HER2陽性復發轉移性乳癌：市場展望、流行病學、競爭格局、市場預測報告（2025-2035年）

市場概覽

• 英國市場預計將從約 1.8 億美元成長到約 3.4 億美元（年複合成長率約 6-7%）。
• 推動這一成長的動力是新一代抗體藥物偶聯物 (ADC) 和標靶治療，而這又得益於晚期疾病治療領域的持續創新。

HER2陽性復發轉移性乳癌概述

HER2陽性復發轉移性乳癌是一種侵襲性極強的分子亞型，由ERBB2基因擴增引起，導致跨膜蛋白酪氨酸激酶人類表皮生長因子受體2（HER2）過度表現。傳統上，該亞型與疾病進展迅速、內臟侵犯率高以及極易發生中樞神經系統（CNS）轉移相關，但標靶治療的出現已顯著改變了其發病機制。

透過免疫組織化學 (IHC) 或原位雜合反應(ISH) 準確地確定 HER2 狀態對於制定治療策略至關重要。目前的治療模式是基於 HER2標靶治療的階梯式方案，首先採用曲妥珠單抗和Pertuzumab合併化療的雙單株抗體抑制劑治療。

隨著疾病進展，治療方法也隨之發展，引入了新一代抗體藥物複合體（ADC），特別是曲妥珠單抗德魯替康（T-DXd）。 T-DXd 療效顯著，幾乎完全取代了先前的藥物，例如 T-DM1。在治療後期，尤其是在腦轉移患者中，中樞神經系統（CNS）滲透性的蛋白酪氨酸激酶抑制劑（例如圖卡替尼）在控制全身和顱內病灶方面發揮著至關重要的作用。

主要亮點

• HER2 陽性復發轉移性乳癌是一種高度侵襲性的癌症亞型，但可透過標靶治療進行治療，並且高度依賴生物標記的治療。
• 英國的患病人數預計將從約 12,500 例增加到約 15,900 例（年均複合成長率約 2.4%）。

格式化和更新訊息

• 詳細報告（PDF）
• 市場預測模型（基於微軟Excel）
• 流行病學數據（MS Excel，互動式工具）
• 高階主管洞察（PPT簡報）
• 其他功能：定期更新、自訂和顧問支援。
• 根據 Thelansis 的政策，我們確保所有最新更新在發布前都反映在報告內容和市場模型中。

主要問題

• 我們如何最佳化 G8 市場（美國、歐盟 5 國、日本、中國）的藥物開發與生命週期管理策略？
• 從發病率、盛行率、人群組成以及接受藥物治療的患者人數來看，患者數量分別是多少？
• 未來十年市場收入和病患佔有率的預測是多少？
• 哪些因素對市場趨勢影響最大？
• 受訪專家對目前和新興的治療方法有何看法？
• 哪款在研發線產品最有前景？其上市潛力及未來市場定位如何？
• 主要未被滿足的需求是什麼？ KOL 對目標受眾有何期望？
• 為確保藥物核准並順利進入市場，必須滿足哪些關鍵的監管和支付方要求？

目標國家

• G8
  • 美國
  • EU5
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 日本
  • 中國

大公司

• Ambrx, Inc.
• Criterium, Inc.
• Jazz Pharmaceuticals
• AstraZeneca
• Affibody
• Beijing Biotech
• Jiangsu HengRui Medicine Co., Ltd.
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Nanjing Chia-tai Tianqing Pharmaceutical

目錄

第1章：主要調查結果及分析師說明

• 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章：疾病背景

• 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

• 重點
• 發病率/盛行率
• 已確診並接受藥物治療的患者人數
• 合併症
• 其他相關患者群

第4章 市場規模及預測

• 重點
• 市場促進因素與限制因素
• 按藥物類別分類的趨勢
• 各國具體趨勢

第5章 競爭情勢

• 目前的治療方法
  • 重點
  • 診斷和治療過程/演算法
  • 主要治療方法概述及KOL洞察
• 新興治療方法
  • 重點
  • 值得關注的後期新治療方法－概述、市場上市預期及KOL洞察
  • 值得關注的早期研發管線

第6章：未滿足的需求與TPP分析

• 主要未滿足的需求以及透過新興治療方法實現的未來可能性
• TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

HER2-Positive Metastatic Breast Cancer Market Outlook

Thelansis's "HER2-Positive Metastatic Breast Cancer Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential HER2-Positive Metastatic Breast Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

HER2-Positive Metastatic Breast Cancer Overview

HER2-positive metastatic breast cancer is a highly aggressive molecular subtype driven by amplification of the ERBB2 gene, resulting in overexpression of the human epidermal growth factor receptor 2 (HER2), a transmembrane tyrosine kinase. Historically associated with rapid disease progression, high visceral involvement, and a strong propensity for central nervous system (CNS) metastases, the disease course has been significantly transformed by targeted therapies.

Accurate determination of HER2 status via immunohistochemistry (IHC) or in situ hybridization (ISH) is essential for guiding treatment. The modern therapeutic paradigm is based on sequential HER2-targeted therapy, beginning with dual monoclonal antibody blockade using trastuzumab and pertuzumab in combination with chemotherapy.

Upon progression, treatment has evolved with the introduction of next-generation antibody-drug conjugates (ADCs), particularly trastuzumab deruxtecan (T-DXd), which has demonstrated superior efficacy and largely replaced earlier agents such as T-DM1. In later lines, especially for patients with brain metastases, CNS-penetrant tyrosine kinase inhibitors (e.g., tucatinib) play a critical role in achieving both systemic and intracranial disease control.

Key Highlights

• HER2+ mBC is a highly aggressive but targetable cancer subtype with strong dependence on biomarker-driven therapy
• UK prevalent cases expected to grow from ~12.5K to ~15.9K (~2.4% CAGR)

Market Overview

• UK market projected to grow from ~$180M to ~$340M (~6-7% CAGR)
• Growth driven by next-generation ADCs and targeted therapies, with continued innovation in later-line settings

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard/report will cost USD 1,750 per country

Companies Mentioned

• Ambrx, Inc.
• Criterium, Inc.
• Jazz Pharmaceuticals
• AstraZeneca
• Affibody
• Beijing Biotech
• Jiangsu HengRui Medicine Co., Ltd.
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Nanjing Chia-tai Tianqing Pharmaceutical

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies - profiles and KOL insights
• Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)