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State-of-the-art Automation is Here

State-of-the-artIn the near term, information technology will play a growing role as an adjunct to technological developments in haematology analysers.

Clinical haematology analyser analysis is one of the oldest and most important sectors of clinical laboratory analysis. Haematology analysers are indispensable diagnostic tools and continue to sustain a strong position in the global healthcare industry. They include analysers, flow cytometers, coagulation analysers, and slide strainers. Haematology analysers are computerized and highly specialized machines that determine the presence, count, and types of cellular elements in a blood sample for disease detection and monitoring. They are also used to determine non-cellular parameters of the blood such as haemoglobin and hematocrit. Samples of blood can be processed alone, in batches, or continuously in a haematology analyser.

In haematology analysers and reagents market, leading players are adopting the strategies of new product development, geographic expansions, agreements, acquisitions, and joint ventures. Market players adopted these strategies to access new technologies, expand their product portfolio, enter into growing markets, and to increase their market share.

Market Dynamics

The global haematology analysers and reagents market is expected to reach US$ 3.13 billion by 2019, at CAGR of 5.2 percent from 2014 to 2019. Technological developments in high throughput haematology analysers, integration of basic flow cytometry techniques in modern haematology analysers, increasing adoption of automated haematology instruments by diagnostic laboratories, technological advancements, and developments in the high sensitivity point-of-care (POC) haematology testing are some of the key factors that are fuelling the growth of the haematology market. However, slow adoption of the advanced haematology instruments in the emerging economies, haematology product recalls, and high cost of haematology analysers are some of the key factors hampering the growth of this market.

As of 2014, North America holds the largest share of 44 percent of the global haematology analysers and reagents market, followed by Europe. However, the Asia- Pacific market is expected to grow at highest CAGR of 9.4 percent from 2014 to 2019. A number of factors including developing healthcare infrastructure, large patient population, increasing funding/investment toward the development of haematology products, and growing focus of both international and domestic players on the Asia-Pacific countries are stimulating the growth of the haematology analysers and reagents market in the Asia- Pacific region.

The Indian haematology analysers and reagents market in 2014 is estimated at `671 crore. Reagents constitute 60 percent of the market.

hematologyMajor Players

Sysmex Corporation (Japan), Beckman Coulter, Inc. (U.S.), Abbott Laboratories (U.S.), HORIBA, Ltd. (Japan), Siemens AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Mindray Medical International Limited (China), Nihon Kohden Corporation (Japan), and Roche Diagnostics (Switzerland) are the key players operating in the global haematology analysers and reagents market.

Growth Factors

A number of factors such as development of the high throughput haematology analysers, integration of basic flow-cytometry techniques in modern haematology analysers, increasing adoption of automated haematology instruments by diagnostics laboratories, technological advancements, and developments in high sensitivity point-of-care (POC) haematology testing are propelling the growth of the global haematology analysers and reagents market. On the other hand, slow adoption of the advanced haematology instruments in the emerging economies, haematology product recalls, and high cost of haematology analysers are restricting the growth of the global haematology analysers and reagents market.

Technology Advancements

Haematology analysers utilize various technological solutions in order to recognize cell types in a blood sample and to count them individually to generate a complete blood count (CBC) with differential. Manufacturers have developed finely tuned haematology analysers that achieve good levels of precision and accuracy in cell counting through the examination and identification of thousands, not hundreds, of cells in each sample analyzed. The challenge of reporting precise results for immature cells using manual methods is exemplified with manual reticulocyte counts, which routinely have a CV of approximately 25 percent. Manual methods, even for immature cell counts, are being replaced with precise, reliable automated haematology systems that provide faster reportable results within the first aspiration.

