U.S CAR-T Cell Therapy Market is expected to reach US$ 3.07 billion with a CAGR of 12.7% by 2033, Dominate by North America with 61% Market Share

The US CAR-T cell therapy market size reached US$ 3.42 billion in 2024 from US$ 3.07 billion in 2023 and is expected to reach US$ 9.85 billion by 2033, growing at a CAGR of 12.7% during the forecast period 2025-2033.

The US CAR-T cell therapy market is growing rapidly due to rising cancer prevalence, personalized immunotherapy adoption, FDA approvals, advanced biotech innovations, and increasing investments in next-generation, targeted, and safer cellular therapies.

Get a Free Sample PDF Of This Report (Get Higher Priority for Corporate Email ID):-https://www.datamintelligence.com/download-sample/us-car-t-cell-therapy-market?prtk

United States: Key Industry Developments (2026-2025)
✅ February 2026: Eli Lilly announced a $2.4 B acquisition of Orna Therapeutics, gaining access to early‐stage in vivo CAR‐T therapy platform ORN‐252 targeting CD19, signaling strategic expansion into CAR‐T innovation beyond traditional ex vivo approaches.
✅ February 2026: Bristol‐Myers Squibb reported strong Q4 2025 financial performance, driven partly by growth in its oncology portfolio including CAR‐T therapies like Breyanzi and Abecma, supporting investor confidence and pipeline investment.
✅ December 2025: US FDA announced plans to tighten approval standards for CAR‐T therapies, proposing randomized controlled trial requirements for future CAR‐T approvals to strengthen evidence of clinical benefit beyond current single‐arm trial designs.
✅ November 2025: The U.S. CAR‐T cell therapy market was forecast to grow significantly, with market size USD 2.7 B in 2025 and projections to expand sharply by 2035 due to increasing cancer incidence and R&D investment.
✅ October 2025: FDA approved Breyanzi (lisocabtagene maraleucel) as the first CAR‐T therapy for relapsed or refractory marginal zone lymphoma, extending its indication in B‐cell malignancies.
✅ October 2025: UCI Health launched a clinical trial exploring investigational CAR‐T approaches in systemic autoimmune disease (lupus), reflecting expansion of CAR‐T research into non‐oncology indications.

US CAR-T cell therapy Market Recent M&A activities:-

→ In February 2026, Tempest Therapeutics completed its acquisition of multiple CAR‐T cell therapy programs from Factor Bioscience and Erigen LLC in an all‐stock transaction, issuing 8,268,495 shares of common stock as consideration to the sellers. The acquisition brings clinical‐stage dual‐targeting CAR‐T assets into Tempest's portfolio and extends its operational runway into 2027.

→ In February 2026, Eli Lilly acquired Orna Therapeutics for up to $2.4 billion, gaining access to Orna's engineered circular RNA platform and in‐body CAR‐T approaches aimed at autoimmune and oncology indications.

→ On November 19, 2025, Tempest Therapeutics entered into a definitive agreement to acquire a set of dual‐targeting CAR‐T programs from Factor Bioscience and affiliates in an all‐stock deal (closing later in early 2026). Issuance of shares to Factor and program assets was the principal consideration; exact cash value was not disclosed in public filings.

→ On August 21, 2025, Gilead Sciences' Kite subsidiary agreed to acquire Interius BioTherapeutics for about $350 million, strengthening Kite's position in in vivo CAR‐T cell therapy development by integrating Interius' CAR‐T platform designed for in‐body delivery.

→ On July 1, 2025, AbbVie agreed to acquire Capstan Therapeutics for up to $2.1 billion in cash, adding Capstan's clinical‐stage in vivo CAR‐T candidate that aims to overcome limitations of traditional autologous CAR‐T therapies.

US CAR-T cell therapy Market key Players:-

Novartis AG, Gilead Sciences, Inc., Bristol Myers Squibb company, Johnson & Johnson, and Autolus, Inc., among others.

Top 5 Key Players Analysis:
Novartis AG - 21% U.S. CAR‐T market share with Kymriah as an early flagship therapy; strong first‐mover advantage and expanded indications in ALL and lymphoma.

Gilead Sciences, Inc. (via Kite Pharma) - Leads with 49% share driven by Yescarta and Tecartus dominance; excels in manufacturing scale and broad lymphoma indications.

Bristol Myers Squibb Company - Holds a significant portion (19% estimated) with Breyanzi/Abecma, focusing on safety profiles and multiple myeloma expansion.

Johnson & Johnson (Janssen/Legend Biotech) - Captures a notable U.S. share with Carvykti, leading BCMA‐targeted multiple myeloma therapy and growing real‐world evidence.

Autolus, Inc. - Smaller share compared with giants, but core strength lies in next‐generation CAR‐T platforms and pipeline innovation targeting hematologic malignancies.

