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市場調查報告書

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乳癌抗體藥物複合體的全球市場:市場機會，專利，價格，認證核可藥的銷售額和臨床試驗趨勢(2030年)

Global Breast Cancer Antibody Drug Conjugates Market Opportunity, Patent, Price, Approved Drug Sales & Clinical Trials Insight 2030

出版日期: 2025年09月01日 | 出版商:

KuicK Research | 英文 330 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄圖表

全球乳癌抗體-藥物偶聯物市場：市場機會、專利、定價、核准藥物銷售及臨床試驗趨勢（2030 年）報告結果及重點

研究方法
全球乳癌抗體-藥物偶聯物市場機會：到 2030 年將超過 200 億美元
全球及各地區市場規模洞察（年度及季度）：2020 年 - 2025 年上半年
核准乳癌抗體-藥物偶聯物銷售趨勢：2020-2025 年
全球癌症抗體-藥物偶聯物市場預測：2026-2030 年
專利、劑量和價格分析已獲準乳癌抗體-藥物偶聯物
臨床試驗中的乳癌抗體-藥物偶聯物：超過100種藥物
按公司、國家、適應症和階段劃分的乳癌抗體-藥物偶聯物臨床試驗洞察
癌症抗體-藥物偶聯物開發平台和公司

乳癌治療對抗體-藥物偶聯物的需求及本報告的意義

抗體藥物偶聯物 (ADC) 正迅速成為對抗乳癌的重要創新，尤其是在滿足 HER2 陽性和 HER2 低表達腫瘤患者未滿足的需求方面。這些藥物利用單株抗體的精準標靶性和化療藥物的強效細胞毒性，在避免全身毒性的同時達到局部腫瘤破壞。全球市場已認識到這一潛力，預計乳癌 ADC 的銷售額將在 2024 年超過 70 億美元，到 2030 年將成長兩倍。

本報告旨在為乳癌 ADC 的開發提供及時且具有戰略意義的見解。隨著該領域從早期研究發展到廣泛的臨床應用，從藥物開發商到投資者等利益相關者都需要了解臨床開發、試驗設計、平台技術和商業化路徑的最新資訊。本報告按地區、亞型和臨床試驗階段提取精煉的全球數據，為決策者提供指導和塑造乳癌治療方向所需的見解。

報告中包含的臨床試驗見解

本報告對乳癌 ADC 候選化合物進行了廣泛的分析，包括已核准的乳癌 ADC 從 I 期早期到 III 期晚期試驗的數據。這些試驗涵蓋美國、歐洲、中國和澳洲等主要地區。臨床數據不僅涵蓋傳統的 HER2 陽性患者，還涵蓋 HER2 低表達患者群體，這是乳癌精準醫療的新興領域。本報告包含對 120 多種乳癌抗體-藥物偶聯物的洞察。

正在考慮的最重要變數包括治療策略（單藥治療或合併治療）、臨床試驗申辦者（學術機構、公司）以及 HER2 以外的分子標靶（TROP2、B7-H4 等）。後期研發管線中的關鍵候選藥物包括 Enhertu、Trodelvy 和 Dataloway，以及 DP303c、isalontamab brengitecan 和 JSKN003 等新進者。 sacituzumab govitecan 與 pembrolizumab 或曲妥珠單抗的組合也正在研究中，以解決抗藥性機制。伴隨診斷（包括羅氏基於人工智慧的 TROP2 檢測）也包含在研究設計中，以便基於生物標記進行患者選擇。這些洞察共同描繪出全球最具成效和最成功的臨床活動。

從事乳癌抗體偶聯藥物研發的頂尖公司

許多製藥公司和尖端生物技術公司正在定義乳癌抗體偶聯藥物市場。第一三共和阿斯特捷利康在全球銷售額方面領先同類領導者Enhertu。羅氏和基因泰克繼續積極推進Kadcyla和診斷產品。最近被輝瑞收購的Seagen正在增強其產品線深度，而ADC Therapeutics和Mersana Therapeutics則憑藉差異化平台獲得關注。

榮昌生物和Zydus Cadila等新興公司正在擴大其地理覆蓋範圍，尤其是在亞洲。每家公司都在開發新的有效載荷、連接體和抗體形式，以降低毒性並提高臨床療效。這些發展不僅代表技術創新，也代表著推動全球開發和可近性的激烈競爭。

