Leukapheresis Devices Market Size, Share and Trends 2026 to 2035

Revenue, 2025

USD 35.12 Bn

Forecast Year, 2035

USD 74.94 Bn

CAGR, 2026 - 2035

7.87%

Report Coverage

Global

What is the Leukapheresis Devices Market Size?

The global leukapheresis devices market size accounted for USD 35.12 billion in 2025 and is predicted to increase from USD 37.91 billion in 2026 to approximately USD 74.94 billion by 2035, expanding at a CAGR of 7.87% from 2026 to 2035. The growing prevalence of leukemia is the key factor driving market growth. Also, technological innovations in leukapheresis procedures, coupled with the rising demand for personalized medicine, can fuel market growth further.

Leukapheresis Devices Market Key Takeaways

• North America dominated the global market with the largest market share of 39% in 2025.
• Asia Pacific is expected to grow at the fastest CAGR over the period studied.
• By device type, the apheresis devices segment dominated the market in 2025.
• By device type, the leukapheresis columns and cell separators segment is expected to grow at the fastest CAGR over the forecast period.
• By application, the research application segment held the largest market share in 2025.
• By application, the therapeutic applications segment is anticipated to grow at the fastest CAGR over the forecast period.
• By end user, The hospital segment dominated the market by holding the largest market share in 2025.
• By end user, the academic and research institutes segment is estimated to grow at the fastest CAGR during the projected period.

What is the Leukapheresis Devices Market?

The market encompasses the global industry for products and specialized equipment utilized in the process of separating and collecting leukocytes from blood for research or therapeutic purposes. The leukapheresis devices market includes an extensive range of devices, like leukapheresis columns, apheresis machines, leukoreduction filters, and cell separators. The latest trend in the is the growing use of leukopaks in CAR cell therapy .

How is AI contributing to the Leukapheresis Devices Market?

Artificial Intelligence is revolutionizing the leukapheresis devices market by improving accuracy, enhancing monitoring, and streamlining procedures and patient outcomes, which can lead to more efficient and sophisticated devices. Furthermore, AI can monitor the performance of the leukapheresis device and the vital signs of patients, alerting medical professionals to any potential deviations or problems from the expected parameters. This can facilitate early detection and intervention, enhancing patient safety and outcomes.

Leukapheresis Devices Market Growth Factors

• The growing number of blood donation campaigns globally is expected to boost market growth soon.
• The surge in usage rates of leukapheresis kits and machines can propel market growth shortly.
• Increasing health awareness among individuals, along with the rise in medical tourism, will likely contribute to the leukapheresis devices market expansion.

Market Outlook

• Industry Growth Overview: The demand for targeted therapy is rising, and that is why the biotech investors OrbiMed, Frazier Healthcare Partners, and ARCH Venture Partners are going to support the industry.
• Global Expansion: The use of advanced devices in the emerging regions is going to be a little faster, but now the thumb of OrbiMed, Frazier Healthcare Partners, and ARCH Venture Partners will be behind it.
• Major Investors: The trio of OrbiMed, Frazier Healthcare Partners, and ARCH Venture Partners is still there to provide the very strong influence of financial support; at the same time, technological progress in leukapheresis solutions is going on.

Market Scope

Market Dynamics

Drivers

Rising incidence of hematologic disorders

The increasing prevalence of hematologic disorders, like lymphoma and leukemia, is a major factor driving the leukapheresis devices market. These disorders necessitate efficient treatment approaches, and hence, leukapheresis devices play an essential role in managing abnormal WBC counts. In addition, leukapheresis devices can rapidly decrease the number of leukemic cells in the blood to tackle symptoms and prepare individuals for therapies.

In September 2024, PharmaEssentia Corporation, a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, announced the availability of BESREMi (ropeginterferon alfa-2b) in Singapore.

Restraint

Regulatory hurdles

Strict regulatory requirements for efficacy, safety, and quality create a substantial hurdle to entry for market players, negatively impacting product development and market growth. Moreover, concerns about the cost-effectiveness of this treatment as compared to other therapies or conventional blood banking methods may affect the overall adoption rates of leukapheresis devices.

Opportunity

Increasing demand for blood and blood products

The ongoing surge in the need for blood and blood products is a major factor boosting the leukapheresis devices market. As the amount of trauma cases, surgical procedures, and chronic diseases increases, the demand for efficient blood component separation becomes crucial. Furthermore, the increasing emphasis on blood donation awareness campaigns will likely contribute to the growing volume of blood collections. Hence, healthcare settings are investing heavily in innovative leukapheresis technologies.

• In August 2024, Haemonetics Corporation, a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, announced the full market release of its VASCADE MVP XL mid-bore venous closure system.

Segment Insights

Device Type Insight

The apheresis devices segment dominated the leukapheresis devices market in 2025. The dominance of the segment can be attributed to the rising prevalence of leukemia across the globe and innovations in medical technology, especially in therapeutic apheresis procedures. Additionally, government initiatives and rising awareness regarding blood donation are propelling the availability of blood components, which impacts segment growth positively.

The leukapheresis columns and cell separators segment is expected to grow at the fastest rate over the forecast period. The growth of the segment can be credited to the rising incidence of autoimmune diseases along with the increasing demand for individualized medicine and research. Also, these devices optimize the separation of blood components, enabling the selective removal or collection of specific cells, such as leukocytes.

• In January 2025, SGS announced the launch of Germany's first commercial cell-sorting service via fluorescent-activated cell sorting (FACS) for the biopharmaceutical industry. This service leverages the BD FACSAria Fusion system to support the development of advanced therapeutic medicinal products (ATMPs) and drive innovation in cell and gene therapy.

