Lateral Flow Assays Market Size By Product (Kits, Readers), By Application (Infectious Disease Testing {Influenza, STDs, Hepatitis, Tuberculosis}, Cardiac Metabolic Testing {CK-MB Testing, Myoglobin, D-dimer}, Pregnancy & Fertility Testing {Pregnancy Testing, Fertility Testing}, Cholesterol Testing, Drug of Abuse), By Technique (Sandwich Assays, Competitive Assays, Multiplex Detection Assays), By End-use (Hospital & Clinics, Diagnostic Laboratories, Homecare Settings), COVID-19 Impact Analysis, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2021 - 2027

Published Date: Oct 2021  |  Report ID: GMI5147  |  Authors: Sumant Ugalmugale, Rupali Swain

Report Format: PDF   |   Pages: 250   |   Base Year: 2020

Summary Table of Contents Industry Coverage Methodology

Industry trends

Lateral Flow Assays Market size exceeded USD 6.9 billion in 2020 and is predicted to grow at CAGR of over 6.8% between 2021 and 2027. Infectious diseases are increasing across the globe owing to a growing number of pathogens and microorganisms.

Lateral Flow Assays Market Overview

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Furthermore, rapid lateral flow tests are capable of operating in any low-resource setting including at home and are needed to adequately combat the COVID-19 pandemic. Hence, in response to the COVID-19 outbreak, the U.S. FDA authorized various lateral flow tests for novel COVID-19 disease, such as the Abingdon Abc-19 test.

These tests require specialized and expensive instrumentation and high-level technical expertise. Hence, scalable, affordable, and easy-to-use lateral flow tests remain vital to fight against the COVID-19 pandemic. Moreover, the growing adoption of lateral flow tests in countries, such as the UK and the U.S. among others, is expected to drive the market growth.

Technological advancements in lateral flow assays to spur the market expansion

Advancements from the initial stages of single pathogen detection to nucleic acid amplification methods have been developed to deliver faster and accurate results. High throughput capability has assisted in generating considerable data on various disease-causing pathogens. The pathogens including parasites, bacteria and viruses are detected with the help of specific disease markers present in the specimen, such as stool, urine, blood, respiratory secretions and cerebrospinal fluid. Thus, technological advancements will augment lateral flow assays market over the coming years due to enhanced specificity, reliability and faster results. Additionally, the introduction of novel products to provide rapid progress in R&D of POCT diagnostic tools will further stimulate the industry growth.

Lower accuracy results may hamper the lateral flow assays market progression

Lateral flow assay tests are observed to have low accuracy than laboratory tests. For instance, the antibody test of SARS-CoV-2 that is based on lateral flow technology shows an error in a large margin in the diagnosis of COVID-19. The error arises as the average sensitivity of LFA towards symptomatic COVID-19 patients is 72%, whereas it is nearly 58% in the case of asymptomatic patients. This indicates that even after negative test results in LFA, people may have to undergo a PCR test.

Further, lateral flow urine lipoarabinomannan assay (LF-LAM) for the detection of tuberculosis does not provide information about drug resistance. Therefore, the positive or negative results that could be false positive/negative or true positive/negative need additional testing. Additional testing through culture testing is needed to find out the evidence for molecular drug or phenotypic resistance to get an accurate result.

Lateral flow test kits are adopted to facilitate timely diagnosis and treatment

The kits segment dominated more than 77.4% of the lateral flow assays market share in 2020. The availability and launch of new kits are anticipated to boost the industry expansion during the forecast period. For instance, in February 2020, Bioeasy Biotechnology announced that the company received CE marking for its COVID-19 LFA immunoassay kits. Similarly, the use of lateral flow kits reduces the need for laboratory testing, eliminating the need for trained laboratory personnel and propelling self-testing.

Increasing prevalence of infectious diseases across the globe will escalate the segment growth

Lateral Flow Assays Market Size

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The infectious disease testing in the lateral flow assays market was valued at over USD 2.1 billion in 2020. The infectious disease testing is sub-classified into influenza, STDs, hepatitis, tuberculosis and others. Increasing prevalence of infectious disease in developed as well as developing economies is one of the major factors poised to impel the segment expansion. Furthermore, increased participation of the government and the increasing awareness programs to control the outbreaks of infectious diseases to contribute to the growth of the global market during the forecast period.

Various benefits of competitive assays will upsurge the lateral flow assays market value

The sandwich assays segment is expected to witness 6.7% growth rate through 2027. The sandwich assays are typically used for detecting relatively large analytes. The sandwich format results in a signal intensity that is proportional to the amount of analyte present in the sample. If the analyte has at least two distinct binding sites that are epitopes, then a sandwich assay can be developed. In addition, the epitope is conjugated to the nanoparticle and an antibody to another epitope is immobilized at the test line.

Hospitals & clinics are primary care settings for the diagnosis and treatment of medical conditions

Lateral flow assays market for hospital & clinics segment is slated to reach USD 3.9 billion by 2027. Hospitals & clinics are primary care settings for the diagnosis and treatment of medical conditions. Increasing number of hospital admissions and rising geriatric population that are susceptible to various disease conditions will drive the segment progression. Also, availability of technologically advanced equipment in hospital setting will further add to its growth. Further, constant changes in the healthcare industry have led to an increase in the need for hospitals with enhanced diagnostic services.

Growing public funding for the development of POCT testing devices in North America region will accelerate the market revenue

Global Lateral Flow Assays Market

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North America lateral flow assays market captured 45.9% of revenue share in 2020 led by the increasing prevalence of infectious diseases and growing application of POC tests for safe and early diagnosis. High R&D investment by government and private funding organizations for the advancement of point of care testing, including lateral flow tests is anticipated to propel the industry value. Additionally, mounting demand for rapid and portable tests that are cost effective and user-friendly among the homecare setting will be a highly influential factor for industry demand.

Organic and inorganic business strategies will pave growth opportunities for companies operating in the market

Prominent players operating in the lateral flow assays market include Abbott, BioMerieux, Bio-Rad Laboratories, Quidel Corporation, Abingdon Health and F. Hoffmann La Roche. New product launch & approval, acquisition and collaboration are the most commonly adopted business strategies to sustain market position.

The lateral flow assays market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:

Market, By Product

  • Kits
  • Readers

Market, By Application

  • Infectious disease testing
    • Influenza
    • STDs
    • Hepatitis
    • Tuberculosis
    • Others
  • Cardiac marker testing
    • CK-MB testing
    • Myoglobin
    • D-dimer
    • Others
  • Pregnancy & fertility testing
    • Pregnancy testing
    • Fertility testing
  • Cholesterol testing
  • Drug of abuse testing
  • Others

Market, By Technique

  • Sandwich assays
  • Competitive assays
  • Multiplex detection assays

Market, By End-use

  • Hospital & clinics
  • Diagnostic laboratories
  • Homecare settings
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
  • Latin America
    • Brazil
    • Mexico
  • Middle East & Africa
    • South Africa
    • Saudi Arabia


Frequently Asked Questions (FAQ) :

Market size of lateral flow assays surpassed USD 7 billion in 2020 and will observe more than 6.8% CAGR from 2021 to 2027 owing to the prevalence of infectious diseases, including COVID-19.
Kits contributed over 77.4% of the market share in 2020 and will grow with the demand for self-testing and subsequently reducing the need for lab testing.
Infectious diseases testing garnered more than USD 2.1 billion in 2020 and could witness a similar trend owing to the rise of tuberculosis and STDs across emerging and advanced economies.
North America accounted for around 45.9% of revenue in 2020 and will expand due to increasing cases of infectious diseases and the application of POC tests.
F. Hoffmann La Roche, Abbott, Bio-Rad Laboratories, Abingdon Health and Quidel Corporation, among others are a few of the key players driving global market growth.

Premium Report Details

  • Published Date: Oct 2021
  • Pages: 250
  • Tables: 355
  • Charts / Figures: 18
  • Companies covered: 10
  • Countries covered: 15

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