Lateral Flow Assay Market

Lateral Flow Assay Market

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raksha

Author :

Raksha Sharma

Vineet

Fact-checked by :

Vineet Pandey

Vishal

Editor :

Vishal Golekar

Lateral Flow Assay Market Outlook 2031

The global lateral flow assay market size was valued at USD 20.50 Billion in 2022 and is expected to reach USD 24.50 Billion by 2031, expanding at a CAGR of 2% during the forecast period, 2023-2031. The growth of the market is attributed to the rising cases of infectious diseases and wide availability of advanced diagnostic devices for diseases.

Lateral flow assays include a range of simple cellulose-based test devices used to detect or identify a particular substance present in the liquid sample, which is primarily used for clinical testing purposes. The assays are mainly designed to detect infectious diseases and examine the causal agents for such diseases.

Lateral Flow Assay Market Outlook

Some of the common diseases detected by the lateral flow assays include hepatitis B and others. These test devices offer certain advantages such as simple to use and cost-effective. One of the key aspects for the wide adoption of the devices is due to easy availability of equipment for laboratory testing, point of care testing and, home testing as they do not require various advanced equipment.

According to a report published by World Health Organization (WHO), around 219 million malaria cases were reported from 87 countries and more than 435,000 deaths were recorded due to malaria in 2017. Another report suggests that an amount of USD 3 billion has been sanctioned by WHO to develop various barriers including preventive drugs against malaria.

As taking a leading initiative, WHO partnered with various organizations such as Roll Back Malaria (RBM), African Union Commission, and others to create awareness on diagnosis of malaria and its prevention. In another report by WHO, around 257 million people were diagnosed with hepatitis B, around 71 million people with hepatitis C, about 10 million people with tuberculosis.

The COVID-19 pandemic had a positive impact on the lateral flow assay market owing to the fact that the tests can be taken at home without having sent the samples to laboratories and can be used with basic training. Small size, low-cost, and high speed in result are major factors that make devices popular in low or mid economic countries where the majority population are deprived of advanced healthcare facilities.

Lateral Flow Assay Market Trends, Drivers, Restraints, and Opportunities

  • Wide prevalent of infectious diseases and the outbreak of COVID-19 pandemic are anticipated to fuel the market growth during the forecast period.
  • Increasing number of initiatives for public awareness regarding the preventive measures of diseases taken by governments such as to develop a barrier against malaria are expected to propel the market growth.
  • Rising collaboration and technological advancement that help in the development of innovative lateral flow kits are anticipated to drive the market expansion in the coming years.
  • High taxation on medical devices and less availability of skilled technicians handling various testing procedures are key challenges that can restrain the market growth. Ongoing R&D programs and clinical experiments to enhance the techniques and procedures of the devices are projected to create lucrative opportunities for the market growth.

Scope of Lateral Flow Assay Market Report

The report on the global lateral flow assay market includes an assessment of the market, trends, segment, and regional markets. Overview and dynamics have also been included in the report.

Attributes

Details

Report Title

Lateral Flow Assay Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast

Base Year

2022

Historic Data

2016-2021

Forecast Period

2023-2031

Segmentation

Products (Kits & Reagents and Lateral Flow Readers [Benchtop Readers and Digital/Mobile Readers]), Applications (Veterinary Diagnostics, Clinical Testing [Infectious Diseases Testing {Mosquito Borne Disease Testing, Influenza Testing, Sexually Transmitted Infection Testing (HPV Testing, HIV Testing, Gonorrhea Testing, Chlamydia Testing, Syphilis Testing, and Others), Hepatitis, Tuberculosis, and Others}, Cardiac Marker Testing {Troponin I & T Testing, BNP & NT-ProBNP Testing, D-Dimer Testing, CK-Mb Testing, and Others}, Pregnancy & Fertility Testing {Pregnancy Testing and Fertility Testing}, Cholesterol Testing/Lipid Profile Testing, Drugs Of Abuse Testing, and Others], Food Safety & Environment Testing, and Drug Development & Quality Testing), Techniques (Sandwich Assay, Competitive Assay, and Multiplex Detection Assay), End-Users (Homecare, Pharmaceutical & Biotechnology Companies, Hospitals & Clinics, Diagnostic Laboratories, and Others)

