Lateral Flow Assays Market
Number of pages: 100 | Report Format: PDF | Published date: April 25, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023 to 2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 19.7 billion |
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Revenue Forecast in 2031 |
US$ 24.60 billion |
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CAGR |
2.50% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
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Segments Covered |
Product, Application, Technique, Sample Type, End user, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global lateral flow assays market was valued at US$ 19.7 billion in 2022 and is expected to register a revenue CAGR of 2.50% to reach US$ 24.60 billion by 2031.
Lateral Flow Assays Market Fundamentals
Lateral flow assays (LFAs), also known as lateral flow immunoassays, are simple and rapid diagnostic tests that detect the presence or absence of a target analyte in a sample. Lateral flow assays are widely used in point-of-care settings, such as clinics and hospitals, as well as in research and industrial applications. Lateral flow assays consist of a test strip, which typically comprises a nitrocellulose membrane that has been impregnated with capture reagents such as antibodies, and a sample pad that contains a conjugate of the target analyte and a visible label such as gold nanoparticles. Lateral flow assays are easy to use, require minimal training, and can produce results within minutes. They are commonly used for the detection of infectious diseases, such as HIV, malaria, and COVID-19, as well as for the detection of food and environmental contaminants, drugs of abuse, and pregnancy tests.
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Lateral Flow Assays Market Dynamics
The growing burden of infectious diseases, such as HIV, malaria, and COVID-19, drives the demand for rapid diagnostic tests. Lateral flow assays are often the preferred diagnostic tool due to their ease of use and ability to deliver results in minutes. Advances in lateral flow assay technologies have enabled the development of more sensitive and specific assays, expanding the range of applications for lateral flow assays. For instance, novel developments in gold nanoparticle synthesis have improved the performance of lateral flow assays, and new assay formats, such as digital lateral flow assays, are being developed. There has been a significant increase in investment in R&D in the lateral flow assay market, which is driving the development of new and innovative solutions. This has led to the development of new products with improved sensitivity, specificity, and ease of use. With the rise of the self-care movement, there is a growing demand for home-based diagnostic testing. Lateral flow assays are well-suited for home-based testing due to their simplicity and ease of use, and this is driving the development of lateral flow assays for home use.
However, one main lateral flow assay challenge is their limited sensitivity and specificity compared to other diagnostic methods, such as polymerase chain reaction (PCR). The risk of false-positive or false-negative results can seriously affect patient care. Lateral flow assays compete with other diagnostic methods, such as PCR and ELISA, which are more sensitive and specific. This limits the adoption of lateral flow assays in certain applications. Lateral flow assays can be highly variable in terms of performance, depending on factors such as the type of assay, the quality of the reagents, and the manufacturing process. This can make it difficult to compare results across different assays and limit lateral flow assays’ reliability. The manufacturing process for lateral flow assays can be complex and requires specialized equipment and expertise. This may limit the scalability of lateral flow assays and can make it difficult for smaller companies to enter the market.
Lateral Flow Assays Market Ecosystem
The global lateral flow assay market is analyzed from seven perspectives: product, application, technique, sample type, end-user, and region.
Lateral Flow Assays Market by Product
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Based on the products, the global lateral flow assay market is segmented into kits and reagents, and lateral flow readers.
The kits and reagents segment dominates the global market with the largest revenue share. These assays are used for the detection of various analytes, such as pathogens, drugs, and biomarkers, in a variety of samples, such as blood, urine, and saliva. Kits and reagents provide a complete solution for lateral flow assays, including all the necessary components, such as conjugates, antibodies, membranes, and buffers. This makes it easy for researchers and laboratories to test with lateral flow assays without sourcing and preparing individual components themselves. In addition, kits and reagents offer several advantages, such as ease of use, reproducibility, and reduced risk of contamination. They also save time and resources since they eliminate the need for researchers to spend time developing and optimizing assay components, which can be time-consuming and expensive. Furthermore, the increasing demand for rapid diagnostic tests for infectious diseases, such as COVID-19, has led to a surge in the adoption of lateral flow assays, which has driven the growth of the lateral flow assay kits and reagents market.
Lateral Flow Assays Market by Application
Based on the applications, the global lateral flow assay market is segmented into drug development & quality testing, clinical testing, food safety & environmental testing, and veterinary diagnostics.
Clinical testing accounts for a significant revenue share in the global market as lateral flow assays are widely used in clinical settings for rapid and accurate diagnosis of various diseases and medical conditions. These assays provide quick and reliable results, making them a valuable tool for healthcare providers, especially in resource-limited settings where time and resources are limited. These assays are easy to perform and require minimal equipment and training, making them accessible to healthcare providers in all settings. Moreover, the growing prevalence of infectious diseases, such as COVID-19, and the need for rapid and accurate diagnostic tests have further increased the demand for lateral flow assays in clinical settings. These assays have played a crucial role in diagnosing and managing COVID-19 by providing quick and reliable results at the point of care. Additionally, the rising demand for personalized medicine and the increasing focus on preventive healthcare has propelled the revenue growth of the lateral flow assays market in clinical testing. These assays enable early and accurate diagnosis of medical conditions, improving patient outcomes and reducing healthcare costs in the long run.
