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再生医学细胞疗法

市场调查报告书

商品编码

1874003

CAR-T细胞疗法市场

CAR-T Cell Therapy Market

出版日期: 2025年11月01日 | 出版商:

The Insight Partners | 英文 150 Pages | 商品交期: 1-5个工作天内

价格

简介目录

预计到 2031 年，CAR-T 细胞疗法市场规模将达到 118 亿美元，高于 2024 年的 38.5 亿美元，2031 年至 2031 年的复合年增长率预计为 17.5%。

市场洞察与分析师观点：

嵌合抗原受体（CAR）T细胞疗法正逐渐成为最有效的癌症治疗策略之一，每年都有大量临床前和临床试验开展，以拓展其应用范围。经过数十年的研究，CAR-T细胞疗法的扩展势在必行。未来的发展不仅将探索自体和异体产品，还将探索新型体内CAR-T细胞基因疗法及其在血液系统恶性肿瘤以外疾病的疗效。然而，商业化的挑战正在阻碍CAR-T细胞疗法市场的成长。

成长动力：

癌症发生率上升推动了对CAR-T细胞疗法的需求

CAR-T细胞疗法是一种新型癌症治疗方法，它透过在实验室中改造T细胞，然后将其重新註入人体，使其靶向攻击癌细胞。目前，该疗法已用于治疗成人和儿童白血病以及某些类型的淋巴瘤，并且正在研究其治疗其他癌症（包括胸部的一些实体瘤）的潜在用途。

遗传易感性、加工食品的摄取、环境污染和生活方式的改变等因素都导致了癌症发生率的上升。美国癌症协会报告称，2020年全球新增癌症病例约1,930万例。因此，癌症患者数量的增长推动了对CAR-T细胞疗法的需求。

战略洞察

报告细分和范围：

「CAR-T 细胞疗法市场」的分析是基于以下几个方面进行的：靶向抗原、适应症和最终用户。

细分市场分析：

就标靶抗原而言，CAR-T细胞疗法市场分为CD19和BCMA两大细分市场。 2022年，CD19细分市场在CAR-T细胞疗法市场中占据较大份额，预计在预测期内将实现17.9%的更高复合年增长率。

CAR-T细胞疗法已被证实对治疗復发/难治性瀰漫性大B细胞淋巴瘤有效。患者来源的T细胞经过基因改造，产生CD19 CAR-T细胞，这些细胞表达能与CD19蛋白结合的受体，CD19蛋白常见于白血病和淋巴瘤细胞。

该领域的成长预计将主要得益于CD19 CAR-T细胞疗法产品的上市。以下是美国食品药物管理局和欧盟批准的产品清单：

製造商

品牌产品

标靶抗原

疾病指征

核准年份

诺华

凯姆里亚

CD19

白血病

2017

吉利德科学公司

YESCARTA

CD19

淋巴瘤

2017

吉利德科学公司

特卡图斯

CD19

淋巴瘤和白血病

2020

百时美施贵宝

布雷扬齐

CD19

淋巴瘤

2021

CAR-T细胞疗法市场依适应症分为淋巴瘤、白血病及多发性骨髓瘤三大类。 2022年，淋巴瘤细分市场占据最大市场份额，预计在预测期内将以18.1%的复合年增长率高速成长。血液系统恶性肿瘤，包括急性淋巴性白血病、慢性淋巴性白血病、淋巴瘤和多发性骨髓瘤，是CAR-T细胞疗法的主要适应症。

依最终用户划分，CAR-T细胞疗法市场可分为医院和专科诊所、门诊手术中心及其他机构。 2022年，医院和专科诊所细分市场占据主导地位，预计在预测期内将以17.9%的复合年增长率保持最高增速。

技术创新将推动 CAR-T 细胞疗法市场成长

利用患者自身白血球靶向特定类型血液癌症的CAR-T疗法的研发和应用，是近年来最重要的医学突破之一。 CAR-T细胞疗法为部分癌症患者带来了治癒的希望。自2017年首个CAR-T疗法获批以来，又有五种疗法获得FDA核准，用于治疗特定类型的成人和儿童白血病、淋巴瘤和多发性骨髓瘤。目前，针对实体瘤的类似疗法的研究也正在进行中。

异体CAR-T细胞疗法一直是全球许多临床前和临床试验的重点，主要针对血液系统恶性肿瘤，其中CD19是最常见的标靶，此外还有CD20、CD22和BCMA等传统标靶。 CD70、CD7和CD5等新标靶也在探索之中。针对实体瘤的新兴疗法则以间皮素、GD2和NKG2DL为标靶。

