The lateral flow assay market size is expected to grow from US$ 8,505.89 million in 2022 to US$ 16,106.13 million by 2030; it is estimated to record a CAGR of 8.4% during 2022-2030.

The lateral flow assay market growth is attributed to the increasing use of home-based assay kits and the rising popularity of point-of-care testing. However, inconsistent assay results due to procedural limitations hinders the market growth.

Lateral flow assays are widely used for infectious disease diagnosis, heart disease diagnosis, and veterinary applications. However, the scope of their applications has expanded in recent years. Behavioral health, saliva-based diagnostics, biological warfare (detection of Bacillus anthracis), environmental testing (detection of contaminating enzymes in production facilities), agriculture (detection of genetically modified organisms and quality control of plants), food microbiology (Detection of E. coli O157, Salmonella, Listeria, and other food spoilage bacteria) have emerged as new application areas for lateral flow assays.

Atlas-Link Biotech (Beijing) provides FASPIT Antigen Saliva Test Kit. NOVA Test SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold Immunochromatography) is a lateral flow assay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from saliva specimens from patients who are suspected of SARS-CoV-2 by a healthcare provider. Only certified laboratories that meet the requirements for performing moderate, high, or waived complexity tests can perform such saliva-based tests. The SARS-CoV-2 antigen saliva test kits provide preliminary test results, with negative results that don't preclude SARS-CoV-2 infection.

Smartphone-based biosensors in optical procedures involving mechanisms such as reflection, absorption, and fluorescence have been instrumental in diagnostics, medical, healthcare, food, and environmental monitoring applications. Artificial intelligence (AI) and machine learning are major technologies that drive this progress, providing real-time and highly accurate reads. With machine learning, reader software can quickly adapt to new tests launched by manufacturers. It can be potentially used as a low-cost, portable POC platform, especially suitable in remote low-income areas in Asia and Africa.

Further, cloud-based systems may turn any tablet or smartphone into a universal digital reader, allowing healthcare organizations to perform lateral flow tests for the detection of any infection or marker on a large scale. For instance, in April 2022, Cambridge-based company PocDoc secured a CE mark for its artificial intelligence (AI) driven digital reader of lateral flow tests. This system allows any smartphone or tablet to become a universal digital reader, allowing healthcare organizations to roll out lateral flow testing for any disease or marker at scale. Furthermore, AI-driven innovative devices that can read a COVID-19 lateral flow diagnostic test using a user's smartphone have received special use approval from the Medicines and Healthcare Products Regulatory Agency (MHRA). Thus, AI integration and smartphone usage are likely to trigger the demand for lateral flow assays in the healthcare sector in the coming years.

Test Type -Based Insights

Based on test type, the lateral flow assay market is bifurcated into lateral flow immunoassay and nucleic acid lateral flow assay. The lateral flow immunoassay segment held a larger share of the market in 2022 and is expected to register a higher CAGR in the market from 2022 to 2030. Lateral flow immunoassay, also known as immunochromatographic assays or strip tests, is an easy-to-use diagnostic tool to determine whether a target analyte, such as pathogens or biomarkers in humans or animals, is present or absent. Lateral flow immunoassay tests have played a critical role in reducing the effects of the COVID-19 outbreak due to their ability to detect infected individuals and stop further transmission of SARS-CoV-2 rapidly. The lateral flow immunoassay segment accounted for the largest share of the market in 2022. Lateral flow-based immunoassays are widely used to detect a wide variety of antibodies & antigens, both quantitatively and qualitatively, in hospitals, clinical laboratories, and clinics. It is a simple and cost-effective analytical method used to screen, monitor, and diagnose various diseases. Because of these factors, the usefulness of lateral flow immunoassays is extremely high; these can be used by any health professional and/or patient at home.

End User-Based Insights

Based on end user, the lateral flow assay market is segmented into hospitals and clinics, diagnostics laboratories, homecare, veterinary clinics, pharmaceutical & biotechnology companies, and others. The hospitals and clinics segment held the largest share of the market in 2022. However, the pharmaceutical & biotechnology companies segment is anticipated to register the highest CAGR during 2022-2030. Hospitals are the primary healthcare centers that a patient seeks for their first aid and treatment. Compared to other healthcare centers, hospital patient visits are higher. Factors such as enhanced care and treatment, availability of necessary equipment, and reimbursements favor the segment growth.

Over the last decade, the cost of medical facilities has surged rapidly. Advanced diagnostic technologies have paved the way for early and improved detection of diseases, as well as supported research for disease treatment. Increasing affordability and awareness among people will continue to contribute significantly to the growth of the gross domestic product. In addition, diagnostic tests for various chronic diseases, such as cancer, cardiovascular disease, asthma, arthritis, and cystic fibrosis, are generally carried out in hospitals to avoid false-positive/negative results.

Further, the increasing number of clinics has paved the way for easier treatments, diagnostics, and vaccines, especially for traveling people, as they can quickly get medical treatment without prior appointments. Factors such as lower treatment cost, timely treatment, easy accessibility, and flexibility with short waiting times have boosted the growth of the clinic segment. Clinics provide treatments, medicines, and vaccines and offer services such as medical laboratory tests and diagnostics. These above factors are anticipated to catalyze the growth of the clinic segment.

Centers for Disease Control and Prevention, the World Health Organization, and the National Institute of Health are among the primary and secondary sources referred to while preparing the lateral flow assay market report.