Immunoassays refer to chemical tests and diagnostic techniques used to measure the concentration of macromolecules i.e. proteins in a solution with the help of an antibody or immunoglobulin. Macromolecules include analytes or proteins and these analytical methods operate on the formation of antigen-antibody complexes resultant of specific immuno reactions. Immunoassay techniques are particularly suitable for the effective analysis of compounds in low volumes, especially in nanogram and picogram concentrations. Their high sensitivity, reliability, and applicability to various range of compounds, distinctive selectivity, and detection abilities at extreme low concentrations make immunoassays a powerful tool used for complex biological fluids such as blood, plasma, or urine. These tests are extensively employed in the clinical, environmental, and pharmaceutical fields. Presently, various immunoassay instruments are available commercially including ARCHITECT ci4100, ci8200, ci16200 (Abbott Diagnostics), VIDAS Immunoassay Analyzer (bioMerieux) Immunoassay System, UniCel DxC 660i Synchron Access Clinical System (Beckman Coulter), Clinical Diagnostics Group, and EVOLIS (Bio-Rad Laboratories).
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Immunoassays are performed in two different formats: homogenous or non-separation and heterogeneous or separation. Homogeneous immunoassays are executed by mixing the sample and reagents, followed by analysis; while heterogeneous assays, also known as multi-step assays, may run in multiple parts by adding and washing away the reagents at different levels during an experiment. With technological advancements leading to the development of new products, the immunoassay market is anticipated to observe incredible growth in the next few years.
Major drivers of the market are the consistent and aggressive investments in research and development by market players, rising focus on developing strong technological platforms for immunoassays, and the extensive application areas of immunoassays such as infectious diseases, cancer, and cardiac disorders. Additionally, the introduction of innovative software tools followed by the need for hospitals and laboratories to reduce service and maintenance costs further boost the demand for these analytical tests in the market. However, lack of access to and awareness about the instruments and techniques involved as well as their high cost may hamper its development of this market.
The global immunoassay instrument market can be segmented by application into the oncology, endocrinology, infectious disease testing, hematology, therapeutic drug monitoring, cardiology, and orthopedic sectors, of which infectious disease testing is expected to be dominant due to their wide prevalence. On the basis of product and technology, the market can be classified into the following categories: chemiluminescence (CLI) analyzers, enzyme linked immunosorbent assay (ELISA), immuno fluorescence analyzers (IFA), enzyme immunoassay instruments, and radioimmunoassay (RIA) analyzers multiplexed assay systems. End-users of the product include academic and research institutes, diagnostic laboratories, and hospitals, of which diagnostic laboratories are likely to lead the market.
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Geographically, the immunoassay market is distributed over North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America, followed by Europe, hold a major share in the immunoassay market due to the technological advancement, the subsequent accessibility and adoption of urbane diagnostic technology including immunoassays, and the presence of prominent instrument manufacturers in these regions. Asia Pacific exhibits growth at an adequate pace due to the economic conditions, rising disposable incomes improving the accessibility of health care services, increasing demand for immune assay kits, and the surge in geriatric population suffering from diseases such as cancer, blood related disorders, and infectious diseases.
Key players competing in this market are Abbott Laboratories, Beckman Coulter, Inc., and bioMerieux S.A, DiaSorin, EMD Millipore Corporation, Siemens Healthcare, Invitrogen (Life Technologies Corporation & Thermo Fisher Scientific), and Ortho-clinical Diagnostics.
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