因此，细胞疗法的进展可能会在未来几年为 CAR-T 细胞疗法市场带来新的趋势。

区域分析：

全球CAR-T细胞疗法市场报告涵盖北美、欧洲、亚太、南美和中美洲以及世界其他地区。 2022年，北美占据CAR-T细胞疗法市场最大份额。该地区的成长得益于领先製造商不断推出新产品以及主要市场参与者的存在。此外，众多製药和生物技术公司以及学术和研究机构的大量研发投入预计也将推动北美市场成长。例如，2022年6月，百时美施贵宝宣布其CD19靶向CAR-T细胞疗法Breyanzi（lisocabtagene maraleucel）获得FDA批准，用于治疗成人大B细胞淋巴瘤（LBCL），包括瀰漫性大B细胞淋巴瘤（DLBCL）。

在美国，CAR-T细胞疗法市场的成长主要得益于製药和生物製药产业的蓬勃发展，其特点是技术进步和适应能力的不断增强。此外，美国製药和生物技术公司为改善临床试验结果和确保患者安全且不断增加的研发投入也推动了市场成长。例如，2021年7月，BioNTech SE与吉利德旗下公司Kite签署收购协议，收购Kite位于马里兰州盖瑟斯堡的临床生产设施及其实体瘤新抗原T细胞受体（TCR）研发平台。该新设施将增强BioNTech位于德国伊达尔-奥伯施泰因的现有细胞疗法生产能力，并提供额外的产能以支持美国的临床试验，从而推进公司创新细胞疗法产品线的研发，该产品线包括基于NEOSTIM和CAR-T细胞扩增mRNA疫苗（CARVac）的癌症候选药物，以及近期收购的个体化新抗原TCR项目。

未来机会与研究进展：

儘管CAR-T细胞疗法在癌症治疗中展现出令人鼓舞的成果，但目前其应用仅限于復发或抗药性的特定血液肿瘤患者。未来几年，美国用于再生医学的多种CAR-T细胞疗法以及欧洲的先进疗法产品预计将获得上市许可。众多关键企业正在针对多种适应症开发创新技术。从长远来看，这些疗法有望透过单次给药即可带来显着的、甚至可能治癒性的健康益处，从而显着改善患者的治疗效果。

鑑于目前正在进行的大量临床试验以及针对各种适应症的新型CAR-T细胞产品的研发，CAR-T细胞疗法的前景一片光明。研究人员致力于探索提高CAR-T细胞疗效的方法，这已从既往接受过广泛治疗的复发/难治性恶性肿瘤患者的完全缓解率和无进展生存期中得到证实。

目前正在研究抗原流失等可能导致免疫逃脱的因素，并制定应对这些挑战的策略。其中一种方法是开发可同时标靶多种抗原的CAR-T细胞疗法。针对CD138和GPRC5D等抗原的新疗法正在研发中，而用于治疗急性淋巴细胞白血病（ALL）和非霍奇金淋巴瘤（NHL）的CAR-T细胞疗法则侧重于CD19抗原，多发性骨髓瘤的疗法则靶向BCMA抗原。

CAR-T细胞疗法市场预测可以帮助该领域的利害关係人制定成长策略。以下是CAR-T细胞疗法市场领导者的一些研发倡议：

2023 年 11 月，Vittoria Biotherapeutics 宣布完成一轮私人融资，筹集了超过 1,500 万美元，用于资助 VIPER-101 的临床试验。 VIPER-101 是一种自体双群体 CD5 敲除 CAR-T 细胞疗法，用于治疗 T 细胞淋巴瘤。
2023 年 12 月，阿斯特捷利康宣布收购 Gracell Biotechnologies Inc.，以增强阿斯特捷利康在细胞疗法领域的现有能力和先前投资。
2021 年 12 月，加州大学圣地牙哥分校医学院的研究人员获得了 410 万美元的拨款，用于支持其创新性 CAR-T 细胞疗法的推进。该拨款由加州再生医学研究所理事会资助，可能有助于将新型癌症疗法从实验室转移到患者身上。

CAR-T细胞疗法市场报告范围

竞争格局及主要公司：

CAR-T细胞疗法市场报告中重点介绍的公司包括：百时美施贵宝公司、诺华公司、吉利德科学公司、强生公司、CARsgen Therapeutics Co., Ltd、Aurora Biopharma、传奇生物科技、辉瑞公司、bluebird bio, Inc.、Mustang Bio、Sorrento Therapeutics, Inceutics Therapeutics, Inceutics Therapeutics。这些公司致力于开发新技术、改进现有产品并扩大业务范围，以满足日益增长的全球需求。

