HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023

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HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023

HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0)1300 321501 or Email: reportstore@bioportfolio.com 2

HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023 HER2-Negative Breast Cancer - 5EU 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). Indeed, the new drugs that will be entering the market will command a premium price in multiple settings, and there will be a steady increase in the incident cases of the disease (1.8% AGR) over the forecast period. However, it should be noted that, compared with other countries in the 5EU, the market in Germany will grow at a slower rate, with its share of the global market ultimately decreasing from 9% in 2013 to 8% in 2023. 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 5EU including product HER2-Negative Breast Cancercription, safety and efficacy profiles as well as a SWOT analysis. - Sales forecast for the top drugs in 5EU from 2013-2023. - Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU. 3

Additional Details Publisher : Global Data Reference : GDHC353CFR Number of Pages : 251 Report Format : PDF Publisher Information : 4

Table Of Contents for HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023 1 Table of Contents1 Table of Contents 21.1 List of Tables 61.2 List of Figures 112 Introduction 132.1 Catalyst 132.2 Related Reports 132.3 Upcoming Related Reports 143 Disease Overview 153.1 Etiology and Pathophysiology 153.1.1 Etiology 153.1.2 Pathophysiology 163.1.3 Basic Breast Anatomy 173.2 Disease Classification/Staging Systems 183.3 Symptoms 203.4 Prognosis 203.5 Quality of Life 214 Disease Management 244.1 Diagnosis and Treatment Overview 244.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 244.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 264.1.3 Treatment Guidelines and Leading Prescribed Drugs 304.2 France 314.2.1 Diagnosis 314.2.2 Clinical Practice 324.3 Germany 354.3.1 Diagnosis 354.3.2 Clinical Practice 364.4 Italy 394.4.1 Diagnosis 394.4.2 Clinical Practice 404.5 Spain 424.5.1 Diagnosis 424.5.2 Clinical Practice 434.6 UK 454.6.1 Diagnosis 454.6.2 Clinical Practice 465 Competitive Assessment 505.1 Overview 505.2 Product Profiles (Branded Therapies) 515.2.1 Abraxane (nab-paclitaxel) 515.2.2 Afinitor (everolimus) 565.2.3 Avastin (bevacizumab) 605.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 655.2.5 Halaven (eribulin mesylate) 705.2.6 Ixempra (ixabepilone) 735.2.7 Xeloda (capecitabine) 765.3 Product Profiles (Hormonal Agents) 795.3.1 Tamoxifen 795.3.2 Faslodex (fulvestrant) 795.3.3 Aromatase Inhibitors 806 Unmet Need and Opportunity 846.1 Overview 846.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 866.1.2 Specific treatment options for TNBC patients 886.1.3 Prevention of brain metastasis 896.1.4 Neoadjuvant therapy that can downstage tumors 916.1.5 For HR+patients, reduced resistance to hormonal agents 926.1.6 Improved convenience of administration of hormonal agents 947 Pipeline Assessment 967.1 Overview 967.1.1 Abemaciclib (LY2835219) 977.1.2 Buparlisib (BKM- 120) 1037.1.3 Javlor (vinflunine) 1097.1.4 LEE011 1137.1.5 NeuVax (nelipepimut-s/e75) 1187.1.6 Niraparib (MK4827) 1237.1.7 NKTR- 102 (etirinotecan pegol) 1287.1.8 Lynparza (olaparib) 1327.1.9 Palbociclib (PD-0332991) 1377.1.10 Talazoparib (BMN 673) 1437.1.11 Veliparib (ABT-888) 1477.2 Promising Drugs in Clinical Development 1527.2.1 PD-/PD-L 1 Immunotherapies 1538 Market Outlook 1558.1 France 1558.1.1 Forecast 1558.1.2 Key Events 1588.1.3 Drivers and Barriers 1598.2 Germany 1608.2.1 Forecast 1608.2.2 Key Events 1648.2.3 Drivers and Barriers 1658.3 Italy 1668.3.1 Forecast 1668.3.2 Key Events 1708.3.3 Drivers and Barriers 1718.4 Spain 1728.4.1 Forecast 1728.4.2 Key Events 1758.4.3 Drivers and Barriers 1768.5 UK 1778.5.1 Forecast 1778.5.2 Key Events 1818.5.3 Drivers and Barriers 1829 Appendix 1859.1 Bibliography 1859.2 Abbreviations 2129.3 Methodology 2209.4 Forecasting Methodology 2209.4.1 Diagnosed HER2-Negative Breast Cancer Patients 2209.4.2 Percentage of Drug-Treated Patients 2219.4.3 Drugs Included in Each Therapeutic Class 2219.4.4 Launch and Patent Expiry Dates 2229.4.5 General Pricing Assumptions 2239.4.6 Individual Drug Assumptions 2259.4.7 Generic Erosion 2339.4.8 Pricing of Pipeline Agents 2339.5 Primary Research - KOLs Interviewed for This Report 2449.6 Primary Research - High- Prescriber Survey 2469.7 About the Authors 2479.7.1 Analyst 2479.7.2 Director of Oncology 2479.7.3 Epidemiologist 2489.7.4 Director of Epidemiology 2489.7.5 Global Head of Healthcare 2499.8 About GlobalData 2509.9 Disclaimer 250 5