技術平台、合作與協議

技術平台是乳癌 ADC 領域最大的差異化因素。各公司正在優化偶聯方法、連接體化學和有效載荷遞送系統。例如，雙特異性 ADC (BsADC) 可以同時靶向兩種抗原，是應對腫瘤異質性的新一代解決方案。 Enhertu 的成功部分歸功於其高藥物抗體比和穩定的連接體技術。

合作研究也正在推動公司擴張。輝瑞收購 Siegen 後，獲得了一個專有的 ADC 平台。學術研究機構與產業界之間的合作，例如臨床試驗夥伴關係，正在加速候選化合物的開發。許可協議和透過 CDMO 提供的本地生產支援也在擴大市場准入，尤其是在印度、中國和拉丁美洲等新興市場。

報告揭示乳癌抗體-藥物偶聯物的未來發展方向

本報告預測，乳癌仍將是ADC創新和商業化的主要適應症。隨著越來越多的候選藥物進入後期臨床試驗，以及聯合方案顯示出早期療效，未來將朝著更個人化、標靶治療的方向發展。值得關注的新興創新包括雙特異性ADC、生物標記檢測的增加、新輔助/輔助治療以及在早期疾病中的應用。

監管勢頭、投資資本和科學進步都在匯聚，為ADC成為乳癌治療的基石鋪平道路。憑藉活躍的研發管線、國際審批和更廣泛的適應症，乳癌ADC有望改變癌症治療的面貌。

Research Methodology
Global Breast Cancer Antibody Drug Conjugates Market Opportunity: > US$ 20 Billion By 2030
Global & Regional Market Size Insight (Yearly & Quarterly): 2020 Till H1'2025
Approved Breast Cancer Antibody Drug Conjugates Sales Insight : 2020 Till 2025
Global Cancer Antibody Drug Conjugates Market Forecast: 2026 Till 2030
Approved Breast Cancer Antibody Drug Conjugates Patent, Dosage and Price Analysis
Breast Cancer Antibody Drug Conjugates In Clinical Trials: > 100 Drugs
Breast Cancer Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase
Cancer Antibody Drug Conjugates Development Platforms By Company

Need For Antibody Drug Conjugates In Breast Cancer Treatment & Why This Report

Antibody drug conjugates (ADCs) are rapidly becoming an essential innovation in the battle against breast cancer, specifically in fulfilling the unmet needs of patients with HER2-positive and HER2-low tumors. These drugs leverage the precision targeting of monoclonal antibodies along with the potent cytotoxic effects of chemotherapeutic drugs to achieve more localized destruction of the tumor while avoiding systemic toxicity. The global market has identified this potential, with breast cancer ADCs sales exceeding US$ 7 Billion in 2024, and further expected to triple by 2030.

The purpose of this report is to provide an incisive, timely, and strategic insight into the developing landscape of breast cancer ADCs. As the space evolves from nascent research into broad clinical acceptance, stakeholders, ranging from pharmaceutical developers to investors, need current intelligence on clinical developments, trial design, platform technologies, and commercialization avenues. By boiling down sophisticated global data by geography, subtype, and trial phase, this report arms decision-makers with the insights needed to navigate and shape the direction of breast cancer treatment.

Clinical Trials Insight Included In Report

The report contains extensive analysis of ADC candidates for breast cancer, from early Phase 1 to late stage Phase 3 trials, including extensive data on already approved breast cancer ADCs These trials span across key geographies like the US, Europe, China, and Australia. Clinical data not only target the classic HER2-positive patients but also the emerging HER2-low patient population, a new area in breast cancer precision medicine. Report includes insight on more than 120 breast cancer antiboduies drug conjugates.

The most crucial variables examined are therapeutic strategy (monotherapy versus combination regimens), sponsorship of trials (academic centers versus industry), and molecular targets other than HER2, i.e., TROP2 and B7-H4. The key contenders in the late-stage pipeline are Enhertu, Trodelvy, Datroway, and new entrants such as DP303c, Izalontamab brengitecan, and JSKN003. Combination studies, such as sacituzumab govitecan with pembrolizumab or trastuzumab, are also investigated, providing solutions to mechanisms of resistance. Companion diagnostics, including Roche's TROP2 assay based on AI, are also included in trial designs to enable biomarker-based patient selection. Combined, all these insights chart the most productive and successful clinical activities globally.