US CAR-T cell therapy Market Top Technological Partnerships (2026 & 2025):-
November 2025: Kelonia Therapeutics partnered with Johnson & Johnson Innovative Medicine to advance in vivo CAR-T therapies targeting BCMA for multiple myeloma patients, leveraging Kelonia's iGPS lipid nanoparticle platform for direct in-body T-cell programming.
​
November 2025: Pregene Biopharma collaborated with Kite Pharma (Gilead Sciences) on in vivo CAR-T delivery constructs valued up to $1.6B, accelerating Phase I trials at U.S. sites for refractory B-cell lymphomas.
October 2025: Oxford Biomedica expanded its lentiviral vector manufacturing partnership with Bristol Myers Squibb, supplying clinical-grade materials for three U.S.-based CAR-T programs targeting solid tumors.
​
September 2025: Lyell Immunopharma acquired global rights to LYL273 CAR-T from collaborator, enhancing its clinical pipeline for metastatic colorectal cancer trials at MD Anderson Cancer Center.

Buy Now & Unlock 360° Market Intelligence:https://www.datamintelligence.com/buy-now-page?report=us-car-t-cell-therapy-market?prtk

US CAR-T cell therapy Market Drivers :-
The U.S. market has grown significantly as regulatory momentum continues. Foundational CAR‐T therapies such as Kymriah, Yescarta, Breyanzi, and Carvykti have not only secured approvals but expanded to new indications, validating clinical performance and unlocking broader patient segments. Each new approval increases the addressable market and supports faster adoption in oncology centers nationwide.

Hematological cancers including diffuse large B‐cell lymphoma (DLBCL), acute lymphoblastic leukemia (ALL), and multiple myeloma remain major unmet needs where CAR‐T shows distinct clinical value. CAR‐T therapies deliver complete remission rates exceeding historical benchmarks, particularly in relapsed or refractory patients with limited alternatives.

Continued R&D in CAR design, cell engineering, and manufacturing technology is a crucial growth pillar. Next‐generation constructs including dual‐target CARs and platforms that improve persistence and reduce toxicity are enabling broader application and better outcomes. Faster and more scalable manufacturing processes also lower costs and turnaround times.

The proliferation of certified CAR‐T treatment sites including major cancer centers and hospitals supports uptake. Adoption is rising not only in specialized academic centers but also in broader hospital networks, enabling more patients to access therapies closer to home.

Robust investor funding and strategic biotech‐pharma collaborations are accelerating pipeline development. Venture capital activity and acquisitions aimed at next‐generation CAR‐T and in‐vivo delivery platforms are increasing the innovation pace and extending the market's long‐term growth runway.

US CAR-T cell therapy Market Regional Insights:-
North America (incl. U.S.)
• 61 % global share (2025): North America is the largest CAR‐T cell therapy market, driven by early FDA approvals, robust R&D, strong healthcare infrastructure, and high adoption rates; the U.S. accounts for the majority of this share within the region.
• U.S. dominance within region: The United States represents the bulk of North America's share with advanced trials, multiple product approvals (e.g., Kymriah, Yescarta), and extensive clinical adoption fueling growth.

Europe
• 30 % global share: Europe is the second‐largest regional market, supported by structured reimbursement frameworks and increasing CAR‐T adoption across major healthcare systems (Germany, UK, France, Italy, Spain).
• Growth is underpinned by expanding access programs and rising numbers of certified treatment centers, though Europe remains behind North America in total share.

Asia‐Pacific
• 19% global share: Asia‐Pacific shows rapid expansion with significant contributions from China and Japan; emerging markets like India are beginning to adopt CAR‐T therapies and build infrastructure.
• China leads APAC regional share, followed by Japan and other developing markets with increasing clinical trials and manufacturing activities.

Get Customization in the report as per your requirements:https://www.datamintelligence.com/customize/us-car-t-cell-therapy-market?prtk

US CAR-T cell therapy Market Market Segmentation
By Therapy Type: The US CAR-T cell therapy market is segmented into allogeneic and autologous therapies. Autologous CAR-T therapy, which uses a patient's own T-cells, currently dominates due to its personalized approach and lower risk of immune rejection, while allogeneic CAR-T therapy, derived from donor cells, is gaining attention for its potential to offer off-the-shelf, more accessible treatment options.

By Target Antigen: Market segmentation by target antigen focuses on the specific proteins that CAR-T cells are engineered to attack. Key targets include CD19, BCMA, CD20, CD22, CD30, and CD33, among others. This segmentation reflects the tailored nature of CAR-T therapies, as different antigens are associated with distinct blood cancers, enabling more precise and effective treatment.

By Application: The market is also segmented by application, covering various hematological malignancies such as acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and follicular lymphoma. This classification highlights the clinical focus of CAR-T therapies on cancers of the blood and lymphatic system, with ongoing research expanding potential applications to other malignancies.

This research report delivers actionable insights, data-driven analysis, and future-ready perspectives that enable informed decision-making, reduce market risks, and uncover growth opportunities across the industry

Unlock 360° Market Intelligence with DataM Subscription Services: https://www.datamintelligence.com/reports-subscription
Power your decisions with real-time competitor tracking, strategic forecasts, and global investment insights all in one place.

✅ Competitive Landscape
✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Unmet Needs & Positioning, Pricing & Market Access Snapshots
✅ Market Volatility & Emerging Risks Analysis
✅ Quarterly Industry Report Updated
✅ Live Market & Pricing Trends
✅ Import-Export Data Monitoring

Have a look at our Subscription Dashboard: https://www.youtube.com/watch?v=x5oEiqEqTWg

Contact Us -

Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.

Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.