CAR-T细胞治疗急性淋巴性白血病市场－全球及区域分析：依来源类型、标靶类型、按区域－分析与预测（2025-2035）

全球急性淋巴性白血病CAR-T细胞治疗市场目前正处于其生命週期的成长阶段。

随着 Kymriah 等先锋疗法核准并证明其在治疗復发/难治性 ALL 方面的疗效，市场出现了显着的增长。这一阶段的特点是临床证据不断扩大、患者可近性不断提高以及研发投入不断增加。此外，随着监管部门的核准和新治疗方法进入市场，该行业预计将进一步扩张。然而，挑战依然存在，包括高昂的治疗成本、製造复杂性以及对长期安全数据的需求。儘管存在这些障碍，但在治疗方法创新、策略伙伴关係以及下一代 CAR T 细胞疗法的持续发展的推动下，市场仍在经历强劲成长。

影响

• 预计在 2025-2035 年预测期内，用于治疗急性淋巴性白血病的 CAR T 细胞疗法的需求不断增加将支持市场的成长。
• 由于诊断技术的进步、创新治疗方法的市场推出以及患者和医疗保健提供者意识的提高，全球急性淋巴性白血病CAR T 细胞疗法市场预计将显着增长。

由于先进的医疗基础设施、高盛行率以及对该疾病的认识不断提高，预计北美将在预测期内主导全球急性淋巴性白血病CAR T 细胞治疗市场。该地区还拥有良好的监管优势和强大的製药公司，有利于获得有效的治疗方法，推动全球急性淋巴性白血病CAR T 细胞治疗市场的成长。

近期动态

• 监管活动：2025 年 3 月，FDA核准了CTD402 针对儿童和成人復发/难治性 T-ALL/LBL 患者的 IND 申请，并且已经开始了单臂、开放标籤 1b/2 期研究。
• 监管活动：2024 年 11 月，FDA核准Autolus Therapeutics 的 CAR-T 细胞疗法 AUCATZYL 用于治疗 r/r B-ALL 成年患者。

需求——驱动因素与限制因素

推动全球急性淋巴性白血病CAR T 细胞治疗市场的因素包括：

• 急性淋巴性白血病盛行率不断上升
• 製造和工艺改进的进步
• 拥有一系列获得区域核准的产品

由于以下挑战，全球急性淋巴性白血病CAR T 细胞治疗市场也预计将面临一些限制：

• 医疗费用高昂

产品/创新策略：全球急性淋巴性白血病CAR T 细胞治疗市场的产品发布和创新专注于推进治疗方案以改善患者护理。这些创新旨在提高治疗效果并简化疾病的检测和管理。包括 Autolus Therapeutics 在内的市场关键参与企业已参与急性淋巴性白血病CAR T 细胞疗法的治疗发展。

竞争策略：全球急性淋巴性白血病CAR T 细胞治疗市场的领导企业不断致力于透过创新治疗方法更新产品系列，以保持竞争力。它提供了全球急性淋巴性白血病CAR T 细胞疗法市场主要企业的深入竞争基准化分析，以及这些公司在产品供应、市场占有率和技术创新方面的竞争考察。透过这种基准化分析，读者可以清楚地了解市场格局和主要企业的地位。此外，包括伙伴关係、协议和联盟在内的综合竞争策略可协助读者发现市场中尚未开发的商机。

主要市场参与企业和竞争对手的摘要

公司简介是根据从主要专家收集的意见以及透过分析公司覆盖范围、产品系列和市场渗透率来选择的。

主要企业包括急性淋巴性白血病CAR T 细胞疗法提供者，占全球急性淋巴性白血病CAR T 细胞疗法市场的约 95%。

本报告研究了全球急性淋巴性白血病CAR T 细胞疗法市场，概述了市场概况以及按来源类型、目标类型和地区分類的趋势，并介绍了参与市场的公司概况。

目录

执行摘要

研究范围

第一章 全球急性淋巴性白血病CAR-T 细胞治疗市场：市场展望

• 产业展望
• 市场动态

2. 全球急性淋巴性白血病CAR-T 细胞治疗市场（按来源类型划分）（百万美元，2023-2035 年）

• 自体移植
• 同种异体

3. 全球急性淋巴性白血病CAR-T细胞疗法市场（按目标类型划分），百万美元，2023-2035年

• CD-19
• CD-22
• 其他的

4. 全球急性淋巴性白血病CAR-T 细胞疗法市场（按地区划分，百万美元），2023 年至 2035 年

• 北美洲
• 欧洲
• 亚太地区

5. 全球急性淋巴性白血病CAR-T 细胞疗法市场竞争基准化分析与公司简介

• 竞争格局
  • 各公司主要策略及发展
  • 关键进展
• 公司简介
  • Novartis AG
  • Autolus Therapeutics
  • Gilead Sciences
  • OneChain Immunotherapeutics
  • Cellectis SA
  • Wugen, Inc.
  • Bioheng Therapeutics

