Digital morphology revolutionizing cellular analysis in hematology

Companies worldwide are augmenting their product portfolios, enhancing efficiency and standardization in the testing workflow, and increasing clinical value through improved precision of cell morphology classification.

With the increasing worldwide prevalence of hematological disorders and malignancies, the importance of early diagnosis and effective treatment initiation is more critical than ever. Digitization of hematology slides is transitioning cell morphology analysis and changing how scientists work inside and outside the lab.

Companies are working to further increase efficiency and standardization of the testing workflow in the hematology field, increase the precision of cell morphology classification, and provide value in supporting diagnosis.

Digital morphology has revolutionized the way blood cell analysis is performed. By harnessing high-resolution imaging systems and sophisticated algorithms, laboratory professionals can now examine and analyze blood cell images digitally, transcending the limitations of traditional manual microscopy. This ground-breaking technology offers enhanced accuracy and efficiency and provides clinicians invaluable insights into various hematological conditions. Through digital morphology, the identification and classification of abnormal blood cells is accelerated, enabling faster and more accurate diagnoses that are critical for timely interventions and improved patient outcomes.

Moreover, the integration of digital morphology and artificial intelligence (AI) with machine learning algorithms has further elevated the capabilities of hematology analyzers, enabling the precise detection of incidental findings that may be missed during manual microscopy due to time constraints.

Powered by AI-based algorithms, digital morphology ensures highly reproducible cellular classification and quantification of abnormalities. Beyond white blood cells, it extends to red cells and platelets, significantly expanding the realms of cellular analysis. The incorporation of AI enables the detection of even the minutest abnormalities, enhancing pick-up rates and facilitating real-time collaboration with experts located remotely.

Simultaneously, automation has emerged as a driving force behind the transformation of hematology laboratories. By automating labor-intensive processes, such as sample preparation, analysis, and result reporting, laboratory workflows have become more streamlined, efficient, and reliable. Automated analyzers and robotic systems now handle large volumes of samples precisely, reducing the risk of human error and allowing laboratory professionals to focus on more complex tasks and patient care. The integration of automation technologies has revolutionized turnaround times, enabling rapid reporting of results and facilitating prompt medical interventions.

The significance of innovation in hematology laboratory practices cannot be overstated. Rapid and accurate diagnosis is the cornerstone of effective healthcare delivery, and the advancements in digital morphology and automation contribute significantly to achieving this goal. These innovative technologies directly impact patient health outcomes by enabling faster and more precise analysis. Early detection of hematological disorders, accurate classification of blood cell abnormalities, and prompt treatment interventions are paramount for improving patient prognosis, enhancing quality of life, and potentially saving lives.

Indian market dynamics
The Indian hematology instruments and reagents market is estimated at ₹1450 crore in 2023, a 13.7-percent growth over 2022. The instruments saw a 2.5-percent increase, while the reagents market saw an 18.8-percent growth over 2022.

The high-end 5-part analyzers with reticulocytes are gradually getting recognition, albeit they have a minuscule share and are primarily catered to by a handful of brands. The competitively priced entry-level analyzer has the major market share within the 5-part analyzer segment.

Despite the price difference narrowing between the 5-part entry-level and 3-part dual chamber analyzers, the large share remains with the 3-part dual chamber models. If the number of tests is insufficient to merit a 5-part analyzer, the labs opt for the cheaper-to-run 3-part analyzer. Also, the consolidation drive seems to be slowing down, for the labs with very few number of tests are no longer considered an attractive buy. The 3-part single-chamber analyzers continue to have a steady market, with Mindray dominating this segment.

Hematology analyzers require ongoing maintenance and the replacement of consumables, such as reagents. The cost of maintaining these devices can be a challenge. Product lifecycles of hematology analyzers are relatively short, so frequent upgrades are necessary to keep pace with technological advancements. The smaller diagnostic centers struggle to allocate funds for frequent upgrades and obsolescence, especially when equipment and peripherals are incompatible with the latest iterations.

A paradigm shift has occurred from mere cell counting to intricate morphological analysis. This evolution is particularly evident in using laser-based flow cytometry technology. These analyzers employ laser beams to measure light scatter and fluorescence emitted as cells pass through, providing detailed insights into cell size, granularity, and maturity. Next-generation hematology platforms and enhanced connectivity allow monitor analyzer performance to be installed outside of the hospital laboratory from virtually anywhere.

