Lateral Flow Assay Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 10.46 Billion |
| Market Size (2029) | USD 14.79 Billion |
| CAGR (2024 - 2029) | 7.18 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Lateral Flow Assay Market Analysis
The Lateral Flow Assay Market size is estimated at USD 10.46 billion in 2024, and is expected to reach USD 14.79 billion by 2029, growing at a CAGR of 7.18% during the forecast period (2024-2029).
The factors driving the growth of the market are increased demand for point-of-care testing (POC) testing with technological advancements, the rise in the adoption of home-based devices, and the global incidence of infectious diseases. For instance, according to the study article published in Asian Biomedicine in December 2023, lateral flow assays (LFAs) are considered ideal POC devices. Consumers and regulatory authorities prefer them the most for disease diagnostics globally. LFAs have a simple designated structure, making them portable and equipment-free. LFAs, with their comparatively low manufacturing costs, are priced affordably in the market. Thus, studies like this emphasize the significant benefits of point-of-care testing in diagnosing diseases, which is expected to contribute to market growth during the forecast period.
Also, the growing prevalence of infectious diseases such as HIV, tuberculosis, and acute hepatitis and increasing demand for testing kits will boost the market during the forecast period. For instance, according to the United Nations Programme on HIV/AIDS Global AIDS Update 2024, globally, 39.9 million people lived with HIV at the end of 2023, an increase of 2.3% compared to 2022. Thus, with the high prevalence of HIV, the demand for its testing increases, thereby driving the market growth during the forecast period.
Additionally, the new research and studies and technological developments in lateral flow assay are expected to drive the growth of the market. For instance, an article published in Multidisciplinary Digital Publishing Institute in October 2022 highlighted advancements in lateral flow immunoassays. The highlighted developments are crucial for detecting adulteration and toxic substances in food and drug samples by integrating robust sensors boasting ultra-high reproducibility. Thus, such technological developments are increasing the adoption of LFAs, thereby driving the growth of the market.
Consequently, driven by rising demand for point-of-care testing, technological advancements, and a significant disease burden, the market is poised for good growth during the forecast period. However, stringent and tedious regulatory frameworks, leading to delays in the approval of products, and the risk of false results and reluctance toward these products among people in emerging nations are expected to hinder the growth of the market during the forecast period.
Lateral Flow Assay Market Trends
The Sandwich Assay Technique Segment is Expected to Have Significant Growth in the Market During the Forecast Period
The sandwich assay technique segment is the most commonly used lateral flow assay for detecting specific analytes, such as proteins or biomarkers. This technique involves using two distinct antibodies or capture molecules to identify and quantify the target analyte. Some products that utilize the sandwich assay technique in lateral flow assays include the Clearblue pregnancy test, BinaxNOW COVID-19 antigen test, and OneTouch Ultra test strips. The sandwich assay technique has witnessed significant growth and adoption in the market due to several factors, such as high sensitivity and specificity, rapid results, versatility, and ease of use.
Chronic diseases such as heart disease, HIV, and diabetes elevate specific biomarkers, detectable through the sandwich assay technique in lateral flow assays. For instance, according to the 2024 International Diabetes Federation, by 2045, an estimated 783 million adults, or 1 in 8, are projected to be living with diabetes worldwide. Additionally, according to data published by the Centers for Disease Control and Prevention in May 2024, approximately 805,000 individuals in the United States experience a heart attack annually. Thus, the high burden of these diseases increases the demand for sandwich-type lateral flow assay products, boosting the segment's growth.
Also, with new product approvals and launches, the availability of sandwich assay techniques for various disease conditions is set to rise, driving segment growth during the forecast period. For instance, in April 2024, Roche Diagnostics India launched its point-of-care NT-proBNP test to screen diabetes patients at risk of cardiovascular diseases (CVD), including heart failure (HF). This extended claim for the NT-proBNP biomarker is exclusively available on the cobas h 232 system, which operates on the sandwich assay technique.
