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

Advanced Clinical Parameters and Modular Systems – Key to Future Advancements

Hematology like all other segments, has witnessed a transition in the field of automation – right from basic cell counts and microscopy to the use of specialized molecular assays not just for diagnosis but also therapeutic purposes. In the past, a physician would prescribe a simple CBC count as a first line of diagnostics and make a differential or definitive interpretation, based on the measured counts and the opinion of the pathologist. Thereafter, the comprehensive red cell and platelet indices were also looked at for evaluation.

From the last 5 years or so, some new advanced clinical parameters have been reported by the state-of-the-art hematology analyzers that have increased clinical utility for the clinician. They are not only helpful in differential diagnosis but can also be monitored for therapeutic purposes – especially in anemia management, thrombocytopenia management, and in infections. So the new term for CBC is extended CBC which now includes the advanced parameters that directly affect patient care and are thus in increased demand by the clinicians.

Accuracy along with speed has become critical to diagnosis. Laboratories prefer systems that provide accurate reporting while reducing the turnaround time. Companies are thus meeting this demand by offering modular systems, that is, a single integrated unit with two to three analyzers combined with slide maker/stainer and digital morphology systems. Digital pathology is here to stay in the field of hematology and histopathology with new platforms coming up not only for hospitals with increased workload but is also made available for labs with lower workload.

The future looks exciting, with the rise in the number and magnitude of scientific breakthroughs in hematological research. With the new parameters and interpretation of scattergrams, it is now easy to differentially diagnose the cause of fever – be it a bacterial, viral, or malarial infection or malignancy. These advances have paved the way for the development of future therapies and technologies. Going forward they will also shape the scientific trends and avenues of investigations.

Transasia Bio-Medicals Ltd. offers the best-in-class Sysmex hematology analyzers and integrated modular systems for reporting of the advanced clinical parameters.

Kanchan Jeswani
Manager – Scientific Affairs,
Transasia Bio-Medicals Ltd.

Industry Speak

Utility of Platelet Mass and Platelet Indices – As Predictive Markers in Dengue Infection

Dengue is the most rapidly spreading mosquito-borne viral disease in the world.In 2015, Delhi, India, recorded its worst outbreak since 2006 with over 15,000 cases. Last year, Ministry of Health (MoH) of Sri Lanka reported 80,732 dengue fever cases, including 215 deaths.

Though serological tests for identification of viral material is predominantly performed in laboratories for dengue confirmations and correlated with clinical manifestations like thrombocytopenia and bleeding.However rapid screenings have limitations and depending on their sensitivity and specificity, and virus isolation can be expensive and time consuming.

Hence, a retrospective study was conducted in our hospital using platelet count and platelet indices (PDW, MPV) along with distinct parameter platelet mass to predict the need for transfusion. Patient data was collected during the period of June to August 2016 and May to July 2017 and platelet mass along with low platelet counts, low MPV, and high PDW was successfully validated for transfusion requirements of dengue positive patients.Patients with dengue infection have low MPV, low platelet mass and high PDW compared to normal subjects.Low MPV indicates marrow suppression and increased risk of bleeding.A high PDW indicates platelet activation. In the study, Platelet mass showed a 96.55 percent sensitivity and 90.7 percent specificity.Hence, in endemic areas platelet mass can be used as predictive marker for transfusion requirements in dengue positive patients.Our findings correlated well with studies conducted by Jayasree et. al. (Indian journal of Hematol Blood Transfusion) and Bashir et. al. (International journal of science and research), thus concluding the role of platelet parameters in dengue infection.

Hematology analyzers with specific parameters are available nowadays but, in remote/peripheral areas with limited reach and resources – support, diagnosis and low costs are essential. Hence, brands should consider promoting existing parameters (for large base of cell counters), rather than promote specific parameters which lack standardization and significant cost considerations.

We also extend our special thanks to Dr Jasper and staff (microbiology and hematology department, Ananthapuri hospital).

