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HER2-Negative Breast Cancer - US Drug Forecast and Market Analysis to 2023

Published By :

GlobalData

Published Date : Jan 2015

Category :

Cancer

No. of Pages : 210 Pages

HER2-Negative Breast Cancer - US Drug Forecast and Market Analysis to 2023

Summary

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-negative breast cancer market, with coverage of multiple settings; neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

Overall five year survival in breast cancer is relatively high, at around 90%, but this is subjective to the subtype and stage of the disease. Importantly this report segments HER2 negative breast cancer into its two major subtypes; hormone receptor positive (HR+) and triple negative breast cancer (TNBC).

The US will remain the largest HER2-negative breast cancer market throughout the forecast period. The growth of this market will be driven by the high incidence of HER2-negative breast cancer in the US, which almost equals that of the entire 5EU, combined with the higher treatment rates in the neoadjuvant and adjuvant settings and the influx of premium-priced products over the forecast period. In particular, the prices for both the current and pipeline therapies are the highest in the world, which is due to the private health insurance system in the US, which can more easily afford to reimburse the latest expensive drugs than the healthcare systems in other countries.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

- Overview of HER2-Negative Breast Cancer including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product HER2-Negative Breast Cancercription, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US HER2-Negative Breast Cancer market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for HER2-Negative Breast Cancer.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2013-2023 in the US.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 9
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 11
2.3 Upcoming Related Reports 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 14
3.1.3 Basic Breast Anatomy 15
3.2 Disease Classification/Staging Systems 16
3.3 Symptoms 18
3.4 Prognosis 18
3.5 Quality of Life 19
4 Disease Management 22
4.1 Diagnosis and Treatment Overview 22
4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 22
4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 24
4.1.3 Treatment Guidelines and Leading Prescribed Drugs 28
4.2 US 29
4.2.1 Diagnosis 29
4.2.2 Clinical Practice 30
5 Competitive Assessment 33
5.1 Overview 33
5.2 Product Profiles (Branded Therapies) 34
5.2.1 Abraxane (nab-paclitaxel) 34
5.2.2 Afinitor (everolimus) 39
5.2.3 Avastin (bevacizumab) 43
5.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 48
5.2.5 Halaven (eribulin mesylate) 53
5.2.6 Ixempra (ixabepilone) 56
5.2.7 Xeloda (capecitabine) 59
5.3 Product Profiles (Hormonal Agents) 62
5.3.1 Tamoxifen 62
5.3.2 Faslodex (fulvestrant) 62
5.3.3 Aromatase Inhibitors 63
6 Unmet Need and Opportunity 67
6.1 Overview 67
6.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 69
6.1.2 Specific treatment options for TNBC patients 71
6.1.3 Prevention of brain metastasis 72
6.1.4 Neoadjuvant therapy that can downstage tumors 74
6.1.5 For HR+patients, reduced resistance to hormonal agents 75
6.1.6 Improved convenience of administration of hormonal agents 77
7 Pipeline Assessment 79
7.1 Overview 79
7.1.1 Abemaciclib (LY2835219) 80
7.1.2 Buparlisib (BKM- 120) 86
7.1.3 Javlor (vinflunine) 92
7.1.4 LEE011 96
7.1.5 NeuVax (nelipepimut-S/E75) 101
7.1.6 Niraparib (MK4827) 106
7.1.7 NKTR- 102 (etirinotecan pegol) 111
7.1.8 Lynparza (olaparib) 115
7.1.9 Palbociclib (PD-0332991) 120
7.1.10 Talazoparib (BMN 673) 126
7.1.11 Veliparib (ABT-888) 130
7.2 Promising Drugs in Clinical Development 135
7.2.1 PD-/PD-L 1 Immunotherapies 136
8 Market Outlook 138
8.1 US 138
8.1.1 Forecast 138
8.1.2 Key Events 141
8.1.3 Drivers and Barriers 142
9 Appendix 144
9.1 Bibliography 144
9.2 Abbreviations 171
9.3 Methodology 179
9.4 Forecasting Methodology 179
9.4.1 Diagnosed HER2-Negative Breast Cancer Patients 179
9.4.2 Percentage of Drug-Treated Patients 180
9.4.3 Drugs Included in Each Therapeutic Class 180
9.4.4 Launch and Patent Expiry Dates 181
9.4.5 General Pricing Assumptions 182
9.4.6 Individual Drug Assumptions 184
9.4.7 Generic Erosion 192
9.4.8 Pricing of Pipeline Agents 192
9.5 Primary Research - KOLs Interviewed for This Report 203
9.6 Primary Research - High-Prescriber Survey 205
9.7 About the Authors 206
9.7.1 Analyst 206
9.7.2 Director of Oncology 206
9.7.3 Epidemiologist 207
9.7.4 Director of Epidemiology 207
9.7.5 Global Head of Healthcare 208
9.8 About GlobalData 209
9.9 Disclaimer 209

