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生物製剂分子标靶治疗学

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1664188

TROP2抗体的全球市场:机会及临床试验趋势(2030年)

Global TROP2 Antibody Market Opportunity & Clinical Trials Insight 2030

出版日期: 2025年02月01日 | 出版商:

KuicK Research | 英文 200 Pages | 商品交期: 最快1-2个工作天内

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简介目录图表

TROP2（滋养层细胞表面抗原 2）已成为对抗各种癌症的重要治疗标靶。这种 I 型跨膜糖蛋白由 TACSTD2 基因编码，在调节细胞信号通路中起关键作用，特别是透过调节 EpCAM 诱导的信号传导。 TROP2 在许多上皮癌中过度表达，导致肿瘤增生和转移增加。此外，它的过度表达与不良预后相关，尤其是在实体肿瘤中，使其成为标靶癌症治疗的理想标靶。

传统癌症治疗方法通常具有局限性，例如严重的副作用或对某些患者群体无效，因此需要新的方法。近年来，标靶治疗领域经历了显着增长，重点关注新型癌症抗原、受体和生物标记。 TROP2标靶治疗就是这样一种有前景的途径，并且在几种主要类型的癌症中表现出良好的安全性和治疗效果。这些疗法旨在将细胞毒药直接输送到肿瘤部位，可能减少与传统治疗相关的副作用。

截至 2025 年 2 月，三种 TROP2 的治疗方法已获准用于临床，标誌着此方法商业化的重要里程碑。其中第一个药物 Trodelvy（sacituzumab govitecan）于 2020 年获得 FDA 加速核准，用于治疗转移性三阴性乳癌 (TNBC)。 Trodelvy 随后于 2021 年获得全面批准，并于 2023 年将其适应症扩大至 HR+/HER2 转移性乳癌。另一项重要批准是在 2024 年末，当时 sacituzumab tilmotecan (SKB264) 在中国获得批准用于治疗 TNBC。此外，阿斯特捷利康和第一三共开发的 ADC Datroway (dato-dxd) 已在美国和日本获批用于治疗乳癌。这些批准凸显了 TROP2 标靶疗法在肿瘤学中日益增长的作用和市场潜力。

Trodelvy 的商业成功是 TROP2 标靶治疗市场的关键驱动力。该药物的成功刺激了对TROP2通路的进一步研究和投资，多家製药和生物技术公司加强了对这一标靶的关注。 TROP2领域的主要公司包括吉利德、阿斯特捷利康、第一三共、CruzPharma、Biothera、Escugen Biotechnology、上海润斯生物科技等。许多公司在其临床管线中都有针对 TROP2 的疗法，其中许多候选药物处于早期和中期开发阶段。

目前有几种针对 TROP2 的药物正在进行临床试验，其中包括 OBI-992、JS108、ESG-401 和 SHR-A1921 等显示出前景的在研药物。这些候选药物包括单株抗体、抗体-药物偶联物（ADC）、免疫疗法和细胞疗法，旨在扩大难治性癌症患者的治疗选择。随着越来越多的治疗方法被推向市场，TROP2 标靶治疗市场预计将大幅成长。

就市场动态而言，预计该领域将继续扩大。在 Trodelvy 临床成功、投资增加和 TROP2 标靶疗法不断增长的推动下，市场有望大幅成长。 TROP2标靶治疗的治疗潜力巨大，可应用于多种癌症类型，包括三阴乳癌、尿路上皮癌和其他实体肿瘤。随着越来越多的治疗方法获得批准并进入市场，TROP2标靶治疗的商业化方面将继续发展，为患者和製药公司提供新的机会。

总之，TROP2 作为治疗标靶具有彻底改变癌症治疗的巨大潜力。目前已有三种药物获批，还有更多药物正在研发中，针对 TROP2 的药物很可能成为癌症标靶治疗的基石。各大製药公司的兴趣日益浓厚，加上研究药物数量的不断增加，显示这种疗法在癌症市场上有着光明的前景。

本报告提供全球TROP2抗体市场相关调查，提供市场概要，以及药物趋势，临床试验趋势，各地区趋势，及加入此市场的主要企业竞争情形等资讯。

TROP2 Antibody Global & Regional Sales Insights
Global TROP2 Antibody Market Opportunity: > US$ 4 Billion
Global TROP2 Antibody Market Witnessed 23% Growth In 2024
TROP2 Therapeutic Market Trends By Region & Indications
Approved Drugs Dosage, Price & Sales Insight: Global & Regional
TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
Insight On More Than 40 Antibodies In Clinical Trials

TROP2 (Trophoblast cell surface antigen 2) has emerged as a significant therapeutic target in the fight against various cancers. This Type-I transmembrane glycoprotein is encoded by the TACSTD2 gene and plays a key role in regulating cell signaling pathways, particularly by modulating EpCAM-induced signaling. TROP2 is overexpressed in numerous epithelial cancers, leading to an increased tumor growth rate and metastasis. Moreover, its overexpression is associated with poor prognosis, particularly in solid tumors, making it an ideal target for targeted cancer therapies.

As traditional cancer therapies often come with limitations, such as severe side effects and ineffectiveness in certain patient populations, the need for new approaches is growing. The targeted therapy segment has seen significant growth in recent years, with a focus on novel cancer antigens, receptors, and biomarkers. TROP2-targeted therapies represent one such promising avenue, demonstrating high safety and therapeutic efficacy across several major cancer types. These therapies aim to deliver cytotoxic drugs directly to tumor sites, potentially reducing the adverse effects associated with traditional treatments.

As of February 2025, three TROP2-targeted therapies have been approved for clinical use, marking a major milestone in the commercialization of this approach. The first of these is Trodelvy (sacituzumab govitecan), which received accelerated FDA approval in 2020 for the treatment of metastatic triple-negative breast cancer (TNBC). Trodelvy was later granted full approval in 2021 and expanded its indication in 2023 to include HR+/HER2- metastatic breast cancer. Another significant approval came in late 2024, when Sacituzumab Tirumotecan (SKB264) was granted approval in China for TNBC. Additionally, Datroway (dato-dxd), an ADC developed by AstraZeneca and Daiichi Sankyo, was approved for breast cancer in the US and Japan. These approvals highlight the growing role of TROP2-targeted therapies in oncology and the expanding market potential.

The commercial success of Trodelvy has been a key driver of the TROP2-targeted therapy market. The drug's success has spurred additional research and investment into the TROP2 pathway, with several pharmaceutical companies and biotechnology firms intensifying their focus on this target. Major players in the TROP2 space include Gilead, AstraZeneca, Daiichi Sankyo, Klus Pharma, Biothera, Escugen Biotechnology, and Shanghai Junshi Biosciences. Many of these companies have incorporated TROP2-targeted therapies into their clinical pipelines, with numerous candidates in early and mid-stages of development.

Several TROP2-targeted therapies are currently in clinical trials, with investigational drugs such as OBI-992, JS108, ESG-401 and SHR-A1921 showing promise. These candidates, including monoclonal antibodies, antibody-drug conjugates (ADCs), immunotherapies and cell therapies, aim to expand the therapeutic options available to patients with difficult-to-treat cancers. As more of these therapies move through the pipeline, the TROP2-targeted therapy market is expected to experience substantial growth.

In terms of market dynamics, the segment is expected to continue its expansion. Driven by the clinical success of Trodelvy, increasing investments, and a growing pipeline of TROP2-targeted therapies, this market is poised for significant growth. The therapeutic potential of TROP2-targeted treatments is vast, with applications for various cancer types, including TNBC, urothelial carcinoma, and other solid tumors. As more therapies are approved and enter the market, the commercial side of TROP2-targeted therapies will see continued development, offering new opportunities for both patients and pharmaceutical companies.

In conclusion, TROP2 as a therapeutic target holds considerable promise in revolutionizing cancer treatment. With three drugs already approved and many more in the pipeline, TROP2-targeted therapies are positioned to become a cornerstone of targeted cancer therapies. The growing interest from major pharmaceutical companies, along with the increasing number of investigational drugs, signals a bright future for this therapeutic approach in the oncology market.

