limitations of lateral flow immunoassays such as high inter-batch variations, error margin, and storage requirements of conventional antibody-based lateral flow assays have led to recent progress in nucleic acid lateral flow assays. In recent years, nucleic acid-based diagnostic tests have gained considerable attention.

End-user Insights

Hospitals & clinics represent primary care setups, with the majority of the population relying on them for diagnosis and treatment of various medical conditions. As a result, the hospitals & clinics segment held the largest market share of 35.8% in 2021. 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 industry.

Furthermore, various infectious diseases, such as influenza, HIV, and hepatitis, are easily transmitted in hospitals, often causing outbreaks. To reduce or even eliminate such occurrences, hospitals have to comply with specific guidelines to ensure adequate patient quarantine measures, the safety of healthcare workers, and proper sanitization. These attributes can positively affect market growth.

The pharmaceutical and biotechnology companies segment is projected to grow at the fastest CAGR during the forecast period as these companies are involved in strategic initiatives, such as mergers & acquisitions, product development, product approvals & launches, and expansion of global operations. Emerging players in the market are undertaking several collaborations to enhance their offerings in lateral flow tests.

For instance, in March 2022, Abingdon Health plc and Vatic Health Limited signed a Memorandum of Understanding for the development and manufacturing of lateral flow tests for infectious diseases. An increase in such strategic collaborations is anticipated to boost the development of lateral flow assays and contribute to segment growth during the forecast period.

Regional Insights

North America accounted for the largest revenue share of 36.09% in 2021. Increased public awareness and a rise in the availability of a wide range of diagnostic tests fueled by the COVID-19 pandemic are expected to lead to significant growth. For instance, as of December 2021, there were about 300 million at-home, rapid tests for COVID-19 available in the U.S., which was tenfold higher than the 24 million tests available in August 2021. Moreover, the Biden Administration announced an investment of about USD 650 million in November 2021 for boosting rapid diagnostic testing and increasing access to COVID-19 tests.

In addition, an increasing number of new entrants and approvals in this domain are anticipated to boost the industry’s growth during the forecast period. For instance, in November 2021, InBios International, Inc. received Emergency Use Authorization (EUA) from the U.S. FDA for its SCoV-2 Ag Detect Rapid Self-Test, which can provide results within approximately 20 minutes.

Asia Pacific is expected to grow at a rapid CAGR owing to the increased collaborations among market entrants, and initiatives undertaken by the government and key players. In addition, an increase in awareness campaigns by leading players is anticipated to fuel the growth of the regional industry.

For instance, the Indian Government’s National Strategic Plan (NSP) for Malaria Elimination (2017-2022) is taking efforts to increase awareness and eliminate malaria in the country by 2030. The plan, under the nation’s National Health Mission, is a part of the National Vector Borne Disease Control Programme and is anticipated to have a budget of USD 106.53 billion.

Key Companies & Market Share Insights

Key players in the lateral flow assay industry are adopting various organic and inorganic strategies such as partnerships, mergers and acquisitions, geographical expansion, and strategic collaborations to expand their market presence. For instance, in December 2021, Quidel Corporation signed an agreement to acquire Ortho Clinical Diagnostics. The acquisition is expected to positively affect the company’s growth by enhancing its diagnostics portfolio. Some prominent players in the global lateral flow assay 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

• BD

• Siemens Healthineers

• Danaher Corporation

• QIAGEN N.V.

Lateral Flow Assay Market Report Scope

Global Lateral Flow Assay Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global lateral flow assay market report based on product, application, technique, test type, end-user, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Kits & Reagents

  • Lateral Flow Readers

  • Lateral Flow Readers

  • Benchtop Readers

  • Digital Readers

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Clinical Testing

  • Infectious Disease Testing

  • COVID-19

  • Mosquito Borne Disease Testing

  • Influenza Testing

  • Sexually Transmitted Infection Testing

  • STI Testing

  • HIV Testing

  • HPV Testing

  • Chlamydia Testing

  • Gonorrhea Testing

  • Syphilis Testing

  • Other STI Testing

  • Hepatitis

  • Tuberculosis

  • Other Infectious Diseases

  • Cardiac Marker Testing

  • Troponin I and T Testing

  • CK-MB Testing

  • BNP and NT-Probnp Testing

  • Myoglobin Testing

  • D-Dimer Testing

  • Other Cardiac Marker Tests

  • Pregnancy & Fertility Testing

  • Pregnancy Testing

  • Fertility Testing

  • Cholesterol Testing/Lipid Profile

  • Drugs of Abuse Testing

  • Other Clinical Tests

  • Veterinary Diagnostics

  • Food Safety & Environment Testing

  • Drug Development & Quality Testing

• Technique Outlook (Revenue, USD Million, 2018 - 2030)

  • Sandwich Assays

  • Competitive Assays

  • Multiplex Detection Assays

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Lateral Flow Immunoassay

  • Nucleic Acid Lateral Flow Assay

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE