CAR T-Cell Therapy Market to Reach $13.78 Billion by 2031; Cell & Gene Delivery Devices at $26.79B

The CAR T-Cell Therapy Market is estimated to reach USD 13.78 billion by 2031 from USD 7.24 billion in 2026, at a CAGR of 13.7%. The Cell & Gene Therapy Drug Delivery Devices Market reached a value of USD 3.39 billion in 2025, with projections indicating growth to USD 4.48 billion in 2026, and a compound annual growth rate (CAGR) estimated at 34.33%. By 2032, the market is forecast to climb to USD 26.79 billion.

The growing prevalence of hematologic malignancies and solid tumors is a primary driver for the CAR T-cell therapy market. Additionally, ongoing advancements in CAR T-cell technology, including improvements in CAR design, vector delivery systems, and manufacturing processes, enhance therapy efficacy, safety, and scalability. This is expected to support higher adoption and application of CAR T-cell therapies across various cancer types, driving market growth.

By product, the YESCARTA segment is expected to dominate the market, with a share of 25.3% in 2025. Yescarta dominated the market, accounting for the largest share in 2025. Its robust clinical profile, featuring high response rates and durable remissions, has fueled market growth in patients with relapsed or refractory large B-cell lymphoma. By target, the CD19 segment is expected to dominate the market, with a share of 62.3%. In 2025, the CD19 segment accounted for the largest share of the CAR T-cell therapy market.

The North America CAR T-cell therapy market accounted for a 67.7% revenue share in 2025. By indication, multiple myeloma dominated the CAR T-cell therapy market. In 2025, B-cell lymphoma dominated the CAR T-cell therapy market due to its high prevalence as the most common malignant lymphoma and significant rates of relapse or refractoriness, creating substantial unmet need. Multiple approved CD19-targeted therapies, such as Yescarta and Breyanzi, have demonstrated robust clinical efficacy, including durable remissions, and have captured the largest market share.

By demographics, the adult segment is expected to dominate the market. In 2025, the adult demographic segment accounted for the largest share of the CAR T-cell therapy market. This is primarily due to higher disease prevalence in adults for key indications such as large B-cell lymphoma and multiple myeloma, compared to rarer pediatric cases. Most approved therapies, such as Yescarta and Breyanzi, target adult relapsed/refractory blood cancers. As the global population ages, the incidence of these cancers is projected to rise, expanding the potential market for CAR T-cell therapies.

By end user, the hospitals segment is expected to dominate the market. In 2025, Hospitals accounted for the largest share of the CAR T-cell therapy market. The dominant share of this segment can primarily be attributed to collaborations between pharmaceutical companies and hospitals, which effectively facilitate the delivery of CAR T-cell therapies to patients. Companies consistently collaborate with hospitals to streamline processes, ensuring timely and efficient treatment.

The Cell & Gene Therapy Drug Delivery Devices Market growth trajectory is driven by ongoing innovation in vector engineering, biologic manufacturing, and the expansion of point-of-care capabilities. Trends in decentralized healthcare and expanded homecare are shaping device design, with a clear emphasis on user-friendly, portable delivery systems that improve patient access beyond traditional clinical settings.

Integrating digital health features-including telemetry, secure data collection, and remote monitoring-enables richer datasets and greater device transparency, supporting improved clinical oversight and post-market surveillance. Widespread adoption of single-use systems and advanced microfluidic technologies is replacing legacy multi-use formats, targeting reduced contamination risk and operational efficiency while enabling scalable production models.

Device types include autoinjectors, implantable pumps, infusion pumps, microfluidic devices, needle-free injectors, pre-filled syringes, and traditional syringes engineered to support diverse requirements for both cell and gene therapy delivery. Each type addresses specific demands related to therapy composition, dosage precision, and user experience. End users include hospitals, clinical settings, specialty centers, and homecare environments requiring customized device solutions focused on ergonomic design, ease of training, and robust support systems for efficient therapy administration.

Devices must demonstrate compatibility with a spectrum of cell therapies, such as CAR-T, dendritic cell, and stem cell modalities, as well as gene therapies-taking into account challenges associated with viral and non-viral vector management. Reusable and single-use devices factor into lifecycle management, sterility, and contamination control. Single-use formats are often preferred for handling high-potency or sensitive biological materials due to reduced risk and operational simplicity.

The introduction of 2025 U.S. tariffs introduced new operational complexities for global device manufacturers, prompting a shift toward increased onshoring, diversification of supplier networks, and the redesign of certain product architectures. Procurement teams adapted by seeking domestic alternatives, focusing on risk mitigation, and enhancing supply chain resilience.