The global lateral flow assays market size is expected to reach USD 13.60 billion by 2030, registering a CAGR of 4.26% over the forecast period. Major factors driving the growth include the rising prevalence of infectious diseases, growing government initiatives to curb infectious and chronic diseases, rise in demand for point-of-care testing, and increasing strategic mergers & acquisitions among others.
Lateral flow assays were developed about half a century ago and have facilitated several diagnostic and testing applications in domains such as healthcare, food & beverage testing, and environmental testing. Similarly, lateral flow assay applications in point-of-care diagnostics are growing and are propelling significant advancements in research for the development of products that evaluate body fluids, such as urine and saliva.
The use of these devices promotes self-testing, reduces the need for laboratory testing, and eliminates the need for trained laboratory personnel. Although there have been several technological advancements in laboratory testing in the recent past, several emerging economies still face challenges regarding timely medical intervention. This represents a major factor that is driving the adoption of dipsticks or lateral flow assays for facilitating timely diagnosis and treatment.
Due to the increasing utility of lateral flow assays for home use and self-testing, several at-home tests were launched after the pandemic began. For instance, tests such as Abbott’s BinaxNOW COVID-19 Antigen Self-Test, Access Bio’s CareStart COVID-19 Antigen Home Test, Becton, Dickinson and Company’s BD Veritor At-Home COVID-19 Test, and Ellume’s COVID-19 Home Test are commercially available.
Government initiatives supporting the use of such tests are expected to enhance the penetration of lateral flow assays and can aid in driving the lateral flow assays market growth. For instance, the Biden-Harris administration has incentivized health plans and insurers for installing a network of locations across the country for providing at-home, over-the-counter COVID-19 tests for free to people with private health coverage.
Continuous strategic initiatives undertaken by leading and emerging players to develop and launch advanced products are anticipated to significantly support market growth. For instance, in November 2021, IUL SA launched the iPeak Europium, a new lateral flow reader used to scan fluorescence-labeled lateral flow tests. Similarly, in March 2021, the company introduced its new lateral flow reader, iPeak+.
Additionally, in January 2021, Sensyne Health, based in the U. K., introduced an innovative smartphone app-MagnifEye-that employs deep machine learning AI to automate the interpretation of lateral flow diagnostic tests. A rise in mergers and collaborations by market players is anticipated to facilitate access to novel lateral flow technologies.
For instance, in February 2022, U. S.-based BD (Becton, Dickinson and Company) and Scanwell Health collaborated to create an at-home rapid test for SARS-CoV-2 using a BD lateral flow antigen test and the Scanwell Health mobile app. The collaboration aims to provide an efficient and scalable rapid antigen home testing solution.
The use of lateral flow devices also eliminates the need to wait for deciphering test results as well as aids in the optimization of timely treatment decisions, improves the efficacy of care provided, and significantly reduces diagnosis costs, especially in areas with resource-constrained settings and insufficient laboratory infrastructure. The rising trend of decentralized testing has been crucial in increasing the adoption of lateral flow devices globally.
The role of these devices has also been observed in controlling major infectious diseases such as malaria and influenza. According to WHO, rapid diagnostic tests are used in diagnosis by healthcare professionals distant from microscopy services; remote diagnosis by professionals in malaria54-endemic countries; and outbreak investigation & survey of parasite prevalence. Thus, various benefits offered by lateral flow devices are among the key factors responsible for increasing the adoption of lateral flow assays globally.
On the other hand, with the advent of advanced technologies, such as PCR and molecular diagnostics, the demand for lateral flow assays may be witnessing sluggish growth to a certain extent. Although lateral flow assays have high specificity and sensitivity, PCR and other molecular diagnostic technologies have emerged to be more sensitive.
Lateral flow assays were developed about half a century ago and have facilitated several diagnostic and testing applications in domains such as healthcare, food & beverage testing, and environmental testing. Similarly, lateral flow assay applications in point-of-care diagnostics are growing and are propelling significant advancements in research for the development of products that evaluate body fluids, such as urine and saliva.
The use of these devices promotes self-testing, reduces the need for laboratory testing, and eliminates the need for trained laboratory personnel. Although there have been several technological advancements in laboratory testing in the recent past, several emerging economies still face challenges regarding timely medical intervention. This represents a major factor that is driving the adoption of dipsticks or lateral flow assays for facilitating timely diagnosis and treatment.
Due to the increasing utility of lateral flow assays for home use and self-testing, several at-home tests were launched after the pandemic began. For instance, tests such as Abbott’s BinaxNOW COVID-19 Antigen Self-Test, Access Bio’s CareStart COVID-19 Antigen Home Test, Becton, Dickinson and Company’s BD Veritor At-Home COVID-19 Test, and Ellume’s COVID-19 Home Test are commercially available.
Government initiatives supporting the use of such tests are expected to enhance the penetration of lateral flow assays and can aid in driving the lateral flow assays market growth. For instance, the Biden-Harris administration has incentivized health plans and insurers for installing a network of locations across the country for providing at-home, over-the-counter COVID-19 tests for free to people with private health coverage.
Continuous strategic initiatives undertaken by leading and emerging players to develop and launch advanced products are anticipated to significantly support market growth. For instance, in November 2021, IUL SA launched the iPeak Europium, a new lateral flow reader used to scan fluorescence-labeled lateral flow tests. Similarly, in March 2021, the company introduced its new lateral flow reader, iPeak+.
