1 Table of Contents 1 Table of Contents 4 1.1 List of Tables 7 1.2 List of Figures 7 2 Introduction 9 2.1 Disease Introduction 9 2.2 Symptoms 10 2.3 Etiology 10 2.4 Pathophysiology 11 2.5 Epidemiology 12 2.6 Diagnosis and Classification 14 2.7 Prognosis and Disease Staging 16 2.8 Treatment Options 18 2.8.1 Surgery and Radiation Therapy 18 2.8.2 Chemotherapy 19 2.8.3 Hormonal Therapies 19 2.8.4 Targeted Therapies 20 2.8.5 Resistance to Pharmacological Therapies 20 2.9 Treatment Guidelines 21 3 Marketed Products 24 3.1 Overview 24 3.1.1 Herceptin (trastuzumab) - Genentech 24 3.1.2 Perjeta (pertuzumab) - Genentech 26 3.1.3 Afinitor (everolimus) - Novartis 27 3.1.4 Tykerb/Tyverb (lapatinib ditosylate monohydrate) - Novartis 28 3.1.5 Ibrance (palbociclib) - Pfizer 29 3.1.6 Ixempra (ixabepilone) - Bristol-Myers Squibb 29 3.1.7 Halaven (eribulin mesylate) - Eisai 30 3.1.8 Avastin (bevacizumab) - Genentech 31 3.1.9 Kadcyla (ado-trastuzumab emtansine) - Genentech 31 3.2 Marketed Products Heatmap 32 3.2.1 Herceptin 33 3.2.2 Perjeta 35 3.2.3 Afinitor 35 3.2.4 Tykerb/Tyverb 35 3.2.5 Ibrance 36 3.2.6 Ixempra 37 3.2.7 Halaven 37 3.3 Measuring the Effectiveness of Treatment 38 3.4 Conclusion 38 4 Pipeline Products 39 4.1 Overall Pipeline 39 4.1.1 Pipeline by Molecular Target 40 4.2 Clinical Trials 43 4.2.1 Failure Rate 43 4.2.2 Patient Enrollment and Clinical Trial Size 45 4.2.3 Duration 49 4.3 Competitive Clinical Trials Metrics Analysis 52 5 Promising Drug Candidates in Pipeline 53 5.1 Abemaciclib - Eli Lily 53 5.1.1 Abemaciclib Forecast 53 5.2 Buparlisib - Novartis 54 5.2.1 Buparlisib Forecast 55 5.3 Lynparza (olaparib) - AstraZeneca 56 5.3.1 Lynparza Forecast 56 5.4 Neratinib - Puma Biotechnology 57 5.4.1 Neratinib Forecast 58 5.5 Ribociclib - Novartis 59 5.5.1 Ribociclib Forecast 60 5.6 NeuVax (nelipepimut-S) - Galena Biopharma 60 5.7 Veliparib - AbbVie 61 5.8 Niraparib - Tesaro 62 5.9 Talazoparib - BioMarin 62 5.10 Alpelisib - Novartis 63 5.11 Atezolizumab - Roche 64 5.12 Entinostat - Syndax 65 5.13 Margetuximab - MacroGenics 66 5.14 Taselisib - Genentech 66 5.15 OBI-822/821 - OBI Pharma 67 5.16 Heat Map for Pipeline Products 67 6 Market Forecast to 2021 69 6.1 Geographical Markets 69 6.2 Asia-Pacific Market 69 6.3 India 71 6.3.1 Treatment Usage Patterns 71 6.3.2 Annual Cost of Therapy 72 6.3.3 Market Size 73 6.4 China 73 6.4.1 Treatment Usage Patterns 73 6.4.2 Annual Cost of Therapy 75 6.4.3 Market Size 76 6.5 Australia 77 6.5.1 Treatment Usage Patterns 77 6.5.2 Annual Cost of Therapy 78 6.5.3 Market Size 79 6.6 Japan 80 6.6.1 Treatment Usage Patterns 80 6.6.2 Annual Cost of Therapy 81 6.6.3 Market Size 82 7 Drivers and Barriers for the Disease Market 83 7.1 Drivers 83 7.1.1 Increased Uptake of Targeted and Combination Therapies for Breast Cancer 83 7.1.2 Growth and Aging of Populations to Increase the Incidence 83 7.1.3 Launch of Premium-Priced Products with Greater Efficacy than Existing Therapies 83 7.2 Barriers 83 7.2.1 High Level of Competition 83 7.2.2 Problems with the Reimbursement of Premium-Priced Therapeutics will Limit their Uptake 84 7.2.3 Delayed Presentation of Symptoms, Lack of Access and Awareness to Hamper Proper Treatment 84 7.2.4 Multiple Drugs to Lose Patent Protection in Forecast Period 85 8 Deals and Strategic Consolidations 86 8.1 Licensing Deals 86 8.1.1 EUSA Pharma Enters into Licensing Agreement with AVEO Pharma for Tivozanib 89 8.1.2 Sprint Bioscience Enters Licensing Agreement with Bayer HealthCare 89 8.1.3 Takeda Enters Licensing Agreement with ImmunoGen 90 8.1.4 Oncothyreon Enters Licensing Agreement with Array BioPharma for ONT-380 90 8.1.5 Halozyme Therapeutics Enters Licensing Agreement with Janssen Biotech 90 8.1.6 CTI BioPharma Enters Licensing Agreement with Servier for Pixuvri 90 8.2 Co-development Deals 91 8.2.1 Peregrine Pharmaceuticals and National Comprehensive Cancer Network (NCCN) Form Clinical Collaboration 94 8.2.2 MacroGenics Enters Agreement with Merck 94 8.2.3 Color Genomics Partners with University of California Health 94 8.2.4 Lycera Enters Co-development Agreement with Celgene 95 8.2.5 Roche Enters Agreement with Oryzon to Develop Epigenetics-Based Medicines 95 8.2.6 Tracon Enters Co-development Agreement with Santen 95 9 Appendix 96 9.1 All Pipeline Drugs by Phase of Development 96 9.1.1 Discovery 96 9.1.2 Preclinical 100 9.1.3 IND/CTA-filed 116 9.1.4 Phase I 117 9.1.5 Phase II 135 9.1.6 Phase III 148 9.1.7 Pre-registration 152 9.2 Market Forecasts to 2021 152 9.2.1 Asia-Pacific 152 9.2.2 China 153 9.2.3 India 153 9.2.4 Australia 154 9.2.5 Japan 154 9.3 Bibliography 154 9.4 Abbreviations 163 9.5 Research Methodology 167 9.5.1 Secondary Research 168 9.5.2 Marketed Product Profiles 168 9.5.3 Late-Stage Pipeline Candidates 168 9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 168 9.5.5 Forecasting Model 170 9.5.6 Deals Data Analysis 170 9.6 Expert Panel Validation 171 9.7 Contact Us 171 9.8 Disclaimer 171

1.1 List of Tables Table 1: Breast Cancer Therapeutics, Global, Tumor, Nodes and Metastasis Staging, 2010-2013 16 Table 2: Breast Cancer Therapeutics Market, Global, Pipeline Products, Discovery, 2015 96 Table 3: Breast Cancer Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 100 Table 4: Breast Cancer Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2015 116 Table 5: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase I, 2015 117 Table 6: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase II, 2015 135 Table 7: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase III, 2015 148 Table 8: Breast Cancer Therapeutics Market, Global, Pipeline Products, Pre-registration, 2015 152 Table 9: Breast Cancer Therapeutics Market, Asia-Pacific, Market Forecast, 2014-2021 152 Table 10: Breast Cancer Therapeutics Market, China, Market Forecast, 2014-2021 153 Table 11: Breast Cancer Therapeutics Market, India, Market Forecast, 2014-2021 153 Table 12: Breast Cancer Therapeutics Market, Australia, Market Forecast, 2014-2021 154 Table 13: Breast Cancer Therapeutics Market, Japan, Market Forecast, 2014-2021 154
1.2 List of Figures Figure 1: Breast Cancer Therapeutics, Asia-Pacific, Age-Standardized Incidence per 100,000 population), 2012 12 Figure 2: Breast Cancer Therapeutics, Australia, Age-Specific Incidence Rate per 100,000 Population, 2001, 2006 and 2011 13 Figure 3: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stages I-III, 2015 22 Figure 4: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV, 2015 23 Figure 5: Breast Cancer Therapeutics Market, Global, Heat Map 33 Figure 6: Breast Cancer Therapeutics Market, Global, Overview of Pipeline Products 40 Figure 7: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline 42 Figure 8: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase (%), 2006-2015 43 Figure 9: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase and Molecule Type (%), 2006-2015 44 Figure 10: Breast Cancer Therapeutics Market, Global, Clinical Trial Attrition Rate and Failure Rate by Phase and Molecular Target (%), 2006-2015 45 Figure 11: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2015 46 Figure 12: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-2015 47 Figure 13: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular target (participants), 2006-2015 48 Figure 14: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-2015 49 Figure 15: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2015 50 Figure 16: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2015 51 Figure 17: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 52 Figure 18: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Mechanism of Action 52 Figure 19: Breast Cancer Therapeutics Market, Asia-Pacific, abemaciclib, Market Forecast ($m), 2018-2021 54 Figure 20: Breast Cancer Therapeutics Market, Asia-Pacific, buparlisib, Market Forecast ($m), 2018-2021 55 Figure 21: Breast Cancer Therapeutics Market, Asia-Pacific, Lynparza, Market Forecast ($m), 2018-2021 57 Figure 22: Breast Cancer Therapeutics Market, Asia-Pacific, neratinib, Market Forecast ($m), 2017-2021 58 Figure 23: Breast Cancer Therapeutics Market, Asia-Pacific, ribociclib, Market Forecast ($m), 2019-2021 60 Figure 24: Breast Cancer Therapeutics Market, Global, Pipeline Heat Map, 2015 68 Figure 25: Breast Cancer Therapeutics Market, Asia-pacific, Treatment Patterns by Number of Patients (million) and Market Size ($bn), 2014-2021 70 Figure 26: Breast Cancer Therapeutics Market, India, Treatment Patterns by Number of Patients (‘000), 2014-2021 71 Figure 27: Breast Cancer Therapeutics Market, India, Annual Cost of Therapy ($), 2014-2021 72 Figure 28: Breast Cancer Therapeutics Market, India, Market Size ($m), 2014-2021 73 Figure 29: Breast Cancer Therapeutics Market, China, Treatment Patterns by Number of Patients (‘000), 2014-2021 74 Figure 30: Breast Cancer Therapeutics Market, China, Annual Cost of Therapy ($), 2014-2021 75 Figure 31: Breast Cancer Therapeutics Market, China, Market Size ($m), 2014-2021 76 Figure 32: Breast Cancer Market, Australia, Treatment Usage Patterns by Number of Patients (‘000), 2014-2021 77 Figure 33: Breast Cancer Therapeutics Market, Australia, Annual Cost of Therapy ($), 2014-2021 78 Figure 34: Breast Cancer Therapeutics Market, Australia, Market Size ($m), 2014-2021 79 Figure 35: Breast Cancer Market, Japan, Treatment Usage Patterns by Number of Patients (‘000), 2014-2021 80 Figure 36: Breast Cancer Market, Japan, Annual Cost of Therapy ($), 2014-2021 81 Figure 37: Breast Cancer Therapeutics Market, Japan, Market Size ($m), 2014-2021 82 Figure 38: Breast Cancer Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 86 Figure 39: Breast Cancer Therapeutics Market, Global, Licensing Deals by Deal Value, 2006-2015 87 Figure 40: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006-2015 87 Figure 41: Breast Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015 88 Figure 42: Breast Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2015 89 Figure 43: Breast Cancer Therapeutics Market, Global, Co-development Deals by Region, 2006-2015 91 Figure 44: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year and Value, 2006-2015 92 Figure 45: Breast Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2015 93 Figure 46: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015 94