Hematology Instruments and Reagents
Empowering Laboratories
Like all diagnostic technology, numerous advances are being made in the field of hematology analyzers and reagents to enable laboratories to meet rapid turnaround time targets, increased workloads, quality assurance requirements, and efficiency standards. In the last 50 years alone, substantial strides have been made in the research and development of analyzers leading to simple handheld photo-optical devices, sophisticated diagnostic point-of-care (POC) instruments, and highly automated or complex laboratory analyzers.
Laboratory diagnosis is rapidly changing from what it used to be in the past due to growing adoption of automated hematology instruments, increasing preference toward high-sensitivity POC, rapid technological advancements leading to integration of flow cytometry techniques, introduction of digital imaging systems in labs, and increasing use of microfluidics technology in analyzers.
Development of precise, flexible, and user-friendly technologies that are cost-effective has been a trend in hematology analyzers market. Advancement in research has led to more professional demands and capabilities in units of testing. Speed-to-market and competitive cost have been the primary drivers in the development of hematology analyzers and reagents.
Hospitals and diagnostic laboratories are shifting their preference to automated instrumentation and integration of different functions in a single platform. The biggest challenge for the vendors is the need to focus on customer concerns and demands along with instruments’ provision with higher effectiveness, throughput, accuracy, and improved productivity at lower cost.
Indian Market
The Indian hematology instruments and reagents market in 2016 is estimated at 952 crore, with reagents constituting a 63 percent market share.
The 6-part high-end automated slide-sharing stainers are being bought by some discerning premium institutes. The slide stainer is directly connected to the analyzer, and when set up and loaded with slides, it offers walkaway capabilities. In general, it takes 5–10 minutes to stain a batch of slides. Only a handful of leading players offer this top-of-the-line product. In 2016, this automated analyzer was procured by Amrita Institute of Medical Sciences, Wadia Hospitals, KLE Hospital, BLK Super Specialty Hospital, Christian Medical College Vellore, Tata Memorial Hospital, and Green Cross Hospital, among others.
Some of the government procurement was made by Directors, Medical Education and Research, Mumbai, Kerala, Gujarat, Uttar Pradesh, and the Defense Services.
In June 2016, the department of pathology and blood bank at AIIMS, Jodhpur, procured Sysmex reagents and consumables for hematology analyzer system models XN 1000 B3 and XP-100 from Transasia Bio Medicals.
While all the segments are facing an increase in demand, the 3-part instruments are gradually being replaced by 5-part entry level Instruments. The 5-part Analyzers, which dominate this segment with a 63 percent share may be segmented as high-end, mid-end, and entry level. While the mid-end, with a share of 21 percent offers features as 100-sample capacity autoloaders, the high-end models, with a volume-wise share of 16 percent, extend the analyzer’s output in the form of reticulocytes, nucleated RBCs, and fluorescent platelet counts for wider clinical application and research.
The 3-part analyzer continues to be the backbone of this segment. It dominates with an 88 percent market share in volume terms and a 64 percent in value terms. The single-chamber models are estimated to have a 40 percent share, the balance being contributed by double-chamber analyzers.
Competitively priced, unlike its 5-part and 6-part counterparts, the 3-part analyzer is not sought to be placed, and all the models are purchased outright. It is estimated that in 2016, an additional 95 units (to the sales of 855 units) 5-part analyzers were placed and only 290 units of 6-part analyzers were sold, which include the premium, automated slide stainer models too.
Semi automated instruments, are gradually making their exit.
Over the last couple of years, the number of companies representing imported brands in India, especially the Chinese have increased, bringing more competition to the market.
Also, some Indian companies have started focusing on manufacturing reagents in India, thereby importing the analyzers from established brands as original equipment, under their own brand name, and marketing the instruments along with the reagents they manufacture. This is creating a more intense demand for open systems and making servicing and prompt availability of spare parts a major differentiator.
Vendor Update – 2016
In August 2016, Abbott introduced Alinity, its harmonized family of next-generation systems across point of care, hematology, blood and plasma screening, and molecular diagnostics.