Top Companies Working On R&D of Breast Cancer Antibody Drug Conjugates

A number of pharma titans and cutting-edge biotech players are defining the breast cancer ADC market. Daiichi Sankyo and AstraZeneca dominate with Enhertu, the category leader in global sales. Roche and Genentech remain active through Kadcyla and diagnostics. Seagen, having just been acquired by Pfizer, is adding pipeline depth, while ADC Therapeutics and Mersana Therapeutics are gaining traction with differentiated platforms.

Emerging companies such as RemeGen and Zydus Cadila are broadening the geographic reach, especially in Asia. Each company is developing new payloads, linkers, and antibody formats to decrease toxicity and enhance clinical efficacy. These are manifestations not only of innovation, but of intense competition that's driving global development and access.

Technology Platforms, Collaborations & Agreements

Technology platforms are the biggest differentiator in breast cancer ADCs. Companies are optimizing conjugation methods, linker chemistry, and payload delivery systems. For instance, bispecific ADCs (BsADCs), targeting two antigens at the same time, are being introduced as a next-generation answer for tumor heterogeneity. Part of the success of Enhertu lies in its high drug-to-antibody ratio and stable linker technology.

Collaborations are also driving expansion. Pfizer's acquisition of Seagen added propriety ADC platforms to its fold. Academic research institution-industry collaborations, like in the form of clinical trial partnerships,are speeding up candidate development. Licensing deals and local manufacturing support through CDMOs are also making access wider, particularly across emerging markets like India, China, and Latin America.

Report Indicating Future Direction Of Breast Cancer Antibody Drug Conjugates

This report predicts that breast cancer will continue to be the predominant indication for ADC innovation and commercialization. With additional candidates making their way into late-stage trials, and combination regimens demonstrating early efficacy, the future is directed toward more personalized and targeted therapy. Emerging innovations to watch are bispecific ADCs, increased biomarker testing, use in neoadjuvant/adjuvant treatment, and use in early-stage disease.

Regulatory momentum, investment capital, and scientific advancements are all coming together to pave the way for ADCs to be a cornerstone in the treatment of breast cancer. With an active pipeline, mounting international approvals, and growing indications, breast cancer ADCs can change the face of oncology care.

1. Introduction To Breast Cancer Antibody Drug Conjugates

2. Antibody Drug Conjugates As Breast Cancer Targeted Therapy

2.1 Mechanism Of Antibody Drug Conjugates
2.2 Applications & Advantages In Breast Cancer
2.3 Comparison With Traditional Therapies
2.4 Breast Cancer Antibody Drug Conjugates Combination Therapies

3. Generations Of Breast Cancer Antibody Drug Conjugates

3.1 Antibody Drug Conjugates - Evolution
3.2 Next Generation Antibody Drug Conjugates Prospects

4. Commercially Approved Breast Cancer Antibody Drug Conjugates By Brand Name, Company & Indication

5. Global Breast Cancer Antibody Drug Conjugates Market Outlook

5.1 Current Market Scenario
5.2 Global Breast Cancer Antibody Drug Conjugates Market Trends & Development
5.3 Future Growth Avenues

6. Global Cancer Antibody Drug Conjugates Research & Market Trends By Region

6.1 US
6.2 China
6.3 Europe
6.4 South Korea
6.5 Australia
6.6 Canada
6.7 Japan
6.8 UK
6.9 India
6.10 Latin America

7. Approved Breast Cancer Antibody Drug Conjugates - Patent, Dosage & Price Analysis

This Chapter Gives Insight On 7 Approved Breast Cancer Antibody Drug Conjugates

7.1 Kadcyla
- 7.1.1 Overview, Availability & Patent Insight
- 7.1.2 P ricing & Dosage Insight

7.7 Aidixi
- 7.7.1 Overview & Availability Insight

8. Approved Breast Cancer Antibody Drug Conjugates Sales Insights

8.1 Kadcyla
8.2 Enhertu
8.3 Trodelvy
8.4 Datroway

9. Global Cancer Antibody Drug Conjugates Clinical Trials Overview

9.1 By Phase
9.2 By Indication
9.3 By Company
9.4 By Country

10. Global Cancer Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase

10.1 Research
10.2 Preclinical
10.3 Phase I
10.4 Phase I/II
10.5 Phase II
10.6 Phase II/III
10.7 Phase III
10.8 Preregistration
10.9 Registered