Regional Scope

Asia Pacific, North America, Latin America, Europe, and Middle East & Africa

Report Coverage

Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast

Key Players Covered in the Report

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

Lateral Flow Assay Market Segment Insights

Products Segment Analysis

On the basis of products, the lateral flow assay market is bifurcated into kits & reagents and lateral flow readers. The lateral flow readers segment is further bifurcated into benchtop readers and digital/mobile readers. The kits & reagents segment is anticipated to hold a high market share in the coming years due to the wide use of kits and reagents for disease diagnosis.

However, the lateral flow reader is expected to account for a large market share during the forecast period owing to provide accurate analysis for research purposes, development of advanced techniques, and regular sample testing. For the advancement of lateral flow test kits, new players in the market are collaborating with various research institutes as a development strategy. This is anticipated to fuel the market during the forecast period.

Moreover, rising approval of diagnostic kits of lateral flow assay from regulatory bodies present another key insight for the segment expansion. For example, Synovasure, a kit developed by Zimmer Biomet was approved by the US Food and Drug Administration (FDA) in 2019 to be a used as lateral flow test kit.

Lateral Flow Assay Market Product

Applications Segment Analysis

On the basis of applications, the market is segmented into veterinary diagnostics, clinical testing, food safety & environment testing, and drug development & quality testing. The clinical testing segment is further categorized as infectious diseases testing, cardiac marker testing, pregnancy & fertility testing, cholesterol testing/lipid profile testing, drugs of abuse testing, and others.

The infectious diseases segment is further segregated into mosquito-borne disease testing, influenza testing, sexually transmitted infection testing, hepatitis, tuberculosis, and others. The sexually transmitted infection testing segment is further segmented into HPV testing, HIV testing, gonorrhea testing, chlamydia testing, syphilis testing, and others.

The cardiac marker testing is divided into troponin I and T testing, BNP and NT-proBNP testing, D-dimer testing, CK-MB testing, and others. 
The clinical testing segment is expected to hold a large share of the market during the forecast period owing to extensive clinical experiments to find advanced drugs and treatment methods for infectious diseases.

According to a report by the U.S. Department of Health & Human Services, around 36.9 million people were living with AIDS/HIV, among which 1.8 million individuals were above the age of 15 in the year 2017. Moreover, rising number of cardiac disorder patients across the globe is anticipated to help the segment growth. Cardiac markers are used to assess the heart’s functioning and offer preventive treatment on early stage.

Techniques Segment Analysis

Based on techniques, the lateral flow assay market is divided into sandwich assay, competitive assay, and multiplex detection assay. The sandwich assay segment is expected to dominate the market during the forecast period owing to factors such as low-cost, affordable, and accurate of the technology.

Sandwich assays do not require any special training to handling the diagnostic process and get the results easily. A colored line mark in the test line shows a positive result; while no colored line denotes negative result.

Lateral Flow Assay Market Techniques

End-users Segment Analysis

On the basis of end-users, the market is categorized as homecare, pharmaceutical & biotechnology companies, hospitals & clinics, diagnostic laboratories, and others. The homecare segment is anticipated to rise at a rapid pace as these kits are extensively used by health professionals by giving minimal training. Moreover, these kits are also adopted rapidly as they provide fast diagnostic test at low resource settings.

Meanwhile, the hospitals & clinics segment is expected to exhibit a significant growth rate in the market during the forecast period owing to wide adopting of the availability of advanced diagnostic devices and presence of specialized medical staff including doctors and technicians in hospitals as well as clinical centers.

Regional Outlook

In terms of region, the global rapid medical diagnostic kits market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market in the coming years due to early adoption of advanced technology for screening test, presence of a large number of health-conscious people, and wide prevalence of infectious diseases such as influenza in the region.

Furthermore, the presence of key global players especially in the US is another major factor driving the regional market growth. Meanwhile, the market of Europe is anticipated to register a strong growth rate due to wide awareness of infectious diseases and inclination to early detection of the diseases.