Mindray received 510(k) clearance from the US Food and Drug Administration to market and sell its first 5-part differential analyzer, BC-5390 in the US market. The analyzer meets the testing needs of mid-volume hematology laboratories while offering state-of-the-art features commonly found on large-volume analyzers.
Beckman Coulter keeps the flag flying with AIM-Automated Intelligent Morphology, a multidimensional, high-definition flow cytometric technology that improves analysis of abnormal specimens, now incorporated into all Beckman Coulter’s cellular analysis systems – the Beckman Coulter UniCel DxH 800 and 600 Coulter Cellular Analysis Systems, as well as the new DxH 500 analyzer. AIM is the only technology currently available that relies solely upon morphologic features to recognize cells.
August 2016 saw Siemens Healthineers Laboratory Diagnostics business launch Sysmex CS-2500 System – a mid-volume, fully automated coagulation analyzer with smartly designed PSI technology – in major markets. Sysmex, recognizing the challenge of laboratories to increase output without sacrificing accuracy or reliability of results, offers this system to mid-volume laboratories to leverage globally-proven PSI technology, while providing regional reference laboratories and integrated delivery networks (IDNs) with the ability to standardize testing results across multiple Sysmex CS and CA hemostasis systems.
In January 2017, Roche Diagnostics marked its entry into the hematology market with the launch of a dedicated hematology testing solution, the cobas m 511 integrated hematology analyzer. It addresses the challenges of hematology testing by combining the three components of the process – a digital morphology analyzer, cell counter, and classifier into one streamlined solution which prepares, stains, and analyzes microscopy blood slides.
In January 2017, PerkinElmer, Inc., entered into a definitive agreement to acquire Tulip Diagnostics Private Ltd.
Global Market
The global hematology analyzers market is expected to grow at a CAGR of 4.93 percent during 2016 to 2020, estimates Research and Markets. The expansion of high-throughput analyzers, growing acceptance of automated instruments by diagnostic laboratories, advancements in technology and development of high sensitivity POC testing are pushing the growth of the global market.
Innovations in genetic therapies, pharmacogenomics, bleeding disorders, stem cell research, and proteomics; introduction of basic cytometry techniques in modern hematology analyzers; rise in public awareness; and consolidation of diagnostic laboratory chains are anticipated to drive the global market over the next 3 years.
The POC hematology analyzers segment is expected to dominate the market over the next 3 years, growing at a CAGR of 6 percent. The bench-top hematology analyzers segment is projected to be driven by the rise in the number of private clinical laboratories supported by an increase in investment, especially from emerging economies.
North America holds the largest share of the global market, followed by Europe, attributing to the high disposable income and implementation of automated hematology instruments by diagnostic laboratories. Asia-Pacific market is expected to grow at the highest CAGR owing to developing healthcare infrastructure, large patient population, increasing funding and investment toward the development of hematology products, and growing focus of both international and domestic players in the region.
Product recalls, high cost of hematology analyzers, and lesser adoption in emerging economies restrain industry growth. Also, time-consuming and stringent regulatory policies, and poor health insurance hamper the growth.
Key global market players include Abbott Laboratories, Beckman Coulter, Horiba Ltd., Siemens AG, Sysmex Corporation, Nihon Kohden Corporation, Bio-Rad Laboratories, Mindray Medical International Ltd., Roche Diagnostics, and Boule Diagnostics AB. The market players are majorly focused on developing innovative technologies to meet the necessities of users. Several companies are also involved in numerous mergers and acquisitions as their key strategy to maintain substantial market share. These factors are expected to have a positive impact on industry growth in coming years.
Technology Trends
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 hematology analyzers may be designed to face these emerging needs whilst maintaining a high degree in the quality of testing.
Automation and computer vision technology. Most modern hematology analyzers are fully automated, allowing the user to place the samples at the start, press a button, and wait for a result to be produced at the end of the analysis. However, state-of-the-art systems are also suitable for incorporation into total automation solutions, in which robotic tracks transport samples between analyzers, carry out pre-analytics, perform reflex testing, and at the end of analysis, archive the specimens. The ongoing revolution in technologies has led to the development of hematology analyzers that can use computer vision technologies to recognize, enumerate, differentiate, and count blood cells. The devices automatically perform analysis of a captured digital image, create a report file, and send it to a printer.
