HER2-low 轉移性乳癌 (mBC) 市場：初步研究 (KOL 見解) - 市場情報 - 流行病學和 2034 年市場預測

HER2低轉移性乳癌（mBC）市場以化療、內分泌治療和曲妥珠單抗deruxtecan（Enhertu）等標靶治療為主。到 2034 年，新興療法的採用將成為一個重大轉折點，將為 HER2 低轉移性乳癌藥物市場帶來巨大變化。在調查國家（美國、法國、德國、義大利、西班牙、英國和日本），用於治療 HER2 低轉移性乳癌的新興療法的銷售額預計在 2020 年至 2034 年的研究期間將出現強勁增長。預料到的。

HER2 低表達轉移性乳癌的治療似乎正在迅速發展。最近的臨床試驗表明，CDK4/6抑制劑與內分泌治療的組合作為標準一線治療是有效的。此外，PI3K抑制劑和AKT抑制劑的使用也在臨床試驗中進行研究，可能在不久的將來提供進一步的治療選擇。"

HER2 低表達的轉移性乳癌代表了乳癌認知和治療的重大轉變。歷史上，乳癌依 HER2 表現量分為 HER2 陽性或 HER2 陰性。然而，目前超過50%的乳癌被定義為“人類表皮生長因子受體2（HER2）低表達乳癌（BC）”，HER2免疫組織化學（IHC）評分為+1或+2，且螢光原位雜交（FISH）測試呈陰性。IHC/ISH 是目前用於定義 HER2 表達的唯一標準技術。最近的證據顯示 HER2 低表達乳癌可能是具有治療意義的目標亞群。

預計到 2034 年，G7 國家 HER2 低轉移性乳癌病例總數將顯著增加。據估計，到 2034 年，美國將成為 HER2 低轉移性乳癌發生率最高的國家。在歐盟五國中，德國的 HER2 低轉移性乳癌病例數最多，其次是英國、法國、義大利和西班牙。據報道，日本的治療病例數僅次於美國、德國和英國。

根據SEER資料庫，預計2022年美國將新診斷出287,850例女性乳癌，其中約50-60%的新診斷乳癌患者患有HER2低轉移性乳癌。確診。

HER2低表達轉移性乳癌治療市場預計將在研究期間（即2020年至2034年）經歷高速成長。與歐洲五國和日本相比，美國的市佔率最高。

本報告檢視了全球 HER2 低轉移性乳癌 (mBC) 市場，並提供了市場現狀以及病例量趨勢、患者趨勢、競爭產品市場定位和市場機會。

目錄

執行摘要

HER2低轉移性乳癌疾病背景

• HER2低轉移性乳癌的定義
• 原因和症狀
• 病理生理學
• 導致乳癌 HER2 低表現的因素

HER2低轉移性乳癌的診斷

流行病學和患者群體

• 主要發現
• 方法和資料來源
• HER2 低轉移性乳癌流行病學和模型參數的主要來源
  • 美國
  • 德國
  • 法國
  • 意大利
  • 西班牙
  • 英國
  • 日本
• 目前的治療方法和醫療實踐
  • 非處方療法
  • 未滿足的需求
  • 新的治療方法
  • 產品分析
  • 發佈時間表和主要市場事件
  • 價格和贖回
  • KOL 洞察（美國、歐洲、日本）
  • 未來的治療範式
  • 目前和未來治療的年度費用
  • HER2低轉移性乳癌晚期治療的策略考慮
  • 市場展望
  • 主要藥品市場HER2低轉移性乳癌藥物銷售（2020-2034年）
  • 按治療方法劃分的 HER2 低轉移性乳癌患者百分比
• 國家市場預測
  • 美國
  • 德國
  • 法國
  • 西班牙
  • 英國
  • 日本
• 市場驅動因素與限制因素
• 附錄

The HER2-Low Metastatic Breast Cancer (mBC) market is hugely contributed by chemotherapy, endocrine therapy and targeted therapy such as Trastuzumab deruxtecan (Enhertu). By 2034, the uptake of novel emerging therapies will serve as a major breakpoint to get a drastic change in the HER2-Low Metastatic Breast Cancer therapeutics market. The sales of the emerging therapies for the treatment of HER2-Low Metastatic Breast Cancer in the study countries (United States, France, Germany, Italy, Spain, United Kingdom and Japan) will experience high growth over the 2020-2034 study period.

"Experts believe that the treatment armamentarium for HER2-low metastatic breast cancer is rapidly evolving. Recent clinical trials have demonstrated the efficacy of CDK4/6 inhibitors in combination with endocrine therapy as a standard first-line treatment option. Additionally, the use of PI3K inhibitors and AKT inhibitors is being explored in clinical trials and may provide further treatment options in the near future."

