Lateral Flow Assays Market Size

Lateral Flow Assays Market Size

Lateral Flow Assays Market size was valued at more than USD 8.75 billion in 2022 and is anticipated to record over 4.5% CAGR between 2023 and 2032. Increasing demand for point-of-care testing and effective diagnostic solutions will influence market growth.

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High prevalence of infectious diseases and the growing adoption rate of home-based point-of-care (POC) testing solutions would fuel market progress. Lateral flow POC testing is preferred over traditional laboratory testing methods due to its cost efficiency and accuracy. Simpler sample requirements and fast specimen handling are some of the benefits of POC testing model that make it a popular choice among practitioners and patients.

Mounting need for affordable diagnostic tools across low-income and developing countries would boost the demand for point-of-care (POC) testing for the diagnosis of diseases like HIV and tuberculosis. New research and development (R&D) activities on POCT along with advancements in Internet of Medical Things (IOMT) should complement industry expansion.

The strict regulatory requirements by healthcare agencies like the U.S. FDA and convoluted approval processes could hinder the lateral flow assays market landscape. Classified as Class II devices, lateral flow assays require premarket notification, or 510(k) process before they can be marketed to the public. Due to strict regulations, these devices are not approved easily and are required to go through lengthy review procedures and laborious documentation. In case these laws are stalled or not followed, there are high chances of heavy fines imposed on the manufacturer.