6-part and 7-part analyzers. After the replacement of 3-part analyzers by 5-part over the years, now nucleated red blood cell counts and immature granulocytes are emerging as sixth and seventh parameters owing to increasing demand for automation to deliver reliable red blood cell counts, platelet counts, and 5-part differentials of white blood cells. The precision and accuracy of low platelet counts has improved considerably for most hematology analyzers. The analyzers today combine both bioelectrical impedance and light scattering detection techniques along with integrated flow cytometry.
Automated hemostasis analyzers. Unlike tilt-tube method for basic hemostasis testing, today’s instruments have automated most of the manual steps. The new hemostasis analyzers now feature automation of under-filled sample tube detection. Assessing sample tubes for fill volume is a time-consuming, visual, and subjective process that is difficult to standardize and implement. The automated tube-fill height detection allows labs to effectively standardize and implement sample acceptance and rejection. Newer and more advanced hemostasis testing systems feature the ability to detect levels of hemolysis, icterus, and lipemia (HIL) in samples and then compare these levels to the established HIL thresholds for each assay.
Thromboelastometry-guided coagulation analyzers. The evolution of remote displays in coagulation analyzers has provided visualization of real-time clot development allowing clinicians to assess the different phases of clot development as they occur, and treat deficiencies accordingly. Use of well-designed algorithms that are guided by thromboelastometry in combination with other laboratory assays has helped to overcome several challenges faced during coagulation analysis. The thromboelastometry-guided analyzers can prevent unnecessary transfusions as well as deleterious effects of allogeneic blood transfusion.
Research Update
The blood cell count is among the most ubiquitous diagnostic tests utilized in primary healthcare. The hematology analyzer that is routinely used in hospitals and testing is large and expensive equipment and requires trained technicians and physical sample transportation. It slows turnaround time, limits throughput in hospitals, and limits accessibility in resource-limited settings.
Now, researchers from the University of Illinois at Urbana-Champaign, led by Rashid Bashir, have demonstrated a biosensor capable of counting complete blood cells electrically using only a drop of blood. The microfluidic biosensor is able to count red blood cells, platelets, and white blood cell counts, and its 3-part differential at the point of care, while using only 11 L of blood cells based on their size and membrane properties. The total time for measurement is expected to be less than 20 min.
The biosensor exhibits the potential to improve patient care in a spectrum of settings, including resource-limited settings where laboratory tests are often inaccessible due to cost, poor availability of laboratory facilities, and the difficulty of follow-up upon receiving results that take days to process. The translation of this technology will result in minimal to no experience being required for operation of the device. In addition, patients can perform the test at home and share the results with their primary care physicians via electronic means.
Way Forward
Over the years, hematology instruments have evolved from simple manual red blood cell counters to sophisticated automated analyzers. Hematologists today are endowed with unprecedented opportunities for usage of cutting-edge technologies for enumeration of advanced clinical parameters, thereby enhancing improvement in detection of cellular abnormalities and providing effective solutions to clinicians for better patient care.
Enhanced awareness amongst clinicians for these parameters has been observed in the recent years. IPF (immature platelet fraction) and Ret He (hemoglobin equivalent in reticulocytes) have become the sought-after parameters in today’s world. Lots of investments are being made in research and development and for advancement of better technologies to improve insights for treating blood disorders. Research is ongoing for manufacturing hematology analyzers with improved sensitivity and specificity to capture abnormalities and minimize smear reviews.
Contrary to the commonly used indirect methods in blood analysis today – primarily impedance and flow cytometry – images of individual cells can now be studied directly. Based on these direct images, the analyzer can count, analyze morphology, and then classify every cell in the viewing area to provide a standard complete blood count (CBC) and 5-part differential and reticulocyte count. While hematologists will continue to have the option of looking at slides under their microscopes, it is now possible to study cell-by-cell images that in many cases eliminate the need for microscopic review.
