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.
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.
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.
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.
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.
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.