Lateral Flow Assay Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

Published Date : Jan 2021 | No. of Pages : 250 Pages | Category : Healthcare

The global Lateral Flow Assay market size is expected to be worth around US$ 7.12 billion by 2028, according to a new report by Vision Research Reports.

The global Lateral Flow Assay market size was valued at US$ 7.2 billion in 2020 and is anticipated to grow at a CAGR of 6.0% during forecast period 2021 to 2028.

Growth Factors

Major drivers include increase in prevalence of infectious diseases, rise in government initiatives to curb infectious and chronic diseases, rise in demand for point of care testing, and strategic mergers and acquisitions.

Rise in mergers and acquisitions by market players is anticipated to fuel market growth during the forecast period. For instance, in May 2017, Quidel Corporation announced the acquisition of AdenoPlus and InflammaDry diagnostic businesses from RPS Diagnostics for about USD 14 million. InflammaDry and AdenoPlus are rapid lateral flow based POC products used for the detection of inflammatory and infectious diseases and other conditions related to the eye. Thus, increase in strategic mergers and acquisitions to develop and expand lateral flow assays are expected to boost growth during the forecast period.

Increase in government initiatives by governments to curb HIV and other communicable diseases is anticipated to create significant demand for lateral flow assays. According to the U.S. Department of Health & Human Services, the U.S. government has formed the President's Emergency Plan for AIDS Relief (PEPFAR). This emergency plan works toward prevention, early detection, and response to new as well as existing risks related to AIDS and HIV. Additionally, the National Institutes of Health (NIH) has several programs aimed at increasing research related activities pertaining to HIV/AIDS treatment and management. NIH engages in research related to prevention, diagnosis, treatment, and precautionary measures to curb HIV infection. Thus, rise in such government initiatives is expected to positively impact market potential in the near future.

Report Highlights

Based on product, the market is segmented into kits & reagents and lateral flow readers. Kits and reagents are expected to account for the largest market share owing to rise in infectious diseases and the increasing use of lateral flow kits in home care settings. New market players are collaborating with each other to enhance the development of effective and sensitive lateral flow test devices. 

Lateral flow readers ensure precise interpretation of results for research, routine sample testing, and other development applications. In March 2019, Alere (now Abbott) announced the launch of its rapid influenza diagnostic test called BinaxNOW Influenza A & B Card 2. This test has been granted CLIA waiver to be used with Abbott’s diagnostic reader DIGIVAL. The diagnostic reader interprets and reads lateral flow tests in a few seconds and delivers objective and automated results in any healthcare setting. Thus, a rise in the use of lateral flow readers to interpret precise results is expected to fuel market growth.

In the recent past, lateral flow kits have also been developed for various new applications.  This surgery is performed to compensate or replace a failed implant. Prior to this, kit there were no lateral flow assay kits approved by the FDA for the detection of infection in the synovial fluid. The commercialization of this kit is anticipated to aid e-healthcare professionals with effective clinical assessments that determine whether the patient needs surgery or not. Thus, a rise in the approval of kits for a wide range of applications is expected to drive demand for lateral flow assays during the forecast period.

Based on application, the market is segmented into clinical testing, food safety & environment testing, and drug development & quality testing. Clinical testing is expected to hold the largest market share owing to increase in the incidence of infectious diseases. According to the U.S. Department of Health & Human Services, it was estimated that in 2017, about 36.9 million people were living with AIDS/HIV, out of which 1.8 million were individuals above the age of 15. An estimated 1.8 million individuals were newly infected with HIV the same year.

Lateral flow assay can be developed in a dipstick format or as a housed cassette. Based on technique, the market is segmented into sandwich, competitive, and multiplex detection assay. The sandwich assay segment is expected to hold the largest market share owing to its affordability, accuracy, and ease of use. In sandwich assays, a positive test is represented by a colored line at the test line position. Results provided by sandwich assays do not require training and the test can be performed at any low resource healthcare setting.

