Lateral Flow Assay Market Forecast Report | Growth, Size & Share 2030

Lateral Flow Assay Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Product Type (Kits & Reagents and Lateral Flow Readers), Technique (Sandwich Assay, Competitive Assays, and Multiplex Detection Assay), Test Type (Lateral Flow Immunoassay and Nucleic Acid Lateral Flow Assay), Application (Clinical Testing, Veterinary Diagnostics, Food Safety & Environment Testing, and Drug Development & Quality Testing), and End User (Hospitals and Clinics, Diagnostics Laboratories, Homecare, Veterinary Clinics, Pharmaceutical & Biotechnology Companies, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, South & Central America)

Publication Month : Nov 2023

  • Report Code : TIPRE00005544
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 246
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[Research Report] The lateral flow assay market size was valued at US$ 8,505.89 million in 2022 and is projected to reach US$ 16,106.13 million by 2030; it is estimated to record a CAGR of 8.4% from 2022 to 2030.

Market Insights and Analyst View:

Lateral flow immunoassay, also known as immunochromatographic assays or strip tests, is an easy-to-use diagnostic tool to determine whether a target analyte, such as pathogens or biomarkers in humans or animals, is present or absent. As lateral flow assays are easy to use, cost-effective, and can detect multiple markers in samples, they are becoming increasingly popular for therapeutic drug monitoring. Additionally, the growing prevalence of infectious diseases and increasing investments by major market players propel the growth of the lateral flow assay market. Furthermore, the growing availability of various diagnostic tests due to increasing demand for lateral flow assay kits, home, and POC testing fuels the growth of the market.

Growth Drivers:

Lateral flow assays (LFA) are paper-based tests designed for the detection of analytes (condition-specific biomolecules) in complex mixtures (biological samples), wherein samples are placed in a designated spot in a test device. These tests provide results within 5–30 minutes. Lateral flow assay kits exhibit stability over various environmental conditions and prolonged shelf life. Home tests based on later flow assays permit users to test self-collected samples and get results without the assistance of a trained medical professional. These tests are generally sold over the counter. A pregnancy test kit is one of the most common examples of home-based lateral flow assays. Further, these assays are designed for the diagnosis of infectious diseases, cardiovascular diseases, and stigmatized diseases such as HIV. Therefore, the rising prevalence of these diseases and the increasing adoption of lateral flow assay testing in home healthcare drive the lateral flow assay market growth. During the COVID-19 pandemic, many companies introduced at-home lateral flow assays for the diagnosis of SARS-CoV-2 infection due to people’s reluctance to visit hospitals or diagnostic labs for testing.

  • In October 2020, Siemens Healthineers launched the CLINITEST Rapid COVID-19 Antigen Self-Test that helps detect the infection in 15 minutes so that the infected individuals can be isolated sooner to avoid the spread of COVID-19.
  • In July 2020, BD Launched a portable, rapid point-of-care antigen test to detect SARS-CoV-2 infection in 15 minutes.
  • In August 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for Abbott BinaxNOW COVID-19 Ag Card, a rapid test to detect SARS-CoV-2. BinaxNOW uses Abbott’s proven lateral flow technology, making it a friendly and reliable method for frequent mass testing among healthcare providers.
  • In September 2020, Roche launched a SARS-CoV-2 Rapid Antigen Test for markets accepting the CE Mark.  

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Lateral Flow Assay Market: Strategic Insights

lateral-flow-assay-market
Market Size Value inUS$ 8,505.89 million in 2022
Market Size Value byUS$ 16,106.13 million by 2030
Growth rateCAGR of 8.4% from 2022 to 2030
Forecast Period2022-2030
Base Year2022
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Report Segmentation and Scope:

The lateral flow assay market is categorized on the basis of product type, technique, test type, application, end user, and geography. Based on product type, the lateral flow assay market is bifurcated into kits & reagents and lateral flow readers. Based on technique, the lateral flow assay market is classified into sandwich assay, competitive assays, and multiplex detection assay. Based on test type, the lateral flow assay market is bifurcated into lateral flow immunoassay and nucleic acid lateral flow assay. The lateral flow assay market, by application, is classified into clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing. The lateral flow assay market, by end user, is categorized into hospitals and clinics, diagnostics laboratories, homecare, veterinary clinics, pharmaceutical & biotechnology companies, and others. The lateral flow assay market, based on geography, is categorized into North America (US, Canada, and Mexico), Europe (France, Germany, UK, Spain, Italy, Benelux, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, and Rest of APAC), Middle East & Africa (Saudi Arabia, UAE, South Africa, Kuwait, Oman, Qatar, Egypt, and Rest of MEA), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

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Segmental Analysis:

The lateral flow assay market, by product type, is bifurcated into kits & reagents and lateral flow readers. The kits & reagents segment held a larger share of the market in 2022 and is expected to register a higher CAGR in the market during 2022–2030. The lateral flow assay market is anticipated to grow rapidly as the demand for kits & reagents is increasing significantly. Many regions have been experiencing a substantial rise in zoonotic and other animal diseases. Asia and Africa are among the hotspots for zoonoses—diseases transmitted from animals to humans. According to the World Health Organization (WHO), Africa has witnessed outbreaks of Marburg virus disease and several zoonotic diseases between 2012 and 2022. The region experienced a rise of 63% from 2012 to 2022, much higher than the previous decade. In addition, zoonotic disease represents ~32% of Africa’s infectious disease outbreaks reported during 2001–2022.