Specifically in India, rising technological advances, adoption of basic flow cytometry technologies in modern hematology analyzers, increased demand for high-throughput hematology analyzers, development of highly sensitive POC hematology testing, and medical tourism are pushing the growth of the Indian hematology instruments and reagents market.
This growth has also percolated down to Tier-II and Tier-III cities, and they too have started to move toward better medical and testing facilities. This is evident from the growing number of corporate hospitals in smaller cities and towns and a proliferation of satellite centers by chain labs in remote areas. Recently, corporate hospital chains and lab chains have also begun to step out of metros and A-towns to capitalize on this opportunity.
Nowadays, laboratories are focusing on accreditations and adoption of automation. Space is a major constraint and hence labs are choosing ergonomically designed analyzers with small footprints. There is an increased demand for automation even in smaller workload standalone labs and rentals with low cost per test.
Budgetary constraints, lack of skilled and experienced technologiest, intense competition among players, high cost of diagnostics, and less proliferated health isurance coverage are few of the challenges. There are abundant opportunities in POC testing, which is still an emerging segment. Rural India is waiting to get tapped with technological advances in diagnosis.
Industry Speak
Current and Future Advancements in Hematology Automation
Archana Ravindranath
Sr. Business Development Manager,
Transasia Bio-Medicals Ltd.
Over the years, automation of hematological instruments has reached new heights. Advanced hematology analyzers are well equipped to enumerate clinical utility parameters in addition to the existing ones with good accuracy and precision.
Laboratories are, however, increasingly challenged to provide speedy, comprehensive, and accurate information to enhance patient care.
In reporting CBC, differential enumeration using manual microscopy is time-consuming with high dependency on experienced personnel. Manual intervention has its added drawbacks such as limited accuracy and standardization of reporting. Advent of newer technologies in hematology analyzers has succeeded in reducing manual dependency. However, onsite presence of experts for morphological identification continues to be imperative. Thus, laboratories need to integrate middleware systems like WAM (work area manager) and technologies like digital cell morphology with hematology analyzers.
Digital cell morphology systems collect and pre-classify cells from a stained blood smear using advanced artificial neural network technology software. This reduces the sample review time by nearly 50 percent. 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.
A few modern hematology analyzers are also equipped with the ability to perform hematopoietic stem cell enumeration without usage of monoclonal antibodies. This procedure is performed on a hematology analyzer equipped with a dedicated channel to improve the apheresis workflow in terms of reduction in both time and costs.
Going forward, laboratories would be focusing on automation for standardization of pre-analytical, analytical, and post-analytical stages in order to increase the workflow proficiency. Online test ordering, sample collection, test identification, transportation, and processing would be completely automated thereby eliminating administrative errors.
In the analytical phase, workstations could be operated by a robotic system to supervise and monitor all instruments and reviews to maximize productivity and aid in dramatic reduction in turnaround time (TAT).
Post analysis, health informatics can play a major role in integration of imaging, histopathology, pathology, and other clinical data under a common software program with precise algorithms. Such a system would prove instrumental in guiding clinicians for speedy diagnosis and bring down the test costs for patient benefit.
Industry Speak
Making Work Easier, Accurate
Nitin Srivastava
National Sales Manager-IVD
Nihon Kohden India
Nowadays we live in a golden age of technological, medical, scientific, and social progress. We cannot imagine life without it. It is all about the reducing the human efforts with the help of technology. Diagnostic division is an important part of healthcare world is also developed in this period.Old and manual methods are been replaced by new automated analyzers in all part of hematology which includes coagulation and ESR.
Earlier the blood counts were performed through traditional methods and counted manually using the hemocytometers or neubauer counting chamber, the differential leukocyte counts by studying the peripheral blood smears (manual counts) and red cell indices through manual calculations. The Coulter principle led to the availability of the cell counters and thereafter, the development of complicated automated blood-cell analyzers. Technological advancements have made it possible to incorporate increasingly more analysis parameters as possible into single instrument, instead of using multiple instruments. The modern versions of analyzers are capable of measuring white blood cells (WBC), WBC differentials (3 part, 5 part, 6 part, and 7 part differentials), RBC, HGB, MCV, MPV, HCT, MCH, MCHC, RDW, PCT, PDW, and many other parameters.