Adequate technical expertise and skilled personnel are required to maintain and service the analyzers. A shortage of trained professionals in certain regions, especially in rural areas, may lead to delayed or inadequate maintenance.

The aging population in India has contributed to a higher incidence of age-related blood disorders, leading to a greater need for hematology testing and analyzers. Anemia is more prevalent among the elderly, and its diagnosis and management require regular blood tests. Certain health conditions, such as myelodysplastic syndromes (MDS), are more common in the elderly. The aging population emphasizes preventive healthcare, which includes regular check-ups and blood tests to detect health issues early. Older adults have higher healthcare utilization rates, leading to more frequent medical appointments and diagnostic tests, including hematological tests. The growing geriatric population has spurred research in geriatric medicine, including the study of age-related blood disorders. Hematology analyzers are indispensable for such research.

Increasing awareness of preventive healthcare has prompted more individuals to undergo routine check-ups, which often include hematology tests.

India is emerging as a hub for medical tourism. The presence of world-class healthcare facilities has increased the requirement for advanced diagnostic equipment tailored to the needs of different healthcare facilities.

The pandemic has prompted a larger part of diagnostic testing to take place closer to the patient. Whereas throughput is greater in central laboratories, decentralized testing facilities, such as primary care units, are more in numbers. This is where many purpose-designed instrument features, such as the micro-pipette adapter (MPA) aspiration methods and space-saving automation solutions, come into play.

India is moving toward a couple of important developments that will pace up demand.

In October 2023, India’s counterpart to the US Food and Drug Administration, the Central Drugs Standard Control Organization, made NexCAR19 India’s first approved CAR-T cell therapy. The CAR-T cell therapy was developed through collaboration between the Indian Institute of Technology, Mumbai, and Tata Memorial Hospital, and with industry partner ImmunoACT. In the United States, an infusion of CAR-T cell therapy costs about USD 400,000. By contrast, NexCAR19 is expected to cost around USD 50,000. ImmunoAct will manufacture the CAR-T cells in a facility built in Mumbai and plans to develop additional manufacturing sites across India. Initially, they expect to treat around 1200 patients a year. Chimeric antigen receptor T (CAR-T) cell therapy has revolutionized the treatment paradigms for other hematological malignancies, too.

India bone marrow transplantation market is flourishing due to the rising burden of blood disorders, increasing advancements in bone marrow transplantation techniques, growing awareness about bone marrow transplantation options, and government initiatives. There has been a rapid expansion of bone marrow transplantation centers and infrastructure enhancement. The Indian Council of Medical Research (ICMR) aims to establish advanced research centers for bone marrow transplants (BMT) in government hospitals nationwide. The National Bone Marrow Donor Registry streamlines donor identification and enhances transplant success rates.

Global market dynamics
The hematology analyzers and reagents market is anticipated to grow from USD 8.29 billion in 2024 to USD 13.65 billion by 2030, at a CAGR of 6.9 percent over the next five years.

The rising prevalence of blood disorders and cancer, increasing demand for accurate hematology testing, and technological advancements in hematology analyzers are expected to support market growth. Additionally, the growing geriatric population is expected to contribute to the market growth as they are more prone to develop blood disorders like leukemia and lymphoma.

However, the high cost of hematology analyzers and the need for skilled laboratory professionals in developing countries may hinder market growth. Providers may be hesitant to invest in premium systems, given budget constraints. Data integrity and security concerns may also linger over fully automated closed systems. In addition, limited access to infrastructure and resources in rural areas is another critical challenge impeding market growth.

Moreover, there has been an increased adoption of hematology analyzer solutions for smaller and mid-sized laboratories over the years. The main advantage of fully automated laboratory solutions is that they are cost-effective and offer precise results. In addition, automated solutions also save the time of hospitals and clinical laboratories as automation replaces manually intensive tasks, enabling researchers to focus more on analyzing and interpreting results by saving time. Furthermore, automation reduces the chances of human error, thereby improving the productivity of laboratories.

Segment insights. In 2024, the instrument segment is estimated to hold 56.8-percent market share. The latest instruments offer high-throughput testing, precise results, and automated functions that improve workflow efficiency.

Manufacturers focus on instruments with advanced capabilities like AI integration, machine learning algorithms, and more minor sample volume requirements.

Portable and table-top instruments allow decentralized testing and expand the applicability of hematology analyzers. In addition, as technologies progress, instruments can analyze an increasing number of parameters from a single sample, offering comprehensive patient insights from a single blood draw.

In 2024, fully automated hematology analyzers will dominate with a 62.8-percent market share. These analyzers offer standardized, precise results without human errors, maximizing lab efficiency. Advanced models analyze multiple parameters accurately, aiding in quick disease detection. With connectivity options for remote monitoring and minimal manual intervention required, they meet the rising demand for error-proof analyzers with multi-test capabilities.

In 2024, diagnostic laboratories are expected to hold 41.6 percent of the market share. They require automation and high-throughput capabilities to handle large test volumes efficiently. Hematology analyzers with continuous random-access loading and automatic rerun features meet these needs. Connectivity enables integrated laboratory management and timely reporting, prioritizing patient care.

Moreover, diagnostic labs offer comprehensive services, including consultations and after-sales support, ensuring seamless performance and differentiation. Growing demand for specialized tests like CBC drives analyzer installation across multiple locations. Advanced analyzers complement their focus on quality, timely reporting, and specialized testing services.

Regional insights. Over the last decade, North America has dominated the hematology analyzer market, capturing 41.3-percent market share in 2024. This is mainly due to its robust healthcare infrastructure, the presence of significant market players, and the strong demand for advanced testing. Leading diagnostic companies benefit from extensive distribution networks, facilitating widespread product promotion and sales across hospitals, diagnostic centers, and research labs. Additionally, the region’s early adoption of new technologies enables rapid acceptance of innovative analyzer models.

Rapid economic growth and increased healthcare investments in the Asia Pacific, especially in India and China, have propelled the hematology analyzer market. Automated analyzers are in high demand in hospitals and clinics due to the region’s growing population and evolving disease patterns. Despite higher import duties, local manufacturers offer affordable solutions, expanding access to advanced testing. Favorable regulations are encouraging international vendors to expand operations in these critical markets.

Vendor update. In February 2024, Sysmex Corporation formed a strategic alliance with CellaVision AB to advance hematology solutions by expanding its portfolio, which includes next-generation cell morphology analyzers.

In January 2024, HORIBA Medical launched the HELO 2.0 high-throughput automated hematology platform, which is CE-IVDR approved and is awaiting US Food and Drug Administration (FDA) certification. This next-generation high-end hematology line was developed in collaboration with customers to improve further, and meet the needs of high throughput and fully automated hematology.

Challenges
The hematology industry faces several challenges. Compliance with regulatory and ethical standards is a critical challenge in the sector, encompassing issues like informed consent, data privacy, confidentiality, and adherence to clinical guidelines. Failure to meet these standards can lead to legal liabilities, reputational damage, and loss of stakeholder trust.

Additionally, players in hematology analytics face technical and scientific challenges, including handling complex data sources, integrating data from various platforms, developing reliable algorithms, and applying insights to clinical practice.

Moreover, hematology analytics entrepreneurs must navigate market and competitive risks by segmenting the target market, understanding customer preferences, evaluating their solutions’ value proposition, and mitigating threats from competitors.

Financial and operational risks include securing funds, retaining talent, forming partnerships, and sustaining business operations as they develop and grow their ventures.

Advancements
These advancements hold tremendous promise for patients worldwide, from improved diagnostics to targeted therapies.

NGS is one of the most significant innovations in hematology, and it is the advent of next-generation sequencing (NGS) technologies. This technology has revolutionized the diagnosis of hematological malignancies, such as leukemia and lymphoma, by providing a detailed genetic profile of tumor cells. Physicians can now use this information to tailor treatment strategies based on the specific mutations present, leading to more precise and personalized therapies.

The field of hematology has witnessed remarkable advancements in recent years, particularly in digital morphology and automation. Digital imaging and sophisticated algorithms enhance accuracy and efficiency in blood cell analysis, accelerating diagnosis and enabling timely interventions. Automation streamlines processes, reduces human error, and allows for rapid reporting of results, contributing to improved patient outcomes. These innovations facilitate early detection, accurate classification of abnormalities, and prompt treatment interventions, ultimately enhancing patient prognosis and quality of life.

In addition, the auto hematology analyzer revolutionizes blood testing by combining advanced technology, workflow optimization, and a dedication to precision. By leveraging advanced algorithms, it offers comprehensive analysis of various blood parameters, including red and white blood cells, hemoglobin levels, and platelets, facilitating swift and accurate diagnoses.

Moreover, the auto hematology analyzer streamlines laboratory workflows by eliminating manual sample preparation, reducing turnaround times, and consistently delivering reliable results. These features not only enhance diagnostic accuracy but also optimize patient care by minimizing waiting times and enabling quicker initiation of treatments.

Furthermore, ongoing investments in research and development are expected to drive further advancements in blood testing, promising even more seamless and accurate diagnostic processes.

Lab-on-a-chip technology has become an advancement in hematology and is designed to assess stored red blood cell units, using quality metrics identified by omics and machine learning. This technology facilitates continuous monitoring of stored RBC quality and matches the properties of the RBC unit to the needs of the patient. By integrating state-of-the-art technologies such as omics and machine learning, lab-on-a-chip platforms can provide a more successful transfusion workflow, ensuring safer and more productive transfusions. This represents a significant step forward for patient safety, particularly for critically ill patients, those on chronic transfusion regimens, and surgeries where large volumes of RBCs are transfused.

Emerging trends
Modern hematology analyzers have evolved significantly, becoming highly automated and capable of processing multiple blood samples rapidly. They provide high data output, reliability, and accuracy, facilitating the automation of hematology laboratories. These instruments offer new parameters that allow for better characterization of different blood cells, aiding clinicians in achieving accurate differential diagnoses.

Additionally, they highlight the significance of complete blood counts (CBCs) and differential leukocyte counts as essential laboratory tests, often performed swiftly using these analyzers. Incorporating morphological study via optical microscopy helps address outlier values. Advancements in hematological instruments have increased data output, reliability, and accuracy, streamlining laboratory processes. Moreover, they enable the identification of erythrocyte abnormalities and defects, enhancing clinical understanding and patient care.

Machine learning is transforming the way hematology instruments are used and managed. A recent study introduced a machine learning-based diagnostic approach for predicting sepsis solely from basic blood count diagnostics, offering earlier detection capabilities. Unlike previous methods requiring complex clinical data, this innovative approach utilizes readily available complete blood count (CBC) data to develop a clinical decision support system (CDSS). The CBC model provides immediate results, lower implementation costs, and significant discriminatory power in predicting sepsis onset before ICU admission. Combining CBC diagnostics with other biomarkers like procalcitonin (PCT) could enhance accuracy. Despite study limitations, this represents a promising tool for early sepsis detection and improved patient outcomes, showcasing the transformative potential of machine learning in hematology.

Portable hematology instruments offer the convenience of on-the-go blood analysis, allowing for quick and efficient testing outside of traditional laboratory settings. Earlier conventional methods, such as hemocytometers and flow cytometers, are bulky and unsuitable for point-of-care (POC) testing. Researchers propose a palm-size optofluidic hematology analyzer that integrates a miniature fluorescence microscope and a microfluidic platform to address this. This portable device is compact and lightweight and offers accurate leukocyte concentration measurement, comparable to conventional methods.

Its design addresses challenges, offering valuable radiation and microgravity biology data in space missions. It enables POC testing outside traditional settings, making it particularly valuable for remote or resource-limited areas, including space environments.

AI and hematology
AI is reshaping the field of hematology by revolutionizing POC testing. Traditional methods for complete blood count (CBC) analysis face cell counting, differentiation, and morphological assessment challenges. AI-powered hematology analyzers leverage advanced technologies like machine vision and machine learning to streamline blood analysis processes.

These AI-driven devices automate cell identification and classification, providing accurate results with minimal training required. By employing innovative algorithms and imaging techniques, they overcome the limitations of traditional methods and offer rapid analysis in emergencies and remote areas.

Outlook
As hematology continues to evolve, these advancements promise to enhance clinical outcomes, empower healthcare professionals, and ultimately improve patients’ lives worldwide. Embracing these transformative technologies will undoubtedly shape the future of hematology, driving innovation and paving the way for a healthier tomorrow.

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Laboratory hematology in the current era.