Lateral Flow Assays Market Size
Lateral Flow Assays Market size was valued at more than USD 8.75 billion in 2022 and is anticipated to record over 4.5% CAGR between 2023 and 2032. Increasing demand for point-of-care testing and effective diagnostic solutions will influence market growth.

High prevalence of infectious diseases and the growing adoption rate of home-based point-of-care (POC) testing solutions would fuel market progress. Lateral flow POC testing is preferred over traditional laboratory testing methods due to its cost efficiency and accuracy. Simpler sample requirements and fast specimen handling are some of the benefits of POC testing model that make it a popular choice among practitioners and patients.
Mounting need for affordable diagnostic tools across low-income and developing countries would boost the demand for point-of-care (POC) testing for the diagnosis of diseases like HIV and tuberculosis. New research and development (R&D) activities on POCT along with advancements in Internet of Medical Things (IOMT) should complement industry expansion.
Lateral Flow Assays Market Report Attributes
Report Attribute |
Details |
Base Year | 2022 |
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Lateral Flow Assays Market Size in 2022 | USD 8.5 Billion |
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Forecast Period | 2023 to 2032 |
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Forecast Period 2023 to 2032 CAGR | 4.5% |
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2032 Value Projection | USD 14.5 Billion |
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Historical Data for | 2018 to 2022 |
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No. of Pages | 240 |
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Tables, Charts & Figures | 482 |
Segments covered | Product, Application, Technique, End-use, and Region |
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Growth Drivers | - Increasing prevalence of infectious disease
- Growing demand for point-of-care testing
- Technological advancements
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Pitfalls & Challenges | - Low accuracy of results
- Availability of substitute product
- Stringent regulatory framework
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The strict regulatory requirements by healthcare agencies like the U.S. FDA and convoluted approval processes could hinder the lateral flow assays market landscape. Classified as Class II devices, lateral flow assays require premarket notification, or 510(k) process before they can be marketed to the public. Due to strict regulations, these devices are not approved easily and are required to go through lengthy review procedures and laborious documentation. In case these laws are stalled or not followed, there are high chances of heavy fines imposed on the manufacturer.
Lateral Flow Assays Market Analysis
Lateral flow assays market share from the multiplex detection assays is expected to cross USD 3.9 billion by 2032. Multiplex detection assays aid in the detection of multiple targets due to their flexibility and functionality. This enables the testing method to analyze several analytes independently and effectively. Multiplex detection assays also offer statistical precision as it collects data using several beads for each ligand. The cost-effectiveness and quicker turnaround time that comes with using these tests is anticipated to drive its application across research and clinical laboratories in the coming years.
Global Lateral Flow Assays Market Share, By Application, 2022 (%)
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Segment
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Global market share (%), 2022
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Infectious disease
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30.6%
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Cardiac marker testing
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26.4%
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Pregnancy & fertility testing
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17.1%
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Cholesterol testing
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11.2%
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Drug of Abuse testing
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6.9%
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Others
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7.8%
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Almost a quarter of the market for rapid tests, called lateral flow assays, was used for cardiac marker testing in 2022. These tests are becoming more popular because of the rise in heart disease and the growing number of older people worldwide. Seniors are more likely to have heart attacks, strokes, and blockages in their heart arteries because their immune systems are weaker. According to the CDC, most people with heart disease are over 65, and almost 1 in 6 adults over 65 has coronary heart disease. This is why there is a growing need for tests like lateral flow assays that can find heart disease and help doctors decide on the best treatment.
Lateral flow assays market share from the hospital & clinics end-use segment will observe a 4.8% CAGR between 2023 and 2032. Lateral flow diagnostics are used across hospitals and clinics as they offer quick and accurate results. During the COVID-19 pandemic, many hospitals and clinical institutions utilized lateral flow immunoassay to detect the infection on a large scale. The requirement for advanced diagnostic solutions in clinical settings will facilitate product penetration over the forthcoming years.

Europe is set to become a major player in the lateral flow assays market, with experts predicting it'll be worth a whopping $4.6 billion by the end of 2032. This surge in popularity is largely due to the widespread use of these tests in hospitals and clinics across Western Europe. Just take countries like Belgium and Germany, where more than a quarter of all medical tests are now done on the spot. And it's not just hospitals; even pharmacies, home healthcare providers, and outpatient centers are embracing lateral flow testing. This growing popularity in Europe is expected to give the market a major boost in the years to come.
Lateral Flow Assays Market Share
Some of the key industry participants in the global lateral flow assays market include
- Bioeasy Biotechnology Inc.
- Abingdon Health
- Quidel Corporation
- Abbott
- Bio-Rad Laboratories
- Hologic Inc.
- Thermo Fischer Scientific
- F. Hoffmann La Roche
- OPERON, S.A.
- bioMerieux SA.
Companies are trying to launch new products and cater to the immediate need of the healthcare sector. For instance, in January 2022, Roche Diagnostics India launched its new lateral flow immunoassay diagnostic solution – the COVID-19 At-Home Test - to improve the detection of the nucleocapsid protein antigen from SARS-CoV-2.
Impact of the COVID-19 pandemic
The COVID-19 pandemic had a positive impact on the lateral flow assays industry revenue. The use of lateral flow test kits helped practitioners to detect COVID-19 cases even in low-resource situations like home-care settings. The U.S. FDA and European Commission approved the use of several quick lateral flow tests to prevent the spread of the virus. As a result, many cutting-edge diagnostic solutions were introduced to the market to meet the growing testing requirements. The use of lateral flow assays in laboratory settings is estimated to grow further with the emergence of new strains of COVID-19 worldwide.
The lateral flow assays market research report includes in-depth coverage of the industry with estimates & forecasts in terms of revenue in USD from 2018 to 2032, for the following segments
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By Product
By Application
- Infectious disease testing
- Influenza
- Sexually transmitted disease (STD)
- Hepatitis
- Tuberculosis
- Others
- Cardiac marker testing
- Creatine kinase-MB (CK-MB)
- Myoglobin
- D-dimer
- Troponin I
- Others
- Pregnancy & fertility testing
- Pregnancy testing
- Fertility testing
- Cholesterol testing
- Drug of abuse testing
- Others
By Technique
- Sandwich assays
- Competitive assays
- Multiplex detection assays
By End-use
- Hospital & clinics
- Diagnostic laboratories
- Homecare settings
- Others
The above information is provided for the following regions and countries
- North America
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Poland
- Switzerland
- Netherlands
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- Indonesia
- Thailand
- Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE