CAR T-cell Therapy Market Forecasts Indicate Strong Growth Trajectory in the 7MM During the Forecast Period (2025-2034) | DelveInsight
The dynamics of the CAR T-cell therapy market are anticipated to change due to the extensive R&D activities, an increase in investment for research and development of the new CAR T-cell therapy, such as zamtocabtagene autoleucel (Miltenyi Biomedicine), rapcabtagene autoleucel (Novartis), descartes-08 (Cartesian Therapeutics), (CABA-201) (Cabaletta Bio), anito-cel (Arcellx and Kite Pharma), and others, and the high effectiveness of CAR T-cell therapy over other conventional drugs for cancer treatment.
LAS VEGAS, Oct. 28, 2025 /PRNewswire/ -- DelveInsight's CAR T-cell Therapy Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Acute Lymphoblastic Leukemia, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Multiple Myeloma, Glioblastoma Multiforme, Systemic Lupus Erythematosus, Myasthenia Gravis, Lupus Nephritis, Multiple Sclerosis, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging CAR T-cell therapy, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the CAR T-cell Therapy Market Report
- The total market size of CAR T-cell therapy in the leading markets is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as Acute Lymphoblastic Leukemia, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Multiple Myeloma, Glioblastoma Multiforme, Systemic Lupus Erythematosus, Myasthenia Gravis, Lupus Nephritis, Multiple Sclerosis, and others.
- Leading CAR T-cell therapy companies, such as Arcellx, Kite Pharma, Miltenyi Biomedicine, Allogene Therapeutics, Luminary Therapeutics, Precigen, Poseida Therapeutics, Roche, Autolus, Cartesian Therapeutics, Cabaletta Bio, Interius BioTherapeutics, Umoja Biopharma, and others, are developing novel CAR T-cell therapies that can be available in the CAR T-cell therapy market in the coming years.
- Some of the key CAR T-cell therapies in clinical trials include Anitocabtagene autoleucel (anito-cel), Zamtocabtagene autoleucel, Cemacabtagene ansegedleucel, LMY-920, PRGN-3006 UltraCAR-T, LMY-920, P-BCMA-ALLO1, AUTO4, Descartes-8, Rapcabtagene autoleucel, INT2104, UB-VV111, and others.
Discover which indication is expected to grab the major CAR T-cell therapy market share @ CAR T-cell Therapy Market Report
Key Factors Driving the CAR T-cell Therapy Market
Large and Growing Unmet Need in Oncology
Rising cancer incidence, especially relapsed/refractory hematologic malignancies and an expanding focus on solid-tumor settings, creates a sustained demand for novel, effective therapies.
Rising CAR T-cell Therapy Clinical Trial Activity
Many emerging CAR-Ts are currently being investigated for various indications. Some of the potential therapies include anitocabtagene autoleucel (Arcellx and Kite Pharma), zamtocabtagene autoleucel (Miltenyi Biomedicine), LMY-920 (Luminary Therapeutics), PRGN-3006 (Precigen), cemacabtagene ansegedleucel (Allogene Therapeutics), P-BCMA-ALLO1 (Poseida Therapeutics and Roche), AUTO4 (Autolus), descartes-08 (Cartesian Therapeutics), resecabtagene autoleucel (CABA-201) (Cabaletta Bio), and others.
Entry of Cemacabtagene Ansegedleucel in First-line
With no approved first-line CAR-T cell therapy, Allogene Therapeutics'cemacabtagene ansegedleucel is an off-the-shelf, allogeneic CD19 CAR-T cell in the Phase II ALPHA3 trial, assessing its role in first-line consolidation for LBCL patients with MRD post-standard treatment. Its market entry could offer a breakthrough option.
Emerging In Vivo CAR-T Candidates in the Pipeline
Some of the CAR-Ts in the pipeline in in vivo include INT2104 (Interius BioTherapeutics), UB-VV111 (Umoja Biopharma), and others.
CAR T-cell Therapy Market Analysis
The CAR T-cell therapy market is projected to experience substantial growth in the coming years, driven by the rising incidence of cancer, increasing awareness of CAR T-cell treatments, and the growing number of therapies advancing through clinical trials or awaiting regulatory approval. The first CAR-T therapy, KYMRIAH, received approval in 2017 for acute lymphoblastic leukemia (ALL), followed later that year by YESCARTA for large B-cell lymphoma (LBCL).
This market is marked by intense competition and rapid innovation, fueled by the urgent demand for more effective cancer treatments. A key advantage of CAR-T therapies lies in their "one-and-done" mechanism, which typically requires a single administration—unlike bispecific antibodies such as TECVAYLI and TALVEY, which require ongoing treatment. The approvals of ABECMA (idecabtagene vicleucel) by Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) by Johnson & Johnson Innovative Medicine further underscore CAR-T therapy's transformative potential in treating multiple myeloma.
These regulatory milestones have created new opportunities for companies developing next-generation CAR-T products at various stages of the pipeline. Notable emerging players include Arcellx and Kite Pharma (a Gilead company) with anitocabtagene autoleucel (anito-cel), Poseida Therapeutics/Roche with P-BCMA-ALLO1, Luminary Therapeutics with LMY-920, and Precigen with PRGN-3006 UltraCAR-T, among others.
Learn more about the CAR T-cell therapy @ CAR T-cell Therapy Analysis
CAR T-cell Therapy Competitive Landscape
Some of the CAR-Ts in the pipeline include zamtocabtagene autoleucel (Miltenyi Biomedicine), rapcabtagene autoleucel (Novartis), descartes-08 (Cartesian Therapeutics), resecabtagene autoleucel(CABA-201) (Cabaletta Bio), anitocabtagene autoleucel (anito-cel) (Arcellx and Kite Pharma), and others. Some of the CAR-Ts in the pipeline in in vivo include INT2104 (Interius BioTherapeutics), UB-VV111 (Umoja Biopharma), and others.
Miltenyi Biomedicine's Zamtocabtagene autoleucel is a CAR-T cell therapy designed to simultaneously target both CD19 and CD20 proteins expressed on B cells. This innovative investigational therapy has been granted inclusion in the European Union's Priority Medicines (PRIME) scheme. It is currently undergoing Phase II clinical trials for diffuse large B-cell lymphoma (DLBCL) in both second- and third-line settings, with additional studies evaluating its potential in first-line DLBCL, B-cell neoplasms, and mantle cell lymphoma (MCL).
Novartis' Rapcabtagene autoleucel is an investigational autologous CAR-T therapy directed against CD19, developed using the T-Charge platform. Another treatment, YTB323, is being studied in a Phase I trial for autoimmune disorders, including rheumatoid arthritis, severe refractory Sjögren's disease, primary progressive multiple sclerosis, generalized myasthenia gravis, and relapsing multiple sclerosis. In Phase II, it is under evaluation for ANCA-associated vasculitis, severe refractory systemic lupus erythematosus/lupus nephritis (SLE/LN), myositis, systemic sclerosis, and first-line high-risk large B-cell lymphoma.
Descartes-08, Cartesian's lead CAR-T candidate, is an autologous therapy targeting B-cell maturation antigen (BCMA) and is in clinical development for autoimmune diseases such as generalized myasthenia gravis and SLE. It is currently in Phase II trials for these two indications, as well as in Phase I/II studies involving pediatric and young adult patients with childhood-onset SLE, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis.
Interius BioTherapeutics' INT2104 is a fully owned investigational gene therapy that selectively targets CD7-positive T and NK cells, delivering a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo. These cells, in turn, attack CD20-positive B cells to treat B-cell malignancies. Unlike conventional ex vivo CAR-T products, INT2104 is an off-the-shelf, single-dose therapy administered intravenously—requiring no lymphodepletion, specialized equipment, or training. The therapy has received regulatory clearance from Australia's Therapeutic Goods Administration (TGA) and German authorities, and its Phase I evaluation is ongoing in Australia and Europe.
Umoja Biopharma's UB-VV111 is another investigational off-the-shelf product designed to generate CD19-directed CAR-T cells in vivo. It aims to overcome limitations of traditional autologous CAR-T approaches, such as high manufacturing costs, extended production timelines, and limited patient access. Developed by Umoja Biopharma in collaboration with AbbVie, UB-VV111 has been granted Fast Track Designation (FTD) by the U.S. FDA for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) following two or more prior therapies.
The anticipated launch of these emerging therapies are poised to transform the CAR T-cell therapy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the CAR T-cell therapy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about CAR T-cell therapy clinical trials, visit @ CAR T-cell Therapy Treatment
Recent Developments in the CAR T-cell Therapy Market
- In September 2025, Umoja Biopharma announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) to UB-VV111 for the treatment of relapsed/refractory large B-cell lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia (CLL) following two or more lines of prior therapy.
- InAugust 2025, Kite Pharma (a Gilead Sciences company) announced plans to acquire Interius BioTherapeutics for USD 350 million to advance in vivo CAR-T therapies.
- In June 2025, Novartis presented Phase I/II data for YTB323 in the treatment of severe, refractory SLE at EULAR 2025.
- In April 2025, Kite Pharma presented findings from a retrospective study of brexucabtagene autoleucel in patients over 70 years of age with R/R MCL who do not benefit from intensive treatment at the 51st Annual EBMT Meeting.
- In February 2025, Miltenyi Biomedicine presented the data from the Phase II DALY II USA trial (NCT04792489) at the 2025 Transplant and Cellular Therapy Meetings.
What is CAR T-cell Therapy?
CAR T-cell therapy is an innovative immunotherapy approach for treating specific blood cancers, such as leukemia and lymphoma. The treatment starts by collecting the patient's T cells through a process called apheresis. In the laboratory, these cells are genetically engineered to produce a Chimeric Antigen Receptor (CAR), which enhances their ability to identify and destroy cancer cells. Once modified, the CAR-T cells are expanded in number and reintroduced into the patient's bloodstream, where they target and eliminate malignant cells. This therapy has demonstrated remarkable success, with some patients achieving complete remission after other treatments have failed. Nonetheless, CAR-T therapy carries potential risks, including Cytokine Release Syndrome (CRS) and neurological side effects, requiring vigilant monitoring by trained healthcare professionals throughout the treatment process.
CAR T-cell Therapy Epidemiology Segmentation
The CAR T-cell therapy market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020–2034 across the leading markets. Among age-specific cases of multiple myeloma, the 65+ age group has the highest number, accounting for more than 70% of cases in the US, followed by 55–64 and 0–54 years.
The CAR T-cell therapy target patient pool is segmented into:
- Total Incident Cases of Selected Indications for CAR T-cell Therapy
- Total Eligible Patient Pool for CAR T-cell Therapy in Selected Indications
- Total Treated Cases in Selected Indications for CAR T-cell Therapy
CAR T-cell Therapy Report Metrics | Details |
Study Period | 2020–2034 |
CAR T-cell Therapy Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | Acute Lymphoblastic Leukemia, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Multiple Myeloma, Glioblastoma Multiforme, Systemic Lupus Erythematosus, Myasthenia Gravis, Lupus Nephritis, Multiple Sclerosis, and others |
Key CAR T-cell Therapy Companies | Arcellx, Kite Pharma, Miltenyi Biomedicine, Allogene Therapeutics, Luminary Therapeutics, Precigen, Poseida Therapeutics, Roche, Autolus, Cartesian Therapeutics, Cabaletta Bio, Interius BioTherapeutics, Umoja Biopharma, Johnson & Johnson Innovative Medicine, Juno Therapeutics, Bristol-Myers Squibb, Novartis, and others |
Key CAR T-cell Therapy | Anitocabtagene autoleucel (anito-cel), Zamtocabtagene autoleucel, Cemacabtagene ansegedleucel, LMY-920, PRGN-3006 UltraCAR-T, LMY-920, P-BCMA-ALLO1, AUTO4, Descartes-8, Rapcabtagene autoleucel, INT2104, UB-VV111, CARVYKTI, TECARTUS, BREYANZI, ABECMA, YESCARTA, KYMRIAH, and others |
Scope of the CAR T-cell Therapy Market Report
- CAR T-cell Therapy Therapeutic Assessment: CAR T-cell Therapy's current marketed and emerging therapies
