Summary
Breast cancer, a malignant neoplasm, is the second-most common cancer and the most common cancer in women worldwide, accounting for 16% of all female cancers, making the disease exceedingly prevalent. In the past, breast cancer occurred less in women in Asia than women in Western countries. However, recent studies show that breast cancer is being diagnosed more frequently in women living in Asia, especially among younger women.
There have been wide-reaching changes in the breast cancer market over the past four decades, particularly in relation to the usage of targeted therapies, which has increased significantly. The marketed products landscape comprises a wide range of treatment options, including hormonal therapies, chemotherapies, combination therapies and targeted therapies. The market is set to be driven by a number of new approvals for drugs and an increased uptake of premium targeted therapies. Nevertheless, significant unmet need remains for products that can improve overall survival rate, time to disease progression, and overall response.
Scope
The current breast cancer market contains novel products, including Perjeta, a targeted therapy; Kadcyla, a human antibody-drug conjugate; and Halaven, a novel chemotherapeutic agent.
- What are the competitive advantages of the existing novel drugs?
- Are these targeted therapies used to the same magnitude in all the countries assessed?
- What are the factors contributing to the uptake of these drugs in each country?
With over 700 active pipeline molecules, most of the investigational drug candidates are being evaluated for the first-line or second-line treatment of advanced-stage breast cancer, featuring new combination therapies, targeted therapies, and promising immunotherapies, as well as chemotherapy drug candidates.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the breast cancer market?
- Which Asia-Pacific countries should expect a late launch and a lower uptake of the late-stage pipeline drugs?
Analysis of clinical trials since 2006 identified that the failure rates of breast cancer molecules were highest in Phase II (41%), with the overall attrition rate for breast cancer in development being 61%.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?
Over the 2014–2021 period, the value of the Asia-Pacific markets for breast cancer therapeutics is expected to increase at a compound annual growth rate of 8.5%, from $1.9 billion to over $3.4 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the Asia-Pacific markets?
- What are the various trends observed in the market over the forecast period in each of the countries?
Rising breast cancer prevalence and increasing use of premium targeted therapies along with new product approvals will lead to significant market growth over the forecast period, despite generic sales erosion resulting from patent expirations.
- Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?
Various drivers and barriers would influence the market over the forecast period.
- What are the barriers that limit the uptake of premium-priced therapeutics in the accessed countries?
- Which factors are most likely to drive the market in these countries?
Reasons to buy
This report will enable you to -
- Understand the clinical context of breast cancer by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need
- Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty
- Consider market opportunities and potential risks by examining trends in breast cancer clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in breast cancer by examining clinical trial data and multi-scenario product forecast projections
- Compare treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain and Japan
- Discover trends in licensing and co-development deals concerning breast cancer products and identify the major strategic consolidations that have shaped the commercial landscape
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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