Dr Ragi K.V
Consultant Pathologist, Ananthapuri Hospital,
Sr QM and Pathologist, Metro Scans,
Laboratory, Quality Consultant, Muthoot Diagnostics

Industry Speak

Hematology Instrumentation Automation – The Future

Hematology systems have been around for over 50 years, and have become a mainstay of laboratories across segments. Over the years, their roles have evolved from being used merely for counting cells, to now assisting the pathologists in clinical decision making with enumeration and flagging of abnormal cells, and now enabling greater efficiency with middle ware, automated slide maker, workload optimization, and capability to share the results over the web interface.

These features enable these cell counters to meet the demands of the modern laboratories that expect accurate results, lower turnaround time, competitive cost per test, and seamless integration with their reporting infrastructure. Specially, in the segment where the number of samples is very high, such as corporate laboratories and hospitals, there is an eminent need of having a single integrated system which can provide customized solution. So, instead of having more number of standalone systems, these labs are now opting for integrated options, which enhance their overall efficiency.

Inspired by the Voice of the Customer and backed by innovative technologies, Mindray is proud to introduce the BC-6000 Series, including the auto hematology analyzers BC-6000, BC-6200, and BC-6800Plus, as well as the cellular analysis line CAL 6000 and CAL 8000, which are developed to address real challenges observed and collected in frontline clinical settings. The BC-6000 Series delivers more than expected of hematology systems in terms of value, operation, and cost performance.

In terms of value, the BC-6000 Series provides NRBCs with every diff analysis, 3D scattergram for differential and retic samples, and many new research parameters which will enhance the clinical decision making. In terms of additional operational advantages, the BC-6000 Series provide smaller footprint, auto rerun, and reflex sampling, throughput of up to 200 samples/hour on a standalone system and AI-based LabXpert. On the cost side, we have utilized the new age technology to optimize reagent consumption, thus making testing, cost-effective.

We are certain with the new BC-6000 series we will be able to address the existing gaps and provide solutions which will revolutionize hematology testing, thus providing healthcare within reach.

Priyank Dubey
Product Manager – Hematology,
Mindray Medical India Private Limited

Industry Speak

Medical Interest of Reticulocytes

The reticulocyte count expresses the measure of erythropoiesis activity in the bone marrow and predicts the status of future RBCs in the peripheral blood. The reticulocyte count is a parameter which provides information for a variety of purposes, e.g. accurately diagnosing anemia in patients, assessing the regenerative activity after anemia treatment, monitoring patients receiving recombinant human erythropoietin, or recovering from chemotherapy or bone marrow transplants.

Why automation?

The limits of the microscopic method and the clinical need of a simple and reliable method to count the total number of reticulocytes have inspired the development of flow cytometric method.

Only single parameter analysis with interpersonal variability.

Technology & Reticulocyte Profile

Flow cytometry is a technology that simultaneously measures and analyzes multiple physical characteristics of single particles, usually cells, as they flow in a fluid stream through a beam of light.

Need for additional information for better clinical judgements.

Reticulocyte Count and Corrected Reticulocyte Count

The reticulocyte count is used to estimate the degree of effective erythropoiesis and its impairment.

Immature Reticulocyte Fraction (IRF)

Indeed, immature reticulocytes are larger than more mature reticulocytes and they have the greatest light scatter properties due to their highest level of ribonucleic acid (RNA). IRF allows evaluating the degree of erythropoiesis and predicting few days in advance the RBCs fluctuation.

Reticulocyte Hemoglobin Content Calculated (RHCc)

Better predictor of marrow iron stores than traditional serum iron parameters in non-macrocytic subjects.

A strongest predictor of iron deficiency than hemoglobin for screening infants and adolescents for iron deficiency prior to the development of anemia.

Mean Reticulocyte Volume (MRV)

MRV is a parameter which refers to the general volume of reticulocytes that naturally are larger than mature RBCs.

The decrease of MRV is correlated with the diminution of reticulocytes size than the circulating RBCs found in macrocytosis after therapy with B12 and/or folic acid.

