The lateral flow assay market is projected to expand from US$ 8,505.89 million in 2022 to US$ 16,106.13 million by 2030, reflecting a compound annual growth rate (CAGR) of 8.4% during the period from 2022 to 2030.

The growth of the lateral flow assay market can be largely attributed to the increasing adoption of home-based testing kits and the growing trend of point-of-care (POC) testing. Nevertheless, the market faces challenges due to inconsistent results that can arise from procedural limitations.

Lateral flow assays are extensively utilized for diagnosing infectious diseases, heart conditions, and in veterinary medicine. Recently, the applications of these assays have broadened significantly. New areas of application now include behavioral health, saliva-based diagnostics, detection of biological threats such as Bacillus anthracis, environmental testing for contaminants in production facilities, agricultural applications for identifying genetically modified organisms and ensuring plant quality, as well as food microbiology for detecting pathogens like E. coli O157, Salmonella, and Listeria, among others.

Companies like Atlas-Link Biotech (Beijing) offer products such as the FASPIT Antigen Saliva Test Kit. Another example is the NOVA Test SARS-CoV-2 Antigen Saliva Test Kit, which employs a colloidal gold immunochromatography method to identify the SARS-CoV-2 nucleocapsid protein in saliva samples from patients suspected of having the virus. These saliva-based tests can only be conducted in certified laboratories that meet specific testing complexity requirements. While these kits provide preliminary results, negative outcomes do not rule out the possibility of SARS-CoV-2 infection.

Innovations such as smartphone-based biosensors utilizing optical techniques like reflection, absorption, and fluorescence have significantly advanced diagnostics across various fields, including healthcare, food safety, and environmental monitoring. The integration of artificial intelligence (AI) and machine learning is a key driver of this advancement, enabling real-time, precise readings. Machine learning algorithms can quickly adapt to new tests introduced by manufacturers, making these technologies particularly valuable in low-resource settings, especially in remote areas of Asia and Africa.

Moreover, cloud-based solutions can transform any tablet or smartphone into a universal digital reader, facilitating large-scale lateral flow testing for various infections or markers. For instance, in April 2022, PocDoc, a company based in Cambridge, received a CE mark for its AI-driven digital reader for lateral flow tests. This innovation allows healthcare providers to implement lateral flow testing for a wide range of diseases efficiently. Additionally, AI-enabled devices that can interpret COVID-19 lateral flow tests using a smartphone have gained special use approval from the Medicines and Healthcare Products Regulatory Agency (MHRA). The incorporation of AI and mobile technology is expected to significantly boost the demand for lateral flow assays in the healthcare sector in the near future.

Insights Based on Test Type

The lateral flow assay market is categorized by test type into lateral flow immunoassays and nucleic acid lateral flow assays. In 2022, the lateral flow immunoassay segment dominated the market and is anticipated to exhibit a higher CAGR from 2022 to 2030. Lateral flow immunoassays, also referred to as immunochromatographic assays or strip tests, serve as user-friendly diagnostic tools to determine the presence or absence of target analytes, such as pathogens or biomarkers in humans and animals. These tests have been crucial in mitigating the impact of the COVID-19 pandemic by enabling rapid detection of infected individuals, thereby curbing the spread of SARS-CoV-2. The lateral flow immunoassay segment accounted for the largest market share in 2022, as these assays are widely employed to qualitatively and quantitatively detect various antibodies and antigens in clinical settings. Their simplicity and cost-effectiveness make them accessible for use by healthcare professionals and patients alike.

Insights Based on End User

The lateral flow assay market is segmented by end user into hospitals and clinics, diagnostic laboratories, homecare, veterinary clinics, pharmaceutical and biotechnology companies, and others. The hospitals and clinics segment held the largest market share in 2022, while the pharmaceutical and biotechnology companies segment is expected to experience the highest CAGR during the forecast period. Hospitals serve as primary healthcare facilities where patients seek initial treatment and care, leading to higher patient volumes compared to other healthcare settings. Factors such as improved care, availability of essential equipment, and reimbursement policies contribute to the growth of this segment.

In recent years, the costs associated with medical services have escalated significantly. Advanced diagnostic technologies have facilitated earlier and more accurate disease detection, supporting research and treatment efforts. Increased affordability and public awareness are expected to further drive growth in this sector. Additionally, diagnostic tests for chronic conditions like cancer, cardiovascular diseases, asthma, arthritis, and cystic fibrosis are typically conducted in hospitals to minimize the risk of false results.

The rise in the number of clinics has also enhanced access to treatments, diagnostics, and vaccinations, particularly for travelers who can receive prompt medical attention without prior appointments. Factors such as lower treatment costs, timely care, easy access, and reduced waiting times have contributed to the growth of the clinic segment. These elements are anticipated to further stimulate the expansion of the clinic segment in the lateral flow assay market.

The data and insights presented in this report are derived from reputable sources, including the Centers for Disease Control and Prevention, the World Health Organization, and the National Institutes of Health.