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PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2025

  • ID:RM0034529
  • Published: December-2016
  • Pages:510
  • GlobalData
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PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2025 Summary Human epidermal growth factor receptor type 2 (HER2-) breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. HER2-negative breast cancer can be subdivided into hormone receptor-positive (HER2-/HR+), and triple negative breast cancer (TNBC). The prognoses of HER2-/HR+ and TNBC differ dramatically, as patients with TNBC progress more rapidly towards metastatic disease and only respond to chemotherapy agents. A large number of pipeline agents are being developed in HER2-/HR+ and/or TNBC, and are likely to change the treatment paradigm for these patients. This report highlights the significant unmet need for expansion
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PharmaPoint: HER2-Negative/HR+ and Triple Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2025 Summary Human epidermal growth factor receptor type 2 (HER2-) breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. HER2-negative breast cancer can be subdivided into hormone receptor-positive (HER2-/HR+), and triple negative breast cancer (TNBC). The prognoses of HER2-/HR+ and TNBC differ dramatically, as patients with TNBC progress more rapidly towards metastatic disease and only respond to chemotherapy agents. A large number of pipeline agents are being developed in HER2-/HR+ and/or TNBC, and are likely to change the treatment paradigm for these patients. This report highlights the significant unmet need for expansion in the HER2- breast cancer marker across the eight major markets; it also discusses the associated commercial opportunities for new market entrants to gain a foothold in the market. The Author anticipates the HER2- breast cancer market to almost double, from $5.43B to $10.58B, over the forecast period of 2015-2025. The key drivers will be the incorporation of CDK4/6 inhibitors into the first-line metastatic setting and the rise of new targeted therapies and immunotherapies. Highlights Key Questions Answered - In HER2-/HR+ breast cancer, the recent launch of CDK4/6 inhibitors in the US market has changed the paradigm of treatment in metastatic setting in these patients. How will new late-stage drugs will be positioned in comparison to the CDK 4/6 inhibitor Ibrance (palbociclib) Which of these drugs will have the highest peak sales at the highest CAGR, and why - Chemotherapy agents used in breast cancer are mostly well-established generics used in combination or as monotherapy. How will the advent of new therapies change the drug treatment landscape for HER2-negative breast cancer - Several new late-stage agents target specific patients population. How will these agents will compete against chemotherapies in terms of efficacy and market size Key Findings - In 2015, the value of the HER2- breast cancer market in the 8MM was estimated to be $5.43B. This is forecast to grow to $10.58B by the end of the forecast period, with China the main driver of growth. - The largest driver will be the incorporation of premium priced CDK4/6 inhibitors into the first line setting. Pfizer s Ibrance and Novartis ribociclib are expected to each reach blockbuster status by the end of the forecast period. - However, patent expiries of several blockbuster drugs and pricing difficulties are expected to limit growth in the HER2- breast cancer market over the forecast period. - Large market opportunities remain for the development of novel therapies in