Lateral Flow Assays Market

Lateral Flow Assays Market Outlook

The global lateral flow assays market size was valued at US$ 7.2 Billion in 2021, with 4.7% CAGR, the projected market growth during 2022-2032 is expected to reach nearly US$ 11.7 Billion in 2032.

The lateral flow assays market is segmented into various product types, including lateral flow readers, digital/mobile readers, benchtop readers, kits & reagents. Among all the types, Benchtop Readers is expected to be the highest revenue generating product, while Clinical Testing is considered to be the highest revenue generating application with a CAGR of 4.6% and 5% respectively during 2022-2032.

Given the multiple advantages that lateral flow technology provides, it is becoming the approach of choice for infectious disease diagnostics. The market's growth can be due to the rising prevalence of infectious diseases, growing elderly population and the growing popularity of point-of-care testing.

The market is also expected to gain from the growing popularity of self-diagnosis, which is driving demand for home-based lateral flow assay devices. Continuing technological breakthroughs in the field of lateral flow tests are also boosting market expansion. These efforts are aimed at improving the selectivity, sensitivity, and quantitation of these tests. In addition, growth is boosted by the integration of enhanced quantification systems, novel labels, and simultaneous detection approaches.

Revenue of Lateral Flow Assay from 2017 to 2021 Compared to Demand Outlook for 2022 to 2032

As per the Lateral Flow Assays industry research by Fact.MR - a market research and competitive intelligence provider, historically, from 2017 to 2021, market value of the Lateral Flow Assay industry increased at around 2.6% CAGR, wherein, countries such as the U.S., China, Japan, U.K. and South Korea held significant share in the global market. Owing to this, Lateral Flow Assay   market is projected to grow at a CAGR of 4.7% over the coming 10 years.

• The Lateral Flow Assays market reached a valuation of US$ 7.4 Bn in 2022 owing to which the worldwide revenues was up by 2% year-over-year.
• Fact.MR estimates that Lateral Flow Assays revenue will grow 1.5X from 2022 to 2032, reaching nearly US$ 11.7 Bn in 2032.

How is the Current Healthcare Requirements Impacting Lateral Flow Assay Revenues?

Due to a number of technological limitations and the time necessary for device development and approval, the adoption of lateral flow assay components is limited and restricted.

These assays, for example, are only useful for primary screening and do not provide a quantitative detection that may be used to determine the severity of the problem being diagnosed. As a result, lateral flow assay results are binomial, with just a positive or negative outcome.

The reliability of lateral flow assays is compromised by poor reproducibility of results and a high proportion of false negative and false positive outcomes. As a result of these constraints, adoption has been impeded, and market growth has been slowed slightly.

What is the impact of COVID 19 Crisis on the Lateral Flow Assay Market?

The COVID-19 pandemic has had a beneficial effect on lateral flow assays markets, as the need for quick identification of the coronavirus pathogen has been a priority for countries since December 2019. As the number of infections in various countries spiked, many of the leading lateral flow assays market leaders invested in research and development and formed partnerships with each other.

A number of COVID-19 antibody and antigen tests have been launched, with growing production and distribution to meet the demand. Though the diagnostic accuracy of these tests is lower than those of other procedures, they stand at a price, simplicity, ease of use, and quick turnaround that make them super popular among test data.

In the best-case scenario, the pandemic's increased focus and attention for point of care diagnostics and diagnostic testing will be long-lasting. This suggests that increasing end-user awareness of lateral flow testing solutions for different medical conditions and applications (such as food and environmental safety testing and medication development) may help the market flourish in the post-COVID-19 period.

Region-wise Analysis

Which Region is projected to Offer the Largest Opportunity for Lateral Flow Assay?

With over 5.5% projected growth rate, Lateral Flow Assay revenue is expected to grow at fastest pace in the North America during 2022 – 2032 with an absolute dollar growth of US$ 2 Bn. Due to multiple mergers, partnerships, and acquisitions by key players, North America is expected to maintain the dominant position in the global Lateral Flow Assays market throughout forecast period.

Country-wise Insights

What Factors are driving the Lateral Flow Assay Revenue in the US?

The presence of the key market leaders in the United States has facilitated lateral flow assays market growth in the country. Furthermore, a favorable reimbursement scenario and advanced point-of-care testing facilities promote the lateral flow assays market in the United States.