The introduction of HER2-low metastatic breast cancer represents a significant shift in the understanding and treatment of breast cancer. Historically, breast cancers were categorized as either HER2-positive or HER2-negative based on the level of HER2 expression. However, more than 50% of breast cancers are currently defined as "Human epidermal growth factor receptor 2 (HER2) low breast cancer (BC)", with HER2 immunohistochemistry (IHC) scores of +1 or +2 with a negative fluorescence in situ hybridization (FISH) test. IHC/ISH is the only standard technique currently applied to define HER2 expression. Recent evidence suggests that HER2-low breast cancer can be a targetable subgroup with potential therapeutic implications.

Mellalta's HER2-Low Metastatic Breast Cancer Report– Market Summary

Mellalta's HER2-Low Metastatic Breast Cancer Report – Epidemiology

The total incident cases of HER2-Low Metastatic Breast Cancer in the G7 countries are anticipated to increase by a significant number of cases by 2034 for the study period (2020-2034). As per estimates, the United States will present with the highest incidence of HER2-Low Metastatic Breast Cancer cases in 2034. Among the EU5, Germany had the highest HER2-Low Metastatic Breast Cancer cases, followed by the UK, France, Italy, and Spain. Japan is reported to have the highest number of treated cases after the United States, Germany, and the UK.

According to SEER database estimates 287,850 new cases of female breast cancer will be diagnosed in 2022 in the U.S. Out of the newly diagnosed breast cancer patient, roughly 50-60% of patients is now diagnosed with HER2 Low metastatic Breast Cancer.

Mellalta's HER2-Low Metastatic Breast Cancer Report – Current Market Size & Forecast Trends

The HER2-Low Metastatic Breast Cancer therapeutics market is expected to experience high growth throughout our study period (i.e., 2020 to 2034). The United States captured the highest market share as compared to the European 5 countries and Japan.

The current standard of care is limited to chemotherapy, endocrine and targeted therapy. In 2022, Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion is approved as the first targeted therapy for the treatment of patients with unresectable or metastatic HER2-low breast cancer in the United States and in 2023 in the European Union. This shift in treatment options has significant implications for the market. The changing treatment landscape has created new opportunities in the market for more companies to develop and commercialize the use of ADCs in HER2-low tumours. Additionally, the entrance of ADCs like Enhertu in the treatment paradigm of HER2-low breast cancer will also pave the way for diagnostic companies to develop the specific test for the identification of HER2-low breast cancer patient pool, which will be in turn increase the treated patient pool and will drive the market of HER2 low breast cancer significantly.

While the results of DESTINY-Breast04 study led to the breakthrough approval of Enhertu in the HER2 low breast cancer treatment space, it also changed the prescribing pattern among clinician's posing significant obstacles. These challenges include raising clinician awareness through education, updating practice guidelines, managing increasing treatment complexity, and addressing a lack of data surrounding the complex characteristics and temporal heterogeneity of HER2-low tumors.

In the 2024-2034 forecast period, there will be tremendous growth and shift in the therapeutic market with the launch of noble emerging therapies like Trastuzumab rezetecan (Jiangsu HengRui Medicine), DB-1303 (Duality Biologics), Disitamab vedotin (Yantai Rongchang Pharmaceutical), Sacituzumab Govitecan (Gilead Sciences), Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo), MRG002 (Miracogen), and more. We expect a greater uptake of the new therapies which will result in better treatment outcomes for HER2-Low Metastatic Breast Cancer market space. The launch of these upcoming therapies will drive the highly competitive therapeutic market in the coming time.

Questions Answered:

• What is the size of clinically and commercially relevant drug-treatable HER2 low BC populations, and how will drug-treatment rates of HER2 change over time?
• What is the expected market impact of recent drug approval such as Enhertu in the treatment landscape of HER2-low metastatic BC?
• Potential challenges and opportunities in implementing targeted therapies for HER2-low breast cancer.
• What are the most promising agents in the pipeline, and how will they shape the future of this therapy market?
• What key drivers and constraints will affect the HER2-low metastatic breast cancer therapy market over the forecast period?

Report Highlights:

• HER2-Low Metastatic Breast Cancer (mBC) – Current Market Trends
• HER2-Low Metastatic Breast Cancer (mBC) – Current & Forecasted Cases across the G7 Countries
• HER2-Low Metastatic Breast Cancer (mBC) – Market Opportunities and Sales Potential for Agents
• HER2-Low Metastatic Breast Cancer (mBC) – Patient-based Market Forecast to 2034
• HER2-Low Metastatic Breast Cancer (mBC) – Untapped Business Opportunities
• HER2-Low Metastatic Breast Cancer (mBC) – Product Positioning Vis-a-vis Competitors' Products
• HER2-Low Metastatic Breast Cancer (mBC) – KOLs Insight

Table of Content

Executive Summary

• Key Findings
• Key Market Challenges and Opportunities
• What Do the Experts Say?

