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PharmaPoint:HER2陽性乳癌 - 世界の医薬品の予測と市場分析

PharmaPoint: HER2-Positive Breast Cancer - Global Drug Forecast and Market Analysis to 2025

発行 GlobalData 商品コード 320818
出版日 ページ情報 英文 416 Pages
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PharmaPoint:HER2陽性乳癌 - 世界の医薬品の予測と市場分析 PharmaPoint: HER2-Positive Breast Cancer - Global Drug Forecast and Market Analysis to 2025
出版日: 2017年06月24日 ページ情報: 英文 416 Pages
概要

HER2陽性乳癌とは、世界で二番目に一般的な癌で、特に女性の間では最も一般的となっています。1998年にRocheがモノクローナル抗体Herceptin(トラスツズマブ)を開発して以来、この疾患の治療法は劇的に変化しました。HER2を標的とした治療が可能となったことから、乳癌の無病生存率(DFS)は大幅に向上し、HER2標的療法の市場を開拓することとなりました。現在でも、RocheがHER2陽性乳癌治療薬市場の95%を押さえています。同社ではHerceptinの特許失効後もジェネリック医薬品(PerjetaおよびKadcyla)を開発して市場の主導権を維持しており、その独占体制は当面は変わらない見通しです。

当レポートでは、世界の主要7ヶ国におけるHER2乳癌の治療法に関する最新の研究・開発状況と、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)、上市済み/治験中の主な治療薬のプロファイル(効能・安全性・市場競争力)、世界全体・各国市場の現状と今後の方向性などの情報をお届けいたします。

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

  • 病因と病態生理学
    • 病因
    • 病態生理学
  • 基本的な胸部解剖学
  • 乳癌の病期分類
  • 予後
  • 生活の質(QoL)
  • 症状

第4章 疫学

  • 疾患の背景事情
  • リスク要因と共存症
    • 乳癌およびBRCA1/2遺伝子突然変異の家族歴のある場合、発症リスクは大幅に上がる
    • 生殖ホルモンの要素が、乳癌にリスクに影響する
    • ライフスタイルで変更可能な要因が、乳癌患者の死亡リスクに影響する
    • 検査プログラムは癌の死亡率を引き下げたが、そのメリットとリスクとをよく対比する必要がある
  • 世界傾向
    • 発症率
    • 患者数・生存者数
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法
  • 乳癌の疫学的予測(今後11年間分):受診した発症者の症例数
    • 診断を受けた乳癌発症者の件数
    • 診断を受けた乳癌発症者の件数:年齢別
    • 診断を受けた乳癌発症者の件数:閉経の有無別
    • 診断を受けた乳癌発症者の件数:診断時の病期(ステージ)別
    • 診断を受けた乳癌発症者の件数(年齢調整済み)
  • 乳癌の疫学的予測(今後11年間分):受診した有病者の症例数
    • 乳癌の5年有病者数(診断済み)
    • 乳癌の5年有病者数(診断済み):閉経の有無別
    • 乳癌の5年有病者数(診断済み):ホルモン受容体の種類別
  • 議論
    • 疫学的予測による考察
    • 分析の限界
    • 分析の強み

第5章 疾患管理

  • 治療概要
    • 早期ステージの乳癌(ステージ0〜IB)の治療法
    • 局所進行性および地域の乳癌(病期IB〜IIIA)の治療法
    • 転移性HER2-陽性乳癌(病期IV)の治療法
  • 米国
    • 診断
    • 臨床診療
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • 中国

第6章 競合評価

  • 概要
  • 製品プロファイル:HER2標的療法
    • Herceptin(トラスツズマブ)
    • Tykerb(ラパティニブ)
    • 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)
    • Xelota(カペシタビン)
    • Avastin(ベバシズマブ)
    • Halaven(メシル酸エリブリン)
    • Abraxane(nab -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)
    • アロマターゼ阻害薬

第7章 アンメットニーズおよび機会

  • 概要
  • 脳転移
    • アンメットニーズ
    • ギャップ分析
    • 機会
  • HER2-標的療法への耐性
    • アンメットニーズ
    • ギャップ分析
    • 機会

第8章 パイプライン評価

  • 概要
  • 治験段階の有望な薬剤
    • Gilotrif(アファチニブ)
    • Neratinib
  • 治験の早期段階にある有望な薬剤
    • Palbociclib
    • NeuVax(nelipepimut-S)
    • Patritumab
    • Ganetespib
    • ARRY-380(ONT-380)
    • NVP-BYL719
  • バイオシミラー

第9章 現在および将来の主要企業

  • 概要
  • 企業戦略の動向
  • 企業プロファイル
    • Roche/Genentech
    • GlaxoSmithKline
    • Boehringer Ingelheim
    • Novartis
    • Pfizer

第10章 市場の見通し

  • 世界市場
    • 予測
    • 推進因子および障害 : 世界の問題
  • 米国
    • 予測
    • 近年の主な動向
    • 推進因子および障害
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • 英国
  • 日本
  • 中国

第11章 付録

図表一覧

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目次
Product Code: GDHC151PIDR

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. Today, HER2-positive breast cancer patients are living longer with their disease, thanks to established disease management strategies using numerous combinations of chemotherapy with Herceptin, Perjeta, and the tyrosine kinase inhibitor (TKI) Tykerb (lapatinib). During the forecast period from 2015-2025, GlobalData expects that the HER2-positive market will grow due to the launch of HER2-targeted agents in the early disease setting and the aging populations in the US, 5EU (France, Germany, Italy, Spain, and the UK), Japan, and China.

Following the patent expiry of Herceptin and the subsequent highly anticipated introduction of trastuzumab biosimilars during the forecast period, the market is expected to face its biggest barrier to growth to date. Despite a lack of game-changing innovation in the HER2-positive market, the pipeline is diverse with several agents being investigated in the extended adjuvant and metastatic settings. A number of these agents are looking to address the greatest unmet need for HER2-positive breast cancer patients-brain metastases-which typically occur in the later lines of metastatic therapy and are caused by increasingly resistant disease.

Key Questions Answered

  • How will biosimilar penetration impact the HER2-positive breast cancer market, especially following the launch of trastuzumab biosimilars in the 8MM?
  • How will new pipeline agents such as Ibrance and neratinib impact the HER2-positive breast cancer market?
  • The HER2-positive breast cancer market is characterized by a number of unmet needs in the current treatments. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil these unmet needs?
  • What impact will the approval of Roche's Perjeta in the adjuvant setting following data from the Aphinity trial have on the HER2-positive breast cancer market? What will be the drug's peak sales, and why?

Scope

  • Overview of HER2-positive breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized HER2-positive breast cancer therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in nine patient segments and two treatment strategies (episodic and prophylactic treatment), forecast from 2016 to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HER2-positive breast cancer therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for HER2-positive breast cancer. The most promising candidate in Phase III development is profiled.
  • Analysis of the current and future market competition in the global HER2-positive breast cancer market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global HER2-positive breast cancer market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2-positive breast cancer market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 7
  • 1.2 List of Figures 11

2 Executive Summary 13

  • 2.1 HER2-Positive Breast Cancer Market to Increase by 50% by 2025 13
  • 2.2 Perjeta Will Be the Strongest Driver of Market Growth 16
  • 2.3 The Launch of Biosimilar Trastuzumab 17
  • 2.4 Roche Will Continue to Monopolize the HER2-Positive Breast Cancer Market, Despite Herceptin Patent Loss 18
  • 2.5 Improved Treatment for Brain Metastases Remains a Pressing Unmet Need 19
  • 2.6 What Do Physicians Think? 21

3 Introduction 24

  • 3.1 Catalyst 24
  • 3.2 Related Reports 24
  • 3.3 Upcoming Related Reports 25

4 Disease Overview 26

  • 4.1 Etiology and Pathophysiology 26
    • 4.1.1 Etiology 26
    • 4.1.2 Pathophysiology 26
  • 4.2 Basic Breast Anatomy 29
  • 4.3 Breast Cancer Staging 30
  • 4.4 Prognosis 31
  • 4.5 Quality of Life 32
  • 4.6 Symptoms 34

5 Epidemiology 35

  • 5.1 Disease Background 35
  • 5.2 Risk Factors and Comorbidities 36
  • 5.3 Global Trends 38
    • 5.3.1 US 39
    • 5.3.2 5EU 39
    • 5.3.3 Japan 40
    • 5.3.4 China (Urban) 40
    • 5.3.5 Prevalence and Survival 41
  • 5.4 Forecast Methodology 44
    • 5.4.1 Sources Used Tables 45
    • 5.4.2 Forecast Assumptions and Methods 57
    • 5.4.3 Sources Not Used 75
  • 5.5 Epidemiological Forecast for Non-Invasive DCIS Breast Cancer (2015-2025) 76
    • 5.5.1 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer 76
    • 5.5.2 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 78
  • 5.6 Epidemiological Forecast for Invasive Breast Cancer (2015-2025) 79
    • 5.6.1 Diagnosed Incident Cases of Invasive Breast Cancer 79
    • 5.6.2 Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer 81
    • 5.6.3 Age-Standardized Diagnosed Incidence of Invasive Breast Cancer 83
    • 5.6.4 Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer 84
    • 5.6.5 Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis 86
    • 5.6.6 Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status 87
    • 5.6.7 Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Menopausal Status, and Site of Metastasis 89
    • 5.6.8 Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Stage at Diagnosis, Menopausal Status, and Type of Biomarker Expression 92
    • 5.6.9 Diagnosed Incident Cases of TN Breast Cancer by Stage at Diagnosis and BRCA Expression 95
  • 5.7 Discussion 97
    • 5.7.1 Epidemiological Forecast Insight 97
    • 5.7.2 Limitations of the Analysis 99
    • 5.7.3 Strengths of the Analysis 101

6 Disease Management 102

  • 6.1 Treatment Overview 102
    • 6.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 102
    • 6.1.2 Treatment of Locally Advanced and Regional Breast Cancer (Stage IB to IIIA) 103
    • 6.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 106
  • 6.2 US 109
    • 6.2.1 Diagnosis 109
    • 6.2.2 Clinical Practice 109
  • 6.3 France 112
    • 6.3.1 Diagnosis 112
    • 6.3.2 Clinical Practice 113
  • 6.4 Germany 114
    • 6.4.1 Diagnosis 114
    • 6.4.2 Clinical Practice 115
  • 6.5 Italy 117
    • 6.5.1 Diagnosis 117
    • 6.5.2 Clinical Practice 117
  • 6.6 Spain 119
    • 6.6.1 Diagnosis 119
    • 6.6.2 Clinical Practice 119
  • 6.7 UK 121
    • 6.7.1 Diagnosis 121
    • 6.7.2 Clinical Practice 122
  • 6.8 Japan 123
    • 6.8.1 Diagnosis 123
    • 6.8.2 Clinical Practice 124
  • 6.9 China 126
    • 6.9.1 Diagnosis 126
    • 6.9.2 Clinical Practice 127

7 Competitive Assessment 129

  • 7.1 Overview 129
  • 7.2 Product Profiles - HER2-Targeted Therapies 130
    • 7.2.1 Herceptin (Trastuzumab) 130
    • 7.2.2 Tykerb (Lapatinib) 143
    • 7.2.3 Perjeta (Pertuzumab) 151
    • 7.2.4 Kadcyla (Ado-trastuzumab Emtansine, T-DM1) 159
  • 7.3 Product Profiles - General Targeted Therapies 165
    • 7.3.1 Halaven (Eribulin Mesylate) 165
    • 7.3.2 Abraxane (Nab-Paclitaxel) 171
    • 7.3.3 Ixempra (Ixabepilone) 176
  • 7.4 Hormonal Agents 181
    • 7.4.1 Tamoxifen 183
    • 7.4.2 Faslodex (Fulvestrant) 183
    • 7.4.3 Aromatase Inhibitors 184

8 Unmet Need and Opportunity 186

  • 8.1 Overview 186
  • 8.2 Treatment of Brain/CNS Metastases 187
    • 8.2.1 Unmet Need 187
    • 8.2.2 Gap Analysis 188
    • 8.2.3 Opportunity 189
  • 8.3 Resistance to HER2-Targeted Therapies 190
    • 8.3.1 Unmet Need 190
    • 8.3.2 Gap Analysis 191
    • 8.3.3 Opportunity 192
  • 8.4 Effective Alternatives to Chemotherapy 193
    • 8.4.1 Unmet Need 193
    • 8.4.2 Gap Analysis 194
    • 8.4.3 Opportunity 194

9 Pipeline Assessment 195

  • 9.1 Overview 195
  • 9.2 HER2-Targeted Therapies 199
    • 9.2.1 Neratinib 199
    • 9.2.2 Margetuximab 212
    • 9.2.3 Tucatinib (ONT-380) 218
    • 9.2.4 Pyrotinib 225
  • 9.3 Other Therapies 230
    • 9.3.1 Utidelone (Depoxythilone; UTD-1) 230
    • 9.3.2 Ibrance (Palbociclib) 236
    • 9.3.3 Onzeald (Etirinotecan Pegol) 245
  • 9.4 Drugs in Early-Stage Development 251
    • 9.4.1 Abemaciclib 252
    • 9.4.2 Adagloxad Simolenin (OBI-822/821) 254
    • 9.4.3 Patritumab 257
    • 9.4.4 NeuVax (nelipepimut-S) 259
    • 9.4.5 Alpelisib 261
    • 9.4.6 Buparlisib 262
    • 9.4.7 Xtandi (Enzalutamide) 263
    • 9.4.8 DS-8201a 264
  • 9.5 Biosimilars 265
    • 9.5.1 Overview 265
    • 9.5.2 Nomenclature 266
    • 9.5.3 EU 267
    • 9.5.4 US 268
    • 9.5.5 Japan 270
    • 9.5.6 China 271
    • 9.5.7 Ex-8MM Trastuzumab Biosimilars 272
    • 9.5.8 Ongoing 8MM Development 273

10 Current and Future Players 277

  • 10.1 Overview 277
  • 10.2 Trends in Corporate Strategy 280
  • 10.3 Company Profiles 282
    • 10.3.1 Roche/Genentech 282
    • 10.3.2 Novartis 285
    • 10.3.3 Pfizer 288
    • 10.3.4 Puma Biotechnology 290
    • 10.3.5 The Biosimilar Players 292

11 Market Outlook 297

  • 11.1 Global Markets 297
    • 11.1.1 Forecast 297
    • 11.1.2 Drivers and Barriers - Global Issues 302
  • 11.2 US 305
    • 11.2.1 Forecast 305
    • 11.2.2 Key Events 309
    • 11.2.3 Drivers and Barriers 309
  • 11.3 5EU 312
    • 11.3.1 Forecast 312
    • 11.3.2 Key Events 315
    • 11.3.3 Drivers and Barriers 316
  • 11.4 Japan 319
    • 11.4.1 Forecast 319
    • 11.4.2 Key Events 322
    • 11.4.3 Drivers and Barriers 322
  • 11.5 China 325
    • 11.5.1 Forecast 325
    • 11.5.2 Key Events 328
    • 11.5.3 Drivers and Barriers 328

12 Appendix 333

  • 12.1 Bibliography 333
  • 12.2 Abbreviations 378
  • 12.3 Methodology 387
  • 12.4 Forecasting Methodology 387
    • 12.4.1 Diagnosed Patients with HER2-Positive Breast Cancer 387
    • 12.4.2 Percent Drug-Treated Patients 388
    • 12.4.3 Drugs Included in Each Therapeutic Class 388
    • 12.4.4 Launch and Patent Expiration Dates 389
    • 12.4.5 General Pricing Assumptions 390
    • 12.4.6 Average Body Weight and Surface Area Across the 8MM 391
    • 12.4.7 General Forecast Assumptions 391
    • 12.4.8 Individual Drug Assumptions 391
    • 12.4.9 Generic Erosion 402
    • 12.4.10 Pricing of Pipeline Agents 403
  • 12.5 Primary Research - KOLs Interviewed for this Report 409
  • 12.6 Primary Research - Prescriber Survey 412
  • 12.7 About the Authors 413
    • 12.7.1 Analysts 413
    • 12.7.2 Epidemiologist 413
    • 12.7.3 Therapy Area Director 413
    • 12.7.4 Epidemiology Director 414
    • 12.7.5 Global Director of Therapy Analysis and Epidemiology 415
    • 12.7.6 Global Head of Healthcare 415
  • 12.8 About GlobalData 416
  • 12.9 Contact Us 416
  • 12.10 Disclaimer 416

List of Tables

1.1 List of Tables

  • Table 1: HER2-Positive Breast Cancer: Key Metrics in the Eight Major Pharmaceutical Markets, 2015-2025 13
  • Table 2: Definitions of HER2 Status by IHC Staining 28
  • Table 3: AJCC Stage Definitions for Breast Cancer 31
  • Table 4: Prognosis for Breast Cancer in the US 32
  • Table 5: Risk Factors and Comorbidities for Breast Cancer 37
  • Table 6: 8MM, Most Recent Five-Year Relative Survival for Invasive Breast Cancer, Women (%) 41
  • Table 7: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Non-Invasive DCIS Breast Cancer 45
  • Table 8: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 46
  • Table 9: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Invasive Breast Cancer 47
  • Table 10: 8MM, Sources of Epidemiological Data Used to Forecast Invasive Breast Cancer by HER2 Status 48
  • Table 11: 8MM, Sources of Epidemiological Data Used to Forecast the Relative Survival of Invasive Breast Cancer 49
  • Table 12: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Stage at Diagnosis 50
  • Table 13: 8MM, Sources of Epidemiological Data Used to Forecast HER2-, HR+ Invasive Breast Cancer by Stage at Diagnosis 51
  • Table 14: 8MM, Sources of Epidemiological Data Used to Forecast TN Invasive Breast Cancer by Stage at Diagnosis 52
  • Table 15: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Menopausal Status 53
  • Table 16: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Site of Metastasis 54
  • Table 17: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Type of Biomarker Expression 55
  • Table 18: 8MM, Sources Not Used in Epidemiological Analysis of Breast Cancer 75
  • Table 19: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015-2025 77
  • Table 20: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages ≥18 Years, N, 2015 78
  • Table 21: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015-2025 80
  • Table 22: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N (Row %), 2015 82
  • Table 23: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, Select Years, 2015-2025 85
  • Table 24: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, N, 2015 86
  • Table 25: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status, Women, Ages ≥18 Years, N, 2015 88
  • Table 26: Treatment Guidelines for HER2-Positive Breast Cancer 108
  • Table 27: Product Profile - Herceptin 131
  • Table 28: Clinical Studies for Herceptin in the Adjuvant Setting 137
  • Table 29: Efficacy of Herceptin + chemotherapy in untreated metastatic HER2-positive breast cancer 138
  • Table 30: Safety of Herceptin Monotherapy in Early-Stage HER2-Positive Breast Cancer 139
  • Table 31: Safety Profile of Herceptin + Chemotherapy in Untreated Metastatic HER2-Positive Breast Cancer 141
  • Table 32: Herceptin SWOT Analysis, 2017 142
  • Table 33: Product Profile - Tykerb 144
  • Table 34: Efficacy of Tykerb in Combination with Capecitabine for the Second-line Treatment of HER2-Positive Metastatic Breast Cancer 147
  • Table 35: Safety Profile of Tykerb in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer 149
  • Table 36: Safety Profile of Tykerb in Combination with Letrozole for the Treatment of Metastatic Breast Cancer 150
  • Table 37: Tykerb SWOT Analysis, 2017 151
  • Table 38: Product Profile - Perjeta 152
  • Table 39: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of HER2-positive Metastatic Breast Cancer (CLEOPATRA, NCT00567190) 155
  • Table 40: Efficacy of Perjeta in Combination with Herceptin and docetaxel for the Treatment of Locally Advanced HER2-positive Breast Cancer (NeoSphere, NCT00545688) 156
  • Table 41: Safety Profile of Perjeta in Combination with Herceptin and Docetaxel for the Treatment of Metastatic Breast Cancer (CLEOPATRA, NCT00567190) 157
  • Table 42: Perjeta SWOT Analysis, 2017 158
  • Table 43: Product Profile - Kadcyla 160
  • Table 44: Efficacy of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166) 163
  • Table 45: Safety Profile of Kadcyla Monotherapy for the Second-Line Treatment of HER2-Positive Metastatic Breast Cancer (EMILIA, NCT00829166) 164
  • Table 46: Kadcyla SWOT Analysis, 2017 165
  • Table 47: Product Profile - Halaven 166
  • Table 48: Efficacy of Halaven in the Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726) 168
  • Table 49: Efficacy of Halaven in the Second-Line Treatment of Metastatic Breast Cancer (Study 301, NCT00337103) 168
  • Table 50: Safety Profile of Halaven in the Third-line Treatment of Metastatic Breast Cancer (EMBRACE, NCT00388726) 169
  • Table 51: Halaven SWOT Analysis, 2017 170
  • Table 52: Product Profile - Abraxane 172
  • Table 53: Efficacy of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer 174
  • Table 54: Safety of Abraxane Monotherapy in the Treatment of Metastatic Breast Cancer 175
  • Table 55: Abraxane SWOT Analysis, 2017 176
  • Table 56: Product Profile - Ixempra 177
  • Table 57: Efficacy of Ixempra in Combination with Xeloda for the Treatment of Metastatic Breast Cancer 179
  • Table 58: Safety of Ixempra in Combination with Capecitabine for the Treatment of Metastatic Breast Cancer 180
  • Table 59: Ixempra SWOT Analysis, 2017 181
  • Table 60: Summary of Minor Therapeutic Classes Used to Treat HER2-Positive Breast Cancer, 2017 183
  • Table 61: Unmet Need and Opportunity in HER2-Positive Breast Cancer 187
  • Table 62: Product Profile - Neratinib 201
  • Table 63: Efficacy of Neratinib from the Phase III ExteNET Trial (Two-Year Data Set) 206
  • Table 64: Efficacy of Neratinib from the Phase III ExteNET Trial (Five-Year Data Set) 206
  • Table 65: Safety of Neratinib Monotherapy Compared to Placebo from the ExteNET trial in HER2-Positive Breast Cancer Patients Who Received Adjuvant Herceptin Therapy 208
  • Table 66: Treatment-Emergent Diarrhea from the Phase III CONTROL Trial 209
  • Table 67: Neratinib SWOT Analysis, 2016 211
  • Table 68: Product Profile - Margetuximab 212
  • Table 69: Safety of Margetuximab Monotherapy in Metastatic HER2-Positve Breast Cancer Patients 215

Table 70: Margetuximab SWOT Analysis 217

  • Table 71: Product Profile - ARRY-380 219
  • Table 72: Efficacy of Tucatinib from the Phase I Trial in HER2-Positive Metastatic Breast Cancer 222
  • Table 73: Safety Profile of Tucatinib Administered at the MTD (600mg or 650 mg BID) from the Phase I Trial in HER2-Positive Metastatic Solid Cancers 223

Table 74: Tucatinib SWOT Analysis 225

  • Table 75: Product Profile - Pyrotinib 226
  • Table 76: Efficacy of Pyrotinib from the Phase I Clinical Trial (NCT01937689) 228
  • Table 77: Pyrotinib SWOT Analysis, 2017 229
  • Table 78: Product Profile - Utidelone 231
  • Table 79: Efficacy of Utidelone as a Monotherapy and in Combination with Capecitabine in the Treatment of Metastatic Breast Cancer 233
  • Table 80: Safety of Utidelone in Combination with Capecitabine and as a Monotherapy for the Treatment of Metastatic Breast Cancer from the Phase II Trial (CHiCTR-TRC-13004205) 234
  • Table 81: Utidelone SWOT Analysis, 2017 235
  • Table 82: Product Profile - Ibrance 237
  • Table 83: Efficacy of Ibrance from the Phase II Study, NA-PHER2 241
  • Table 84: Efficacy of Ibrance from the Phase II Study (NCT01037790) 241
  • Table 85: Ibrance SWOT Analysis, 2017 244
  • Table 86: Product Profile - Onzeald 245
  • Table 87: Efficacy of Onzeald from the Phase III Study, BEACON 248
  • Table 88: Safety of Onzeald from the Phase III Study, BEACON 249
  • Table 89: Onzeald SWOT Analysis, 2017 250
  • Table 90: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2017 251
  • Table 91: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2017 252
  • Table 92: Safety of Adagloxad Simolenin in Combination with Cyclophosphamide for the Treatment of Metastatic Breast Cancer 256
  • Table 93: Trastuzumab Biosimilars, 2017 266
  • Table 94: Trastuzumab Biosimilars, 2016 274
  • Table 95: Key Companies in the HER2-Positive Breast Cancer Market in the 8MM, 2015-2025 278
  • Table 96: Roche's HER2-Positive Breast Cancer Portfolio Assessment, 2017 284
  • Table 97: Roche SWOT Analysis, 2017 285
  • Table 98: Novartis' HER2-Positive Breast Cancer Portfolio Assessment, 2017 287
  • Table 99: Novartis SWOT Analysis, 2017 287
  • Table 100: Pfizer's HER2-Positive Breast Cancer Portfolio Assessment, 2017 289
  • Table 101: Pfizer SWOT Analysis, 2017 289
  • Table 102: Puma Biotechnology's HER2-Positive Breast Cancer Portfolio Assessment, 2017 291
  • Table 103: Puma Biotechnology SWOT Analysis, 2017 292
  • Table 104: Mylan's HER2-Positive Breast Cancer Portfolio Assessment, 2017 293
  • Table 105: Mylan/Biocon SWOT Analysis, 2017 294
  • Table 106: Teva's HER2-Positive Breast Cancer Portfolio Assessment, 2017 295
  • Table 107: Teva/Celltrion SWOT Analysis, 2017 295
  • Table 108: Merck & Co.'s HER2-Positive Breast Cancer Portfolio Assessment, 2017 296
  • Table 109: Merck & Co./Samsung Bioepsis SWOT Analysis, 2017 296
  • Table 110: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 302
  • Table 111: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2015-2025 309
  • Table 112: US HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 309
  • Table 113: Key Events Impacting Sales for HER2-Positive Breast Cancer in the 5EU, 2015-2025 315
  • Table 114: 5EU HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 316
  • Table 115: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2015-2025 322
  • Table 116: Japanese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 322
  • Table 117: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2015-2025 328
  • Table 118: Chinese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2015-2025 328
  • Table 119: Key Launch Dates in HER2-Positive Breast Cancer 389
  • Table 120: Key Patent/Exclusivity Expiries 389
  • Table 121: Average Body Weight and Surface Area Across the 8MM 391
  • Table 122: Average Cost of Therapy of Generic Chemotherapy in the 8MM 392
  • Table 123: Average Cost of Therapy of Liposomal Doxorubicin in the 8MM 393
  • Table 124: Cost of Therapy of Generic Capecitabine in the US 393
  • Table 125: Average Cost of Therapy of Herceptin in the 8MM 395
  • Table 126: Average Cost of Therapy of Perjeta in the 8MM 396
  • Table 127: Average Cost of Therapy of Tykerb/Tyverb in the 8MM 397
  • Table 128: Average Cost of Therapy of Kadcyla in the 8MM 398
  • Table 129: Average Cost of Endocrine Therapy in the 8MM 399
  • Table 130: Average Cost of Therapy of Faslodex in the 8MM 400
  • Table 131: Average Cost of Therapy of Halaven in the 8MM 401
  • Table 132: Average Cost of Therapy of Abraxane in the 8MM 402
  • Table 133: Average Cost of Therapy of Ixempra in the 8MM 402
  • Table 134: Average Cost of Therapy of Neratinib in the 8MM 403
  • Table 135: Average Cost of Therapy of Ibrance in the 8MM 404
  • Table 136: Average Cost of Therapy of Onzeald in the 8MM 405
  • Table 137: Average Cost of Therapy of Tucatinib in the 8MM 406
  • Table 138: Average Cost of Therapy of Margetuximab in the 8MM 406
  • Table 139: Average Cost of Therapy of Pyrotinib in the 8MM 407
  • Table 140: Average Cost of Therapy of UTD-1 in the 8MM 408
  • Table 141: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 412

List of Figures

1.2 List of Figures

  • Figure 1: Global Sales for HER2-Positive Breast Cancer by Region, 2015-2025 16
  • Figure 2:Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2015-2025 19
  • Figure 3: Competitive Assessment of Most Promising Agents for HER2-Positive Breast Cancer, 2015-2025 20
  • Figure 4: Basic Breast Anatomy, Including Key Lymph Nodes 29
  • Figure 5: 8MM, Crude Diagnosed Incidence Rates of Invasive Breast Cancer, Ages ≥18 Years, Women, Cases per 100,000 Population, 2005?2014 38
  • Figure 6: Case Flow Map 44
  • Figure 7: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages ≥18 Years, Selected Years, 2015-2025 77
  • Figure 8: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages ≥18 Years, 2015 79
  • Figure 9: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, Selected Years, 2015-2025 80
  • Figure 10: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2015 83
  • Figure 11: 8MM, Age-Standardized Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, N, 2015 84
  • Figure 12: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages ≥18 Years, Select Years, 2015-2025 85
  • Figure 13: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015 87
  • Figure 14: 8MM, Diagnosed Incident Cases of Breast Cancer by HER2 Status, Women, Ages ≥18 Years, 2015 88
  • Figure 15: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015 89
  • Figure 16: 8MM, Proportion of HER2+/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015 90
  • Figure 17: 8MM, Proportion of HER2+/HR- Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015 91
  • Figure 18: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Site of Metastasis, Women, Ages ≥18 Years, 2015 92
  • Figure 19: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015 93
  • Figure 20: 8MM, Proportion of HER2-/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages ≥18 Years, 2015 94
  • Figure 21: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Type of Biomarker Expression, Women, Ages ≥18 Years, 2015 95
  • Figure 22: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer by Stage at Diagnosis, Women, Ages ≥18 Years, 2015 96
  • Figure 23: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer with BRCA Expression, Women, Ages ≥18 Years, 2015 97
  • Figure 24: Active Late-Stage Clinical Trials for Herceptin 134
  • Figure 25: Active Late-Stage Clinical Trials for Tykerb 146
  • Figure 26: Active Late-Stage Clinical Trials for Perjeta 154
  • Figure 27: Active Phase III Clinical Trials for Kadcyla 161
  • Figure 28: Active Phase III Clinical Trials for Halaven 167
  • Figure 29: Active Phase III Clinical Trials for Abraxane 173
  • Figure 30: Overview of the Development Pipeline in HER2-Positive Breast Cancer 196
  • Figure 31: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2015 198
  • Figure 32: Competitive Assessment of Late-Stage Pipeline Agents in HER2-Positive Breast Cancer, 2015-2025 199
  • Figure 33: Neratinib's Clinical Development 204
  • Figure 34: Clinical and Commercial Positioning of Neratinib 210
  • Figure 35: Margetuximab's Clinical Development 214
  • Figure 36: Clinical and Commercial Positioning of Margetuximab 216
  • Figure 37: Tucatinib's Clinical Development 221
  • Figure 38: Clinical and Commercial Positioning of tucatinib 224
  • Figure 39: Pyrotinib's Clinical Development 227
  • Figure 40: Clinical and Commercial Positioning of pyrotinib 229
  • Figure 41: Utidelone's Clinical Development 232
  • Figure 42: Clinical and Commercial Positioning of utidelone 235
  • Figure 43: Ibrance's Clinical Development 240
  • Figure 44: Clinical and Commercial Positioning of Ibrance 243
  • Figure 45: Onzeald's Clinical Development 247
  • Figure 46: Clinical and Commercial Positioning of Onzeald 249
  • Figure 47: Global Sales ($m) of Branded Products for HER2-Positive Breast Cancer by Company, 2015-2025 279
  • Figure 48: Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013-2023 280
  • Figure 49: Global Sales for HER2-Positive Breast Cancer, by Region, 2015 and 2025 300
  • Figure 50: Global Sales for HER2-Positive Breast Cancer by Drug Class, 2015 and2025 301
  • Figure 51: Sales ($m) for HER2-Positive Breast Cancer in the US, by Drug Class, 2015-2025 308
  • Figure 52: Sales for HER2-Positive Breast Cancer in the 5EU, by Drug Class, 2015-2025 314
  • Figure 53: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2015-2025 321
  • Figure 54: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2015-2025 327
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