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再生醫學細胞療法

市場調查報告書

商品編碼

1874003

CAR-T細胞療法市場

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個工作天內

價格

簡介目錄

預計到 2031 年，CAR-T 細胞療法市場規模將達到 118 億美元，高於 2024 年的 38.5 億美元，2031 年至 2031 年的複合年成長率預計為 17.5%。

市場洞察與分析師觀點：

嵌合抗原受體（CAR）T細胞療法正逐漸成為最有效的癌症治療策略之一，每年都有大量臨床前和臨床試驗開展，以拓展其應用範圍。經過數十年的研究，CAR-T細胞療法的擴展勢在必行。未來的發展不僅將探索自體和異體產品，還將探索新型體內CAR-T細胞基因療法及其在血液系統惡性腫瘤以外疾病的療效。然而，商業化的挑戰正在阻礙CAR-T細胞療法市場的成長。

成長動力：

癌症發生率上升推動了對CAR-T細胞療法的需求

CAR-T細胞療法是一種新型癌症治療方法，它透過在實驗室中改造T細胞，然後將其重新註入人體，使其靶向攻擊癌細胞。目前，該療法已用於治療成人和兒童白血病以及某些類型的淋巴瘤，並且正在研究其治療其他癌症（包括胸部的一些實體瘤）的潛在用途。

遺傳易感性、加工食品的攝取、環境污染和生活方式的改變等因素都導致了癌症發生率的上升。美國癌症協會報告稱，2020年全球新增癌症病例約1,930萬例。因此，癌症患者數量的成長推動了對CAR-T細胞療法的需求。

戰略洞察

報告細分和範圍：

「CAR-T 細胞療法市場」的分析是基於以下幾個方面進行的：靶向抗原、適應症和最終用戶。

細分市場分析：

就標靶抗原而言，CAR-T細胞療法市場分為CD19和BCMA兩大細分市場。 2022年，CD19細分市場在CAR-T細胞療法市場中佔據較大佔有率，預計在預測期內將實現17.9%的更高複合年成長率。

CAR-T細胞療法已被證實對治療復發/難治性瀰漫性大B細胞淋巴瘤有效。患者來源的T細胞經過基因改造，產生CD19 CAR-T細胞，這些細胞表達能與CD19蛋白結合的受體，CD19蛋白常見於白血病和淋巴瘤細胞。

該領域的成長預計將主要得益於CD19 CAR-T細胞療法產品的上市。以下是美國食品藥物管理局和歐盟批准的產品清單：

製造商

品牌產品

標靶抗原

疾病指徵

核准年份

諾華

凱姆裡亞

CD19

白血病

2017

吉利德科學公司

YESCARTA

CD19

淋巴瘤

2017

吉利德科學公司

特卡圖斯

CD19

淋巴瘤和白血病

2020

百時美施貴寶

布雷揚齊

CD19

淋巴瘤

2021

CAR-T細胞療法市場依適應症分為淋巴瘤、白血病及多發性骨髓瘤三大類。 2022年，淋巴瘤細分市場佔據最大市場佔有率，預計在預測期內將以18.1%的複合年成長率高速成長。血液系統惡性腫瘤，包括急性淋巴性白血病、慢性淋巴性白血病、淋巴瘤和多發性骨髓瘤，是CAR-T細胞療法的主要適應症。

依最終用戶分類，CAR-T細胞療法市場可分為醫院和專科診所、門診手術中心及其他機構。 2022年，醫院和專科診所細分市場佔據主導地位，預計在預測期內將以17.9%的複合年成長率保持最高增速。

技術創新將推動 CAR-T 細胞療法市場成長

利用患者自身白血球靶向特定類型血液癌症的CAR-T療法的研發和應用，是近年來最重要的醫學突破之一。 CAR-T細胞療法為部分癌症患者帶來了治癒的希望。自2017年首個CAR-T療法獲批以來，又有五種療法獲得FDA核准，用於治療特定類型的成人和兒童白血病、淋巴瘤和多發性骨髓瘤。目前，針對實體瘤的類似療法的研究也正在進行中。

異體CAR-T細胞療法一直是全球許多臨床前和臨床試驗的重點，主要針對血液系統惡性腫瘤，其中CD19是最常見的標靶，此外還有CD20、CD22和BCMA等傳統標靶。 CD70、CD7和CD5等新標靶也在探索之中。針對實體瘤的新興療法則以間皮素、GD2和NKG2DL為標靶。

