ALLOGENEIC STEM CELL TRANSPLANTATION MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

The allogeneic stem cell transplantation market size is expected to reach US$ 6.62 Bn by 2030, from US$ 3.90 Bn in 2023, at a CAGR of 7.8% during the forecast period. Allogeneic stem cell transplantation involves transferring stem cells from a genetically similar donor to the patient for the treatment of various disorders and cancers. It has key applications in treating blood cancers, autoimmune diseases, and genetic disorders. The rising prevalence of chronic diseases is a key factor driving the market growth.

The allogeneic stem cell transplantation market is segmented based on source, application, end user, cell type, and region. Based on source, the market is segmented into bone marrow, peripheral blood, umbilical cord blood, adipose tissue, dental pulp, and others. Bone marrow is expected to account for the largest share during the forecast period owing to the established history of hematopoietic stem cell transfer from bone marrow for transplantation.

Allogeneic Stem Cell Transplantation Market Regional Insights:

• North America is expected to be the largest market for allogeneic stem cell transplantation during the forecast period, which accounted for over 40.5% of the market share in 2022. The growth of the market in North America is attributed to the high adoption of stem cell therapies, advanced healthcare infrastructure, and rising R&D investments.
• Europe is expected to be the second-largest market for allogeneic stem cell transplantation, which accounted for over 27.2% of the market share in 2022. The growth of the market in Europe is attributed to the increased funding for clinical trials and growing cases of cancers and blood disorders.
• Asia Pacific is expected to be the fastest-growing market for allogeneic stem cell transplantation, growing at a CAGR of over 23.1% during the forecast period. The growth of the market in Asia Pacific is attributed to the growing healthcare expenditure and increasing government support for R&D regarding allogeneic stem cell transplantation.

Figure 1. Global Allogeneic Stem Cell Transplantation Market Share (%), By Region, 2023

Analyst’s View

The Allogeneic Stem Cell Transplantation Market is expected to witness substantial growth in the coming years. This growth is primarily driven by the increasing prevalence of hematologic malignancies and other non-malignant disorders, where allogeneic stem cell transplantation has proven to be a promising treatment option. Moreover, the growing investments in research and development activities, coupled with a robust pipeline of stem cell therapies, are expected to provide a significant push to the market. The increasing number of clinical trials focusing on the application of allogeneic stem cell transplantation in various therapeutic areas is a positive sign for the market's future growth. However, the high cost of transplantation procedures, lack of awareness, and stringent regulatory scenarios could pose challenges to the market growth. Regionally, North America is expected to dominate the market due to the advanced healthcare infrastructure, high prevalence of hematologic disorders, and presence of key market players. However, the Asia Pacific region is expected to exhibit the fastest growth rate owing to the improving healthcare infrastructure and increasing patient population. In conclusion, the Allogeneic Stem Cell Transplantation Market is poised for significant growth, driven by the increasing prevalence of diseases, advancements in technology, and robust pipeline of therapies. However, factors such as high costs and regulatory challenges could potentially hinder the market growth.

Allogeneic Stem Cell Transplantation Market Drivers:

• Rising Incidence of Chronic Diseases: The rising prevalence of chronic diseases, such as cancer, autoimmune diseases, and blood disorders, is a major factor driving the growth of the allogeneic stem cell transplantation market. The number of new cases of diseases like leukemia, multiple myeloma, and lymphoma has steadily increased over the past decade. Allogeneic hematopoietic stem cell transplantation represents a potentially curative treatment approach for many of these high-risk and drug-resistant hematological malignancies. According to the World Health Organization (WHO), cancer was responsible for nearly 10 million deaths worldwide in 2020. The surging patient pool and demand for advanced therapies to treat these conditions will drive the market growth.
• Increased Research and Clinical Trials: A number of research studies and clinical trials are underway to evaluate the safety and efficacy of allogeneic stem cell therapies for newer applications beyond traditional blood cancers and disorders. Several phase 2 and 3 trials are ongoing to assess allogeneic stem cell therapies for indications such as bone marrow fibrosis, osteoarthritis, stroke, traumatic brain injury, and myocarditis among others. Robust pipeline activities focused on broadening the treatment landscape will provide new avenues for market growth. For instance, Novartis, a global pharmaceutical company, initiated a study using allogeneic stem cell transplantation for the treatment of bone marrow fibrosis. The study is in phase 2 of clinical trials and is expected to be completed by October 2024.
• Technological Advancements in Stem Cell Therapies: Significant advances in stem cell harvesting, expansion, and therapeutic application have enhanced the scope of allogeneic stem cell-based treatments. New developments in apheresis for stem cell collection from peripheral blood, use of cord blood as a source, and advances in ex-vivo expansion techniques have improved cell yields and transplantation outcomes. Companies are also developing advanced allogeneic 'off-the-shelf' cell therapies using gene editing tools like CRISPR to make universal CAR T-cell therapies for cancer treatment. Such cutting-edge technologies and treatment modalities will propel the market growth.
• Favorable Government Regulations: Regulatory bodies like the U.S. FDA (Food & Drugs Administration) and EMA (European Medicines Agency) have enacted expedited approval pathways, such as breakthrough therapy, fast track, and priority review, to accelerate approval timelines for promising regenerative medicine therapies. The U.S. FDA has also implemented the Regenerative Medicine Advanced Therapy designation to provide benefits to cell therapies showing significant efficacy in early studies. Such regulatory support and initiatives are creating a favorable environment for growth of the allogeneic stem cell transplantation market.

Allogeneic Stem Cell Transplantation Market Opportunities:  

• Increasing Use of Allogeneic MSCs: Mesenchymal stem cells sourced from adult tissues like bone marrow and adipose tissue hold significant promise for allogeneic applications owing to their immunomodulatory functions. Allogeneic MSC (mesenchymal stem cell) therapies are being increasingly evaluated in regenerative medicine applications beyond traditional hematopoietic stem cell transplantation. This presents a key growth opportunity as players expand their capabilities to tap the strong clinical potential of allogeneic MSCs for newer indications.
• Combination Therapies: Combining allogeneic cell therapies with approved drugs or treatment modalities is an emerging opportunity to improve patient outcomes. Early research on combining allogeneic NK (Natural killer) cells and MSCs with checkpoint inhibitors for cancer is showing synergistic effects. Cell therapy and drug combinations for blood cancers have also shown positive results. Such combination approaches are expected to gain traction and maximize the benefits of allogeneic stem cell therapies.
• Scale-up in Emerging Markets: Emerging markets across Asia Pacific, Latin America, and the Middle East represent significant growth opportunities owing to expanding healthcare budgets, rise in medical tourism, and improving regulations for cell-based research. Companies are increasingly establishing high-tech stem cell manufacturing and processing facilities in these markets to serve the growing regional demand. Rising partnerships and distributor agreements will help players tap growth prospects.
• Expanding Applications: In gene therapy, allogeneic stem cells are gaining increasing relevance as delivery vehicles for gene therapies, especially for monogenic diseases. Advances in genetic modification tools have enhanced the prospects of engineering allogeneic cells with desired gene sequences before transplantation into patients. The expanding application scope of gene-modified allogeneic cell therapies will provide new market prospects.

Allogeneic Stem Cell Transplantation Market Trends:

• Mergers and Acquisitions: The allogeneic stem cell therapy domain has witnessed significant merger and acquisition activity aimed at consolidating market presence as well as expanding cell therapy pipelines. For instance, in July 2022, Vertex Pharmaceuticals, a global pharmaceutical company, announced that it has entered into a definitive agreement to acquire ViaCyte, a biotechnology company focused on delivering novel stem cell-derived cell replacement therapies. Vertex Pharmaceuticals will accelerate ViaCyte’s VX-880 clinical trial program. VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D, which has already achieved proof-of-concept with highly promising safety and efficacy results from a phase 1/2 study.
• Automation in Cell Processing: Players are adopting more automated and closed systems for stem cell harvesting and manufacturing to improve standardization and scale-up production. Automation enables consistent quality and minimizes contamination risks. Companies like Terumo BCT, ThermoGenesis, and Biosafe America provide advanced automated cell processing platforms widely used by cell therapy players. The shift towards automation will increase following cGMP (Current Good Manufacturing Practices) guidelines.
• Strategic Industry Collaborations: Robust collaboration activities focused on R&D, clinical trials, manufacturing, and commercialization are steadily increasing among allogeneic cell therapy stakeholders across the pharmaceutical, biotechnology, medical technology, and healthcare sectors. Such strategic partnerships are enabling companies to maximize their capabilities and accelerate development timelines.

