CAR-T細胞治療急性淋巴性白血病市場－全球及區域分析：依來源類型、標靶類型、按區域－分析與預測（2025-2035）

全球急性淋巴性白血病CAR-T細胞治療市場目前正處於其生命週期的成長階段。

隨著 Kymriah 等先鋒療法核准並證明其在治療復發/難治性 ALL 方面的療效，市場出現了顯著的成長。這一階段的特點是臨床證據不斷擴大、患者可近性不斷提高以及研發投入不斷增加。此外，隨著監管部門的核准和新治療方法進入市場，該行業預計將進一步擴張。然而，挑戰依然存在，包括高昂的治療成本、製造複雜性以及對長期安全數據的需求。儘管存在這些障礙，但在治療方法創新、策略夥伴關係以及下一代 CAR T 細胞療法的持續發展的推動下，市場仍在經歷強勁成長。

影響

• 預計在 2025-2035 年預測期內，用於治療急性淋巴性白血病的 CAR T 細胞療法的需求不斷增加將支持市場的成長。
• 由於診斷技術的進步、創新治療方法的市場推出以及患者和醫療保健提供者意識的提高，全球急性淋巴性白血病CAR T 細胞療法市場預計將顯著成長。

由於先進的醫療基礎設施、高盛行率以及對該疾病的認知不斷提高，預計北美將在預測期內主導全球急性淋巴性白血病CAR T 細胞治療市場。該地區還擁有良好的監管優勢和強大的製藥公司，有利於獲得有效的治療方法，推動全球急性淋巴性白血病CAR T 細胞治療市場的成長。

近期動態

• 監管活動：2025 年 3 月，FDA核准了CTD402 針對兒童和成人復發/難治性 T-ALL/LBL 患者的 IND 申請，並且已經開始了單臂、開放標籤 1b/2 期研究。
• 監管活動：2024 年 11 月，FDA核准Autolus Therapeutics 的 CAR-T 細胞療法 AUCATZYL 用於治療 r/r B-ALL 成年患者。

需求——促進因素與限制因素

推動全球急性淋巴性白血病CAR T 細胞治療市場的因素包括：

• 急性淋巴性白血病盛行率不斷上升
• 製造和工藝改進的進步
• 擁有一系列獲得區域核准的產品

由於以下挑戰，全球急性淋巴性白血病CAR T 細胞治療市場也預計將面臨一些限制：

• 醫療費用高昂

產品/創新策略：全球急性淋巴性白血病CAR T 細胞治療市場的產品發布和創新專注於推進治療方案以改善患者護理。這些創新旨在提高治療效果並簡化疾病的檢測和管理。包括 Autolus Therapeutics 在內的市場關鍵參與企業已參與急性淋巴性白血病CAR T 細胞療法的治療發展。

競爭策略：全球急性淋巴性白血病CAR T 細胞治療市場的領導企業不斷致力於透過創新治療方法更新產品系列，以保持競爭力。它提供了全球急性淋巴性白血病CAR T 細胞療法市場主要企業的深入競爭基準化分析，以及這些公司在產品供應、市場佔有率和技術創新方面的競爭考察。透過這種基準化分析，讀者可以清楚地了解市場格局和主要企業的地位。此外，包括夥伴關係、協議和聯盟在內的綜合競爭策略可協助讀者發現市場中尚未開發的商機。

主要市場參與企業和競爭對手的摘要

公司簡介是根據從主要專家收集的意見以及透過分析公司覆蓋範圍、產品系列和市場滲透率來選擇的。

主要企業包括急性淋巴性白血病CAR T 細胞療法提供者，佔全球急性淋巴性白血病CAR T 細胞療法市場的約 95%。

本報告研究了全球急性淋巴性白血病CAR T 細胞療法市場，概述了市場概況以及按來源類型、目標類型和地區分類的趨勢，並介紹了參與市場的公司概況。

目錄

執行摘要

研究範圍

第1章 全球急性淋巴性白血病CAR-T 細胞治療市場：市場展望

• 產業展望
• 市場動態

2. 全球急性淋巴性白血病CAR-T 細胞治療市場（按來源類型分類）（百萬美元，2023-2035 年）

• 自體移植
• 同種異體

3. 全球急性淋巴性白血病CAR-T細胞療法市場（按目標類型分類），百萬美元，2023-2035年

• CD-19
• CD-22
• 其他

4. 全球急性淋巴性白血病CAR-T 細胞療法市場（按地區分類，百萬美元），2023 年至 2035 年

• 北美洲
• 歐洲
• 亞太地區

5. 全球急性淋巴性白血病CAR-T 細胞療法市場競爭基準化分析與公司簡介

• 競爭格局
  • 各公司主要策略及發展
  • 關鍵進展
• 公司簡介
  • Novartis AG
  • Autolus Therapeutics
  • Gilead Sciences
  • OneChain Immunotherapeutics
  • Cellectis SA
  • Wugen, Inc.
  • Bioheng Therapeutics

第6章調查方法

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