Thus, there is a rising need for diagnosing animal diseases across the globe. This is encouraging companies, such as Thermo Fisher Scientific Inc; Bio-Rad Laboratories, Inc; and F. Hoffmann-La Roche AG, to offer various reagents and kits, including FDA emergency use authorized RT-PCR detection kits, for sample collection, viral nucleic acid isolation, qualification, and quantification for reliable and accurate SARS-CoV-2 testing, antimicrobial susceptibility testing, rabies diagnosis testing, and qPCRs.

Lateral Flow Assay Market, by Product Type – 2022 and 2030

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Based on technique, the lateral flow assay market is categorized into sandwich assay, competitive assay, and multiplex detection assay. The sandwich assay segment held the largest share of the market in 2022. However, the multiplex detection assay segment is projected to record the highest CAGR from 2022 to 2030.

The lateral flow assay market, by test type, is bifurcated into lateral flow immunoassay and nucleic acid lateral flow assay. The lateral flow immunoassay segment held a larger share of the market in 2022 and is expected to register a higher CAGR in the market from 2022 to 2030. Lateral flow immunoassay, also known as immunochromatographic assays or strip tests, is an easy-to-use diagnostic tool to determine whether a target analyte, such as pathogens or biomarkers in humans or animals, is present or absent. Lateral flow immunoassay tests have played a critical role in reducing the effects of the COVID-19 outbreak due to their ability to rapidly detect infected individuals and stop further transmission of SARS-CoV-2. The lateral flow immunoassay segment accounted for the largest share of the market in 2022. Lateral flow-based immunoassays are widely used to detect a wide variety of antibodies & antigens, both quantitatively and qualitatively, in hospitals, clinical laboratories, and clinics. It is a simple and cost-effective analytical method used to screen, monitor, and diagnose various diseases. As a result, the usefulness of lateral flow immunoassays is extremely high; these can be used by any health professional and/or patient at home.

In terms of application, the lateral flow assay market is categorized into clinical testing, veterinary diagnostics, drug development & quality testing, and food safety & environment testing. The clinical testing segment dominated with the largest share of the market in 2022. However, the drug development & quality testing segment is anticipated to register the highest CAGR during the forecast period.

Based on end user, the lateral flow assay market is categorized into hospitals and clinics, diagnostics laboratories, homecare, veterinary clinics, pharmaceutical & biotechnology companies, and others. Furthermore, the hospitals and clinics segment dominated with the largest market share in 2022. However, the pharmaceutical & biotechnology companies segment is anticipated to record the highest CAGR over the forecast period.

Regional Analysis:

The lateral flow assay market is primarily segmented into North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. North America held a major share of the market in 2022. In the same year, the US held the largest share of the market in the region. The market growth in North America is characterized by the growing prevalence of various diseases, government support for advanced diagnostics adoption, and increasing efforts in R&D and other activities undertaken by market players. In addition, technological advancements in the diagnosis industry are likely to be a major driver for the North American lateral flow assay market over the coming years.

The US Department of Health and Human Services report states that ~30–40% of people in the US suffer from H. Pylori infection. Similarly, according to a study published in PubMed Central (2020), the prevalence of H. pylori in Canada is estimated to be between 20% and 30%. To overcome the high prevalence of H. Pylori in the US, various top competitive players launched innovative products based on lateral flow immunoassay for qualitatively detecting H. pylori antigen. For example, Thermo Fisher Scientific's innovative "RAPID Hp StAR Lateral Flow Kit" helps detect H. pylori antigen directly from fecal samples.

Furthermore, the US has a high prevalence of hepatitis virus infection, which fuels the adoption of lateral flow assay-based testing kits. According to the 2020 Viral Hepatitis Surveillance Report, more than ten thousand people are infected with hepatitis annually in the US. Among these, the incidence rate of acute hepatitis C has increased by 124% in the past decade, and during 2020, it increased by 15% from 2019.

