Lateral Flow Assays Market

Market Study on Lateral Flow Assays: Increasing Prevalence of Infectious Diseases to Aid Demand Growth

Lateral Flow Assay Market Segmented By Bench top Readers, Handheld Readers, Test strip, Dipstick, Cassette, Lancets Product Type Infectious Diseases like Mosquito-borne Diseases, Streptococcus Infections, Sexually transmitted infections, Hepatitis, Tuberculosis, Gastrointestinal Infections, Pregnancy Test, Drug of Abuse Testing Indications

  • November-2021
  • PMRREP18613
  • 190 Pages
  • Healthcare

Market Snapshot

The global lateral flow assay market was valued at US$ 3.7 Bn in 2020, and is projected to register a CAGR of 5.1% through 2031. Share of lateral flow assays in overall demand for rapid diagnostics was around 13% in 2020.

Lateral flow assay (LFA) kits hold a substantial 70% market share in 2021, and their popularity will continue to be high over the coming years as well. As per this detailed lateral flow assay industry analysis, global demand for lateral flow assay testing kits and components is slated to expand 1.7X in value by 2031.

Lateral Flow Assay Market Size Value (2020)

US$ 3.7 Bn

Projected Sales Value of Lateral Flow Assays (2031)

US$ 6.4 Bn

Global Market Growth Rate (2021-2031)

5.1% CAGR

Market Share Held (100%)

  • Abbott Laboratories
  • bioMerieux S.A
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Thermo Fisher Scientific Inc.
  • Siemens Healthineers
  • Hologic Inc.
  • F. Hoffmann-La Roche Ltd.

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  • Abbott Laboratories
  • bioMerieux S.A
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Thermo Fisher Scientific, Inc.
  • Siemens Healthineers
  • Hologic Inc.
  • F. Hoffmann-La Roche Ltd

Demand Analysis of Lateral Flow Assays from 2016 to 2020 Vs Market Outlook for 2021 to 2031

Global lateral flow assay (LFA) market value was US$ 3.7 Bn in 2020. Rapid antigen testing at point-of-care is possible using lateral flow assay devices that can provide test results in a shorter time when compared to ELISA tests. Also, there has been rapid adoption of lateral flow assay tests in the veterinary sector, which is providing impetus to overall market growth.

During the COVID-19 pandemic, a large number of diagnostic manufactures have focused their efforts on developing COVID-19 lateral flow tests for rapid diagnostics. Lateral flow device (LFD) viral antigen immunoassays have been developed across the world as diagnostic tests for SARS-CoV-2 infection.

Expanding emphasis on drug development and therapeutic research for disease and infections, such as COVID-19, HIV, malaria, salmonella, and others, is creating huge opportunities for lateral flow assay development.

The global market for lateral flow assays and diagnostics is expected to register a CAGR of 5.1% over the forecast period (2021-2031).


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What are the Key Opportunities for Lateral Flow Assay Suppliers?

Technological advancements and significant collaboration efforts among key players in the pharmaceutical industry, funding programs, and presence of reimbursement agencies will further demand growth of lateral flow rapid test diagnostics.

Players in the home diagnostics market are aggressively marketing and promoting their lateral flow assay products online. This ensures better visibility of the products to the general public. Furthermore, manufacturers are making efforts by conducting awareness programs to increase their customer base.

Continuous strategic initiatives by prominent players to develop and launch advanced products are anticipated to significantly support market growth.

  • In June 2021, Thermo Fisher Scientific launched a new CE-IVD-marked rapid flow essay COVID-19 test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's range of tests that detect active SARS-CoV-2 infections.
  • In May 2021, Bio-Rad Laboratories, Inc. announced the introduction of the Reliance SARS-CoV-2 RT-PCR Kit (IVD) for the European market after meeting CE-IVD mark standards.
  • In December 2020, Eurofins Technologies launched a new and improved lateral flow device product line for allergen detection in foodstuffs and environmental samples.

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What are the Factors Restraining Demand for Lateral Flow Assays?

Adoption of lateral flow assay components is limited and restricted due to a number of technology limitations and time required for the development and approval of devices.

For instance, these assays are only suitable for primary screening and do not furnish a quantitative detection to enable the severity of the condition under diagnosis. Thus, results from lateral flow assays are of a binomial nature, which give a positive or negative result only.

Lateral flow assays suffer from poor reproducibility of results and significant number of false negative and false positive results, which reduces the reliability of these tests. Such limitations have hampered adoption and restricted market growth slightly.

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Country-wise Insights

What Makes the U.S. the Largest Market for Lateral Flow Assays?

Presence of majority of market leaders in the U.S. has made it easier for LFA products to be adopted in the country. Additionally, favourable reimbursement scenario and advanced point-of-care testing facilities further support the U.S. market for LFAs.

Why is Germany Considered a Lucrative Market for Lateral Flow Assays in Europe?

Germany dominates the European market for lateral flow assays owing to rising demand for rapid assays. Furthermore, presence of several large hospitals and advanced health systems, changing regulations, growing demand for point-of-care testing, and rising adoption of home-based lateral flow assay equipment are driving regional market expansion.

Why are China and India Emerging Markets for Lateral Flow Assays?

China holds over 35% market share in the Asia Pacific region in 2021, and the market is projected to expand at a high single-digit CAGR. Advanced healthcare infrastructure, increasing government initiatives, and rising prevalence of infectious and chronic diseases are major factors attributed to the growth of the market in the country.