patients who acquire resistance to endocrine therapy. Scope - Overview of HER2- breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, treatment guidelines and disease management. - Annualized HER2- breast cancer therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2015 and forecast for seven years to 2025. - Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the HER2- breast cancer therapeutics market. - Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of middle- to late-stage pipeline drugs. - Analysis of the current and future market competition in the global HER2- breast cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications. Reasons to buy The report will enable you to - - Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list. - Develop business strategies by understanding the trends shaping and driving the global HER2- breast cancer therapeutics market. - Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2- breast cancer therapeutics market in future. - Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors. - Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage. - Track drug sales in the global HER2- breast cancer therapeutics market from 2015-2025. - Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


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1 Table of Contents 1 Table of Contents 11 1.1 List of Tables 18 1.2 List of Figures 25 2 Introduction 30 2.1 Catalyst 30 2.2 Related Reports 31 2.3 Upcoming Related Reports 31 3 Disease Overview 32 3.1 Etiology and Pathophysiology 32 3.1.1 Etiology 32 3.1.2 Pathophysiology 33 3.1.3 Basic Breast Anatomy 35 3.2 Disease Classification/Staging Systems 36 3.3 Symptoms 38 3.4 Prognosis 38 3.5 Quality of Life 39 4 Epidemiology 42 4.1 Disease Background 42 4.2 Risk Factors and Comorbidities 43 4.3 Global Trends 46 4.3.1 US 46 4.3.2 5EU 47 4.3.3 Japan 47 4.3.4 China (Urban) 48 4.3.5 Prevalence and Survival 49 4.4 Forecast Methodology 52 4.4.1 Sources Used Tables 53 4.4.2 Forecast Assumptions and Methods 65 4.4.3 Sources Not Used 85 4.5 Epidemiological Forecast for Non-Invasive DCIS Breast Cancer (2015-2025) 86 4.5.1 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer 86 4.5.2 Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 88 4.6 Epidemiological Forecast for Invasive Breast Cancer (2015-2025) 90 4.6.1 Diagnosed Incident Cases of Invasive Breast Cancer 90 4.6.2 Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer 92 4.6.3 Age-Standardized Diagnosed Incidence of Invasive Breast Cancer 94 4.6.4 Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer 95 4.6.5 Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis 97 4.6.6 Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status 99 4.6.7 Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Menopausal Status, and Site of Metastasis 101 4.6.8 Diagnosed Incident Cases of HER2-/HR+ Breast Cancer by Stage at Diagnosis, Menopausal Status, and Type of Biomarker Expression 105 4.6.9 Diagnosed Incident Cases of TN Breast Cancer by Stage at Diagnosis and BRCA Expression 108 4.7 Discussion 110 4.7.1 Epidemiological Forecast Insight 110 4.7.2 Limitations of the Analysis 112 4.7.3 Strengths of the Analysis 114 5 Disease Management 116 5.1 Diagnosis and Treatment Overview 116 5.1.1 Screening and Diagnosis 116 5.1.2 Treatment Overview of Loco-Regional Breast Cancer 117 5.1.3 Neoadjuvant and Adjuvant Treatment Regimen 121 5.1.4 Treatment of Metastatic HR+ Disease 127 5.1.5 Treatment of Metastatic TNBC 128 5.1.6 Treatment Guidelines and Leading Prescribed Drugs 130 5.2 US 131 5.2.1 Diagnosis 131 5.2.2 Clinical Practice 132 5.3 France 135 5.3.1 Diagnosis 135 5.3.2 Clinical Practice 136 5.4 