On the other hand, the market of Asia Pacific is projected to constitute a major market share during the forecast period owing to wide prevalence of infectious diseases such as HIV/AIDS and broad governments’ initiatives for the development of advanced treatment from emerging economies including China, Japan, and India.

Lateral Flow Assay Market Region

Segments

The global lateral flow assay market has been segmented on the basis of

Products

  • Kits & Reagents
  • Lateral Flow Readers
    • Benchtop Readers
    • Digital/Mobile Readers

Applications

  • Veterinary Diagnostics
  • Clinical Testing
    • Infectious Diseases Testing
      • Mosquito Borne Disease Testing
      • Influenza Testing
      • Sexually Transmitted Infection Testing
        • HPV Testing, HIV Testing
        • Gonorrhea Testing
        • Chlamydia Testing
        • Syphilis Testing
        • Others
      • Hepatitis
      • Tuberculosis
      • Others
    • Cardiac Marker Testing
    • Pregnancy & Fertility Testing
    • Cholesterol Testing/Lipid Profile Testing
    • Drugs of Abuse Testing
    • Others
  • Food Safety & Environment Testing
  • Drug Development & Quality Testing

Techniques

  • Sandwich Assay
  • Competitive Assay
  • Multiplex Detection Assay

End-users

  • Homecare
  • Pharmaceutical & Biotechnology Companies
  • Hospitals & Clinics
  • Diagnostic Laboratories

Regions

  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa

Key Players

  • Abbott Laboratories
  • Quidel Corp.
  • Hologic Inc.
  • Thermo Fisher Scientific Inc.
  • F.Hoffmann-La Roche
  • Siemens AG
  • Danaher Corp.
  • Becton
  • Dickinson and Co.
  • Bio-Rad
  • bioMerieux
  • PerkinElmer

Competitive Landscape

Key Players competing in the global lateral flow assay market are Abbott Laboratories; Quidel Corp; Hologic Inc.; Thermo Fisher Scientific Inc.; F.Hoffmann-La Roche; Siemens AG; Danaher Corp; Becton, Dickinson and Company; Bio-Rad; bioMerieux; and PerkinElmer.

Some of these key players have been actively engaged in the development of new technology to improve their testing kits. For instance, in December 2017, Atomo Diagnostics announced that its newly launched device named Atomo HIV Self-test was given CE mark by regulatory bodies.

Moreover, BinaxNOW Influenza A & B Card 2, a test for rapid influenza diagnostic test, was launched by Alere (now Abbott) in 2019 to analyze and read lateral flow tests with the aim to deliver results in a short period of time. This test was to be used with DIGIVAL, another Abbott’s diagnostic reader.