1. Introduction to TROP2 Targeting Therapy Market

1.1 Overview
1.2 TROP2 Targeting Therapeutics Mechanism
1.3 TROP2 Ideal Clinical Biomarker For Cancer

2. Global TROP2 Targeted Antibodies Clinical Trials Insight

2.1 By Company
2.2 By Country
2.3 By Patient Segment
2.4 By Phase
2.5 By Priority Status

3. Global TROP2 Antibody Market Outlook

3.1 Current Market Scenario
3.2 Future Market Opportunities

4. Unveiling TROP2 Therapeutic Frontiers Market Trend By Region

4.1 US
4.2 China
4.3 Australia
4.4 South Korea
4.5 Europe
4.6 Taiwan
4.7 Japan

5. Global TROP2 Targeting Antibodies Market By Cancer

5.1 Breast Cancer
5.2 Lung Cancer
5.3 Gastrointestinal Cancer
5.4 Urothelial Cancer
5.5 Ovarian Cancer

6. Trodelvy - First Approved TROP2 Targeting Therapy

6.1 Overview, Availability & Patent Insight
6.2 Dosage & Price Analysis
6.3 Sales Analysis (2020 - 2024)

7. Sacituzumab Tirumotecan

7.1 Overview, Availability & Patent Insight

8. Datroway

8.1 Overview, Availability & Patent Insight
8.2 Dosage & Price Analysis

9. TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

9.1 Research
9.2 Preclinical
9.3 Phase I
9.4 Phase I/II
9.5 Phase II
9.6 Phase III

10. Marketed TROP2 Antibody Clinical Insight

11. Combination Approaches for TROP2 Antibody

12. Competitive Landscape

12.1 Aptamer Sciences
12.2 Aston Science
12.3 AstraZeneca
12.4 Beijing Biocytogen
12.5 BiOneCure Therapeutics
12.6 Biosion
12.7 Bio-Thera Solutions
12.8 Daiichi Sankyo Company
12.9 Hangzhou DAC Biotech
12.10 Innovent Biologics
12.11 LegoChem Biosciences
12.12 Merck
12.13 OBI Pharma
12.14 Peak Bio
12.15 Shanghai Henlius Biotech
12.16 Suzhou GeneQuantum Healthcare

简介目录图表

List of Figures

Figure 1-1: History & Milestones In TROP2 Targeting Therapeutics Market
Figure 1-2: TROP2 Stimulated Effectors, Biomarker & Pathways
Figure 1-3: TROP2 Regulated Oncogenic Cell Signaling Pathways
Figure 1-4: General Mechanism of TROP2 Targeting ADC
Figure 1-5: Trodelvy - Mechanism Of Action
Figure 1-6: Frequency of TROP2 Expression by Cancer Type (%)
Figure 1-7: Role of TROP2 In Cancer
Figure 2-1: Global -TROP2 Antibodies Clinical Pipeline By Company, 2025 - 2030
Figure 2-2: Global - TROP2 Antibodies Clinical Pipeline By Country, 2025 - 2030
Figure 2-3: Global - TROP2 Antibodies Clinical Pipeline By Patient Segment, 2025 - 2030
Figure 2-4: Global - TROP2 Antibodies Clinical Pipeline By Phase, 2025 - 2030
Figure 2-5: Global - TROP2 Antibodies Clinical Pipeline By Priority Status, 2025 - 2030
Figure 3-1: Phase 3 - Key TROP2 Drugs & Companies
Figure 3-2: Global - TROP2 Targeting Therapy Market (US$ Million), 2020-2024
Figure 3-3: Global - TROP2 Antibody Market (US$ Million), Q1-Q4'2024
Figure 3-4: Global - TROP2 Antibody Market By Region (US$ Million), 2024
Figure 3-5: Global - TROP2 Antibody Market By Region (%), 2024
Figure 3-6: Future TROP2 Market
Figure 3-7: Global - TROP2 Antibodies Market (US$ Million), 2025 - 2030
Figure 4-1: China TROP2 - Key Players & Drugs
Figure 4-2: FDA018-ADC Phase III Study (NCT06519370) - Initiation & Completion Year
Figure 4-3: South Korea - Key TROP2 Companies
Figure 4-4: OBI Pharma TROP2 Therapy Pipeline
Figure 5-1: Breast Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 5-2: TROPION-Breast01 (NCT05104866) Phase 3 Study - Initiation & Completion Year
Figure 5-3: ESG401-101 (NCT04892342) Phase 1a/1b Study - Initiation & Completion Year
Figure 5-4: ESG401-301 (NCT06383767) Phase 3 Study - Initiation & Completion Year
Figure 5-5: ESG401-302 (NCT06732323) Phase 3 Study - Initiation & Completion Year
Figure 5-6: Lung Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 5-7: EVOKE-01 (NCT05609968) Phase 3 Study - Initiation & Completion Year
Figure 5-8: EVOKE-03 (NCT05609968) Phase 3 Study - Initiation & Completion Year
Figure 5-9: EVOKE-02 (NCT05186974) Phase 2 Study - Initiation & Completion Year
Figure 5-10: Gastrointestinal Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 5-11: KL264-01 Phase 1/2 Study - Initiation & Completion Year
Figure 5-12: MK-3475-06C (NCT06469944) Phase 1/2 Study - Initiation & Completion Year
Figure 5-13: MK-2870-015 (NCT06356311) Phase 3 Study - Initiation & Completion Year
Figure 5-14: OBI-992-001 (NCT06480240) Phase 1/2 Study - Initiation & Completion Year
Figure 5-15: MT-302 Phase I Study (NCT05969041) - Initiation & Completion Year
Figure 5-16: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 5-17: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 5-18: BNT-325 (NCT05438329) Phase 1/2 Study - Initiation & Completion Year
Figure 5-19: TROPION-PanTumor03 (NCT05489211) Phase 2 Study - Initiation & Completion Year
Figure 6-1: Trodelvy - Patent Expiration Year By Region
Figure 6-2: Trodelvy - Approval Year By Region
Figure 6-3: Trodelvy - FDA Orphan Designation Year By Indication
Figure 6-4: US - Price Of 180mg Vial Of Trodelvy Intravenous Powder (US$), February'2025
Figure 6-5: EU - Price Of 180mg & 200mg Vials Of Trodelvy Intravenous Powder (US$), February'2025
Figure 6-6: Global - Trodelvy Sales (US$ Million), 2020-2024
Figure 6-7: Global - Trodelvy Sales (US$ Million), Q1-Q4'2024
Figure 6-8: Regional -Trodelvy Sales by Region (US$ Million), 2024
Figure 6-9: Trodelvy Sales By Region (%),2024
Figure 6-10: US -Trodelvy Sales (US$ Million), 2021-2024
Figure 6-11: US -Trodelvy Sales (US$ Million), Q1-Q4'2024
Figure 6-12: Europe - Trodelvy Sales (US$ Million), 2021-2024
Figure 6-13: Europe - Trodelvy Sales (US$ Million), Q1-Q4'2024
Figure 6-14: ROW - Trodelvy Sales (US$ Million), 2021-2024
Figure 6-15: ROW - Trodelvy Sales (US$ Million), Q1-Q4'2024
Figure 11-1: TROP2 Antibodies Combinations

