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Fluorescent Immunoassay Market Value Chain, Stakeholder Analysis and Trends, 2028

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According to our new market research study on “Fluorescent Immunoassay Market to 2028 – Global Analysis and Forecast – by Product Type, Application, and End User,” the market is expected to grow from US$ 2,578.66 million in 2021 to US$ 3,778.78 million by 2028. The market is estimated to grow at a CAGR of 5.6% from 2021 to 2028. The report highlights trends prevailing in the market and drivers and hindrances pertaining to the global fluorescent immunoassay market growth.

Factors such as growing prevalence of chronic diseases and increasing demand for cell therapies are expected to boost the growth of the global fluorescent immunoassay market. However, the market is likely to get impacted by the disadvantages of fluorescent immunoassays during the forecast period. Several immunoassay techniques do not require the use of a labeled reactant. Some depend upon the precipitation line that forms gel support when any form of protein antigen comes into contact with its specific antibody. In contrast, other manual and automated methods for endpoint detection depend on the increase in light scatter generated. Despite their extensive and rapidly increasing use, unlabeled methods are limited to analyzing proteins and other large molecules present at relatively high concentrations. Only with high concentrations are the resulting antigen: antibody complexes large enough to produce a precipitate line or scatter to form bright. Additional disadvantages include the need for relatively large amounts of monospecific antisera, problems with very turbid or hemolyzed samples, and the possibility of erroneous results in the presence of antigen excess due to the prozone phenomenon.

Fluorescence immunoassay is a sensitive technique that is used in the measurement of many compounds, including drugs, hormones, and proteins; in the identification of antibodies; and in the quantification of antigens such as viral particles and, potentially, bacteria. The fluorescence detection system includes higher sensitivity detection of the analyte, simplified reagents, and simpler assay designs.

According to the National Center for Chronic Disease Prevention, in 2018, little over a quarter of adults in the US (27.2%) had several chronic illnesses. Multiple chronic illnesses were more common in women, non-Hispanic white people, older adults, Medicaid-eligible individuals aged 18–64, dual-eligible adults (Medicare and Medicaid), and adults in rural areas. Chronic diseases are among the most common and expensive health problems in the US.

North America dominated the fluorescence immunoassay analyzers market due to the high prevalence of infectious and chronic diseases, improved technology, laboratory automation, and a favorable reimbursement landscape. According to the National Center for Chronic Disease Prevention and Health Promotion, at least one chronic condition affects six out of ten Americans. Chronic diseases such as heart disease and stroke, cancer, and diabetes are the main causes of death and disability in the US, as well as a major driver of healthcare expenses.

The spread of COVID-19 severely affected medical systems in the region. Many commercially available tests for detecting SARS-CoV-2-specific antigens have recently been developed. The identification of COVID-19 antibodies in people as an alternative diagnostic method has recently received a lot of attention. To identify SARS-CoV-2, several clinics have used quick colloidal gold, enzyme-linked immunosorbent assay (ELISA), and chemiluminescence assays. These approaches, however, have flaws in terms of accuracy and sensitivity, with a large frequency of COVID-19 false positive and false negative reports. The STANDARD F COVID-19 Ag fluorescence immunoassay (FIA) kit is also available, which uses a fluorescent immunoassay to detect specific nucleoprotein antigens to SARS-CoV-2 in the human nasopharynx.

The development of a time-resolved fluorescence immunoassay (TRFIA) for detecting total COVID-19 antibodies in humans is the subject of a new study published in the journal Biotechnology and Applied Biochemistry. The authors of this study claim that TRFIA is a more sensitive and accurate approach for detecting the SARS-CoV-2 virus than the existing colloidal gold and chemiluminescence methods. The identification of antibodies is crucial in the diagnosis of COVID-19. To determine COVID-19 total antibodies, the manufacturers have developed a novel time-resolved fluorescence immunoassay (TRFIA). COVID-19 had positively impacted the global fluorescent immunoassay market as the technology was being used for COVID-19 diagnostics. Moreover, in May 2020, ERBA Diagnostics Mannheim GmbH (Germany) launched its immunoassay-based kit—ErbaLisa COVID-19 ELISA kits—to detect IgG and IgM antibodies against SARS-CoV-2. This kit enables the qualitative and semi-quantitative detection of IgG and IgM antibodies. In further research, the researchers improved the technique to increase the sensitivity and specificity of the strips for the inactivated viruses. In addition, researchers developed portable devices, reagents, and standards suitable for home use, similar to those used as a blood glucose meter.

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Fluorescence immunoassay is a sensitive technique that is used in the measurement of many compounds, including drugs, hormones, and proteins; in the identification of antibodies; and in the quantification of antigens such as viral particles and, potentially, bacteria. The fluorescence detection system includes higher sensitivity detection of the analyte, simplified reagents, and simpler assay designs. A modern fluorescent-based immunoassay uses as the detection reagent a fluorescent compound that absorbs light or energy (excitation energy) at a specific wavelength and then emits light or energy at a different wavelength.

A few of the most notable companies occupying a considerable share of the market are Abbott, BD, bioMerieux SA, F. Hoffman-La Roche Ltd., Siemens AG, Sysmex Corp., Thermo Fisher Scientific Inc., Quidel Corp., Ortho Clinical Diagnostics Holdings plc, and Danaher. 

Market leaders are involved in partnerships, product launches, acquisitions, and other strategies to improve their performance and consolidate the market position. The companies are focusing on organic strategies such as product launches, and product approvals. Inorganic growth strategies witnessed in the market were acquisitions, collaboration, and partnerships. These growth strategies have aided the market players in the expansion of their business and enhanced their geographic presence. Additionally, growth strategies such as acquisitions and partnerships helped in strengthening their customer base and increase the product portfolio.

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