3-PDAs continue to dominate the hematology market, as of now

Despite a distinct shift toward 5-part differential analyzers, the tried and tested 3-part differential analyzers continue to dominate the market, with an estimated 30,000 units sold globally every year.

Traditional manual methods for characterizing blood cells and components are accepted as being unreliable and time-consuming. Often, re-processing samples and performing additional procedures, such as nucleated red blood cells and optical counting, are necessary to obtain the necessary data for disease detection and monitoring. In addition, as qualified laboratory technicians age, less experienced technologists are replacing them without sufficient training in multiple specializations and complex manual analyses. This makes it challenging to address the labor requirements in multi-discipline laboratories. However, fully automated hematology analyzers can accommodate a wide range of analyses, minimizing manual intervention and human error.

Another significant advantage of utilizing hematology analyzers over traditional cell counting is their large-scale capacity. Hematology analyzers can process hundreds of samples simultaneously, making them ideal for high-throughput industrial, medical, and research applications. Advanced models with improved sensitivity can also detect not just blood cell and platelet count, but also the reticulocyte function and cell size.

Modern hematology analyzers are operated by advanced algorithms that implement data-fusion capabilities to integrate information from multiple separate modules, identify patterns, and detect and correct interfering elements. This function leads to greater convenience in detection and correction of errors, and reduces the need for manual reviews.

Hematology analyzers provide laboratory technicians with access to greater and more specific cell information for highly accurate complete blood count (CBC) with differential and lower review rates. They are crucial for streamlining lab processes and improving diagnostic testing. Like any other industry, hematology analyzers were also impacted by new developments in other areas, such as introduction of laser and efficient pneumatic control, leading to smaller analyzers and increased efficiency.

However, the focus has shifted toward improving clinical utility and exceeding expectations, with new-age data informatics and algorithmic science. Hematology analyzers have evolved greatly, and now they can perform a variety of morphology analyses in addition to cell counting. Aspirations have replaced expectations, and users are interested in achieving even more from hematology analyzers.

Indian market dynamics
The Indian hematology market in 2022 is estimated at ₹1275 crore, a significant increase over 2021. Reagents contributed ₹830 crore, at a 65-percent share, the balance being from instruments. Instruments have seen a miniscule 6-percent increase in 2022 over 2021, by value, thus resulting in an increased percentage contribution of reagents from 60 percent in 2021 to 65 percent in 2022.

Within the instruments segment, 85 percent of the 5-part high-end analyzers with auto loaders continue to be on rentals. With the price differential between 5-part entry level analyzers and 3-part dual-chamber analyzers narrowing even further, there is a distinct shift toward the 5-part analyzers. Within the 3-part analyzers segment, there are three price points, the discerning large labs, the smaller labs, and the government that in this segment is an exception and prefers the entry-level models. The 3-part single-chamber analyzers segment is a dying category.

With a major consolidation taking place, smaller labs selling out, and the PPP model on the rise, the vendor’s realization is declining. The number of tests is on the rise, but the vendors are having to offer the volume discounts to the large lab that has now taken over the smaller labs.

With the Indian currency nearly 10 percent down against the US dollar in the last one-year, erratic supply chain, and hike in transportation costs, the government’s Make in India program is gaining traction. Vendors are seeking that diagnostics industry also be included in the PLI scheme and the inverted duty structure in imports be resolved.

Hematology instruments and reagents market 2022
Leading brands
Segment	Brands
High-end 5-part instruments	Sysmex, Horiba, Mindray and Transasia
Entry 5- part instruments	Sysmex, Horiba, Mindray, Transasia, Boule, Dirui, Urit, Zybio, Bioelad and Genury
3-part instruments	Transasia, Horiba, Mindray, and Sysmex
Others – 3 part instruments	Agappe, Beckman Coulter, Vector, Boule, INDO-MIM, Trivitron, Urit, Zybio, Bioelad, Genury, Biogene, Rapid, Meril and many other small importers
ADI MEDIA RESEARCH

Bar coding is becoming almost mandatory. It not only ensures specimen integrity and prevents fraud, but also helps labs in Tier-II and Tier-III cities and increases the life of the machines. In the US and Europe, major IVD-reagent manufacturers have long since adopted GS1 standards for the unique identification of their products (e.g., Thermo Fisher, Sysmex, BioMérieux, Roche, and others). Yet, some manufacturers are applying GS1 barcodes only at the IVD-reagent’s secondary level of packaging, which limits the granularity of tracing individual items. Using GS1 standards in IVD-reagent distribution in India is gaining momentum. With ongoing adoption by key stakeholders, the overall IVD industry’s distribution costs are reduced while the service quality, security, and customer satisfaction levels increase.

The hematology instruments and reagents market is a rapidly growing segment in the Indian IVD industry. The Covid-19 pandemic had a significant impact on the hematology market in India, with several challenges faced by the industry. However, with the resumption of elective procedures and an increasing focus on healthcare infrastructure, the market is projected to experience significant growth in the coming years.

Automation has been the key to replacing manual workload and countering reduced laboratory throughput, accuracy, and cell-counting speed over time. Hematology analyzers have also decreased in size, thanks to revolutionary advances in computing, electronics and manufacturing, fluidics, and mechanics.

In the upcoming years, the hematology analyzer market in India is expected to expand at a rapid pace. This expansion will be fueled by an increase in the number of cases of blood disorders, automated alternatives for blood testing, greater accessibility, and raised patient awareness following the pandemic. The choice of providers and brands will be based on accuracy, repeatability, trouble-free service, and price.

India’s hematology market dynamics is unique and influenced by several factors. One of the key factors driving the growth is the increasing incidence of blood disorders, such as leukemia, sickle-cell anemia, and thalassemia. With an estimated 1.5 million patients suffering from thalassemia, there is a growing demand for hematology instruments and reagents.

Another factor driving growth is the shift toward automated alternatives for blood testing. With the increasing demand for faster and more accurate testing, automated hematology analyzers are becoming the preferred choice for clinical laboratories. These analyzers are capable of processing large volumes of samples with greater accuracy and speed than manual methods.

Furthermore, accessibility and affordability are crucial factors. As the Indian healthcare system continues to evolve, there is a growing demand for affordable and accessible diagnostic tools. Hematology instruments and reagents that are cost-effective and provide accurate results are highly valued.

In terms of provider and brand choice, accuracy, repeatability, trouble-free service, and price are the key factors that influence the decision-making process. Providers and brands that can deliver these factors are likely to be preferred by customers.

Going forward, the hematology market in India is a rapidly growing segment in the IVD industry, driven by an increase in the number of blood disorders, the shift toward automated alternatives for blood testing, and greater accessibility and affordability. With a projected high CAGR, the market is expected to continue its growth trajectory in the coming years. As the industry continues to evolve, providers and brands that can deliver accurate, reliable, and affordable hematology instruments and reagents are likely to be the preferred choice of customers.

Global market dynamics
The global hematology analyzer market size is estimated at USD 3.59 billion in 2022, projected to hit USD 6.47 billion by 2032, growing at a CAGR of 6.06 percent during 2023–2032. In 2022, the reagents segment generated more than 45 percent of the revenue share, according to Precedence Research.

The 3-part differential hematology market is a high-volume segment, with more than 30,000 analyzers sold globally per year. Due to their simplicity, 3-part differential analyzers (PDA) are still cost-efficient devices for developing healthcare systems, while in the more mature markets, the local availability of hemograms is becoming increasingly relevant. For small hospitals, clinics, and physician offices that conduct sophisticated testing, 3-part hematology analyzer system is the best option.

Although 3-part hematology analyzers are more economical for typical hematological tests, 5-part hematology analyzers are gaining in popularity. Additionally, the market is anticipated to rise significantly due to technological developments, the global availability of these instruments, and their reasonable prices.

A new tendency to partially revert the long ongoing trend of centralization in healthcare systems is emerging in various countries, and this has been intensified, if not set off, by the Covid-19 pandemic. Covid exposed the weaknesses of the centralization approach, resulting in initiatives to de-centralize access to diagnostic laboratories by providing local healthcare services in healthcare centers or joint practices that may be connected to a bigger facility, such as a hospital or a private lab in the region.

With advancements of several diagnostic fields, including genetic treatments, pharmacogenomics, bleeding disorders, hemoglobinopathies, stem cell research, and proteomics, the global market for hematology analyzers is predicted to expand significantly in coming years. Likewise, the worldwide hematology market has been expanding due to factors, such as the increase in public awareness and the consolidation of diagnostic laboratory chains.

It is expected that the increasing adoption rates of automated hematology analyzers and the rising consumer demand for high-sensitivity hematological tests will propel the global market over the next 9 years. Additionally, the market has been growing with the rising technological advancements, like the introduction of basic cytometry methods analyzers and the high-throughput expansion of hematology analyzers, and the trend is anticipated to continue over the next few years.

Key market drivers The rising global awareness of chronic diseases is anticipated to fuel the market for hematology analyzers’ revenue growth during 2023–2032. With a high incidence, chronic diseases are the main cause of death. Globally, the rate of these diseases is increasing, spreading to every region of the world, and impacting people from all socioeconomic strata. Healthcare is strongly focused on the early detection and treatment of such disorders to control the progression of such diseases. Previously, only tissue biopsy tests were used for early diagnosis of many chronic diseases, but blood analysis has grown in popularity over a period. The development of the market for hematology analyzers is significantly influenced by improvements in blood indicators for illnesses.

The prevalence of blood disorders is on the rise, technological improvements are accelerating, and automated hematology devices are being adopted at an increasing rate. With several causes and a high fatality rate, blood diseases have emerged as a global health concern. Anemia, blood malignancies, hemorrhagic diseases, and blood-borne infections are just a few of the blood problems that impact millions of individuals annually across all ages.

According to a World Federation of Hemophilia research study published in July 2022, there were a higher number of 1,125,000 males worldwide having an inherited problem of bleeding, and about 418,000 of these have a severe type of condition that is the most underdiagnosed. The Department of Health and Aged Care of the Australian Government reported in 2022 that there were about 330,000 affected babies born every year, 83 percent of whom had disorders of sickle cell and 17 percent had thalassemia, 7 percent of expectant mothers had hemoglobin disorders, and more than 1 percent of the couples worldwide were at risk. Early diagnosis, as well as treatment, are some of the most effective ways to maintain a patient’s quality of life when they have a blood cell problem. The increased prevalence of blood diseases is therefore expected to boost the market in the future.

Key market opportunities In the upcoming years, the use of the product in combination with flow cytometry processes will offer further potential growth prospects for the hematology analyzers market. Moreover, in the hematology analyzers market, many new products are launched in the global market and these new product launches will proliferate the market to a great extent.

Industry updates
The hematology market is fragmented and moderately competitive. Some key industry players include Abbott Laboratories, Bio-Rad Laboratories Inc., Danaher Corporation (Beckman Coulter), Siemens Healthineers, HORIBA Medical, Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd. The companies are implementing certain strategic initiatives, such as mergers, new product launches, acquisitions, partnerships, and investments in research and development activities, which help them strengthen their market positions globally.

In July 2022, Beckman Coulter and Scopio Labs partnered to accelerate adoption of hematology digital cell morphology platform. Scopio’s technology employs full-field imaging and AI decision support to truly eliminate manual microscopy, while providing laboratory professionals and clinicians a true workflow benefit. With simple-to-use remote viewing, the Scopio solutions simplify lab operations and improve workflow in a distributed network. High-resolution full-field images can now be shared in real time over a secure hospital network – no more slides being shipped between locations.

In July 2022, HORIBA Medical launched new products in its Yumizen H500 and H550 hematology product family, the compact benchtop hematology analyzers with enhanced performance, new features, and increased benefits.

In June 2022, Thermo Fisher Scientific Inc. introduced the new EliA RNA Pol III and EliA Rib-P blood tests for aiding in the diagnosis of systemic sclerosis and systemic lupus erythematosus (SLE), thus further expanding its comprehensive menu of automated connective tissue disease tests.

In March 2022, Mindray launched novel BC-700 analyzer series, a hematology analyzer series that incorporates both complete blood count (CBC) and erythrocyte sedimentation rate (ESR) tests. This series, including two open vial models BC-700/BC-720 and two autoloader models BC-760/BC-780, is designed to empower medium-volume laboratories with advanced diagnostic technologies that are applied in the premium products.

In April 2022, Sysmex Europe launched the automated 3-part differential hematology analyzer, XQ-320. The XQ-320 offers superior quality to a range of clinical laboratory situations with robust technology and a new level of usability. It is a dependable device that only needs a small amount of bench space, sample volume, and upkeep in Europe.

Challenges
There are several challenges that the hematology industry faces. One significant challenge is the industry development, which is expected to be constrained by fierce competition among the existing players and the high price of hematology analyzers. Additionally, it is expected that time-consuming and strict regulatory standards for hematological instruments will restrain market expansion in coming years.

The new hematology analyzing devices that are launched in the market are expensive as compared to the already existing analyzers and these automated products have less demand in the underdeveloped and developing nations of the world, and this is another challenge for the growth of the market.

In addition, there is a shortage of qualified laboratory technicians. Many experienced technicians are aging, and the newer technicians replacing them lack sufficient training in multiple specializations and complex manual analyses.

There is a need for consistent quality-control measures to ensure the accuracy and precision of hematology instruments. This requires significant investment in quality-control procedures, training of personnel, and ensuring the consistency and standardization of reagents and controls.

Furthermore, there is a growing demand for faster and more accurate testing, especially in critical care settings. This requires continued research and development of newer technologies and more sophisticated algorithms to achieve greater accuracy and faster turnaround times.

There is also an increasing demand for personalized medicine, which requires tailored treatment plans based on individual patient characteristics. Hematology instruments need to keep pace with this demand by providing more specific and detailed information on individual patient samples.

Finally, with the rise of telemedicine and remote patient monitoring, there is a growing need for hematology instruments that can be easily used outside of the laboratory setting, such as in home-based or point-of-care testing. This requires the development of smaller, more portable, and user-friendly instruments that can be used by non-specialists.

Emerging technologies
The increasing worldwide prevalence of hematological disorders and malignancies is exponentially increasing the required amount of diagnostic testing, making the importance of early diagnosis and effective treatment initiation more important than ever. Understanding blood cellular morphology adds to the value of a routine blood count and can help to identify hematologic disorders. Traditionally, peripheral blood smear analysis has been performed manually. To improve both speed and accuracy, however, the industry needs to lean into technology – especially as laboratorians and clinicians are already required to do more with fewer people and resources. Here are some of the trends expected to have an impact on hematology market in coming years:

Automation. Automated hematology analyzers have revolutionized the field of hematology by providing rapid and accurate blood cell analyses. These instruments can process large numbers of samples quickly and efficiently, reducing the workload of laboratory staff and improving turnaround times for test results. The most advanced automated hematology analyzers can analyze blood cells in great detail, detecting subtle abnormalities that might be missed by manual analysis. These instruments use advanced algorithms to detect abnormalities in blood cells and provide rapid and reliable results.

The hematology analyzers market has seen the emergence of automated solutions from leading manufacturers. The latest automated analyzers are equipped to test components of red blood cells (RBC) and platelets (PLT), while also performing residual white blood cell counting, all in a single sample aspiration. This new capability offers blood-processing centers the potential for significant gains in efficiency, consistency, and accuracy, allowing them to process more samples in a shorter timeframe with minimal errors. These automated analyzers also offer the added advantage of freeing up resources, allowing medical professionals to focus on more critical tasks.

Digitization. Digitization is transforming the way hematology instruments are used and managed. Digital hematology instruments can be connected to hospital information systems, allowing for seamless data transfer and analysis. This improves efficiency and reduces errors in diagnosis. Digital hematology instruments can store patient data and test results in electronic medical records, facilitating longitudinal tracking of patients’ blood disorders.

Digitization of hematology slides is also transforming cell morphology analysis and changing how scientists work both inside and outside the lab. Because the samples are fully digital, clinicians and lab professionals have the ability to analyze samples from anywhere in their hospital’s secure network, supporting more collaboration and faster review.

Miniaturization. The miniaturization of hematology instruments has not only enabled the development of smaller and more portable devices but it has also revolutionized the field of healthcare. These smaller devices can now be used in remote or underserved areas, where access to laboratory infrastructure is limited, allowing for better healthcare delivery to those in need.

Portable hematology instruments have made point-of-care testing a reality, allowing for faster diagnosis and treatment of blood disorders. This is particularly useful in emergency situations, where time is of the essence, and quick and accurate diagnoses can be the difference between life and death.

In addition to providing faster results, these portable devices are also more user-friendly and require less training than traditional laboratory equipment. This means that healthcare providers with minimal training can use these instruments to perform hematology tests, expanding access to high-quality care to a larger population.

Overall, the miniaturization of hematology instruments and the development of smaller and more portable devices have had a profound impact on the field of healthcare. They have enabled faster and more accurate diagnoses, expanded access to high-quality care, and improved health outcomes for patients in remote or underserved areas.

Artificial intelligence and 3D printing technology. The introduction of AI and 3D printing technology has had a significant impact on the field of hematology analysis. These technologies have enabled the development of new and advanced hematology instruments that are more accurate, efficient, and versatile.

One of the most significant changes in hematology analysis has been the shift toward cell sorting and counting, which is becoming increasingly popular overflow-based counting. Cell sorting and counting involves separating individual cells from a mixture and analyzing them individually. This method allows for more precise analysis of individual cells, resulting in more accurate diagnoses of blood disorders.

In addition, the combination with digital morphology has emerged as a powerful tool in the diagnosis of blood diseases and cancer. This platform combines traditional hematology methods with digital image analysis and AI algorithms to provide more detailed and accurate diagnostic information. The digital morphology platform allows for the analysis of individual cells at high resolution, identifying subtle abnormalities that may not be detectable with traditional methods.

AI is increasingly being integrated into hematology instruments to improve accuracy and speed of analysis. AI algorithms can analyze large datasets of blood cell images and detect patterns that may be difficult for human analysts to identify.

By using AI, hematology instruments can provide more precise diagnoses, allowing for more targeted treatment and better patient outcomes.

3D printing technology has also been used to develop new hematology instruments, such as microfluidic devices that can sort and analyze individual blood cells. These devices are more efficient and versatile than traditional methods, allowing for more precise analysis of individual cells and more accurate diagnoses of blood disorders.

The introduction of AI and 3D printing technology has enabled significant advancements in the field of hematology analysis. These technologies have facilitated the development of new and advanced hematology instruments, leading to more accurate and efficient diagnosis and treatment of blood disorders.

Point-of-care testing. Point-of-care testing for hematology is expanding in many areas of the world where it provides real benefits in managing patients’ needs quickly and efficiently. There have been several important areas in the development of point-of-care full blood count testing analyzers. They have become easier to use and more reliable. This is accomplished by robust design and user-friendly software development, which means that they can be safely operated by non-laboratory personnel, and inspire confidence in the results.

These devices can be used outside of a laboratory setting and provide rapid results, enabling faster diagnosis and treatment of blood disorders. They are particularly useful in remote or resource-limited settings, where access to laboratory infrastructure is limited.

Overall, technological advance- ments in hematology instruments are improving accuracy, speed, and efficiency in the diagnosis and treatment of blood disorders. These trends are expected to continue to shape the industry in the coming years.

Outlook
The increasing prevalence of hematological disorders and malignancies has made early diagnosis and effective treatment initiation more critical than ever. To meet this challenge, the hematology industry has turned to technology, and various trends are expected to have an impact on the hematology market. These trends include automation, digitization, miniaturization, AI, 3D printing, and point-of-care testing. These advancements have enabled the development of new and advanced hematology instruments that are more accurate, efficient, and versatile than ever before, leading to more precise diagnosis and treatment of blood disorders, improved health outcomes, and expanded access to high-quality care. The way forward for the industry is to continue to embrace technology and innovation to meet the growing demand for hematological diagnosis and treatment.