The lateral flow assay market size is projected to be valued at USD 4.3 billion in 2023 and is expected to rise to USD 6.9 billion by 2033. The sales of lateral flow assay are expected to register a CAGR of 4.7% during the forecast period. Various factors propelling the demand for lateral flow assay are:
The lateral flow assay (LFA) is a well-known commercial tool in the field of on-site diagnosis as it can produce results that are accurate, quick, and affordable, like those from at-home pregnancy tests.
Over time, lateral flow assay technology has rapidly advanced and is now frequently employed for companion diagnostic and point-of-care applications.
Home-based lateral flow assay equipment is becoming more popular as a result of its many advantages, including portability, low production costs, quick results, and general usability.
The quality of treatment is improved by lateral flow assay-based point-of-care testing due to several benefits they provide, including cost savings, fewer doctor visits, and lower laboratory overhead expenses.
Infectious disease diagnosis is greatly aided by LFA. It is mostly used to identify multiple infectious diseases like influenza, STDs, and tuberculosis.
Leading manufacturers of in-vitro clinical diagnostic devices are developing new point-of-care tests that is likely to produce less variability and more reliable test findings.
The expansion of awareness campaigns regarding the transmission of infections, diagnosis, and prevention, as well as the introduction of diagnosis systems in home care settings, are additional factors that are anticipated to assist in the growth of the global market.
However, problems like incorrect test results and delays in product approvals caused by strict regulatory rules are anticipated to limit the expansion of the studied market.
| Attribute | Details |
|---|---|
| Market Estimated Size (2023) | USD 4.3 billion |
| Market CAGR (2023 to 2033) | 4.7% |
| Market Forecasted Size (2033) | USD 6.9 billion |
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The market for lateral flow assays is set to witness an absolute dollar growth of USD 2.6 billion during the comparison period. Since the count of sexually transmitted diseases (STDs) has increased dramatically, so has the demand for standard care and rapid diagnosis.
The Centers for Disease Control and Prevention recently released data showing a 30% increase in reported cases of sexually transmitted diseases. According to WHO data, there was around 374 million cases of sexually transmitted infections in 2020.
The rising prevalence of these diseases is fueling the growth of the lateral flow assay market for disease diagnosis.
Furthermore, both government and private organizations are making efforts to raise public awareness and implement self-testing policies. Manufacturers such as Abbott are collaborating with organizations such as the African First Ladies Against HIV/AIDS (OAFLA) to reduce the spread of HIV in developing regions such as Africa. This is fueling a surge in demand for lateral flow assay tests across the globe.
Fast test diagnostics is likely to be fueled by technological advancements, significant collaboration efforts among critical participants in the pharmaceutical sector, funding programs, and the presence of reimbursement agencies.
Players in the home diagnostics industry are pushing and selling their lateral flow assay products extensively on the internet. This guarantees that the products are more visible to the general population. Furthermore, manufacturers are attempting to expand their customer base by implementing awareness activities.
Increased competition in the European food business and the development of the European validation system for alternative food testing methods, MICROVAL, allow Europe to catch up to the United States in terms of employing rapid food testing procedures.
In addition, significant food-exporting countries like Mexico and Brazil and Asia Pacific's burgeoning processed food sectors give another potential opportunity for lateral flow assay players.
Lateral flow assay-based diagnostic techniques have seen limited acceptance due to reimbursement concerns. In addition, the rising cost of healthcare is forcing insurance companies to reconsider the need for new diagnostic tests.
In addition, payers are shifting from fee-for-service reimbursement systems to fee-for-value-based reimbursement systems, and expenses are associated with the correction of assays that fail to pass stability testing. As a result, the time-to-market would be pushed back. In the projected term, these factors would represent a hurdle to the growth of the lateral flow tests market.
Most diagnostic tests are conducted in laboratories. These point-of-care (POC) assays are increasingly replacing lengthy laboratory procedures.
POC diagnostic tests are less expensive than laboratory diagnostic tests because they require less complicated infrastructure and training. The point-of-care diagnostic market is expected to dominate the lateral flow assays market, owing to the rising illness burden.
Infectious illness tests and cardiac indicators are the accelerating areas in the point-of-care diagnostic market. In addition, POC testing includes pregnancy and fertility tests, coagulation tests, and urine chemistry. The lateral flow assay Point of care diagnostic market has developed dramatically due to the increased utilization of in-home care settings.
Point-of-care testing with lateral flow assays for covid 19 is simple, quick, cheap, convenient, and straightforward to interpret. These tests might detect infections in whole blood, plasma, serum, and saliva, improving their value in point-of-care testing. In addition, Point-of-care and lateral flow assay diagnostics can discover sub-clinically infected people using biomarkers in certain circumstances.
Companies increasingly focus on developing innovative POC devices that measure protein markers in the blood to aid rapid clinical diagnosis of life-threatening events (such as heart attacks, strokes, and deep-vein thrombosis). The ARCHITECT STAT Troponin I Blood Test from Abbott Laboratories and the CLINITEK Microalbumin 2 strips from Siemens AG were developed in 2019.
The lateral flow assays for the COVID-19 market are likely to rise due to increasing demand for the point-of-care diagnostic market and increasing focus on lateral flow assay-based POC testing devices for portability.
With a revenue share of roughly 57% in 2022, the lateral flow assay kits segment dominated the market. The segment's popularity in the global lateral flow assay market is primarily fueled by its affordability and ease of use.
Customers can benefit from the expanding pharmacies that sell these items as OTC medical devices. The kits & reagents enable the delicate nature of some tests, the results of which consumers choose to keep to themselves, thereby increasing their use globally.
