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市场调查报告书
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1814812

肿瘤组织浸润淋巴球疗法的全球市场:市场机会,专利技术平台和临床试验趋势(2030年)

Global Tumor Infiltrating Lymphocytes Therapy Market Opportunity, Proprietary Technologies Platforms & Clinical Trials Insight 2030

出版日期: | 出版商: KuicK Research | 英文 180 Pages | 商品交期: 最快1-2个工作天内

价格

全球肿瘤浸润淋巴细胞治疗市场机会、专有技术平台和临床试验洞察 2030 年报告结果和要点:

  • 全球与区域市场展望
  • 全球肿瘤浸润淋巴球治疗市场机会:超过 10 亿美元
  • 已核准的肿瘤浸润淋巴球治疗数量:1
  • 已获批准的肿瘤浸润淋巴细胞治疗:剂量、价格和销售洞察
  • 临床试验中的肿瘤浸润淋巴球治疗数量:超过 30 个
  • 全球肿瘤浸润淋巴球治疗临床试验:依公司、适应症及阶段
  • 公司特定技术洞察

肿瘤浸润淋巴球疗法的需求及本报告的意义

肿瘤浸润淋巴细胞 (TIL) 疗法已被证明是实体瘤最有前景的治疗方法之一,尤其适用于对检查点抑制剂等传统疗法不再有反应的患者。与其他传统免疫疗法不同,TIL 疗法利用患者自身的肿瘤浸润淋巴细胞(已接触过癌症抗原的免疫细胞)来发起特异性、个人化的免疫反应。此疗法尤其适用于黑色素瘤和其他已尝试过其他疗法且预后不佳的晚期癌症。 Amtagbi (lifileucel) 于 2024 年 2 月在美国获批,是迄今为止全球唯一获批的 TIL 疗法,加速了该领域的商业兴趣和科学发展。

本报告旨在为利害关係人概述不断发展的TIL疗法格局,涵盖临床开发、活跃的行业参与者、技术进步和市场预测。

本报告包​​含的临床试验见解

本报告探讨了正在进行且新兴的临床试验趋势,并确定了最有潜力成为下一代癌症治疗方案的候选药物。本部分的数据包括具体的临床试验阶段、申办者、地理分布、技术提供者、合作者和被授权者。例如,在中国,在上海交通大学的支持下,Bennu Biotherapeutics正在进行BEN-101治疗实体肿瘤的I期临床试验。在美国,许多学术机构和生物技术公司正在进行早期临床试验,以将TIL疗法扩展到子宫颈癌、肺癌和头颈癌等适应症。数据显示,全球对TIL研究的兴趣日益浓厚,其中美国、中国、澳洲和欧洲在临床试验方面处于领先地位。

从事肿瘤浸润淋巴球疗法研发的主要公司

除了凭藉lifileucel产品製定全球标准的Iovance Biotherapeutics之外,Juncell Therapeutics(中国)、Biosyngen(新加坡)、SunAct Cancer Institute(印度)和Instil Bio(美国)也积极参与TIL研发。这些公司不仅致力于拓宽TIL疗法的治疗应用,还致力于克服若干关键课题,包括可扩展性、可负担性和患者可近性。新加坡国家癌症中心和美国罗马琳达大学癌症中心等学术研究型医院也透过资助的试点计画和机构合作发挥积极作用。

技术平台、合作与协议

报告强调了统一技术平台的趋势,该平台简化了TIL疗法的生命週期。例如,Creative Biolabs提供了一个用于肿瘤新抗原分析和TIL扩增的端到端平台。此外,Xcell Biosciences Australia与皇家珀斯医院合作,利用AVATAR™铸造系统建立了自动化生产流程。

许多授权协议和跨境合作,例如马来西亚Abgentil Biomedical和印度SunAct Cancer Institute在在地化生产和取得方面的合作,也在加速创新。

报告揭示了肿瘤组织浸润淋巴细胞治疗 (TIL) 市场的未来发展方向

报告预测,在临床试验结果、企业活动和基础设施投资的推动下,TIL 治疗市场将爆炸性成长。随着 Amtagbi 成为首个获得验证的产品,该市场目前正从学术和实验环境转向更广泛的临床应用和商业化。未来的关键趋势包括更快的生产速度、非黑色素瘤适应症领域的发展、区域生产中心以及针对中等收入国家的定价模式。

