Leukapheresis devices market

Leukapheresis Devices Market, By Device Type, By Application, By End User, By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

  • Aug 2023
  • CMI4142
  • 180 Pages
  • Excel & Pdf
  • Medical Devices

The global leukapheresis devices market is estimated to be valued at US$ 29.9 Million in 2023 and is expected to exhibit a CAGR of 7.9% during the forecast period (2023-2030).

Analysts’ Views on Global Leukapheresis Devices Market:

The market is mainly driven such as global cases of blood cancers, especially leukemia, growing applications of leaukopaks in research, and rise in the number of blood donations globally. The rising incidence of leukemia disorders is expected to boost the demand by increasing the usage rates of leukapheresis machines and kits. Incidence of leukemia is the highest among white people and the lowest among Chinese, Japanese, and Koreans in both men and women. It is the highest among men than women. Some of the signs and symptoms of leukemia are fatigue and weakness, bleeding from gums, trauma, bruising, fever, and weight loss.

Figure 1. Global Leukapheresis Devices Market Share (%), By DeviceType, 2023

Global Leukapheresis Devices Market– Driver

Increasing incidence of leukemia

Increasing incidence of leukemia is expected to propel growth of the  global leukapheresis devices market over the forecast period. For instance, according to the Leukemia and Lymphoma Society (2020), every 3 minutes, one person in the U.S. is diagnosed with blood cancer. According to the North American Association of Central Cancer Registries (NAACCR), in 2022, the country is estimated to record 6,660 cases of acute lymphocytic leukemia. According to the American Cancer Society, 60,530 were diagnosed with leukemia in 2020.

Increasing number of blood donations

Increasing number of blood donations can also drive the leukapheresis devices market growth. For instance, according to an article published in World Health Orgnisation in June 2023, reported  79 countries collect over 90% of its blood supply from voluntary unpaid blood donors; however, 54 countries collect more than 50% of its blood supply from family/replacement globally.

Figure 2. Global Leukapheresis Devices Market Share (%), By Region, 2023

Global Leukapheresis Devices Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global leukapheresis devices market over the forecast period. North America is estimated to hold 38.3% of the market share North America holds a significant market share in the leukapheresis devices market worldwide, mainly due to the key market players are focusing on organic statergies such as launch of novel leukapheresis devices. For instance, in June 2021, OrganaBio, LLC, a biotechnology company in U.S., announced the launch of adult peripheral blood-derived products, including vialed peripheral blood mononuclear cells (PBMCs) and whole leukopaks (LeukoPAC). These products contain high concentrations of PBMCs, such as T cells, NK cells, B cells and monocytes, which are critical raw materials for immunotherapy research and allogeneic cell therapy development and manufacturing. OrganaBio’s unique supply chain and manufacturing capabilities enable it to process PBMCs within hours of collection to ensure delivery of high-quality starting material to researchers and therapeutics developers.

Global Leukapheresis Devices Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with the transportation of drugs from one place to another.

However, The COVID-19 pandemic positively impacted the market as leukapheresis is a laboratory procedure in which white blood cells, including leukemia cells, are separated from the blood. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. In May 2020, the National Institutes of Health Clinical Center (CC) And (National Institute of Allergy and Infectious Diseases (NIAID), initiated a clinical study to identify how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system using the leukapheresis technique by collecting white blood cells from the patients who recovered from COVID-19. Currently, the study is enrolling participants and being conducted at MedStar Georgetown University Hospital and the National Institutes of Health Clinical Center in U.S.

Leukapheresis Devices Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 29.9 Mn
Historical Data for: 2018 to 2021 Forecast Period: 2023 to 2030
Forecast Period 2023 to 2030 CAGR: 7.9% 2030 Value Projection: US$ 51 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Device Type: Apheresis Devices, Leukapheresis Columns & Cell Separators, Leukoreduction Filters, Leukapheresis Disposables.
  • By Application: Research Applications, Therapeutic Applications
  • By End User: Hospitals, Academic & Research Institutes, Pharmaceutical & Biotechnology Companies, Blood Component Providers, Blood Centers
Companies covered:

Asahi Kasei Medical Co. Ltd., Haemonetics Corporation, Terumo BCT Inc., STEMCELL Technologies Inc., Fresenius SE & Co. KGaA, BioIVT, Grifols, S.A, HemaCare, B. Braun Melsungen AG, Caltag Medsystems Limited, AllCells, StemExpress, PPA, Cellero, Precision for Medicine, Inc., The Intelligent Tissue Group Lonza, BioIVT, Lmb Technologie GmbH, Kaneka Medical Europe N.V. and Key Biologics, LLC. 

Growth Drivers:
  • Increasing incidence of leukemia 
  • Increasing number of blood donations 
Restraints & Challenges:
  • High cost associated with apheresis procedure and devices 

Global Leukapheresis Devices Market Segmentation:

The global leukapheresis devices market report is segmented into by Device Type, By Application, by End User, and By Region.

By Device Type, the global leukapheresis devices market is segmented into Apheresis Devices, Leukapheresis Columns & Cell Separators, Leukoreduction Filters, and Leukapheresis disposables. Out of which, the apheresis devices is expected to dominate the leukapheresis devices market during the forecast period and this is due to Increasing incidence of leukemia.