第六章调查方法

Market Lifecycle Stage

The global CAR T-cell therapy for acute lymphoblastic leukemia market is currently in the growth stage of its lifecycle. Following the approval of pioneering therapies such as Kymriah and the successful demonstration of their efficacy in treating relapsed and refractory ALL, the market has seen a significant increase in adoption. This stage is characterized by expanding clinical evidence, increasing patient access, and growing investment in research and development. Furthermore, with regulatory approvals and new therapies entering the market, the industry is poised for further expansion. However, challenges such as high treatment costs, manufacturing complexities, and the need for long-term safety data remain. Despite these obstacles, the market is experiencing robust growth driven by innovations in therapy, strategic partnerships, and the ongoing development of next-generation CAR T-cell therapies.

Impact

• Increasing demand for CAR T-cell therapy for acute lymphoblastic leukemia therapies is anticipated to support the growth of the global CAR T-cell therapy for acute lymphoblastic leukemia market during the forecast period 2025-2035.
• The global CAR T-cell therapy for acute lymphoblastic leukemia market is expected to grow at a significant rate due to advancements in diagnostic technologies, the development of innovative therapies, and increasing awareness among patients and healthcare providers.

Market Segmentation:

Segmentation 1: by Source Type

• Autologous
• Allogeneic

Segmentation 2: by Target Type

• CD19
• CD22
• Others

Segmentation 3: by Region

• North America
• Europe
• Asia-Pacific
• Rest-of-the-World

North America is expected to dominate the global CAR T-cell therapy for acute lymphoblastic leukemia market during the forecast period due to its advanced healthcare infrastructure, high prevalence of disease, and increased awareness of the disease. The region also benefits from regulatory advantages and a strong pharmaceutical presence, which accelerates the availability of effective treatments and drives the growth of the global CAR T-cell therapy for acute lymphoblastic leukemia market.

Recent Developments:

• Regulatory Activities: In March 2025, the FDA approved the IND application for CTD402 for treating pediatric and adult patients with relapsed/refractory T-ALL/LBL, which enabled the commencement of a single-arm, open-label phase 1b/2 trial.
• Regulatory Activities: In November 2024, the FDA granted marketing approval for Autolus Therapeutics' CAR-T cell therapy, AUCATZYL, for the treatment of adult patients with r/r B-ALL.

Demand - Drivers and Limitations

The following are the drivers for the global CAR T-cell therapy for acute lymphoblastic leukemia market:

• Rising Prevalence of Acute Lymphoblastic Leukemia
• Advancements in Manufacturing and Process Improvements
• Robust Product Pipeline with Regulatory Approvals Across Geographies

The global CAR T-cell therapy for acute lymphoblastic leukemia market is expected to face some limitations too, due to the following challenges:

• High Treatment Costs

How Can This Report Add Value to an Organization?

Product/Innovation Strategy: Product launches and innovations in the global CAR T-cell therapy for acute lymphoblastic leukemia market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease. Key players in the market, such as Autolus Therapeutics, have been involved in the development of therapies for CAR T-cell therapy for acute lymphoblastic leukemia.

Competitive Strategy: Enterprises led by market leaders in the global CAR T-cell therapy for acute lymphoblastic leukemia market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players in the global CAR T-cell therapy for acute lymphoblastic leukemia market has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the market.

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and by analyzing company coverage, product portfolio, and market penetration.

The top segment players include CAR T-cell therapy for acute lymphoblastic leukemia therapy providers that capture around 95% of the global CAR T-cell therapy for acute lymphoblastic leukemia market.

