Hematology Diagnostic Devices And Equipment Global Market Report 2024

The hematology diagnostic devices and equipment market size has grown rapidly in recent years. It will grow from $2.15 billion in 2023 to $2.41 billion in 2024 at a compound annual growth rate (CAGR) of 11.8%. The growth observed in the historical period can be attributed to factors such as the advancement of clinical diagnostics, the expansion of blood banking services, the increasing prevalence of oncology and hematological disorders, and the need for monitoring disease progression. These factors have driven the demand for hematology diagnostic devices and equipment.

The hematology diagnostic devices and equipment market size is expected to see rapid growth in the next few years. It will grow to $3.7 billion in 2028 at a compound annual growth rate (CAGR) of 11.4%. The anticipated growth in the forecast period can be attributed to various factors, including the aging population, the growing adoption of personalized medicine, an increase in blood-related disorders, and the development of hematological biomarkers. Notable trends expected during this period encompass technological advancements, the rise of point-of-care hematology testing, increased automation and integration of diagnostic processes, as well as the utilization of telemedicine and remote monitoring for hematological diagnostics.

The increasing prevalence of blood disorders is a significant driver for the growth of hematology diagnostic devices. These devices play a crucial role in identifying and categorizing various blood disorders, which can impact the counts of different blood cell types, including red blood cells, white blood cells, and platelets. Blood disorders affect millions of individuals worldwide, regardless of age, race, or gender. For instance, the World Health Organization reports that hemoglobin disorders affect 75% of global births, and the prevalence of anemia in men is 12.7%.

The primary product categories within hematology diagnostics devices and equipment encompass instruments and consumables. Hematology diagnostic instruments are employed to diagnose a wide range of conditions associated with the blood, vascular systems, bone marrow, autoimmune disorders, and hemostasis. Hematology diagnostics consumables consist of reagents, stains, and other related materials, while the instruments include analyzers, flow cytometers, and various other diagnostic devices. These tools find applications in diverse medical fields, including drug testing, autoimmune disease diagnostics, cancer detection, diabetes mellitus monitoring, infectious disease testing, and more. They are utilized by a range of end-users, such as hospitals, specialized diagnostic centers, and dedicated research institutes.

The hematology diagnostics devices and equipment market research report is one of a series of new reports that provides hematology diagnostics devices and equipment market statistics, including hematology diagnostics devices and equipment industry global market size, regional shares, competitors with a hematology diagnostics devices and equipment market share, detailed hematology diagnostics devices and equipment market segments, market trends and opportunities, and any further data you may need to thrive in the hematology diagnostics devices and equipment industry. This hematology diagnostics devices and equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The rising incidence of chronic diseases is expected to boost the hematology diagnostics devices and equipment market. Chronic diseases are long-term illnesses that persist for three months or more, often worsening over time. Hematology diagnostic devices and equipment are essential for conducting regular blood tests and continuous monitoring, which are crucial for managing chronic diseases. As of January 2023, the National Center for Biotechnology Information predicts that the number of people with chronic diseases worldwide will increase to 142.66 million by 2050, up from 71.522 million in 2020. This rising prevalence of chronic diseases is a driving force behind the growth of the hematology diagnostics devices and equipment market.

One of the significant challenges faced by companies in this field is product recalls. Product recalls involve the return of faulty devices, often due to manufacturing errors. These faulty devices can impact the accuracy of tests conducted in diagnostic centers. For example, Becton Dickinson (BD) and Company recalled Vacutainer EDTA Blood Collection Tubes due to their chemical interference with blood samples, affecting the test results. This recall was classified as a Class I recall, the most serious type, by the Food and Drug Administration (FDA). Such product recalls can have a negative impact on market growth.

Companies operating in the hematology diagnostic devices sector are increasingly investing in automation technology. Advancements in automation technology are driving the demand for hematology analyzers, which can reduce errors caused by manual practices in diagnostic centers. For example, prominent companies like Sysmex have obtained a CLIA waiver for a new automated hematology analyzer, enabling clinical facilities to perform hematology testing without manual errors. CLIA regulations establish quality standards for laboratory testing performed on human specimens, such as blood, body fluids, and tissues, for disease diagnosis, prevention, or treatment, and health assessment.

Major companies in the hematology diagnostics and equipment market are focusing on the development of innovative solutions like hematology analyzers to gain a competitive edge. Hematology analyzers are specialized medical devices used in clinical laboratories and healthcare settings to automate the analysis of blood samples. In May 2023, Siemens Healthineers launched the Atellica HEMA 570 and Atellica HEMA 580 Analyzers, designed to streamline and enhance high-volume hematology testing. These analyzers offer automation, integrated intelligence, and user-friendly interfaces to overcome workflow challenges and deliver faster results. They can process up to 120 tests per hour, provide advanced data management features, and facilitate direct result integration into laboratory information systems, improving patient care and supporting follow-up actions when necessary.

Although the hematology diagnostic devices market has the potential for rapid growth, stringent regulatory policies are currently constraining its expansion. The FDA regulates class I, class II, and class III hematology devices, each with varying levels of regulatory requirements, with class III devices being subject to premarket approval (PMA), the most stringent category.

Major companies operating in the hematology diagnostic devices and equipment market include Abbott Diagnostics, Beckman Coulter Inc., Bio-Rad Laboratories Inc., Drucker Diagnostics Inc., Horiba Ltd., Instrumentation Laboratory Inc., Siemens Healthcare, Shenzhen Mindray Bio-Medical Electronics Co. Ltd., F.Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., HemoCue AB, Mindray Medical International Limited, NORMA Group, Danaher Corporation, Edan Instruments Inc., Novo Nordisk, Sysmex Corporation, Fluidigm Corporation, CellaVision, Maccura Biotechnology Co., DY mind Biotech, Balio Diagnostics, BioSystems Diagnostics Pvt. Ltd., Wiener Lab, Accurex Biomedical Pvt. Ltd., ARKRAY USA, Boule Diagnostics AB, DermaFlow, Diagnostics Holdings, Diatron Group, EKF Diagnostics Holdings, Grifols, S.A., ICU Medical Inc., Nihon Kohden Corporation, Ortho Clinical Diagnostics, PixCell Medical, STRATEC Biomedical AG, Terumo BCT, Z-Medica Corporation

North America was the largest region in the global hematology diagnostics devices and equipment market in 2023. Asia-Pacific was the second-largest region in the hematology diagnostics devices and equipment market. The regions covered in the hematology diagnostic devices and equipment market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The countries covered in the hematology diagnostic devices and equipment market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The hematology diagnostic devices and equipment market consists of sales of flow cytometers, slide strainers, automated cell counters, red cell indices devices, micro sedimentation centrifuges, or blood volume measuring devices, occult blood tests, platelet aggregometer, erythrocyte sedimentation rate tests, red blood cell enzyme assay kits, glutathione reductase assays, and hematology reagents that are used for the diagnosis of hematology. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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