因此，細胞療法的進展可能會在未來幾年為 CAR-T 細胞療法市場帶來新的趨勢。

區域分析：

全球CAR-T細胞療法市場報告涵蓋北美、歐洲、亞太、南美和中美洲以及世界其他地區。 2022年，北美佔據CAR-T細胞療法市場最大佔有率。該地區的成長得益於領先製造商不斷推出新產品以及主要市場參與者的存在。此外，眾多製藥和生物技術公司以及學術和研究機構的大量研發投入預計也將推動北美市場成長。例如，2022年6月，百時美施貴寶宣布其CD19靶向CAR-T細胞療法Breyanzi（lisocabtagene maraleucel）獲得FDA批准，用於治療成人大B細胞淋巴瘤（LBCL），包括瀰漫性大B細胞淋巴瘤（DLBCL）。

在美國，CAR-T細胞療法市場的成長主要得益於製藥和生物製藥產業的蓬勃發展，其特點是技術進步和適應能力的不斷增強。此外，美國製藥和生物技術公司為改善臨床試驗結果和確保患者安全且不斷增加的研發投入也推動了市場成長。例如，2021年7月，BioNTech SE與吉利德旗下公司Kite簽署收購協議，收購Kite位於馬裡蘭州蓋瑟斯堡的臨床生產設施及其實體瘤新抗原T細胞受體（TCR）研發平台。該新設施將增強BioNTech位於德國伊達爾-奧伯施泰因的現有細胞療法生產能力，並提供額外的產能以支持美國的臨床試驗，從而推進公司創新細胞療法產品線的研發，該產品線包括基於NEOSTIM和CAR-T細胞擴增mRNA疫苗（CARVac）的癌症候選藥物，以及近期收購的個體化新抗原TCR項目。

未來機會與研究進展：

儘管CAR-T細胞療法在癌症治療中展現出令人鼓舞的成果，但目前其應用僅限於復發或抗藥性的特定血液腫瘤患者。未來幾年，美國用於再生醫學的多種CAR-T細胞療法以及歐洲的先進療法產品預計將獲得上市許可。眾多關鍵企業正在針對多種適應症開發創新技術。從長遠來看，這些療法有望透過單次給藥即可帶來顯著的、甚至可能治癒性的健康益處，從而顯著改善患者的治療效果。

鑑於目前正在進行的大量臨床試驗以及針對各種適應症的新型CAR-T細胞產品的研發，CAR-T細胞療法的前景一片光明。研究人員致力於探索提高CAR-T細胞療效的方法，這已從既往接受過廣泛治療的複發/難治性惡性腫瘤患者的完全緩解率和無進展生存期中得到證實。

目前正在研究抗原流失等可能導致免疫逃脫的因素，並制定應對這些挑戰的策略。其中一種方法是開發可同時標靶多種抗原的CAR-T細胞療法。針對CD138和GPRC5D等抗原的新療法正在研發中，而用於治療急性淋巴細胞白血病（ALL）和非霍奇金淋巴瘤（NHL）的CAR-T細胞療法則側重於CD19抗原，多發性骨髓瘤的療法則靶向BCMA抗原。

CAR-T細胞療法市場預測可以幫助該領域的利害關係人制定成長策略。以下是CAR-T細胞療法市場領導者的一些研發舉措：

2023 年 11 月，Vittoria Biotherapeutics 宣布完成一輪私人融資，籌集了超過 1,500 萬美元，用於資助 VIPER-101 的臨床試驗。 VIPER-101 是一種自體雙群體 CD5 敲除 CAR-T 細胞療法，用於治療 T 細胞淋巴瘤。
2023 年 12 月，阿斯特捷利康宣布收購 Gracell Biotechnologies Inc.，以增強阿斯特捷利康在細胞療法領域的現有能力和先前投資。
2021 年 12 月，加州大學聖地牙哥分校醫學院的研究人員獲得了 410 萬美元的撥款，用於支持其創新性 CAR-T 細胞療法的推進。該撥款由加州再生醫學研究所理事會資助，可能有助於將新型癌症療法從實驗室轉移到患者身上。

CAR-T細胞療法市場報告範圍

競爭格局及主要公司：

CAR-T細胞療法市場報告中重點介紹的公司包括：百時美施貴寶公司、諾華公司、吉利德科學公司、強生公司、CARsgen Therapeutics Co., Ltd、Aurora Biopharma、傳奇生物科技、輝瑞公司、bluebird bio, Inc.、Mustang Bio、Sorrento Therapeutics, Inceutics Therapeutics, Inceutics Therapeutics。這些公司致力於開發新技術、改進現有產品並擴大業務範圍，以滿足日益成長的全球需求。

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