The global allogeneic cell therapy devices market is growing at a strongest CAGR of 25.28% from 2023 to 2032.
The global allogeneic cell therapy devices market is growing at a strongest CAGR of 25.28% from 2023 to 2032. The global allogeneic cell therapy devices market size was evaluated at USD 325.77 million in 2023 and it is expected to attain around USD 2,476.57 million by 2032. The emergence of allogeneic stem cell transplant (Allo-SCT) as a critical treatment for hematologic malignancies like acute lymphocytic leukemia and myelodysplastic syndrome is driving growth in the allogeneic cell therapy devices market. With expanding clinical adoption, technological advancements, and supportive regulatory environments, Allo-SCT is poised to be a key growth factor in the market.
The allogeneic cell therapy market is experiencing rapid growth during the forecast period, driven by its disruptive concept in biology. Traditionally, immunologic dogma dictated that any foreign tissue would trigger an immune reaction, necessitating aggressive immunosuppression in transplantation procedures. However, the evolution of cell-based therapy has revealed that certain cell types, notably mesenchymal stem cells (MSCs), possess the ability to evade or suppress the immune system effectively. This breakthrough enables the utilization of allografts without the need for concomitant immunosuppression.
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Allogeneic stem cell transplants, a cornerstone of this field, involve the transfer of healthy blood-forming stem cells from a donor to a recipient, typically for the treatment of blood cancers and immune system disorders. Unlike xenogeneic therapies, which utilize cells from different species, allogeneic cell therapies source cells from donors of the same species. These therapies involve the expansion and potential modification of cells from healthy donors for treating multiple patients. Critical to the market's success is stringent human donor screening and Good Manufacturing Practice (GMP) biosafety testing, ensuring the safety and efficacy of allogeneic cell therapies. As the market continues to expand, advancements in cell processing technologies and regulatory frameworks will further drive innovation and adoption, solidifying allogeneic cell therapy's position as a transformative approach in medical treatment.
- In March 2024, Getinge and CellRev unveiled a platform with the potential to revolutionize allogeneic cell therapy manufacturing. This collaboration aimed to streamline processes and enhance efficiency in the production of cell therapies.
- In October 2022, Allogene Therapeutics introduced CAR T Together, a pioneering initiative in collaboration with leading oncologists nationwide. This initiative focused on expediting the development and recruitment of clinical trials for "off-the-shelf" allogeneic cell therapy investigational products.
Key Insights
- North America has held highest revenue share of around 72% in 2022.
- U.S. allogeneic cell therapy devices market size was estimated at USD 115.11 million in 2022.
- U.S. allogeneic cell therapy devices market size is estimated to surpass around USD 1,095.88 million by 2032 and is growing at a CAGR of 25.28% from 2023 to 2032.
- Asia-Pacific accounted 12% revenue share in 2023.
- By therapy, the stem cell therapy segment has generated highest revenue share in 2023.
- By therapeutic area, the hematological disorders segment is poised to hold the highest market share in 2023.
- By therapeutic area, the dermatological disorders segment is expected to grow at notable CAGR from 2023 to 2032.
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Regional Stance
North America has emerged as the leader in revenue generation within the allogeneic cell therapy devices market. This dominance can be attributed to several factors, including a robust infrastructure supporting research and development in the field of gene and cell therapy. The American Society of Gene & Cell Therapy (ASGCT) plays a pivotal role in driving advancements, serving as the primary professional membership organization for experts in this domain. Its diverse membership, comprising scientists, physicians, patient advocates, and industry professionals, reflects the breadth of expertise contributing to the region's leadership in cell therapy innovation.
Organizations like Americans for Medical Progress (AMP) contribute to fostering an environment conducive to medical breakthroughs by advocating for supportive regulatory frameworks and public awareness. Their efforts complement the endeavors of entities like Health Canada, which regulate cell therapy products to ensure safety and efficacy. Under Health Canada's jurisdiction, cell therapy products are classified as drugs, highlighting the stringent regulatory oversight governing their development and commercialization.
- In October 2022, Century Therapeutics and Bristol Myers Squibb initiated a strategic collaboration to develop iPSC-derived allogeneic cell therapies. This partnership aimed to leverage their respective expertise in advancing innovative cell therapies for various diseases.
- In August 2023, Astellas and Poseida Therapeutics announced a strategic investment to bolster Poseida's efforts in redefining cancer cell therapy. This investment aimed to accelerate the development and commercialization of innovative cancer therapies.
- In January 2022, Fujifilm expanded its Advanced Therapies CDMO business by acquiring a dedicated cell therapy manufacturing facility from Atara Biotherapeutics, Inc. This acquisition strengthened Fujifilm's capabilities in providing comprehensive cell therapy manufacturing services.