Clinical interests -The measure of reticulocytes parameters of is useful in several cases:

  • Prediction and differential screening of anemia.
  • Assessing the regenerative activity after anemia treatment,
  • Monitoring patients receiving recombinant human erythropoietin (rHuEPO) or for evaluates the response to therapy (vitamin-B12 and iron supplementation).
  • Assessment of bone marrow recovery after transplantation or intensive therapy.
  • Searching for bleeding.

Dr Prakash Suvasia
Head – Medical Affairs,
Horiba (Medical) India Pvt. Ltd.

Industry Speak

Technology and Hematology

In the past few years the IVD market is growing expeditiously and it is an important segment in the global healthcare industry. This growth is fueled by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests. Technological advancement in high-throughput hematology analyzers, integration of basic flow-cytometry techniques in modern hematology analyzers, 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.

In hematology CBCs contribute to the general assessment of health for patients during regular check-ups. Conditions such as anemia, other blood disorders, infections, allergy, iron, and vitamin deficiencies are easily diagnosed through a CBC. Hematology can also be used to monitor patient health and alert medical professionals to diseases requiring diagnosis through additional testing or changes to ongoing treatment. Clinical hematology leverages various IVD technologies including blood analysis, flow cytometry, immunodiagnostics, molecular diagnostics, hemostasis, or coagulation testing, histology, and cytology. Now technological advances are being incorporated into hematology analyzers and it allows the laboratories access to more cellular information than was ever available before through a simple routine CBC with differential. This new information is used to improve cellular counting and decrease the rate of unnecessary manual reviews. The use of these technologies, while often invisible to the operator, can translate into a smoother workflow for the laboratory and an improved diagnostic quality of care for patients.

Despite a high number of automated blood cell counters with latest technology in use, a significant percentage of samples requires a manual cell differential count of blood specimens under a microscope. The detection of abnormal cells is on the basis of complex morphology, especially the size and shape of abnormal cells such as immature white blood cells or diseased cells. It is important, though, to accurately detect the presence of immature white blood cells since they are often associated with conditions such as leukemia, infection, inflammation, or tissue injury. Accordingly, manufacturers are working to decrease the number of manual reviews that are required through improvements in analyzer accuracy in differential count.

Nitin Srivastava
National Sales Manager, IVD,
Nihon Kohden India Pvt. Ltd

Industry Speak

Slow Adoption of Advanced Instruments to Hamper Indian Market

India accounts for 1 percent of the global IVD share and is expected to double its share to 2 percent with an 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. 60 percent of medical diagnostic equipments 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 equipment are generally placed on rentals or seeded at the customer place.

Hematology is the third largest segment in the Indian IVD market with 18–20 percent Indian market share and a value of approximately `800–900 crore. Out of this, 63 percent is on account of reagents. The 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 the 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 CROs where increasing instances of reagent rental partnership among hematology instruments and consumables are a popular trend.

DiaSys Diagnostics India Private Limited, a subsidiary of DiaSys Diagnostic systems GmBH, announced its foray in the field of hematology by launching innovative hematology analyzers christened as respons 3H and respons 5H. These technologically innovative systems perfectly compliment the broad existing DiaSys product portfolio of biochemistry, urine analysis, and PoC. With a footprint of A4 size paper and weight of approximately 9 kg, these are the new gen-next instruments in the field of hematology currently present in the Indian IVD market. Respons hematology systems are state-of-the-art instruments with elegant design, exiting features, and utilize only three reagents in the smallest of quantities. With respons hematology, we also contribute to the go green initiative with use of low-volume cyanide free reagents generating very less waste, low power consumption, and no paper printing.

Harshad Bhanushali
Product Manager – Instruments,
DiaSys Diagnostic India Pvt. Ltd.

Industry Speak

New Trends in Hematology

For the last 5 years, the hematology market in India is growing faster than expected.

