Hematology Diagnostic Devices And Equipment Global Market Report 2021: COVID 19 Impact and Recovery to 2030

Hematology Diagnostic Devices And Equipment Global Market Report 2021: COVID 19 Impact and Recovery to 2030

  • April 2021 •
  • 175 pages •
  • Report ID: 6067934 •
  • Format: PDF
Major players in the hematology diagnostics devices and equipment market are Abbott Diagnostics, Beckman Coulter, Bio-Rad Laboratories, Drucker Diagnostics, and Horiba Ltd.

The global hematology diagnostic devices and equipment market is expected to grow from $2.79 billion in 2020 to $4.31 billion in 2021 at a compound annual growth rate (CAGR) of 54.5%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $5.78 billion in 2025 at a CAGR of 7.6%.

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.

The hematology diagnostic devices market has a potential market to grow rapidly but stringent regulation policies are restricting their growth.The FDA currently regulates class I, class II, and class III hematology devices.

This means that class I hemostasis devices are regulated to use these devices are exempt from the premarket notification requirements and they only be used for the general controls. 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).

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 due to the manual practices in the diagnostic centers.

Example top companies like Sysmex acquired CLIA waiver for newly automated hematology analyzer and by selling this product, Sysmex makes it possible for clinical facilities to perform hematology testing without any manual errors.

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.

Blood disorder is a condition which is impacting the count of the blood cells like red blood cells, white blood cells, platelets, etc.Blood disorder affecting millions of people each year across the world irrespective of age, race, and sex.

E.g. As per the World Health Organization, Hemoglobin disorder is affecting 75% of the total births globally and the prevalence of Anemia is 12.7% is men.

Product recall is one of the major problems that the companies are facing.Product recalls is the process of returning the faulty devices which can be due to the errors in the manufacturing of the device.

Because of the faulty devices tests conducted in the diagnostic centers may get affected.Example, 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.

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.