While manufacturers have reshaped hematology diagnostics with various innovative analyzers, this is only the beginning of a series of advancements in the pipeline.
The cellular and morphological analysis is an integral part of any hematology laboratory. The original hematology analyzers first appeared in the 1950s, but the truly functional and automated versions of these machines did not become available for two more decades. Before this time, cell counts were performed manually. Now hematology analyzers are computerized, highly specialized, and automated machines that count and characterize blood cells rapidly and easily. Most current hematology analyzers provide red blood cell (RBC) counts, hemoglobin in RBCs, hematocrit levels, platelet counts, corpuscular data, and counts of five different types of white blood cells. Some newer machines also measure numbers of two specialized cell types – immature white cells and nucleated RBCs – that are necessary to confirm specific diagnoses.
Hematology analyzers have come a long way from disease detection and monitoring to counting and characterizing blood cells. Current technologies include complete automation of the hematology analyzer, electrical impedance, flow cytometry, and fluorescent flow. Combination of these technologies has increased the yield and productivity of test results. Test volume, that is number of tests performed, has also increased owing to technological advances in disease diagnosis and the rise in demand for preventive diagnosis and treatment monitoring. This is also augmenting the demand for hematology analyzers with high throughput. Such technological revolution is expected to propel the market in the coming years.
Globally, the hematology products market is projected to reach USD 4.98 billion by 2023 from USD 3.31 billion in 2018, at a CAGR of 8.5 percent, predicts MarketsandMarkets. The market has witnessed high investments by various multinational manufacturers in the last few years. The market is driven by significant demand for laboratory automation and consolidation in order to improve precision and efficiency, and advancement in technology leading to easy usage. Key companies operating in the global market are adopting advanced techniques to develop analyzers in order to expand their product offerings, strengthen their geographical reach, increase customer base, and garner market share. For instance, in June 2017, Abbott Laboratories announced the availability of Sekisui’s CP3000 coagulation analyzer in Europe, the Middle East, and Asia-Pacific. In another instance, in April 2018, Danaher (Beckman Coulter, Inc.) received CE Mark of its DxH 520 hematology analyzer, which is designed to help physician office laboratories.
In India, for the last 5 years, the hematology market is growing faster than expected. Hematology is the third largest segment in the Indian IVD market constituting 18–20 percent of the total IVD market share. Developing healthcare infrastructure, large patient population, increasing investment toward the development of hematology products, growing focus of both international and domestic players, and increase in incidence of diseases such as dengue, swine flu, malaria, and chikungunya are stimulating the growth of the hematology market in India. However, slow adoption of the advanced hematology instruments, high cost, safety, and quality of analyzers and reagents are some of the key factors hampering the growth of this market.
The continuous and rather extensive influx of new information regarding the key features and underlying mechanisms as well as treatment options have led to tremendous advancement in the hematology analyzers and their availability to the general practitioner.
Automation. Fully automated cell counters with autoloaders can process up 120–150 samples per hour. In addition, the precision of the automated differential makes the absolute leukocyte counts reliable and reproducible with controlled mixing of samples. These instruments provide all necessary information which is required for the pathologist and technicians to understand abnormality in patient sample. These top-of-the-line automated analyzers tend to have enhanced laboratory operations by providing faster output by reducing turnaround time, increased productivity by reducing manual work, and increased efficiency and auto-validation. The more automated the laboratory, the faster the results are released to physicians, which results in better patient care.
Double hydrodynamic sequential system. Hydrodynamic focusing has been one of the basic methods utilized by various analyzers in cell counting. However, the same focusing is now available with double power and thus more reliable and accurate counting. The new double hydrodynamic sequential system (DHSS) provides more reliable and better results compared to previous conventional focusing techniques. The technology has a good potential with high resolution and accurate quantification of abnormal cells. Use of DHSS technology helps the pathologists in utilizing the parameters like atypical lymphocytes (ALY) and large immature cells (LIC), which are helpful in diagnosis and differentiation of various blood pathologies.
High-fluorescence body fluid technology. Recently, a new detection mode, called high-fluorescence body fluid (HF-BF), has been equipped to the automatic hematoanalyzer perusing to discriminate non-hematopoietic cells. XN-BF gating reduces unnecessary microscopic analyses. However, the current HF-BF based analysis still offers low specificity. The combinational usage of automated high-definition microscopy images may help to improve both specificity and sensitivity. Further improvement of the HF-BF to realize more accurate detection of cells by modification of its parameter setting is warranted. The XN-BF has a potential to be the alternative method to the morphological examination, which can benefit for hematology laboratories to screen malignant cells rapidly without requiring additional sample preparation procedure and with minimal operator bias.
Digital cell morphology. In reporting CBC, the manual microscope is considered the standard, however differential enumeration using manual microscopy is time-consuming with high dependency on experienced personnel. Advent of newer technologies in hematology analyzers has succeeded in reducing manual dependency. The current hematology analyzers integrated with digital cell morphology collect and pre-classify cells from a stained blood smear using advanced artificial neural network technology software. This leads to a faster detection by reducing the sample review time by nearly 50 percent and offers higher sensitivity and specificity in the detection of hematological malignancies. In the next few years, there would be a surge in the consolidated workflow systems, resulting in an exponential increase in the sample volumes due to acquisition of smaller labs by bigger chain entities. Digital cell morphology will thus serve as a boon for handling the increased workflow.
Among the many remarkable advances in medical science in the last few decades, hematology analyzers have quietly revolutionized medical practice. Application of hematology technology in medical analysis has leveraged use of these analyzers. It is now taken for granted that CBC tests can be ordered, the blood drawn, and results available within the hour in facilities with an analyzer. Hematology analyzer manufacturing companies, to meet the safety standards of blood donation activities and procurement of precise diagnosis information, are keen to produce accurate hematology analyzers that demonstrate accurate results. Adoption of technological innovations such as VCS technology by manufacturers has enabled them to meet industry-specific needs. Besides introducing technological novelties players in market are also investing thoroughly in attaining FDA-approved certifications to harbor their precedence in the market. Manufacturers have reshaped hematology diagnostics with various innovative analyzers. But these advanced tools and technologies are only the beginning, the future is predicted to have more advancements. The next generation of analyzers may include expanded CBC to give the clinician more information about various disease states such as infection, advanced clinical parameters to improve 3D imaging and clinical utility, and process optimization for the lab to help balance work flow.