Germany 138 5.4.1 Diagnosis 138 5.4.2 Clinical Practice 139 5.5 Italy 141 5.5.1 Diagnosis 141 5.5.2 Clinical Practice 142 5.6 Spain 144 5.6.1 Diagnosis 144 5.6.2 Clinical Practice 145 5.7 UK 147 5.7.1 Diagnosis 147 5.7.2 Clinical Practice 148 5.8 Japan 150 5.8.1 Diagnosis 150 5.8.2 Clinical Practice 151 5.9 China 153 5.9.1 Diagnosis 153 5.9.2 Clinical Practice 154 6 Competitive Assessment 157 6.1 Overview 157 6.2 Product Profiles (Branded Therapies) 158 6.2.1 Ibrance (palbociclib) 158 6.2.2 Abraxane (nab-paclitaxel) 170 6.2.3 Afinitor (everolimus) 176 6.2.4 Avastin (bevacizumab) 183 6.2.5 Halaven (eribulin mesylate) 189 6.2.6 Ixempra (ixabepilone) 196 6.2.7 Faslodex (fulvestrant) 202 6.2.8 Doxil/Caelyx (pegylated liposomal doxorubicin) 212 6.3 Product Profiles (Hormonal Agents) 216 6.3.1 Tamoxifen 216 6.3.2 Aromatase Inhibitors 219 7 Unmet Needs and Opportunities 223 7.1 Overview 223 7.1.1 Defined Treatment Plan for BRCA+ Patients and the Prevention of Prophylactic Surgeries 225 7.1.2 Targeted Treatment Options for Triple Negative Breast Cancer Patients 227 7.1.3 Treatment of Brain Metastasis 230 7.1.4 For HR+ Patients, Reduced Resistance to Hormonal Agents 232 7.1.5 Improved Convenience of Administration of Hormonal Agents 234 8 Pipeline Assessment 237 8.1 Overview 237 8.2 CDK4/6 inhibitors 241 8.2.1 Abemaciclib (LY2835219) 242 8.2.2 Ribociclib (LEE011) 250 8.3 Poly ADP-Ribose Polymerase Inhibitors 258 8.3.1 Lynparza (olaparib) 259 8.3.2 Talazoparib (BMN 673) 267 8.3.3 Veliparib (ABT-888) 272 8.3.4 Niraparib (MK4827) 277 8.4 Phosphoinositide 3 Kinase Inhibitors 285 8.4.1 Buparlisib (BKM- 120) 286 8.4.2 Alpelisib (BYL-719) 293 8.4.3 Taselisib (GDC-0032) 300 8.5 PD-1/PD-L1 Checkpoint Inhibitors 306 8.5.1 Tecentriq (atezolizumab) 308 8.5.2 Keytruda (pembrolizumab) 314 8.6 Histone Deacetylase Inhibitors 320 8.6.1 Entinostat 320 8.6.2 Epidaza (chidamide) 326 8.7 Antibody Drug Conjugates 333 8.7.1 Sacituzimab govitecan (IMMU-132) 333 8.7.2 Glembatumumab vedotin (CDX-011) 339 8.8 Others 346 8.8.1 Xtandi (enzalutamide) 346 8.9 Promising Drugs in Early Stage Clinical Development 354 8.9.1 Seviteronel 355 8.9.2 Ipatasertib 356 8.9.3 Vanctitumab 357 8.9.4 IDO Checkpoint Inhibitors 359 9 Current and Future Players 362 9.1 Overview 362 9.2 Trends in Corporate Strategy 366 9.3 Company Profiles 369 9.3.1 Pfizer 369 9.3.2 Novartis 373 9.3.3 Roche 375 9.3.4 AstraZeneca 378 10 Market Outlook 382 10.1 Global Markets 382 10.1.1 Forecast 382 10.1.2 Drivers and Barriers - Global Issues 388 10.2 US 391 10.2.1 Forecast 391 10.2.2 Key Events 395 10.2.3 Drivers and Barriers 397 10.3 5EU 399 10.3.1 Forecast 399 10.3.2 Key Events 403 10.3.3 Drivers and Barriers 405 10.4 Japan 408 10.4.1 Forecast 408 10.4.2 Key Events 411 10.4.3 Drivers and Barriers 412 10.5 China 414 10.5.1 Forecast 414 10.5.2 Key Events 417 10.5.3 Drivers and Barriers 418 11 Appendix 422 11.1 Bibliography 422 11.2 Abbreviations 470 11.3 Methodology 479 11.4 Forecasting Methodology 479 11.4.1 Diagnosed Patients with HER2- Breast Cancer 479 11.4.2 Percent Drug-Treated Patients 480 11.4.3 Drugs Included in Each Therapeutic Class 480 11.4.4 Launch and Patent Expiration Dates 482 11.4.5 General Pricing Assumptions 483 11.4.6 Average Body Weight and Surface Area Across the 8MM 485 11.4.7 General Forecast Assumptions 485 11.4.8 Individual Drug Assumptions 485 11.4.9 TS-1 Assumptions 492 11.4.10 Generic Erosion 492 11.4.11 Pricing of Pipeline Agents 492 11.5 Primary Research - Key Opinion Leaderss Interviewed for This Report 503 11.6 Primary Research - High-Prescribers Surveyed for this Report 505 11.7 About the Authors 506 11.7.1 Author 506 11.7.2 Epidemiologist 506 11.7.3 Therapy Director 507 11.7.4 Epidemiology Director 508 11.7.5 Global Director of Therapy Analysis and Epidemiology 508 11.8 About The Author 509 11.9 Disclaimer 509



