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PharmaPoint:HER2陽性乳がん - 欧州主要5ヶ国での医薬品の予測と市場分析

PharmaPoint: HER2-Positive Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023

発行 GlobalData 商品コード 316762
出版日 ページ情報 英文 196 Pages
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PharmaPoint:HER2陽性乳がん - 欧州主要5ヶ国での医薬品の予測と市場分析 PharmaPoint: HER2-Positive Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023
出版日: 2014年09月30日 ページ情報: 英文 196 Pages
概要

HER2標的治療薬として最初に上市されたHerceptinは、フランスを初めとする分析対象国で市場の主導権を握っています。一方、新規に認証された治療薬の市場成長率はドイツが最大となっています。同国におけるPerjetaおよびKadcylaの販売状況がこの動きを物語っています。2013年現在、HerceptinはイタリアのHER2標的治療薬市場の94%を占めています。一方で、HER2標的のネオアジュバント(米国で既に認証されたPerjetaなど)の利用増加を受けて、スペインの乳がん市場は今後拡大する見通しです。

当レポートでは、欧州主要5ヶ国(フランス・ドイツ・イタリア・スペイン・英国)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、各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
  • フランス
    • 診断
    • 臨床診療
  • ドイツ
  • イタリア
  • スペイン
  • 英国

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)
  • 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標的治療薬への耐性

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

  • 世界市場
    • 市場促進・阻害要因:世界的な問題
  • フランス
    • 将来予測
    • 主要動向
    • 市場促進・阻害要因
  • ドイツ
  • イタリア
  • スペイン
  • 英国

第9章 付録

図表一覧

目次
Product Code: GDHC254CFR

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.

As in the other seven countries covered in this report, Herceptin is the market leader in France, since it was the first HER2-targeting agent to market. Newly-approved drugs tend to gain market access faster in Germany than in the other four EU countries, and this is reflected in the use of Perjeta and Kadcyla in the German HER2-positive breast cancer market. In 2013, Herceptin was the market leader, accounting for 94% of sales in the Italian HER2-positive market. There will be an increase in the breast cancer market size in Spain during the forecast period due to the increased use of HER2-targeted therapies in the neoadjuvant setting, in particular, Perjeta, which is already approved for use in this setting in the US.

Scope

  • An overview of HER2-Positive Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
  • Annualized the 5EU 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 5EU 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 5EU 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 5EU 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. France
    • 4.2.1. Diagnosis
    • 4.2.2. Clinical Practice
  • 4.3. Germany
    • 4.3.1. Diagnosis
    • 4.3.2. Clinical Practice
  • 4.4. Italy
    • 4.4.1. Diagnosis
    • 4.4.2. Clinical Practice
  • 4.5. Spain
    • 4.5.1. Diagnosis
    • 4.5.2. Clinical Practice
  • 4.6. UK
    • 4.6.1. Diagnosis
    • 4.6.2. 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)
  • 5.4. 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. Global Markets
    • 8.1.1. Drivers and Barriers - Global Issues
  • 8.2. France
    • 8.2.1. Forecast
    • 8.2.2. Key Events
    • 8.2.3. Drivers and Barriers
  • 8.3. Germany
    • 8.3.1. Forecast
    • 8.3.2. Key Events
    • 8.3.3. Drivers and Barriers
  • 8.4. Italy
    • 8.4.1. Forecast
    • 8.4.2. Key Events
    • 8.4.3. Drivers and Barriers
  • 8.5. Spain
    • 8.5.1. Forecast
    • 8.5.2. Drivers and Barriers
  • 8.6. United Kingdom
    • 8.6.2. Key Events
    • 8.6.3. 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: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013
  • Table 25: Unmet Need and Opportunity in HER2-Positive Breast Cancer
  • Table 26: Product Profile - Gilotrif
  • Table 27: Gilotrif SWOT Analysis, 2014
  • Table 28: Product Profile - Neratinib
  • Table 29: Neratinib SWOT Analysis, 2013
  • Table 30: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014
  • Table 31: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014
  • Table 32: Product Profile - Palbociclib
  • Table 33: Palbociclib SWOT Analysis, 2014
  • Table 34: Product Profile - NeuVax
  • Table 35: NeuVax SWOT Analysis, 2014
  • Table 36: Product Profile - Patritumab
  • Table 37: Patritumab SWOT Analysis, 2014
  • Table 38: Product Profile - Ganetespib
  • Table 39: Ganetespib SWOT Analysis, 2014
  • Table 40: Product Profile - ARRY-380
  • Table 41: ARRY-380 SWOT Analysis, 2014
  • Table 42: Product Profile - NVP-BYL719
  • Table 43: NVP-BYL719 SWOT Analysis, 2014
  • Table 44: Trastuzumab Biosimilars, 2014
  • Table 45: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 46: Sales Forecast ($m) for HER2-Positive Breast Cancer in France, 2013-2023
  • Table 47: Key Events Impacting Sales for HER2-Positive Breast Cancer in France, 2013-2023
  • Table 48: French HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 49: Sales Forecast ($m) for HER2-Positive Breast Cancer in Germany, 2013-2023
  • Table 50: Key Events Impacting Sales for HER2-Positive Breast Cancer in Germany, 2013-2023
  • Table 51: German HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 52: Sales Forecast ($m) for HER2-Positive Breast Cancer in Italy, 2013-2023
  • Table 53: Key Events Impacting Sales for HER2-Positive Breast Cancer in Italy, 2013-2023
  • Table 54: Italian HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 55: Sales Forecast ($m) for HER2-Positive Breast Cancer in Spain, 2013-2023
  • Table 56: Key Events Impacting Sales for HER2-Positive Breast Cancer in Spain, 2013-2023
  • Table 57: Spanish HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 58: Sales Forecast ($m) for HER2-Positive Breast Cancer in the UK, 2013-2023
  • Table 59: Key Events Impacting Sales for HER2-Positive Breast Cancer in the UK, 2013-2023
  • Table 60: UK HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023
  • Table 61: HER2-Positive Breast Cancer Incidence, 2013-2023
  • Table 62: HER2-Positive Breast Cancer Drugs, Key Launch Dates
  • Table 63: HER2-Positive Breast Cancer Drugs, Key Patent Expiries
  • Table 64: Average Body Weight and Surface Area Across the 5EU Markets
  • Table 65: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant
  • Table 66: Average Annual Cost of Therapy ($) - Subcutaneous Herceptin, Adjuvant
  • Table 67: Average Annual Cost of Therapy ($) - Perjeta, First Line
  • Table 68: Average Annual Cost of Therapy ($) - Tykerb, First Line
  • Table 69: Average Annual Cost of Therapy ($) - Kadcyla, Second Line
  • Table 70: Average Annual Cost of Therapy ($) - Halaven, Fourth Line
  • Table 71: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line
  • Table 72: Average Annual Cost of Therapy ($) - Neratinib, Third Line
  • Table 73: 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 France by Drug Class, 2013-2023
  • Figure 13: Sales for HER2-Positive Breast Cancer in Germany by Drug Class, 2013-2023
  • Figure 14: Sales for HER2-Positive Breast Cancer in Italy by Drug Class, 2013-2023
  • Figure 15: Sales for HER2-Positive Breast Cancer in Spain by Drug Class, 2013-2023
  • Figure 16: Sales for HER2-Positive Breast Cancer in the UK by Drug Class, 2013-2023
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