Geographical Analysis
North America region accounted for the largest market share in the global hematology testing products market
The rising incidence of blood diseases and FDA approvals in this region is expected to dominate the global hematology testing products market. Most patients with haemophilia in the United States are diagnosed when they are very young. According to the Centers for Disease Control and Prevention, the median age at diagnosis for persons with mild haemophilia is 36 months, 8 months for those with moderate haemophilia, and 1 month for those with severe haemophilia. Anemia, infection, haemophilia, blood-clotting problems, and leukaemia can all be diagnosed with haematological tests. Hence, with the rising incidence of blood diseases, the demand for hematology testing is also estimated to increase the market growth.
On March 21st, 2019, Beckman Coulter, a global leader in clinical diagnostics, has obtained FDA 510(k) approval for their DxH 520 haematology analyzer which is now available for purchase in the United States
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Market Dynamics
The factors driving the market growth of hematology testing products market are the technological advancements in the hematology analyzer and the increasing number of patients opting for blood tests.
Technological advancements in the hematology analyzer are expected to drive market growth in the forecast period
Hematology analyzers employ a variety of technologies to identify cell types in a blood sample and count them separately to provide a complete blood count (CBC) with differential. Internal cellular particles are stained with a fluorescent dye and the emitted light is captured, enzymatic properties of cells such as the presence of myeloperoxidase are used, and cellular volume is measured using direct current impedance (Coulter Principle). To separate cellular elements, some analyzers only have one histogram per module; however, modern analyzers can retrieve data from many histograms. This is achievable in analyzers that contain modern VCSn technology, which can collect multiple additional cellular metrics for each cell, including but not limited to five various angles of light scatter and pulse time, in addition to volume and conductivity. This data can be combined in a variety of ways to generate dozens of histograms per module, allowing distinct cellular constituents to be distinguished.
The VCS technology was primarily employed to generate the differential count in haematological analyzers that did not have this technology. The enhanced VCSn data is used across all analytical modules in newer analyzers, including the differential, reticulocyte, and nRBC modules, allowing the instrument to leverage this powerful technology to improve counting and detect many more important cellular elements, as well as provide an accurate and precise CBC-diff. Today’s technical advancements in haematology analyzers provide the laboratory with more cellular information than was previously available through a basic routine CBC with differential. This new information can be used to improve cellular counting and reduce the number of unnecessary manual checks.
For example, On February 1st, 2021, Beckman Coulter launched, the DxH 560 AL which is a tabletop haematology analyzer developed to decrease the time and resource restrictions faced by small- to mid-sized laboratories. The DxH 560 AL produces results in less than 60 seconds. Because it only requires a 17-litre sample (less than a drop of blood), it can be utilised with difficult-to-draw patients (infants, cancer, and the elderly).
The increasing number of patients opting for blood tests is expected to drive the market growth
A review of clinical data from primary care that sheds insight on the frequency of blood test requests suggests the possibility for diagnostic platforms that integrate numerous commonly requested tests onto ‘multiplex’ panels, potentially moving blood testing from laboratory settings to the community. The data revealed a variety of typical community-requested test combinations, including tests for a general health check and to explore anaemia, hormone levels, serum iron and vitamin levels, weariness, and renal and liver function, among more than 500 distinct blood tests examined.
Multiplex technologies have the potential to integrate numerous biochemical and haematological tests that may be performed in a short amount of time from a single blood sample, which is very useful when patients have a wide range of symptoms. Data from 11,763,473 laboratory blood tests requested by primary care practises in Oxfordshire for over 413,000 patients was analysed by a research team from the University of Oxford’s Nuffield Department of Primary Care Health Sciences and the University of Leuven in Belgium to highlight the frequency and combination of tests requests in community settings.
Limitations of hematology testing are expected to hamper the market growth
Analytically and technically, haematology analyzers (HA) or automated blood cell counters are highly complicated automated analyzers. The total blood count is measured using these analyzers (CBC, also known as full blood count). The laboratory should only use HA that has been validated for the specified purpose, according to ISO 15189. Validation, for example, according to CLSI recommendations, should be undertaken in principle by the manufacturer for the intended scope, and verification of the manufacturer’s claim by the clinical laboratory is sufficient. Due to these validation requirements, many manufacturers face challenges. For example, some parameters must be compared to a standard way. Haematocrit, red blood cell count, white blood cell count, and white blood cell differential are just a few of the current reference systems. In such circumstances, the new method’s increased performance is compared or calibrated to a relatively weak benchmark, resulting in a performance that is less analytically and technically realistic. Unfortunately, registration authorities in some countries require a comparison with these reference procedures and/or a current-generation analyzer. As a result, this requirement may result in less-than-optimal analytical performance and may also stifle innovation.
It has been difficult to obtain samples from healthy children and neonates. In the paediatric population, reference intervals are frequently based on publications from decades ago, using technology that is no longer widely available, making it unclear whether these reference ranges can be applied today; or new parameters or parameters are using a new analytical technique for which no published reference ranges are available. As a result, manufacturers should make significant efforts to develop reference intervals for their new HA in these populations.
COVID-19 Impact Analysis
COVID-19 has affected the healthcare industry moderately. To stop its spread, government-imposed lockdown. People are fearful they may experience occupational effects and negative health from the COVID-19 pandemic. The pandemic disrupted many diagnosis procedures, as well as the approvals. This has moderately affected the global hematology testing products market due to limitations to avoid transmission of COVID.
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Segment Analysis
On basis of product type, hematology analyzer segment dominated the hematology testing products market
A full blood count (CBC) or hemogram is performed using a haematology analyzer (or haematology automaton). It analyses the blood’s produced elements, including red blood cells (erythrocytes), white blood cells (leukocytes), and platelets, quantitatively and qualitatively (thrombocytes). It is primarily utilised in medical analysis laboratories or haematology units in hospitals. The recent technological advancements in the equipment are expected to increase the market growth. For example, the majority of haematology analyzers now include an integrated reticulocyte count analysis with the routine complete blood count analysis, which not only provides reticulocyte per cent and absolute reticulocyte counts, but also additional data such as reticulocyte haemoglobin content (CHr), per cent hypochromic cells, per cent microcytic cell or microcytic anaemia factor, immature reticulocyte fraction, and so on. The degree of hemoglobinization in maturing erythroid precursors is reflected by CHr, which is a measure of total haemoglobin content in a reticulocyte expressed in pg. Modern white cell analyzers provide a five to seven-part differential white cell analysis using various technologies such as electrical impedance, radiofrequency conductivity, light scatter, fluorescent scatter, and cytochemistry, among others. They also provide additional data in the form of cell population data (CPD) and Lymph Index (Beckman Coulter LH series analyzers using the volume, conductivity, and scatter [VCS] technology), Granularity Index (Sysmex XE series), and Large unstained cell population (Advia Systems) that can be used in the screening of benign and malignant haematological conditions.
On June 2nd,2021, Sysmex America, Inc., expanded its haematology portfolio with the FDA-cleared XN-10 Automated Hematology Analyzer with Blood Bank mode. The company is the first and only manufacturer of Automated Hematology devices that have FDA-approved intended use claims for the Blood Center/Blood Bank market. The XN Blood Bank mode is designed for QC release testing of post-processed components in blood processing centres..
Competitive Landscape
The global hematology testing products market is highly competitive with the rising number of diseases and technological advancements in diagnostics.
Some of the major key players in this market are Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Boule Diagnostics AB, Horiba, Ltd., Mindray Medical International Limited, Siemens Healthcare, Sysmex Corporation, Abbott Corelaboratory, Agappe Diagnostics and Bio way Biological Technology Co., Ltd
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