Leading Innovators in the Autologous Cell Therapy Market
- Novartis AG
- Gilead Sciences, Inc. (Kite Pharma)
- Bristol Myers Squibb
- Bluebird Bio, Inc.
- Vericel Corporation
- Adaptimmune Therapeutics plc
- Autolus Therapeutics plc
- BrainStorm Cell Therapeutics Inc.
- Sangamo Therapeutics, Inc.
- Lineage Cell Therapeutics, Inc.
- Athersys, Inc.
- Iovance Biotherapeutics, Inc.
- Celyad Oncology SA
- Orchard Therapeutics plc
- Fibrocell Science, Inc. (Castle Creek Biosciences)
- Cynata Therapeutics Limited
- Pluristem Therapeutics Inc.
- Tmunity Therapeutics
- Cellular Biomedicine Group, Inc.
- Poseida Therapeutics, Inc.
Market Growth
The global autologous cell therapy market size is calculated at US$ 9.6 in 2024, grew to US$ 11.41 billion in 2025, and is projected to reach around US$ 54.21 billion by 2034. The market is expanding at a CAGR of 18.9% between 2025 and 2034.
What are the Trends in the Autologous Cell Therapy Market?
- In April 2025, Abeona Therapeutics announced that it received U.S. FDA approval for Zevaskyn (prademagene zamikeracel), the first autologous, cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). The therapy uses a patient’s skin cells, genetically corrected to address the defective COL7A1 gene, and is designed to promote durable wound healing.
- In July 2025, Autolus Therapeutics announced that it received European Commission marketing authorization for Aucatzyl (obecabtagene autoleucel), an autologous CAR-T cell therapy indicated for adults aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This approval followed a positive CHMP opinion and expands access to personalized cancer immunotherapy across the EU.
Value Chain Analysis
R&D
Autologous cell therapy R&D involves several key steps cell sourcing, cell processing, and cell delivery. These steps include cell collection, expansion, genetic modification, purification, formulation, and cryopreservation, all while ensuring product safety and efficacy.
Key players include: Bristol-Myers Squibb, Novartis, and Vericel, as well as emerging companies such as Iovance Biotherapeutics and CARsgen Therapeutics.
Clinical Trials & Regulatory Approvals
Key steps include establishing Institutional Review Board (IRB) approval, obtaining necessary regulatory approvals (like IND in the US or CTA in Singapore), conducting preclinical and clinical trials, and ultimately, securing a Biologics License Application (BLA) for commercialization.
Key players include: Bristol-Myers Squibb, Johnson & Johnson, Vericel Corporation, Novartis, and JW Therapeutics.
Patient Support & Services
Key patient support and services in autologous cell therapy focus on navigating the complex process, managing treatment side effects, and addressing the financial and logistical challenges. This includes education, access to clinical trials, insurance navigation, financial assistance, transportation, and comprehensive care coordination.
Key players include: Gilead Sciences, Bristol Myers Squibb, and Novartis.
Latest Announcements by Industry Leaders
- In January 2025, Hope Biosciences Donna Chang, CEO of Hope Biosciences, commented that MSCs have had an incredible track record in terms of safety and application, noting that globally there have been over 1,200 clinical trials using MSCs, and a large proportion have met their clinical endpoints. She also said that these results reinforce the therapeutic potential of MSC-based autologous therapies across multiple indications.
- In July 2025, Autolus Therapeutics' Christian Itin, CEO of Autolus Therapeutics, commented that this is a complex therapy, but one that has a very high level of activity and creates remarkable outcomes for patients. He also said that the company remains committed to overcoming logistical challenges to make these therapies more broadly accessible.
Recent Developments in the Autologous Cell Therapy Market
- In May 2025, Regeneration Biomedical presented updated Phase 1 results from its autologous, adipose-derived stem cell therapy in Alzheimer's disease, showing safety and cognitive improvements at the ISCT scientific annual meeting.
- In June 2025, MaxCyte & Ori Biotech announced a collaboration to enhance manufacturing efficiency and scale for autologous cellular therapies via integrated closed-loop systems.
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