Leukapheresis Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Leukapheresis Devices, Apheresis Devices, Leukapheresis Columns, Cell Separators, Leukoreduction Filters, Leukapheresis Disposables), By Application (Research Applications, Therapeutic Applications), By End User (Blood Component Providers and Blood Centers, Academic and Research Institutes, Pharmaceutical and Biotechnology Companies, Hospitals and Transfusion Centers), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 83.49 Million
CAGR (2026-2031)	5.37%
Fastest Growing Segment	Leukapheresis Devices
Largest Market	North America
Market Size (2031)	USD 114.27 Million

Market Overview

The Global Leukapheresis Market will grow from USD 83.49 Million in 2025 to USD 114.27 Million by 2031 at a 5.37% CAGR. Leukapheresis constitutes a specialized medical procedure wherein white blood cells are isolated from withdrawn blood and the remaining components are returned to the circulation. The primary drivers propelling market growth include the rising prevalence of hematological malignancies and the consequent demand for therapeutic apheresis to manage high white blood cell counts. Furthermore, the expansion of cell-based immunotherapy research necessitates high-quality leukopaks for manufacturing Advanced Therapy Medicinal Products. This increasing clinical need is evidenced by recent disease statistics. According to the American Cancer Society, in 2024, approximately 62,770 new cases of leukemia were projected to be diagnosed in the United States. Such figures underscore the critical requirement for efficient cellular separation technologies to support ongoing treatment and research protocols.

Despite the strong demand factors, the market encounters a significant impediment regarding the substantial costs associated with apheresis equipment and procedures. The high capital expenditure required for automated devices and the recurring expense of disposable kits restrict accessibility for smaller healthcare facilities and create adoption barriers in cost-sensitive developing regions.

Key Market Drivers

The accelerated commercialization of CAR-T cell therapies serves as a paramount driver for the global leukapheresis market, fundamentally increasing the utilization of apheresis systems for harvesting autologous T-cells. As regulatory bodies expand approvals for these treatments to earlier lines of therapy, manufacturing networks must rapidly scale to accommodate higher patient volumes, necessitating a denser infrastructure of apheresis-capable collection centers. This commercial trajectory is highlighted by the financial performance of key market products which rely directly on leukapheresis procedures. According to Johnson & Johnson, October 2024, in the 'Q3 2024 Earnings Report', worldwide operational sales for Carvykti, a CAR-T therapy for multiple myeloma, surged 87.6% year-over-year to reach $286 million. Such rapid revenue growth reflects widening patient access and directly correlates with an increased number of collection procedures required to generate these personalized treatments, thereby fueling market expansion.

A simultaneous surge in immuno-oncology and cell therapy clinical trials is substantially elevating the demand for both clinical procedures and research-grade leukopaks used in process development. Developers require consistent access to high-quality cellular starting materials to validate manufacturing processes and conduct safety studies for new candidates, creating a sustained revenue stream for apheresis providers. According to the American Society of Gene + Cell Therapy, April 2024, in the 'Gene, Cell, + RNA Therapy Landscape Q1 2024 Quarterly Report', the global pipeline expanded to include 4,021 gene, cell, and RNA therapies in development, ranging from preclinical to pre-registration stages. This extensive research activity is underpinned by significant federal investment which stabilizes the supply chain ecosystem. According to the National Cancer Institute, in 2024, the agency received a total operating budget of $7.22 billion to support broad-spectrum cancer research and training. Consequently, the combination of active pipelines and secure funding perpetuates a steady requirement for leukapheresis technologies in both clinical and laboratory settings.

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Key Market Challenges

The substantial financial burden associated with leukapheresis equipment and associated operational expenses serves as a primary obstruction to broader market expansion. Automated apheresis devices command a high capital expenditure, effectively restricting their acquisition to large, well-funded medical centers and reference laboratories. This financial threshold prevents smaller healthcare facilities and community clinics, particularly in cost-sensitive developing regions, from adopting these essential technologies, thereby limiting the overall installed base and accessible patient volume.

Beyond the initial asset purchase, the market faces sustained pressure from rising recurring costs related to disposable kits and maintenance. These operational expenses directly impact the affordability of procedures and the final cost of blood products. This upward cost trajectory is substantiated by recent industry data. According to the Association for the Advancement of Blood & Biotherapies (AABB), in 2025, findings from the National Blood Collection and Utilization Survey revealed that the median price hospitals paid for apheresis-derived platelets surged, recording a unit cost increase of $65 over the previous reporting cycle. Such escalating costs for apheresis-derived components underscore the economic strain on healthcare providers, ultimately compelling them to limit procedure volumes and hampering the widespread scalability of leukapheresis-dependent therapies.

Key Market Trends

The emergence of portable and mobile leukapheresis units is fundamentally reshaping the market by decentralizing access to essential cellular starting materials. By deploying self-contained, mobile collection centers, providers can overcome logistical barriers that historically limited donor participation in remote or underserved areas. This shift allows for the collection of high-quality leukopaks directly within communities, thereby reducing the burden on patients who previously traveled to fixed-site reference centers. This trend is exemplified by recent infrastructure developments aimed at widening the geographic reach of cell therapy supply chains. According to BioBridge Global, May 2025, in the 'BBG Advanced Therapies Launches First Mobile Leukapheresis Center' press release, the organization's new mobile unit is designed to support healthcare services across a region of more than 63,000 square miles, significantly expanding the catchment area for immune cell collection.