未来几年,我们预计将看到市场从单一产品市场转变为一个多方参与、竞争激烈的生态系统,在全球范围内提供各种 TIL 解决方案。

目录

第1章 肿瘤浸润淋巴球(TIL):简单的简介

第2章 肿瘤组织浸润淋巴球疗法的出现

  • TIL 作为预后生物标记
  • TIL 联合疗法

第3章 Amtagvi - 首个核准的 TIL 疗法

  • 摘要和专利信息
  • 剂量与价格分析
  • 销售分析

第4章 全球肿瘤组织浸润淋巴球疗法市场概要

  • 目前市场情境
  • 未来的机会

第5章 肿瘤组织浸润淋巴球疗法的各地区开发趋势

  • 美国
  • 加拿大
  • 中国
  • 英国
  • 欧洲联盟

第6章 肿瘤浸润淋巴球癌症治疗方法

  • 黑色素瘤
  • 肺癌症
  • 乳癌
  • 消化器官癌症(大肠癌症,胃癌,胰臟癌症,肝细胞癌症)
  • 妇产科癌症(卵巢癌症,子宫体癌症,子宫内膜癌症,子宫颈癌症)
  • 泌尿系统癌症(膀胱/尿路表皮癌症,肾细胞癌症,前列腺癌症)
  • 头颈椎癌症
  • 脑瘤

第7章 全球肿瘤组织浸润淋巴球疗法市场动态

  • 推动市场要素和机会
  • 市场课题与阻碍因素

第8章 肿瘤组织浸润淋巴球疗法实验概要

  • 突破&贸易快速审批现状
  • 各国
  • 各企业
  • 各适应症
  • 各期
  • 按孤儿的状态

第9章 肿瘤组织浸润淋巴球疗法的临床试验(各企业,各适应症,各期)

  • 研究
  • 前临床
  • 第0相
  • 第一阶段
  • 第一/二阶段
  • 第二阶段
  • 第三阶段

第10章 已上市的肿瘤组织浸润淋巴球疗法的临床实验平台(各企业,各适应症,各期)

第11章 肿瘤组织浸润淋巴球疗法独家技术的洞察,各企业

第12章 竞争情形

  • Adaptimmune
  • AgonOx
  • GRIT Biotechnology
  • ImmuneCyte
  • Intima Bioscience
  • Iovance Biotherapeutics
  • Juncell Therapeutics
  • Leman Biotech
  • Obsidian Therapeutics
  • RootPath

Global Tumor Infiltrating Lymphocytes Therapy Market Opportunity, Proprietary Technologies Platforms & Clinical Trials Insight 2030 Report Finding & Highlights:

  • Global & Regional Market Outlook
  • Global Tumor Infiltrating Lymphocytes Therapy Market Opportunity: > US$ 1 Billion
  • Number Of Approved Tumor Infiltrating Lymphocytes Therapy: 1 Therapy
  • Approved Tumor Infiltrating Lymphocytes Therapy Dosage, Pricing & Sales Insight
  • Number Of Tumor Infiltrating Lymphocytes Therapies in Clinical Trials: > 30 Therapies
  • Global Tumor Infiltrating Lymphocyte Therapies Clinical Trials By Company, Indication & Phase
  • Proprietary Technologies Insight By Companies

Tumor Infiltrating Lymphocytes Therapy Need & Why This Report?

Tumor Infiltrating Lymphocytes Therapy (TIL) therapy has proven to be one of the most promising treatments for solid tumors, particularly in patients who are no longer responsive to conventional treatments like checkpoint inhibitors. In contrast to other conventional immunotherapies, TIL therapy leverages a patient's own tumor infiltrating lymphocytes, already cancer antigen experienced immune cells, to execute a specific, individualized immune response. This treatment is especially relevant for melanoma and other late-stage cancers when alternatives are exhausted and prognoses unfavorable. Recent US approval in February 2024 of Amtagvi (lifileucel), i.e., the only globally approved TIL therapy to date, has moved commercial interest and scientific impetus in the field ahead at an accelerated pace.

This report is intended to give stakeholders a holistic overview of the changing TIL therapy landscape, touching on clinical development, active industry players, technological advancements, and market projections.