Application Insight

The research application segment held the largest leukapheresis devices market share in 2025. The dominance of the segment can be linked to the rise in research on blood cancer along with the innovations in leukapheresis procedures. Moreover, researchers are emphasizing developing novel therapies for many diseases, such as cancer and autoimmune disorders. Leukapheresis procedures can be utilized to separate specific cell populations, such as T cells or stem cells.

The therapeutic applications segment is anticipated to grow at the fastest rate over the forecast period. The growth of the segment can be driven by the growing adoption of cell-based therapies and individualized medicine. Therapeutic applications include utilizing leukapheresis to collect bone and blood marrow stem cells to help build bone marrow after chemotherapy treatment. Emergency leukapheresis also has better outcomes and lower mortality rates.

End User Insight

In 2025, the hospital segment dominated the leukapheresis devices market by holding the largest share. The dominance of the segment is owing to the growing emphasis on patient-centered treatments coupled with innovative therapeutic procedures. Furthermore, the hospital plays a key role in the treatment of blood disorders such as lymphoma and leukemia and in the stem cell transplantation process. Hospitals are major caregivers for patients with hematologic conditions.

The academic and research institutes segment is estimated to grow at the fastest rate during the projected period. The growth of the segment is due to interdisciplinary research, global collaboration, and government investment. Moreover, government funding and policies play a key role in funding research projects and supporting research infrastructure. Partnerships between universities and businesses are essential for translating research into practical applications.

Regional Insights

What is the U.S. Leukapheresis Devices Market Size?

The U.S. leukapheresis devices market size was exhibited at USD 9.59 billion in 2025 and is projected to be worth around USD 20.97 billion by 2035, growing at a CAGR of 8.14% from 2026 to 2035.

North America dominated the leukapheresis devices market in 2025. The dominance of the region can be attributed to the innovative healthcare infrastructure, coupled with the increasing adoption of advanced medical technologies. Moreover, the region also benefits from the strong presence of major market players, research centers, and academic institutions emphasizing the latest leukapheresis procedures.

• In May 2023, TERUMO BCT, INC. launched the first training program initiative to support cell and gene therapy manufacturers in improving the cell collection processes and boosting therapeutic commercialization.

In North America, the U.S. led the market owing to the supportive regulatory environment, well-established healthcare system, and growing incidence of hematologic disorders. Also, innovations in cell therapies and the growing demand for leukoplakia can impact market growth positively.

Asia Pacific is expected to grow at the fastest rate over the period studied. The growth of the region can be credited to the growing healthcare expenditure, rapid urbanization, and an increasing patient population with autoimmune diseases and hematologic disorders. Furthermore, countries such as China, India, and Japan are heavily investing in medical infrastructure development.

In Asia Pacific, China dominated the leukapheresis devices market by holding the largest market share. The dominance of the country is due to the rapidly evolving healthcare sector in China and the government's initiatives to enhance healthcare affordability and access. The region is also witnessing a rising incidence of blood cancers and autoimmune disorders.

Leukapheresis Devices Market -Value Chain Analysis

• R&D: Step-by-step, discovery and preclinical testing procedures can be carried out to ensure the device is safe and effective before moving on to human trials.
  Key players: Pfizer, Novartis, and Johnson & Johnson
• Clinical Trials and Regulatory Approvals: Human studies can be conducted, and all necessary documentation will be submitted to the regulatory authorities for approval and compliance.
  Key players: IQVIA, Parexel, PPD (part of Thermo Fisher Scientific), and ICON plc.
• Packaging and Serialization: The final products can be secured, and unique tracking identifiers will be applied for safety and supply chain management oversight.
  Key players: Körber, Bosch Packaging Technology, Kezzler
• Distribution of Leukapheresis Devices to Hospitals and Pharmacies: Logistics will be closely coordinated so that specialized medical systems can be delivered to clinical facilities for patient use.
  Key players: McKesson Corporation, Cardinal Health, and AmerisourceBergen

Leukapheresis Devices Market Companies

• Terumo BCT : The company grants access to the Spectra Optia Apheresis System, which is capable of fully automating and thus speeding up the cell collection process, which is a basic requirement for the smooth functioning of the clinical workflow within the cell and gene therapy applications.
• Fresenius SE and Co. KGaA: Hospitals and blood banks willing to have a reliable therapeutic processing solution will be able to benefit from the user-friendly operation of the Prismaflex system and apheresis machines, and consumables offered by the company.
• Haemonetics Corporation : The company is developing advanced apheresis devices and software that support the efficient leukapheresis and component collection in the international clinical and blood management settings that are widespread.
• Asahi Kasei Corporation
• Macopharma SA
• Miltenyi Biotec
• Medical Spa
• Puriblood Medical Co. Ltd.
• Beijing ZKSK Technology Co. Ltd.
• SB-Kawasumi Laboratories, Inc.
• Nikkiso Co., Ltd.
• Charles River Laboratories International, Inc.
• Discovery Life Sciences, Inc.
• Precision for Medicine, Inc.

Latest Announcements by Market Leaders

• In December 2024, Lonza announced its "One Lonza" restructuring strategy, which aims to reorganize its CDMO business, simplify its operating model, enhance manufacturing and engineering, and expand its production footprint. The company plans to exit the Capsules and Health Ingredients (CHI) business to focus on its core CDMO business, which will be structured into three new platforms.

Segments Covered in the Report

By Device Type

• Therapeutic Leukapheresis
• Cytapheresis
• Stem Cell Collection
• Research Applications
• Leukapheresis Columns and Cell Separators
• Leukapheresis Disposables
• Apheresis Devices

By Application

• Research Application
• Therapeutic Application

By End User

• Hospitals
• Blood Centers
• Academic and Research Institutes

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa