DelveInsight’s “CAR-T Cell Therapy for Acute Lymphoblastic Leukemia Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Acute Lymphoblastic Leukemia, historical and forecasted epidemiology as well as the CAR-T Cell Therapy for Acute Lymphoblastic Leukemia market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

Discover which therapies are expected to grab the CAR T-Cell Therapy for ALL Market Share @ CAR T-Cell Therapy for ALL Market Outlook

Key Takeaways from the CAR T-Cell Therapy for ALL Market Report

• In June 2025, Peter MacCallum Cancer Centre, Australia conducteda Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.
• In June 2025, M.D. Anderson Cancer Center conducted a Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia.
• Among the 7MM, the US accounted for the highest Acute Lymphoblastic Leukemia incidence.
• The total incident cases of Acute Lymphoblastic Leukemia in the US comprised approximately 6,800 cases in 2023 and are projected to increase during the forecast period.
• Amongst EU4 and the UK, Germany accounted for the highest number of incident cases of Acute Lymphoblastic Leukemia, while Spain accounted for the lowest number of cases.
• Among the gender-specific cases, males accounted for nearly 3,800 cases, while females accounted for 3,000 in the US in 2023.
• Among the type-specific cases of Acute Lymphoblastic Leukemia, the incident cases of B-Acute Lymphoblastic Leukemia accounted for nearly 85%, while that of T-Acute Lymphoblastic Leukemia accounted for nearly 15% in the US.
• The leading CAR T-Cell Therapy for ALL Companies such as Autolus Therapeutics, Cellectis, Wugen, Servier, Allogene, Precision Biosciences and others.
• Promising CAR T-Cell Therapy for ALL Pipeline Therapies such as Cevostamab, Epcoritamab, BCMA CAR-T cells, Talquetamab, CTO1681 10 μg, Bortezomib, Dexamethasone, Lenalidomide and others.

Stay ahead in the CAR T-Cell Therapy for ALL Therapeutics Market with DelveInsight’s Strategic Report @ CAR T-Cell Therapy for ALL Treatment Market

CAR T-Cell Therapy for ALL Epidemiology Segmentation in the 7MM

• Total CAR T-Cell Therapy for ALL Incident Cases
• CAR T-Cell Therapy for ALL Gender-specific cases
• CAR T-Cell Therapy for ALL Age-specific cases
• CAR T-Cell Therapy for ALL Subtype-specific cases
• CAR T-Cell Therapy for ALL Genetic-mutation specific cases
• Total CAR T-Cell Therapy for ALL treated cases

Download the report to understand which factors are driving CAR T-Cell Therapy for ALL Epidemiology trends @ CAR T-Cell Therapy for ALL Prevalence

Marketed CAR-T Cell Therapy for Acute Lymphoblastic Leukemia Drugs

• TECARTUS (brexucabtagene autoleucel): Gilead Sciences

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, which binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR-T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to the killing of CD19-expressing cells. In October 2021, the US FDA approved TECARTUS for adult patients with R/R B-Acute Lymphoblastic Leukemia. It was approved by the EC in September 2022.

• KYMRIAH (tisagenlecleucel): Novartis

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy that involves reprogramming a patient’s T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment that recognizes CD19 and is fused to intracellular signaling domains. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T cell expansion, activation, target cell elimination, and persistence of the KYMRIAH cells. In August 2017, the US FDA approved KYMRIAH for the treatment of patients up to age 25 years with R/R B-Acute Lymphoblastic Leukemia. It was approved by the EC in August 2018, and by the MHLW in March 2019.

CAR-T Cell Therapy for Acute Lymphoblastic Leukemia Emerging Drugs

• Obecabtagene autoleucel (obe-cel): Autolus Therapeutics

Obe-cel is an autologous CD19 CAR-T cell therapy with a unique CD19 CAR. The CAR is designed to have a fast-off kinetic, which mimics physiological T-cell receptor interactions. In March 2022, obe-cel was granted Orphan Medical Product Designation by the EMA for the treatment of Acute Lymphoblastic Leukemia, having previously received ODD by the US FDA for B-Acute Lymphoblastic Leukemia. In April 2022, the US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for the treatment of adult B-Acute Lymphoblastic Leukemia. Obe-cel also received PRIME designation from the EMA and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare Products Regulatory Agency (MHRA), UK.