Lateral Flow Assays Market by Technique
Based on the techniques, the global lateral flow assay market is segmented into sandwich assays, multiplex detection assays, and complex assays.
Sandwich assays capture the larger global lateral flow assays market revenue share because they offer high sensitivity and specificity, essential for accurately detecting low-concentration analytes in various samples. Sandwich assays involve using two antibodies that bind to different epitopes on the analyte, allowing for more specific and sensitive detection. Sandwich assays are widely used to detect biomarkers, such as proteins and nucleic acids, in various samples, including blood, urine, and saliva. These assays offer several advantages, including detecting multiple analytes simultaneously, high specificity, and detecting analytes at low concentrations. Moreover, the increasing prevalence of chronic diseases, such as cancer and cardiovascular diseases, has led to a growing demand for sensitive and specific diagnostic tests, driving the sandwich assay market reenue growth. Sandwich assays are also preferred in lateral flow assays because they offer high reproducibility, which is critical for the development of robust and reliable assays. They are also easy to perform, require minimal equipment, and offer rapid results, making them ideal for point-of-care testing.
Lateral Flow Assays Market by Sample Type
Based on the sample types, the global lateral flow assays market is segmented into blood samples, saliva samples, urine samples, and others.
The blood sample segment accounts for a notable revenue share in the global market. Lateral flow assays are amply used for infectious disease diagnosis, pregnancy testing, drug testing, and food safety testing. Blood samples are used in many of these applications, such as infectious disease diagnosis and drug testing. Blood samples are highly sensitive and can detect even low levels of analytes, making them ideal for use in lateral flow assays. Blood samples are relatively easy to collect compared to other types of samples, such as urine or saliva. This makes them a convenient option for healthcare providers and patients. Procedures for collecting and handling blood samples are well-established and standardized, which helps ensure accuracy and reliability in lateral flow assays. An established infrastructure for collecting, handling, and testing blood samples in healthcare settings makes it easier to incorporate lateral flow assays into existing workflows.
Lateral Flow Assays Market by End-User
Based on the end users, the global lateral flow assays market is segmented into pharmaceutical & biotechnology companies, hospitals & clinics, diagnostic laboratories, home care settings, and others.
The hospital's segment registered for the largest revenue share in the global lateral flow assays market in 2022 and is estimated to retain its dominance during the projected time frame. Since, hospitals are the primary providers of healthcare services and are responsible for diagnosing and treating a vast range of medical conditions. Lateral flow assays are widely used in hospitals for the rapid and accurate diagnosis of various diseases, including infectious diseases, cancer, and pregnancy. Hospitals typically have large and sophisticated laboratories equipped with the latest diagnostic technologies, making it easier for them to adopt lateral flow assays in their diagnostic procedures. They also have well-trained medical professionals who can effectively use and interpret the results of lateral flow assays. Furthermore, the increasing prevalence of infectious diseases, particularly in developing countries, has led to a growing demand for rapid hospital diagnostic tests. Lateral flow assays are cost-effective, easy to use, and provide results within a few minutes, making them an ideal choice for hospitals that need to diagnose many patients quickly.
Lateral Flow Assays Market by Region
Based on the regions, the global lateral flow assays market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominates the global lateral flow assays market with the largest revenue share. North America has a well-established healthcare infrastructure and is an early adopter of advanced diagnostic technologies, which has facilitated the adoption and development of lateral flow assays. The United States and Canada have higher healthcare expenditures than other regions, increasing the demand for diagnostic tests, including lateral flow assays. North America has a higher prevalence of chronic diseases, such as diabetes, cancer, and cardiovascular diseases, which require frequent monitoring and diagnosis. The governments of the United States and Canada have initiated various healthcare reforms and policies that encourage the adoption of advanced diagnostic technologies, including lateral flow assays.
Competitive Landscape of Lateral Flow Assays Market
The prominent players operating in the global lateral flow assays market are:
Strategic Development in Lateral Flow Assays Market
The lateral flow assay is a paper-based method for the identification and measurement of analytes in complicated mixtures. It involves placing a sample on a test instrument, and the results are available in 5 to 30 minutes.
The global lateral flow assays market was valued at US$ 19.7 billion in 2022.
The kits and reagents segment dominates the global lateral flow assays market with the largest revenue share.
The expected size of the global lateral flow assays market in 2031 is US$ 24.60 billion.
The main challenge of lateral flow assays is their limited sensitivity and specificity compared to other diagnostic methods, such as PCR. This can lead to false-positive or false-negative results, which can have serious consequences for patient care, thus, hampering the growth of the global market revenue.
Key players operating in the global lateral flow assays market are Abbott Laboratories Inc., Thermo Fisher Scientific Inc., QIAGEN N.V., Becton, Dickinson and Company, and others.
*Insights on financial performance are subject to the availability of information in the public domain