HER2低発現乳がん-パイプライン分析：2023年

現在、乳がんの50％以上が「ヒト上皮成長因子受容体2（HER2）低値乳がん（BC）」と定義されており、HER2免疫組織化学（IHC）スコアが+1または+2、蛍光in situハイブリダイゼーション（FISH）検査が陰性です。治療状況の変化により、HER2低発現腫瘍における治療用ADCの開発・商業化を目指す企業が増え、市場に新たな機会が生まれています。

現在、HER2低発現乳がんパイプラインには33以上の候補があり、臨床試験および前臨床試験で評価中です。市場で事業を展開する主な主要企業は、HER2低発現乳がん候補の強固な臨床パイプラインを有するJiangsu HengRui Medicine、Duality Biologics、Yantai Rongchang Pharmaceutical、Gilead Sciences、AstraZeneca/Daiichi Sankyoなどです。

当レポートでは、世界のHER2低発現乳がん市場について調査し、開発ステージ別のパイプライン製品分析、相別の競合情勢、企業、治療領域、適応症を網羅しています。また、現在の市場機会、市場促進要因・課題などを提供しています。

目次

第1章 レポートの概要

第2章 概要

第3章 HER2低発現乳がんパイプライン分析

• 概要
• 適応症/相別の資産
• 開発段階別のパイプライン製品
• HER2低発現乳がんの競合情勢
• 企業別およびフェーズ別のパイプライン製品
• HER2低発現乳がんの臨床および規制スケジュール

第4章 HER2低発現乳がんの買収、ライセンシング、および提携契約

• HER2低発現乳がんの取得、ライセンシングおよび取引額
• HER2低発現乳がんの獲得数、取引タイプ別のライセンシングおよび総額規模、相別
• 有望な技術開発

第5章 HER2低発現乳がんのパイプライン情勢

• プロファイルの概要
• 後期段階の資産比較の概要
• HER2低発現乳がんパイプライン医薬品プロファイル

第6章 HER2低発現乳がん市場概要

• 現在の市場シナリオ
• HER2低発現乳がん市場の市場可能性
• HER2低発現乳がん市場の潜在力市場の障壁と課題

第7章 HER2低発現乳がんの将来の見通し

第8章 SWOT分析

第9章 付録

The “HER2-Low Breast Cancer -Pipeline Analytics -2023” report published by Mellalta Meets covers the HER2-Low Breast Cancer Therapies market opportunity providing Key Competitive Analysis, 30+ Companies with Pipeline Drug Profiles, Clinical Trials, Other Developments (Collaboration Details, Funding, etc.), Licensing and Agreements, Business Agreement, Business Partner as well as Clinical Partner. Reports cover pipeline product analysis by stage of development, competitive landscape by phases, companies, therapy area and indication by phases. HER2-Low Metastatic Breast Cancer reports add value in terms of providing the description of clinical-stage products with respect to their clinical & regulatory timelines as well as in terms of providing the current market opportunity, drivers and challenges.

The introduction of HER2-low breast cancer represents a significant shift in the understanding and treatment of breast cancer. 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. The changing treatment landscape has created new opportunities in the market for more companies to develop and commercialize the use of therapeutic ADCs in HER2-low tumors.

In this report, Mellalta Meets provides an in-depth analysis of the HER2-Low Breast Cancer Pipeline covering preclinical and clinical studies, details of partnerships and business deal values, targeted technologies and therapy areas, investments, and acquisition trends. Currently, there are more than 33+ candidates in the HER2-Low Breast Cancer Pipeline under evaluation in clinical and preclinical studies. The major key players operating in the market are Jiangsu HengRui Medicine, Duality Biologics, Yantai Rongchang Pharmaceutical, Gilead Sciences, AstraZeneca/Daiichi Sankyo and many more which have robust clinical pipeline of HER2-Low Breast Cancer candidates.

As per analysis, the development pipeline is full of different ADCs and combination approaches which can help in addressing this new subtype of Breast cancer.

Mellalta's HER2-Low Breast Cancer Pipeline Report- Market Summary

Report Attributes	Details
Key Late Stage Market Players:	Jiangsu HengRui Medicine; Duality Biologics; Yantai Rongchang Pharmaceutical; Gilead Sciences; AstraZeneca/Daiichi Sankyo.
Lead Assets:	Phase 3 (10+); Phase 2 (10+); Phase 1 (5+); Preclinical (3+); Discovery stages.

Mellalta's HER2-Low Breast Cancer Pipeline Report - Key Highlights

• There are ~10 products in the Phase 3 stage of development, representing ~35% of the total share of the developing HER2-Low Breast Cancer Therapeutics landscape.