List Of Tables

1.1 List of Tables Table 1: Molecular Subtypes of Breast Cancer 33 Table 2: AJCC Stage Definitions for Breast Cancer 37 Table 3: Prognosis for Breast Cancer 38 Table 4: Risk Factors and Comorbidities for Breast Cancer 44 Table 5: 8MM, Most Recent Five-Year Relative Survival for Invasive Breast Cancer, Women (%) 49 Table 6: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Non-Invasive DCIS Breast Cancer 53 Table 7: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status 54 Table 8: 8MM, Sources of Epidemiological Data Used to Forecast Diagnosed Incidence of Invasive Breast Cancer 55 Table 9: 8MM, Sources of Epidemiological Data Used to Forecast Invasive Breast Cancer by HER2 Status 56 Table 10: 8MM, Sources of Epidemiological Data Used to Forecast the Relative Survival of Invasive Breast Cancer 57 Table 11: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Stage at Diagnosis 58 Table 12: 8MM, Sources of Epidemiological Data Used to Forecast HER2-, HR+ Invasive Breast Cancer by Stage at Diagnosis 59 Table 13: 8MM, Sources of Epidemiological Data Used to Forecast TN Invasive Breast Cancer by Stage at Diagnosis 60 Table 14: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Menopausal Status 61 Table 15: 8MM, Sources of Epidemiological Data Used to Forecast HER2+ Invasive Breast Cancer by Site of Metastasis 62 Table 16: 8MM, Sources of Epidemiological Data Used to Forecast HER2-Specific Invasive Breast Cancer by Type of Biomarker Expression 63 Table 17: 8MM, Sources Not Used in Epidemiological Analysis of Breast Cancer 85 Table 18: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 87 Table 19: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages 18 Years, N, 2015 89 Table 20: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 91 Table 21: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N (Row %), 2015 93 Table 22: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, Select Years, 2015-2025 96 Table 23: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, N, 2015 98 Table 24: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by HER2 Status, Women, Ages 18 Years, N, 2015 100 Table 25: Treatment Guidelines for HER2- Breast Cancer 130 Table 26: Most Prescribed Regimens for HER2- Breast Cancer by Drug Class in the Global Markets, 2015 131 Table 27: Country Profile - US 132 Table 28: Country Profile - France 136 Table 29: Country Profile - Germany 139 Table 30: Country Profile - Italy 142 Table 31: Country Profile - Spain 145 Table 32: Country Profile - UK 148 Table 33: Country Profile - Japan 151 Table 34: Country Profile - China 154 Table 35: Product Profile - Ibrance 160 Table 36: Summary of the Results of the PALOMA-2 Trial 164 Table 37: Summary of the Results of the PALOMA-3 Trial 165 Table 38: Safety profile of Ibrance + letrozole 167 Table 39: Safety Profile of Ibrance in Combination with Faslodex 168 Table 40: Ibrance SWOT Analysis, 2016 169 Table 41: Product Profile - Abraxane 172 Table 42: Efficacy of Abraxane 174 Table 43: Safety Profile of Abraxane 175 Table 44: Abraxane SWOT Analysis, 2016 176 Table 45: Product Profile - Afinitor (everolimus) 178 Table 46: Efficacy of Afinitor in Second-Line HER2-/HR+ Advanced Breast Cancer 181 Table 47: Safety Profile of Afinitor 182 Table 48: Afinitor SWOT Analysis, 2016 182 Table 49: Product Profile - Avastin 184 Table 50: Efficacy of Avastin in First Line Metastatic Breast Cancer 187 Table 51: Safety of Avastin in First-Line Metastatic Breast Cancer 188 Table 52: Avastin