首頁 > 市場調查報告書 > 製藥

癌症

市場調查報告書

商品編碼

1814812

腫瘤組織浸潤淋巴球療法的全球市場:市場機會，專利技術平台和臨床試驗趨勢(2030年)

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

出版日期: 2025年09月01日 | 出版商:

KuicK Research | 英文 180 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄圖表

全球腫瘤浸潤淋巴細胞治療市場機會、專有技術平台和臨床試驗洞察 2030 年報告結果和要點：

全球與區域市場展望
全球腫瘤浸潤淋巴球治療市場機會：超過 10 億美元
已核准的腫瘤浸潤淋巴球治療數量：1
已獲批准的腫瘤浸潤淋巴細胞治療：劑量、價格和銷售洞察
臨床試驗中的腫瘤浸潤淋巴球治療數量：超過 30 個
全球腫瘤浸潤淋巴球治療臨床試驗：依公司、適應症及階段
公司特定技術洞察

腫瘤浸潤淋巴球療法的需求及本報告的意義

腫瘤浸潤淋巴細胞 (TIL) 療法已被證明是實體瘤最有前景的治療方法之一，尤其適用於對檢查點抑制劑等傳統療法不再有反應的患者。與其他傳統免疫療法不同，TIL 療法利用患者自身的腫瘤浸潤淋巴細胞（已接觸過癌症抗原的免疫細胞）來發起特異性、個人化的免疫反應。此療法尤其適用於黑色素瘤和其他已嘗試過其他療法且預後不佳的晚期癌症。 Amtagbi (lifileucel) 於 2024 年 2 月在美國獲批，是迄今為止全球唯一獲批的 TIL 療法，加速了該領域的商業興趣和科學發展。

本報告旨在為利害關係人概述不斷發展的TIL療法格局，涵蓋臨床開發、活躍的行業參與者、技術進步和市場預測。

本報告包含的臨床試驗見解

本報告探討了正在進行且新興的臨床試驗趨勢，並確定了最有潛力成為下一代癌症治療方案的候選藥物。本部分的數據包括具體的臨床試驗階段、申辦者、地理分佈、技術提供者、合作者和被授權者。例如，在中國，在上海交通大學的支持下，Bennu Biotherapeutics正在進行BEN-101治療實體腫瘤的I期臨床試驗。在美國，許多學術機構和生物技術公司正在進行早期臨床試驗，以將TIL療法擴展到子宮頸癌、肺癌和頭頸癌等適應症。數據顯示，全球對TIL研究的興趣日益濃厚，其中美國、中國、澳洲和歐洲在臨床試驗方面處於領先地位。

從事腫瘤浸潤淋巴球療法研發的主要公司

除了憑藉lifileucel產品製定全球標準的Iovance Biotherapeutics之外，Juncell Therapeutics（中國）、Biosyngen（新加坡）、SunAct Cancer Institute（印度）和Instil Bio（美國）也積極參與TIL研發。這些公司不僅致力於拓寬TIL療法的治療應用，還致力於克服若干關鍵課題，包括可擴展性、可負擔性和患者可近性。新加坡國家癌症中心和美國羅馬琳達大學癌症中心等學術研究型醫院也透過資助的試點計畫和機構合作發揮積極作用。

技術平台、合作與協議

報告強調了統一技術平台的趨勢，該平台簡化了TIL療法的生命週期。例如，Creative Biolabs提供了一個用於腫瘤新抗原分析和TIL擴增的端到端平台。此外，Xcell Biosciences Australia與皇家珀斯醫院合作，利用AVATAR™鑄造系統建立了自動化生產流程。

許多授權協議和跨境合作，例如馬來西亞Abgentil Biomedical和印度SunAct Cancer Institute在在地化生產和取得方面的合作，也在加速創新。

報告揭示了腫瘤組織浸潤淋巴細胞治療 (TIL) 市場的未來發展方向

報告預測，在臨床試驗結果、企業活動和基礎設施投資的推動下，TIL 治療市場將爆炸性成長。隨著 Amtagbi 成為首個獲得驗證的產品，該市場目前正從學術和實驗環境轉向更廣泛的臨床應用和商業化。未來的關鍵趨勢包括更快的生產速度、非黑色素瘤適應症領域的發展、區域生產中心以及針對中等收入國家的定價模式。

未來幾年，我們預計將看到市場從單一產品市場轉變為一個多方參與、競爭激烈的生態系統，在全球範圍內提供各種 TIL 解決方案。

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.

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

簡介目錄圖表

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

02-2729-4219

+886-2-2729-4219