List of Tables

Table 4-1: US - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-2: China - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-3: Preclinical TROP2 Candidates Development In China
Table 4-4: Australia - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-5: South Korea - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-6: Europe - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-7: Taiwan - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 4-8: Japan - Ongoing Clinical Trials For TROP2 Targeting Therapies
Table 5-1: Breast Cancer - Approved TROP2 Targeted Therapies
Table 5-2: Breast Cancer - Some TROP2 Targeted Candidates In Development
Table 5-3: Lung Cancer - TROP2 ADCs Under Review
Table 5-4: Lung Cancer - Some TROP2 Targeted Candidates In Development
Table 5-5: Gastric Cancer - Some TROP2 Targeted Candidates In Development
Table 5-6: Urothelial Cancer -Key TROP2 Targeted Candidates In Development
Table 5-7: Urothelial Cancer - Key TROP2 Targeted Candidates In Development
Table 6-1: Trodelvy - Dose Modifications For Adverse Reactions
Table 8-1: Datroway - Premedication & Concomitant Medications
Table 8-2: Datroway - Recommended Dosage Reductions For Adverse Reactions
Table 8-3: Datroway - Recommended Dosage Modifications
Table 11-1: TROP2 Targeting Therapy Combination In Development

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TROP2抗体的全球市场:机会及临床试验趋势(2030年)

Global TROP2 Antibody Market Opportunity & Clinical Trials Insight 2030

目录

第1章 TROP2标靶治疗市场简介

第2章 TROP2标的抗体的临床试验相关世界的洞察

第3章全球TROP2抗体市场预测

第4章 TROP2治疗的最前线的市场趋势，各地区

第5章按全球TROP2标的抗体市场，癌症

第6章 Trodelvy－首个获准的 TROP2 标靶疗法

第7章 Sacituzumab Tirumotecan

第8章 datorowei

第9章 TROP2抗体的临床试验的洞察(企业，国家，适应症，各代)

第10章已上市TROP2抗体的临床性洞察

第11章 TROP2抗体的组合方法

第12章竞争情形