Over the years, hematology instruments have evolved from simple manual red blood cell counters to sophisticated automated analyzers. Manufacturers are developing analytical automation systems that simplify the testing process, reduce manual work, and further increase the efficacy and productivity of laboratories. Demand for these systems is influenced by development of alternative technologies such as POC instruments and integrated analyzers, advancements in product automation, and highly streamlined lab processes.
Technological developments in high-throughput hematology analyzers, integration of basic flow-cytometry techniques in modern hematology analyzers, increasing adoption of automated hematology instruments by diagnostic laboratories, technological advancements, and developments in the high-sensitivity point-of-care (POC) hematology testing are some of the key factors that are fueling the growth of the hematology market. However, the high cost of hematology analyzers and intense competition among existing players are restraining the growth of the global hematology analyzers and reagents market. In addition, stringent and time-consuming regulatory policies for hematology instruments also impede market growth.
Usage of microfluidics technology in hematology analyzers and introduction of digital imaging system in hematology laboratories could open up opportunities for new players in the global hematology analyzers and reagents market. In addition, increasing focus toward emerging markets, such as India and China, could also open up opportunities for new players in the global hematology analyzers and reagents market.
Moreover, safety and quality of a hematology analyzer could be a challenge for the growth of the global hematology analyzers and reagents market. Increasing instances of partnership among hematology instruments and consumables manufacturers is one of the recent trends in the global hematology analyzers and reagents market.
Indian Market Dynamics
The Indian hematology instruments and reagents market in 2015-16 increased by 17 percent in value terms, and there was an increase of 13 percent for instruments in quantity terms. Reagents continued to hold sway with a 62 percent share in the total market.
While all the segments are increasing, the 3-part instruments are gradually being replaced by 5-part entry level instruments. Each and every brand is strengthening its entry level 5-part analyzers product range, because that is where the increase in demand is emanating from. Semi-automated instruments, which were expected to make a complete exit, continue to have presence. In 2015-16, intense competition has resulted in stable prices.
The private sector continues to dominate this segment. Medall Healthcare Pvt Limited, operating 60 centers across South India, procured 200 instruments in 2015-16. This year, government buying was slow. Large corporate chains are either replacing their instruments or having made their procurements are more or less at a saturated demand level.
Challenges and Opportunities
Automation of leukocyte differentials has been achieved by two different methods. Computerized electro-optical microscopes analyze 100 to 500 white cells on Wright-stained smears and classify cells by recognizing patterns of nuclear size, shape, and chromatin structure, and cytoplasmic color and granulation. Automated flow cytochemistry can rapidly classify much larger numbers (10,000) of white cells by joint measurement of cytochemical stain intensity (absorbance) and cell size (optical scatter); however, neutrophils cannot be sub-classified by this technique. In the future, the combination of multiple fluorescent probes and light-scattering measurements at different angles may result in rapid and complete cytofluorographic leukocyte differentials. The future of hematology will focus on new technologic developments currently in use in clinical laboratories.
Point-of-care testing (POCT) remains a major interest among laboratorians, and a significant growth area for in vitro diagnostics manufacturers. But access to the convenience and speed of POCT is not a solution for all diagnostic needs. POCTs are sometimes not used according to their instructions, and experts caution that proper use is essential for attaining correct test results. Many clinical labs are involved in the development of new and emerging technologies for hematology lab applications. In some cases, such efforts are focused on laboratory-developed procedures to be performed within the lab's own facilities.
But labs are also engaged with in vitro diagnostics manufacturers to examine and refine future generations of instruments and related tests, giving them advanced insight into such products long before they are ready for commercialization. Image-analysis technologies have the potential to supplant much of the manual slide review that occurs in hematology laboratories. The main challenges include obtaining a monolayer of cells and the appropriate classification of abnormal cells.
The ongoing revolution of diagnostic testing, squeezed between reduced funding and increasing volumes, carries notable implications in the way laboratory resources are organized and coagulation tests delivered. It is, therefore, predictable that the newer generation of hemostasis analyzers may be designed to face these emerging needs whilst maintaining a high degree in the quality of testing.
The future of hemostasis is currently unpredictable. The challenge of coagulation analysis in the context of the widespread use of novel anticoagulants, which is very likely increasing further in the future, is a paradigmatic example. According to ongoing reorganization of laboratory diagnostics and continuous technological innovations such as miniaturization, improvement of hardware and software components, and predictable trends of disease prevalence, some basic ideas can be proposed to envisage a next-generation coagulation analyzer.
Indian Market Dynamics is based on market research conducted by Medical Buyer in May 2016.