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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, Troponin I}, 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), Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2022 - 2028

  • Report ID: GMI5147
  • Base Year: 2021
  • Report Format: PDF

Industry Overview

Lateral Flow Assays Market size accounted for more than USD 7.9 billion in 2021 and is estimated to grow at 5.7% between 2022 and 2028 owing to an increasing prevalence of infectious diseases such as tuberculosis, STDs, influenza, and others coupled with technological advancements. Increasing public awareness pertaining to point of care testing (POCT) and the high adoption of lateral tests in homecare settings is expected to spur the product demand.
 

Lateral Flow Assays Market

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For instance, according to the World Health Organization (WHO) statistics, in 2020, an estimated 37.7 million people were suffering with HIV. Further, during the same period, HIV infection accounted for approximately 680,000 mortalities and around 1.5 million new HIV cases were reported. Such growing number of infectious diseases including HIV cases have boosted the demand for diagnostic tools such as lateral flow tests.
 

Lateral flow assays (LFAs) also referred to as lateral flow immunochromatographic assays, are cellulose-based devices used to detect the presence of a target analyte in the sample. The different applications of LFAs include rapid cardiac markers diagnostics, drugs of abuse screening, pregnancy testing and infectious disease testing, among others. Further, lateral flow assays do not require running water, electricity, or expertise for its functioning. They deliver analytical information rapidly and cost-effectively. Furthermore, they can identify presence of wide range of pathogens, biomarkers, and environmental contaminants.
 

Furthermore, lateral flow tests can operate in any low-resource setting including home care settings and have been identified to adequately combat the COVID-19 pandemic. Thus, in response to COVID-19, the U.S. FDA and European Commission among other regulatory bodies authorized the use of several rapid lateral flow tests to prevent the spread of virus infection or illness.
 

For instance, The European Commission – Directorate General for Health and Food Safety stated that, the lateral flow assays demonstrated the potential to detect both symptomatic and asymptomatic coronavirus infections. Therefore, the association proposed robust testing strategy such as usage of lateral flow assay for early detection of potentially infectious individuals and, thus reduce the transmission within communities. Thus, usage of lateral flow tests during the pandemic had positive impact on the market growth.
 

Substantial investment by market players to develop lateral flow tests will spur the market statistics

The manufacturers are noted to be investing substantially to develop & commercialize lateral flow assay solutions that would inculcate features such as precision and increased functionality. For instance, in October 2020, Siemens Healthineers AG launched Clinitest Rapid COVID-19 Antigen Test, a lateral flow test, in Europe that enables the clinicians to detect COVID-19 infection in 15 minutes. This novel product offering is a POC test that possess the ability to function without the requirement of laboratory instruments or specialized lab personnel.
 

Similarly, in April 2020, Bio-Rad Laboratories launched its SARS-CoV-2 Total Ab test. This LFA test is a blood-based immunoassay kit that enables rapid detection of the antibodies developed due to SARS CoV-2. Thus, the novel advancements, emergence of integrative technologies that promote the precision & reduce the turn-around time, and product launches are projected to accelerate the lateral flow assays market growth of lateral flow assays in near future.
 

Lower accuracy of results may hamper the market demand

Low accuracy of results may act as a barrier to the lateral flow assays market growth. 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 error in large margin in the diagnosis of COVID-19. As per studies, the average error sensitivity of LFA towards symptomatic COVID-19 patients is 72%, whereas it is nearly 58% in case of asymptomatic patients. This indicates that even after negative test results in LFA, people must undergo PCR tests.
 

Further, lateral flow urine lipoarabinomannan assay (LF-LAM) for the detection of tuberculosis does not provide the information about drug resistance. Therefore, the positive or negative results whether they are false positive/negative or true positive/negative needs additional testing. The additional testing through culture testing is needed to find out the evidence for molecular drug or phenotypic resistance to get an accurate result. Thus, owing to such aforementioned factors, the doctors and clinicians are preferring more laboratory test than rapid lateral flow test.
 

Usage of lateral flow test to facilitate timely diagnosis and treatment will spur the market forecasts

Based on product, the market is segmented into kits and readers. The kits segment accounted for market share over 77% in 2021 and is expected to dominate the market throughout the forecast period due to the significantly increasing preference for lateral flow testing kits to detect from any antibody including COVID-19 virus. Therefore, the availability and launch of new kits by major players are anticipated to drive the lateral flow assays market share 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. Thus, introduction of novel product coupled with adoption of lateral flow tests for timely diagnosis and treatment are factors propelling market growth as lateral flow assays.
 

