Global Hematology Diagnostic Devices and Equipment Market to Reach USD 2.35 Billion by 2022

The global hematology diagnostic devices and equipment market was valued at about USD 1.9 billion in 2018 and is projected to grow to at a CAGR of 5.5% to USD 2.35 billion in 2022. The market growth is driven mainly by an increase in the use of hematology diagnostic devices due to the rising prevalence of blood disorders which affect millions of people each year across the world, irrespective of age, race, and sex.

These are the latest findings of The Business Research Company (London, UK), a market research and intelligence company.


Despite its potential for rapid growth, the hematology diagnostic devices market is constrained by stringent regulation policies. Currently, the FDA regulates class I, class II, and class III hematology devices. Class I hemostasis devices are exempt from premarket notification requirements and are used only for general control. Regulations for class II devices are exempt from premarket notification requirements and they can be used for special controls. Class III is the most stringent category as it requires premarket approval (PMA).

Companies in the hematology diagnostic devices market are increasingly investing in automation technology. The advancements in automation technology are driving the demand for hematology analyzers and will continue to reduce the errors caused by manual practices in diagnostic centers. However, product recall is one of the major problems being faced by companies in the hematology diagnostic devices market and can negatively affect market growth.

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