11. Marketed Cancer Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication & Phase

12. Cancer Antibody Drug Conjugates Development Platforms By Company

13. Global Cancer Antibody Drug Conjugates Market Overview

13.1 Key Market Growth Drivers
13.2 Challenges For Market Growth

14. Competitive Landscape

14.1 ADC Therapeutics
14.2 AstraZeneca
14.3 Biocytogen
14.4 Biokin
14.5 Bristol Myers Squibb
14.6 Daiichi Sankyo
14.7 Duality Biologics
14.8 Eli Lilly
14.9 Gilead
14.10 Immunogen
14.11 Innovent Biologics
14.12 LigaChem Biosciences
14.13 Merck
14.14 Pfizer
14.15 Roche

簡介目錄圖表

List of Figures

Figure 2-1: Antibody Drug Conjugates - General Working Mechanism
Figure 2-2: Advantages Of Antibody Drug Conjugates
Figure 2-3: Antibody Drug Conjugate Combinations In Studies
Figure 3-1: Cancer Antibody Drug Conjugates - Opportunities For Next Generation Development
Figure 5-1: Global - Breast Cancer Antibody Drug Conjugates Market (US$ Million), 2020-2025
Figure 5-2: Global - Breast Cancer Antibody Drug Conjugate Sales By Drugs (US$ Million), H1'2025
Figure 5-3: Global - Cancer Antibody Drug Conjugate Market Share By Drugs (%), H1'2025
Figure 5-4: Global - Breast Cancer Antibody Drug Conjugate Market (US$ Million), Q1 & Q2'2025
Figure 5-5: Global - Breast Cancer Antibody Drug Conjugate Sales By Drugs (US$ Million), 2024
Figure 5-6: Global - Breast Cancer Antibody Drug Conjugate Market Share By Drugs (%), 2024
Figure 5-7: Global - Breast Cancer Antibody Drug Conjugate Market (US$ Million), Q1 -Q4'2024
Figure 5-8: Global - Breast Cancer Antibody Drug Conjugate Market By Drugs (US$ Million), 2023
Figure 5-9: Global - Cancer Antibody Drug Conjugate Market Share By Drugs (%), 2023
Figure 5-10: D926QC00001 Phase 3 (NCT06112379) Study - Initiation & Completion Year
Figure 5-11: TQB2102-III-01 Phase 3 (NCT06561607) Study - Initiation & Completion Year
Figure 5-12: IZABRIGHT-Breast01 Phase 2/3 (NCT06926868) Study - Initiation & Completion Year
Figure 5-13: STARt-002 Phase 1/2 (NCT06827613) Study - Initiation & Completion Year
Figure 5-14: Global - Breast Cancer Antibody Drug Conjugate Market Forecast (US$ Billion), 2026 - 2030
Figure 6-1: India - Branded v/s Biosimilar Trastuzumab Emtansine Price by Supply (US$), September'2025
Figure 7-1: US - Kadcyla FDA Approval Year By Indication
Figure 7-2: Kadcyla - Approval Year By Region
Figure 7-3: US - Kadcyla FDA Approval & Patent Expiration Year
Figure 7-4: Kadcyla - Cost of Supply In US & Europe (US$), September'2025
Figure 7-5: Kadcyla - Recommended Dose after 1st & 2nd Dose Reduction (mg/kg)
Figure 7-6: Enhertu - Approval Year By Region
Figure 7-7: US - Polivy FDA Approval Year by Indication
Figure 7-8: Enhertu - FDA Orphan Drug Designation & Exclusivity Expiration Year
Figure 7-9: Enhertu - Cost of 100 mg Supply In US & Europe (US$), September'2025
Figure 7-10: US - Trodelvy FDA Approval by Indication
Figure 7-11: Trodelvy - Approval Year By Region
Figure 7-12: Trodelvy - Patent Expiration By Region
Figure 7-13: Trodelvy - Cost of Supply In US & Europe (US$), September'2025
Figure 7-14: Ujvira - Cost of 100 mg & 160 mg Supply in India (US$), September'2025
Figure 7-15: Datroway - Cost of 100 mg Supply In US & Europe (US$), September'2025
Figure 8-1: Kadcyla - Global Sales (US$ Million), 2020-2025
Figure 8-2: Kadcyla - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-3: Kadcyla - Global Sales By Region (%), H1'2025
Figure 8-4: Kadcyla - Global Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-5: Kadcyla - Global Sales By Region (US$ Million), 2024
Figure 8-6: Kadcyla - Global Sales By Region (%), 2024
Figure 8-7: Kadcyla - US Annual Sales (US$ Million), 2020-2025
Figure 8-8: Kadcyla - US Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-9: Kadcyla - US Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-10: Kadcyla - Europe Annual Sales (US$ Million), 2020-2025
Figure 8-11: Kadcyla - Europe Quarterly Sales (US$ Million), Q1'2025
Figure 8-12: Kadcyla - Europe Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-13: Kadcyla - Japan Annual Sales (US$ Million), 2020-2025
Figure 8-14: Kadcyla - Japan Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-15: Kadcyla - Japan Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-16: Kadcyla - ROW Annual Sales (US$ Million), 2020-2025
Figure 8-17: Kadcyla - ROW Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-18: Kadcyla - ROW Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-19: Enhertu - Global Annual Sales (US$ Million), 2020-2025
Figure 8-20: Enhertu - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-21: Enhertu - Global Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-22: Trodelvy - Global Annual Sales (US$ Million), 2020-2025
Figure 8-23: Trodelvy - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-24: Trodelvy - Annual Sales By Region (US$ Million), 2025
Figure 8-25: Trodelvy - Annual Sales By Region (%), 2025
Figure 8-26: Trodelvy - Global Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-27: Trodelvy - Annual Sales By Region (US$ Million), 2024
Figure 8-28: Trodelvy - Annual Sales By Region (%), 2024
Figure 8-29: Trodelvy - US Annual Sales (US$ Million), 2020-2025
Figure 8-30: Trodelvy - US Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-31: Trodelvy - US Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-32: Trodelvy - Europe Annual Sales (US$ Million), 2020-2025
Figure 8-33: Trodelvy - Europe Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-34: Trodelvy - Europe Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-35: Trodelvy - ROW Annual Sales (US$ Million), 2022-2025
Figure 8-36: Trodelvy - ROW Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 8-37: Trodelvy - ROW Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 8-38: Datroway - Global Annual Sales (US$ Million), 2025
Figure 8-39: Datroway - Global Quarterly Sales (US$ Million), Q1 & Q2'2025
Figure 9-1: Global - Cancer Antibody Drug Conjugate In Clinical Trials By Phase, 2025 Till 2030
Figure 9-2: Global- Cancer Antibody Drug Conjugate In Clinical Trials By Indication, 2025 Till 2030
Figure 9-3: Global - Cancer Antibody Drug Conjugate In Clinical Trials By Company, 2025 Till 2030
Figure 9-4: Global - Cancer Antibody Drug Conjugate In Clinical Pipeline By Country, 2025 Till 2030
Figure 12-1: Proprietary ADC Technology - Seagen
Figure 12-2: ALE.P02 & ALE.P03 - Alentis Therapeutics
Figure 12-3: TRAAC - Tallac Therapeutics
Figure 12-4: ATAC - Heidelberg Pharma
Figure 12-5: Tub-tag(R) & P5 - Tubulis