SWOT Analysis, 2016 189 Table 53: Product Profile - Halaven 191 Table 54: Efficacy of Halaven 194 Table 55: Safety Profile of Halaven 195 Table 56: Halaven SWOT Analysis, 2016 196 Table 57: Product Profile - Ixempra 197 Table 58: Efficacy of Ixempra Monotherapy 199 Table 59: Efficacy of Ixempra in Combination with Xeloda 200 Table 60: Safety Profile of Ixempra 201 Table 61: Ixempra SWOT Analysis, 2016 202 Table 62: Product Profile - Faslodex 205 Table 63: Efficacy of Faslodex in the First Line 207 Table 64: Efficacy of Faslodex Monotherapy in the Second Line 208 Table 65: Efficacy of Faslodex in the First Line 208 Table 66: Safety of Faslodex in the First Line 209 Table 67: Safety of Faslodex in the Second Line 210 Table 68: Faslodex SWOT Analysis, 2016 211 Table 69: Product Profile - Doxil 213 Table 70: Doxil SWOT Analysis, 2016 216 Table 71: Product Profile - Nolvadex/Soltamox 218 Table 72: AI Approvals in the 8MM 221 Table 73: Unmet Need and Opportunity in HER2- Breast Cancer 225 Table 74: Product Profile - Abemaciclib (LY2835219) 244 Table 75: Efficacy of Abemaciclib in Monotherapy in Pretreated HER2-/HR+ Metastatic Breast Cancer Patients (MONARCH 1 NCT02102490) 246 Table 76: Safety of Abemaciclib in Monotherapy in Pretreated HER2-/HR+ Metastatic Breast Cancer Patients 247 Table 77: Abemaciclib SWOT Analysis, 2016 249 Table 78: Product Profile - Ribociclib 251 Table 79: Efficacy of Ribociclib in Combination with Letrozole in HER2-/HR+ Metastatic Breast Cancer Patients (MONALEESA 2, NCT01958021) 254 Table 80: Most Common AEs of Ribociclib in Combination with Letrozole in HER2-/HR+ Metastatic Breast Cancer Patients (MONALEESA 2, NCT01958021) 255 Table 81: Ribociclib SWOT Analysis, 2015 257 Table 82: Product Profile - Lynparza 261 Table 83: Summary of the Results of the ICEBERG 1 Phase II Trial (NCT00494234) 263 Table 84: Summary of the Most Commonly Reported AEs, Occurring in at Least 20% of Patients With Advanced Ovarian Cancers Treated with Lynparza Monotherapy 264 Table 85: Lynparza SWOT Analysis, 2016 266 Table 86: Product Profile - Talazoparib 268 Table 87: Summary of the Most Commonly Reported AEs in Patients Treated with Talazoparib Monotherapy 270 Table 88: Talazoparib SWOT Analysis, 2016 272 Table 89: Product Profile - Veliparib 274 Table 90: Veliparib SWOT Analysis, 2016 277 Table 91: Product Profile - Niraparib 279 Table 92: Summary of the Main Reported AEs in Ovarian Cancer Patients Treated with Niraparib 282 Table 93: Niraparib SWOT Analysis 2016 284 Table 94: Product Profile - Buparlisib (BKM-120) 287 Table 95: Summary of the Results of the Trial of Buparlisib + Faslodex vs. Faslodex 290 Table 96: Summary of AEs From the Trial of Buparlisib + Faslodex vs. Faslodex 291 Table 97: Buparlisib SWOT Analysis 293 Table 98: Product Profile - Alpelisib (BYL- 719) 294 Table 99: Summary of the Results of the Alpelisib Trial 296 Table 100: Summary of AEs from the Trial of Alpelisib 297 Table 101: Alpelisib SWOT Analysis 299 Table 102: Product Profile - Taselisib (GDC-0032) 300 Table 103: Summary of the Results of the Taselisib Trial 303 Table 104: Summary of the Safety of Taselisib 304 Table 105: Taselisib SWOT Analysis 306 Table 106: Product Profile - Tecentriq 309 Table 107: Summary of the Results of the Phase Ib Trial of Tecentriq in Combination with Abraxane in Patients with mTNBC (Genetech, NCT01633970) 311 Table 108: Summary of AEs from the Phase Ib Trial of Tecentriq + Abraxane in Patients with mTNBC (Genetech, NCT01633970) 312 Table 109: Tecentriq SWOT Analysis, 2016 312 Table 110: Product Profile - Keytruda (Pembrolizumab) 314 Table 111: Summary of the Results of Keytruda in HER2-/HR+ Patients