Market Flourishing with Integrated Hematology Solutions

The market is seeing introduction of various hematology testing solutions combining a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution.

In a popular and diverse country like India, pathologists face distinct and unique challenges in their day-to-day laboratory practice. Hematology is one of the basic specialties that forms the majority of tests performed in a routine medical laboratory operations. Due to increasing work load pathologists are forced to use the best methods with high degree of precision and accuracy to give their final diagnosis. The modern day analyzers are providing five to seven parts differential white-cell analysis, based on different technologies, such as, electrical impedance, radiofrequency conductivity, light scatter, fluorescent scatter, and cytochemistry, etc. In addition to this, they also provide additional information in the form of cell population data (CPD) and lymph index, granularity index, large unstained cell population, and hemoparasites which can be utilized in the screening of benign and malignant hematological conditions.

Laboratories select hematology analyzers and reagents on the basis of patient population, reliability, service, precision, accuracy budgetary constraints, current and anticipated scope of laboratory services, etc. Manufacturers have overseen and researched these requirements in order to target specific analyzers to varied number of laboratories and have thus brought prosperity to the hematology market. For example, traditional bench-top optical hematology analyzers measured up to 50–60 cm in length and 10 cm in diameter and were too expensive while today due to the drive toward miniaturization the same analyzers are 10–15 cm long and 3 cm in diameter. Recent advancements including artificial intelligence systems such as six-part differential type, C-reactive protein analyzer, and simultaneous blood cell analyzer are just a few of the innovations the market has seen in recent years. The touchscreen and silent design concept are well-suited to meet present-day requirements in the hematology laboratories.

The market is also flooded with various diagnostic companies coming up with new analyzers, new combinations of testing parameters, and various cost-efficient features. Advancements in information technology have garnered demand for IT-driven medical information networks in the healthcare sector, contributing to effective collection and analysis of hematology test data. Automated analyzers, point-of-care (PoC) diagnostic analyzers, and handheld photo-optic devices have become complex and high-tech along with being user-friendly and easy in operation. With the ongoing advancement in the flow cytometry techniques, companies are also offering differential hematology systems, which can detect immature cells also. Additionally, with the improvement in the electronic–fluidic systems, the new hematology systems are becoming more and more compact making it affordable for the laboratories.

Indian Market
The Indian hematology instruments and reagents market in 2017 is estimated at `1057 crore, an 11 percent increase over 2016. Reagents constitute 63.4 percent of the market. While, reagents increased by 11.6 percent in 2017 over 2016, and instruments by 9.9 percent in value terms; the increase of 19.1 percent of instruments in quantity terms was larger in the same period.

Fully automated 3-part analyzers dominate the instruments market with a 86 percent share in volume terms and 63 percent share in value terms. Semi automated analyzers are gradually exiting the segment, and have a mere 2 percent share in value terms.

Within the 5-part fully automated analyzers, the high-end dominate with a 56 percent share in value terms, whereas the entry level 5-part ones have a 64 percent share in quantity terms. The high-end 5-part are primarily bought by government institutions, the private sector favors the rental path. It is not so for the 5-part entry-level analyzers, where outright purchase is preferred and rentals form a very small part of the market. Apart from increasing adoption of automated hematology instruments, integration of basic flow-cytometry techniques in modern hematology analyzers is driving the market. In addition, rising demand for high-throughput hematology analyzers and development of high-sensitivity point-of-care (POC) hematology testing are also fuelling growth. However, the high cost of hematology analyzers and intense competition among existing players are the restraining factors. 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. Moreover, safety and quality of hematology analyzer could be a challenge for the growth of the market. Increasing instances of partnership among hematology instruments and consumables manufacturers is one of the recent trends in the analyzer & reagent market.

Global Market
The global hematology analyzer and reagent market is projected to register an impressive expansion at 5.7 percent CAGR during 2018–2024, predicts Persistence Market Research (PMR). In 2017, the market was evaluated at revenues worth USD 1433.43 million, and is estimated to surpass USD 2000 million by the end of 2024. Increasing adoption of automated hematology analyzers, rising technological advancements, and integration of basic flow-cytometry techniques in modern analyzers are some of the key factors driving the growth of the global market. In addition, rising demand for high-throughput hematology analyzers and development of high-sensitivity PoC hematology testing are also fueling the growth of the market.

Other factors such as increasing awareness about chronic diseases, blood testing requirement for large number of blood-related disorders, and surging demand on the back of a growing geriatric population are also expected to drive the market growth. However, the high cost of analyzers, intense competition among existing players, low adoption of advanced analyzers and reagents in emerging and under developed countries, and product recall are restraining the growth of the global market. Moreover, increasing presence of excess and obsolete inventories such as semi-automatic hematology analyzer owing to the rise in automation, stringent, and time-consuming regulatory policies also impede the market growth.

