Lateral Flow Assay Market Size (2024 - 2029)

The lateral flow assay market is projected to experience growth due to its increasing adoption for diagnosing infectious diseases, HIV, and cancer, driven by the need for effective and accessible diagnostic methods. The market's expansion is further supported by technological advancements in lateral flow assays, such as novel signal enhancement techniques and improved quantification systems. The COVID-19 pandemic has also accelerated the use of these assays, particularly in settings with limited laboratory facilities. Government initiatives and increased awareness about infection control and home diagnostic systems are expected to bolster the market. However, challenges like regulatory delays and the potential for false results may hinder market growth.

Market Size of Lateral Flow Assay Industry

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Lateral Flow Assay Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 10.46 Billion
Market Size (2029) USD 13.77 Billion
CAGR (2024 - 2029) 5.65 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Lateral Flow Assay Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Lateral Flow Assays Market Analysis

The Lateral Flow Assay Market size is estimated at USD 10.46 billion in 2024, and is expected to reach USD 13.77 billion by 2029, growing at a CAGR of 5.65% during the forecast period (2024-2029).

The COVID-19 pandemic had a positive impact on the market. Instead of sending patient samples to the laboratory, the usage of lateral flow test kits can be convenient as they are smaller, portable, and can be controlled with minimal training. This makes them attractive for deployment outside of healthcare facilities, in low- and middle-income countries, or for countries rolling out mass population screening programs. Even though they are less accurate than PCR tests, their low cost, speed, and ease of use make lateral flow tests particularly attractive to countries that do not have extensive laboratory facilities or trained health workers to easily conduct PCR tests for COVID-19 screening. Some countries, such as Slovakia and the United Kingdom, are extensively using lateral flow tests as a means of mass screening programs. For example, the British government has been monitoring the use of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test in Liverpool, which currently has high COVID-19 rates, and it plans to roll it out nationwide.

The major factor driving the growth of the lateral flow assay market is the growing global rate of infectious diseases, HIV, and cancer around the world, which require new diagnostic methods of effective treatment to end the growing mortality rate. For instance, according to the November 2021 report of the World Health Organization (WHO) on HIV/AIDS, about 37.7 million people around the world were living with HIV in 2020, of which 25.4 million were residing in the WHO African region. As per the same report, in 2020, about 1.5 million people were diagnosed with HIV around the world. Thus, the high prevalence of HIV is expected to drive the demand for effective and precise diagnostics tests for the efficient and early diagnostics of HIV, which is anticipated to drive the market growth as they provide accurate diagnostics.

Further, technological advancements in the field of lateral flow assays (LFA) have also boosted the market growth. In recent years, major advances in LFA development have included novel signal enhancement techniques, the use of new labels, improved quantification systems, and simultaneous detection. Some new techniques have been used to enhance the signal from gold nanoparticles (colloidal nanoparticles). With the advancement in technology, GNPs have adopted silver enhancement technology or combinations of GNPs with an enzyme (such as horseradish peroxidase), which results in catalytic amplification of the signal. For instance, in June 2021, Novacyt launched two COVID-19 antigen lateral flow tests called PathFlow COVID-19 Rapid Antigen Pro and PathFlow COVID-19 Rapid Antigen.

Additionally, increased participation of the government to control the outbreaks of infectious diseases and the increasing awareness programs about the spread of infections, diagnosis, and prevention, along with the launch of diagnosis systems at home care settings, are expected to contribute to the growth of the global market during the forecast period. However, factors such as delays in product approvals due to stringent regulatory policies and false results from the test are expected to impede the growth of the studied market over the forecast period.

Lateral Flow Assays Industry Segmentation

As per the scope of the report, lateral flow assays, also referred to as lateral flow immunochromatographic assays, are cellulose-based devices used to detect the presence of a target analyte in the sample without the need for specialized and costly equipment and highly skilled healthcare professionals for their operation. They gained significant traction in home care settings, thereby fuelling the market.

The lateral flow assay market is segmented by application (clinical testing, drug abuse testing, and other applications), technique (sandwich assay, competitive assay, and multiplex assay), product (lateral flow readers and kits and reagents), end user (home care, hospitals and clinics, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for all the above segments.

