The hematology market is centered on hematology analyzers. These instruments can take the form of a relatively simple handheld unit, a more sophisticated point-of-care diagnostic instrument, or a highly complex clinical laboratory analyzer. While all blood analyzers are designed to be accurate and reliable, the primary factors that set these three types of instruments apart from each other are sample throughput rate and the number of blood parameters measured.
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.
Indian Market Dynamics
The Indian hematology instruments and reagents market in 2014 is estimated at Rs.662 crore, with a 20 percent growth over 2014. Reagents at Rs.412 crore constituting 62 percent of the market showed an increase of 25 percent over 2013.
The instruments market in 2014 is estimated at Rs.250 crore. Transasia Biomedicals leads the way with Beckman a close second. Mindray has aggressive presence in this segment. These three players have a combined market share of 85 percent. Other players are Horiba, Nihon Kohden, Abbot, Trivitron, Avantor, Siemens, and AGD.
The government continues to be the mainstay in this segment. There have been increased purchases by the government, and the major customers in 2014 included AIIMS, HLL Lifecare Limited, state governments of West Bengal and Orissa, TNMSC (Tamil Nadu Medical Services Corporation), KMSCL (Kerala Medical Services Corporation), DGAFMS (Director General, Armed Forces Medical Services), and DMER (Directorate of Medical Education and Research), Maharashtra. The trend is gradually shifting from outright sales to rentals, and 2015 shall see the ratio change from 95 percent buying and 5 percent placed.
In the private sector, corporate chains as Path Labs and SRL, and labs in corporate chain hospitals continued to be the major buyers. The private sector continues to procure only 20 percent and balance are placed instruments. The market continues to be fragmented with not too many large facilities, unlike their counterparts in developed countries, which increases the exposure of the vendors.
The 5-part segment is gaining preference, and the demand is shifting from 3-part analyzers toward 5-part analyzers. The spur created by automation is increasing the use of high-end fully automation line. Slide separation units (rack module with 2-3 instruments in one rack) are gaining acceptance due to the current trend of automation. The market is moving toward advanced hematology analyzers with advanced parameters like immature platelet fraction (IPF) and parasite RBC (pRBC) for malaria detection gaining impetus. At the reagents front, generic reagents from Chinese players are forcing the leading established brands to redefine their return-on-investment model and re-establish their matrix.
Although the global hematology market remains steady, advances in software have led to automated resulting and reporting rules, better patient data management, and increased data storage. Some facilities use imaging software to perform differential reviews previously done only by trained laboratory professionals.
Indeed, the largest advances have been in digital morphology automation. Digital morphology allows automation of a complete blood count (CBC) differential, a procedure once strictly a manual process of counting and differentiating cells done using a microscope. Although many small- to medium-volume laboratories still employ the manual method of doing a differential, the high-volume facilities have automated this process. Automation of the manual differential improves resource utilization, the quality and speed of the results, and helps to standardize the differential process across facilities and personnel.
Adding imaging software automation to the hematology lab can tack on USD 85,000 to 140,000 to the cost of a hematology analyzer. Reimbursement for the blood count (CBC) differential is fairly unchanged, and a manual differential will only reimburse a few dollars more than the automated differential test. In addition, one has to consider the cost of licenses and software maintenance and upgrades. For high-volume laboratories, the extra cost of automating can be recouped by requiring less trained FTEs and increasing the output volume of results.
The hematology market is seeing an increased interest in vendors who can offer automation and scalability of instruments. Some vendors have developed their own imaging instruments to add to their portfolio of hematology products, giving them a significant competitive lead.
A number of factors such as development of high-throughput hematology analyzers, integration of basic flow-cytometry techniques in modern hematology analyzers, increasing adoption of automated hematology instruments by diagnostics laboratories, and rising technological advancements and developments in high-sensitivity point-of-care (POC) hematology testing are propelling the growth of hematology analyzers and reagents 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 the 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 on 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 hematology analyzers could be a challenge for the growth of the global hematology analyzers and reagents market. Leading players are adopting the strategies of new product development, geographic expansions, agreements, acquisitions, and joint ventures. Market players adopt these strategies to access new technologies, expand their product portfolio, enter into growing markets, and to increase their market share.
Future directions of hematology instrumentation include the addition of new parameters and the development of point-of-care instrumentation. In the future, in vivo analysis of blood cells may allow noninvasive and near-continuous measurements.
Indian Market Dynamics is based on market research conducted by Medical Buyer in May 2015.