Clinical Trials Insight Included In Report

This report investigates the current trend of ongoing and emerging clinical trials and identifies the most promising pipeline candidates that have the potential to be next-generation oncology treatments. Data in this section includes specifically trial stages, sponsors, geographical distribution, technology providers, collaborators and license holders. For example, in China, Bennu Biotherapeutics is running a Phase I trial of BEN-101 in solid tumors under the auspices of the Shanghai Jiao Tong University. In the US, a number of academic institutions and biotechnology companies are conducting early-stage trials extending TIL therapy to indications such as cervical, lung, and head and neck cancers. The data indicate an increasing global interest in TIL research, with the US, China, Australia, and regions of Europe leading trial activity.

Leading Companies Engaged In R&D Of Tumor Infiltrating Lymphocytes Therapy

Apart from Iovance Biotherapeutics, the global standard setter with its lifileucel product, other players such as Juncell Therapeutics (China), Biosyngen (Singapore), SunAct Cancer Institute (India), and Instil Bio (US) are also seriously involved in TIL R&D. These companies are not merely trying to broaden the therapeutic applications of TIL therapy but also to overcome the several key challenges in scalability, affordability, and access to patients. Academic research hospitals like the National Cancer Centre Singapore and Loma Linda University Cancer Center in the US are also playing active roles through funded pilot programs and institutional partnerships.

Technology Platforms, Collaborations & Agreements

The report indicates a trend towards unified technology platforms that simplify the TIL therapy life cycle. Creative Biolabs, for example, provides an end-to-end platform for the profiling of tumor neoantigens and expansion of TILs. Additionally, Xcell Biosciences Australia has partnered with Royal Perth Hospital to establish an automated production process through the AVATAR(TM) Foundry system.

Numerous licensing deals and cross-border collaborations are also accelerating innovation, such as the partnership between Malaysia's Abgentil Biomedical and India's SunAct Cancer Institute to localize manufacturing and access.

Report Indicating Future Direction Of Tumor Infiltrating Lymphocytes Therapy Segment

From trial results, company activity, and investment in infrastructure, the report determines that the TIL therapy market is poised for explosive growth. As Amtagvi became the first proven product, the market now is transitioning from academic and experimental to more extensive clinical use and commercialization. Important future trends are shorter manufacturing times, growth into non-melanoma indications, regional manufacturing centers, and middle-income country pricing models.

The coming years are expected probably witness a shift from an individual-product market to a multi-player, competitive ecosystem providing various TIL solutions globally.

Table of Contents

1. Tumor Infiltrating Lymphocytes (TIL): A Brief Introduction

  • 1.1 Overview
  • 1.2 TIL History & Concept

2. Emergence Of Tumor Infiltrating Lymphocytes Therapy

  • 2.1 Tumor Infiltrating Lymphocytes As Prognostic Biomarkers
  • 2.2 Tumor Infiltrating Lymphocytes Therapy Combinational Approach

3. Amtagvi - First Approved Tumor Infiltrating Lymphocyte Therapy

  • 3.1 Overview & Patent Insight
  • 3.2 Dosage & Price Analysis
  • 3.3 Sales Analysis

4. Global Tumor Infiltrating Lymphocytes Therapy Market Overview

  • 4.1 Current Market Scenario
  • 4.2 Future Opportunities

5. Tumor Infiltrating Lymphocytes Therapy Development Trends By Region

  • 5.1 US
  • 5.2 Canada
  • 5.3 China
  • 5.4 UK
  • 5.5 EU

6. Tumor Infiltrating Lymphocytes Therapy Approaches By Cancer

  • 6.1 Melanoma
  • 6.2 Lung Cancer
  • 6.3 Breast Cancer
  • 6.4 Gastrointestinal Cancers (Colorectal Cancer, Gastric Cancer, Pancreatic

Cancer, Hepatocellular Carcinoma)

  • 6.5 Gynecological Cancers (Ovarian Cancer, Uterine/ Endometrial Cancer, Cervical

Cancer)

  • 6.6 Genitourinary Cancers (Bladder/Urothelial Carcinoma, Renal Cell, Prostate

Cancer)

  • 6.7 Head & Neck Cancers
  • 6.8 Brain Cancers

7. Global Tumor Infiltrating Lymphocytes Therapy Market Dynamics

  • 7.1 Market Drivers & Opportunities
  • 7.2 Market Challenges & Restraints

8. Global Tumor Infiltrating Lymphocytes Therapy Trials Overview

  • 8.1 By Breakthrough & Fast Track Status
  • 8.2 By Country
  • 8.3 By Company
  • 8.4 By Indication
  • 8.5 By Phase
  • 8.6 By Orphan Status

