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Breast Cancer Therapeutics in Major Developed Markets to 2021-Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence

Breast Cancer Therapeutics in Major Developed Markets to 2021-Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence


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Executive Summary

Breast Cancer Therapeutics in Major Developed Markets to 2021-Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence

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. The number of women diagnosed with breast cancer has increased over the past few decades, but the number of deaths has declined due to earlier diagnosis and better treatment options.

Breast cancer treatment has been revolutionized in the past four decades, especially with increasing usage of targeted therapies. The marketed products landscape comprises a wide range of treatment options, including hormonal therapies, chemotherapies, combination therapies, and 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?

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?

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 forecast period, the breast cancer therapeutics market in the eight major markets is expected to increase in value at a CAGR of 7.3%, from USD 10.4 billion to over USD 17.2 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 eight major markets?

Rising breast cancer incidence and 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?

-Which patent expirations will have the most significant impact on the market?

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.

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 15

2.8 Treatment Options 17

2.8.1 Surgery and Radiation Therapy 18

2.8.2 Chemotherapy 18

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

3.1.10 Marketed Products Heatmap 32

3.1.11 Measuring the Effectiveness of Treatment 38

3.2 Conclusion 39

4 Pipeline Products 40

4.1 Pipeline Products 40

4.1.1 Overall Pipeline 40

4.1.2 Pipeline by Molecular Target 41

4.2 Clinical Trials 44

4.2.1 Failure Rate 44

4.2.2 Patient Enrollment and Clinical Trial Size 46

4.2.3 Duration 50

4.3 Competitive Clinical Trials Metrics Analysis 52

5 Promising Drug Candidates in Pipeline 54

5.1 Abemaciclib-Eli Lily 54

5.1.1 Abemaciclib Forecast 54

5.2 Buparlisib-Novartis 55

5.2.1 Buparlisib Forecast 56

5.3 NeuVax (nelipepimut-S)-Galena Biopharma 56

5.3.1 NeuVax Forecast 57

5.4 Niraparib-Tesaro 57

5.4.1 Niraparib Forecast 58

5.5 Lynparza (Olaparib)-AstraZeneca 58

5.5.1 Lynparza Forecast 59

5.6 Veliparib-AbbVie 60

5.6.1 Veliparib Forecast 60

5.7 Neratinib-Puma Biotechnology 61

5.7.1 Neratinib Forecast 62

5.8 Ribociclib-Novartis 62

5.8.1 Ribociclib Forecast 63

5.9 Talazoparib-BioMarin 64

5.10 Alpelisib-Novartis 64

5.11 Atezolizumab-Roche 65

5.12 Entinostat-Syndax 65

5.13 Margetuximab-MacroGenics 66

5.14 Taselisib-Genentech 67

5.15 OBI-822/821-OBI Pharma 68

5.16 Heat Map for Pipeline Products 68

6 Market Forecast to 2021 70

6.1 Geographical Markets 70

6.2 Global Market 70

6.3 North America 72

6.3.1 Treatment Usage Patterns 72

6.3.2 Annual Cost of Therapy 73

6.3.3 Market Size 74

6.4 Five Leading European Markets 75

6.4.1 Treatment Usage Patterns 75

6.4.2 Annual Cost of Therapy 77

6.4.3 Market Size 78

6.5 Japan 79

6.5.1 Treatment Usage Patterns 79

6.5.2 Annual Cost of Therapy 80

6.5.3 Market Size 81

7 Drivers and Barriers for the Disease Market 82

7.1 Drivers 82

7.1.1 Increased Uptake of Targeted and Combination Therapies for Breast Cancer 82