Similarly, in August 2023, Clearblue unveiled its latest innovation, the Clearblue Menopause Stage Indicator. The sandwich assay-based product combines the follicle-stimulating hormone (FSH) readings gathered from the user's urine with the user's age and cycle history to identify the stage in the menopause journey accurately. Therefore, similar new product approvals and launches are anticipated to increase the availability of sandwich assay products, thereby boosting the segment growth during the forecast period.
The segment is expected to grow significantly during the forecast period due to factors such as the high burden of chronic diseases and new product approvals and launches.
North America is Expected to Witness a Significant Growth During the Forecast Period
North America is expected to dominate the overall lateral flow assay market during the forecast period owing to a rise in the incidence of various infectious, such as influenza and tuberculosis, and newly diagnosed HIV/AIDS in the region. For instance, according to the updated data published by the Centers for Disease Control and Prevention in the Weekly US Influenza Surveillance Report, in April 2023, FluSurv-NET locations reported a total of 25,317 laboratory-confirmed influenza-related hospitalizations in the United States between October 1, 2023, and August 3, 2024, compared to 17,997 laboratory-confirmed influenza-related hospitalizations between October 1, 2022, and April 15, 2023, in the United States.
The same source reported that, between October 1, 2023, and August 3, 2024, a total of 21,409 hospitalizations (84.6 %) were related to the influenza A virus, 3,734 (14.7%) to the influenza B virus, 53 (0.2%) to influenza A virus and influenza B virus co-infection, and 121 (0.5%) to flu for which the type of the virus could not be identified. Thus, the increasing burden of influenza virus infection increases the demand for lateral flow assay testing, which is anticipated to bolster the market growth during the forecast period.
Further, the launch of advanced products contributes to the growth of the market. For instance, in June 2022, Lumos Diagnostics, a provider of point-of-care (POC) diagnostic technologies, reported that Health Canada granted Interim Order authorization for ViraDx, a three-in-one COVID-19/Flu A/Flu B rapid antigen test for use by healthcare professionals. Thus, such product launches will likely drive market growth during the forecast period.
Lateral Flow Assay Industry Overview
The lateral flow assay market is competitive and consists of several major global and regional players. With the rising technological advancements in lateral flow assays, more companies are expected to penetrate the market. The competitive landscape includes analyzing a few international and local companies that hold market shares and are well known, such as Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, F. Hoffmann-La Roche AG, and bioMérieux.
Lateral Flow Assay Market Leaders
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F. Hoffmann-La Roche AG
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Abbott Laboratories
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Danaher Corporation
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Thermo Fisher Scientific Inc.
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bioMérieux
*Disclaimer: Major Players sorted in no particular order
Lateral Flow Assay Market News
- May 2024: In collaboration with Salignostics and Crest Medical, Abingdon Health PLC, one of the key lateral flow Contract Development and Manufacturing Organisation (CDMO), launched Boots' own-brand saliva pregnancy self-test in the United Kingdom.
- September 2023: Lumos Diagnostics received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its combined COVID-19/Flu A/Flu B rapid point-of-care test, ViraDx. The ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test utilizes a lateral flow immunoassay designed for the vitro rapid, simultaneous qualitative detection of influenza A and B.
Lateral Flow Assays Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increased Demand for Point-of-Care Testing with Technological Advancements
4.2.2 Rise in Adoption of Home-based Devices, along with Global Incidence of Infectious Diseases
4.3 Market Restraints
4.3.1 Stringent and Tedious Regulatory Framework that Delays the Approval of Products
4.3.2 Risk of False Results and Reluctance Toward these Products among the People in Emerging Nations
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Application
5.1.1 Clinical Testing
5.1.1.1 Pregnancy Testing
5.1.1.2 Influenza Testing
5.1.1.3 Tuberculosis
5.1.1.4 D-dimer Testing
5.1.1.5 Other Clinical Testing
5.1.2 Drug Abuse Testing
5.1.3 Other Applications
5.2 By Technique
5.2.1 Sandwich Assay
5.2.2 Competitive Assay
5.2.3 Multiplex Assay
5.3 By Product
5.3.1 Lateral Flow Readers
5.3.1.1 Digital/Mobile Readers
5.3.1.2 Benchtop Readers
5.3.2 Kits and Reagents
5.4 By End User
5.4.1 Home Care
5.4.2 Hospitals and Clinics
5.4.3 Other End Users
5.5 Geography
5.5.1 North America
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 Japan
5.5.3.3 India
5.5.3.4 Australia
5.5.3.5 South Korea
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle East and Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle East and Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Revvity