Moreover, various other technological advancements in the biotechnology industry in Canada have increased the demand for lateral flow assay-based tests. For instance, in February 2021, Canadian firm Laipac Technology Inc. partnered with YAS Pharmaceuticals LLC and Pure Health LLC, two UAE-based companies, to launch the first artificial intelligence (AI)-powered rapid COVID-19 antigen test. In April 2020, US-based Bio-Rad Laboratories launched a blood-based immunoassay kit to identify antibodies to SARS-CoV-2. Also, companies are distributing test kits intended for H. pylori bacteria in Canada. For instance, in June 2021, Biomerica Inc. announced a five-year agreement with a Canadian partner involved in distributing and marketing a new proprietary Helicobacter pylori test called Biomerica hp+ detect. The test was developed to identify and monitor H. pylori infection, a leading cause of duodenal and gastric ulcers, as well as a contributing risk factor associated with gastric cancer. Thus, the above-mentioned factors support the growth of the market in North America.

Industry Developments and Future Opportunities:

Various initiatives taken by key players operating in the global lateral flow assay market are listed below:

  1. In March 2023, Roche announced that the FDA approved the Ventana PD-L1 (SP263) assay to detect patients with non-small cell lung cancer who are eligible for treatment with Libtayo, a PD-1 inhibitor therapy developed by Regeneron.
  2. In May 2022, Bio-Rad Laboratories launched the CFX Duet Real-Time PCR system to support researchers in developing singleplex and duplex quantitative PCR assays. The system offers the robust thermal performance and proprietary, accurate optical shuttle system of the company’s CFX Opus system.
  3. In April 2021, Hologic acquired Mobidiag Oy, a privately held Finnish-French developer of molecular diagnostic tests and instrumentation, for ~US$ 795 million. Hologic intends to invest in assay development in order to boost the adoption of the Novodiag platform. The Novodiag system combines real-time PCR and microarray capabilities.
  4. In April 2020, Hologic launched a new Aptima molecular assay that runs on the Panther system for the detection of SARS-CoV-2. The system is fully automated, with a high-throughput molecular diagnostic platform that has been installed in 60 countries and 50 states in the US. It can deliver initial results in three hours and can process over 1,000 COVID-19 tests a day.

Competitive Landscape and Key Companies:

Abbott Laboratories; F. Hoffmann-La Roche Ltd.; Thermo Fisher Scientific Inc.; Bio-Rad Laboratories, Inc.; bioMerieux SA; Quidel Corporation; PerkinElmer Inc.; Hologic Inc; Merck KGaA; Becton, Dickinson and Company; Siemens Healthineers AG; and QIAGEN are among the foremost players in the lateral flow assay market. These companies focus on introducing new high-tech products, advancements in existing products, and geographic expansions to meet the growing consumer demand worldwide. 

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product Type, Technique, Test Type, Application, and End User

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


Who are the major players in the global lateral flow assay market worldwide?

The global lateral flow assay market majorly consists of the players such as Abbott Laboratories, F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., bioMerieux SA, Quidel Corporation, Hologic Inc, PerkinElmer Inc., Merck KGaA, Becton Dickinson and Co, Siemens Healthineers AG, and QIAGEN.

What are lateral flow assay?

Lateral flow assay is a type of diagnostic test that is used to detect the presence or absence of a target molecule in a sample. It is a simple and rapid testing method that does not require specialized equipment or technical expertise, making it suitable for point-of-care and home testing applications. Lateral flow assays are commonly used for various applications, including pregnancy tests, infectious disease diagnostics, food safety testing, and genetic testing. In genetic testing, lateral flow assays can be used to detect specific genetic mutations or sequences associated with various conditions or diseases.

Which segment is dominating the global lateral flow assay market?

The global lateral flow assay market, by product type, is segmented into Kits & Reagents and Lateral Flow Readers. The Kits & Reagents is expected to dominate the market owing to it is substantial rise in zoonotic and other animal diseases. Asia and Africa are among the hotspots for zoonoses—diseases transmitted from animals to humans. Thus, to meet the rising demand for diagnosing animal diseases, companies, including Thermo Fisher Scientific Inc; Bio-Rad Laboratories, Inc; and F. Hoffmann-La Roche AG, among others, offers various reagents and kits for sample collection, viral nucleic acid isolation, qualification and quantification for reliable and accurate SARS-CoV-2 testing, antimicrobial susceptibility testing, rabies diagnosis testing, qPCRs, FDA emergency use authorized RT-PCR detection kits in the market.

What are the driving factors for the global lateral flow assay market worldwide?

The factors driving the market include increasing use of home-based assay kits and rising popularity of point-of-care testing. However, inconsistent assay results due to procedural limitations hinder the market growth.

The List of Companies - Lateral Flow Assay Market 

  1. Abbott Laboratories
  2. F. Hoffmann-La Roche Ltd.
  3. Thermo Fisher Scientific Inc.
  4. Bio-Rad Laboratories, Inc.
  5. bioMerieux SA
  6. Quidel Corporation 
  7. Hologic Inc
  8. PerkinElmer Inc.
  9. Merck KGaA
  10. Becton Dickinson and Co
  11. Siemens Healthineers AG
  12. QIAGEN

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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