Market Trends of Lateral Flow Assay Industry
The Sandwich Assay Technique Segment is Expected to Have Significant Growth in the Market During the Forecast Period
The sandwich assay technique segment is the most commonly used Lateral Flow Assay for detecting specific analytes, such as proteins or biomarkers. This technique involves using two distinct antibodies or capture molecules to identify and quantify the target analyte. Some products that utilize the sandwich assay technique in lateral flow assays include the Clearblue Pregnancy Test, BinaxNOW COVID-19 antigen test, and OneTouch Ultra test strips. The sandwich assay technique has witnessed significant growth and adoption in the Rapid Diagnostic Testing field due to several factors, such as high sensitivity and specificity, rapid results, versatility, and ease of use.
Chronic diseases such as heart disease, HIV, and diabetes elevate specific biomarkers, detectable through the sandwich assay technique in Lateral Flow Tests. For instance, according to the 2024 International Diabetes Federation, by 2045, an estimated 783 million adults, or 1 in 8, are projected to be living with diabetes worldwide. Additionally, according to data published by the Centers for Disease Control and Prevention in May 2024, approximately 805,000 individuals in the United States experience a heart attack annually. Thus, the high burden of these diseases increases the demand for sandwich-type Lateral Flow Assay Products, boosting the segment's growth.
Also, with new product approvals and launches, the availability of sandwich assay techniques for various disease conditions is set to rise, driving segment growth during the forecast period. For instance, in April 2024, Roche Diagnostics India launched its Point-of-Care Testing NT-proBNP test to screen diabetes patients at risk of cardiovascular diseases (CVD), including heart failure (HF). This extended claim for the NT-proBNP biomarker is exclusively available on the cobas h 232 system, which operates on the sandwich assay technique.
Similarly, in August 2023, Clearblue unveiled its latest innovation, the Clearblue Menopause Stage Indicator. The sandwich assay-based product combines the follicle-stimulating hormone (FSH) readings gathered from the user's urine with the user's age and cycle history to identify the stage in the menopause journey accurately. Therefore, similar new product approvals and launches are anticipated to increase the availability of sandwich assay products, thereby boosting the segment growth during the forecast period.
The segment is expected to grow significantly during the forecast period due to factors such as the high burden of chronic diseases and new product approvals and launches in the Lateral Flow Assay Market.
North America is Expected to Witness a Significant Growth During the Forecast Period
North America is expected to dominate the overall Lateral Flow Assay Market during the forecast period owing to a rise in the incidence of various infectious diseases, such as Influenza and Tuberculosis, and newly diagnosed HIV/AIDS in the region. For instance, according to the updated data published by the Centers for Disease Control and Prevention in the Weekly US Influenza Surveillance Report, in April 2023, FluSurv-NET locations reported a total of 25,317 laboratory-confirmed influenza-related hospitalizations in the United States between October 1, 2023, and August 3, 2024, compared to 17,997 laboratory-confirmed influenza-related hospitalizations between October 1, 2022, and April 15, 2023, in the United States.
The same source reported that, between October 1, 2023, and August 3, 2024, a total of 21,409 hospitalizations (84.6%) were related to the Influenza A virus, 3,734 (14.7%) to the Influenza B virus, 53 (0.2%) to Influenza A virus and Influenza B virus co-infection, and 121 (0.5%) to flu for which the type of the virus could not be identified. Thus, the increasing burden of Influenza virus infection increases the demand for Rapid Antigen Tests and Lateral Flow Assay Testing, which is anticipated to bolster the market growth during the forecast period.
Further, the launch of advanced products contributes to the growth of the market. For instance, in June 2022, Lumos Diagnostics, a provider of Point-of-Care Testing diagnostic technologies, reported that Health Canada granted Interim Order authorization for ViraDx, a three-in-one COVID-19/Flu A/Flu B Rapid Antigen Test for use by healthcare professionals. Thus, such product launches will likely drive Rapid Diagnostics Market growth during the forecast period.
