HER2阳性復发转移性乳癌：市场展望、流行病学、竞争格局、市场预测报告（2025-2035年）

市场概览

• 英国市场预计将从约 1.8 亿美元成长到约 3.4 亿美元（年复合成长率约 6-7%）。
• 推动这一成长的动力是新一代抗体药物偶联物 (ADC) 和标靶治疗，而这又得益于晚期疾病治疗领域的持续创新。

HER2阳性復发转移性乳癌概述

HER2阳性復发转移性乳癌是一种侵袭性极强的分子亚型，由ERBB2基因扩增引起，导致跨膜蛋白酪氨酸激酶人类表皮生长因子受体2（HER2）过度表现。传统上，该亚型与疾病进展迅速、内臟侵犯率高以及极易发生中枢神经系统（CNS）转移相关，但标靶治疗的出现已显着改变了其发病机制。

透过免疫组织化学 (IHC) 或原位杂合反应(ISH) 准确地确定 HER2 状态对于制定治疗策略至关重要。目前的治疗模式是基于 HER2标靶治疗的阶梯式方案，首先采用曲妥珠单抗和Pertuzumab合併化疗的双单株抗体抑制剂治疗。

随着疾病进展，治疗方法也随之发展，引入了新一代抗体药物复合体（ADC），特别是曲妥珠单抗德鲁替康（T-DXd）。 T-DXd 疗效显着，几乎完全取代了先前的药物，例如 T-DM1。在治疗后期，尤其是在脑转移患者中，中枢神经系统（CNS）渗透性的蛋白酪氨酸激酶抑制剂（例如图卡替尼）在控制全身和颅内病灶方面发挥着至关重要的作用。

主要亮点

• HER2 阳性復发转移性乳癌是一种高度侵袭性的癌症亚型，但可透过标靶治疗进行治疗，并且高度依赖生物标记的治疗。
• 英国的患病人数预计将从约 12,500 例增加到约 15,900 例（年均复合成长率约 2.4%）。

格式化和更新讯息

• 详细报告（PDF）
• 市场预测模型（基于微软Excel）
• 流行病学数据（MS Excel，互动式工具）
• 高阶主管洞察（PPT简报）
• 其他功能：定期更新、自订和顾问支援。
• 根据 Thelansis 的政策，我们确保所有最新更新在发布前都反映在报告内容和市场模型中。

主要问题

• 我们如何优化 G8 市场（美国、欧盟 5 国、日本、中国）的药物开发与生命週期管理策略？
• 从发病率、盛行率、人群组成以及接受药物治疗的患者人数来看，患者数量分别是多少？
• 未来十年市场收入和病患份额的预测是多少？
• 哪些因素对市场趋势影响最大？
• 受访专家对目前和新兴的治疗方法有何看法？
• 哪款在研发线产品最有前景？其上市潜力及未来市场定位如何？
• 主要未被满足的需求是什么？ KOL 对目标受众有何期望？
• 为确保药物核准并顺利进入市场，必须满足哪些关键的监管和支付方要求？

目标国家

• G8
  • 我们
  • EU5
    • 法国
    • 德国
    • 义大利
    • 西班牙
    • 英国
  • 日本
  • 中国

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

目录

第一章：主要调查结果及分析师说明

• 主要趋势：市场概况、SWOT分析、商业性利益与风险等。

第二章：疾病背景

• 疾病定义、分类、病因和病理生理学、药物标靶等。

第三章：流行病学

• 重点
• 发病率/盛行率
• 已确诊并接受药物治疗的患者人数
• 合併症
• 其他相关患者群

第四章 市场规模及预测

• 重点
• 市场驱动因素与限制因素
• 按药物类别分類的趋势
• 各国具体趋势

第五章 竞争情势

• 目前的治疗方法
  • 重点
  • 诊断和治疗过程/演算法
  • 主要治疗方法概述及KOL洞察
• 新兴治疗方法
  • 重点
  • 值得关注的后期新治疗方法－概述、市场上市预期及KOL洞察
  • 值得关注的早期研发管线

第六章：未满足的需求与TPP分析

• 主要未满足的需求以及透过新兴治疗方法实现的未来可能性
• TPP分析与KOL展望

第七章 监理与报销环境

第八章附录

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)