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生物製劑分子標靶治療學

市場調查報告書

商品編碼

1531956

TROP2抗體的全球市場:臨床試驗相關洞察(2029年)

Global TROP2 Antibody Market & Clinical Trials Insight 2029

出版日期: 2024年08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

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簡介目錄圖表

TROP2（滋養層細胞表面抗原2）最近作為癌症治療的標靶引起了人們的關注，因為它在乳腺癌、肺癌和尿路上皮癌等各種上皮癌中過度表達。這種膜蛋白對於細胞增殖和生存至關重要，使其成為創新療法的有吸引力的目標，特別是抗體藥物偶聯物（ADC），它構成了開發管道的主要部分。針對 TROP2- 的治療正在迅速發展，人們對使用這種生物標記進行更有效的癌症治療越來越感興趣。

目前，Trodelvy（sacituzumab govitecan）是唯一核准的針對 TROP2 的藥物。它由Immunomedics（現為吉利德科學公司的一部分）開發，於2020年4月獲得FDA批准用於治療三陰性乳癌，並於2021年4月擴大到包括尿路上皮癌。截至 2024 年 8 月，Trodelvy 在約 50 個國家獲得批准。 Trodelvy 的商業成功體現在其強勁的銷售成長。 2024年上半年銷售額較2023年同期激增超過30%，主要是由於二線轉移性三陰性乳癌和先前治療的HR+/HER2轉移性乳癌需求增加推動，銷售額超過6億美元。

Datapotamab deruxtecan 是由第一三共和阿斯特捷利康開發的另一種有前景的針對 TROP2 的研究藥物，在多種實體瘤的試驗中顯示出積極的結果。 2024年上半年，FDA和EMA都接受了針對非鱗狀非小細胞肺癌和HR陽性、HER2陰性乳癌的生物製品許可申請（BLA）和行銷授權申請（MAA）。這項進展凸顯了人們對 TROP2 作為治療標靶日益增長的興趣，並表明更多的治療方法可能很快就會獲得批准。

針對 TROP2 的療法主要以抗體藥物偶聯物 (ADC) 為特徵。 ADC 有效地將單株抗體的特異性與有效的細胞毒性藥物結合。這種策略有利於將化療直接且精確地遞送至癌細胞，從而減少全身副作用。 ADC 在 TROP2 標靶治療方面處於領先地位，但其他創新方法也在研究中。這包括基於 RNA 的細胞療法，重點是改變 TROP2 表達並利用免疫系統攻擊表達 TROP2 的癌細胞。

圍繞 TROP2 療法的競爭環境正在迅速發展，目前正在進行大量臨床試驗。默克、豪森生物醫療、BiOneCure Therapeutics、Bio-Thera Solutions、Biohaven Therapeutics 和上海復旦張江生物製藥等著名製藥和生物技術公司都在這一領域進行了大量投資。這種日益激烈的競爭可以促進創新並加速為患者推出新療法。

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。

Abion Bio
Amunix
Aptamer Sciences
Arbele
Aston Science
AstraZeneca
Beijing Biocytogen
BiOneCure Therapeutics
Biosion
Bio-Thera Solutions
Daiichi Sankyo Company
Hangzhou DAC Biotech
Innovent Biologics
Janux Therapeutics
LegoChem Biosciences
Merck
Molecular Templates
OBI Pharma
Peak Bio
Radiopharm Theranostics
Shanghai Henlius Biotech
Suzhou GeneQuantum Healthcare

簡介目錄圖表

Global TROP2 Antibody Market & Clinical Trials Insight 2029 Report Offering:

Global TROP2 Antibody Market Opportunity: > USD 3 Billion
Global & Regional Market Insight
Approved Drug Annual & Quarterly Sales By Region
Approved Drug Dosage & Pricing Insight
TROP2 Antibodies In Clinical Trials: > 45 Drugs
TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
Combination Approaches for TROP2 Antibody

TROP2 (trophoblast cell surface antigen 2) has recently gained prominence as target for cancer therapies due to its overexpression in a range of epithelial cancers, such as breast, lung, and urothelial cancers. This membrane protein, crucial for cell growth and survival, presents an appealing target for innovative treatments, especially antibody-drug conjugates (ADCs), which dominate the development pipeline. The landscape for TROP2- targeted therapies has experienced rapid evolution, marked by significant advancements and growing interest in harnessing this biomarker for more effective cancer treatment.