Chimeric antigen receptor (CAR) T cell therapy is emerging as one of the most effective cancer treatment strategies, with numerous pre-clinical and clinical trials conducted annually to broaden its applications. Following decades of research, the expansion of CAR-T cell therapy is inevitable. Future developments will explore not only autologous and allogeneic products but also new in-vivo CAR-T cell gene therapies and their effectiveness in conditions beyond hematologic malignancies. However, challenges in commercialization are hindering the growth of the CAR-T cell therapy market.

Growth Drivers:

Increasing Cancer Incidence Fuels CAR-T Cell Therapy Demand

CAR-T cell therapy represents a novel approach to cancer treatment, where T cells are engineered in a laboratory and reintroduced into the body to target cancer cells. This therapy is currently used to treat adult and pediatric leukemia, as well as certain types of lymphoma, and is being investigated for potential use against other cancers, including some solid tumors in the chest area.

Factors such as genetic predisposition, consumption of processed foods, environmental pollution, and lifestyle changes are contributing to the rising incidence of cancer. The American Cancer Society reported approximately 19.3 million new cancer cases worldwide in 2020. Consequently, the growing number of cancer patients is driving the demand for CAR-T cell therapies.

Strategic Insights

Report Segmentation and Scope:

The analysis of the "CAR-T cell therapy market" has been conducted based on the following segments: targeted antigen, indication, and end user.

Segmental Analysis:

In terms of targeted antigen, the CAR-T cell therapy market is divided into CD19 and BCMA segments. The CD19 segment accounted for a larger share of the CAR-T cell therapy market in 2022 and is expected to achieve a higher CAGR of 17.9% during the forecast period.

CAR-T cells have proven effective in treating relapsed/refractory diffuse large B cell lymphoma. Patient-derived T cells are genetically modified to create CD19 CAR T cells, which express receptors that bind to the CD19 protein, commonly found in leukemia and lymphoma cells.

The growth of this segment is expected to be driven by the availability of CD19 CAR-T cell therapy products. Below is a list of products approved by the US Food and Drug Administration and the European Union:

Manufacturer

Brand Product

Target Antigen

Disease Indication

Approval Year

Novartis

KYMRIAH

CD19

Leukemia

2017

Gilead Sciences, Inc

YESCARTA

CD19

Lymphoma

2017

Gilead Sciences, Inc

TECARTUS

CD19

Lymphoma and Leukemia

2020

Bristol Myers Squibb

BREYANZI

CD19

Lymphoma

2021

The CAR-T cell therapy market is categorized by indication into lymphomas, leukemia, and multiple myeloma. The lymphomas segment held the largest market share in 2022 and is projected to grow at a higher CAGR of 18.1% during the forecast period. Hematological malignancies, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, lymphoma, and multiple myeloma, are the primary indications for CAR-T cell therapy.

By end user, the CAR-T cell therapy market is divided into hospitals and specialty clinics, ambulatory surgical centers, and others. The hospitals and specialty clinics segment dominated the market in 2022 and is expected to register the highest CAGR of 17.9% during the forecast period.

Technological Innovations to Propel CAR-T Cell Therapy Market Growth

The development and implementation of CAR-T therapy, which utilizes a patient's white blood cells to target specific blood cancer types, is among the most significant medical breakthroughs in recent years. CAR-T cell therapy offers hope for some cancer patients as a potential cure. Since the first CAR-T therapy was approved in 2017, five additional therapies have received FDA approval for specific adult and pediatric leukemia, lymphoma, and multiple myeloma types. Research is also underway to develop similar therapies for solid tumors.

Allogeneic CAR-T cell therapy has been the focus of numerous global pre-clinical and clinical trials, primarily targeting hematological malignancies, with CD19 being the most common target, alongside traditional targets like CD20, CD22, and BCMA. New targets such as CD70, CD7, and CD5 are also being explored. Emerging therapies for solid tumors are targeting mesothelin, GD2, and NKG2DL.

Thus, advancements in cell-based therapies are likely to introduce new trends in the CAR-T cell therapy market in the coming years.