Several hematology analyzers have been developed to improve accuracy and to reduce manual work. The new analyzers use traditional impedance technology or optical detectors alone or in combination. Cell counting with these instruments is rapid, objective, statistically significant, and not subject to the distributional bias of the manual count. They are also more efficient and cost effective than the manual method. The 3 part cell counters are still used laboratories having low workload because they are cost effective. But still manual differential is required.
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. Nearly about 90 percent of the information we get from the instrument as flagging in case of abnormal samples. These instruments provide all necessary information which is required for the pathologist and technicians to understand abnormality in patient sample. Featured with many useful options highlighting the abnormal parameter with color codes and reflex testing for the accurate values.
Moving from traditional manual cell counting technique toward automation for making the work easier and accurate, these auto analyzers required liquid solution, which includes isotonic solution (Diluent) who preserve the cells morphology and also used for dilution. Lysing agent for hemoglobin estimation and TLC counting (Cyanide free reagents for the safety and environmental reason), cleaning solutions. Some high end blood cell counter needs special solutions for the WBC differential counting and cells like Reticulocyte count.
Companies are competing to release the new and upgraded models of cell counters with new technologies and new parameters.
Industry Speak
The 3rd Largest Segment in the Indian IVD Market
Harshad Bhanushali
Product Manager-Instruments,
DiaSys Diagnostic India Pvt. Ltd.
India accounts for 1 percent of the global IVD share and is expected to double its share to 2 percent with expected CAGR of 15–18 percent by 2020.
The Indian IVD market can be classified into multiple segments. Biochemistry, immunoassay, and hematology segments dominate the IVD market with 65-70 percent share.
About 60 percent of medical diagnostic equipment are imported and distributed within the country through regional distributors and their network of sub-distributors. Reagents account for 60–65 percent of value share as instruments are generally placed on rentals or seeded at customer place.
Hematology is the 3rd largest segment in the Indian IVD market with 18–20 percent Indian market share and a value of approx. 800–900 crore. Out of this, 63 percent is on account of reagents. Balance 37 percent is on account of instruments.
Technological developments, integration of basic flow-cytometry techniques 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.
Factors such as 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 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.
Potential customers for hematology are pathology laboratories, commercial organizations, private and government hospitals, research institutes, and CRO’s where increasing instances of reagent rental partnership among hematology instruments and consumables is a popular trend.
DiaSys India is exclusively involved in branding, promotion, sales and service of the flagship 3-part cell counter known as Swelab Alfa. This is a state-of-the-art instrument and also one of the fastest 3-part differential cell counters in Indian hematology market at present. It is available in three models namely: Swelab Alfa Basic, Swelab Alfa MCI (patented micro-capillary mode); and Swelab Alfa Auto sampler (autoloader module for hands free operation).
Industry Speak
India at the Threshold of Increased Self-Reliance
Veena Kohli
CEO
Vanguard Diagnostics (P) Ltd.
The environment in India could not be more conducive than it is presently for in-house manufacturing and import substitution, backed by the Make in India initiative of the Prime Minister.
The Indian diagnostics fraternity is recognizing the merit in self-reliance. The depreciation of the Indian rupee, high import duties, prohibitively exorbitant freight costs, long inventory-carrying costs, and slow product complaint resolutions, are some of the critical negative factors that have already forced the importers of hematology reagents to look within the country for their sourcing.
Indigenous manufacturers of hematology reagents have witnessed an impetus in the demand for their goods during the past 4 to
5 years. It is the responsibility of the manufacturers now to ensure that this demand grows from strength to strength in the years to come, by maintaining consistent quality and stable pricing.
Having said that, it would be pertinent to recognize that the reagent development and manufacturing business is that of followers and not innovators. It is about time that we brought in some innovation in the Indian in vitro diagnostics space.
