表紙
市場調査レポート

PharmaPoint:HER2陽性乳がん - 米国での医薬品の予測と市場分析

PharmaPoint: HER2-Positive Breast Cancer - US Drug Forecast and Market Analysis to 2023

発行 GlobalData 商品コード 316761
出版日 ページ情報 英文 165 Pages
即納可能
価格
本日の銀行送金レート: 1USD=101.50円で換算しております。
Back to Top
PharmaPoint:HER2陽性乳がん - 米国での医薬品の予測と市場分析 PharmaPoint: HER2-Positive Breast Cancer - US Drug Forecast and Market Analysis to 2023
出版日: 2014年09月30日 ページ情報: 英文 165 Pages
概要

米国ではHER2陽性乳がんの発症者数が多く、欧州主要5ヶ国の全体とほぼ同じ人数となっています。また、全てのステージ(病期)において、HER2標的治療薬としてアジュバンド(補助剤)やネオアジュバンドを用いた事例も多く、それが米国のHER2標的治療薬市場の促進材料となっています。一方、米国の民間健康保険制度では最新・高価格の医薬品にも大抵は医療費を償還する制度になっているため、HER2標的治療薬の費用は高額になっています。

当レポートでは、米国におけるHER2陽性乳がんの治療薬に関する最新の研究・開発状況と、関連市場の将来展望とを分析し、疾患の概要や治療法、市場機会とアンメットニーズ、市場規模の動向(今後10年間分)、現在発売中および治験中の主な薬剤のプロファイル、米国市場の現状と今後の方向性などの情報をお届けします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因と病態
    • 病因
    • 病態生理
  • 乳房の解剖学的基本構造
  • 乳がんのステージング
  • 予後
  • 生活の質(QoL)
  • 症状

第4章 疾患管理

  • 治療法の概要
    • 初期段階での乳がん治療(ステージ0〜IB)
    • 局所進行性・局所性の乳がん(ステージIB〜IIIA)
    • 転移性・HER2陽性乳がん(ステージIV)の治療
  • 米国
    • 診断
    • 臨床診療

第5章 競合製品の評価

  • 概要
  • 製品プロファイル:HER2標的療法
    • Herceptin(トラスツズマブ)
    • Tykerb(ラパチニブ)
    • Perjeta(ペルツズマブ)
    • Kadcyla(Ado-トラスツズマブ・エムタンシン、T-DM1)
  • 製品プロファイル:一般的な標的療法
    • Afinitor(エベロリムス)
    • Xeloda(カペシタビン)
    • Avastin(ベバシズマブ)
    • Halaven(エリブリンメシル酸塩)
    • Abraxane(ナノ粒子アルブミンパクリタキセル)
    • Ixempra(イキサベピロン)
  • ホルモン剤
    • Tamoxifen
    • Faslodex(フルベストラント)
    • アロマターゼ阻害剤

第6章 アンメットニーズと市場機会

  • 概要
  • 脳転移
    • アンメットニーズ
    • ギャップ分析
    • 市場機会
  • HER2標的治療薬に対する耐性

第7章 パイプライン評価

  • 概要
  • 治験段階にある有望な薬剤
    • Gilotrif(アファチニブ)
    • Neratinib
  • 治験の初期段階にある有望な薬剤
    • Palbociclib
    • NeuVax(ネリペプムト-S)
    • Patritumab
    • Ganetespib
    • ARRY-380 (ONT-380)
    • NVP-BYL719
  • バイオシミラー

第8章 市場の見通し

  • 米国
    • 将来予測
    • 主要動向
    • 市場促進・阻害要因:世界的な問題
    • 市場促進・阻害要因:米国の場合

第9章 付録

図表一覧

目次
Product Code: GDHC253CFR

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-positive breast cancer market, with coverage of multiple settings of the disease including neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

The high incidence of HER2-positive breast cancer in the US, almost equaling that of the entire 5EU, and the high treatment rates in the neoadjuvant and adjuvant settings using HER2-targeted therapies in all stages, have helped drive the sales of HER2-positive therapeutics in the US. HER2-targeting therapies are priced at a premium in the US, owing to the country's private health insurance system, which can most easily afford to reimburse the latest expensive drugs.