List Of Tables in HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023 1.1 List of Tables Table 1: AJCC Stage Definitions for Breast Cancer 19 Table 2: Prognosis for Breast Cancer 20 Table 3: Treatment Guidelines for HER2-Negative Breast Cancer 30 Table 4: Most Prescribed Regimens for HER2-Negative Breast Cancer by Drug Class in the Global Markets, 2013 31 Table 5: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - France 32 Table 6: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Germany 36 Table 7: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Italy 40 Table 8: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - Spain 43 Table 9: HER2-Negative Breast Cancer Diagnosis and Treatment, Country Profile - UK 46 Table 10: Product Profile - Abraxane 53 Table 11: Abraxane SWOT Analysis, 2013 55 Table 12: Global Sales Forecast ($m) for Abraxane, 2013-2023 56 Table 13: Product Profile - Afinitor (everolimus) 58 Table 14: Afinitor SWOT Analysis, 2013 59 Table 15: Global Sales Forecast ($m) for Afinitor, 2013-2023 60 Table 16: Product Profile - Avastin 62 Table 17: Avastin SWOT Analysis, 2013 64 Table 18 Global Sales Forecast ($m) for Avastin, 2013-2023 65 Table 19: Product Profile - Doxil 67 Table 20: Doxil SWOT Analysis, 2013 69 Table 21: Global Sales Forecast ($m) for Doxil/Caelyx, 2013-2023 69 Table 22: Product Profile - Halavan 71 Table 23: Halaven SWOT Analysis, 2013 72 Table 24: Global Sales Forecast ($m) for Halaven, 2013-2023 73 Table 25: Product Profile - Ixempra 74 Table 26: Ixempra SWOT Analysis, 2013 75 Table 27: Global Sales Forecast ($m) for Ixempra, 2013-2023 76 6