Hematology market in India is estimated at USD 145 million in 2017. For the last 5 years, the hematology market in India is growing faster than expected. A decade ago the segment was controlled by the multinational companies. The systems are completely imported and hence was highly dependent on the forex rates. The hematology systems offered by the MNC’s was with huge investment and this eluded the Indian mid segment laboratories which accounts to more than 15,000 labs in India.

A decade ago the majority of hematology systems in India are 3-part hematology systems. Out of which the most popular systems in the rural area was single chambered hematology systems due to the low investment cost and cost of testing. The scenario was changed when highly affordable dual chamber analyzers was introduced in the market. When we look today, the single chamber systems are minimal with their presence majorly in the veterinary segment. One of the reason for the exponential growth in the 3-part segment is the reduction in the cost of testing. The major reason behind the reduction in the cost came from the local reagent manufacturers who could provide compatible reagents at an affordable price. Today compatible reagents are available for most of the 3-part hematology systems in India. The other reason was the increase in the tender business where huge number of 3-part systems are purchased annually. Today government business plays an important role in this segment. The latest trend in this segment is the introduction of highly compact 3-part hematology systems at affordable price. These systems are equipped with the latest IT and having the latest micro fluidics technology with very low reagent requirement, reducing the cost of testing drastically. These systems can perform with low sample volume with higher accuracy.

5-part hematology analyzers was once present only in the bigger hospitals, laboratories because of the huge size of the hardware and very high recurring cost. The systems were highly complicated and requires more space and is with huge maintenance cost making the cost of testing very high. One of the major reason for the huge size in the 5-part systems was the conventional flow cytometry module used for differential. The other limitation in these systems was the usage of multiple reagents which add on to the total space requirement and the recurring cost.

Around a decade ago, LED based flow cytometers are introduced which revolutionized the 5-part hematology industry. These systems are with sheath fluidics technology using three reagent systems and with a highly compact optical bench flow cytometer making it highly affordable to the common laboratories.There are systems can detect immature cells making the diagnosis more effective. The introduction of such compact 5-part systems in India was one of the reason for the exponential growth in the number of 5-part analyzers sold. Because of the very minimal difference in the price between the 3-part and the entry level 5-part analyzer’s, most of the existing 3-part customers are moving to 5-part hematology systems.Since these systems are very compact, it is highly suitable for the urban and well as metro cities where space is always a constrain. There are systems available in the market capable of giving 6-part or 7-part differential using specific dye based technology but is not much popular because of the huge recurring cost.

The latest entrant in to this segment is hematology analyzer capable of performing CBC and CRP from the same sample. The basic technology behind these systems are latex based turbidometry where a separate latex based reagent is used for the CRP estimation. CRP is measured from the lysed sample using turbidometry measurements. At present this technology in in the nascent stage, and requires more studies before it becomes popular in the industry.

Hematology instrument manufacturers are working hard to introduce highly compact systems with more parameters in the coming future.We expect to have the double-digit growth in the hematology segment for the next 5 years.

Rajesh M Patel
Business Head,
Agappe Diagnostics Ltd.

Industry Speak

Diabetes in India and HbA1c Test

Diabetes mellitus is a chronic lifelong condition which is characterized by increased blood sugar levels in the blood. The body loses its ability to use the energy found in the food and hence sugar level in blood rises. There are three major types of diabetes: Type I, Type II, and gestational diabetes. In diabetes mellitus, either the body is not able to use the insulin by or it is not able to produce the insulin. It could also be a combination of both. High levels of blood glucose in body damage tiny blood vessels of eyes, heart, kidneys, and nervous system.

About 422 million people worldwide have diabetes. India has over 60 million diabetics out of a population of 1.3 billion. In as recently as 2015, over 0.9 million deaths in India were attributed to diabetes directly or indirectly. The number of diabetics in the country are expected to increase to a staggering 109 million cases by 2035 out of an estimated population of 1.5 billion, as per a World Health Organization (WHO) estimate.

In India, an estimated 7.8 percent of the population above 18 years of age has raised blood glucose level or are on treatment for diabetes. However more significantly, nearly half of the population with diabetes is unaware about their disease.

