The global immunochemistry diagnostic devices and equipment market was valued at about $16.7 billion in 2018 and is expected to grow to $19.24 billion at a CAGR of 3.6% through 2022. 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 was 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.
Companies in the immunochemistry diagnostic 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 has 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.
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.
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.
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.
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