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

Summary

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.

In 2013, Herceptin was the market leader, taking 92% of the Japanese market. This is due to the fact that it is the most established agent in this disease and is used in all settings, although over half of all Herceptin use is in the adjuvant setting.

Scope

- An overview of HER2-Positive Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized the Japan 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 Japan 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 Japan 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 Japan HER2-Positive Breast Cancer market landscape? Identify, understand and capitalize.

Table Of Contents

PharmaPoint: HER2-Positive Breast Cancer - Japan Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 16
3.2 Basic Breast Anatomy 18
3.3 Breast Cancer Staging 19
3.4 Prognosis 20
3.5 Quality of Life 21
3.6 Symptoms 23
4 Disease Management 24
4.1 Treatment Overview 24
4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 24
4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA) 25
4.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 28
4.2 Japan 30
4.2.1 Diagnosis 30
4.2.2 Clinical Practice 30
5 Competitive Assessment 32
5.1 Overview 32
5.2 Product Profiles - HER2-Targeted Therapies 33
5.2.1 Herceptin (trastuzumab) 33
5.2.2 Tykerb (lapatinib) 39
5.2.3 Perjeta (pertuzumab) 44
5.2.4 Kadcyla (ado-trastuzumab emtansine, T-DM1) 48
5.3 Product Profiles - General Targeted Therapies 52
5.3.1 Afinitor (everolimus) 52
5.3.2 Xeloda (capecitabine) 56
5.3.3 Avastin (bevacizumab) 59
5.3.4 Halaven (eribulin mesylate) 62
5.3.5 Abraxane (nab-paclitaxel) 65
5.4 Hormonal Agents 68
5.4.1 Tamoxifen 68
5.4.2 Faslodex (fulvestrant) 69
5.4.3 Aromatase Inhibitors 69
6 Unmet Need and Opportunity 71
6.1 Overview 71
6.2 Brain Metastases 72
6.2.1 Unmet Need 72
6.2.2 Gap Analysis 72
6.2.3 Opportunity 74
6.3 Resistance to HER2-Targeting Therapies 74
6.3.1 Unmet Need 74
6.3.2 Gap Analysis 75
6.3.3 Opportunity 76
7 Pipeline Assessment 78
7.1 Overview 78
7.2 Promising Drugs in Clinical Development 79
7.2.1 Gilotrif (afatinib) 79
7.2.2 Neratinib 84
7.3 Promising Drugs in Early-Stage Development 88
7.3.1 Palbociclib 90
7.3.2 NeuVax (nelipepimut-S) 94
7.3.3 Patritumab 98
7.3.4 Ganetespib 101
7.3.5 ARRY-380 (ONT-380) 104
7.3.6 NVP-BYL719 107
7.4 Biosimilars 109
8 Market Outlook 111
8.1 Japan 111
8.1.1 Forecast 111
8.1.2 Key Events 114
8.1.3 Drivers and Barriers - Global Issues 114
8.1.4 Japan - Drivers and Barriers 117
9 Appendix 120
9.1 Bibliography 120
9.2 Abbreviations 136
9.3 Methodology 141
9.4 Forecasting Methodology 141
9.4.1 Diagnosed HER2-Positive Breast Cancer Patients 141
9.4.2 Percent Drug-Treated Patients 142
9.4.3 Drugs Included in Each Therapeutic Class 142
9.4.4 Launch and Patent Expiry Dates 143
9.4.5 General Pricing Assumptions 144
9.4.6 Individual Drug Assumptions 145
9.4.7 Generic Erosion 151
9.4.8 Pricing of Pipeline Agents 152
9.5 Primary Research - KOLs Interviewed for this Report 153
9.6 Primary Research - Prescriber Survey 154
9.7 About the Authors 155
9.7.1 Analyst 155
9.7.2 Therapy Area Director 155
9.7.3 Global Head of Healthcare 156
9.8 About GlobalData 157
9.9 Disclaimer 157

1.1 List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 20
Table 2: Prognosis for Breast Cancer in the US 21
Table 3: Treatment Guidelines for HER2-Positive Breast Cancer 30
Table 4: Product Profile - Herceptin 35
Table 5: Clinical Studies for Herceptin in the Adjuvant Setting 37
Table 6: Herceptin SWOT Analysis, 2013 39
Table 7: Product Profile - Tykerb 41
Table 8: Tykerb SWOT Analysis, 2013 43
Table 9: Product Profile - Perjeta 46
Table 10: Perjeta SWOT Analysis, 2013 48
Table 11: Product Profile - Kadcyla 50
Table 12: Kadcyla SWOT Analysis, 2013 52
Table 13: Product Profile - Afinitor 54
Table 14: Afinitor SWOT Analysis, 2013 55
Table 15: Product Profile - Xeloda 57
Table 16: Xeloda SWOT Analysis, 2013 59
Table 17: Product Profile - Avastin 60
Table 18: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer 61
Table 19: Avastin SWOT Analysis, 2013 62
Table 20: Product Profile - Halaven 63
Table 21: Halaven SWOT Analysis, 2013 65
Table 22: Product Profile - Abraxane 66
Table 23: Abraxane SWOT Analysis, 2013 68
Table 24: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013 70
Table 25: Unmet Need and Opportunity in HER2-Positive Breast Cancer 71
Table 26: Product Profile - Gilotrif 81
Table 27: Gilotrif SWOT Analysis, 2014 83
Table 28: Product Profile - Neratinib 85
Table 29: Neratinib SWOT Analysis, 2013 88
Table 30: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014 89
Table 31: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014 89
Table 32: Product Profile - Palbociclib 92
Table 33: Palbociclib SWOT Analysis, 2014 94
Table 34: Product Profile - NeuVax 96
Table 35: NeuVax SWOT Analysis, 2014 98
Table 36: Product Profile - Patritumab 99
Table 37: Patritumab SWOT Analysis, 2014 101
Table 38: Product Profile - Ganetespib 102
Table 39: Ganetespib SWOT Analysis, 2014 104
Table 40: Product Profile - ARRY-380 105
Table 41: ARRY-380 SWOT Analysis, 2014 106
Table 42: Product Profile - NVP-BYL719 107
Table 43: NVP-BYL719 SWOT Analysis, 2014 108
Table 44: Trastuzumab Biosimilars, 2014 110
Table 45: Sales Forecast ($m) for HER2-Positive Breast Cancer in Japan, 2013-2023 112
Table 46: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2013-2023 114
Table 47: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 114
Table 48: Japanese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 117
Table 49: HER2-Positive Breast Cancer Incidence, 2013-2023 142
Table 50: HER2-Positive Breast Cancer Drugs, Key Launch Dates 143
Table 51: HER2-Positive Breast Cancer Drugs, Key Patent Expiries 144
Table 52: Average Body Weight and Surface Area Across Japan Market 145
Table 53: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant 146
Table 54: Average Annual Cost of Therapy ($) - Perjeta, First Line 147
Table 55: Average Annual Cost of Therapy ($) - Tykerb, First Line 148
Table 56: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 149
Table 57: Average Annual Cost of Therapy ($)- Halaven, Fourth Line 149
Table 58: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line 150
Table 59: Average Annual Cost of therapy ($) - Ixempra, Fourth Line 151
Table 60: Average Annual Cost of Therapy ($) - Neratinib, Third Line 152
Table 61: Physicians Surveyed by Country 154

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 18
Figure 2: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb 40
Figure 3: Active Late-Stage Clinical Trials for Perjeta 45
Figure 4: Active Phase III Clinical Trials for Kadcyla 49
Figure 5: Active Phase III Clinical Trials for Afinitor 53
Figure 6: Clinical Trials for Halaven 63
Figure 7: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 79
Figure 8: Gilotrif's Clinical Development in Breast Cancer 80
Figure 9: Clinical and Commercial Positioning of Gilotrif 83
Figure 10: Neratinib's Clinical Development 85
Figure 11: Clinical and Commercial Positioning of neratinib. 87
Figure 12: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2013-2023 113

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