- CAR T-cell Therapy Market Dynamics: Conjoint Analysis of Emerging CAR T-cell Therapy Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, CAR T-cell Therapy Market Access and Reimbursement
Discover more about CAR T-cell therapies in development @ CAR T-cell Therapy Clinical Trials
Table of Contents
1 | CAR T-cell Therapy Market Key Insights |
2 | CAR T-cell Therapy Market Report Introduction |
3 | Executive Summary |
4 | Key Events |
4.1 | Upcoming Key Catalyst |
4.2 | Key Conference and Meeting Insights |
4.3 | Key Transactions and Collaborations |
4.4 | News Flow |
5 | Epidemiology and Market Forecast Methodology |
6 | CAR T-cell Therapies Market Overview at a Glance |
6.1 | Clinical Landscape (Analysis by Molecule Type, Phase, and Route of Administration [RoA]) |
6.2 | Market Share (%) Distribution by Class of CAR T-cell Therapies in 2024 |
6.3 | Market Share (%) Distribution by Class of CAR T-cell Therapies in 2034 |
7 | Background and Overview |
7.1 | Understanding CAR T-cell |
7.2 | Oncology |
7.3 | Non-oncology |
8 | CAR T-cell Therapy Treatment Guidelines |
9 | Epidemiology and Patient Population |
9.1 | Key Findings |
9.2 | Assumptions and Rationale: 7MM |
9.3 | Epidemiology Scenario in the 7MM |
9.3.1 | Total Cases of Selected Indications for CAR Ts in the 7MM |
9.3.2 | Total Eligible Patient Pool for CAR Ts in Selected Indications in the 7MM |
9.3.3 | Total Treated Cases in Selected Indications for CAR Ts in the 7MM |
10 | Marketed CAR T-cell Therapies |
10.1 | Keycross Competition |
10.2 | YESCARTA (axicabtagene ciloleucel): Kite Pharma and Gilead Sciences |
10.2.1 | Product Description |
10.2.2 | Regulatory Milestones |
10.2.3 | Other Development Activities |
10.2.4 | Summary of Pivotal Trial |
10.2.5 | Clinical Development |
10.2.5.1 | Clinical Trial Information |
10.2.6 | Safety and Efficacy of Ongoing Clinical Trials |
10.2.7 | Analyst Views |
10.3 | KYMRIAH (tisagenlecleucel): Novartis |
List to be continued... | |
11 | Emerging CAR T-cell Therapies |
11.1 | Key Cross Competition |
11.2 | Zamtocabtagene autoleucel: Miltenyi Biomedicine |
11.2.1 | Product Description |
11.2.2 | Other Development Activities |
11.2.3 | Clinical Development |
11.2.3.1 | Clinical Trial Information |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst Views |
11.3 | Rapcabtagene autoleucel (YTB323): Novartis |
List to be continued... | |
12 | CAR T-cell Therapies Market: Seven Major Market Analysis |
12.1 | Key Findings |
12.2 | CAR T-cell Therapy Market Outlook |
12.3 | Conjoint Analysis |
12.4 | Key Market Forecast Assumptions |
12.5 | Total CAR T-cell Therapy Market Size by Country in the 7MM |
12.6 | Total CAR T-cell Therapy Market Size by Indications in the 7MM |
12.7 | Total CAR T-cell Therapy Market Size by Therapies in the 7MM |
12.8 | The United States CAR T-cell Therapy Market Size |
12.9 | EU4 and the UK CAR T-cell Therapy Market Size |
12.10 | Japan CAR T-cell Therapy Market Size |
13 | CAR T-cell Therapy Market Unmet Needs |
14 | CAR T-cell Therapy Market SWOT Analysis |
15 | KOL Views on CAR T-cell Therapy |
16 | CAR T-cell Therapy Market Access and Reimbursement |
16.1 | The United States |
16.2 | In EU4 and the UK |
16.3 | Japan |
16.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
16.5 | Market Access and Reimbursement of CAR T-cell Therapy |
17 | Bibliography |
18 | CAR T-cell Therapy Market Report Methodology |
Related Reports
CAR T-cell Therapy Clinical Trial Analysis
CAR T-cell Therapy Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy companies, including Cartesian Therapeutics, Arcellx, Inc, Nexcella, Inc, Autolus Therapeutics, Sana Biotechnology, Orgenesis, CARsgen, TILT Biotherapeutics, Poseida Therapeutics, Precision BioSciences, Novartis, Kyverna Therapeutics, Hrain Biotechnology, UTC Therapeutics, Kiromic, Suzhou Fundamenta Therapeutics, Gracell Biotechnology, Innovent Biologics, Nanjing IASO Biotherapeutics, CellabMED, Umoja Biopharma, TC BioPharm, ElevateBio, Century Therapeutics, Allogene Therapeutics, among others.
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