Asia-Pacific is poised to experience the swiftest expansion in the allogeneic cell therapy devices market, reflecting the region's burgeoning healthcare sector and a conducive environment for innovation. With seven of the world's 10 most populous countries, the Asia-Pacific (APAC) region emerges as a focal point for global medical device companies seeking growth opportunities. This shift underscores the vast potential inherent in the APAC market, characterized by its diverse population and evolving healthcare landscape. The demand for healthcare services in the APAC region is witnessing a notable uptick, with medical devices playing a pivotal role in meeting this growing need. Factors such as rising income levels, increasing private sector investments, and government incentives are propelling the sector's robust growth trajectory. These dynamics underscore the region's attractiveness as a key market for allogeneic cell therapy devices, as companies leverage the expanding healthcare infrastructure and market demand to drive innovation and market penetration.
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Report Highlights
By Therapy Type
In the allogeneic cell therapy devices market, stem cell therapy type has emerged as the dominant revenue generator. Allogeneic stem cell therapy offers distinct advantages over its autologous counterpart, primarily stemming from its derivation from young, healthy donors, thereby avoiding potential complications associated with disease states. These stem cells are cultivated and stored in stem cell banks, ensuring their immediate availability for delivery. One of the key benefits of allogeneic stem cell therapies lies in their potential to address a wide range of unmet medical needs, spanning from dry eye related macular degeneration to acute myocardial infarction. The scalability of allogeneic stem cell therapies is particularly promising, as they can be sourced from universal donors and manufactured at a large scale, making them well-suited for treating large patient populations.
In the allogeneic cell therapy devices market, non-stem cell therapy type is poised for substantial growth at a significantly high compound annual growth rate (CAGR) during the projected period. Non-stem cell therapies represent a diverse category that utilizes somatic cells isolated from the human body, which are then propagated, expanded, and administered to patients for therapeutic or diagnostic purposes. These therapies serve various functions, acting as in vivo sources of enzymes, cytokines, and growth factors.
Non-stem cell therapies find application in adoptive cell therapy (ACT) for cancer treatment, transplantation of cells for metabolic disorders, and as scaffolding cells for addressing open wound injuries like burns or lesions. Techniques for isolation and propagation vary depending on the specific cell type, its localization, and intended use. These therapies can be broadly categorized into immune and non-immune cell types, each serving distinct therapeutic purposes.
By Therapeutic Area
In the allogeneic cell therapy devices market, the hematological disorders segment is projected to dominate, holding the largest market share. This segment's prominence is underscored by the therapeutic efficacy of allogeneic stem cell transplant (Allo-SCT) in addressing a spectrum of hematological conditions. Allo-SCT shows significant promise in treating patients with cutaneous T cell lymphoma, acute myeloid leukemia, Sezary syndrome, and myelodysplastic syndrome. Moreover, it is deemed a critical treatment for individuals with acute lymphocytic leukemia, particularly those testing positive for the Philadelphia chromosome. The anticipated dominance of the hematological disorders segment reflects the pressing need for effective therapeutic interventions in this area and the growing recognition of allogeneic cell therapy's potential to address these unmet medical needs. As research and development efforts continue to advance in this field, the hematological disorders segment is poised to remain a key driver of growth within the allogeneic cell therapy devices market, offering hope to patients and healthcare providers alike.
- In December 2023, both autologous and allogeneic approaches were recognized as viable options in the rapidly expanding cell therapy market. This acknowledgment underscored the diversity and potential of cell therapy treatments.
In the allogeneic cell therapy devices market, the dermatological disorders segment is forecasted to exhibit the most rapid growth rate over the projected period. Dermatology has emerged as a pioneering field in both stem cell biology and therapy, with significant advancements in the isolation and in vitro expansion of keratinocyte stem cells. This progress has facilitated swift translation into the treatment of burns and wounds, addressing a critical need in dermatological care. The utilization of allogeneic cell therapy devices in dermatological disorders has shed light on the limitations of wound coverage solely by epidermal cells. This insight underscores the importance of incorporating advanced therapeutic approaches to enhance wound healing and improve outcomes for patients with dermatological conditions. As research continues to drive innovation in dermatological therapies, the segment is poised for exponential growth within the allogeneic cell therapy devices market.