A periodic test called the HbA1C blood test estimates glucose levels in your blood over the previous three months. It also helps identify overall glucose level control and the risk of complications from diabetes, including organ damage like heart, eye, kidneys etc.

The WHO suggests the following diagnostic guidelines for diabetes:

  • HbA1c below 42 mmol/mol (6.0%): Non-diabetic
  • HbA1c between 42 and 47 mmol/mol (6.0–6.4%): Impaired glucose regulation (IGR) or Prediabetes
  • HbA1c of 48 mmol/mol (6.5%) or over: for Type II diabetes

In the recent decade, testing of HbA1c has become a commonplace and there has been a growing demand for performing HbA1c testing on POCT instruments and other miniature equipment or analyzers which can give fast, easy and accurate results and reduce the dependency on the centralized labs.J. Mitra & Co. Pvt. Ltd. could see the opportunity in this challenge; it developed and launched HbA1c kits called HbA1c Quanti Card, on its FIA analyzer known as i-Quant. i-Quant has been developed by J. Mitra in partnership with Healthcare Technology Innovation Center at I.I.T. Chennai.The HbA1c kits developed by J. Mitra on FIA Analyzer have a very high level of accuracy and are NGSP-2018, certified.

Jatin Mahajan
Managing Director,
J.Mitra and Co. Pvt. Ltd.

Industry Speak

TB Free India

India has both a high tuberculosis (TB) and a high multi drug resistant (MDR)-TB burden, and accounts for 24 percent of the world’s incident TB cases. India continues to have the highest number of TB cases in the world, as per the global TB report 2017 revealed by World Health Organization (WHO).

Quality laboratory testing is essential in order to reach the goal of TB elimination in India. Improvements in laboratory testing must be maintained and translated into expedited and enhanced treatment and control. The WHO has set protocols for TB diagnosis and four tests have been approved.

It is imperative that the laboratory community provides healthcare providers and TB controllers with accurate smear, culture, drug susceptibility, and molecular results (GeneXpert and Line probe assay) within acceptable turnaround times while providing a safe work environment for laboratory personnel. Accessible laboratories with quality assured tests for TB are one of the essential elements in the control of the TB epidemic.

At Thyrocare, one of the leading laboratories operating throughout India, we recognize our important role and responsibility in providing services and infrastructure to support the fight against TB free India. We strive to provide results of the highest accuracy and precision and deliver efficient turnaround times along with seeking new ways to improve the efficiency of our service delivery.

Focus TB working toward a TB free world is a state-of-the-art TB diagnostics facility that is a technically advanced laboratory in India. It is built up at the central processing laboratory of Thyrocare, Navi Mumbai in accordance with guidelines of infectious diseases. Focus TB is the 167th IPAQT partner laboratory; armored with the best diagnostics methodologies currently available for TB diagnosis. The brand with quality reporting with trained executives and experts implements science to get the maximum impact. Focus TB aims to make an influential impact on patient outcomes by accurate and timely diagnosis for ensuring prompt and appropriate treatment and infection control. Quality diagnosis is a valuable investment in the health of communities, and is paramount to improving the health of the nation.

Dr Caesar Sengupta
Vice President, Operations,
Thyrocare Technologies Limited

Industry Speak

Autoimmune Disease Diagnostics Market

First described in the early 1900s, autoimmune disease is a condition arising from an abnormal immune response to a normal body part, resulting in damage or destruction of tissues, alteration of organ growth and organ function. Often starting during adulthood, autoimmune diseases can affect anyone. Yet certain people are at greater risk (e.g., childbearing women, people inheriting certain genes, and people of certain races or ethnicities). There are more than 80 illnesses, caused by autoimmunity, involving any body part, which are often chronic, debilitating, and life-threatening. However, the cause of autoimmunity is generally unknown.

Typical systemic autoimmune diseases include systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis (SSc), polymyositis and dermatomyositis (PM/DM), Sicca syndrome (SS), as well as mixed connective tissue disease (MCTD), among which SLE and RA take the lead. Typical organ-specific autoimmune diseases include Graves’ Disease, Hashimoto’s thyroiditis, Type 1 diabetes, etc.

