Lateral Flow Assay Components Market Dynamics:

DRIVERS: Growing demand for lateral flow assay kits due to the COVID-19 pandemic

During COVID-19, many companies launched home-based lateral flow assays for COVID-19 testing as people were afraid to get tested at diagnostic laboratories or hospitals, which supported the demand for home-based lateral flow assays. This led to the launches of several

# The BinaxNOW COVID-19 Ag Card was launched in August 2020, and the Panbio Rapid COVID-19 test was launched in September 2020.

# Roche Diagnostics launched the SARS-CoV-2 Rapid Antigen test in September 2020.

# Other tests launched during COVID-19 include Sofia 2 Flu+ SARS Antigen FIA (Quidel Corporation), CLINITEST Rapid COVID-19 Antigen test (Danaher Corporation), and BD Veritor SARS CoV-2 Test (BD).

Growing Usage of home-based lateral flow assay devices:

Home-based lateral flow assay devices play a vital role in managing cardiovascular and infectious diseases. These devices are also very useful in testing pregnancy and stigmatized conditions such as HIV as they potentially empower patients to perform self-tests in their homes. Hence, the increasing incidence of these diseases and the higher adoption of lateral flow assay tests in home care settings are expected to boost the demand for lateral flow assay components in the coming years.

Growing demand for point-of-care testing

Lateral flow assay-based point-of-care (POC) tests are increasingly being adopted to replace lengthy, conventional laboratory procedures. POC diagnostic tests do not require complex infrastructures and training, owing to which the cost of these tests is lower than conventional laboratory diagnostic procedures. POC testing is anticipated to hold the greatest share in the lateral flow assays market because of its importance in combating the growing disease burden.

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Increasing public and private investment to develop lateral flow assays

Medical device companies use lateral flow membranes in rapid diagnostic test kit manufacturing, enabling reproducible results due to their consistent quality and optimized properties. Rapid test kits are used for a variety of applications, including infectious disease testing (COVID-19, HIV, influenza, and malaria), as well as in women’s health, biomarker detection, drug testing, food safety, and animal health. Due to the continuously increasing demand for lateral flow membranes, public and private investors are investing in developing lateral flow assays and their components. These investments may improve the manufacturing capacity of assay components, leading to growth in the lateral flow assay components market during the forecast period.

RESTRAINTS: Availability of alternative diagnostics technologies

Although lateral flow assay kits have many advantages like low cost, rapid detection, stability over a wide range of environmental conditions, and a very long shelf life, they are also associated with a number of disadvantages. These kits are mostly qualitative or semi-quantitative, reproducibility varies from lot to lot, they suffer from low biomolecule affinity toward analytes, the tendency of cross-reactivity, and the occasional requirement of pretreatment of samples which is time-consuming. Once a sample is applied to a strip, capillary action cannot be decreased or sped up, and the analysis time is also dependent on the nature of the sample itself, i.e., viscosity or surface tension. This limits the adoption of lateral flow assay kits to a greater extent, affecting the demand for lateral flow assay components.

CHALLENGES: Requirement of specialized storage and shipping facilities for membrane

One of the most challenging aspects of developing lateral flow assay tests is the procurement of membranes such as nitrocellulose membranes or polyvinylidene difluoride membranes, which are critical components. Nitrocellulose membranes are biological membranes made up of nitrocellulose and have a different grade of pore size. The performance of lateral flow assay kits depends on the quality of the nitrocellulose membrane used. Nitrocellulose membranes must be stored properly to ensure maximum shelf life.

These components need to be stored away from room temperature or chemical vapors, which may partially dissolve the nitrocellulose and thereby disrupt the pore structure. They also need to be protected from direct sunlight, which may cause them to dry out and become brittle. Nitrocellulose membranes are highly flammable and must be kept away from heat and open flames. These factors pose a challenge to the growth of the lateral flow assay components market in the forecast period.

OPPORTUNITY: Evolving application of lateral flow assays

Lateral flow assays have evolved rapidly in the last two decades and are routinely used in POC and diagnostic applications. Although lateral flow tests are widely used for infectious disease diagnostics, the diagnosis of cardiac diseases, and veterinary applications, their use has increased in several new applications over the last few years. For instance, saliva diagnostics, behavioral health, agriculture (genetically modified organism detection and crop quality testing), biowarfare (anthrax detection), environmental testing (detection of contaminating enzymes in manufacturing plants), and food microbiology (detection of E. coli O157, Salmonella, Listeria, and other food spoilage organisms) have emerged as new application areas for lateral flow assays.

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