Report : North America Fluorescent Immunoassay Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Product Type (ELISA, Rapid Lateral Flow Immunoassay, and Others), Application (Infectious Diseases, Oncology, Cardiovascular Diseases, and Others), and End User (Hospitals & Clinics, Diagnostic Centers, Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, and Others) 

At 5.9% CAGR, the North America Fluorescent Immunoassay Market is speculated to be worth US$ 1,598.58 million by 2028, says Business Market Insights              

According to Business Market Insights’ research, the North America fluorescent immunoassay market was valued at US$ 1,072.41 million in 2021 and is expected to reach US$ 1,598.58 million by 2028, registering an annual growth rate of 5.9%  from 2021 to 2028.  Growing prevalence of chronic diseases and increasing demand for cell therapies are the critical factors attributed to the market expansion. 

Chronic diseases and conditions are on the rise across the region. The need for costly chronic care is increasing, placing significant demands on healthcare systems. The rise in the aging population and changes in societal behavior contribute to a steady rise in these common and costly long-term health problems. The middle class is growing, and with the rise in urbanization, people are adopting a more sedentary lifestyle. This drives obesity rates and cases of diseases such as diabetes. The chronic kidney disease (CKD) is the 14th leading cause of death and is responsible for 1.2 million deaths each year. The increasing incidence of CKD is primarily associated with lifestyle disorders such as hypertension, cardiovascular disease, hormonal imbalances, and diabetes. Early detection and treatment are crucial, as progressive CKD is associated with unfortunate clinical consequences, including end-stage kidney disease (ESKD), cardiovascular diseases, and increased mortality. The diagnosis, prognosis, and control of chronic kidney disease are based on understanding the glomerular filtration rate (GFR). Cystatin-C is a better GFR marker than the commonly used creatinine. The fluorescence lateral flow immunoassay was developed and optimized to estimate the cystatin C value to calculate the glomerular filtration rate. The COVID-19 pandemic highlighted the need for rapid and accurate nucleic acid detection at the point-of-care. Fluorescence-based quantitative reverse transcription PCR (RT-qPCR) has high sensitivity and specificity, but turnaround times can be extended in part (ranging from hours to days) due to the need for nucleic acid purification and amplification. In addition, a maximum of people infected with SARS-CoV-2 develop mild or no symptoms. There is, therefore, an urgent need to develop rapid, simple, and high-throughput assays for the detection of nucleic acids. A standard fluorescence immunoassay system is a multiparametric, random access system that provides accurate and reliable diagnostic results. It is a system capable of performing qualitative and quantitative analyses of infections, respiratory diseases, and chronic diseases. A convenient user interface and laboratory information system (LIS)/ hospital information system (HIS) connectivity save valuable time, and ambiguous test results are a thing of the past as the analyzer automatically reads and interprets the results. A cut-off index provides a good reference point for medical decision-making. Therefore, there is a growing need for fluorescent immunoassays owing to the rising number of chronic diseases across the region.

On the contrary, disadvantages of fluorescent immunoassays hurdles the growth of North America fluorescent immunoassay market.   

Based on product type, the North America fluorescent immunoassay market is segmented into ELISA, rapid lateral flow immunoassay, and others. The ELISA held 56.5% market share in 2021, amassing US$  605.76 million. It is projected to garner US$  932.25 million by 2028 to expand at 6.4% CAGR during 2021–2028.

Based on application, the North America fluorescent immunoassay market is segmented into infectious diseases, oncology, cardiovascular diseases, and others. The infectious disease segment held 54.7% market share in 2021, amassing US$  586.71 million. It is projected to garner US$  904.33 million by 2028 to expand at 6.4% CAGR during 2021–2028.  

Based on end user, the North America fluorescent immunoassay market is segmented into hospitals & clinics, diagnostic centers, pharmaceutical & biotechnology companies, academic & research institutes, and others. The hospitals and clinics segment held 42.3% market share in 2021, amassing US$ 453.14 million. It is projected to garner US$  722.52 million by 2028 to expand at 6.9% CAGR during 2021–2028.  

Based on country, the North America fluorescent immunoassay market is segmented into the US, Canada, and Mexico. Our regional analysis states that the US captured 84.8% market share in 2021. It was assessed at US$ 908.99 million in 2021 and is likely to hit US$  1,376.96 million by 2028, exhibiting a CAGR of 6.1% during the forecast period.    

Key players dominating the North America fluorescent immunoassay market are Abbott, BD, bioMerieux SA, Danaher, F. Hoffmann-La Roche Ltd., Ortho Clinical Diagnostics Holdings plc, Quidel Corporation, Siemens AG,Sysmex Corporation, and Thermo Fisher Scientific Inc.  among others.  

  • In June 2021, Roche announced that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infections. The laboratory-based Elecsys SARS-CoV-2 Antigen test had earlier received CE mark and has recently obtained the import license from CDSCO.
  • In Apr 2021, bioMérieux announced the CE marking of its innovative and fully-automated assays to diagnose dengue infection - VIDAS DENGUE NS1 Ag, VIDAS Anti-DENGUE IgM, VIDAS Anti-DENGUE IgG. These VIDAS DENGUE assays can be used independently to detect the viral antigen (NS1) and antibodies (IgM and IgG) produced by the host in response to the infection. These 3 serological tests are recommended by international guidelines.

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