6.1.2 Merck KGaA
6.1.3 QIAGEN N.V.
6.1.4 Abbott Laboratories
6.1.5 QuidelOrtho Corporation
6.1.6 Hologic Inc.
6.1.7 Thermo Fisher Scientific Inc.
6.1.8 bioMérieux
6.1.9 Becton, Dickinson and Company
6.1.10 Bio-Rad Laboratories Inc.
6.1.11 Sysmex Corporation
6.1.12 Danaher Corporation
6.1.13 F. Hoffmann-La Roche AG
6.1.14 Siemens Healthineers AG
6.1.15 ChembioDiagnostics
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Lateral Flow Assay 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.
The lateral flow assay market is segmented by application, technique, product, end user, and geography. By application, the market is segmented into clinical testing, drug abuse testing, and other applications. The clinical testing segment includes pregnancy testing, influenza testing, tuberculosis, D-dimer testing, and other clinical testing. By technique, the market is segmented into sandwich assay, competitive assay, and multiplex assay. By product, the market is segmented into lateral flow readers and kits and reagents. The lateral flow readers include digital/mobile readers and benchtop readers. By end user, the market is segmented into home care, hospitals and clinics, and other end users. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for all the above segments.
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Lateral Flow Assays Market Research FAQs
How big is the Lateral Flow Assay Market?
The Lateral Flow Assay Market size is expected to reach USD 10.46 billion in 2024 and grow at a CAGR of 7.18% to reach USD 14.79 billion by 2029.
What is the current Lateral Flow Assay Market size?
In 2024, the Lateral Flow Assay Market size is expected to reach USD 10.46 billion.
Who are the key players in Lateral Flow Assay Market?
F. Hoffmann-La Roche AG, Abbott Laboratories, Danaher Corporation, Thermo Fisher Scientific Inc. and bioMérieux are the major companies operating in the Lateral Flow Assay Market.
Which is the fastest growing region in Lateral Flow Assay Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Lateral Flow Assay Market?
In 2024, the North America accounts for the largest market share in Lateral Flow Assay Market.
What years does this Lateral Flow Assay Market cover, and what was the market size in 2023?
In 2023, the Lateral Flow Assay Market size was estimated at USD 9.71 billion. The report covers the Lateral Flow Assay Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Lateral Flow Assay Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Lateral Flow Assays Industry Report
The report provides a comprehensive industry overview of the Lateral Flow Assays market, segmented by application, technique, product, end user, and geography. This market analysis includes clinical testing, drug abuse testing, and other applications, with techniques such as sandwich assay, competitive assay, and multiplex assay. The industry reports cover products like lateral flow readers and kits and reagents, with end users including home care, hospitals and clinics, and other end users.
The industry research indicates significant market growth, driven by various factors. The market forecast suggests positive trends, with market leaders playing a crucial role in shaping the industry outlook. The market segmentation by geography includes North America, Europe, Asia-Pacific, Middle-East and Africa, and South America, providing detailed market data for each region.
The industry statistics highlight the market size and market share, reflecting the industry's value and potential. The industry analysis and market review offer insights into the market trends and market predictions, providing a detailed market overview. The report pdf is available for a more in-depth understanding of the market.
The report example includes growth rate, industry information, and industry sales, offering a complete market outlook. The industry trends and market growth are supported by extensive research companies, ensuring accurate and reliable market information. The report also includes a detailed market forecast, industry size, and market value, essential for understanding the industry's future direction.