By 2024, the six-part differential analyzers segment is anticipated to touch USD 230 million on account of a high CAGR of 6.1 percent during 2018–2024. The revenue in the six-part differential segment is poised to rise 1.6× over the years owing to their rising demand mainly because of the quicker pace of innovation seen in the six-part differential segment.

The five-part differential analyzers are estimated to remain sought-after products, with sales estimated to reach USD 1386.7 million by end of 2024. Three-part and five-part differential analyzers are expected to witness parallel expansion at 5.6 percent CAGR through 2024. Additionally, the standalone hematology analyzers will remain most-lucrative in the market, expanding at 5.8 percent CAGR through 2024. These analyzers are highly preferred among large-scale hospitals in developed economies. In addition, sales of PoC hematology analyzers are estimated to reach USD 929.2 million by the end of 2024.

North America is the largest market for hematology analyzers and reagents owing to easy adoption of highly advanced laboratory analyzers, high disposable income, and increasing adoption of automated hematology instruments by diagnostics laboratories. Sales in the region will surpass USD 700 million in revenues by end of 2024. Asia-Pacific is expected to be the fastest growing market in the next 7 years attributing to the developing healthcare infrastructure, rising awareness about better healthcare, and increasing funding toward the development of hematology products in this region. The market in Asia-Pacific is expected to expand at 7.1 percent CAGR through 2024.

Increasing instances of partnership among hematology instruments and consumables manufacturers is one of the recent trends in the global market. In addition, increasing focus toward emerging markets, such as India and China, could open up opportunities for new players in the global market. The major companies operating in this market are Abbott Laboratories, Abaxis, Beckman Coulter, Bio-Rad Laboratories, Hoffmann-La Roche, Horiba, Mindray Medical, Nihon Kohden, Siemens Healthineers, and Sysmex.

Vendors Update
Key players active in the hematology analyzer market are introducing new and innovative products to maintain or increase their market share. In addition, several companies are manufacturing and marketing miniature instruments with high accuracy. Analyzers are converging multi-parameter tests into single platforms through these miniaturized instruments, thereby helping labs and hospitals to save on heavy investments.

Roche received 510,000 clearance from the US FDA in March 2018 for its new cobas m511 integrated hematology analyzer, featuring patented bloodhound technology, to address the challenges of hematology testing by offering an integrated solution

Abbott received CE Mark for its Alinity h-series integrated system for hematology testing in Jan 2018. With built-in simplicity designed specifically for hematology testing, the Alinity h-series is smaller, faster, and more automated than current systems, incorporating advanced features

DiaSys Diagnostics India introduced the new respons 5H – an innovative five-part differential hematology analyzer, in December 2017. With a footprint of A4 size paper and weighing only 9.4 kg, it uses shear rotary valve (SRV) for sample aspiration

Sysmex acquired CLIA waiver for its new XW-100 automated hematology analyzer from the US FDA in November 2017 – making it one of the first CLIA-waived, complete blood count (CBC) system. The XW-100 allows healthcare professionals to provide patients with blood test results in as few as 3 minutes. Sysmex also offered XN-9100 and XN-3100 hematology automation systems in October 2017 and the XN-L automated hematology analyzer in July 2017

Diatron showcased its new Aquila three-part differential hematology analyzer (60 samples/hour throughput) at Medica 2017 held in November 2017. Specifically designed for the de-centralized laboratory and near-patient testing situations, Aquila can be used in many testing locations where high-quality CBC results are desired

Horiba Medical entered into a long-term agreement with Siemens in October 2017 to combine the complimentary innovative technology offerings of each company to address the multidisciplinary requirements of IVD testing and expand innovative hematology technology solutions

In order to enhance its hematology portfolio for the small–mid size laboratories segment, Horiba Medical in May 2017 developed a new hematology diagnostic solution, Yumizen H550, which is a compact six-part differential hematology analyzer with an auto sampling system which aims at providing a full walk away capability to a variety of clinical environments

Technological Advances
Development of precise, flexible, and user-friendly technologies that are cost-effective has been a trend in the hematology market. Advancement in research has led to more professional demands and capabilities in these units of testing.

Integrated analyzers. The industry has come a long way in automating one of the most time-consuming tasks in the laboratory. It is no longer necessary for highly skilled and trained laboratory professionals to stand over the slide preparation bench. Staff can now spend more time on the difficult cases that require careful analysis and assessment. Together, automated slide making and staining integrated with automated cell image analysis enhances the level of service a laboratory provides its clinicians and patients. The market has currently seen introduction of various hematology testing solutions combining a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution.

