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

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

2 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) or 2

3 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 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 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 in the 5EU. 3

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

5 Table Of Contents for HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to Table of Contents1 Table of Contents 21.1 List of Tables 61.2 List of Figures 112 Introduction Catalyst Related Reports Upcoming Related Reports 143 Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Basic Breast Anatomy Disease Classification/Staging Systems Symptoms Prognosis Quality of Life 214 Disease Management Diagnosis and Treatment Overview Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) Treatment Guidelines and Leading Prescribed Drugs France Diagnosis Clinical Practice Germany Diagnosis Clinical Practice Italy Diagnosis Clinical Practice Spain Diagnosis Clinical Practice UK Diagnosis Clinical Practice 465 Competitive Assessment Overview Product Profiles (Branded Therapies) Abraxane (nab-paclitaxel) Afinitor (everolimus) Avastin (bevacizumab) Doxil/Caelyx (pegylated liposomal doxorubicin) Halaven (eribulin mesylate) Ixempra (ixabepilone) Xeloda (capecitabine) Product Profiles (Hormonal Agents) Tamoxifen Faslodex (fulvestrant) Aromatase Inhibitors 806 Unmet Need and Opportunity Overview Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries Specific treatment options for TNBC patients Prevention of brain metastasis Neoadjuvant therapy that can downstage tumors For HR+patients, reduced resistance to hormonal agents Improved convenience of administration of hormonal agents 947 Pipeline Assessment Overview Abemaciclib (LY ) Buparlisib (BKM- 120) Javlor (vinflunine) LEE NeuVax (nelipepimut-s/e75) Niraparib (MK4827) NKTR- 102 (etirinotecan pegol) Lynparza (olaparib) Palbociclib (PD ) Talazoparib (BMN 673) Veliparib (ABT-888) Promising Drugs in Clinical Development PD-/PD-L 1 Immunotherapies 1538 Market Outlook France Forecast Key Events Drivers and Barriers Germany Forecast Key Events Drivers and Barriers Italy Forecast Key Events Drivers and Barriers Spain Forecast Key Events Drivers and Barriers UK Forecast Key Events Drivers and Barriers 1829 Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed HER2-Negative Breast Cancer Patients Percentage of Drug-Treated Patients Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Pricing of Pipeline Agents Primary Research - KOLs Interviewed for This Report Primary Research - High- Prescriber Survey About the Authors Analyst Director of Oncology Epidemiologist Director of Epidemiology Global Head of Healthcare About GlobalData Disclaimer 250 5

6 List Of Tables in HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 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, 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, Table 12: Global Sales Forecast ($m) for Abraxane, Table 13: Product Profile - Afinitor (everolimus) 58 Table 14: Afinitor SWOT Analysis, Table 15: Global Sales Forecast ($m) for Afinitor, Table 16: Product Profile - Avastin 62 Table 17: Avastin SWOT Analysis, Table 18 Global Sales Forecast ($m) for Avastin, Table 19: Product Profile - Doxil 67 Table 20: Doxil SWOT Analysis, Table 21: Global Sales Forecast ($m) for Doxil/Caelyx, Table 22: Product Profile - Halavan 71 Table 23: Halaven SWOT Analysis, Table 24: Global Sales Forecast ($m) for Halaven, Table 25: Product Profile - Ixempra 74 Table 26: Ixempra SWOT Analysis, Table 27: Global Sales Forecast ($m) for Ixempra,

7 Table 28: Product Profile - Xeloda 77 Table 29: Xeloda SWOT Analysis, 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 (LY ) 100 Table 33: Abemaciclib SWOT Analysis, Table 34: Global Sales Forecast ($m) for Abemaciclib, Table 35: Product Profile - Buparlisib (BKM- 120) 105 Table 36: Buparlisib SWOT Analysis, Table 37: Global Sales Forecast ($m) for Buparlisib, Table 38: Product Profile - Javlor 110 Table 39: Javlor SWOT Analysis, Table 40: Global Sales Forecast ($m) for Buparlisib, Table 41: Product Profile - LEE Table 42: LEE011 SWOT Analysis, Table 43: Global Sales Forecast ($m) for LEE011, Table 44: Product Profile - NeuVax 120 Table 45: NeuVax SWOT Analysis, Table 46: Global Sales Forecast ($m) for NeuVax, Table 47: Product Profile - Niraparib 125 Table 48: Niraparib SWOT Analysis, Table 49: Global Sales Forecast ($m) for Niraparib, Table 50: Product Profile - NKTR Table 51: NKTR-102 SWOT Analysis, Table 52: Global Sales Forecast ($m) for NKTR 102, Table 53: Product Profile - Lynparza 134 Table 54: Lynparza SWOT Analysis, Table 55: Global Sales Forecast ($m) for Lynparza, Table 56: Product Profile - Palbociclib 139 Table 57: Palbociclib SWOT Analysis, Table 58: Global Sales Forecast ($m) for Palbociclib,

8 Table 59: Product Profile - Talazoparib 145 Table 60: Talazoparib SWOT Analysis, Table 61 Global Sales Forecast ($m) for Talazoparib, Table 62: Product Profile - Veliparib 149 Table 63: Veliparib SWOT Analysis, Table 64: Global Sales Forecast ($m) for Veliparib, Table 65: Early-Stage Immunotherapies in Development for HER2-Negative Breast Cancer, Table 66: Sales Forecasts ($m) for HER2-Negative Breast Cancer in France, Table 67: Key Events Impacting Sales for HER2-Negative Breast Cancer in France, Table 68: French HER2-Negative Breast Cancer Market - Drivers and Barriers, Table 69: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Germany, Table 70: Key Events Impacting Sales for HER2-Negative Breast Cancer in Germany, Table 71: German HER2-Negative Breast Cancer Market - Drivers and Barriers, Table 72: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Italy, Table 73: Key Events Impacting Sales for HER2-Negative Breast Cancer in Italy, Table 74: Italian HER2-Negative Breast Cancer Market - Drivers and Barriers, Table 75: Sales Forecasts ($m) for HER2-Negative Breast Cancer in Spain, Table 76: Key Events Impacting Sales for HER2-Negative Breast Cancer in Spain, Table 77: Spanish HER2-Negative Breast Cancer Market - Drivers and Barriers, Table 78: Sales Forecasts ($m) for HER2-Negative Breast Cancer in the UK, Table 79: Key Events Impacting Sales for HER2-Negative Breast Cancer in the UK, Table 80: UK HER2-Negative Breast Cancer Market - Drivers and Barriers, Table 81: HER2-Negative Breast Cancer Incidence, Table 82: Key Launch Dates of Marketed and Pipeline Drugs for HER2-Negative Breast Cancer 222 Table 83: Key Expiry Dates of Marketed and Pipeline Drugs Used in HER2-Negative Breast Cancer 223 Table 84: Average Body Weight and Surface Area Across the 8MM 224 Table 85: Cost per Treatment Cycle ($) - 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

9 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

10 List Of Figures, Charts and Diagrams in HER2-Negative Breast Cancer - 5EU Drug Forecast and Market Analysis to 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 LEE Figure 15: Clinical and Commercial Positioning of LEE 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 Figure 21: Clinical and Commercial Positioning of NKTR 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

11 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, Figure 31: Sales for HER2-Negative Breast Cancer in Germany by Drug, Figure 32: Sales for HER2-Negative Breast Cancer in Italy by Drug, Figure 33: Sales for HER2-Negative Breast Cancer in Spain by Drug, Figure 34: Sales for HER2-Negative Breast Cancer in the UK by Drug,

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