DUBLIN--(BUSINESS WIRE)--The "Hematology Diagnostic Devices And Equipment Global Market Report 2020" report has been added to ResearchAndMarkets.com's offering.
The global hematology diagnostic devices and equipment market was valued at about $1.9 billion in 2018 and is expected to grow to $2.35 billion at a CAGR of 5.5% through 2022.
The hematology diagnostics devices and equipment market consists of sales of hematology diagnostics devices and related services. Hematology diagnostics instruments are used to diagnose diseases related to blood, vascular systems, bone marrow, auto immune disorders and hemostasis.
These devices include automated cell counters, red cell indices devices, micro sedimentation centrifuges, or blood volume measuring devices, occult blood tests, platelet aggregometers, erythrocyte sedimentation rate tests, red blood cell enzyme assay kits, glutathione reductase assays and hematology reagents.
Hematology diagnostic devices are driven by the increase in the prevalence of blood disorders. Hematology diagnostic devices are widely used in order to identify the type of blood disorder. A blood disorder is a condition which impacts the count of blood cells like red blood cells, white blood cells, platelets, etc. Blood disorders affect millions of people each year across the world irrespective of age, race, and sex. E.g.. As per the World Health Organization, Hemoglobin disorder affects 75% of the total births globally and the prevalence of Anemia in men is 12.7%.
Product recall is one of the major problems that the companies are facing. Product recall is the process of returning faulty devices due to the errors in the manufacturing of the devices. Because of the faulty devices, tests conducted in diagnostic centers may get affected. For example, In 2018, Becton Dickinson (BD) and Company recalled Vacutainer EDTA Blood Collection Tubes because they are affecting the test due to the chemical interference of test tubes with the blood samples. This recall was classified as Class I recall, the most serious type of recall, by the Food and Drug Administration (FDA). Such product recalls can negatively affect market growth.
Companies in the hematology diagnostic devices are increasingly investing on the automation technology. Automation technology advancements are driving the demand for hematology analyzers and this automation will reduce the errors caused by manual practices in diagnostic centers. For example, Sysmex acquired a CLIA waiver for a newly automated hematology analyzer; by selling this product, Sysmex makes it possible for clinical facilities to perform hematology testing without manual errors.
CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
The hematology diagnostic devices market has a potential to grow rapidly, but stringent regulation policies are restricting its growth. The FDA currently regulates class I, class II, and class III hematology devices. Class I hemostasis devices are exempt from the premarket notification requirements and only used for general control. Regulations for class II devices are exempt from the premarket notification requirements and they can be used for special controls. Class III is the most stringent category as it requires premarket approval (PMA).
Major players in the market are Abbott Diagnostics, Beckman Coulter, Bio-Rad Laboratories, Drucker Diagnostics, Horiba Ltd.
- Instrumentation Laboratory Inc
- Siemens Healthcare
- Shenzhen Mindray Bio-Medical Electronics Co. Ltd
- F.Hoffmann-La Roche AG
- Thermo Fisher Scientific Inc.
- Roche Diagnostics
- Danaher Corporation
- Novo Nordisk
- Sysmex Corporation
- Fluidigm Corporation
- DY mind Biotech
- Bio systems
- Wiener Lab
For more information about this report visit https://www.researchandmarkets.com/r/ktkvuu