The market is expanding rapidly due to the rising adoption of CAR-T therapies and strong investment in advanced cancer research. Growing clinical trials, FDA approvals, and the presence of major biotech companies are further supporting market growth.
Cell and gene therapy for oncology in the U.S. refers to advanced cancer treatment approaches that use modified cells or genetic materials to target, destroy, or prevent cancer cells more precisely and effectively. The cell and gene therapy for oncology market is growing rapidly due to increasing cancer prevalence and rising demand for personalized and targeted treatments. Strong investments in biotechnology research, rapid FDA approvals, and continuous advancements in CAR-T and gene editing technologies are accelerating therapy development. In addition, the presence of leading pharmaceutical companies, expanding clinical trials, and advanced healthcare infrastructure are further supporting market expansion.
The global cell and gene therapy for oncology market size was estimated at USD 14.82 billion in 2025 and is predicted to increase from USD 18.48 billion in 2026 to approximately USD 134.53 billion by 2035, expanding at a CAGR of 24.68% from 2026 to 2035.
The U.S. cell and gene therapy for oncology market is expected to witness significant opportunitites through advancements in personalized medicine, next-generation CAR-T therapies, and gene editing technologies for solid tumors. Increasing investments in AI-driven drug discovery, expanding clinical research, and growing demand for targeted cancer therapies are expected to further accelerate innovation and commercialization.
| Year | Demand for Personalized & Targeted Oncology Treatments |
| 2023 | 62% |
| 2024 | 68% |
The demand for personalized and targeted cancer therapies increased from approximately 62% in 2023 to around 68% in 2024 due to growing adoption of CAR-T therapies, biomarker-based treatment selection, and precision oncology approaches. Rising cancer burden and improved clinical outcomes from targeted therapies further accelerated the shift away from traditional chemotherapy.
The cell therapy segment held a dominant share of 68% in 2025 due to strong clinical success of CAR-T therapies in treating blood cancers such as leukemia, lymphoma, and multiple myeloma. Increased FDA approvals, expanding treatment indications, and growing adoption of personalized immunotherapies further supported its dominance. Additionally, continuous innovation in engineered cell therapies strengthened its market leadership position.
The hematological malignancies segment led the U.S. cell and gene therapy for oncology market with a share of 64% in 2025 due to the high success rate of CAR-T and other cell-based therapies in treating blood cancers such as leukemia, lymphoma, and multiple myeloma. Easier treatment accessibility compared to solid tumors, strong clinical approvals, and rapid adoption of personalized immunotherapies further strengthened its market dominance in this segment.
The hospitals segment held a dominant share of 38% in 2025 due to their advanced infrastructure, availability of specialized oncology departments, and skilled healthcare professionals required for complex treatment like CAR-T therapy. Hospitals also manage a high patient volume, have better access to clinical trials, and provide integrated care, making them the primary centers for administering advanced cancer therapies.
The in-house manufacturing segment dominated the U.S. cell and gene therapy for oncology market with a share of 58% in 2025 due to the need for strict quality control, process consistency, and production of sensitive intellectual property. Companies prefer internal production to ensure faster turnaround for personalized therapies like CAR-T and reduce reliance on third-party CDMOs. Additionally, it supports better regulatory compliance and long-lasting cost efficiency in complex therapy development.
Leading companies in the U market include Amgen Inc., Gilead Sciences, Inc. (Kite Pharma), Bristol Myers Squibb Company, bluebird bio, Inc., and Legend Biotech. These players are driving market growth through advanced CAR-T therapies, gene-modified cell therapies, and expanding oncology pipelines focused on hematologic malignancies and solid tumors. Continuous innovation in gene editing, strong clinical trial activity, and increasing R&D investments further strengthen their leadership in the U.S. oncology cell and gene therapy landscape.
By Therapy Type
By Cancer Type
By Therapy Source
By Delivery Vector
By Application
By End User
By Manufacturing Type
By Route of Administration