1.1 List of Tables
Table 1: AJCC Stage Definitions for Breast Cancer 17
Table 2: Prognosis for Breast Cancer 18
Table 3: Treatment Guidelines for HER2-Negative Breast Cancer 28
Table 4: Most Prescribed Regimens for HER2-Negative Breast Cancer by Drug Class in the Global Markets, 2013 29
Table 5: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - US 30
Table 6: Product Profile - Abraxane 36
Table 7: Abraxane SWOT Analysis, 2013 38
Table 8: Global Sales Forecast ($m) for Abraxane, 2013-2023 39
Table 9: Product Profile - Afinitor (everolimus) 41
Table 10: Afinitor SWOT Analysis, 2013 42
Table 11: Global Sales Forecast ($m) for Afinitor, 2013-2023 43
Table 12: Product Profile - Avastin 45
Table 13: Avastin SWOT Analysis, 2013 47
Table 14 Global Sales Forecast ($m) for Avastin, 2013-2023 48
Table 15: Product Profile - Doxil 50
Table 16: Doxil SWOT Analysis, 2013 52
Table 17: Global Sales Forecast ($m) for Doxil/Caelyx, 2013-2023 52
Table 18: Product Profile - Halavan 54
Table 19: Halaven SWOT Analysis, 2013 55
Table 20: Global Sales Forecast ($m) for Halaven, 2013-2023 56
Table 21: Product Profile - Ixempra 57
Table 22: Ixempra SWOT Analysis, 2013 58
Table 23: Global Sales Forecast ($m) for Ixempra, 2013-2023 59
Table 24: Product Profile - Xeloda 60
Table 25: Xeloda SWOT Analysis, 2013 61
Table 26: AI Approvals in the US and 5EU 65
Table 27: Unmet Need and Opportunity in HER2-Negative Breast Cancer 69
Table 28: Product Profile - Abemaciclib (LY2835219) 83
Table 29: Abemaciclib SWOT Analysis, 2013 85
Table 30: Global Sales Forecast ($m) for Abemaciclib, 2013-2023 86
Table 31: Product Profile - Buparlisib (BKM- 120) 88
Table 32: Buparlisib SWOT Analysis, 2013 90
Table 33: Global Sales Forecast ($m) for Buparlisib, 2013-2023 91
Table 34: Product Profile - Javlor 93
Table 35: Javlor SWOT Analysis, 2013 95
Table 36: Global Sales Forecast ($m) for Buparlisib, 2013-2023 96
Table 37: Product Profile - LEE011 98
Table 38: LEE011 SWOT Analysis, 2013 100
Table 39: Global Sales Forecast ($m) for LEE011, 2013-2023 101
Table 40: Product Profile - NeuVax 103
Table 41: NeuVax SWOT Analysis, 2013 105
Table 42: Global Sales Forecast ($m) for NeuVax, 2013-2023 106
Table 43: Product Profile - Niraparib 108
Table 44: Niraparib SWOT Analysis, 2013 110
Table 45: Global Sales Forecast ($m) for Niraparib, 2013-2023 111
Table 46: Product Profile - NKTR- 102 112
Table 47: NKTR-102 SWOT Analysis, 2013 114
Table 48: Global Sales Forecast ($m) for NKTR 102, 2013-2023 115
Table 49: Product Profile - Lynparza 117
Table 50: Lynparza SWOT Analysis, 2013 119
Table 51: Global Sales Forecast ($m) for Lynparza, 2013-2023 120
Table 52: Product Profile - Palbociclib 122
Table 53: Palbociclib SWOT Analysis, 2013 124
Table 54: Global Sales Forecast ($m) for Palbociclib, 2013-2023 126
Table 55: Product Profile - Talazoparib 128
Table 56: Talazoparib SWOT Analysis, 2013 129
Table 57 Global Sales Forecast ($m) for Talazoparib, 2013-2023 130
Table 58: Product Profile - Veliparib 132
Table 59: Veliparib SWOT Analysis, 2013 134
Table 60: Global Sales Forecast ($m) for Veliparib, 2013-2023 135
Table 61: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, 2014 136
Table 62: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the US, 2013-2023 139
Table 63: Key Events Impacting Sales for HER2-Negative Breast Cancer in the US, 2013-2023 141
Table 64: US HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 142
Table 65: HER2-Negative Breast Cancer Incidence, 2013-2023 180
Table 66: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 181
Table 67: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 182
Table 68: Average Body Weight and Surface Area Across the 8MM 183
Table 69: Cost per Treatment Cycle ($) - Abraxane, Metastatic Setting (HR+) 186
Table 70 Cost per Treatment Cycle ($) - Avastin, Metastatic Setting (HR+/TNBC) 187
Table 71: Cost per Treatment Cycle ($) - Afinitor, Third-Line Hormonal/ Targeted Therapy 188
Table 72: Cost per Treatment Cycle ($) - Doxil, Metastatic Setting (HR+/TNBC) 189
Table 73: Cost per Treatment Cycle ($) - Halaven, Metastatic Setting (HR+/TNBC) 190
Table 74: Cost per Treatment Cycle ($) - Ixempra, Metastatic Setting (HR+/TNBC) 191
Table 75 Cost per Treatment Cycle ($) - Xeloda, Metastatic Setting (HR+/TNBC) 192
Table 76: Cost per Treatment Cycle ($) - Abemaciclib, First-/Second-Line Hormonal/Targeted Metastatic Setting (HR+) 193
Table 77: Cost per Treatment Cycle ($) - Buparlisib, Postmenopausal Hormonal Neoadjuvant, Second- and Third-Line Hormonal/Targeted Metastatic Settings (HR+) 194
Table 78: Cost per Treatment Cycle ($) - Javlor, Third-Line Chemotherapy Metastatic Setting (HR+) 195
Table 79: Cost per Treatment Cycle ($) - LEE011, Postmenopausal Hormonal Neoadjuvan, and First-Line Hormonal/Targeted Metastatic Settings (HR+) 196
Table 80: Cost per Treatment Cycle ($) - NeuVax, Adjuvant Setting (HR+) 197
Table 81: Cost per Treatment Cycle ($) - Niraparib, Metastatic TNBC Setting 197
Table 82: Cost per Treatment Cycle ($) - NKTR-102, Third Line Chemotherapy Metastatic Setting (HR+) 198
Table 83: Cost per Treatment Cycle ($) - Lynparza, Adjuvant and First-Line Metastatic TNBC Settings 199
Table 84: Cost per Treatment Cycle ($) - Palbociclib, First- and Second-Line Hormonal/Targeted Metasatatic Setting (HR+) 200
Table 85: Cost per Treatment Cycle ($) - Talazoparib, Third-Line Metastatic TNBC Setting 201
Table 86: Cost per Treatment Cycle ($) - Veliparib, Neoadjuvant and Second-Line Metastatic TNBC Settings 202
Table 87: Physicians Surveyed by Country 205

