Press release
United States CAR-T Cell Therapy Market set for steady growth to US$ 9.85 billion by 2033 at a CAGR of 12.7% | Key Players:- Novartis, Gilead/Kite Pharma, Bristol Myers Squibb
US CAR-T Cell Therapy
This growing number of FDA-approved CAR-T cell therapies in the US, targeting key antigens like CD19 and BCMA, is a major driver of market expansion. These approvals validate the clinical efficacy of CAR-T treatments and broaden their use across multiple hematologic cancers such as ALL, LBCL, CLL, and multiple myeloma.
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United States: Key Industry Developments
✅ October 2025: Kincell Bio partnered with Moonlight Bio to advance Moonlight's lead T-cell therapy program into clinical trials, focusing on innovative CAR-T designs for enhanced efficacy in hematologic cancers.
✅ September 2025: Made Scientific and Hemogenyx Pharmaceuticals formed a manufacturing partnership to scale HG-CT-1 CAR-T therapy, targeting improved production for relapsed/refractory blood cancers amid rising U.S. demand.
✅ May 2025: Researchers demonstrated "armored" CAR-T therapy huCART19-IL18 achieving 52% complete remission in pre-treated lymphoma patients, boosting optimism for next-generation applications in non-Hodgkin lymphoma.
Key Merges and Acquisitions(2025):
Bristol Myers Squibb (Orbital Therapeutics) - October 15, 2025
Bristol Myers Squibb solidified its leadership in the US CAR-T cell therapy market by acquiring Orbital Therapeutics for $1.5 billion, focusing on the investigational in vivo CAR-T therapy OTX-20 (also referenced as OTX-201). This deal enhances BMS's cell therapy portfolio with RNA-based technologies that reprogram immune cells directly in the body, reducing manufacturing complexities and targeting autoimmune diseases alongside oncology indications.
Gilead Sciences' Kite Pharma (Interius BioTherapeutics) - August 21, 2025
Gilead's Kite Pharma strengthened its CAR-T dominance in the US through the $350 million acquisition of Philadelphia-based Interius BioTherapeutics, integrating an innovative in vivo CAR-T platform that generates CAR-T cells via a single IV infusion. The move advances Kite's pipeline beyond ex vivo therapies like Yescarta, aiming to simplify treatments, cut costs, and broaden access for blood cancer patients.
Market Segmentation Analysis:
-By Target Antigen: CD19 vs BCMA vs Others
CD19 dominates with 61.87% market share in 2024, driven by its early FDA approvals for B-cell malignancies like ALL and lymphomas, including therapies such as Kymriah and Yescarta.
BCMA holds around 25% share (based on revenue proportions), targeting multiple myeloma with products like Abecma and Carvykti, and is poised for fastest growth at 24.17% CAGR.
Others (CD22, GD2, etc.) account for the remainder, with emerging applications in solid tumors and additional blood cancers.
-By Type of Therapy: Autologous vs Allogeneic
Autologous CAR-T therapies lead with 81.1% market share in 2024, favored for personalized use of patient cells reducing rejection risks in hematologic cancers.
Allogeneic variants hold the remaining 19%, gaining traction for off-the-shelf scalability and faster access, with 23.21% CAGR projected through 2034.
-By Indication: Hematologic Malignancies vs Solid Tumors
Hematologic malignancies capture 93.85% share in 2024, led by lymphoma (largest sub-segment) and leukemia, due to proven efficacy in relapsed/refractory cases.
Solid tumors comprise the rest at 6%, with rapid growth at 23.66% CAGR amid R&D to overcome tumor microenvironment challenges.
-By End-User: Hospitals Lead with 44.0%
Hospitals command 44.0% share in 2024 (revenue $1,993 million), as primary sites for complex administration and side-effect management like CRS.
Cancer treatment centers follow at 29% ($1,347 million), with fastest growth via specialized adoption; others include academic institutes (16%), clinics (9%), and CDMOs (9%).
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Growth Drivers:
Rising cancer prevalence, especially hematological malignancies such as leukemia, lymphoma, and multiple myeloma.
Strong FDA approvals and regulatory support accelerating commercialization of new CAR-T therapies.
Growing adoption of personalized & precision medicine, driving demand for targeted immunotherapies.
Advancements in CAR-T technology including next-generation allogeneic ("off-the-shelf"), dual-targeted, and safer constructs.
Expanding clinical pipeline with significant investments from pharma & biotech companies in R&D.
Increasing availability of treatment centers and improving healthcare infrastructure for advanced cell therapies.
Favorable reimbursement policies and insurance coverage improvements, gradually boosting patient access.
Strategic partnerships, collaborations & manufacturing scale-ups, reducing production costs and improving supply chain efficiency.
Growing awareness among oncologists and patients about CAR-T's superior therapeutic outcomes vs. conventional therapies.
Regional Insights:
North America, led by the U.S., commands the largest share of the global CAR-T cell therapy market, estimated at around 68% in recent assessments, driven by advanced healthcare infrastructure, robust biopharmaceutical R&D, high prevalence of hematologic cancers, FDA approvals, and favorable reimbursement policies.
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Key Players:
Novartis (Kymriah), Gilead/Kite Pharma (Yescarta, Tecartus), Bristol Myers Squibb (Breyanzi, Abecma), Johnson & Johnson (Carvykti), and Autolus (Aucatzyl).
Key Highlights (Top 5 Key Players) :
Novartis (Kymriah)
Novartis pioneered CAR-T with Kymriah (tisagenlecleucel), FDA-approved in 2017 for pediatric ALL and adult relapsed/refractory large B-cell lymphoma. Priced at $475,000 for ALL and $373,000 for lymphoma, it generated $536 million in 2022 sales despite a slight decline. Manufacturing occurs at Morris Plains, New Jersey, with contract support.
Gilead/Kite Pharma (Yescarta, Tecartus)
Gilead's Kite Pharma leads with Yescarta (axicabtagene ciloleucel), approved 2017 for large B-cell lymphoma, and Tecartus (brexucabtagene autoleucel), cleared for mantle cell lymphoma and adult ALL. Yescarta earned $1.16 billion in 2022, driving market dominance amid supply challenges.
Bristol Myers Squibb (Breyanzi, Abecma)
BMS offers Breyanzi for large B-cell lymphoma and Abecma for multiple myeloma, with Q2 sales of $39 million and $89 million respectively, projecting $500 million annually despite manufacturing bottlenecks. Both target BCMA/CD19, facing strong demand outstripping supply.
Johnson & Johnson (Carvykti)
J&J's Carvykti (ciltacabtagene autoleucel), partnered with Legend Biotech, gained FDA approval for relapsed multiple myeloma post-four therapies at $465,000 list price. In-house manufacturing ensures supply stability, competing directly with Abecma in a phased U.S. launch.
Autolus (Aucatzyl)
Autolus' Aucatzyl, FDA-approved in 2024 for relapsed B-cell ALL, boasts a favorable safety profile with low CRS (3% grade 3) and no REMS requirement. It targets 60% of U.S. patients initially via 30 centers, positioning as a tolerable CD19 CAR-T option.
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