By Application, the global leukapheresis devices market is segmented into research applications and therapeutic applications. Out of which, the research applications is expected to dominate the global leukapheresis devices market during the forecast period and this is due to increasing research on blood cancer.

By End User, the global leukapheresis devices market is segmented into hospitals, academic & research institutes, pharmaceutical and biotechnology companies, and blood component providers and blood centers. Out of which, the hospitals is expected to dominate the global leukapheresis devices market during the forecast period and this is due to dingnose the leukemia disease.

Among all the segmentations, the application has the potential due to the increasing  blood cancer this is expected to drive the growth of the segment over the forecast period. For instance, on April 06, 2023, according to the World Health Organization (WHO), reported 45 percent to 65.7 percent for leukemia remarkable progress in blood cancer treatments in recent years has significantly increased survivability rates for these hard-to-treat cancers, aided in large part by major advances in the fields of immunotherapy and targeted therapy.

Global Leukapheresis Devices Market Cross Sectional Analysis:

North America is expected to dominate the global Leukapheresis Devices market over the forecast period, owing to factors such as the product launch is boosting the market and the rising occurrence of blood cancer in the region. For instance, in June 2021, GRAIL, a healthcare company innovating to solve medicine's most important challenges in U.S., launched long-awaited Galleri blood test, a groundbreaking multi-cancer screening diagnostic test.

Global Leukapheresis Devices Market: Key Developments

In April 2022, Asahi Kasei Medical Co., Ltd., a pharmaceutical corporation, has completed its acquisition of Bionova Scientific, LLC, a provider of contract process development services, and GMP, compliant contract manufacturing services to biopharmaceutical companies as announced on April 19, 2022.

On June 22, 2023, Haemonetics Corporation, a medical technology company focused on delivering innovative solutions to drive better patient outcomes, announced it has received clearance from the U.S. Food and Drug Administration (FDA) for advancements to its NexSys PCS plasma collection system. These include a new plasma collection bowl, featuring a patented design that optimizes performance, and new Express Plus Technology engineered to reduce procedure time.

On July 14, 2023, PredOmix is an innovation driven health tech company aim to pioneer cancer detection through our state-of-the-art multi-cancer early detection test, has unveiled one-of-its-kind innovative cancer detection blood test, OncoVeryx-F, capable of detecting early-stage cancers in women with a 98% accuracy. Backed by advanced metabolomics technology coupled with artificial intelligence (AI), the new-age innovation will enable the screening for early-stage cancers. Designed for women, the screening tool accurately diagnoses cancer before tumor development begins.

In January 2022, Cryoport, Inc., a global leader in temperature-controlled supply chain solutions for the life sciences industry, announced that it has entered into a strategic partnership with Cell Matters, S.A., to deliver to the life sciences industry end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies. The companies will jointly develop the commercial approach for marketing these services.

Global Leukapheresis Devices Market: Key Trends

Researchers are researching pediatrics for applying leukapheresis

Researchers are researching pediatrics for applying leukapheresis is expected to offer lucrative growth opportunities for players in the global leukapheresis devices market. For instance, in February 2022, according to an article published in Multidisciplinary Digital Publishing Institute (MDPI) Journal, reported leukapheresis in pediatric acute leukemia with hyperleukocytosis. Pediatric acute leukemia is associated with increased morbidity and mortality and at present there is no consensus on the use of leukapheresis (LPH) for its management. institution, LPH was used in 8 of 62 (13%) patients with hyperleukocytosis with minimal complications. Mean leukocyte count in patients who received LPH versus those who did not was 498 k cells/mm3 and 237 k cells/mm3, respectively.

Global Leukapheresis Devices Market: Restraint

High cost associated with apheresis procedure and devices

High cost associated with apheresis procedure and devices are major factors that hinder growth of the market. For instance, in the U.S., the cost of an apheresis procedure is around US$ 2,500 per treatment, which is very high. Furthermore, in India, the apheresis machine costs US$ 23,459 and there is an apheresis kit, which is required for separating components costing around US$ 134, which is very costly for low-income individuals to afford.

Key market players are focusing on cost effective products.

Global Leukapheresis Devices Market- Key Players

Major players operating in the global Leukapheresis Devices market include Asahi Kasei Medical Co. Ltd., Haemonetics Corporation, Terumo BCT Inc., STEMCELL Technologies Inc., Fresenius SE & Co. KGaA, BioIVT, Grifols, S.A,  STEMCELL Technologies Inc., HemaCare, B. Braun Melsungen AG, Caltag Medsystems Limited, AllCells, StemExpress, PPA, Cellero, Precision for Medicine, Inc., The Intelligent Tissue Group Lonza, BioIVT, Lmb Technologie GmbH, Kaneka Medical Europe N.V. and Key Biologics, LLC.