Lateral Flow Assay Market Key Players

1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. Lateral Flow Assay Market Overview
  4.1. Introduction
     4.1.1. Market Taxonomy
     4.1.2. Market Definition
  4.2. Macro-Economic Factors
     4.2.1. Industry Outlook
  4.3. Lateral Flow Assay Market Dynamics
     4.3.1. Market Drivers
     4.3.2. Market Restraints
     4.3.3. Opportunity
     4.3.4. Market Trends
  4.4. Lateral Flow Assay Market - Supply Chain
  4.5. Global Lateral Flow Assay Market Forecast
     4.5.1. Lateral Flow Assay Market Size (US$ Mn) and Y-o-Y Growth
     4.5.2. Lateral Flow Assay Market Size (000’ Units) and Y-o-Y Growth
     4.5.3. Lateral Flow Assay Market Absolute $ Opportunity
5. Global Lateral Flow Assay Market Analysis and Forecast by Applications
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by Applications
     5.2.2. Y-o-Y Growth Projections by Applications
  5.3. Lateral Flow Assay Market Size and Volume Forecast by Applications
     5.3.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  5.4. Absolute $ Opportunity Assessment by Applications
  5.5. Market Attractiveness/Growth Potential Analysis by Applications
6. Global Lateral Flow Assay Market Analysis and Forecast by End Users
  6.1. Market Trends
  6.2. Introduction
     6.2.1. Basis Point Share (BPS) Analysis by End Users
     6.2.2. Y-o-Y Growth Projections by End Users
  6.3. Lateral Flow Assay Market Size and Volume Forecast by End Users
     6.3.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  6.4. Absolute $ Opportunity Assessment by End Users
  6.5. Market Attractiveness/Growth Potential Analysis by End Users
7. Global Lateral Flow Assay Market Analysis and Forecast by Region
  7.1. Market Trends
  7.2. Introduction
     7.2.1. Basis Point Share (BPS) Analysis by Region
     7.2.2. Y-o-Y Growth Projections by Region
  7.3. Lateral Flow Assay Market Size and Volume Forecast by Region
     7.3.1. North America
     7.3.2. Latin America
     7.3.3. Europe
     7.3.4. Asia Pacific
     7.3.5. Middle East and Africa (MEA)
  7.4. Absolute $ Opportunity Assessment by Region
  7.5. Market Attractiveness/Growth Potential Analysis by Region
  7.6. Global Lateral Flow Assay Demand Share Forecast, 2019-2026
8. North America Lateral Flow Assay Market Analysis and Forecast
  8.1. Introduction
     8.1.1. Basis Point Share (BPS) Analysis by Country
     8.1.2. Y-o-Y Growth Projections by Country
  8.2. North America Lateral Flow Assay Market Size and Volume Forecast by Country
     8.2.1. U.S.
     8.2.2. Canada
  8.3. Absolute $ Opportunity Assessment by Country
  8.4. North America Lateral Flow Assay Market Size and Volume Forecast by Applications
     8.4.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  8.5. Basis Point Share (BPS) Analysis by Applications
  8.6. Y-o-Y Growth Projections by Applications
  8.7. North America Lateral Flow Assay Market Size and Volume Forecast by End Users
     8.7.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  8.8. Basis Point Share (BPS) Analysis by End Users
  8.9. Y-o-Y Growth Projections by End Users
  8.10. Market Attractiveness/Growth Potential Analysis
     8.10.1. By Country
     8.10.2. By Product Type
     8.10.3. By Application
  8.11. North America Lateral Flow Assay Demand Share Forecast, 2019-2026
9. Latin America Lateral Flow Assay Market Analysis and Forecast
  9.1. Introduction
     9.1.1. Basis Point Share (BPS) Analysis by Country
     9.1.2. Y-o-Y Growth Projections by Country
     9.1.3. Latin America Average Pricing Analysis
  9.2. Latin America Lateral Flow Assay Market Size and Volume Forecast by Country
      9.2.1. Brazil
      9.2.2. Mexico
      9.2.3. Rest of Latin America
   9.3. Absolute $ Opportunity Assessment by Country
  9.4. Latin America Lateral Flow Assay Market Size and Volume Forecast by Applications
     9.4.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  9.5. Basis Point Share (BPS) Analysis by Applications
  9.6. Y-o-Y Growth Projections by Applications
  9.7. Latin America Lateral Flow Assay Market Size and Volume Forecast by End Users
     9.7.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  9.8. Basis Point Share (BPS) Analysis by End Users
  9.9. Y-o-Y Growth Projections by End Users
  9.10. Market Attractiveness/Growth Potential Analysis
     9.10.1. By Country