Scope

  • An overview of HER2-Positive Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized the US HER2-Positive Breast Cancer market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
  • Investigation of current and future market competition for HER2-Positive Breast Cancer.
  • Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
  • Competitor assessment including device approval analysis and device sales forecasts.
  • Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
  • Analysis of unmet needs within the market and opportunities for future players.
  • Technology trends evaluation to assess strength of pipeline.
  • An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
  • Company profiles including business description, financial overview and SWOT analysis.
  • Coverage of key market players.
  • Strategic assessment of the HER2-Positive Breast Cancer sector through market impact analysis, future market scenario and company analysis.
  • Direct quotes from Key Opinion Leaders (KOL) as well as doctors

Reasons to buy

  • Understand the trends shaping and driving the US HER2-Positive Breast Cancer market.
  • Realize device preferences of physicians who have performed the tests already.
  • Access market sizing, forecasts and quantified growth opportunities in the US HER2-Positive Breast Cancer market through 2018.
  • Quantify candidate patient populations to better design product pricing & launch plans.
  • Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
  • Perform benchmarking analysis of growth opportunities against currently marketed products.
  • Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
  • Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.
  • Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
  • What's the next big thing in the US HER2-Positive Breast Cancer market landscape Identify, understand and capitalize.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Basic Breast Anatomy
  • 3.3. Breast Cancer Staging
  • 3.4. Prognosis
  • 3.5. Quality of Life
  • 3.6. Symptoms

4. Disease Management

  • 4.1. Treatment Overview
    • 4.1.1. Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB)
    • 4.1.2. Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA)
    • 4.1.3. Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV)
  • 4.2. US
    • 4.2.1. Diagnosis
    • 4.2.2. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Product Profiles - HER2-Targeted Therapies
    • 5.2.1. Herceptin (trastuzumab)
    • 5.2.2. Tykerb (lapatinib)
    • 5.2.3. Perjeta (pertuzumab)
    • 5.2.4. Kadcyla (ado-trastuzumab emtansine, T-DM1)
  • 5.3. Product Profiles - General Targeted Therapies
    • 5.3.1. Afinitor (everolimus)
    • 5.3.2. Xeloda (capecitabine)
    • 5.3.3. Avastin (bevacizumab)
    • 5.3.4. Halaven (eribulin mesylate)
    • 5.3.5. Abraxane (nab-paclitaxel)
    • 5.3.6. Ixempra (ixabepilone)
  • 5.4. Hormonal Agents
    • 5.4.1. Tamoxifen
    • 5.4.2. Faslodex (fulvestrant)
    • 5.4.3. Aromatase Inhibitors

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Brain Metastases
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Resistance to HER2-Targeting Therapies
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development
    • 7.2.1. Gilotrif (afatinib)
    • 7.2.2. Neratinib
  • 7.3. Promising Drugs in Early-Stage Development
    • 7.3.1. Palbociclib
    • 7.3.2. NeuVax (nelipepimut-S)
    • 7.3.3. Patritumab
    • 7.3.4. Ganetespib
    • 7.3.5. ARRY-380 (ONT-380)
    • 7.3.6. NVP-BYL719
  • 7.4. Biosimilars

8. Market Outlook

  • 8.1. United States
    • 8.1.1. Forecast
    • 8.1.2. Key Events
    • 8.1.3. Drivers and Barriers - Global Issues
    • 8.1.4. United States - Drivers and Barriers

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed HER2-Positive Breast Cancer Patients
    • 9.4.2. Percent Drug-Treated Patients
    • 9.4.3. Drugs Included in Each Therapeutic Class
    • 9.4.4. Launch and Patent Expiry Dates
    • 9.4.5. General Pricing Assumptions
    • 9.4.6. Individual Drug Assumptions
    • 9.4.7. Generic Erosion
    • 9.4.8. Pricing of Pipeline Agents
  • 9.5. Primary Research - KOLs Interviewed for this Report
  • 9.6. Primary Research - Prescriber Survey
  • 9.7. About the Authors
    • 9.7.1. Analyst
    • 9.7.2. Therapy Area Director
    • 9.7.3. Global Head of Healthcare
  • 9.8. About GlobalData
  • 9.9. Disclaimer

List of Tables

  • Table 1: AJCC Stage Definitions for Breast Cancer
  • Table 2: Prognosis for Breast Cancer in the US
  • Table 3: Treatment Guidelines for HER2-Positive Breast Cancer
  • Table 4: Product Profile - Herceptin
  • Table 5: Clinical Studies for Herceptin in the Adjuvant Setting
  • Table 6: Herceptin SWOT Analysis, 2013
  • Table 7: Product Profile - Tykerb
  • Table 8: Tykerb SWOT Analysis, 2013
  • Table 9: Product Profile - Perjeta
  • Table 10: Perjeta SWOT Analysis, 2013
  • Table 11: Product Profile - Kadcyla
  • Table 12: Kadcyla SWOT Analysis, 2013
  • Table 13: Product Profile - Afinitor
  • Table 14: Afinitor SWOT Analysis, 2013
  • Table 15: Product Profile - Xeloda
  • Table 16: Xeloda SWOT Analysis, 2013
  • Table 17: Product Profile - Avastin
  • Table 18: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer
  • Table 19: Avastin SWOT Analysis, 2013
  • Table 20: Product Profile - Halaven
  • Table 21: Halaven SWOT Analysis, 2013
  • Table 22: Product Profile - Abraxane
  • Table 23: Abraxane SWOT Analysis, 2013
  • Table 24: Product Profile - Ixempra
  • Table 25: Ixempra SWOT Analysis, 2013
  • Table 26: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013
  • Table 27: Unmet Need and Opportunity in HER2-Positive Breast Cancer
  • Table 28: Product Profile - Gilotrif
  • Table 29: Gilotrif SWOT Analysis, 2014
  • Table 30: Product Profile - Neratinib
  • Table 31: Neratinib SWOT Analysis, 2013
  • Table 32: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014
  • Table 33: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014
  • Table 34: Product Profile - Palbociclib
  • Table 35: Palbociclib SWOT Analysis, 2014
  • Table 36: Product Profile - NeuVax
  • Table 37: NeuVax SWOT Analysis, 2014
  • Table 38: Product Profile - Patritumab
  • Table 39: Patritumab SWOT Analysis, 2014
  • Table 40: Product Profile - Ganetespib
  • Table 41: Ganetespib SWOT Analysis, 2014
  • Table 42: Product Profile - ARRY-380
  • Table 43: ARRY-380 SWOT Analysis, 2014
  • Table 44: Product Profile - NVP-BYL719
  • Table 45: NVP-BYL719 SWOT Analysis, 2014
  • Table 46: Trastuzumab Biosimilars, 2014
  • Table 47: Sales Forecast ($m) for HER2-Positive Breast Cancer in the US, 2013-2023
  • Table 48: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2013-2023
  • Table 49: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 50: US HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 51: HER2-Positive Breast Cancer Incidence, 2013-2023
  • Table 52: HER2-Positive Breast Cancer Drugs, Key Launch Dates
  • Table 53: HER2-Positive Breast Cancer Drugs, Key Patent Expiries
  • Table 54: Average Body Weight and Surface Area in the US
  • Table 55: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant
  • Table 56: Average Annual Cost of Therapy ($) - Perjeta, First Line
  • Table 57: Average Annual Cost of Therapy ($) - Tykerb, First Line
  • Table 58: Average Annual Cost of Therapy ($) - Kadcyla, Second Line
  • Table 59: Average Annual Cost of Therapy ($)- Halaven, Fourth Line
  • Table 60: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line
  • Table 61: Average Annual Cost of therapy ($) - Ixempra, Fourth Line
  • Table 62: Average Annual Cost of Therapy ($) - Neratinib, Third Line
  • Table 63: Physicians Surveyed by Country

List of Figures

  • Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes
  • Figure 2: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb
  • Figure 3: Active Late-Stage Clinical Trials for Perjeta
  • Figure 4: Active Phase III Clinical Trials for Kadcyla
  • Figure 5: Active Phase III Clinical Trials for Afinitor
  • Figure 6: Clinical Trials for Halaven
  • Figure 7: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013
  • Figure 8: Gilotrif's Clinical Development in Breast Cancer
  • Figure 9: Clinical and Commercial Positioning of Gilotrif
  • Figure 10: Neratinib's Clinical Development
  • Figure 11: Clinical and Commercial Positioning of neratinib.
  • Figure 12: Sales for HER2-Positive Breast Cancer in the US by Drug Class, 2013-2023
Back to Top