Regional Analysis:

The global CAR-T cell therapy market report encompasses North America, Europe, Asia Pacific, South and Central America, and the Rest of the World. In 2022, North America held the largest share of the CAR-T cell therapy market. The growth in this region is fueled by the increasing number of product launches by leading manufacturers and the presence of key market players. Additionally, extensive research and development by various pharmaceutical and biotechnology companies, as well as academic and research institutions, are expected to drive market growth in North America. For example, in June 2022, Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR-T cell therapy for adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL).

In the US, the growth of the CAR-T cell therapy market is primarily driven by the expanding pharmaceutical and biopharmaceutical sectors, characterized by technological advancements and increasing adaptability. Furthermore, rising R&D investments by US-based pharmaceutical and biotechnology companies aimed at improving clinical trial outcomes and ensuring patient safety are propelling market growth. For instance, in July 2021, BioNTech SE signed a purchase agreement with Kite, a Gilead Company, to acquire Kite's clinical manufacturing facility in Gaithersburg, MD, along with its solid tumor neoantigen T cell receptor (TCR) R&D platform. This new facility will enhance BioNTech's existing cell therapy manufacturing capabilities in Idar-Oberstein, Germany, and provide additional capacity to support clinical trials in the US, advancing the company's innovative cell therapy pipeline, which includes candidates for cancer based on NEOSTIM and CAR-T Cell Amplifying mRNA Vaccine (CARVac) and the recently acquired Individualized Neoantigen TCR program.

Future Opportunities and Research Developments:

While CAR-T cell therapies have demonstrated promising results in cancer treatment, their application is currently limited to patients with specific liquid tumors that are relapsed and resistant. In the coming years, several CAR-T cell therapies for regenerative medicine in the US and advanced therapy medicinal products in Europe are expected to gain market authorization. Numerous key players are developing innovative techniques for a wide array of indications. In the long term, these therapies may significantly enhance patient outcomes by providing substantial, potentially curative health benefits from a single dose.

The future of CAR-T cell therapy appears bright, given the number of ongoing clinical trials and the development of new CAR-T cell products for various indications. Researchers are motivated to explore ways to improve the efficacy of CAR-T cells, as evidenced by the complete response rates and progression-free survival seen in patients with relapsed/refractory malignancies who have undergone extensive prior treatments.

Investigations are underway into factors such as antigen loss that may lead to immune escape, with strategies being developed to address these challenges. One approach involves creating CAR-T cell therapies that target multiple antigens simultaneously. New therapies are being developed to target antigens like CD138 and GPRC5D, while CAR-T cell therapies for ALL and NHL focus on the CD19 antigen, and therapies for multiple myeloma target the BCMA antigen.

The CAR-T cell therapy market forecast can assist stakeholders in this sector in planning their growth strategies. Below are some research and development initiatives by leading players in the CAR-T cell therapy market:

In November 2023, Vittoria Biotherapeutics announced the completion of a private financing round, raising over US$15 million to fund clinical trials for VIPER-101, an autologous dual population CD5-knockout CAR-T cell therapy for T cell lymphoma.
In December 2023, AstraZeneca revealed its acquisition of Gracell Biotechnologies Inc. to enhance AstraZeneca's existing capabilities and previous investments in cell therapy.
In December 2021, researchers at the University of California San Diego School of Medicine received a US$4.1 million grant to support the advancement of their innovative CAR-T cell therapy, funded by the governing board of the California Institute for Regenerative Medicine, which may facilitate the transition of novel cancer treatments from the lab to patients.

CAR-T Cell Therapy Market Report Scope

Competitive Landscape and Key Companies:

Prominent companies profiled in the CAR-T cell therapy market report include Bristol-Myers Squibb Company, Novartis AG, Gilead Sciences, Inc., Johnson and Johnson Services, Inc., CARsgen Therapeutics Co., Ltd, Aurora Biopharma, Legend Biotech, Pfizer Inc., bluebird bio, Inc., Mustang Bio, Sorrento Therapeutics, Inc., and Fate Therapeutics. These companies are focused on developing new technologies, enhancing existing products, and expanding their geographic reach to meet the growing global demand.