     9.10.2. By Product Type
     9.10.3. By Application
  9.11. Latin America Lateral Flow Assay Demand Share Forecast, 2019-2026
10. Europe Lateral Flow Assay Market Analysis and Forecast
  10.1. Introduction
     10.1.1. Basis Point Share (BPS) Analysis by Country
     10.1.2. Y-o-Y Growth Projections by Country
     10.1.3. Europe Average Pricing Analysis
  10.2. Europe Lateral Flow Assay Market Size and Volume Forecast by Country
     10.2.1. Germany
     10.2.2. France
     10.2.3. Italy
     10.2.4. U.K.
     10.2.5. Spain
     10.2.6. Russia
     10.2.7. Rest of Europe
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Europe Lateral Flow Assay Market Size and Volume Forecast by Applications
     10.4.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  10.5. Basis Point Share (BPS) Analysis by Applications
  10.6. Y-o-Y Growth Projections by Applications
  10.7. Europe Lateral Flow Assay Market Size and Volume Forecast by End Users
     10.7.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  10.8. Basis Point Share (BPS) Analysis by End Users
  10.9. Y-o-Y Growth Projections by End Users
  10.10. Market Attractiveness/Growth Potential Analysis
     10.10.1. By Country
     10.10.2. By Product Type
     10.10.3. By Application
  10.11. Europe Lateral Flow Assay Demand Share Forecast, 2019-2026
11. Asia Pacific Lateral Flow Assay Market Analysis and Forecast
  11.1. Introduction
     11.1.1. Basis Point Share (BPS) Analysis by Country
     11.1.2. Y-o-Y Growth Projections by Country
     11.1.3. Asia Pacific Average Pricing Analysis
  11.2. Asia Pacific Lateral Flow Assay Market Size and Volume Forecast by Country
     11.2.1. China
     11.2.2. Japan
     11.2.3. South Korea
     11.2.4. India
     11.2.5. Australia
     11.2.6. Rest of Asia Pacific (APAC)
  11.3. Absolute $ Opportunity Assessment by Country
  11.4. Asia Pacific Lateral Flow Assay Market Size and Volume Forecast by Applications
     11.4.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  11.5. Basis Point Share (BPS) Analysis by Applications
  11.6. Y-o-Y Growth Projections by Applications
  11.7. Asia Pacific Lateral Flow Assay Market Size and Volume Forecast by End Users
     11.7.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  11.8. Basis Point Share (BPS) Analysis by End Users
  11.9. Y-o-Y Growth Projections by End Users
  11.10. Market Attractiveness/Growth Potential Analysis
     11.10.1. By Country
     11.10.2. By Product Type
     11.10.3. By Application
  11.11. Asia Pacific Lateral Flow Assay Demand Share Forecast, 2019-2026
12. Middle East & Africa Lateral Flow Assay Market Analysis and Forecast
  12.1. Introduction
     12.1.1. Basis Point Share (BPS) Analysis by Country
     12.1.2. Y-o-Y Growth Projections by Country
     12.1.3. Middle East & Africa Average Pricing Analysis
  12.2. Middle East & Africa Lateral Flow Assay Market Size and Volume Forecast by Country
     12.2.1. Saudi Arabia
     12.2.2. South Africa
     12.2.3. UAE
     12.2.4. Rest of Middle East & Africa (MEA)
  12.3. Absolute $ Opportunity Assessment by Country
  12.4. Middle East & Africa Lateral Flow Assay Market Size and Volume Forecast by Applications
     12.4.1. Veterinary Diagnostics Clinical Testing Food Safety & Environment Testing Drug Development & Quality Testing
  12.5. Basis Point Share (BPS) Analysis by Applications
  12.6. Y-o-Y Growth Projections by Applications
  12.7. Middle East & Africa Lateral Flow Assay Market Size and Volume Forecast by End Users
     12.7.1. Homecare Pharmaceutical & Biotechnology Companies Hospitals & Clinics Diagnostic Laboratories
  12.8. Basis Point Share (BPS) Analysis by End Users
  12.9. Y-o-Y Growth Projections by End Users
  12.10. Market Attractiveness/Growth Potential Analysis
     12.10.1. By Country
     12.10.2. By Product Type
     12.10.3. By Application
  12.11. Middle East & Africa Lateral Flow Assay Demand Share Forecast, 2019-2026
13. Competition Landscape
  13.1. Global Lateral Flow Assay Market: Market Share Analysis
  13.2. Lateral Flow Assay Distributors and Customers
  13.3. Lateral Flow Assay Market: Competitive Dashboard
  13.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     13.4.1. Abbott Laboratories Quidel Corp. Hologic Inc. Thermo Fisher Scientific Inc. F.Hoffmann-La Roche Siemens AG  

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