Market Dynamics
Driver
Increased Demand for Healthy Allogeneic Donors and Advancements in Regenerative Medicine
The ongoing development of allogeneic cell therapies has sparked a surge in demand for healthy allogeneic donors. To meet this demand efficiently, organizations are forging partnerships with experienced entities adept in both collections and allogeneic donor recruitment. This collaborative approach ensures a sustainable supply of donor material, essential for the continued growth of the allogeneic cell therapy devices market. The escalating demand for regenerative medicine products is being propelled by the rising incidence of degenerative and chronic diseases, which exert significant cost pressures on healthcare providers. Simultaneously, advancements in novel technologies like nanotechnology, bioengineering, and stem cell therapy are further amplifying this demand. These technological innovations are revolutionizing the treatment landscape, driving the adoption of allogeneic cell therapy devices as integral components in regenerative medicine solutions.
- In October 2023, the allogeneic CAR cell therapy market experienced a surge following advancements in gene editing and intellectual property trends. These developments marked a significant milestone in the progression of allogeneic cell therapy.
Restraint
Risk of Graft-versus-Host Disease (GVHD)
The inherent risk of graft-versus-host disease (GVHD) associated with allogeneic cell therapies or tissue transplants poses a significant restraint on the growth of the market. GVHD, often triggered by HLA mismatched donor T cells, can lead to severe and life-threatening complications. In response, physicians and clinicians are actively seeking ways to mitigate GVHD risk without compromising treatment efficacy. However, the pursuit of novel gene editing techniques, targeted T cell subset therapies, and biochemical pathway disruptions to address GVHD poses challenges in terms of regulatory approval, clinical implementation, and cost-effectiveness, thereby impeding the expansion of the allogeneic cell therapy devices market.
Opportunity
Advancements in Allogeneic Cell Cancer Immunotherapy
The continuous innovation in allogeneic cell cancer immunotherapy presents a significant opportunity for the allogeneic cell therapy devices market. Progress toward clinical utilization, such as the banking of third-party T-iPSCs (induced pluripotent stem cells) or the generation of hypoimmunogenic iPSCs through HLA editing, offers the potential for "off-the-shelf" therapy. This approach leverages banked cells as an unlimited source of therapeutic T cells, facilitating urgent use at a reasonable cost. The introduction of T-iPSC technology into T cell therapy holds promise for improving clinical outcomes, potentially revolutionizing cancer treatment. Moreover, the incorporation of the iC9 system serves as an efficient safeguard for iPSC-derived cell therapy, enhancing safety and efficacy. These advancements represent a new and promising era for allogeneic immunotherapy in cancer treatment, creating substantial opportunities for growth within the allogeneic cell therapy devices market. As these innovative approaches continue to progress toward widespread clinical adoption, they have the potential to significantly expand the market and address unmet needs in cancer therapy.
- In August 2023, Astellas and Poseida Therapeutics announced a strategic investment to bolster Poseida's efforts in redefining cancer cell therapy. This investment aimed to accelerate the development and commercialization of innovative cancer therapies. In August 2023, Precision BioSciences completed a strategic transaction with Imugene for Azer-Cel in cancer treatment. This transaction aimed to enhance Precision BioSciences' capabilities in developing novel cancer therapies.
Recent Developments
- In January 2024, MaxCyte and Wugen entered into a strategic platform license agreement to expedite the scale-up of clinical and commercial manufacturing of Wugen's investigational allogeneic cell therapies for cancers. This collaboration aimed to accelerate the development and availability of innovative cancer treatments.
- In June 2022, Immatics and Bristol Myers Squibb expanded their strategic alliance to develop gamma delta allogeneic cell therapy programs. This collaboration aimed to leverage both companies' expertise to advance novel cell therapies for various diseases.
- In May 2023, Precision BioSciences provided an update on its allogeneic CAR T programs and the regulatory path forward. This update highlighted the company's progress in advancing novel CAR T cell therapies for cancer treatment.
Key Players in the Allogeneic cell therapy devices Market
- SSM Cardinal Glennon Children's Medical Center
- Cleveland Cord Blood Center
- Duke University School of Medicine
- New York Blood Center
- Clinimmune Labs, University of Colorado Cord Blood Bank
- MD Anderson Cord Blood Bank
- LifeSouth Community Blood Centers, Inc.
- Bloodworks Northwest
- JCR Pharmaceuticals Co., Ltd.
- Sumitomo Pharma Co., Ltd.
- Atara Biotherapeutics
- Mallinckrodt Pharmaceuticals
- Tego Science Inc
- Takeda Pharmaceutical Company Limited
- STEMPEUTICS RESEARCH PVT LTD
- Biosolution Co., Ltd.
- MEDIPOST Co., Ltd.
Market Segmentation
By Therapy Type
- Stem Cell Therapies
- Non-stem Cell Therapies
By Therapeutic Area
- Hematological Disorders
- Dermatological Disorders
- Others
By Geography
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
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