TROP2抗體的全球市場:機會及臨床試驗趨勢(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個工作天內

價格

簡介目錄圖表

TROP2（滋養層細胞表面抗原 2）已成為對抗各種癌症的重要治療標靶。這種 I 型跨膜糖蛋白由 TACSTD2 基因編碼，在調節細胞信號通路中起關鍵作用，特別是透過調節 EpCAM 誘導的信號傳導。 TROP2 在許多上皮癌中過度表達，導致腫瘤增生和轉移增加。此外，它的過度表達與不良預後相關，尤其是在實體腫瘤中，使其成為標靶癌症治療的理想標靶。

傳統癌症治療方法通常具有局限性，例如嚴重的副作用或對某些患者群體無效，因此需要新的方法。近年來，標靶治療領域經歷了顯著增長，重點關注新型癌症抗原、受體和生物標記。 TROP2標靶治療就是這樣一種有前景的途徑，並且在幾種主要類型的癌症中表現出良好的安全性和治療效果。這些療法旨在將細胞毒藥直接輸送到腫瘤部位，可能減少與傳統治療相關的副作用。

截至 2025 年 2 月，三種 TROP2 的治療方法已獲準用於臨床，標誌著此方法商業化的重要里程碑。其中第一個藥物 Trodelvy（sacituzumab govitecan）於 2020 年獲得 FDA 加速核准，用於治療轉移性三陰性乳癌 (TNBC)。 Trodelvy 隨後於 2021 年獲得全面批准，並於 2023 年將其適應症擴大至 HR+/HER2 轉移性乳癌。另一項重要批准是在 2024 年末，當時 sacituzumab tilmotecan (SKB264) 在中國獲得批准用於治療 TNBC。此外，阿斯特捷利康和第一三共開發的 ADC Datroway (dato-dxd) 已在美國和日本獲批用於治療乳癌。這些批准凸顯了 TROP2 標靶療法在腫瘤學中日益增長的作用和市場潛力。

Trodelvy 的商業成功是 TROP2 標靶治療市場的關鍵驅動力。該藥物的成功刺激了對TROP2通路的進一步研究和投資，多家製藥和生物技術公司加強了對這一標靶的關注。 TROP2領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、上海潤斯生物科技等。許多公司在其臨床管線中都有針對 TROP2 的療法，其中許多候選藥物處於早期和中期開發階段。

目前有幾種針對 TROP2 的藥物正在進行臨床試驗，其中包括 OBI-992、JS108、ESG-401 和 SHR-A1921 等顯示出前景的在研藥物。這些候選藥物包括單株抗體、抗體-藥物偶聯物（ADC）、免疫療法和細胞療法，旨在擴大難治性癌症患者的治療選擇。隨著越來越多的治療方法被推向市場，TROP2 標靶治療市場預計將大幅成長。

就市場動態而言，預計該領域將繼續擴大。在 Trodelvy 臨床成功、投資增加和 TROP2 標靶療法不斷增長的推動下，市場有望大幅成長。 TROP2標靶治療的治療潛力巨大，可應用於多種癌症類型，包括三陰乳癌、尿路上皮癌和其他實體腫瘤。隨著越來越多的治療方法獲得批准並進入市場，TROP2標靶治療的商業化方面將繼續發展，為患者和製藥公司提供新的機會。

總之，TROP2 作為治療標靶具有徹底改變癌症治療的巨大潛力。目前已有三種藥物獲批，還有更多藥物正在研發中，針對 TROP2 的藥物很可能成為癌症標靶治療的基石。各大製藥公司的興趣日益濃厚，加上研究藥物數量的不斷增加，顯示這種療法在癌症市場上有著光明的前景。

本報告提供全球TROP2抗體市場相關調查，提供市場概要，以及藥物趨勢，臨床試驗趨勢，各地區趨勢，及加入此市場的主要企業競爭情形等資訊。

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

簡介目錄圖表

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