Application
Clinical Testing
Pregnancy Testing
Influenza Testing
Tuberculosis
D-Dimer Testing
Other Clinical Testings
Drug Abuse Testing
Other Applications
Technique
Sandwich Assay
Competitive Assay
Multiplex Assay
Product
Lateral Flow Readers
Digital/Mobile Readers
Benchtop Readers
Kits and Reagents
End User
Home Care
Hospitals and Clinics
Other End Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America
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Lateral Flow Assay Market Size Summary

The lateral flow assay market is poised for significant growth over the forecast period, driven by the increasing global prevalence of infectious diseases, HIV, and cancer, which necessitate effective diagnostic methods. The COVID-19 pandemic has notably accelerated the adoption of lateral flow tests due to their portability, ease of use, and rapid results, making them ideal for mass screening programs, especially in regions with limited laboratory infrastructure. Technological advancements in lateral flow assays, such as novel signal enhancement techniques and improved quantification systems, have further bolstered market expansion. The market is also witnessing increased government participation in controlling infectious disease outbreaks and raising awareness about diagnosis and prevention, which is expected to contribute to its growth.

North America is anticipated to dominate the lateral flow assay market, supported by a high incidence of infectious and chronic diseases and a robust healthcare infrastructure. The United States, in particular, is expected to hold a significant market share due to its large patient pool and increased disposable income. The region's market growth is further fueled by the rapid spread of infectious diseases and the implementation of mass screening programs during the pandemic. The market is moderately competitive, with major players like Abbott Laboratories, Hologic Inc., and Quidel Corporation expanding their presence through strategic mergers, acquisitions, and the introduction of new diagnostic products. These developments are expected to sustain the market's upward trajectory in the coming years.

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Lateral Flow Assay Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increased Demand for Point-of-care Testing with Technological Advancements

      2. 1.2.2 Rise in Adoption of Home-based Devices, along with Global Incidence of Infectious Diseases

    3. 1.3 Market Restraints

      1. 1.3.1 Stringent and Tedious Regulatory Framework that Delays the Approval of Products

      2. 1.3.2 Risk of False Results and Reluctance Toward these Products among the People in Emerging Nations

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 2.1 Application

      1. 2.1.1 Clinical Testing

        1. 2.1.1.1 Pregnancy Testing

        2. 2.1.1.2 Influenza Testing

        3. 2.1.1.3 Tuberculosis

        4. 2.1.1.4 D-Dimer Testing

        5. 2.1.1.5 Other Clinical Testings

      2. 2.1.2 Drug Abuse Testing

      3. 2.1.3 Other Applications

    2. 2.2 Technique

      1. 2.2.1 Sandwich Assay

      2. 2.2.2 Competitive Assay

      3. 2.2.3 Multiplex Assay

    3. 2.3 Product

      1. 2.3.1 Lateral Flow Readers

        1. 2.3.1.1 Digital/Mobile Readers

        2. 2.3.1.2 Benchtop Readers

      2. 2.3.2 Kits and Reagents

    4. 2.4 End User

      1. 2.4.1 Home Care

      2. 2.4.2 Hospitals and Clinics

      3. 2.4.3 Other End Users

    5. 2.5 Geography

      1. 2.5.1 North America

        1. 2.5.1.1 United States

        2. 2.5.1.2 Canada

        3. 2.5.1.3 Mexico

      2. 2.5.2 Europe

        1. 2.5.2.1 Germany

        2. 2.5.2.2 United Kingdom

        3. 2.5.2.3 France

        4. 2.5.2.4 Italy

        5. 2.5.2.5 Spain

        6. 2.5.2.6 Rest of Europe

      3. 2.5.3 Asia-Pacific

        1. 2.5.3.1 China

        2. 2.5.3.2 Japan

        3. 2.5.3.3 India

        4. 2.5.3.4 Australia

        5. 2.5.3.5 South Korea

        6. 2.5.3.6 Rest of Asia-Pacific

      4. 2.5.4 Middle-East and Africa

        1. 2.5.4.1 GCC

        2. 2.5.4.2 South Africa

        3. 2.5.4.3 Rest of Middle-East and Africa

      5. 2.5.5 South America

        1. 2.5.5.1 Brazil

        2. 2.5.5.2 Argentina

        3. 2.5.5.3 Rest of South America

Lateral Flow Assay Market Size FAQs

The Lateral Flow Assay Market size is expected to reach USD 10.46 billion in 2024 and grow at a CAGR of 5.65% to reach USD 13.77 billion by 2029.

In 2024, the Lateral Flow Assay Market size is expected to reach USD 10.46 billion.

Lateral Flow Assays Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)