7.1.2 Growth and Aging of Western Populations 82

7.1.3 Launch of Premium-Priced Products with Greater Efficacy than Existing Therapies 82

7.2 Barriers 82

7.2.1 Patent Expiries 82

7.2.2 High Level of Competition 83

7.2.3 Problems with the Reimbursement of Premium-Priced Therapeutics will Limit their Uptake 83

8 Deals and Strategic Consolidations 84

8.1 Licensing Deals 84

8.1.1 Sprint Bioscience Enters Licensing Agreement with Bayer HealthCare 88

8.1.2 Takeda Enters Licensing Agreement with ImmunoGen 88

8.1.3 Oncothyreon Enters Licensing Agreement with Array BioPharma for ONT-380 89

8.1.4 Halozyme Therapeutics Enters Licensing Agreement with Janssen Biotech 89

8.1.5 CTI BioPharma Enters Licensing Agreement with Servier for Pixuvri 89

8.2 Co-development Deals 90

8.2.1 MacroGenics Enters Agreement with Merck 93

8.2.2 Color Genomics Partners with University of California Health 93

8.2.3 Lycera Enters Co-development Agreement with Celgene 93

8.2.4 Roche Holding Enters Agreement with Oryzon to Develop Epigenetics-Based Medicines 94

8.2.5 Tracon Enters Co-development Agreement with Santen Pharma 94

9 Appendix 95

9.1 All Pipeline Drugs by Phase of Development 95

9.1.1 Discovery 95

9.1.2 Preclinical 99

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 Global 152

9.2.2 US 153

9.2.3 Canada 153

9.2.4 UK 154

9.2.5 France 154

9.2.6 Germany 155

9.2.7 Italy 155

9.2.8 Spain 156

9.2.9 Japan 156

9.3 Bibliography 157

9.4 Abbreviations 164

9.5 Research Methodology 166

9.5.1 Secondary Research 166

9.5.2 Marketed Product Profiles 167

9.5.3 Late-Stage Pipeline Candidates 167

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 167

9.5.5 Forecasting Model 169

9.5.6 Deals Data Analysis 170

9.6 Contact Us 170

9.7 Disclaimer 170

1.1 List of Tables

Table 1: Breast Cancer Therapeutics, US, Disease Stage at Diagnosis (%), 2013 15

Table 2: Breast Cancer Therapeutics, Global, Tumor, Nodes and Metastasis Staging, 2010-2013 16

Table 3: Breast Cancer Therapeutics, US, Disease Stage at Diagnosis and Five-Year Relative Survival (%), 2013 17

Table 4: Breast Cancer Therapeutics Market, Global, Pipeline Products, Discovery, 2015 95

Table 5: Breast Cancer Therapeutics Market, Global, Pipeline Products, Preclinical, 2015 99

Table 6: Breast Cancer Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2015 116

Table 7: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase I, 2015 117

Table 8: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase II, 2015 135

Table 9: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase III, 2015 148

Table 10: Breast Cancer Therapeutics Market, Global, Pipeline Products, Pre-registration, 2015 152

Table 11: Breast Cancer Therapeutics Market, Global, Market Forecast, 2014-2021 152

Table 12: Breast Cancer Therapeutics Market, US, Market Forecast, 2014-2021 153

Table 13: Breast Cancer Therapeutics Market, Canada, Market Forecast, 2014-2021 153

Table 14: Breast Cancer Therapeutics Market, UK, Market Forecast, 2014-2021 154

Table 15: Breast Cancer Therapeutics Market, France, Market Forecast, 2014-2021 154

Table 16: Breast Cancer Therapeutics Market, Germany, Market Forecast, 2014-2021 155

Table 17: Breast Cancer Therapeutics Market, Italy, Market Forecast, 2014-2021 155

Table 18: Breast Cancer Therapeutics Market, Spain, Market Forecast, 2014-2021 156

Table 19: Breast Cancer Therapeutics Market, Japan, Market Forecast, 2014-2021 156

1.2 List of Figures

Figure 1: Breast Cancer Therapeutics, Eight Leading Markets, Age-Standardized Incidence Rates of Breast Cancer (per 100,000), 2012 12

