Fluorescent Immunoassay Market Research Report and Outlook by 2028

The global fluorescent immunoassay market was valued at approximately US$ 2,578.66 million in 2021 and is anticipated to grow to US$ 3,778.78 million by 2028, reflecting a compound annual growth rate (CAGR) of 5.6% from 2021 to 2028.

The expansion of the fluorescent immunoassay market can be primarily attributed to the rising incidence of chronic diseases globally and the increasing demand for cell therapies. Nevertheless, the market may face challenges due to the inherent limitations associated with fluorescent immunoassays during the forecast period.

Fluorescent immunoassays represent a distinct category of immunoassays, characterized by the biochemical methods employed to detect the interaction between the "detector" antibody and the target analyte. This technique is known for its sensitivity, enabling the measurement of various compounds, including drugs, hormones, and proteins, as well as the identification of antibodies and quantification of antigens such as viral particles and bacteria. The fluorescence detection system enhances the sensitivity of analyte detection, simplifies reagent requirements, and streamlines assay designs. Recent advancements have facilitated the development of fluorescence-based immunoassay systems suitable for point-of-care applications. Innovations such as affordable narrow-wavelength light sources, stable fluorophores with significant Stokes shifts, reliable solid-state light detectors, and advanced microprocessors for data analysis have all contributed to the evolution of these systems. When integrated with lateral flow assays and paired with efficient yet cost-effective analyzers, the performance of these assays is significantly improved.

Since the declaration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a public health emergency in late January 2020, there has been an urgent need for comprehensive and rapid testing to implement measures aimed at curbing the virus's spread. Over time, real-time PCR tests and antibody tests have become essential tools for managing the pandemic. Fluorescent immunoassays play a crucial role in the differential diagnosis of SARS-CoV-2, utilizing patient serum or plasma with specific reagents to detect antibodies against viral and bacterial pathogens, thereby guiding appropriate therapeutic interventions. The implementation of fluorescent immunoassays is vital for effective public health strategies aimed at mitigating the negative impacts of the COVID-19 pandemic and supporting global return-to-work initiatives.

The COVID-19 pandemic has posed significant challenges to healthcare systems worldwide, particularly in developing nations, where disruptions in global trade have hindered imports. As of now, no definitive treatment for COVID-19 has been established, creating substantial opportunities for the fluorescent immunoassay market. In the long term, the market is expected to experience considerable growth, especially as numerous companies have received emergency use authorization for their newly developed testing kits. For instance, in May 2020, ERBA Diagnostics Mannheim GmbH launched its immunoassay-based kit, the ErbaLisa COVID-19 ELISA kit, designed to detect IgG and IgM antibodies against SARS-CoV-2. Additionally, researchers have developed portable devices, reagents, and standards suitable for home use, further driving the demand for fluorescent immunoassays.

The global fluorescent immunoassay market is categorized by product type into ELISA, rapid lateral flow immunoassay, and others. In 2021, the ELISA segment dominated the market, attributed to its widespread application in diagnosing cancer, infectious diseases, and other chronic conditions. This segment is projected to exhibit the highest CAGR during the forecast period.

In terms of application, the market is divided into infectious diseases, oncology, cardiovascular diseases, and others. The infectious diseases segment held the largest market share in 2021 and is expected to maintain the highest growth rate in the coming years.

Based on end users, the market is segmented into hospitals & clinics, diagnostic centers, pharmaceutical & biotechnology companies, academic & research institutes, and others. The hospitals & clinics segment accounted for the largest share in 2021 and is forecasted to achieve the highest CAGR of 6.6% during the forecast period.

Key organizations such as the World Health Organization (WHO), Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Center for Biotechnology Information, National Institute of Cancer Prevention and Research (NICPR), Public Health Agency of Canada, and Organization for Economic Co-operation and Development (OECD) have been referenced as primary and secondary sources in the preparation of this report.