In competitive assays a positive test is determined by the absence of a colored line at the position where the test line is situated. Both competitive and sandwich assays can be developed to include more than one test lines. For example, a nucleic acid lateral flow assay is multiplexed as it contains more than one test line. It is used for detecting multiple targets using a single test rather than using multiple tests.

Based on end-use, the lateral flow assay market is segmented into homecare, hospitals and clinics, pharmaceutical and biotechnology companies, and diagnostic laboratories. Home care settings are expected to account for the largest market share due to increase in adoption of rapid diagnostic tests at low resource settings. As these test kits can be used by minimally trained healthcare professionals and are easily available in both underdeveloped and developed countries, they are widely used for the detection of infectious diseases, food safety, and veterinary diagnostics.

Hospitals and clinics are expected to witness lucrative growth due to increase in adoption of point of care testing, technological advancements, launch of innovative devices and technologies, and rise in patient inclination toward early and fast diagnosis. Rise in incidence of influenza is prompting more number of individuals to visit healthcare providers or physicians for the diagnosis of influenza. According to CDC, in 2017, 22.7 million individuals visited healthcare physicians or providers for the diagnosis of influenza in the U.S. Thus, increasing use of lateral flow devices at hospital settings is anticipated to drive demand for lateral flow assays during the forecast period.

North America is expected to witness the highest growth due to increase in incidence of influenza. According to the CDC in 2016, 15.5 million infectious disease diagnosed patients visited hospital settings for primary treatment and disease management. It is also estimated that 9,272 new cases of tuberculosis and 36,429 new cases of Lyme disease were diagnosed in 2016. Thus, the rise in incidence of infectious diseases is expected to drive demand for lateral flow assays during the forecast period.

Key Players

Abbott Laboratories; Quidel Corporation; Hologic Inc.; Thermo Fisher Scientific Inc.; F.Hoffmann-La Roche; Siemens AG; Danaher Corporation; Becton, Dickinson and Company; Bio-Rad; bioMerieux; and PerkinElmer.

Market Segmentation

  • Product Outlook 

    • Kits & Reagents       

    • Lateral Flow Readers         

      • Digital/Mobile Readers

      • Benchtop Readers

  • Application Outlook 

    • Clinical Testing

      • Infectious Diseases Testing

        • Mosquito Borne Disease Testing

        • Influenza Testing

        • Sexually Transmitted Infection Testing

          • HIV Testing

          • HPV Testing

          • Chlamydia Testing

          • Gonorrhea Testing

          • Syphilis Testing

          • Others

        • Hepatitis

        • Tuberculosis

        • Others

      • Cardiac Marker Testing

        • Troponin I and T Testing

        • CK-MB Testing

        • BNP and NT-ProBNP Testing

        • Myoglobin Testing

        • D-Dimer Testing

        • Others

      • Pregnancy & Fertility Testing

        • Pregnancy Testing

        • Fertility Testing

      • Cholesterol Testing/Lipid Profile Testing

      • Drugs of Abuse Testing

      • Others

    • Veterinary Diagnostics

    • Food safety & Environment Testing

    • Drug Development & Quality Testing

  • Technique Outlook 

    • Sandwich Assay

    • Competitive Assay

    • Multiplex Detection Assay

  • End-use Outlook 

    • Hospitals & Clinics

    • Diagnostic Laboratories

    • Home Care

    • Pharmaceutical & Biotechnology Companies

    • Others

  • Regional Outlook 

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

The Lateral Flow Assay market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Lateral Flow Assay market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Lateral Flow Assay market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Lateral Flow Assay market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Lateral Flow Assay market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Lateral Flow Assay capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Lateral Flow Assay by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Lateral Flow Assay market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Lateral Flow Assay market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Lateral Flow Assay market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Lateral Flow Assay industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Lateral Flow Assay market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Lateral Flow Assay market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Lateral Flow Assay market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Lateral Flow Assay market. These factors have benefited the growth of the global market for Lateral Flow Assay. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Lateral Flow Assay. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Lateral Flow Assay are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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