A glaring opportunity lies in the hematology analyzers segment. Hematology constitutes 15 percent of the total Indian in vitro diagnostics market, growing at a CAGR of 20 percent. There are approximately 6000 units of 3-part hematology analyzers being imported into India annually, at an average estimated price of
USD 2500/unit, amounting to over 100 crore of imports per year.
The Indian hematology reagent manufacturers have successfully identified local raw materials to effect self-reliance to a large extent in the 3-part market. Similarly, it is time to open our minds toward the in-house manufacturing and import substitution of the first line of hematology analyzers.
The 3-part hematology analyzers are at the most basic level of technological hierarchy. India has know-how and expertise in the areas of software and hardware development; our optimal labor cost is already a differentiator when compared to developed countries. The only bottleneck is the components, requiring precision engineering, that need to be imported. As soon as we are able to become self-sufficient with respect to these components and spare parts, India will be all set to replicate the local reagent manufacturing success.
Industry Speak
A Promising Future
Sanjaymon KR
AGM-Marketing
Agappe Diagnostics
Hematology segment is one of the fastest-growing segments in the Indian IVD sector. The segment is valued at 1250 crore in the year 2017. This market is dominated by 3-part systems followed by entry-level 5-part systems. Approximately 89 percent of the total installed units are in 3-part systems. One of the major factors responsible for the highest growth in this segment was the reduction in the cost of hardware followed by reduction in the cost per test. Once dominated by a few multinational players, who offered only a few models at high price and high recurring cost, this segment bloomed with the entry of affordable low-cost instruments from the Chinese market, which revolutionized the segment. 3-part systems are mostly on sales whereas the high-end 5-part systems are installed as rentals at the high-end customers.
The last few years have shown a large number of installations in the government segment through tender business, which was one of the factors for growth in the 3-part hardware segment. The size of the 3-part system reduced considerably to make the system easy to use in smaller laboratories in the metro cities and doctors’ clinics where space was always a concern. This segment also witnessed the introduction of touch-screen systems with android-based user interface. Instruments with low reagent consumption also were one of the factors for the growth in this segment.
The latest advancements in technology have made it possible to reduce the size of the hematology analyzers, especially in the 5-part system. With new technological advancements, the number of reagents used to perform the tests is reduced which is one of the major factors for reduction in the recurring cost. The cost of doing the test has reduced by 25 percent in the last 5 years.
One of the major changes in the higher-end differential hematology systems was the introduction of 6-part systems with additional parameters like reticulocytes. With the introduction of modular systems in this segment, the throughput has increased considerably improving the TAT of the central diagnostic center. With the introduction of integrated systems with automatic slide making, staining, and cell sorting, this segment in now entering into the total laboratory automation space.
Cost of reagents was one of the major issues faced in the hematology reagent segment due to the high import costs of liquid reagents used in the hematology systems. This was addressed by a few companies in India, which started manufacturing compatible reagents for hematology analyzers. Today one of the biggest hematology reagent manufacturing facilities is available in India, capable of high-volume production to meet the customer needs.
With current CAGR of 18 percent, the segment is expected to reach Rs.2750 crore by the year 2022.
Industry Speak
Trends and Technology
Anil Grover
National Sales Manager,
Meril Diagnostics Pvt. Ltd.
The global hematology market is projected to grow substantially due to the new breakthroughs in areas such as stem cell research, genetic therapies, hemoglobinopathies, proteomics, pharmacogenomics, and bleeding disorders, in the coming years. Similarly, factors such as the consolidation of diagnostic laboratory chains and the increase in public awareness are driving the growth of the hematology market. The emerging countries are expected to outperform the US and European countries. This is mainly due to the increase in major hospital chains opening new centers in major cities as well as an increase in government expenditure being used to purchase automated hematological analyzers and reagents.
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 fuelling the growth of the hematology market. 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.
However, slow adoption of advanced hematology instruments in the emerging economies, hematology product recalls, and high cost of hematology analyzers are some of the key factors hampering the growth of this market. 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.
Moreover, safety and quality of 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 market.
Meanwhile some of the Indian companies have indigenously started with the manufacturing and marketing hematology instruments and reagents. Meril has emerged as a company with the largest pool of instruments and reagents manufactured and marketed indigenously.
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