Immunochemistry Diagnostic Devices And Equipment Market:
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Executive Summary
The immunochemistry diagnostic devices and equipment market consists of sales of immunochemistry diagnostic devices and related services. Immunochemistry diagnostic devices and equipment are designed to diagnose diseases or conditions by studying the functions of the immune system through analyzing the nature of specific proteins, antigens, antibodies and their interaction.
The global immunochemistry diagnostic devices and equipment market is expected to grow from $13.6 billion in 2019 to $15 billion in 2020 at a compound annual growth rate (CAGR) of 10%. The growth of this market is mainly due to the increased diagnostic testing in laboratories, hospitals, and other testing sites across various country to detect the pandemic COVID-19 virus. The need for rapid diagnostic testing such as molecular and RT PCR based testing to identify people infected by coronavirus is driving the in-vitro diagnostics market. The market is then expected to grow at a CAGR of 5.2% from 2021 and reach $16.4 billion in 2023.
An increase in the incidence of target diseases is a major driver for the immunochemistry diagnostic devices and equipment market. The incidence rate of diseases such as viral infections, cardiovascular diseases, cancer or hormonal disorders is increasing worldwide, mainly due to poor lifestyle choices. For example, according to the American Heart Association, cardiovascular disease is the leading global cause of death, accounting for over 17.6 million deaths per year in 2016. This number is expected to grow to over 23.6 million by 2030.
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Stringent regulatory policies related to approval of immunoassay instruments and consumables is a major restraint for the immunochemistry diagnostic devices and equipment market. Immunochemistry devices and equipment manufacturers are required to obtain multiple and separate clearances from the Food and Drug Administration (FDA) for launching their products. The entire process of regulatory approval is time consuming, with a minimum of about 18-30 months required for approval of class III devices and around 6-9 months required for approval of class II devices.
Companies in the immunochemistry diagnostic devices and equipment market are increasingly investing in automated immunoassay systems. This is mainly because automation has led to an increase in capabilities of diagnostic devices in testing higher volumes of patient specimens. In addition, the development of various integrated clinical chemistry systems have immensely improved the efficiency of analytical phase of clinical chemistry laboratory testing, and led to further automation. For example, ichroma-50 is an automatic immunoassay analyzer of Boditech Med Inc. that measures the concentration of targeted analyte in body fluids such as blood, urine, and other samples in few minutes, and reduces the labor cost and human error in the process.
In the USA, the immunochemistry diagnostic devices and equipment market is regulated under the U.S. Food and Drug Administration (FDA), and all diagnostic laboratory tests are regulated by the clinical laboratory improvement amendments of 1988 (CLIA), which is administered by the centers for medicare & medicaid services (CMS). A CLIA/FDA compliant laboratory is required to file a PMA/510(k) for market approval of any immunochemistry device. Hence, the regulatory scenario related to immunochemistry diagnostic devices and equipment will keep a check on the companies that manufacture these devices and equipment.
Major players in the market are Abbott Diagnostics , Roche Diagnostics , Siemens Healthcare Diagnostics , Diamond Diagnostics , Dynex Technologies
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