Lateral Flow Assay Market, by Product Type (Kits and Reagents, and Lateral Flow Readers), By Technique (Competitive Assay, Multiplex Detection Assay and Sandwich Assay), By Application (Veterinary Diagnostic, Drug Development and Quality Testing, Clinical Testing and Food Safety and Environmental Testing), by End User (Hospitals, Diagnostic Laboratories, Pharmaceutical and Biotechnology Companies and Home Care Settings), and by Geography - Global Industry Insights, and Forecast to 2025

  • Published On : Apr 2018 |
  • Pages : 170 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Lateral Flow Assay Market – Insights

In the field of on-site diagnostics, lateral flow assay (LFA) are well-established commercial product due to their ability of providing precise, fast, and low-cost result such as home-based pregnancy tests. Lateral flow assay technology are rapidly evolved over the years and routinely used for point-of-care and companion diagnostic applications. Moreover, technological advances to transform the assays from simple qualitative tests into complex multi-analyte quantitative assay are driving growth of the lateral flow assay market. Lateral flow assay market is projected to witness growth over the forecast period, owing to increasing application in medical diagnostics, high prevalence of infectious disease, increasing demand for point-of-care testing, and high adoption of home-based lateral flow assay test. The global lateral flow assay market was valued at US$ 5.6 billion in 2017 and is expected to witness a CAGR of 7.5% over the forecast period (2017 – 2025).

Global Lateral Flow Assay Market Share (%), By Product Type, 2017 & 2025

lateral flow assay market

Source: Coherent Market Insights Analysis (2018)

Increasing adoption of home-based lateral flow assay test are driving growth of the lateral flow assay market

Increasing prevalence of lifestyle and infectious diseases rising the demand for point-of-care testing under home care settings which has the ability to provide result in real-time (5-15 minutes), and ease of use. The home pregnancy test is well recognized example of lateral flow assay technology, which detects the presence of a hormone produced during pregnancy and displays a binary result. Adoption of home-based lateral flow assay devices is increasing, owing to various features such as portable device, low production cost, immediate results, and overall ease of use. Lateral flow assay based point-of-care testing improves the quality of care, owing to various advantages offered by them such as cost savings, reduced doctor, visits and laboratory overhead costs. However, variance in lateral flow assay test results may hinder growth of the lateral flow assay market.

Lateral flow assay tests are designed to provide cheap, rapid, and easy tests. However, lateral flow assay tests are only suitable for primary screening of point-of-care. Moreover, they have several disadvantages such as inaccurate sample volume which reduces the precision of result, restricting the total volume in the test and gives a limit of sensitivity, and the analysis time is dependent on the nature of sample (if the sample is viscous, then the time for analysis increases).

Key players in the in-vitro clinical diagnostic device manufacturing are engaged in development of new point-of-care tests, which will provides the less variance and more accurate test results. For instance, in March 2018, U.S. Food and Drug Administration (FDA), approved immunoassay fecal occult blood test of Alfa Scientific Designs, Inc. for the diagnosis of precancerous polyps and colorectal cancer. This new test uses one drop of sample solution and provides result in less than one minute. It is five times quicker than the standard lateral flow assay test. For instance, in October 2014, Agdia, Inc., announced a new lateral flow test strip. The test is developed for examining seed quality by determining the presence or absence of Vip3A protein in transgenic corn. This increase in the demand for point-of-care testing devices and technological advancements in the lateral flow assay devices to introduce cost-effective, rapid, and affordable devices in market for early detection of disease are expected to drive growth of the lateral flow assay market over the forecast period.

High prevalence of infectious disease is expected to drive growth of the lateral flow assay market

High prevalence and increasing incidence of infectious disease are the major factors driving growth of the lateral flow assay market. According to the study published in journal Lancet Infectious Disease, in 2017, around 54,984,661 cases of 45 infectious diseases were reported with average yearly incidence 417·98 per 100?000 in china between January 2004 and December 2013. Furthermore, Hepatitis B and tuberculosis has shown high incidence rate of 81.57 and 80.33 per 100,000, respectively. Moreover, World Health Organization (WHO) estimated 212 million malaria cases worldwide in 2015, with highest incidence in African regions.

Key players operating in market include Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Inc., Qiagen N.V., Becton, Dickinson and Company, Diagnostic Consulting Network, Inc., Tetracore, Inc., Humasis Co. Ltd., and F. Hoffmann-La Roche AG.

Lateral flow assay (LFA) offers simple, low-cost, rapid, point-of-care detection and quantification of analytes in complex mixtures, within 5-30 min. Low development costs and ease of operation of LFAs are results into expansion of its application in biomedicine, agriculture, veterinary, food safety and drug development. High prevalence of infectious disease and increasing adoption of lateral flow assay device in hospitals, physician’s clinics and clinical laboratories for the qualitative and quantitative detection of specific antigen and antibodies is expected to drive growth of lateral flow assay market over the forecast period. For instance, according to the World health Organization (WHO) January 2018 data findings, tuberculosis(TB) was reported to be one of the top 10 causes of death, in 2016 worldwide. Furthermore, in 2016, an estimated 1 million children were suffer from tuberculosis and 2, 50,000 children died of TB (including children with HIV associated TB).

Market Dynamics

The global lateral flow assay market is projected to witness significant growth over the forecast period, owing to growing adoption of lateral flow assay in various applications including clinical diagnostics, drug development, quality testing, veterinary diagnostic, food and environmental testing, micronutrient monitoring, diagnosing invasive pulmonary aspergillosis, qualitative and quantitative detection of specific antigens and antibodies, and gene amplification. For instance, according to the American Pharmaceutical Association (APhA) Academy of Student Pharmacists: Resolutions Committee-2015 report, 8,856 community pharmacies have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, which enables pharmacists to perform POC tests such as glucose measurement and other POC testing. Moreover, increasing adaptation of point-of-care testing in clinical diagnosis and integration of POC testing in lateral flow assay tests are expected to drive growth of the lateral flow assay market over the forecasted period. However, variance or inconsistency results by lateral flow assay would lead to lower adoption of the technology, which in turn would hinder the growth of lateral flow assay market.

Key features of the study:

  • This report provides in-depth analysis of the lateral flow assay market and its market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2017 – 2025, considering 2016 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global lateral flow assay market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies
  • Key companies covered as a part of this study include Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Inc., Qiagen N.V., Becton, Dickinson and Company, Diagnostic Consulting Network, Inc., Tetracore, Inc., Humasis Co. Ltd., and F. Hoffmann-La Roche AG.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, governmental initiatives, technological up-gradation, market expansion and marketing tactics.
  • The global lateral flow assay market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors and suppliers for lateral flow assay kits and reagents, research and consulting firms, new entrants and financial analysts.

Detailed Segmentation:

  • Global Lateral Flow Assay Market, By Product Type:
    • Kits and Reagents
    • Lateral Flow Readers
  • Global Lateral Flow Assay Market, By Technique:
    • Competitive Assay
    • Multiplex Detection Assay
    • Sandwich Assay
  • Global Lateral Flow Assay Market, By Application:
    • Veterinary Diagnostics
    • Drug Development and Quality Testing
    • Clinical Testing
    • Food Safety and Environmental Testing
  • Global Lateral Flow Assay Market, By End User:
    • Hospitals
    • Diagnostic Laboratories
    • Pharmaceutical and Biotechnology Companies
    • Home Care Settings
  • Global Lateral Flow Assay Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
    • Europe
      • By Country
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
    • Asia-Pacific
      • By Country:
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
    • Africa
      • By Country:
        • North Africa
        • Central Africa
        • South Africa
      • By Product Type:
        • Kits and Reagents
        • Lateral Flow Readers
      • By Technique:
        • Competitive Assay
        • Multiplex Detection Assay
        • Sandwich Assay
      • By Application:
        • Veterinary Diagnostics
        • Drug Development and Quality Testing
        • Clinical Testing
        • Food Safety and Environmental Testing
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Pharmaceutical and Biotechnology Companies
        • Home Care Settings
  • Company Profiles
    • Bio-Rad Laboratories, Inc. *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Thermo Fisher Scientific Inc.
    • Siemens Healthineers, Inc.
    • Qiagen N.V.
    • Becton, Dickinson and Company
    • Diagnostic Consulting Network, Inc.
    • Tetracore, Inc.
    • Humasis Co. Ltd.
    • Hoffmann-La Roche AG

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Overview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product Type
      • Market Snippet, By Technique
      • Market Snippet, By Application
      • Market Snippet, By End User
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Market Trends
    • Epidemiology 
    • Product Launches
    • PEST Analysis
  4. Global Lateral Flow Assay Market, By Product Type, 2015 – 2025, (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016 – 2025
      • Segment Trends
    • Kits and Reagents
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Lateral Flow Readers
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
  5. Global Lateral Flow Assay Market, By Technique, 2015 – 2025, (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016 – 2025
      • Segment Trends
    • Competitive Assay
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Multiplex Detection Assay
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Sandwich Assay
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
  6. Global Lateral Flow Assay Market, By Application, 2015 – 2025, (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016 – 2025
      • Segment Trends
    • Veterinary Diagnostics
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Drug Development and Quality Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Clinical Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Food Safety and Environmental Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
  7. Global Lateral Flow Assay Market, By End User, 2015 – 2025, (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016 – 2025
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Diagnostic Laboratories
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Pharmaceutical and Biotechnology Companies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
    • Home Care Settings
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015 – 2025, (US$ Million)
  8. Global Lateral Flow Assay Market, By Region, 2015 – 2025, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2017 and 2025 (%)
      • Y-o-Y Growth Analysis, By Region, 2016 – 2025
    • North America
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • China
        • Japan
        • India
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • Northern Africa
        • Central Africa
        • South Africa
    • Middle East
      • Market Size and Forecast, By Product Type, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Technique, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Application, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By End User, 2015 – 2025, (US$ Million)
      • Market Size and Forecast, By Country, 2015 - 2025, (US$ Million)
        • GCC Countries
        • Israel
        • Rest of Middle East
  9. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Bio-Rad Laboratories, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Thermo Fisher Scientific Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Siemens Healthineers, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Qiagen N.V.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Becton, Dickinson and Company
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Diagnostic Consulting Network, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Tetracore, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Humasis Co. Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • F. Hoffmann-La Roche AG
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
  10. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 47 market data tables and 45 figures on "Lateral Flow Assay Market - Global forecast to 2025”.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Smiley face

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Smiley face

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

Choose License Type

"How Can I Help You" ?

Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.

[email protected]

Key Benefits

  • Custom Research Solution

    Talk to our research consultant to design an exclusive report as per your research needs.

  • Customer Fulfilment

    We aim to fulfil client's research demands with tailored research solutions.

  • Quick Turnaround Time Reports

    We aim to provide research studies in quickest turnaround time and in a much cost effective manner.

  • 360-degree Approach

    We cover each industry from supply and demand side with an aim to provide a most holistic research study.

  • Assured Quality

    We strive to provide most accurate and reliable research findings in our research reports.