1. Introduction

1.1 Scope of the Study
1.2 Market Definition, Assumptions and Limitations
1.3 Market Segmentation

2. Executive Summary

2.1 Key Insights
2.2 Market Attractiveness Analysis

3. Research Methodology

4. CAR-T Cell Therapy Market Landscape

4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
- 4.3.1 List of Vendors in the Value Chain

5. CAR-T Cell Therapy Market - Key Market Dynamics

5.1 Key Market Drivers
5.2 Key Market Restraints
5.3 Key Market Opportunities
5.4 Future Trends
5.5 Impact Analysis of Drivers and Restraints

6. CAR-T Cell Therapy Market - Global Market Analysis

6.1 CAR-T Cell Therapy - Global Market Overview
6.2 CAR-T Cell Therapy - Global Market and Forecast to 2031

7. CAR-T Cell Therapy Market and Revenue Analysis (USD Billion) and By Targeted Antigen, 2021-2031

7.1 Overview
7.2 CD19
7.3 BCMA

8. CAR-T Cell Therapy Market and Revenue Analysis (USD Billion) and By Indication, 2021-2031

8.1 Overview
8.2 Lymphomas
8.3 Leukemia
8.4 Multiple Myeloma

9. CAR-T Cell Therapy Market and Revenue Analysis (USD Billion) and By End User, 2021-2031

9.1 Overview
9.2 Hospitals and Specialty Clinics
9.3 Ambulatory Surgical Centers
9.4 Others

10. CAR-T Cell Therapy Market - Revenue Analysis (USD Billion), 2021-2031 and Geographical Analysis

10.1 North America
- 10.1.1 North America CAR-T Cell Therapy Market Overview
- 10.1.2 North America CAR-T Cell Therapy Market Revenue and Forecasts to 2031
- 10.1.3 North America CAR-T Cell Therapy Market Revenue and Forecasts and Analysis - By Targeted Antigen
- 10.1.4 North America CAR-T Cell Therapy Market Revenue and Forecasts and Analysis - By Indication
- 10.1.5 North America CAR-T Cell Therapy Market Revenue and Forecasts and Analysis - By End User
- 10.1.6 North America CAR-T Cell Therapy Market Revenue and Forecasts and Analysis - By Countries
  - 10.1.6.1 United States CAR-T Cell Therapy Market
    - 10.1.6.1.1 United States CAR-T Cell Therapy Market, by Targeted Antigen
    - 10.1.6.1.2 United States CAR-T Cell Therapy Market, by Indication
    - 10.1.6.1.3 United States CAR-T Cell Therapy Market, by End User
  - 10.1.6.2 Canada CAR-T Cell Therapy Market
    - 10.1.6.2.1 Canada CAR-T Cell Therapy Market, by Targeted Antigen
    - 10.1.6.2.2 Canada CAR-T Cell Therapy Market, by Indication
    - 10.1.6.2.3 Canada CAR-T Cell Therapy Market, by End User
  - 10.1.6.3 Mexico CAR-T Cell Therapy Market
    - 10.1.6.3.1 Mexico CAR-T Cell Therapy Market, by Targeted Antigen
    - 10.1.6.3.2 Mexico CAR-T Cell Therapy Market, by Indication
    - 10.1.6.3.3 Mexico CAR-T Cell Therapy Market, by End User
10.2 Europe
- 10.2.1 Germany
- 10.2.2 France
- 10.2.3 Italy
- 10.2.4 Spain
- 10.2.5 United Kingdom
- 10.2.6 Rest of Europe
10.3 Asia-Pacific
- 10.3.1 Australia
- 10.3.2 China
- 10.3.3 India
- 10.3.4 Japan
- 10.3.5 South Korea
- 10.3.6 Rest of Asia-Pacific
10.4 Rest of World

11. Industry Landscape

11.1 Mergers and Acquisitions
11.2 Agreements, Collaborations, Joint Ventures
11.3 New Product Launches
11.4 Expansions and Other Strategic Developments

12. Competitive Landscape

12.1 Heat Map Analysis by Key Players
12.2 Company Positioning and Concentration

13. CAR-T Cell Therapy Market - Key Company Profiles

13.1 Bristol-Myers Squibb Company
- 13.1.1 Key Facts
- 13.1.2 Business Description
- 13.1.3 Products and Services
- 13.1.4 Financial Overview
- 13.1.5 SWOT Analysis
- 13.1.6 Key Developments
13.2 Novartis AG
13.3 Gilead Sciences, Inc.
13.4 Gilead Sciences, Inc.
13.5 Johnson and Johnson Services, Inc
13.6 CARsgen Therapeutics Holdings Limited
13.7 Aurora Biopharma
13.8 Legend Biotech
13.9 Pfizer Inc
13.10 bluebird bio, Inc.
13.11 Mustang Bio
13.12 Sorrento Therapeutics, Inc.
13.13 Fate Therapeutics