9. Global Tumor Infiltrating Lymphocyte Therapies Clinical Trials By Company, Indication & Phase

  • 9.1 Research
  • 9.2 Preclinical
  • 9.3 Phase-0
  • 9.4 Phase-I
  • 9.5 Phase-I/II
  • 9.6 Phase-II
  • 9.7 Phase-III

10. Marketed Tumor Infiltrating Lymphocyte Therapies Clinical Pipeline By Company, Indication & Phase

11. Tumor Infiltrating Lymphocytes Therapy Proprietary Technologies Insight By Companies

12. Competitive Landscape

  • 12.1 Adaptimmune
  • 12.2 AgonOx
  • 12.3 GRIT Biotechnology
  • 12.4 ImmuneCyte
  • 12.5 Intima Bioscience
  • 12.6 Iovance Biotherapeutics
  • 12.7 Juncell Therapeutics
  • 12.8 Leman Biotech
  • 12.9 Obsidian Therapeutics
  • 12.10 RootPath

List of Figures

  • Figure 1-1: Procedure Of Tumor Infiltrating Lymphocytes Therapy
  • Figure 1-2: Phenotypic Composition of TILs
  • Figure 1-3: Components Of Rapid Expansion Protocol
  • Figure 1-4: Historical Evolution Of TIL Therapy
  • Figure 2-1: Advantages Of TIL Therapy
  • Figure 2-2: TILs As Biomarkers
  • Figure 2-3: Combination Strategies To Boost TIL Therapy
  • Figure 3-1: Amtagvi - Approval Year by Region
  • Figure 3-2: Amtagvi - US Patent/Application Information
  • Figure 3-3: Amtagvi - Global Annual Sales (US$ Million), 2024-2025
  • Figure 3-4: Amtagvi - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
  • Figure 3-5: Amtagvi - Global Quarterly Sales (US$ Million), Q2-Q4'2024
  • Figure 4-1: Global - Tumor Infiltrating Lymphocytes Therapy Market (US$ Million), 2024 & 2025
  • Figure 4-2: Global Tumor Infiltrating Lymphocyte Therapy Market - Future Opportunities
  • Figure 4-3: Global - Tumor Infiltrating Lymphocytes Therapy Market (US$ Million), 2029 - 2030
  • Figure 6-1: NCI-2022-06873 Phase I (NCT05470283) Study - Initiation & Estimated Completion Year
  • Figure 6-2: NCI-2022-06873 Phase I (NCT05470283) Study - Initiation & Estimated Completion Year
  • Figure 6-3: MM2319 Phase I (NCT06204991) Study - Initiation & Estimated Completion Year
  • Figure 6-4: TILVANCE-301 Phase III (NCT05727904) Study - Initiation & Estimated Completion Year
  • Figure 6-5: BaseTIL-03M Phase I (NCT05869539) Study - Initiation & Estimated Completion Year
  • Figure 6-6: NCI-2012-01368 Phase II (NCT00338377) Study - Initiation & Estimated Completion Year
  • Figure 6-7: MCC-21971 Phase I (NCT05681780) Study - Initiation & Estimated Completion Year
  • Figure 6-8: 14-C-0104 Phase II (NCT02133196) Study - Initiation & Estimated Completion Year
  • Figure 6-9: IOV-COM-202 Phase II (NCT03645928) Study - Initiation & Estimated Completion Year
  • Figure 6-10: IOV-LUN-202 Phase II (NCT04614103) Study - Initiation & Estimated Completion Year
  • Figure 6-11: IOV-GM1-201 Phase I/II (NCT05361174) Study - Initiation & Estimated Completion Year
  • Figure 6-12: CCI-2005 Phase I (NCT05676749) Study - Initiation & Estimated Completion Year
  • Figure 6-13: MCC-21971 Phase I (NCT05681780) Study - Initiation & Estimated Completion Year
  • Figure 6-14: CheckCell-2 Phase I/II (NCT05566223) Study - Initiation & Estimated Completion Year
  • Figure 6-15: TIL-2021001 Phase I (NCT05366478) Study - Initiation & Estimated Completion Year
  • Figure 6-16: ITIL-306-201 Phase I (NCT05397093) Study - Initiation & Estimated Completion Year
  • Figure 6-17: 14-C-0104 Phase II (NCT02133196) Study - Initiation & Estimated Completion Year
  • Figure 6-18: TILS001 Phase I/II (NCT05451784) Study - Initiation & Estimated Completion Year
  • Figure 6-19: GC101-21K177 Phase I (NCT05142475) Study - Initiation & Estimated Completion Year