in the KEYNOTE-028 Trial (MSD, NCT02054806) 316 Table 112: Summary of AEs of All Grades for Keytruda in HER2-/HR+ Patients in the Keytruda KEYNOTE-028 Trial (MSD, NCT02054806) 317 Table 113: Summary of Grade 3-4 AEs from the Trial of Keytruda (MSD, NCT02054806) 317 Table 114: Keytruda SWOT Analysis, 2016 318 Table 115: Product Profile - Entinostat 321 Table 116: Efficacy Results from the ENCORE301 Trial of Exemestane + Entinostat vs. Exemestane + Placebo 323 Table 117: Most Commonly Reported AEs from the ENCORE301 trial of Exemestane + Entinostat vs. Exemestane + Placebo 324 Table 118: Entinostat SWOT, 2016 326 Table 119: Product Profile - Epidaza 327 Table 120: Most Commonly Reported AEs from the Phase II Trial of Epidaza + Exemestane 330 Table 121: Epidaza SWOT Analysis 332 Table 122: Product Profile - Sacituzumab Govitecan 334 Table 123: Summary of the Results of Sacituzimab Govitecan Phase I/II Trial in Metastatic TNBC (Immunomedics Inc., NCT01631552) 336 Table 124: Summary of AEs from the Phase I/II Trial of Sacituzimab Govitecan (Immunomedics Inc., NCT01631552) 337 Table 125: Sacituzimab Govitecan SWOT, 2016 339 Table 126: Product Profile - Glembatumumab vedotin 340 Table 127: Efficacy Results of the Phase IIb EMERGE Trial of Glembatumumab Vedotin Monotherapy in Metastatic TNBC (NCT01156753) 342 Table 128: Safety Results of the Phase IIb EMERGE Trial of Glembatumumab Vedotin Monotherapy in Solid Tumors 343 Table 129: Glembatumumab Vedotin SWOT, 2016 345 Table 130: Product Profile - Xtandi 347 Table 131: Summary of the Results of ENZA Phase II Xtandi Trial (NCT01889238) 350 Table 132: Summary of the Results of Xtandi Trial 351 Table 133: Xtandi SWOT Analysis, 2016 353 Table 134: Early Stage Clinical Development in HER2- Breast Cancer 355 Table 135: Key Companies in the Disease HER2- Breast Cancer Market in the 8MM, 2015 364 Table 136: Pfizer s HER2- Metastatic Breast Cancer Portfolio Assessment, 2016 372 Table 137: Novartis HER2- Metastatic Breast Cancer Portfolio Assessment, 2016 374 Table 138: Roche s HER2- Breast Cancer Portfolio Assessment, 2016 377 Table 139: AZ s HER2- Breast Cancer Portfolio Assessment, 2016 381 Table 140: Global HER2- Breast Cancer Market - Drivers and Barriers, 2015-2025 388 Table 141: Key Events Impacting Sales for HER2-/HR+ in the US, 2015-2025 395 Table 142: Key Events Impacting Sales for TNBC in the US, 2015-2025 396 Table 143: US HER2- Breast Cancer Market - Drivers and Barriers, 2015-2025 397 Table 144: Key Events Impacting Sales for HER2-/HR+ Breast Cancer in the 5EU, 2015-2025 403 Table 145: Key Events Impacting Sales for TNBC in the 5EU, 2015-2025 404 Table 146: 5EU HER2- Breast Cancer Market - Drivers and Barriers, 2015-2025 405 Table 147: Key Events Impacting Sales for HER2-/HR+ breast cancer in Japan, 2015-2025 411 Table 148: Key Events Impacting Sales for TNBC in Japan, 2015-2025 412 Table 149: Japanese HER2- Breast Cancer Market - Drivers and Barriers, 2015-2025 412 Table 150: Key Events Impacting Sales for HER2-/HR+ Breast Cancer in China, 2015-2025 417 Table 151: Key Events Impacting Sales for TNBC in China, 2015-2025 418 Table 152: Chinese HER2- Breast Cancer Market - Drivers and Barriers, 2015-2025 418 Table 153: Key Launch Dates in HER2- Breast Cancer 482 Table 154: Key Patent Expiries 483 Table 155: Average Body Weight and Surface Area Across the 8MM 485 Table 156: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 505



List of Figures

