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PharmaPoint: HER2-Positive Breast Cancer - US 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.

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

PharmaPoint: HER2-Positive Breast Cancer - US 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 US 30
4.2.1 Diagnosis 30
4.2.2 Clinical Practice 31
5 Competitive Assessment 34
5.1 Overview 34
5.2 Product Profiles - HER2-Targeted Therapies 35
5.2.1 Herceptin (trastuzumab) 35
5.2.2 Tykerb (lapatinib) 41
5.2.3 Perjeta (pertuzumab) 45
5.2.4 Kadcyla (ado-trastuzumab emtansine, T-DM1) 50
5.3 Product Profiles - General Targeted Therapies 54
5.3.1 Afinitor (everolimus) 54
5.3.2 Xeloda (capecitabine) 58
5.3.3 Avastin (bevacizumab) 61
5.3.4 Halaven (eribulin mesylate) 64
5.3.5 Abraxane (nab-paclitaxel) 67
5.3.6 Ixempra (ixabepilone) 70
5.4 Hormonal Agents 73
5.4.1 Tamoxifen 73
5.4.2 Faslodex (fulvestrant) 74
5.4.3 Aromatase Inhibitors 74
6 Unmet Need and Opportunity 76
6.1 Overview 76
6.2 Brain Metastases 77
6.2.1 Unmet Need 77
6.2.2 Gap Analysis 77
6.2.3 Opportunity 79
6.3 Resistance to HER2-Targeting Therapies 79
6.3.1 Unmet Need 79
6.3.2 Gap Analysis 80
6.3.3 Opportunity 81
7 Pipeline Assessment 83
7.1 Overview 83
7.2 Promising Drugs in Clinical Development 84
7.2.1 Gilotrif (afatinib) 84
7.2.2 Neratinib 89
7.3 Promising Drugs in Early-Stage Development 93
7.3.1 Palbociclib 95
7.3.2 NeuVax (nelipepimut-S) 99
7.3.3 Patritumab 103
7.3.4 Ganetespib 106
7.3.5 ARRY-380 (ONT-380) 109
7.3.6 NVP-BYL719 112
7.4 Biosimilars 114
8 Market Outlook 116
8.1 United States 116
8.1.1 Forecast 116
8.1.2 Key Events 119
8.1.3 Drivers and Barriers - Global Issues 119
8.1.4 United States - Drivers and Barriers 123
9 Appendix 126
9.1 Bibliography 126
9.2 Abbreviations 143
9.3 Methodology 148
9.4 Forecasting Methodology 148
9.4.1 Diagnosed HER2-Positive Breast Cancer Patients 148
9.4.2 Percent Drug-Treated Patients 149
9.4.3 Drugs Included in Each Therapeutic Class 149
9.4.4 Launch and Patent Expiry Dates 150
9.4.5 General Pricing Assumptions 151
9.4.6 Individual Drug Assumptions 152
9.4.7 Generic Erosion 158
9.4.8 Pricing of Pipeline Agents 158
9.5 Primary Research - KOLs Interviewed for this Report 160
9.6 Primary Research - Prescriber Survey 161
9.7 About the Authors 162
9.7.1 Analyst 162
9.7.2 Therapy Area Director 162
9.7.3 Global Head of Healthcare 163
9.8 About GlobalData 164
9.9 Disclaimer 164

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 37
Table 5: Clinical Studies for Herceptin in the Adjuvant Setting 39
Table 6: Herceptin SWOT Analysis, 2013 41
Table 7: Product Profile - Tykerb 43
Table 8: Tykerb SWOT Analysis, 2013 45
Table 9: Product Profile - Perjeta 48
Table 10: Perjeta SWOT Analysis, 2013 50
Table 11: Product Profile - Kadcyla 52
Table 12: Kadcyla SWOT Analysis, 2013 54
Table 13: Product Profile - Afinitor 56
Table 14: Afinitor SWOT Analysis, 2013 57
Table 15: Product Profile - Xeloda 59
Table 16: Xeloda SWOT Analysis, 2013 61
Table 17: Product Profile - Avastin 62
Table 18: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer 63
Table 19: Avastin SWOT Analysis, 2013 64
Table 20: Product Profile - Halaven 65
Table 21: Halaven SWOT Analysis, 2013 67
Table 22: Product Profile - Abraxane 68
Table 23: Abraxane SWOT Analysis, 2013 70
Table 24: Product Profile - Ixempra 71
Table 25: Ixempra SWOT Analysis, 2013 73
Table 26: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013 75
Table 27: Unmet Need and Opportunity in HER2-Positive Breast Cancer 76
Table 28: Product Profile - Gilotrif 86
Table 29: Gilotrif SWOT Analysis, 2014 88
Table 30: Product Profile - Neratinib 90
Table 31: Neratinib SWOT Analysis, 2013 93
Table 32: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014 94
Table 33: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014 94
Table 34: Product Profile - Palbociclib 97
Table 35: Palbociclib SWOT Analysis, 2014 99
Table 36: Product Profile - NeuVax 101
Table 37: NeuVax SWOT Analysis, 2014 103
Table 38: Product Profile - Patritumab 104
Table 39: Patritumab SWOT Analysis, 2014 106
Table 40: Product Profile - Ganetespib 107
Table 41: Ganetespib SWOT Analysis, 2014 109
Table 42: Product Profile - ARRY-380 110
Table 43: ARRY-380 SWOT Analysis, 2014 111
Table 44: Product Profile - NVP-BYL719 112
Table 45: NVP-BYL719 SWOT Analysis, 2014 113
Table 46: Trastuzumab Biosimilars, 2014 115
Table 47: Sales Forecast ($m) for HER2-Positive Breast Cancer in the US, 2013-2023 117
Table 48: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2013-2023 119
Table 49: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 119
Table 50: US HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 123
Table 51: HER2-Positive Breast Cancer Incidence, 2013-2023 149
Table 52: HER2-Positive Breast Cancer Drugs, Key Launch Dates 150
Table 53: HER2-Positive Breast Cancer Drugs, Key Patent Expiries 151
Table 54: Average Body Weight and Surface Area in the US 152
Table 55: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant 153
Table 56: Average Annual Cost of Therapy ($) - Perjeta, First Line 154
Table 57: Average Annual Cost of Therapy ($) - Tykerb, First Line 154
Table 58: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 155
Table 59: Average Annual Cost of Therapy ($)- Halaven, Fourth Line 156
Table 60: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line 157
Table 61: Average Annual Cost of therapy ($) - Ixempra, Fourth Line 158
Table 62: Average Annual Cost of Therapy ($) - Neratinib, Third Line 159
Table 63: Physicians Surveyed by Country 161

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 42
Figure 3: Active Late-Stage Clinical Trials for Perjeta 47
Figure 4: Active Phase III Clinical Trials for Kadcyla 51
Figure 5: Active Phase III Clinical Trials for Afinitor 55
Figure 6: Clinical Trials for Halaven 65
Figure 7: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 84
Figure 8: Gilotrif's Clinical Development in Breast Cancer 85
Figure 9: Clinical and Commercial Positioning of Gilotrif 88
Figure 10: Neratinib's Clinical Development 90
Figure 11: Clinical and Commercial Positioning of neratinib. 92
Figure 12: Sales for HER2-Positive Breast Cancer in the US by Drug Class, 2013-2023 118

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