India holds the second-largest share in the Asia Pacific market after China. Demand for lateral flow assays in this country is driven due to increasing prevalence of infectious diseases, rising geriatric population, and advancements in related R&D.

Category-wise Insights

Why Lateral Flow Assay Product is Driving Market Growth the Most?

In terms of product, LFA kits will hold over 70% market share in 2021, expanding at mid-single digit CAGR over the forecast period. Primary factors that support rising adoption of LFA kits include ease of use, low cost, and easy production.

Which Indication Accounts for Highest Share in Demand for Lateral Flow Assays?

By indication, infectious diseases are expected to hold well over 50% market share in 2021, and the segment is expected to continue growing at a moderate rate in correlation with increasing prevalence of infectious diseases across the world.

Why Do Hospital Pharmacies Lead Market Share by Distribution Channel?

High adoption of point-of-care testing for quick diagnosis at hospitals has led to hospital pharmacies hold a high market share. Furthermore, government initiatives to promote hospital pharmacies are also expected to promote growth of the segment through the forecast period.

Impact of COVID-19

The COVID-19 pandemic shifted public healthcare priorities and investments, and yet, it has had a favorable influence on the market, especially the COVID lateral flow test control line. Instead of sending patient samples to labs, lateral flow test kits are more convenient since they are smaller, portable, and need little training to operate.

COVID-19 infections are diagnosed with lateral flow assay-based tests all over the world, since LFA test kits have showed the ability to identify both, symptomatic and asymptomatic COVID-19 infections.

Many healthcare companies have been working on lateral flow assay technologies that can identify patient antibodies (IgG and IgM) or COVID-19 viral antigens in blood samples, saliva samples, or nasal fluid swabs using a finger prick.

Minimal cost of lateral flow assay devices and the fact that these tests do not require trained staff are two factors that are driving demand for LFA-based devices for COVID-19 testing. The key benefit of LFA devices over other detection methods is their ability to identify symptomatic as well as asymptomatic COVID-19 infections.

For example, RT-PCR can only detect current infections in patients, but LFA-based testing equipment can detect asymptomatic individuals who have been cured of the illness and are no longer at danger of transmitting the virus to others.

LFA-based tests can also detect various phases of COVID-19 infection in a patient. As a result, LFA-based testing influence medical and economic decisions in nations that are now dealing with the COVID-19 pandemic.

Competitive Landscape

Key players are focusing on expansion in emerging markets, and new product manufacturing is expected to further strengthening their market presence.

  • In October 2021, Bio-Rad Laboratories, a life science research and clinical diagnostic products company, launched Bio-Plex Pro Human IgA and IgM SARS-CoV-2 panels to detect IgA and IgM antibodies against four SARS-CoV-2 antigens.
  • In October 2020, Siemens Healthineers launched a rapid antigen test for the detection of SARS-CoV-2.
  • In September 2020, Roche announced the launch of the SARS-CoV-2 rapid antigen test for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).

Similarly, recent developments in the market related to lateral flow assays have been tracked by the team at Persistence Market Research, which are available in the full report.

Lateral Flow Assay Industry Report Scope



Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East & Africa

Key Countries Covered

  • US
  • Canada
  • Brazil
  • Mexico
  • Argentina
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • China
  • Japan
  • India
  • Australia
  • New Zealand

Key Market Segments Covered

  • Product
  • Indication
  • Distribution Channel
  • Region

Key Companies Profiled

  • Abbott Laboratories
  • bioMerieux S.A
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Thermo Fisher Scientific, Inc.,
  • Siemens Healthineers
  • Hologic Inc.
  • F. Hoffmann-La Roche Ltd.


Available upon Request

Key Segments Covered in Lateral Flow Assay Industry Survey

By Product

  • Readers
    • Bench-top Readers
    • Hand-held Readers
  • LFA Kits
    • Test Strips
    • Dipsticks
    • Cassettes
    • Lancets

By Indication

  • Infectious Diseases
    • Mosquito-borne Diseases
    • Streptococcus Infections
    • Sexually Transmitted Diseases
    • Hepatitis
    • Tuberculosis
    • Gastrointestinal Infections
    • Others
  • Pregnancy Test
  • Drug of Abuse Testing

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Supermarkets/Hypermarkets
  • e-Commerce

Media Release

- FAQs -

The global lateral flow assay market is worth US$ 3.9 Bn in 2021, and is set to expand 1.7X over the next ten years.

The market for lateral flow assays is expected to reach US$ 6.4 Bn by 2031, while expanding at a CAGR of 5.1%.

From 2016-2020, the market for lateral flow assays expanded at a CAGR of 3.9%.

Development of smartphone-based device disease screening, technological advancements, rising awareness regarding self-diagnosis, and aggressive marketing & promotion strategies are some of the key trends being witnessed in this marketplace.

The U.S., China, Japan, Germany, and U.K. are expected to drive most demand for lateral flow assays.

North America is one of the key markets for lateral flow assays. The U.S. is expected to account over 85% of the North American market share.

Demand of lateral flow assays is expected to register 5.2% CAGR during the forecast period.

Demand for lateral flow assays is expected to surge at a growth rate of 7.5% CAGR over the decade, in the Asia Pacific region.


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