HER2-Low Metastatic Breast Cancer Disease Background

• HER2-Low Metastatic Breast Cancer Definition
• Cause & Symptoms
• Pathophysiology
• Factors contributing to the HER2-Low Expression in Breast Cancer

HER2-Low Metastatic Breast Cancer–Diagnosis

• HER2 Assessment with Immunohistochemistry (IHC) and In Situ Hybridization (ISH) (ASCO/CAP Guidelines)

Epidemiology and Patient Populations

• Key Findings
• Methods and data Sources
  • Country Specific Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
  • Country Specific Incident cases of HER2-Low Metastatic Breast Cancer
  • Country Specific Treated cases of HER2-Low Metastatic Breast Cancer
• Key Sources for HER2-Low Metastatic Breast Cancer Epidemiology and Model Parameters
  • United States
    • United States Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • United States Incident cases of HER2-Low Metastatic Breast Cancer
    • United States Treated cases of HER2-Low Metastatic Breast Cancer
  • Germany
    • Germany Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • Germany Incident cases of HER2-Low Metastatic Breast Cancer
    • Germany Treated cases of HER2-Low Metastatic Breast Cancer
  • France
    • France Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • France Incident cases of HER2-Low Metastatic Breast Cancer
    • France Treated cases of HER2-Low Metastatic Breast Cancer
  • Italy
    • Italy Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • Italy Incident cases of HER2-Low Metastatic Breast Cancer
    • Italy Treated cases of HER2-Low Metastatic Breast Cancer
  • Spain
    • Spain Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • Spain Incident cases of HER2-Low Metastatic Breast Cancer
    • Spain Treated cases of HER2-Low Metastatic Breast Cancer
  • United Kingdom
    • United Kingdom Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • United Kingdom Incident cases of HER2-Low Metastatic Breast Cancer
    • United Kingdom Treated cases of HER2-Low Metastatic Breast Cancer
  • Japan
    • Japan Incident cases of Metastatic Breast Cancer (US, Germany, France, Italy, Spain, UK, and Japan)
    • Japan Incident cases of HER2-Low Metastatic Breast Cancer
    • Japan Treated cases of HER2-Low Metastatic Breast Cancer
• Current Therapy and Medical Practice
  • Key Findings
  • Treatment Algorithm
  • Marketed Therapy
    • ENHERTU (AstraZeneca/Daiichi Sankyo)
      • Product Profile
      • Clinical Development
      • Market & Sales Opportunity Forecasted to 2034
  • Unmet Needs
  • Emerging Therapy
    • Key Findings
    • Pipeline Overview
    • Notable Developments in the HER2-Low Metastatic Breast Cancer space
      • Product Analysis
        • Trastuzumab rezetecan (Jiangsu HengRui Medicine)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • DB-1303 (Duality Biologics)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • Disitamab vedotin (Yantai Rongchang Pharmaceutical)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • Sacituzumab Govitecan (Gilead Sciences)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • MRG002 (Miracogen)
          • Product Profile
          • Clinical Development
          • Market & Sales Opportunity Forecasted to 2034
        • Others
  • Launch Timeline & Key Market Events for HER2-Low Metastatic Breast Cancer
  • HER2-Low Metastatic Breast Cancer – Pricing & Reimbursement
  • KOLs Insight (US, EU, JP)
    • Unmet Needs
    • Analysis of the progresses in terms of approvals & current pipeline;
    • Impact on the treatment algorithm and product positioning
    • Relevance of new targets/platforms/ therapies Uptake Share %
    • Physicians Preferences for the new therapies
  • Future Treatment Paradigm
    • HER2-Low Metastatic Breast Cancer Competitor Landscape and Approvals Anticipated
    • Future Treatment Algorithms and Competitor Positioning
    • Key Data Summary for Emerging Treatment
  • Annual Cost of Current & Emerging Treatment
  • Late Phase Therapy Strategic Considerations in HER2-Low Metastatic Breast Cancer
  • Market Outlook
    • Key Findings
    • Overview
    • Country Specific Market Forecast to 2034
      • Sales of Drugs to Treat HER2-Low Metastatic Breast Cancer in the Major Pharmaceutical Markets, 2020-2034
      • Patient Share of HER2-Low Metastatic Breast Cancer by Therapies
    • Market Forecast by Country
      • United States
        • United States Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • United States Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • Germany
        • Germany Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • Germany Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • France
        • France Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • France Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • Italy • Italy Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million) • Italy Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • Spain
        • Spain Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • Spain Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • United Kingdom
        • United Kingdom Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • United Kingdom Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
      • Japan
        • Japan Market for HER2-Low Metastatic Breast Cancer 2020-2034 (USD Million)
        • Japan Market for HER2-Low Metastatic Breast Cancer by Therapy 2020-2034 (USD Million)
  • Market Drivers and Constraints
    • What Factors Are Driving the Market for HER2-Low Metastatic Breast Cancer?
    • What Factors Are Constraining the Market for HER2-Low Metastatic Breast Cancer?
  • Appendix
    • Methodology