The increasing prevalence of infectious diseases throughout the world is a key driver fueling the expansion of the lateral flow assay market. These diseases necessitate novel diagnostic techniques for efficient treatment to stop the rising mortality rate.
For instance, around 37.7 million individuals worldwide were living with HIV in 2020, of whom 25.4 million were located in the WHO African area, according to the World Health Organization's (WHO) November 2021 report on HIV/AIDS.
Due to the increasing incidence of HIV, there is likely to be a significant need for reliable diagnostic tests that can detect the virus early. This demand is likely to lead market expansion as these tests offer an exact diagnosis.
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According to a report from the United States Department of Health & Human Services that was released in January 2020, 38,000 new HIV infections still take place in the country each year, and over 37,832 persons received HIV diagnoses in 2018.
Various infectious disorders, including meningitis and urinary tract infections, have been observed to spread quickly, demanding an instant diagnosis. This has increased the demand for quick diagnostic test devices and fueled the market's expansion.
| Attribute | Details |
|---|---|
| United States Market Size (USD million/billion) by End of Forecast Period(2033) | USD 1.6 billion |
| CAGR % 2018 to 2022 | 4.5% |
| CAGR % 2023 to End of Forecast(2033) | 4.0% |
The United Kingdom is expected to experience growth in the market, which help to maintain its impressive revenue share of USD 305.2 million, due to the increased adoption rate of advanced infrastructure, diagnostic centers, and the increase in public awareness.
Additionally, the pandemic severely affected the area and compelled the government to undertake widespread screening programs, which helped the local market grow.
| Attribute | Details |
|---|---|
| United Kingdom Market Size (USD million/billion) by End of Forecast Period (2033) | USD 305.2 million |
| CAGR % 2018 to 2022 | 5.4% |
| CAGR % 2023 to End of Forecast (2033) | 5.0% |
China is anticipated to be the most opportunistic region among others due to its vast and dense population. The population of low- and middle-income in the region is exposed to a variety of infectious diseases due to a lack of preventative healthcare measures.
The prevalence of infectious diseases is rising, which fuels market expansion. The rising costs of public healthcare also accelerate market growth. A supply-demand imbalance results from the region's large population lacking access to competent medical treatment and inadequate public healthcare infrastructure. The region's unfulfilled needs present private market enterprises with significant market potential.
| Attribute | Details |
|---|---|
| China Market Size (USD million/billion) by End of Forecast Period (2033) | USD 1.2 billion |
| CAGR % 2018 to 2022 | 8.6% |
| CAGR % 2023 to End of Forecast (2033) | 9.3% |
There are several significant competitors in the moderately competitive lateral flow assay market. To maintain their market share, a few of the firms are releasing new goods and creating new test methods for diagnosis, while others are growing their market positions through various strategies like mergers and acquisitions.
For instance, the market was positively impacted when Abbott announced in February 2019 that its most recent rapid influenza diagnostic test (RIDT), BinaxNOW Influenza A & B Card 2, was now available.
This test was approved by the United States Food and Drug Administration (FDA) under the Clinical Laboratory Improvements Amendments (CLIA) for the quick detection of the influenza virus.
Abbott Laboratories, Hologic Inc., Quidel Corporation, PerkinElmer Inc., and bioMerieux SA are a few of the firms now leading the market.
The RapidScan ST5-W lateral flow reader from Eurofins Technologies was introduced in December 2021. It was designed for field and in-process testing applications requiring qualitative to semi-quantitative test findings.
Abbott declared in January 2021 that their Panbio COVID-19 Ag Rapid Test Device, which can identify the SARS-CoV-2 virus for asymptomatic screening and self-administered sample collection using a nose swab, had been granted CE Mark for two new purposes.
| Attribute | Details |
|---|---|
| Growth Rate | CAGR of 4.7% from 2023 to 2033 |
| Base Year of Estimation | 2023 |
| Historical Data | 2018 to 2022 |
| Forecast Period | 2023 to 2033 |
| Quantitative Units | Revenue in USD billion and Volume in Units and F-CAGR from 2023 to 2033 |
| Report Coverage | Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, growth factors, Trends, and Pricing Analysis |
| Key Segments Covered | By Application, By Technique, By Sample Type, By End User, By Region |
| Regions Covered | North America; Latin America; Europe; East Asia; South Asia; The Middle East & Africa; Oceania |
| Key Countries Profiled | United States, Canada, Brazil, Mexico, Germany, Italy, France, United Kingdom, Spain, Russia, China, Japan, India, GCC Countries, Australia |
| Key Companies Profiled | Abbott Laboratories; Becton, Dickinson and Company; Biomérieux SA; Bio-Rad Laboratories; Danaher Corporation; F Hoffmann-La Roche Ltd.; Merck; Quidel Corporation; Siemens Healthineers AG; Thermo Fisher Scientific Inc. |
| Customization & Pricing | Available upon Request |
The market is valued at US$ 4.3 billion in 2023.
A CAGR of 5.4% was recorded from 2018 to 2022.
Lateral flow readers may dominate the market.
China is expected to generate US$ 1.2 billion by 2033.
Biomerieux SA, Abbott Laboratories and Danaher Corporation dominate the market.
| Estimated Size, 2024 | USD 904.5 million |
|---|---|
| Projected Size, 2034 | USD 1,635.1 million |
| Value-based CAGR (2024 to 2034) | 6.1% |
| Market Size (2022) | USD 995.8 million |
|---|---|
| Revenue Forecast (2030) | USD 2 billion |
| Market Growth Rate (2022 to 2030) | 9.2% CAGR |
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Lateral Flow Assays Market
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