At the highest level of haematology laboratory automation are scalable, configurable automation systems dedicated to shepherding lavender (EDTA) top tubes through the following analytic determinations: CBC, 6-part white blood count (WBC) differential, nucleated red blood cell (NRBC), reticulocyte count (RET) and immature retic fraction (IRF), automated immature platelet fraction (IPF), and automated smear preparation and staining. These on-demand tests are standardized assays that meet performance goals, decrease technologist handson time, eliminate batch testing, and provide results faster to physicians. When this testing is supported by a haematology-specific middleware product, clinical laboratories are automatically reporting up to 85 percent of their test volume without any operator intervention.

NNowadays, haematology automation platforms offer more than CBC testing from a single EDTA sample. Laboratories that have incorporated HbA1c testing on high speed haematology lines are performing >90 percent of assays from lavender top tubes with minimal technologist intervention. Auto validation of HbA1c results can run as high as 90 percent. Further process improvements are coming to the forefront of haematology, such as pre- and post-analytical sample sorting/archiving and automation of digital smear review. Now, these newly formed EDTA work areas can manage traditional haematology testing as well as the HbA1c traditionally tested in the chemistry department.

• Automation: pre-analytical

One area of haematology testing that was late to become automated was reagent preparation. Haematology technologists frequently have been frustrated about the time and effort required to change 20L cubes of diluent. Recent additions to automated haematology lines address this concern by including units that utilize concentrated reagent which is diluted using an in-lab water supply. This approach minimizes the time and effort required to prep the analysers prior to the highest volume run of the day and enables laboratorians to avoid interruptions in testing due to the need to frequently change diluent in high-volume testing settings.

• Automation: clinical decision making

The latest haematology technologies automatically provide results to the physician on immature cell population characteristics that can reflect the state of leukopoiesis, erythropoesis, and thrombopoiesis in the bone marrow through analysis of peripheral blood.

• Automation: standardization

Today, both small and large integrated networks and other entities having multiple haematology testing sites can achieve standardization of sample and data management. Haematology testing systems for these multi-lab operations provide the following for standardization, thereby eliminating discrepancies that may occur when a patient is tested at different laboratories: identical technology platforms; quality control procedures; calibrators and controls; and reagents.

• Automation: post-analytical

Sample processing after analysis also flows differently with complete automation of haematology testing. The presence of immature granulocytes in the peripheral blood typically triggers a sample for manual smear review. New haematology analysers now report these automatically in the WBC differential as immature granulocytes, reflecting the presence of metamyelocytes, myelocytes, and promyelocytes in the sample.

The latest haematology technologies automatically provide results to the physician on immature cell population characteristics that can reflect the state of leukopoiesis, erythropoesis, and thrombopoiesis

• Automation: staff shortages

Automation in the haematology lab may play a significant role in addressing anticipated staff shortages in a number of locations.

In the near term, information technology will play a growing role as an adjunct to technological developments in haematology analysers. There is a tendency for new haematology analysers to employ increasingly more detectors than the older models, for improved specificity in cell classification and for more accurate flagging of abnormal blood cells. In other words, blood-cell analysis will become more multi-dimensional, and this multitude of cellular information will rapidly expand. Moreover, a more detailed look into the characteristics of a certain cell can possibly yield more information than just WBC, such as data associated with cellular activation pathways and apoptosis or other cellular processes. It is even conceivable that information that is connected to certain disease states will be available. Thus, advanced information technology could be useful for unveiling information that is “hidden” in signals that register, but currently are used only for cell counting and classification.

Key Points

Rising popularity of automated haematology analyzers: Automated instruments enable faster processing of samples and generate results much faster than manually operated ones. Automated haematology analyzers are also more efficient and cost-effective.

Increase in aging population is a key driver of this market: The number of older adults is increasing at a fast pace worldwide. As older people are susceptible to many age-related diseases, they require access to medical therapies that depend on accurate diagnostic test results. Haematology analyzers play an important role in the early detection of diseases.

High cost of instrument: The report identifies the high cost of the instrument as a major challenge in the market. Modern automated haematology analyzers come are portable with advanced features, making it difficult for small vendors to gain from investing in them.

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