Table 28: Product Profile - Xeloda 77 Table 29: Xeloda SWOT Analysis, 2013 78 Table 30: AI Approvals in the US and 5EU 82 Table 31: Unmet Need and Opportunity in HER2-Negative Breast Cancer 86 Table 32: Product Profile - Abemaciclib (LY2835219) 100 Table 33: Abemaciclib SWOT Analysis, 2013 102 Table 34: Global Sales Forecast ($m) for Abemaciclib, 2013-2023 103 Table 35: Product Profile - Buparlisib (BKM- 120) 105 Table 36: Buparlisib SWOT Analysis, 2013 107 Table 37: Global Sales Forecast ($m) for Buparlisib, 2013-2023 108 Table 38: Product Profile - Javlor 110 Table 39: Javlor SWOT Analysis, 2013 112 Table 40: Global Sales Forecast ($m) for Buparlisib, 2013-2023 113 Table 41: Product Profile - LEE011 115 Table 42: LEE011 SWOT Analysis, 2013 117 Table 43: Global Sales Forecast ($m) for LEE011, 2013-2023 118 Table 44: Product Profile - NeuVax 120 Table 45: NeuVax SWOT Analysis, 2013 122 Table 46: Global Sales Forecast ($m) for NeuVax, 2013-2023 123 Table 47: Product Profile - Niraparib 125 Table 48: Niraparib SWOT Analysis, 2013 127 Table 49: Global Sales Forecast ($m) for Niraparib, 2013-2023 128 Table 50: Product Profile - NKTR- 102 129 Table 51: NKTR-102 SWOT Analysis, 2013 131 Table 52: Global Sales Forecast ($m) for NKTR 102, 2013-2023 132 Table 53: Product Profile - Lynparza 134 Table 54: Lynparza SWOT Analysis, 2013 136 Table 55: Global Sales Forecast ($m) for Lynparza, 2013-2023 137 Table 56: Product Profile - Palbociclib 139 Table 57: Palbociclib SWOT Analysis, 2013 141 Table 58: Global Sales Forecast ($m) for Palbociclib, 2013-2023 143 7

Table 59: Product Profile - Talazoparib 145 Table 60: Talazoparib SWOT Analysis, 2013 146 Table 61 Global Sales Forecast ($m) for Talazoparib, 2013-2023 147 Table 62: Product Profile - Veliparib 149 Table 63: Veliparib SWOT Analysis, 2013 151 Table 64: Global Sales Forecast ($m) for Veliparib, 2013-2023 152 Table 65: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, 2014 153 Table 66: Sales Forecasts ($m) for HER2-Negative Breast Cancer in France, 2013-2023 156 Table 67: Key Events Impacting Sales for HER2-Negative Breast Cancer in France, 2013-2023 158 Table 68: French HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 159 Table 69: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Germany, 2013-2023 162 Table 70: Key Events Impacting Sales for HER2-Negative Breast Cancer in Germany, 2013-2023 164 Table 71: German HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 165 Table 72: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Italy, 2013-2023 168 Table 73: Key Events Impacting Sales for HER2-Negative Breast Cancer in Italy, 2013-2023 170 Table 74: Italian HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 171 Table 75: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Spain, 2013-2023 173 Table 76: Key Events Impacting Sales for HER2-Negative Breast Cancer in Spain, 2013-2023 175 Table 77: Spanish HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 176 Table 78: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the UK, 2013-2023 179 Table 79: Key Events Impacting Sales for HER2-Negative Breast Cancer in the UK, 2013-2023 181 Table 80: UK HER2-Negative Breast Cancer Market - Drivers and Barriers, 2013-2023 182 Table 81: HER2-Negative Breast Cancer Incidence, 2013-2023 221 Table 82: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 222 Table 83: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 223 Table 84: Average Body Weight and Surface Area Across the 8MM 224 Table 85: Cost per Treatment Cycle ($) - Abraxane, Metastatic Setting (HR+) 227 Table 86 Cost per Treatment Cycle ($) - Avastin, Metastatic Setting (HR+/TNBC) 228 Table 87: Cost per Treatment Cycle ($) - Afinitor, Third-Line Hormonal/ Targeted Therapy 229 Table 88: Cost per Treatment Cycle ($) - Doxil, Metastatic Setting (HR+/TNBC) 230 Table 89: Cost per Treatment Cycle ($) - Halaven, Metastatic Setting (HR+/TNBC) 231 8