1.2 List of Figures Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 36 Figure 2: 8MM, Crude Diagnosed Incidence Rates of Invasive Breast Cancer, Ages 18 Years, Women, Cases per 100,000 Population, 2005 2014 46 Figure 3: Case Flow Map 52 Figure 4: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer, Women, Ages 18 Years, Selected Years, 2015-2025 88 Figure 5: 8MM, Diagnosed Incident Cases of Non-Invasive DCIS Breast Cancer by HER2 Status, Women, Ages 18 Years, 2015 90 Figure 6: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, Selected Years, 2015-2025 92 Figure 7: 8MM, Age-Specific Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, 2015 94 Figure 8: 8MM, Age-Standardized Diagnosed Incident Cases of Invasive Breast Cancer, Women, Ages 18 Years, N, 2015 95 Figure 9: 8MM, Five-Year Diagnosed Prevalent Cases of Invasive Breast Cancer, Women, Ages 18 Years, Select Years, 2015-2025 97 Figure 10: 8MM, Diagnosed Incident Cases of Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 99 Figure 11: 8MM, Diagnosed Incident Cases of Breast Cancer by HER2 Status, Women, Ages 18 Years, 2015 101 Figure 12: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 102 Figure 13: 8MM, Proportion of HER2+/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 103 Figure 14: 8MM, Proportion of HER2+/HR- Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 104 Figure 15: 8MM, Diagnosed Incident Cases of HER2+ Invasive Breast Cancer by Site of Metastasis, Women, Ages 18 Years, 2015 105 Figure 16: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 106 Figure 17: 8MM, Proportion of HER2-/HR+ Diagnosed Incident Cases of Invasive Breast Cancer by Menopausal Status, Women, Ages 18 Years, 2015 107 Figure 18: 8MM, Diagnosed Incident Cases of HER2-/HR+ Invasive Breast Cancer by Type of Biomarker Expression, Women, Ages 18 Years, 2015 108 Figure 19: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer by Stage at Diagnosis, Women, Ages 18 Years, 2015 109 Figure 20: 8MM, Diagnosed Incident Cases of TN Invasive Breast Cancer with BRCA Expression, Women, Ages 18 Years, 2015 110 Figure 21: Overview of Non-Invasive and Invasive Breast Cancer Treatment 117 Figure 22: Neoadjuvant/Adjuvant Settings Treatment Paradigm in HER2- Breast Cancer 124 Figure 23: Key Late-Stage Key Clinical Trials of Ibrance 162 Figure 24: Key Late-Stage Key Clinical Trials of Abraxane 173 Figure 25: Key Late-Stage Key Clinical Trials of Afinitor 179 Figure 26: Key Late-Stage Clinical Trials of Avastin 186 Figure 27: Key Late-Stage Clinical Trials of Halaven 192 Figure 28: Key Late-Stage Clinical Trials of Ixempra 198 Figure 29: Key Late-Stage Clinical Trials of Faslodex 206 Figure 30: Late-Stage Clinical Trials of Drugs in HR+ Breast Cancer 239 Figure 31: Late-Stage Clinical Trials of Drugs in TNBC 240 Figure 32: Key Late-Stage Clinical Trials of Abemaciclib 244 Figure 33: Clinical and Commercial Positioning of Abemaciclib 248 Figure 34: Key Late-Stage Clinical Trials of Ribociclib 251 Figure 35: Clinical and Commercial Positioning of Ribociclib 256 Figure 36: Key Late-Stage Clinical Trials of Lynparza 260 Figure 37: Clinical and Commercial Positioning of Lynparza 265 Figure 38: Key Late-Stage Clinical Trials of Talazoparib 267 Figure 39: Clinical and Commercial Positioning of Talazoparib 271 Figure 40: Key Late-Stage Clinical Trials of Veliparib 273 Figure 41: Clinical and Commercial Positioning of Veliparib 276 Figure 42: Key Late-Stage Clinical Trials of Niraparib 279 Figure 43: Clinical and Commercial Positioning of Niraparib 283 Figure 44: Key Late-Stage Clinical Trials of Buparlisib 289 Figure 45: Clinical and Commercial Positioning of Buparlisib 292 Figure 46: Key Late-Stage Clinical Trials of Alpelisib 295 Figure 47: Clinical and Commercial Positioning of Alpelisib 298 Figure 48: Key Late-Stage Clinical Trials of Taselisib 302 Figure 49: Clinical and Commercial Positioning