Some of the prominent names established in this market are:

• Autolus Therapeutics
• Bioheng Therapeutics
• Cellectis S.A.
• Gilead Sciences
• Novartis AG
• Wugen, Inc.
• OneChain Immunotherapeutics

Table of Contents

Executive Summary

Scope of Study

1. Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market: Market Outlook

• 1.1 Industry Outlook
  • 1.1.1 Market Overview and Ecosystem
  • 1.1.2 Key Trends
  • 1.1.3 Epidemiological Analysis of Acute Lymphoblastic Leukemia
    • 1.1.3.1 By Region
  • 1.1.4 Clinical Trials
    • 1.1.4.1 By Phase
    • 1.1.4.2 By Sponsor Type
  • 1.1.5 Regulatory Landscape / Compliance
    • 1.1.5.1 Legal Requirement and Framework in the U.S.
    • 1.1.5.2 Legal Requirement and Framework in the E.U.
    • 1.1.5.3 Legal Requirement and Framework in Japan
    • 1.1.5.4 Legal Requirement and Framework in Rest-of-the-World
• 1.2 Market Dynamics
  • 1.2.1 Impact Analysis
  • 1.2.2 Market Drivers
  • 1.2.3 Market Restraints
  • 1.2.4 Market Opportunities

2. Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, By Source Type, $Million, 2023-2035

• 2.1 Autologous
• 2.2 Allogeneic

3. Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, By Target Type, $Million, 2023-2035

• 3.1 CD-19
• 3.2 CD-22
• 3.3 Others

4. Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, By Region, $Million, 2023-2035

• 4.1 North America
  • 4.1.1 Key Findings
  • 4.1.2 Market Dynamics
  • 4.1.3 Market Sizing and Forecast
    • 4.1.3.1 U.S. CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Country)
      • 4.1.3.1.1 U.S.
• 4.2 Europe
  • 4.2.1 Key Findings
  • 4.2.2 Market Dynamics
  • 4.2.3 Market Sizing and Forecast
    • 4.2.3.1 Europe CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Country)
    • 4.2.3.2 U.K.
    • 4.2.3.3 Germany
    • 4.2.3.4 France
    • 4.2.3.5 Italy
• 4.3 Asia-Pacific
  • 4.3.1 Key Findings
  • 4.3.2 Market Dynamics
  • 4.3.3 Market Sizing and Forecast
    • 4.3.3.1 Asia-Pacific CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Country)
    • 4.3.3.2 China
    • 4.3.3.3 Japan

5. Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market - Competitive Benchmarking and Company Profiles

• 5.1 Competitive Landscape
  • 5.1.1 Key Strategies and Developments by Company
    • 5.1.1.1 Funding Activities
    • 5.1.1.2 Mergers and Acquisitions
    • 5.1.1.3 Regulatory Approvals
    • 5.1.1.4 Partnerships, Collaborations and Business Expansions
  • 5.1.2 Key Developments Analysis
• 5.2 Company Profiles
  • 5.2.1 Novartis AG
    • 5.2.1.1 Company Overview
    • 5.2.1.2 Product Portfolio
    • 5.2.1.3 Target Customers/End Users
    • 5.2.1.4 Analyst View
  • 5.2.2 Autolus Therapeutics
    • 5.2.2.1 Company Overview
    • 5.2.2.2 Product Portfolio
    • 5.2.2.3 Target Customers/End Users
    • 5.2.2.4 Analyst View
  • 5.2.3 Gilead Sciences
    • 5.2.3.1 Company Overview
    • 5.2.3.2 Product Portfolio
    • 5.2.3.3 Target Customers/End Users
    • 5.2.3.4 Analyst View
  • 5.2.4 OneChain Immunotherapeutics
    • 5.2.4.1 Company Overview
    • 5.2.4.2 Product Portfolio
    • 5.2.4.3 Target Customers/End Users
    • 5.2.4.4 Analyst View
  • 5.2.5 Cellectis S.A.
    • 5.2.5.1 Company Overview
    • 5.2.5.2 Product Portfolio
    • 5.2.5.3 Target Customers/End Users
    • 5.2.5.4 Analyst View
  • 5.2.6 Wugen, Inc.
    • 5.2.6.1 Company Overview
    • 5.2.6.2 Product Portfolio
    • 5.2.6.3 Target Customers/End Users
    • 5.2.6.4 Analyst View
  • 5.2.7 Bioheng Therapeutics
    • 5.2.7.1 Company Overview
    • 5.2.7.2 Product Portfolio
    • 5.2.7.3 Target Customers/End Users
    • 5.2.7.4 Analyst View

6. Research Methodology

List of Figures

• Figure: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, Market Overview
• Figure: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, Epidemiological Analysis, U.S.
• Figure: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market Coverage
• Figure: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market Key Trends, Impact Analysis, 2023-2035
• Figure: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, Competitive Landscape, January 2022-April 2025

List of Tables

• Table: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market, Regulatory Scenario
• Table: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market Dynamics, Impact Analysis
• Table: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Source Type), $Million, 2023-2035
• Table: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Target Type), $Million, 2023-2035
• Table: Global CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market (by Region), $Million, 2023-2035