DUBLIN–(BUSINESS WIRE)–The “Global Hematology Diagnostic Devices And Equipment Market Report 2022” report has been added to ResearchAndMarkets.com’s offering.
The global hematology diagnostic devices and equipment market is expected to grow from $1.64 billion in 2021 to $1.91 billion in 2022 at a compound annual growth rate (CAGR) of 16.4%. The market is expected to grow to $3.28 billion in 2026 at a compound annual growth rate (CAGR) of 14.5%.
Major players in the hematology diagnostics devices and equipment 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, and Thermo Fisher Scientific Inc.
The hematology diagnostics devices and equipment market consist of sales of hematology diagnostics devices and related services. Hematology diagnostics instruments are used to diagnose diseases related to blood, vascular systems, bone marrow, autoimmune disorders, and hemostasis. These devices include automated cell counters, red cell indices devices, micro sedimentation centrifuges, blood volume measuring devices, occult blood tests, platelet aggregometer, erythrocyte sedimentation rate tests, red blood cell enzyme assay kits, glutathione reductase assays, and hematology reagents.
The main products of the hematology diagnostics devices and equipment are instruments and consumables. Hematology diagnostics instruments are used to diagnose diseases related to blood, vascular systems, bone marrow, autoimmune disorders, and hemostasis.
The hematology diagnostics consumables involved are reagents, stains, and others and hematology diagnostics instruments involved are analyzers; flow cytometers, and others. These are used in various applications including drug testing, autoimmune disease, cancer, diabetes mellitus, infectious disease, and other applications. The end-users are hospitals, specialized diagnostic centers, and specialized research institutes.
North America was the largest region in the hematology diagnostics devices and equipment market in 2021. Asia Pacific was the second-largest region in the hematology diagnostics devices and equipment market. The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
Hematology diagnostic devices are driven by the increase in the prevalence of blood disorders. Hematology diagnostic devices are widely used to identify the type of blood disorder. A blood disorder is a condition which is impacting the count of the 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 is affecting 75% of the total births globally and the prevalence of Anemia is 12.7% in men.
Product recall is one of the major problems that companies are facing. Product recalls are the process of returning faulty devices which can be due to errors in the manufacturing of the device. Because of the faulty devices tests conducted in the diagnostic centers may get affected.
For 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.
Companies in hematology diagnostic devices are increasingly investing in 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 a new automated hematology analyzer and by selling this product, Sysmex makes it possible for clinical facilities to perform hematology testing without any manual errors.
CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, for diagnosis, prevention, or treatment of disease, or assessment of health.
The hematology diagnostic devices market has a potential market to grow rapidly but stringent regulatory 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).
Key Topics Covered:
1. Executive Summary
2. Hematology Diagnostic Devices And Equipment Market Characteristics
3. Hematology Diagnostic Devices And Equipment Market Trends And Strategies
4. Impact Of COVID-19 On Hematology Diagnostic Devices And Equipment
5. Hematology Diagnostic Devices And Equipment Market Size And Growth
5.1. Global Hematology Diagnostic Devices And Equipment Historic Market, 2016-2021, $ Billion
5.1.1. Drivers Of The Market
5.1.2. Restraints On The Market
5.2. Global Hematology Diagnostic Devices And Equipment Forecast Market, 2021-2026F, 2031F, $ Billion
5.2.1. Drivers Of The Market
5.2.2. Restraints On the Market
6. Hematology Diagnostic Devices And Equipment Market Segmentation
6.1. Global Hematology Diagnostic Devices And Equipment Market, Segmentation By Product, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
- Instruments
- Consumables
6.2. Global Hematology Diagnostic Devices And Equipment Market, Segmentation By End User, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
- Hospitals
- Specialized Diagnostic Centers
- Specialized Research Institutes
6.3. Global Hematology Diagnostic Devices And Equipment Market, Segmentation By Instruments, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
- Analyzers
- Flow cytometers
- Other Instruments
6.4. Global Hematology Diagnostic Devices And Equipment Market, Segmentation By Consumables, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
- Reagents
- Stains
- Other Consumables
6.5. Global Hematology Diagnostic Devices And Equipment Market, Segmentation By Application, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
- Drug Testing
- Auto Immune Disease
- Cancer
- Diabetes Mellitus
- Infectious Disease
- Other Applications
7. Hematology Diagnostic Devices And Equipment Market Regional And Country Analysis
7.1. Global Hematology Diagnostic Devices And Equipment Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
7.2. Global Hematology Diagnostic Devices And Equipment Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
Companies Mentioned
- 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.
- Hemocue
- Roche Diagnostics
- Mindray
- Norma
- Danaher Corporation
- EDAN
- Novo Nordisk
- Sysmex Corporation
- Fluidigm Corporation
- CellaVision
- Maccura
- DY mind Biotech
- Balio
- Bio systems
- Wiener Lab
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