Hydrodynamic focusing. It is 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.

Additional parameters. The hematology analyzers are being used predominantly for cell counts and differential leukocyte analysis, but in addition, these analyzers are now capable of reporting many additional parameters and can provide much more information than what they are intended to provide. Recent technological advancements in the automated hematology analyzers have resulted in generation of many novel parameters to characterize the blood cells. Majority of the hematology analyzers are now available with an integrated reticulocyte count analysis with the routine CBC analysis which not only provides the reticulocyte percentage and absolute reticulocyte counts but also provides additional data in the form of reticulocyte hemoglobin content (CHr), percentage hypochromic cells, percentage microcytic cell or microcytic anemia factor, immature reticulocyte fraction, etc. These parameters, though currently for research purposes, hold a promising value to aid clinicians in certain clinical scenarios.

VCS technology. Volume, conductivity, and scatter (VCS) technology is an approach to WBC analysis where in addition to numerically quantifying and sub-classifying these cells, it also yields a large amount of information on their physical, electrical, optical, and hence, structural properties. The numerical VCS data or coordinates are visualized graphically in the form of a 3D cube. A total of 24 parameters are thus available with every routine differential leukocyte count without any further analyses or increased cost, and regardless of clinical suspicion.

Digital morphological imaging. Currently, the manual microscope method is considered the standard. However digital technology of using digital images and software algorithms to classify hematological cells, such as leukocytes and red blood cells leads to a faster, more efficient, and more standardized way of performing a morphological analysis of a peripheral blood smear. The current systems present in the market are equipped with software capable of not only detecting these cells, but also subsequently classifying them into the correct cell class. The software application is developed using an artificial neural network, and it considers a large number of features, such as size, roundness, and size and shape of the nucleus for the morphological classification of leukocytes. The number of cells counted by the system can be set by the operator, and the system will present the results in both absolute numbers and percentages. Integration of digital imaging with basic cell counter results leads to a faster detection and higher sensitivity and specificity in the detection of hematological malignancies.

Automation in hematological slide makers. With today’s ever-changing healthcare environment, laboratory managers and directors are challenged to find ways to optimize the utilization of laboratorians and support staff while maintaining and improving turnaround times, and continuing to provide the highest quality patient care. Continuing to perform manual tasks such as preparing manual blood smears takes laboratory professionals away from tasks that require critical thinking that they were trained to do and are relied upon to perform. Today, there are automated and semi-automated slide makers and slide maker/stainers in the market that can ease the burden on the laboratorian while providing consistency in the smear preparation process. Customizable stain times, another feature of automated slide maker/stainers, allow for the laboratory to achieve the desired coloration not only for whole blood smears but also for body fluid or bone marrow smears.

Remote review software. The new hematology workstations provide not only a more ergonomic workspace but flexibility for lab staff and for pathologists also. Abnormal cells can be reviewed from any networked computer licensed with remote review software, allowing more frequent interaction between the laboratorian and pathologist leading to faster interpretation and quicker result reporting.

Outlook
The primary responsibility of the manufacturer is to improve patient care by helping labs operate more efficiently and make better clinical decisions and they are doing this by continually improving their product offerings in terms of usability, reliability, and cost, and by adding useful clinical indicators. The hematology analyzers have witnessed fierce technological evolutions in the recent years due to the introduction of new methods for cellular analysis and the rapid development of software. Modern products in the analyzer market are able to provide a wealth of information that is both qualitative and quantitative in nature. Real-time graphical data allows information pertaining to disease patterns and abnormal cell populations to be easily obtained. All these processes go a long way in reducing manual reviews, thereby boosting the efficiency of the hematology analyzer. The future is predicted to have more advancement because of the large R&D funds that market leaders in the hematology analyzer market have pledged in this field. Next-generation analyzer technology will be created with advanced clinical parameters to improve 3D imaging and clinical utility.

While hematology is often thought of as a mature field, there are several active areas of innovation that promise to change our thinking about standard lab practices. What is foreseen is a shift that will greatly reduce the physical burden of lab work, shorten the time spent on necessary but non-value-added tasks, and provide better ergonomic experiences, thus supporting lab staff members throughout the testing procedure. There will come a day when there is little need for manual review of slides.

The technology exists today. Between the powerful flow cytometry product line and automated particle recognition technology, one can greatly reduce the need for costly and time-consuming slide reviews, thereby freeing lab staff to focus on critically challenging patients and other parts of their daily work. Moreover, it is expected that the informatics revolution will transform hematology, further integrating cellular analysis with physiological symptoms, chemistry, and immunoassays into a complete patient record to support clinical decisions.

Industry Speak

Industry Speak

Industry Speak