Table 90: Cost per Treatment Cycle ($) - Ixempra, Metastatic Setting (HR+/TNBC) 232 Table 91 Cost per Treatment Cycle ($) - Xeloda, Metastatic Setting (HR+/TNBC) 233 Table 92: Cost per Treatment Cycle ($) - Abemaciclib, First-/Second-Line Hormonal/Targeted Metastatic Setting (HR+) 234 Table 93: Cost per Treatment Cycle ($) - Buparlisib, Postmenopausal Hormonal Neoadjuvant, Second- and Third- Line Hormonal/Targeted Metastatic Settings (HR+) 235 Table 94: Cost per Treatment Cycle ($) - Javlor, Third-Line Chemotherapy Metastatic Setting (HR+) 236 Table 95: Cost per Treatment Cycle ($) - LEE011, Postmenopausal Hormonal Neoadjuvan, and First-Line Hormonal/Targeted Metastatic Settings (HR+) 237 Table 96: Cost per Treatment Cycle ($) - NeuVax, Adjuvant Setting (HR+) 238 Table 97: Cost per Treatment Cycle ($) - Niraparib, Metastatic TNBC Setting 238 Table 98: Cost per Treatment Cycle ($) - NKTR-102, Third Line Chemotherapy Metastatic Setting (HR+) 239 Table 99: Cost per Treatment Cycle ($) - Lynparza, Adjuvant and First-Line Metastatic TNBC Settings 240 Table 100: Cost per Treatment Cycle ($) - Palbociclib, First- and Second-Line Hormonal/Targeted Metasatatic Setting (HR+) 241 Table 101: Cost per Treatment Cycle ($) - Talazoparib, Third-Line Metastatic TNBC Setting 242 Table 102: Cost per Treatment Cycle ($) - Veliparib, Neoadjuvant and Second-Line Metastatic TNBC Settings 243 Table 103: Physicians Surveyed by Country 246 9

List Of Figures, Charts and Diagrams in HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 2023 1.2 List of Figures Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 18 Figure 2: Key Late-Stage Clinical Trials of Abraxane 52 Figure 3: Key Late-Stage Clinical Trials of Afinitor 57 Figure 4: Key Late-Stage Clinical Trials of Avastin 62 Figure 5: Key Late-Stage Clinical Trials of Halaven 70 Figure 6: Late Stage Clinical Trials of Drugs in HR+ Breast Cancer 98 Figure 7: Late Stage Clinical Trials of Drugs in TNBC 99 Figure 8: Key Late-Stage Clinical Trials of Abemaciclib 99 Figure 9: Clinical and Commercial Positioning of Abemaciclib 101 Figure 10: Key Late-Stage Clinical Trials of Buparlisib 105 Figure 11: Clinical and Commercial Positioning of Buparlisib 107 Figure 12: Key Late-Stage Clinical Trials of Javlor 110 Figure 13: Clinical and Commercial Positioning of Javlor 111 Figure 14: Key Late-Stage Clinical Trials of LEE011 115 Figure 15: Clinical and Commercial Positioning of LEE011 116 Figure 16: Key Late-Stage Clinical Trials of NeuVax 120 Figure 17: Clinical and Commercial Positioning of NeuVax 122 Figure 18: Key Late-Stage Clinical Trials of Niraparib 124 Figure 19: Clinical and Commercial Positioning of Niraparib 126 Figure 20: Key Late-Stage Clinical Trials of NKTR-102 129 Figure 21: Clinical and Commercial Positioning of NKTR-102 130 Figure 22: Key Late-Stage Clinical Trials of Lynparza 133 Figure 23: Clinical and Commercial Positioning of Lynparza 135 Figure 24: Key Late-Stage Key Clinical Trials of Palbociclib 138 Figure 25: Clinical and Commercial Positioning of Palbociclib 141 Figure 26: Key Late-Stage Clinical Trials of Talazoparib 144 10

Figure 27: Clinical and Commercial Positioning of Talazoparib 146 Figure 28: Key Late-Stage Clinical Trials of Veliparib 148 Figure 29: Clinical and Commercial Positioning of Veliparib 150 Figure 30: Sales for HER2-Negative Breast Cancer in France by Drug, 2013-2023 157 Figure 31: Sales for HER2-Negative Breast Cancer in Germany by Drug, 2013-2023 163 Figure 32: Sales for HER2-Negative Breast Cancer in Italy by Drug, 2013-2023 169 Figure 33: Sales for HER2-Negative Breast Cancer in Spain by Drug, 2013-2022 174 Figure 34: Sales for HER2-Negative Breast Cancer in the UK by Drug, 2013-2023 180 11

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