Alongside, the region's high rate of respiratory illnesses such COVID-19, influenza, and RSV is driving up demand for detection and treatment. The availability of government funding for research and the presence of well-established healthcare infrastructure are expected to boost the market for lateral flow assays in the country. The National Institute of Health (NIH) spent US$ 248.7 Mn for the development of new technologies to overcome issues related with COVID-19 testing in July 2020.

Category-wise Insights

Why Lateral Flow Assay Kits Command the Highest Revenue in the Market?

Lateral Flow Assay Kits will account for over 70% of the market in 2022, growing at a CAGR of around 5%, during the forecast period. The ease of use, low cost, and ease of production are the primary elements driving lateral flow assays kits acceptance. Top product type being Benchtop Readers expected to grow at a CAGR of 4.6% and top application being Clinical testing are growing at a CAGR of 5% throughout the forecast period.

Clinical testing segment is likely to dominate the market among lateral flow assay applications. This is due to an increase in the occurrence of infectious diseases, notably the COVID-19 outbreak. For the quantitative and qualitative identification of specific antibodies, products of gene amplification, and antigens, lateral flow-based assays are frequently employed at physicians' offices, hospitals, and clinical laboratories. Owing to its ease of use and mobility, lateral flow assay testing makes illness testing easier.

Vertical flow readers and lateral flow readers are often picked for R&D and sample testing applications, therefore it is expected that vertical flow readers demand will grow at a considerable rate.

As an increasing number of lateral flow assay readers make use of digital formats to enhance the accuracy of information-gathering, digital lateral flow assay readers using mobile apps are expected to be the fastest growing sector in the following years. The addition of a digital connectivity platform to lateral flow readers is projected to transform single-use diagnostic procedures by allowing test results to be accessed from any laboratory location, thus saving time.

Competitive Analysis

Product approvals, new product releases, acquisitions, collaborations, and innovations are all important methods used by leading market players to maintain their market position.

According to the market research analysis, partnerships and expansion have been the prominent development in Lateral Flow Assays market in recent year. 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; Becton, Dickinson and Company; Siemens Healthineers; Danaher Corporation; Qiagen N.V. are the prominent providers of Lateral Flow Assay services.

The leading players in the Lateral Flow Assays market have been implementing various tactics to increase growth potential over the next years. Furthermore, the presence of many rising and well-established firms has defined the market for Lateral Flow Assay. Well-known market players are pursuing a variety of tactics, including acquisitions, mergers, and new product releases. Some of the recent developments of key Lateral Flow Assay providers are as follows:

• In October 2021, Bio-Plex Pro human immunoglobulin A (IgA) and immunoglobulin M (IgM) SARS-CoV-2 antigen panels were launched by Bio-Rad Laboratories, a life science research and clinical diagnostic products firm, to detect IgA and IgM antibodies against four SARS-CoV-2 antigens.
• In September 2021, The FDA granted ANP Technologies Inc. authorization to use its NIDS COVID-19 Antigen Rapid Test Kit as a treatment for the act of NANs in children as well as adults with suspected COVID-19. Following analyses in the United States, this test utilizes a technology by ANP.
• In October 2020, Siemens Healthineers launched a rapid antigen test for the detection of SARS-CoV-2.
• In September 2020, Roche announced the launch of the SARS-CoV-2 fast antigen test for markets that accept the CE Mark. Roche also plans to apply to the US Food and Drug Administration for an Emergency Use Authorization (EUA) (FDA).

Similarly, recent developments related to companies offering Lateral Flow Assay have been tracked by the team at Fact.MR, which are available in the full report.

Lateral Flow Assay Market Report Scope

Report Attribute	Details
Forecast Period	2022-2032
Historical Data Available for	2017-2021
Key Countries Covered	U.S. Canada Germany U.K. France Italy Spain Russia China; India; Japan South Korea Australia Singapore Brazil; Mexico Argentina South Africa Saudi Arabia UAE
Key Market Segments Covered	Product Type Application Technique Region
Key Companies Profiled	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 Becton, Dickinson and Company Siemens Healthineers Danaher Corporation Qiagen N.V

Market Segments Covered in Lateral Flow Assay Industry Analysis

• By Product Type

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

• By Application

  • Drug Development & Quality Testing
  • Clinical Testing
  • Veterinary Diagnostics
  • Food safety & Environment Testing

• By Technique

  • Sandwich Assays
  • Competitive Assays
  • Multiplex Detection Assays

• By Region

  • North America
  • Latin America
  • Europe
  • APAC
  • MEA