The global immunochemistry diagnostic devices and equipment market was valued at about USD 16.7 billion in 2018 and is projected to grow at a CAGR of 3.6% to USD 19.24 billion in 2022. The market growth will be driven by an increase in the incidence of target diseases, such as viral infections, cardiovascular diseases, cancer or hormonal disorders worldwide, mainly due to poor lifestyle choices.
These are the latest findings of Radiant Insights (San Francisco, CA, USA), a market research and consulting company.
However, stringent regulatory policies related to the approval of immunoassay instruments and consumables will act as a major restraint to the growth of 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.
The major players in the immunochemistry diagnostic devices and equipment market are increasingly investing in automated immunoassay systems, as automation has led to an increase in capabilities of diagnostic devices for testing higher volumes of patient specimens. Additionally, the development of various integrated clinical chemistry systems has significantly improved the efficiency of analytical phase of clinical chemistry laboratory testing, and led to further automation.