Currently, only one drug targeting TROP2 has been approved, namely Trodelvy (sacituzumab govitecan). Developed by Immunomedics (now part of Gilead Sciences), it received FDA approval in April 2020 for triple negative breast cancer and had its indication expanded to urothelial cancer in April 2021. As of August 2024, Trodelvy is approved in around 50 countries. Trodelvy's commercial success is evident from its significant sales growth. In the first half of 2024, sales jumped over 30% to surpass USD 600 million compared to the same period in 2023, driven mainly by increased demand for treatments in second-line metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.

Datopotamab deruxtecan, another promising investigational TROP2-targeting drug developed by Daiichi Sankyo and AstraZeneca, has shown positive results in trials for various solid cancers. In the first half of 2024, both the FDA and EMA accepted applications for its Biologics License Application (BLA) and Marketing Authorization Application (MAA) for treating non-squamous non-small cell lung cancer and HR-positive, HER2-negative breast cancer. This progress highlights the growing interest in TROP2 as a therapeutic target and suggests the potential for more approved treatments soon.

The landscape of TROP2-targeted therapies is primarily characterized by antibody-drug conjugates (ADCs), which effectively merge the specificity of monoclonal antibodies with potent cytotoxic agents. This strategy facilitates the precise delivery of chemotherapy directly to cancer cells, thereby reducing systemic side effects. Although ADCs lead the way in TROP2-targeted therapies, other innovative methods are also under investigation. These include RNA-based therapies and cell therapies, which focus on altering TROP2 expression or leveraging the immune system to attack cancer cells that express TROP2.

The competitive environment surrounding TROP2 therapies is rapidly evolving, with a multitude of clinical trials currently in progress. Prominent pharmaceutical and biotechnology companies, such as Merck, Hansoh BioMedical, BiOneCure Therapeutics, Bio-Thera Solutions, Biohaven Therapeutics, and Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, are making significant investments in this area. This heightened competition is fostering innovation and may expedite the introduction of new treatment alternatives for patients.

Notably, China is leading the TROP2 therapeutic landscape, showcasing a significant number of clinical trials and participating companies, with the US closely trailing behind. This development underscores the increasing significance of the Chinese biopharmaceutical sector and its commitment to pioneering cancer treatments. The international scope of TROP2 research and development indicates that patients around the globe may soon have access to these innovative therapies.

As the field progresses, several key factors will be crucial for advancing TROP2-targeted therapies. Extensive long-term data on the efficacy and safety of both approved and experimental treatments will be essential for integrating these therapies into standard protocols and achieving broader acceptance. Identifying biomarkers for patient stratification will be critical to enhance treatment outcomes and ensure therapies are administered to those most likely to benefit. Additionally, understanding resistance mechanisms to TROP2-targeted therapies will be vital for developing strategies to mitigate or prevent resistance, potentially through combination therapies or next-generation agents.

The rapid development of therapies targeting TROP2 marks a notable progression in the field of precision oncology. As additional data is gathered from ongoing clinical trials and the practical application of approved treatments, the comprehensive potential of TROP2 targeting in cancer management will become more evident. The achievements observed to date indicate that TROP2-targeted therapies could assume a more prominent position in the treatment of diverse epithelial cancers, thereby enhancing outcomes for patients who have few treatment alternatives.

