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Executive Summary HER2-Negative Breast Cancer - Japan 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). There are several reasons for this decline, the most important of which is the fact that fewer drugs will be entering fewer settings in the Japanese market than in the US and 5EU, in particular, NeuVax in the highly lucrative adjuvant setting, and several premium-priced PARP inhibitors in the TNBC setting. Japan will also see the highest number of patent expiries (six) of any of the forecast countries, which will result in significant downsizing and curtailment of growth compared with the rest of the world. Japan also has a steadily declining population (AGR = -0.03%), meaning that the total potential patient pool that could be eligible for any given drug is reduced. Furthermore, the higher drug prices observed in the US and 5EU compared with the more modest prices observed in Japan, will contribute to the decline in the Japanese market. *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 Japan including product HER2-Negative Breast Cancercription, safety and efficacy profiles as well as a SWOT analysis. - Sales forecast for the top drugs in Japan from 2013-2023. - Analysis of the impact of key events as well the drivers and restraints affecting the Japan 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 Japan. Read More Contact 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 Japan 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 Japan 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 1.2 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 Japan by Drug, 2013-2023 140 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 - Japan 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 Japan, 2013-2023 139 Table 63: Key Events Impacting Sales for HER2-Negative Breast Cancer in Japan, 2013-2023 141 Table 64: Japanese 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 Single User License: Site License: Corporate User License: |
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