Simultaneously, the implementation of closed-system automated processing platforms is influencing the market by mandating upstream compatibility with sterile manufacturing workflows. As cell therapy developers transition from manual, open-lab procedures to fully automated ecosystems, there is a heightened requirement for leukapheresis products that integrate seamlessly with downstream bioreactors to minimize contamination risks and labor costs. This drive towards automation ensures that the cellular starting material retains viability and consistency throughout the vein-to-vein process. The efficacy of such integrated systems is highlighted by recent industry collaborations focused on process optimization. According to Terumo Blood and Cell Technologies, November 2025, in the 'Terumo BCT and University of Chicago Achieve Automated 3-in-1 TCR-T Manufacturing' announcement, researchers successfully expanded 10 million PBMCs to 9 billion cells in 10 days using the Quantum Flex platform, demonstrating the scalability achievable when collection and processing technologies are effectively aligned.

Segmental Insights

Within the Global Leukapheresis Market, the Leukapheresis Devices segment is projected to register the fastest growth, driven by the rising prevalence of leukemia and autoimmune disorders necessitating therapeutic apheresis. Healthcare facilities and blood centers are increasingly investing in advanced centrifugal and membrane separation systems to enhance the efficiency of white blood cell extraction. This surge in demand is further supported by the growing adoption of cellular immunotherapies, which require specialized equipment for high-quality leukopak collection. Additionally, continuous product approvals by regulatory bodies, such as the U.S. Food and Drug Administration, facilitate market expansion by ensuring access to innovative, automated technologies.

Regional Insights

North America holds a dominant position in the Global Leukapheresis Market, primarily driven by the rising prevalence of hematologic malignancies such as leukemia. This leadership is supported by a robust healthcare infrastructure and the presence of major biopharmaceutical companies focusing on cell-based immunotherapies. The region has experienced a significant surge in demand for leukopaks to facilitate research for CAR-T cell treatments. Additionally, favorable regulatory frameworks established by bodies like the U.S. Food and Drug Administration (FDA) accelerate the approval of essential apheresis devices, further consolidating North America’s market supremacy.

Recent Developments

• In September 2025, Charles River Laboratories International, Inc. announced a collaboration with Akadeum Life Sciences to enhance its Cell Therapy Flex Program. The partnership involves the integration of Akadeum's GMP-grade Human T Cell Leukopak Isolation Kit into Charles River's platform, which is used for cell therapy process development. This integration allows for more efficient cell separation and higher cell viability by utilizing a microbubble-based isolation technology directly within the leukopak bag. The Corporate Senior Vice President of Global Manufacturing at Charles River highlighted that this scalable solution would help reduce complexity and accelerate the delivery of therapies to patients.
• In November 2024, Terumo Blood and Cell Technologies launched its new Global Therapy Innovations business unit to integrate its expertise across the patient journey, from cell collections to manufacturing. This strategic move aims to streamline the process for cell and gene therapy developers by leveraging data from systems such as the Spectra Optia Apheresis System and the Quantum Flex Cell Expansion System. The General Manager of Global Therapy Innovations stated that the unit would help connect cell quality and collection access with downstream manufacturing processes, ultimately improving patient access to therapies.
• In November 2024, Sanguine Biosciences introduced LeukoCer, a new GMP-grade leukopak product designed to support the development of cell therapies. The launch of this product addresses the critical need for high-quality, compliant cellular starting materials in the advanced therapy market. These leukopaks are collected via leukapheresis and are manufactured under rigorous standards to ensure consistency and reliability for clinical and commercial applications. The company aims to facilitate the smooth transition of therapies from research to commercialization by providing a robust supply of GMP-compliant leukopaks.
• In February 2024, BioIVT announced a significant expansion of its capabilities in Europe to provide fresh leukopaks, a critical starting material for cell and gene therapy research. The company increased its capacity to deliver standard and mobilized human leukopaks to researchers in the UK and mainland Europe within 24 hours of collection. This development was designed to meet the growing demand in the region for high-quality, reliable cellular starting materials. The Vice President of Cell and Gene Therapy at BioIVT noted that access to fresh leukopaks allows clients to maintain high cell viability and quality, which is essential for effective therapeutic development.

Key Market Players

• Asahi Kasei Medical Co. Ltd
• Haemonetics Corporation
• TERUMO BCT INC.
• STEMCELL Technologies Canada Inc.
• Fresenius SE & Co. KGaA
• B. Braun SE
• Caltag Medsystems Limited
• Precision Medicine Group, LLC
• LMB Technologie GmbH
• Grifols, S.A.
• Kaneka Pharma Europe NV

By Type	By Application	By End User	By Region
Leukapheresis Devices Apheresis Devices Leukapheresis Columns Cell Separators Leukoreduction Filters Leukapheresis Disposables	Research Applications Therapeutic Applications	Blood Component Providers and Blood Centers Academic and Research Institutes Pharmaceutical and Biotechnology Companies Hospitals and Transfusion Centers	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Leukapheresis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Leukapheresis Market, By Type:

• Leukapheresis Devices
• Apheresis Devices
• Leukapheresis Columns
• Cell Separators
• Leukoreduction Filters
• Leukapheresis Disposables

• Leukapheresis Market, By Application:

• Research Applications
• Therapeutic Applications

• Leukapheresis Market, By End User:

• Blood Component Providers and Blood Centers
• Academic and Research Institutes
• Pharmaceutical and Biotechnology Companies
• Hospitals and Transfusion Centers

• Leukapheresis Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE