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 6
1.1 List of Tables 10
1.2 List of Figures 14

2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 16
2.3 Upcoming Related Reports 17

3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 18
3.2 Basic Breast Anatomy 20
3.3 Breast Cancer Staging 21
3.4 Prognosis 22
3.5 Quality of Life 23
3.6 Symptoms 25

4 Disease Management 26
4.1 Treatment Overview 26
4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 26
4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA) 27
4.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 30
4.2 France 32
4.2.1 Diagnosis 32
4.2.2 Clinical Practice 33
4.3 Germany 35
4.3.1 Diagnosis 35
4.3.2 Clinical Practice 36
4.4 Italy 38
4.4.1 Diagnosis 38
4.4.2 Clinical Practice 38
4.5 Spain 41
4.5.1 Diagnosis 41
4.5.2 Clinical Practice 42
4.6 UK 43
4.6.1 Diagnosis 43
4.6.2 Clinical Practice 44

5 Competitive Assessment 47
5.1 Overview 47
5.2 Product Profiles - HER2-Targeted Therapies 48
5.2.1 Herceptin (trastuzumab) 48
5.2.2 Tykerb (lapatinib) 54
5.2.3 Perjeta (pertuzumab) 59
5.2.4 Kadcyla (ado-trastuzumab emtansine, T-DM1) 63
5.3 Product Profiles - General Targeted Therapies 67
5.3.1 Afinitor (everolimus) 67
5.3.2 Xeloda (capecitabine) 71
5.3.3 Avastin (bevacizumab) 74
5.3.4 Halaven (eribulin mesylate) 77
5.3.5 Abraxane (nab-paclitaxel) 80
5.4 Hormonal Agents 83
5.4.1 Tamoxifen 83
5.4.2 Faslodex (fulvestrant) 84
5.4.3 Aromatase Inhibitors 84

6 Unmet Need and Opportunity 86
6.1 Overview 86
6.2 Brain Metastases 87
6.2.1 Unmet Need 87
6.2.2 Gap Analysis 87
6.2.3 Opportunity 89
6.3 Resistance to HER2-Targeting Therapies 89
6.3.1 Unmet Need 89
6.3.2 Gap Analysis 90
6.3.3 Opportunity 91

7 Pipeline Assessment 93
7.1 Overview 93
7.2 Promising Drugs in Clinical Development 94
7.2.1 Gilotrif (afatinib) 94
7.2.2 Neratinib 99
7.3 Promising Drugs in Early-Stage Development 103
7.3.1 Palbociclib 105
7.3.2 NeuVax (nelipepimut-S) 109
7.3.3 Patritumab 113
7.3.4 Ganetespib 116
7.3.5 ARRY-380 (ONT-380) 119
7.3.6 NVP-BYL719 122
7.4 Biosimilars 124

8 Market Outlook 126
8.1 Global Markets 126
8.1.1 Drivers and Barriers - Global Issues 126
8.2 France 129
8.2.1 Forecast 129
8.2.2 Key Events 132
8.2.3 Drivers and Barriers 132
8.3 Germany 134
8.3.1 Forecast 134
8.3.2 Key Events 137
8.3.3 Drivers and Barriers 137
8.4 Italy 139
8.4.1 Forecast 139
8.4.2 Key Events 142
8.4.3 Drivers and Barriers 142
8.5 Spain 144
8.5.1 Forecast 144
8.5.2 Drivers and Barriers 147
8.6 United Kingdom 149
8.6.2 Key Events 152
8.6.3 Drivers and Barriers 152

9 Appendix 155
9.1 Bibliography 155
9.2 Abbreviations 172
9.3 Methodology 178
9.4 Forecasting Methodology 178
9.4.1 Diagnosed HER2-Positive Breast Cancer Patients 178
9.4.2 Percent Drug-Treated Patients 179
9.4.3 Drugs Included in Each Therapeutic Class 179
9.4.4 Launch and Patent Expiry Dates 180
9.4.5 General Pricing Assumptions 181
9.4.6 Individual Drug Assumptions 182
9.4.7 Generic Erosion 189
9.4.8 Pricing of Pipeline Agents 189
9.5 Primary Research - KOLs Interviewed for this Report 191
9.6 Primary Research - Prescriber Survey 192
9.7 About the Authors 193
9.7.1 Analyst 193
9.7.2 Therapy Area Director 193
9.7.3 Global Head of Healthcare 194
9.8 About GlobalData 195
9.9 Disclaimer 195

List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 22
Table 2: Prognosis for Breast Cancer in the US 23
Table 3: Treatment Guidelines for HER2-Positive Breast Cancer 32
Table 4: Product Profile - Herceptin 50
Table 5: Clinical Studies for Herceptin in the Adjuvant Setting 52
Table 6: Herceptin SWOT Analysis, 2013 54
Table 7: Product Profile - Tykerb 56
Table 8: Tykerb SWOT Analysis, 2013 58
Table 9: Product Profile - Perjeta 61
Table 10: Perjeta SWOT Analysis, 2013 63
Table 11: Product Profile - Kadcyla 65
Table 12: Kadcyla SWOT Analysis, 2013 67
Table 13: Product Profile - Afinitor 69
Table 14: Afinitor SWOT Analysis, 2013 70
Table 15: Product Profile - Xeloda 72
Table 16: Xeloda SWOT Analysis, 2013 74
Table 17: Product Profile - Avastin 75
Table 18: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer 76
Table 19: Avastin SWOT Analysis, 2013 77
Table 20: Product Profile - Halaven 78
Table 21: Halaven SWOT Analysis, 2013 80
Table 22: Product Profile - Abraxane 81
Table 23: Abraxane SWOT Analysis, 2013 83
Table 24: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013 85
Table 25: Unmet Need and Opportunity in HER2-Positive Breast Cancer 86
Table 26: Product Profile - Gilotrif 96
Table 27: Gilotrif SWOT Analysis, 2014 98
Table 28: Product Profile - Neratinib 100
Table 29: Neratinib SWOT Analysis, 2013 103
Table 30: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014 104
Table 31: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014 104
Table 32: Product Profile - Palbociclib 107
Table 33: Palbociclib SWOT Analysis, 2014 109
Table 34: Product Profile - NeuVax 111
Table 35: NeuVax SWOT Analysis, 2014 113
Table 36: Product Profile - Patritumab 114
Table 37: Patritumab SWOT Analysis, 2014 116
Table 38: Product Profile - Ganetespib 117
Table 39: Ganetespib SWOT Analysis, 2014 119
Table 40: Product Profile - ARRY-380 120
Table 41: ARRY-380 SWOT Analysis, 2014 121
Table 42: Product Profile - NVP-BYL719 122
Table 43: NVP-BYL719 SWOT Analysis, 2014 123
Table 44: Trastuzumab Biosimilars, 2014 125
Table 45: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 126
Table 46: Sales Forecast ($m) for HER2-Positive Breast Cancer in France, 2013-2023 130
Table 47: Key Events Impacting Sales for HER2-Positive Breast Cancer in France, 2013-2023 132
Table 48: French HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 132
Table 49: Sales Forecast ($m) for HER2-Positive Breast Cancer in Germany, 2013-2023 135
Table 50: Key Events Impacting Sales for HER2-Positive Breast Cancer in Germany, 2013-2023 137
Table 51: German HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 137
Table 52: Sales Forecast ($m) for HER2-Positive Breast Cancer in Italy, 2013-2023 140
Table 53: Key Events Impacting Sales for HER2-Positive Breast Cancer in Italy, 2013-2023 142
Table 54: Italian HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 142
Table 55: Sales Forecast ($m) for HER2-Positive Breast Cancer in Spain, 2013-2023 145
Table 56: Key Events Impacting Sales for HER2-Positive Breast Cancer in Spain, 2013-2023 147
Table 57: Spanish HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 147
Table 58: Sales Forecast ($m) for HER2-Positive Breast Cancer in the UK, 2013-2023 150
Table 59: Key Events Impacting Sales for HER2-Positive Breast Cancer in the UK, 2013-2023 152
Table 60: UK HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 152
Table 61: HER2-Positive Breast Cancer Incidence, 2013-2023 179
Table 62: HER2-Positive Breast Cancer Drugs, Key Launch Dates 180
Table 63: HER2-Positive Breast Cancer Drugs, Key Patent Expiries 181
Table 64: Average Body Weight and Surface Area Across the 5EU Markets 182
Table 65: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant 183
Table 66: Average Annual Cost of Therapy ($) - Subcutaneous Herceptin, Adjuvant 184
Table 67: Average Annual Cost of Therapy ($) - Perjeta, First Line 185
Table 68: Average Annual Cost of Therapy ($) - Tykerb, First Line 186
Table 69: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 187
Table 70: Average Annual Cost of Therapy ($) - Halaven, Fourth Line 188
Table 71: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line 189
Table 72: Average Annual Cost of Therapy ($) - Neratinib, Third Line 190
Table 73: Physicians Surveyed by Country 192

List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 20
Figure 2: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb 55
Figure 3: Active Late-Stage Clinical Trials for Perjeta 60
Figure 4: Active Phase III Clinical Trials for Kadcyla 64
Figure 5: Active Phase III Clinical Trials for Afinitor 68
Figure 6: Clinical Trials for Halaven 78
Figure 7: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 94
Figure 8: Gilotrif’s Clinical Development in Breast Cancer 95
Figure 9: Clinical and Commercial Positioning of Gilotrif 98
Figure 10: Neratinib’s Clinical Development 100
Figure 11: Clinical and Commercial Positioning of neratinib. 102
Figure 12: Sales for HER2-Positive Breast Cancer in France by Drug Class, 2013-2023 131
Figure 13: Sales for HER2-Positive Breast Cancer in Germany by Drug Class, 2013-2023 136
Figure 14: Sales for HER2-Positive Breast Cancer in Italy by Drug Class, 2013-2023 141
Figure 15: Sales for HER2-Positive Breast Cancer in Spain by Drug Class, 2013-2023 146
Figure 16: Sales for HER2-Positive Breast Cancer in the UK by Drug Class, 2013-2023 151