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. TROP2 Targeted Antibodies Ongoing 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. Trodelvy (Sacituzumab Govitecan) - First Approved TROP2 Targeting Antibody

4.1 Overview
4.2 Approval, Patent & Exclusivity

5. Trodelvy (Sacituzumab Govitecan) - Commercial Insight

5.1 Dosage & Price Analysis
5.2 Sales Analysis (2020 - 2024)

6. Unveiling TROP2 Therapeutic Frontiers Market Trend By Region

6.1 US
6.2 China
6.3 Australia
6.4 South Korea
6.5 Europe
6.6 Taiwan
6.7 Japan

7. Global TROP2 Targeting Antibodies Market by Cancer

7.1 Breast Cancer
7.2 Lung Cancer
7.3 Gastric Cancer
7.4 Urothelial Cancer
7.5 Ovarian Cancer

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

8.1 Research
8.2 Preclinical
8.3 Phase I
8.4 Phase I/II
8.5 Phase II
8.6 Phase III
8.7 Preregistration

9. Marketed TROP2 Antibody Clinical Insight

10. Combination Approaches for TROP2 Antibody

11. Competitive Landscape

11.1 Abion Bio
11.2 Amunix
11.3 Aptamer Sciences
11.4 Arbele
11.5 Aston Science
11.6 AstraZeneca
11.7 Beijing Biocytogen
11.8 BiOneCure Therapeutics
11.9 Biosion
11.10 Bio-Thera Solutions
11.11 Daiichi Sankyo Company
11.12 Hangzhou DAC Biotech
11.13 Innovent Biologics
11.14 Janux Therapeutics
11.15 LegoChem Biosciences
11.16 Merck
11.17 Molecular Templates
11.18 OBI Pharma
11.19 Peak Bio
11.20 Radiopharm Theranostics
11.21 Shanghai Henlius Biotech
11.22 Suzhou GeneQuantum Healthcare

簡介目錄圖表

List of Figures

Figure 1-1: Evolution of TROP2 Targeting Therapeutics
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 Therapy
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, 2024 - 2029
Figure 2-2: Global -TROP2 Antibodies Clinical Pipeline By Country, 2024 - 2029
Figure 2-3: Global -TROP2 Antibodies Clinical Pipeline By Patient Segment, 2024 - 2029
Figure 2-4: Global -TROP2 Antibodies Clinical Pipeline By Phase, 2024 - 2029
Figure 2-5: Global -TROP2 Antibodies Clinical Pipeline By Priority Status, 2024 - 2029
Figure 3-1: Global - TROP2 Antibody Market (US$ Million), 2020-2024
Figure 3-2: Global - TROP2 Antibody Market (US$ Million), Q1 - Q2'2024
Figure 3-3: Global - TROP2 Antibody Market by Region (US$ Million), H1'2024
Figure 3-4: Global - TROP2 Antibody Market by Region (%), H1'2024
Figure 3-5: Phase 3 - Key TROP2 Drugs & Companies
Figure 3-6: Gilead Secures Investment From Abingworth To Fund Trodelvy Trials
Figure 3-7: Future TROP2 Market
Figure 3-8: Global - TROP2 Antibodies Market (US$ Million), 2024-2029
Figure 4-1: Trodelvy - FDA Approval Year by Indication
Figure 4-2: Trodelvy - Patent Expiration Year by Region
Figure 4-3: Trodelvy - Approval Year by Region
Figure 4-4: Trodelvy - FDA Orphan Designation Year by Indication
Figure 5-1: US - Price of 180mg Vial of Trodelvy Intravenous Powder (US$), August'2024
Figure 5-2: EU - Price of 180mg & 200mg Vials of Trodelvy Intravenous Powder (US$), August'2024
Figure 5-3: Global - Trodelvy Sales (US$ Million), 2020-2024
Figure 5-4: Global - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-5: Regional -Trodelvy Sales by Region (US$ Million), H1'2024
Figure 5-6: Trodelvy Sales by Region (%), H1'2024
Figure 5-7: US -Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-8: Europe - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-9: ROW - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-10: US -Trodelvy Sales (US$ Million), 2021-2024
Figure 5-11: Europe - Trodelvy Sales (US$ Million), 2021-2024
Figure 5-12: ROW - Trodelvy Sales (US$ Million), 2021-2024
Figure 5-13: Global - Trodelvy Sales (US$ Million), Q1- Q4'2023
Figure 5-14: Trodelvy - Sales By Region (US$ Million), 2023
Figure 5-15: Trodelvy - Sales By Region (%), 2023
Figure 5-16: US - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 5-17: Europe - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 5-18: ROW - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 6-1: China TROP2 - Key Players & Drugs
Figure 6-2: FDA018-ADC Phase III Study (NCT06519370) - Initiation & Completion Year
Figure 6-3: SHR-A1921 Phase III Study (NCT06394492) - Initiation & Completion Year
Figure 6-4: FZ-AD004 Phase I Study (NCT05914545) - Initiation & Completion Year
Figure 6-5: Trodelvy - TGA Priority Review for HR+/HER2 Metastatic Breast Cancer
Figure 6-6: MT-302 Phase I Study (NCT05969041) - Initiation & Completion Year
Figure 6-7: Radiopharm Theranostics & Lantheus Holdings Agreement
Figure 6-8: South Korea - Key TROP2 Companies
Figure 6-9: LegoChem Biosciences (LCB) & Johnson & Johnson Collaboration
Figure 6-10: LCB84 with an Anti-PD-1 Antibody Phase I/II Study (NCT05941507) - Initiation & Completion Year
Figure 6-11: Dato-DXd Received two EMA marketing authorization applications (MAAs)
Figure 6-12: DB-1305/BNT325 Phase I/II Study (NCT05438329) - Initiation & Completion Year
Figure 6-13: Mediterranea TROP2 antibody, Hu-2G10
Figure 6-14: OBI Pharma TROP2 Therapy Pipeline
Figure 6-15: OBI-992 Phase I/II Study (NCT06480240) - Initiation & Completion Year
Figure 6-16: Dato-DXd & Durvalumab Phase III Study (NCT06112379) - Initiation & Completion Year
Figure 7-1: Breast Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-2: Lung Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-3: TROPION-Lung01 Phase 3 Study - Initiation & Completion Year
Figure 7-4: EVOKE-01 Phase 3 Study - Initiation & Completion Year
Figure 7-5: EVOKE-03 Phase 3 Study - Initiation & Completion Year
Figure 7-6: EVOKE-02 Phase 2 Study - Initiation & Completion Year
Figure 7-7: Gastrointestinal Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-8: MK-2870-015 Phase 3 Study - Initiation & Completion Year
Figure 7-9: MK-3475-06C Phase 1/2 Study - Initiation & Completion Year
Figure 7-10: KL264-01 Phase 1/2 Study - Initiation & Completion Year
Figure 7-11: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-12: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-13: BNT-325 (NCT05438329) Phase 1/2 Study - Initiation & Completion Year
Figure 10-1: TROP2 Antibodies Combinations