• The pipeline of HER2-Low Breast Cancer therapies is dominated by the Phase III (10+) assets; Phase II (10+); Phase I (5+) and Preclinical (3+) and Discovery assets.

• To be continued…

Report Coverage:

• Indication Prioritization: HER2-Low Breast Cancer market potential based on Indications

• Business Transactions & Strategies: Key collaborations and deal values

• HER2-Low Breast Cancer Pipeline Development: Product Profiles, Clinical Trials & Results

• HER2-Low Breast Cancer Acquisition Targets

• HER2-Low Breast Cancer Competitive Intelligence

• Recent and upcoming events

Table of Content

1. REPORT OVERVIEW

2. OVERVIEW

• 2.1. HER2-Low Breast Cancer - Overview
• 2.2. Diagnostic tools for HER2-Low Breast Cancer
• 2.3. AI-based HER2-low IHC scoring in breast cancer
• 2.4. Diagnostic tools for HER2-Low Breast Cancer detection: Limitations
• 2.5. Current Challenges with HER2-Low Breast Cancer

3. HER2-LOW BREAST CANCER PIPELINE ANALYSIS

• 3.1. Overview
• 3.2. Assets by Indication/Phase
• 3.3. Pipeline Products by Stage of Development
• 3.4. HER2-Low Breast Cancer Competitive Landscape
• 3.5. Pipeline Products by Company and Phases
• 3.6. HER2-Low Breast Cancer Clinical & Regulatory Timelines

4. HER2-LOW BREAST CANCER ACQUISITIONS, LICENSING AND COLLABORATION DEALS

• 4.1. HER2-Low Breast Cancer Acquisitions, Licensing and Deal values
• 4.2. HER2-Low Breast Cancer Acquisitions, Licensing by Transaction type and total amount size by Phases
• 4.3. Promising Technologies Under development

5. HER2-Low Breast Cancer PIPELINE LANDSCAPE

• 5.1. Profile at Glance
• 5.2. Late-Stage Assets Comparisons At-a-glance
• 5.3. HER2-Low Breast Cancer Pipeline Drug Profiles
  • 5.3.1. Phase III
    • 5.3.1.1. Duality Biologics: DB-1303
      • 5.3.1.1.1. Product Profile & Description
      • 5.3.1.1.2. Collaborations
      • 5.3.1.1.3. Other Developments
      • 5.3.1.1.4. Clinical Trials
    • 5.3.1.2. Jiangsu HengRui Medicine: Trastuzumab rezetecan
      • 5.3.1.2.1. Product Profile & Description
      • 5.3.1.2.2. Collaborations
      • 5.3.1.2.3. Other Developments
      • 5.3.1.2.4. Clinical Trials
    • 5.3.1.3. RemeGen/Seagen: Disitamab vedotin
      • 5.3.1.3.1. Product Profile & Description
      • 5.3.1.3.2. Collaborations
      • 5.3.1.3.3. Other Developments
      • 5.3.1.3.4. Clinical Trials
      • 5.3.1.3.5. Others…
    • 5.3.1.4. Phase II
      • 5.3.1.4.1. Miracogen: MRG002
        • 5.3.1.4.1.1. Product Profile & Description
        • 5.3.1.4.1.2. Collaborations
        • 5.3.1.4.1.3. Other Developments
        • 5.3.1.4.1.4. Clinical Trials
      • 5.3.1.4.2. Merus: MCLA-128
        • 5.3.1.4.2.1. Product Profile & Description
        • 5.3.1.4.2.2. Collaborations
        • 5.3.1.4.2.3. Other Developments
        • 5.3.1.4.2.4. Clinical Trials
        • 5.3.1.4.2.5. Others…
      • 5.3.1.4.3. Phase I
        • 5.3.1.4.3.1. Sichuan Baili Pharmaceutical/SystImmune: BL-M07D1
        • 5.3.1.4.3.2. Product Profile & Description
        • 5.3.1.4.3.3. Collaborations
        • 5.3.1.4.3.4. Other Developments
        • 5.3.1.4.3.5. Clinical Trials
      • 5.3.1.4.4. HighField Biopharmaceuticals Corporation: HF158K1
        • 5.3.1.4.4.1. Product Profile & Description
        • 5.3.1.4.4.2. Collaborations
        • 5.3.1.4.4.3. Other Developments
        • 5.3.1.4.4.4. Clinical Trials
        • 5.3.1.4.4.5. Others…

6. HER2-LOW BREAST CANCER MARKET OVERVIEW

• 6.1. Current Market Scenario
• 6.2. Market Potential of HER2-Low Breast Cancer Market
• 6.3. Market Potential of HER2-Low Breast Cancer Market Barriers & Challenges

7. HER2-LOW BREAST CANCER FUTURE PROSPECTS

8. SWOT ANALYSIS

9. APPENDIX