Figure 2: Breast Cancer Therapeutics, US, Age-Specific Incidence Rates of Breast Cancer in Women (per 100,000), 1992-2012 13

Figure 3: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stages I-III, 2015 21

Figure 4: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV, 2015 22

Figure 5: Breast Cancer Therapeutics Market, Global, Heat Map 33

Figure 6: Breast Cancer Therapeutics Market, Global, Overview of Pipeline Products 41

Figure 7: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline 43

Figure 8: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase, 2006-2015 44

Figure 9: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase and Molecule Type (%), 2006-2015 45

Figure 10: Breast Cancer Therapeutics Market, Global, Clinical Trial Attrition Rate and Failure Rate by Phase and Molecular Target (%), 2006-2015 46

Figure 11: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2015 47

Figure 12: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-2015 48

Figure 13: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular target (participants), 2006-2015 49

Figure 14: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006-2015 50

Figure 15: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2015 51

Figure 16: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2015 52

Figure 17: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 53

Figure 18: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Mechanism of Action 53

Figure 19: Breast Cancer Therapeutics Market, Global, Abemaciclib, Market Forecast (USD m), 2020-2021 55

Figure 20: Breast Cancer Therapeutics Market, Global, Buparlisib, Market Forecast (USD m), 2020-2021 56

Figure 21: Breast Cancer Therapeutics Market, Global, NeuVax, Market Forecast (USD m), 2020-2021 57

Figure 22: Breast Cancer Therapeutics Market, Global, Niraparib, Market Forecast (USD m), 2020-2021 58

Figure 23: Breast Cancer Therapeutics Market, Global, Lynparza, Market Forecast (USD m), 2020-2021 59

Figure 24: Breast Cancer Therapeutics Market, Global, Lynparza, Market Forecast (USD m), 2020-2021 61

Figure 25: Breast Cancer Therapeutics Market, Global, Neratinib, Market Forecast(USD m) 2020-2021 62

Figure 26: Breast Cancer Therapeutics Market, Global, Ribociclib, Market Forecast (USD m), 2020-2021 63

Figure 27: Breast Cancer Therapeutics Market, Global, Pipeline Heat Map, 2015 69

Figure 28: Breast Cancer Therapeutics Market, Global, Treatment Patterns (million) and Market Size (USD bn), 2014-2021 71

Figure 29: Breast Cancer Therapeutics Market, North America, Treatment Patterns ('000), 2014-2021 72

Figure 30: Breast Cancer Therapeutics Market, North America, Annual Cost of Therapy (USD ), 2014-2021 73

Figure 31: Breast Cancer Therapeutics Market, North America, Market Size (USD bn), 2014-2021 74

Figure 32: Breast Cancer Therapeutics Market, Five Leading European Markets, Treatment Patterns ('000), 2014-2021 76

Figure 33: Breast Cancer Therapeutics Market, Five Leading European Market, Annual Cost of Therapy (USD ), 2014-2021 77

Figure 34: Breast Cancer Therapeutics Market, Five Leading European Markets, Market Size (USD m), 2014-2021 78

Figure 35: Breast Cancer Market, Japan, Treatment Usage Patterns ('000), 2014-2021 79

Figure 36: Breast Cancer Market, Japan, Annual Cost of Therapy (USD ), 2014-2021 80

Figure 37: Breast Cancer Therapeutics Market, Japan, Market Size (USD m), 2014-2021 81

Figure 38: Breast Cancer Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 84

Figure 39: Breast Cancer Therapeutics Market, Global, Licensing Deals by Deal Value, 2006-2015 85

Figure 40: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Payment Value (USD m), 2006-2015 86

Figure 41: Breast Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 87

Figure 42: Breast Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2015 88

Figure 43: Breast Cancer Therapeutics Market, Global, Co-development Deals by Region, 2006-2015 90

Figure 44: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year and Value, 2006-2015 91

Figure 45: Breast Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2015 92

Figure 46: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015 93

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