of Taselisib 305 Figure 50: Key Late-Stage Clinical Trials of Tecentriq 310 Figure 51: Clinical and Commercial Positioning of Tecentriq 313 Figure 52: Key Late-Stage Clinical Trials of Keytruda 315 Figure 53: Clinical and Commercial Positioning of Keytruda 319 Figure 54: Key Late-Stage Clinical Trials of Entinostat 322 Figure 55: Clinical and Commercial Positioning of Entinostat 325 Figure 56: Key Late-Stage Clinical Trials of Epidaza 329 Figure 57: Clinical and Commercial Positioning of Epidaza 331 Figure 58: Key Late-Stage Clinical Trials of Sacituzumab Govitecan 335 Figure 59: Clinical and Commercial Positioning of sacituzimab govitecan 338 Figure 60: Key Late-Stage Clinical Trials of Glembatumumab Vedotin 341 Figure 61: Clinical and Commercial Positioning of Glembatumumab Vedotin 344 Figure 62: Key Late-Stage Clinical Trials of Xtandi 349 Figure 63: Clinical and Commercial Positioning of Xtandi 352 Figure 64: Global Sales of Branded Products for HER2- Breast Cancer by Company, 2015 and 2025 365 Figure 65: Company Portfolio Gap Analysis in HER2- Breast Cancer, 2015-2025 366 Figure 66: Pfizer SWOT Analysis in HER2- Metastatic Breast Cancer, 2016 372 Figure 67: Novartis SWOT Analysis in HER2- Metastatic Breast Cancer, 2016 375 Figure 68: Roche SWOT Analysis in HER2- Metastatic Breast Cancer, 2016 378 Figure 69: Roche SWOT Analysis in HER2- Metastatic Breast Cancer, 2016 381 Figure 70: Global Sales ($M) for HER2- Breast Cancer by Region, 2015-2025 386 Figure 71: Global Sales for HER2- Breast Cancer by Drug, 2015-2025 387 Figure 72: Sales for HER2-/HR+ Breast Cancer in the US by Drug, 2015-2025 393 Figure 73: Sales for TNBC Breast Cancer in the US by Drug, 2015-2025 394 Figure 74: Sales for HER2-/HR+ Breast Cancer in the 5EU by Drug, 2015-2025 401 Figure 75: Sales for TNBC Breast Cancer in the 5EU by Drug, 2015-2025 402 Figure 76: Sales for HER2-/HR+ Breast Cancer in Japan by Drug, 2015-2025 409 Figure 77: Sales for TNBC Breast Cancer in Japan by Drug, 2015-2025 410 Figure 78: Sales for HER2-/HR+ Breast Cancer in China by Drug, 2015-2025 415 Figure 79: Sales for TNBC Breast Cancer in China by Drug, 2015-2025 416


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1 – 15 USERS Electronic (PDF) The report will be delivered to your email address in PDF format. The license allows up to fifteen users have access to the product.
1 - 5 USERS Online Access (For Databases) Database is accessed online through a secure website. You will receive a username and password via email to access to the online directory. The license allows up to five users have access to the product.
1 - 10 USERS Online Access(For Databases) Database is accessed online through a secure website. You will receive a username and password via email to access to the online directory. The license allows up to ten users have access to the product.
1 - 15 USERS Online Access(For Databases) Database is accessed online through a secure website. You will receive a username and password via email to access to the online directory. The license allows up to fifteen users have access to the product.
1 - 5 USERS Electronic (Excel) The Excel spreadsheet will be emailed to you. The license allows up to five users have access to the product.

PLEASE SELECT A FORMAT

  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is a 1-10 user licence, allowing up to ten users have access to the product.

  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is a 1-15 user licence, allowing up to fifteen users have access to the product.

  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is a 1-15 user licence, allowing up to fifteen users have access to the product.