List of Tables

Table 2-1: Comparison Between Antibody Drug Conjugates & Traditional Cancer Therapies
Table 2-2: Breast Cancer - Ongoing Antibody Drug Conjugate Combination Clinical Trials
Table 3-1: Breast Cancer - Approved Second Generation Antibody Drug Conjugates
Table 3-2: Breast Cancer - Approved Third Generation Antibody Drug Conjugates
Table 3-3: Fourth Generation Antibody Drug Conjugates - Examples
Table 4-1: Breast Cancer - Approved Antibody Drug Conjugates, September'2025
Table 5-1: Breast Cancer - Approved Antibody Drug Conjugates
Table 6-1: US - Approved Breast Cancer Antibody Drug Conjugates, September'2025
Table 6-2: China - Approved Antibody Drug Conjugates, September'2025
Table 6-3: EU - Approved Cancer Antibody Drug Conjugates, September'2025
Table 6-4: Australia - Approved Cancer Antibody Drug Conjugates, September'2025
Table 6-5: Canada - Approved Cancer Antibody Drug Conjugates, September'2025
Table 6-6: Japan - Approved Cancer Antibody Drug Conjugates, September'2025
Table 6-7: UK - Approved Antibody Drug Conjugates, September'2025
Table 7-1: Datroway - Premedication & Concomitant Medications
Table 7-2: Datroway - Recommended Dosage Reductions for Adverse Reactions