  • Figure 6-20: Phase I (NCT05505812) Study - Initiation & Estimated Completion Year
  • Figure 6-21: ZZTIL-012 Phase I (NCT04842812) Study - Initiation & Estimated Completion Year
  • Figure 6-22: 10-C-0166 Phase II (NCT01174121) Study - Initiation & Estimated Completion Year
  • Figure 6-23: 2019LS002 Phase I (NCT04426669) Study - Initiation & Estimated Completion Year
  • Figure 6-24: NCI-2024-07763 Phase I/II (NCT06598371) Study - Initiation & Estimated Completion Year
  • Figure 6-25: Phase I (NCT04766320) Study - Initiation & Estimated Completion Year
  • Figure 6-26: GC203-1.0 Phase II (NCT05468307) Study - Initiation & Estimated Completion Year
  • Figure 6-27: GC201-1.0 Phase I (NCT05098171) Study - Initiation & Estimated Completion Year
  • Figure 6-28: 10-C-0166 Phase II (NCT01174121) Study - Initiation & Estimated Completion Year
  • Figure 6-29: NCI-2018-00918 Phase II (NCT03449108) Study - Initiation & Estimated Completion Year
  • Figure 6-30: XHKT-SCT006-2022 Phase II (NCT05342506) Study - Initiation & Estimated Completion Year
  • Figure 6-31: TIL-2021001 Phase I (NCT05366478) Study - Initiation & Estimated Completion Year
  • Figure 6-32: C-145-04 Phase II (NCT03108495) Study - Initiation & Estimated Completion Year
  • Figure 6-33: NCI-2024-08121 Phase II (NCT06626256) Study - Initiation & Estimated Completion Year
  • Figure 6-34: MCC-21894 Phase I (NCT05768347) Study - Initiation & Estimated Completion Year
  • Figure 6-35: ITIL-306-201 Phase I (NCT05397093) Study - Initiation & Estimated Completion Year
  • Figure 6-36: IOV-COM-202 Phase II (NCT03645928) Study - Initiation & Estimated Completion Year
  • Figure 6-37: NCI-2018-00918 Phase II (NCT03449108) Study - Initiation & Estimated Completion Year
  • Figure 6-38: GC101-JD-LK Phase I (NCT04943913) Study - Initiation & Estimated Completion Year
  • Figure 6-39: BAH2472 Phase I/II (NCT06626256) Study - Initiation & Estimated Completion Year
  • Figure 7-1: Global Tumor Infiltrating Lymphocyte Therapy Market - Drivers & Opportunities
  • Figure 7-2: Global Tumor Infiltrating Lymphocyte Therapy Market - Challenges & Strategic Solutions
  • Figure 8-1: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Priority Status, 2025 Till 2030
  • Figure 8-2: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Country, 2025 Till 2030
  • Figure 8-3: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Company, 2025 Till 2030
  • Figure 8-4: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Indication, 2025 Till 2030
  • Figure 8-5: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Phase, 2025 Till 2030
  • Figure 8-6: Global - Tumor Infiltrating Lymphocytes Therapy In Clinical Trials By Orphan Status, 2025 Till 2030
  • Figure 11-1: Iovance Biotherapeutics - TIL Therapy Platform
  • Figure 11-2: Iovance Biotherapeutics - Streamlined 22-day GMP Manufacturing Process
  • Figure 11-3: Obsidian Therapeutics - cytoDRiVE Platform
  • Figure 11-4: Novoleucel Steps Involved

List of Tables

  • Table 1-1: TIL Therapy vs Conventional Therapies
  • Table 1-2: TIL Presence In Different Cancers
  • Table 1-3: Improvements Over Time In TIL Manufacturing
  • Table 1-4: TIL Manufacturing Process - Traditional & Modern TIL Production Protocols
  • Table 2-1: TIL Therapy vs CAR-T Therapy
  • Table 2-2: Key Prognostic TIL Subtypes & Their Functions
  • Table 2-3: Tumor Microenvironment Transformation By Combination Therapy
  • Table 2-4: Combinational Approaches In TILs For Different Cancer Indications
  • Table 3-1: Global Regulatory Status Of Amtagvi