Immunoassays are bioanalytical methods that use the specificity of an antigen-antibody reaction to detect and quantify target molecules in biological samples. These methods are frequently used in clinical diagnostics, drug discovery, drug monitoring, and food testing. Immunoassays have played a vital role in pharmaceutical analysis, such as diagnosis of diseases, therapeutic drug monitoring, clinical pharmacokinetics, and bioequivalence studies in drug discovery and pharmaceutical industries. The immunoassays industry is growing steadily due to various factors such as increased research and diagnosis for infectious disease testing as new pathogen strains develop each year. The market comprises kits & reagents, systems or analyzers, and software and services that can detect diseases or other conditions and can be used for research activities.
The immunoassay market is primarily segmented by product & solutions, platform, application, end user, and geography. The study also evaluates industry competitors and analyzes their market share at the global and regional level.
On the basis of product and solutions, the immunoassay kits and reagents segment accounted for the largest share of the overall immunoassay market in 2021. The largest share of this segment was mainly attributed to increasing number of immunoassay tests being performed globally, leading to recurrent purchases of kits and reagents, increasing focus on vaccine development to address challenges such as antimicrobial resistance and pandemics, and technological advancements in ELISpot assay kits. Furthermore, increase in demand for immunoassay based COVID-19 testing products along with cost-effectiveness of these products is likely to expand the growth of immunoassay kits and reagents segment in the upcoming years.
On the basis of platform, the chemiluminescence immunoassays segment accounted for the largest share of the overall immunoassay market in 2021. Factors such as increasing adoption of chemiluminescence assays in clinical diagnostics, research applications, and pharmaceutical analysis due to low cost per test, and requirement of simple equipment, propel the segment growth.
On the basis of application, the infectious diseases segment accounted for the largest share of immunoassay market in 2021 owing to recent regulatory approvals for infectious disease screening products, product launches, rising incidence of infectious diseases, and an increase in the availability of COVID-19 test kits across the globe.
On the basis of end user, immunoassay market is broadly segmented into diagnostic reference laboratories, hospitals & clinics, research and academic laboratories, pharmaceutical and biotechnology companies, and other end users which comprises of nursing homes, ambulatory care centers, blood banks, and home healthcare agencies. In 2021, the diagnostic reference laboratories segment accounted for largest share of the overall immunoassay market. Rising level of laboratory automation, rise in the patient volume leading towards the rise in the number of tests being carried out in the diagnostic labs, availability of well-equipped immunoassay systems and skilled labor, growing prevalence of infectious diseases, and rising government initiatives are the factors supporting the largest share of diagnostic reference laboratories end user segment. However, the hospitals & clinics segment is expected to grow fastest during the forecast period due to the growing patient population, rising Medicare reimbursement for clinical tests performed in hospitals, and improving healthcare infrastructure.
On the basis of geography, the global immunoassays market is mainly divided into five major regions, namely, North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2021, North America accounted for the largest share which can be attributed to the rising prevalence of various infectious diseases, well-established healthcare sector, higher awareness regarding early disease diagnosis, increasing penetration of advanced medical devices, and increasing funding activities coupled with the development of novel advanced immunoassay solutions.
The report also includes extensive assessment of the product portfolio, geographic analysis, and key strategic developments adopted by leading market participants in the industry over the past 4 years. The immunoassay market has witnessed number of new product launches, approvals, agreements, collaborations, partnerships, & expansions in recent years. For instance, in April 2021, F. Hoffmann-La Roche AG (Switzerland) launched Elecsys Anti-p53 immunoassay for the detection of anti-p53 antibodies in cancer patients. The test is used in patients with bowel cancer, oesophageal cancer, and breast cancer. In September 2020, Siemens Healthineers AG (Germany) collaborated with Novartis Pharma AG (Switzerland), a pharmaceutical company, to support Novartis’s therapeutic pipeline by developing assays, primarily for serum neurofilament light chain (sNFL) immunoassay. The collaboration was also made to support Novartis’ MS and other neuroscience programs.
The key players operating in the global immunoassay market are F. Hoffman-La Roche AG (Switzerland), Abbott Laboratories (U.S.), Siemens AG (Germany), Danaher Corporation (U.S.), Sysmex Corporation (Japan), bioMérieux SA (France), Thermo Fisher Scientific Inc. (U.S.), Becton, Dickinson and Company (U.S.), Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), and PerkinElmer, Inc. (U.S.) among others.
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