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PharmaPoint: HER2-Positive Breast Cancer - China 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.

Currently, treatment rates for HER2-positive breast cancer in China are low, with Roche reporting that approximately 30% of patients diagnosed with the disease actually received a treatment that contained an HER2-targeting therapy in 2013.

Scope

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

Table Of Contents

PharmaPoint: HER2-Positive Breast Cancer - China 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 China 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 Abraxane (nab-paclitaxel) 62
5.4 Hormonal Agents 64
5.4.1 Tamoxifen 65
5.4.2 Faslodex (fulvestrant) 65
5.4.3 Aromatase Inhibitors 65
6 Unmet Need and Opportunity 67
6.1 Overview 67
6.2 Brain Metastases 68
6.2.1 Unmet Need 68
6.2.2 Gap Analysis 68
6.2.3 Opportunity 70
6.3 Resistance to HER2-Targeting Therapies 70
6.3.1 Unmet Need 70
6.3.2 Gap Analysis 71
6.3.3 Opportunity 72
7 Pipeline Assessment 74
7.1 Overview 74
7.2 Promising Drugs in Clinical Development 75
7.2.1 Gilotrif (afatinib) 75
7.2.2 Neratinib 80
7.3 Promising Drugs in Early-Stage Development 84
7.3.1 Palbociclib 86
7.3.2 NeuVax (nelipepimut-S) 90
7.3.3 Patritumab 94
7.3.4 Ganetespib 97
7.3.5 ARRY-380 (ONT-380) 100
7.3.6 NVP-BYL719 103
7.4 Biosimilars 105
8 Market Outlook 107
8.1 China 107
8.1.1 Forecast 107
8.1.2 Key Events 110
8.1.3 Drivers and Barriers - Global Issues 110
8.1.4 China - Drivers and Barriers 114
9 Appendix 116
9.1 Bibliography 116
9.2 Abbreviations 131
9.3 Methodology 137
9.4 Forecasting Methodology 137
9.4.1 Diagnosed HER2-Positive Breast Cancer Patients 137
9.4.2 Percent Drug-Treated Patients 138
9.4.3 Drugs Included in Each Therapeutic Class 138
9.4.4 Launch and Patent Expiry Dates 139
9.4.5 General Pricing Assumptions 140
9.4.6 Individual Drug Assumptions 141
9.4.7 Generic Erosion 147
9.4.8 Pricing of Pipeline Agents 148
9.5 Primary Research - KOLs Interviewed for this Report 149
9.6 Primary Research - Prescriber Survey 150
9.7 About the Authors 151
9.7.1 Analyst 151
9.7.2 Therapy Area Director 151
9.7.3 Global Head of Healthcare 152
9.8 About GlobalData 153
9.9 Disclaimer 153

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 - Abraxane 63
Table 21: Abraxane SWOT Analysis, 2013 64
Table 22: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013 66
Table 23: Unmet Need and Opportunity in HER2-Positive Breast Cancer 67
Table 24: Product Profile - Gilotrif 77
Table 25: Gilotrif SWOT Analysis, 2014 79
Table 26: Product Profile - Neratinib 81
Table 27: Neratinib SWOT Analysis, 2013 84
Table 28: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast Cancer, 2014 85
Table 29: HER2-Positive Breast Cancer - Early-Phase Pipeline, 2014 85
Table 30: Product Profile - Palbociclib 88
Table 31: Palbociclib SWOT Analysis, 2014 90
Table 32: Product Profile - NeuVax 92
Table 33: NeuVax SWOT Analysis, 2014 94
Table 34: Product Profile - Patritumab 95
Table 35: Patritumab SWOT Analysis, 2014 97
Table 36: Product Profile - Ganetespib 98
Table 37: Ganetespib SWOT Analysis, 2014 100
Table 38: Product Profile - ARRY-380 101
Table 39: ARRY-380 SWOT Analysis, 2014 102
Table 40: Product Profile - NVP-BYL719 103
Table 41: NVP-BYL719 SWOT Analysis, 2014 104
Table 42: Trastuzumab Biosimilars, 2014 106
Table 43: Sales Forecast ($m) for HER2-Positive Breast Cancer in China, 2013-2023 108
Table 44: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2013-2023 110
Table 45: Global HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 110
Table 46: Chinese HER2-Positive Breast Cancer Market - Drivers and Barriers, 2013-2023 114
Table 47: HER2-Positive Breast Cancer Incidence, 2013-2023 138
Table 48: HER2-Positive Breast Cancer Drugs, Key Launch Dates 139
Table 49: HER2-Positive Breast Cancer Drugs, Key Patent Expiries 140
Table 50: Average Body Weight and Surface Area Across China Market 141
Table 51: Average Annual Cost of Therapy ($) - Herceptin, Adjuvant 142
Table 52: Average Annual Cost of Therapy ($) - Perjeta, First Line 143
Table 53: Average Annual Cost of Therapy ($) - Tykerb, First Line 144
Table 54: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 145
Table 55: Average Annual Cost of Therapy ($) - Halaven, Fourth Line 145
Table 56: Average Annual Cost of Therapy ($) - Abraxane, Fourth Line 146
Table 57: Average Annual Cost of therapy ($) - Ixempra, Fourth Line 147
Table 58: Average Annual Cost of Therapy ($) - Neratinib, Third Line 148
Table 59: Physicians Surveyed by Country 150

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 19
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: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 75
Figure 7: Gilotrif's Clinical Development in Breast Cancer 76
Figure 8: Clinical and Commercial Positioning of Gilotrif 79
Figure 9: Neratinib's Clinical Development 81
Figure 10: Clinical and Commercial Positioning of neratinib. 83
Figure 11: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2013-2023 109

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