Autoantibody test is performed primarily to evaluate a person for autoimmune disorder. An autoantibody is an antibody produced by the immune system which is directed against one or more of the individual’s own proteins. Many autoimmune diseases are caused by such autoantibodies. Common autoantibodies include ANA, anti-dsDNA, anti-sm, anti-ribosomal-P, anti-SS-A, anti-SS-B, anti-histone, anti-CCP, anti-RNP, anti-Scl-70, anti-CENP-B, anti-Jo-1, anti-M2, etc. The joint detection of autoantibodies helps the diagnosis of autoimmune diseases, for example, anti-GAD, IA-2, and IAA are associated with type-1 diabetes; anti-dsDNA, ANA, anti-sm is associated with SLE; anti-RO(SS-A) and anti-LA(SS-B) are associated with SS; TGA, TMA, TRAB are associated with Graves’ Disease, etc.

Substantial market reports show us that the global autoimmune disease diagnostics market was valued at USD 14 billion last year, with a compound average growth rate (CAGR) of 3.8 percent. Geographically, North America accounted for the largest share of 40 percent of the global autoimmune disease diagnostics market, followed by Europe at 25 percent. However, Asia-Pacific witnesses the highest CAGR of 4.3 percent due to the rise in the disposable income, development in health care infrastructure and distribution, growing public awareness, increasing patient pool and partnership strategies adopted by the players, which support market growth in the region.

The autoantibody is commonly tested by ELISA. However, the long processing time, insufficient sensitivity, and high frequency of false positive results could hamper the growth of the market. Seeing the need for advanced methodology for autoantibody detection, SNIBE launched autoantibody reagents after years of research, which can be used in its CLIA analyzer Maglumi series. Maglumi has more autoantibody assays than any other CLIA commercial manufacturers to fulfill customers’ demand.

Alex Xu
Overseas Technical Director
Snibe Co., Ltd.

Industry Speak

How Can POCT Supplement the Traditional Lab Approach

Point of care testing (POCT) devices have an important role to play in improving global health, particularly in Asia-Pacific (APAC) countries, where healthcare provision is developing rapidly and increasing the demand for responsive diagnostic solutions in addition to the traditional central laboratory approach.

The most successful application of POCT is achieved when it adds value to central lab practices. There are a number of new developments within the POCT sector that are helping to make this a reality:

Connectivity. The focus from POCT manufacturers to provide connected devices is helping to provide a joined-up approach to patient management, enabling clinicians to integrate patient results and records quickly and easily, saving time and improving traceability. Some devices also offer smartphone data management apps that provide a useful alternative to full LIS integration, especially in fast developing markets where innovative technology developments are outpacing the developments in central labs.

Miniaturization. One of the primary product benefits of POCT is the portable nature of the analyzers and tests. This trend can provide complimentary patient benefits over a healthcare system reliant solely on central laboratory testing. Small, hand-held devices enable accurate testing outside of the traditional medical setting. This has practical uses in rural communities and when dealing with large geographical areas where access to larger clinics and hospitals may be limited.

Tailored design features. It is essential that new POCT devices developed for use in fast developing countries are fit for purpose, in often challenging conditions. Many devices fail to penetrate the market because they don’t have the right features to address specific challenges, such as tests that can be stored at high temperatures or high humidity and analyzers with a long battery lifespan, to cope with remote testing where power supply may be unreliable or even non-existent.

Each evolution in POCT brings with it new levels of innovation that help the medical profession keep pace with the changes in people’s lifestyles and personal health, ensuring it plays a valuable part in the diagnostic process alongside central lab testing.

Katja Lemburg
Global Product Manager – Hemoglobin Analyzers,
EKF Diagnostics

Share this:

Related Post

Leave a Reply

Stay Updated on Medical Equipment and Devices industry.
Receive our Daily Newsletter.