• UCART22: Cellectis

UCART22 is an allogeneic-engineered T-cell product candidate designed for the treatment of CD22-expressing hematologic malignancies and is currently being developed for the treatment of B-Acute Lymphoblastic Leukemia. Currently, the company is evaluating the drug in Phase I/II B Acute Lymphoblastic Leukemia I-01 Study in patients with R/R Acute Lymphoblastic Leukemia. As of the December 2021 report, the company is enrolling patients in the third dose level of the B Acute Lymphoblastic Leukemia I-01 Study with a fludarabine cyclophosphamide alemtuzumab lymphodepletion regimen.

To learn more about CAR T-Cell Therapy for ALL Treatment guidelines, visit @ CAR T-Cell Therapy for ALL Clinical Trials Assessment

CAR T-Cell Therapy for ALL Companies

Autolus Therapeutics, Cellectis, Wugen, Servier, Allogene, Precision Biosciences and others.

CAR-T Cell Therapy for Acute Lymphoblastic Leukemia Market Outlook

Traditional cytotoxic chemotherapy-containing regimens have been the backbone of treatment for adults with Acute Lymphoblastic Leukemia for decades. Common complications of traditional chemotherapy can be fatal and include infection, bleeding, thrombosis, neuropathy, osteonecrosis, and the development of secondary cancers, including AML and MDS.

CAR T-Cell Therapy for ALL Drugs Market Insights

Since the first successful report of CAR-T cell therapy for pediatric Acute Lymphoblastic Leukemia more than a decade ago, the field has exploded with new constructs and targets, insights into CAR T-cell persistence, and novel antigen escape mechanisms; first came KYMRIAH (tisagenlecleucel, or tisa-cel, Novartis) for pediatric and young adult patients who had received at least two prior lines of therapy, followed by TECARTUS (brexucabtagene autoleucel, or brexu-cel, Kite) for adults following first relapse. It is anticipated that CAR-T cells will bring out the next big leap forward in leukemia immunotherapy.

Learn more about the FDA-approved drugs for CAR T-Cell Therapy for ALL @ Drugs for CAR T-Cell Therapy for ALL Treatment

Scope of the CAR T-Cell Therapy for ALL Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• CAR T-Cell Therapy for ALL Companies- Autolus Therapeutics, Cellectis, Wugen, Servier, Allogene, Precision Biosciences, and others.
• CAR T-Cell Therapy for ALL Pipeline Therapies- Cevostamab, Epcoritamab, BCMA CAR-T cells, Talquetamab, CTO1681 10 μg, Bortezomib, Dexamethasone, Lenalidomide, and others.
• CAR T-Cell Therapy for ALL Market Dynamics: CAR T-Cell Therapy for ALL Market Drivers and Barriers
• CAR T-Cell Therapy for ALL Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Contents

1 KEY INSIGHTS

2 REPORT INTRODUCTION

3 EXECUTIVE SUMMARY OF CAR-T IN Acute Lymphoblastic Leukemia

4 KEY EVENTS

5 EPIDEMIOLOGY AND MARKET METHODOLOGY

6 CAR-T IN Acute Lymphoblastic Leukemia MARKET OVERVIEW AT A GLANCE

7 DISEASE BACKGROUND AND OVERVIEW

8 CURRENT TREATMENT PRACTICES: Acute Lymphoblastic Leukemia

9 EPIDEMIOLOGY AND PATIENT POPULATION OF 7MM

10 PATIENT JOURNEY

10.1 TYPICAL CAR T-CELL PATIENT JOURNEY

11 MARKETED DRUGS

12 EMERGING DRUGS

13 CAR-T IN Acute Lymphoblastic Leukemia: THE 7MM ANALYSIS

14 UNMET NEEDS

15 SWOT ANALYSIS

16 KOL VIEWS

17 MARKET ACCESS AND REIMBURSEMENT

18 APPENDIX

19 DELVEINSIGHT CAPABILITIES

20 DISCLAIMER

21 ABOUT DELVEINSIGHT

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