*Defination: Leukapheresis is a process in which white blood cells are separated from a sample of blood. It is a specific type of apheresis used for separating a particular constituent of blood and returning the remaining part to the circulation. Leukapheresis is distinctly different from plasmapheresis and red cell exchange procedures.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snapshot, By Device Type
      • Market Snapshot, By Application
      • Market Snapshot, By End User
      • Market Snapshot, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
      • Impact Analysis
      • Recent Product Launches
      • Epidemiology
      • Merger, Acquisition, and Collaboration
      • Regulatory Scenario
      • Key Developments
      • PEST Analysis
  4. Global Leukapheresis Devices Market– COVID-19 Impact Analysis
    • Economic Impact
    • COVID-19 Epidemiology
    • Impact on Supply and Demand
  5. Global Leukapheresis Devices Market, By Device Type, 2018–2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2023 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018–2030
      • Segment Trends
    • Apheresis Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018–2030, (US$ Mn)
    • Leukapheresis Columns & Cell Separators
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018–2030, (US$ Mn)
    • Leukoreduction Filters
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018–2030, (US$ Mn)
    • Leukapheresis Disposables
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018–2030, (US$ Mn)
  6. Global Leukapheresis Devices Market, By Application, 2018–2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2023 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018-2030
      • Segment Trends
    • Research Applications
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
    • Therapeutic Applications
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
  7. Global Leukapheresis Devices Market, By End User, 2018–2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2023 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018-2030
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
    • Academic & Research Institutes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
    • Pharmaceutical & Biotechnology Companies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
    • Blood Component Providers
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
    • Blood Centers
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018-2030, (US$ Mn)
  8. Global Leukapheresis Devices Market, By Region, 2018–2030, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2023 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018-2030
    • North America
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country, 2018–2030, (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country, 2018–2030, (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country, 2018–2030, (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country, 2018–2030, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country, 2018–2030, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Introduction
      • Market Size and Forecast, By Device Type, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Application, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By End User, 2018–2030, (US$ Mn)
      • Market Size and Forecast, By Country/Region, 2018–2030, (US$ Mn)
        • North Africa
        • Central Africa
        • South Africa
        • Rest of Africa
  9. Company Profiles
    • Asahi Kasei Medical Co. Ltd.*
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Haemonetics Corporation
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Terumo BCT Inc.
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • STEMCELL Technologies Inc.
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Fresenius SE & Co. KGaA
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • BioIVT
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Grifols, S.A
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • HemaCare
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Braun Melsungen AG
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Caltag Medsystems Limited
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • AllCells
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • StemExpress
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • PPA
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Cellero
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Precision for Medicine, Inc.
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • The Intelligent Tissue Group Lonza
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Lmb Technologie GmbH
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Kaneka Medical Europe N.V.
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Key Biologics, LLC.
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
  10. Section
    • Analyst view
    • References
    • Research Methodology

About us and Sales Contact*Browse 36 market data tables and 33 figures on “Leukapheresis Devices Market ”- Global Forecast to 2030

Detailed Segmentation:

  • Global Leukapheresis Devices Market, By Device Type:
    • Apheresis Devices
    • Leukapheresis Columns & Cell Separators
    • Leukoreduction Filters
    • Leukapheresis Disposables
  • Global Leukapheresis Devices Market, By Application :
    • Research Applications
    • Therapeutic Applications
  • Global Leukapheresis Devices Market, By End User:
    • Hospitals
    • Academic & Research Institutes
    • Pharmaceutical & Biotechnology Companies
    • Blood Component Providers
    • Blood Centers
  • Global Leukapheresis Devices Market , By Region:
    • North America
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Device Type:
        • Apheresis Devices
        • Leukapheresis Columns & Cell Separators
        • Leukoreduction Filters
        • Leukapheresis Disposables
      • By Application :
        • Research Applications
        • Therapeutic Applications
      • By End User:
        • Hospitals
        • Academic & Research Institutes
        • Pharmaceutical & Biotechnology Companies
        • Blood Component Providers
        • Blood Centers
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
- Frequently Asked Questions -

What is the current market size and compound annual growth rate (CAGR) of the global leukapheresis devices market during the forecast period (2023-2030)?

The global leukapheresis devices market is estimated to be valued at US$ 29.9 Million in 2023 and is expected to exhibit a CAGR of 7.9% between 2023 and 2030.

What are the major factors driving the market growth?

Increasing incidence of leukemia and increasing number of blood donations are expected to propel growth to expand the product portfolio is expected to drive the market growth.

Which is the leading Device type segment in the market?

Apheresis Devices is the leading segment in the market.

What are the key factors hampering the growth of the market?

High cost associated with apheresis procedure and devices are expected to hinder the market over the forecast period.

Which are the major players operating in the market?

Major players operating in the market include Asahi Kasei Medical Co. Ltd., Haemonetics Corporation, Terumo BCT Inc., STEMCELL Technologies Inc., Fresenius SE & Co. KGaA, BioIVT, Grifols, S.A,  STEMCELL Technologies Inc., HemaCare, B. Braun Melsungen AG, Caltag Medsystems Limited, AllCells, StemExpress, PPA, Cellero, Precision for Medicine, Inc., The Intelligent Tissue Group Lonza, BioIVT, Lmb Technologie GmbH, Kaneka Medical Europe N.V. and Key Biologics, LLC.
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