1.2 List of Figures
Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 16
Figure 2: Key Late-Stage Clinical Trials of Abraxane 35
Figure 3: Key Late-Stage Clinical Trials of Afinitor 40
Figure 4: Key Late-Stage Clinical Trials of Avastin 45
Figure 5: Key Late-Stage Clinical Trials of Halaven 53
Figure 6: Late Stage Clinical Trials of Drugs in HR+ Breast Cancer 81
Figure 7: Late Stage Clinical Trials of Drugs in TNBC 82
Figure 8: Key Late-Stage Clinical Trials of Abemaciclib 82
Figure 9: Clinical and Commercial Positioning of Abemaciclib 84
Figure 10: Key Late-Stage Clinical Trials of Buparlisib 88
Figure 11: Clinical and Commercial Positioning of Buparlisib 90
Figure 12: Key Late-Stage Clinical Trials of Javlor 93
Figure 13: Clinical and Commercial Positioning of Javlor 94
Figure 14: Key Late-Stage Clinical Trials of LEE011 98
Figure 15: Clinical and Commercial Positioning of LEE011 99
Figure 16: Key Late-Stage Clinical Trials of NeuVax 103
Figure 17: Clinical and Commercial Positioning of NeuVax 105
Figure 18: Key Late-Stage Clinical Trials of Niraparib 107
Figure 19: Clinical and Commercial Positioning of Niraparib 109
Figure 20: Key Late-Stage Clinical Trials of NKTR-102 112
Figure 21: Clinical and Commercial Positioning of NKTR-102 113
Figure 22: Key Late-Stage Clinical Trials of Lynparza 116
Figure 23: Clinical and Commercial Positioning of Lynparza 118
Figure 24: Key Late-Stage Key Clinical Trials of Palbociclib 121
Figure 25: Clinical and Commercial Positioning of Palbociclib 124
Figure 26: Key Late-Stage Clinical Trials of Talazoparib 127
Figure 27: Clinical and Commercial Positioning of Talazoparib 129
Figure 28: Key Late-Stage Clinical Trials of Veliparib 131
Figure 29: Clinical and Commercial Positioning of Veliparib 133
Figure 30: Sales for HER2-Negative Breast Cancer in the US by Drug, 2013-2022 140

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