Allogeneic Stem Cell Transplantation Market Restraints:

• High Costs of Cell Therapies: Allogeneic stem cell transplantation involves substantial upfront costs for specialized infrastructure, stringent manufacturing protocols, robust quality control, and skilled personnel. Complex handling and transportation requirements also add logistics expenses. Lack of adequate reimbursement and limited insurance coverage in several regions negatively impacts affordability. The resultant high costs of therapy are a key restraint to the market growth.
• Stringent Regulatory Frameworks: While regulatory policies are evolving to support cell therapy approval and commercialization, ambiguity around long-term safety and efficacy continues to warrant strict regulatory evaluation. Companies have to comply with extensive manufacturing regulations right from stem cell sourcing to good tissue practices, cGMP protocols, quality checks, and mandated preclinical studies. Navigating changing regulatory landscapes across major markets like the U.S., EU, China, and Japan remains challenging.
• Limited Donor Availability: While sources like mobilized peripheral blood and umbilical cord blood provide abundant stem cell material, finding HLA (Human Leukocyte Antigens)-matched allogeneic donors, especially among minority populations, continues to be difficult. Low volunteer registrations and donor attrition also impact donor grafts. Such limitations in sourcing HLA-matched donors can restrict patient therapy access and hinder growth prospects.

 Figure 2. Global Allogeneic Stem Cell Transplantation Market Share (%), by Source, 2023

Recent Developments:

Key Strategic Initiatives

• On September 8, 2023, MaaT Pharma, a France-based biotechnology company, announced that the European Medicines Agency (EMA) has granted orphan drug designation to MaaT033, an adjunctive and maintenance therapy developed by the MaaT Pharma to improve overall survival in allo-HSCT (Allogeneic Hematopoietic Stem Cell Transplant)
• In May 2023, Astellas Pharma, a global pharmaceutical company, and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) announced topline results from the Phase 3 MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML)
• In April 2023, Gamida Cell, a global biopharmaceutical company, announced that the company’s allogeneic cell therapy, Omisirge (omidubicel-onlv) has received the U.S. FDA approval for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection

Collaborations & Partnerships

• In October 2022, Century Therapeutics, a biotechnology company, and Bristol Myers Squibb, a global biopharmaceutical company, announced that the companies have entered into research collaboration and license agreement for the development and commercialization of pluripotent stem cell (iPSC) derived, engineered natural killer cell (iNK) and/or T cell (iT) programs for hematologic malignancies and solid tumors

Top Companies in the Allogeneic Stem Cell Transplantation Market:

• Celgene Corporation
• Mesoblast Ltd.
• Pluristem Therapeutics Inc.
• MEDIPOST Co., Ltd.
• Osiris Therapeutics, Inc.
• Cynata Therapeutics Limited
• Takeda Pharmaceutical Company Limited
• Astellas Pharma Inc.
• Cellular Biomedicine Group, Inc.
• Biosolution Co., Ltd.
• StemCell Technologies Inc.
• Caladrius Biosciences, Inc.
• ViaCord
• Vericel Corporation
• Regen Biopharma Inc.
• Gamida Cell Ltd.
• Histogenics Corporation
• BrainStorm Cell Therapeutics Inc.
• Lineage Cell Therapeutics, Inc.

Definition: Allogeneic stem cell transplantation involves transferring healthy stem cells from a genetically similar donor to the patient to replace damaged cells. It is an established therapeutic technique to treat various hematological cancers, blood, and immunological disorders. Allogeneic transplants can use stem cells derived from peripheral blood, bone marrow, umbilical cord blood, or adipose tissue. The field has seen significant advances in harvesting techniques, expansion protocols, cryopreservation, and cell processing. Key drivers are the rising incidence of blood cancers and autoimmune diseases along with an increase in clinical trials assessing allogeneic stem cell therapies for various regenerative medicine applications.