Increasing prevalence of infectious disease across the globe is expected to escalate the segmental expansion

Lateral Flow Assays Market Share, By Application

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Based on application, the lateral flow assays market is divided into infectious disease, cardiac marker testing, pregnancy & fertility testing, cholesterol testing, drug of abuse testing and others. The infectious disease testing accounted for market revenue of USD 2.4 billion in 2021 and is expected to show significant market growth from 2022 to 2028 owing to the rise in the prevalence and increased disease burden of infectious diseases.
 

According to the World Health Organization (WHO) statistics, in 2019, pneumonia was amongst the largest infectious conditions inflicting significant death among children globally. Pneumonia was responsible for 740,180 deaths and accounting for approximately 14% of all deaths in children aged 5 years & below. Similarly, as per the Center for Disease Control and Prevention (CDC) data, the STIs are on rise in the U.S. Thus, such rising disease burden is anticipated to drive the demand for lateral flow assays for disease diagnosis.
 

Various benefits of sandwich assays will upsurge the market trends

Based on technique, the lateral flow assays market is segmented into sandwich assays, competitive assays and multiplex detection assays. The sandwich assays segment held a dominant market share in 2021 and is expected to exhibit market CAGR of 5.7% through 2027 due to the rising demand and increasing awareness related to extensive advantages delivered by the sandwich assay method in the diagnosis of pregnancy & fertility testing, drug of abuse testing, etc.
 

This method of diagnosis offers high sensitivity & specificity that increases its adoption in numerous diagnostic laboratories positively. Further, availability of a broad spectrum of kits for performing sandwich assays with proven accuracy are also fuelling the products preference worldwide. Such benefits associated with sandwich assays are expected to drive the lateral flow assays market growth over the coming years.
 

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

The end-use segment of lateral flow assays market is bifurcated into hospitals & clinics, diagnostic laboratories, homecare settings and others. Hospital & clinics segment is expected to surpass USD 4 billion market revenue by end of 2028. The soaring use of novel lateral flow tests in hospital & clinics settings delivering rapid and reliable outcomes is estimated to surge the patient preference for these healthcare facilities. 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. Thus, accessibility to an effective diagnosis coupled with rising infectious disease across the globe are few factors boosting the uptake of lateral flow test kits in hospital settings over the analysis period.
 

Increasing public funding for the development of POCT testing devices in North America region will boost the market outlook

Lateral Flow Assays Market Size, By Region

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North America accounted for the market share of 45.7% of the global lateral flow assays market in 2021. Increasing prevalence of infectious diseases and growing application of POC tests for safe and early diagnosis will reinforce the regional dominance. 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 size over the forecast period.
 

For instance, in July 2020, the National Institute Health (NIH) invested USD 248.7 million in the development of new POCT technologies including lateral flow assays to address challenges that are associated with the testing of COVID-19. Thus, increasing support from government for research and development in field of COVID-19 testing is expected to upsurge the regional market growth. 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 growth of lateral flow assays.
 

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

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

Some of the recent industry developments:

  • In September 2021, the Abingdon Health launched a score-card product, an accessory of AbC-19 rapid test that offers semi-quantitative result to show the strength of antibody response and possible immunity. The use of the score-card accessory alongside AbC-19 LFD allows the researchers to understand the presence and strength of IgG neutralizing antibodies following infection and/or vaccination. This product launch was targeted at enhancing the company’s product portfolio, while expanding the features of AbC-19 rapid test.
     
  • In July 2021, Abbott launched Panbio COVID-19 Antigen Self-Test for the detection of SARS-CoV-2 virus in children and adults with or without symptoms. This self-test detects the infection from the sample obtained from the nasal swab and provides quick result within 15 minutes. This strategy enabled the company to expand its lateral flow assays product portfolio and increases the revenue generation.
     

The lateral flow assays market report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2022 to 2028, for the following segments:

By Product

  • Kits
  • Readers

By Application

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

By Technique

  • Sandwich assays
  • Competitive assays
  • Multiplex detection assays

By End-use

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

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

By Region

  • 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

 

Authors: Sumant Ugalmugale, Rupali Swain

Frequently Asked Questions (FAQ) :

The lateral flow assays industry accounted for a valuation of close to USD 7.9 billion in 2021 and will observe a growth rate of 5.7% between 2022 and 2028 led by rising technological advancements and growing burden of infectious diseases.

Kits held more than 77% of the lateral flow assays business share in 2021 and will witness expansion due to growing adoption for detecting antibodies, like the COVID-19 virus.

The lateral flow assays industry revenue from infectious disease testing crossed USD 2.4 billion in 2021 impelled by the rising threat of infectious diseases.

North America accounted for close to 45.7% of the lateral flow assays industry share in 2021 driven by the rising burden of infectious diseases and higher application of POC tests for safe and early diagnosis in the region.

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Premium Report Details

  • Published Date: Mar 2022
  • Companies covered: 10
  • Tables & Figures: 375
  • Countries covered: 15
  • Pages: 231

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