Additionally, in January 2021, Sensyne Health, based in the U. K., introduced an innovative smartphone app-MagnifEye-that employs deep machine learning AI to automate the interpretation of lateral flow diagnostic tests. A rise in mergers and collaborations by market players is anticipated to facilitate access to novel lateral flow technologies.
For instance, in February 2022, U. S.-based BD (Becton, Dickinson and Company) and Scanwell Health collaborated to create an at-home rapid test for SARS-CoV-2 using a BD lateral flow antigen test and the Scanwell Health mobile app. The collaboration aims to provide an efficient and scalable rapid antigen home testing solution.
The use of lateral flow devices also eliminates the need to wait for deciphering test results as well as aids in the optimization of timely treatment decisions, improves the efficacy of care provided, and significantly reduces diagnosis costs, especially in areas with resource-constrained settings and insufficient laboratory infrastructure. The rising trend of decentralized testing has been crucial in increasing the adoption of lateral flow devices globally.
The role of these devices has also been observed in controlling major infectious diseases such as malaria and influenza. According to WHO, rapid diagnostic tests are used in diagnosis by healthcare professionals distant from microscopy services; remote diagnosis by professionals in malaria54-endemic countries; and outbreak investigation & survey of parasite prevalence. Thus, various benefits offered by lateral flow devices are among the key factors responsible for increasing the adoption of lateral flow assays globally.
On the other hand, with the advent of advanced technologies, such as PCR and molecular diagnostics, the demand for lateral flow assays may be witnessing sluggish growth to a certain extent. Although lateral flow assays have high specificity and sensitivity, PCR and other molecular diagnostic technologies have emerged to be more sensitive.
Lateral Flow Assays Market Report Highlights
- Kits & reagents dominated the market share of 67.81% in 2022. These products offer versatility for use in pharmaceuticals, animal health, environmental testing, feed & food testing, and crop & plant testing
- The launch of new self-testing and at-home kits by major players is anticipated to boost market growth during the forecast period. For instance, in July 2021, Abbott Laboratories launched its Panbio COVID-19 Antigen Self-Test in India, which was followed by Roche Diagnostics India’s launch of its COVID-19 At-Home Test in January 2022
- Clinical testing held the majority share of 76.87% in 2022. Lateral flow assays are used in clinical testing by multiple diagnostic facilities due to ease of use & portability. These tests offer results with a reduced turnaround time as compared to other laboratory tests. In addition, as oral fluid-based testing is gradually developing, the use of lateral flow assays is becoming convenient because of the noninvasive nature of collecting specimens
- Sandwich assays held the largest market share of 39.35% in 2022, owing to their affordability, accuracy, and ease of use. These assays can also be performed in low-resource healthcare settings without the need for prior training. As a result, sandwich assays are widely used, which drives the growth
- Lateral flow immunoassays dominated the largest revenue share of 64.50% in 2022. These assays can be used for the detection of antigens or antibodies in clinical samples and offer an effective diagnostic option that conforms with the WHO ASSURED criteria for diagnostics. With increasing requirements for point-of-care testing alternatives in recent years, the demand for such assays is projected to grow over the forecast period
- The hospitals & clinics segment held the largest revenue share of 35.69% in 2022. The increasing need for hospitals with enhanced diagnostic services and rising global healthcare expenditure are anticipated to fuel market growth
- Various infectious diseases, such as influenza, HIV, and hepatitis, are easily transmitted in hospitals, often causing outbreaks. To reduce or even eliminate such occurrences, hospitals have to comply with specific guidelines to ensure adequate patient quarantine measures, the safety of healthcare workers, and proper sanitization
- North America held the dominant revenue share of 35.87% in 2022, owing to an increase in the incidence of infectious diseases such as influenza. For instance, as per the U. S. CDC estimates, between 2010 and 2020, there have been around 9 million to 41 million influenza infection cases, leading to about 140,000 to 710,000 hospitalizations and 12,000 to 52,000 deaths annually in the U. S.
- Asia Pacific is expected to grow at the fastest CAGR from 2023 to 2030 owing to increasing collaborations among market entrants and a rise in product approval for various infectious disease tests is anticipated to boost the growth. For instance, in February 2020, Shenzen Bioeasy Biotechnology announced that the company received CE marking for its COVID-19 LFA immunoassay kits
Table of Contents
Chapter 1 Lateral Flow Assay Market : Research Methodology And Scope
Chapter 2 Lateral Flow Assay Market Market : Executive Summary
Chapter 3 Lateral Flow Assay Market Variables, Trends, & Scope
Chapter 4 Lateral Flow Assay Market: Product Estimates and Trend Analysis
Chapter 5 Lateral Flow Assay Market: Application Estimates and Trend Analysis
Chapter 6 Lateral Flow Assay Market: Technique Estimates and Trend Analysis
Chapter 7 Lateral Flow Assay Market: End-use Estimates and Trend Analysis
Chapter 8 Lateral Flow Assay Market: Test Type Estimates and Trend Analysis
Chapter 9 Lateral Flow Assay Market: Regional Estimates and Trend Analysis
List of Tables
List of Figures
Companies Mentioned
- Abbott Laboratories
- Thermo Fisher Scientific, Inc.
- F. Hoffmann-La Roche AG
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- Quidel Corporation
- Hologic, Inc.
- PerkinElmer, Inc.
- Merck KGaA
- BD
- Siemens Healthineers
- Danaher Corporation
- QIAGEN N.V.
Methodology
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