List of Tables

Table 5-1: Trodelvy - Dose Modifications for Adverse Reactions
Table 6-1: US - Some Clinical Trials Assessing TROP2 Targeting Therapies
Table 6-2: China - Ongoing Clinical Trial for TROP2 Therapies
Table 6-3: SKB264 (MK-2870) - NMPA Designations, Indications & Year Insight
Table 6-4: Preclinical TROP2 Candidates Development in China
Table 6-5: Australia - Ongoing Clinical Trial for TROP2 Therapies
Table 6-6: South Korea - Ongoing Clinical Trial for TROP2 Therapies
Table 6-7: Europe - Ongoing Clinical Trial for TROP2 Therapies
Table 6-8: Taiwan - Ongoing Clinical Trial for TROP2 Therapies
Table 6-9: Japan - Ongoing Clinical Trial for TROP2 Therapies
Table 7-1: Breast Cancer - TROP2 ADC under Review
Table 7-2: Breast Cancer - Some TROP2 Targeted Candidates in Development
Table 7-3: Lung Cancer - TROP2 ADC under Review
Table 7-4: Lung Cancer - Some TROP2 Targeted Candidates in Development
Table 7-5: Gastric Cancer - Some TROP2 Targeted Candidates in Development
Table 7-6: Urothelial Cancer -Key TROP2 Targeted Candidates in Development
Table 7-7: Urothelial Cancer - Key TROP2 Targeted Candidates in Development
Table 10-1: Ongoing Preclinical & Clinical trials for Combination of TROP2 Therapy