GBI Research has released the pharmaceutical report “Monoclonal Antibodies Market in Breast Cancer to 2019 – Strong Uptake of Novel HER-2 Targeted Therapies to Drive Robust Growth”. The current market for breast cancer consists of five monoclonal Antibodies (mAbs), three of which are targeted at the Human Epidermal growth factor Receptor 2 (HER-2) protein. Four are aimed at improving overall survival in the metastatic setting, and two of these have also received further approvals in the early setting in order to improve long-term remission rates. The market is currently led by the HER-2 inhibitor Herceptin, which achieved global sales amounting to $6.2 billion in 2012. Over the forecast period from 2012 to 2019, the two novel HER-2 inhibitors, Kadcyla and Perjeta, are expected to achieve strong market penetration due to their appreciable incremental efficacy benefits. Additionally, the market conditions are currently favorable towards mAbs, with a low rate of price depreciation following patent expiry and a high rate of inflation for specialty pharmaceuticals in the US. As a result of this, and despite the empty Phase III pipeline, GBI Research believes that the global market across the leading eight countries have the potential to grow to a value of $10.6 billion by 2019.

Scope

• An introduction to the treatments available for breast cancer, treatment algorithms and the contexts in which mAbs are clinically relevant to this type of cancer.
• In-depth analysis of the five mAbs approved for breast cancer, with analysis of their safety, efficacy, treatment patterns and strengths and weaknesses. This includes a heat map comparing the drugs in terms of clinical trial results.
• A comprehensive review of the pipeline for breast cancer therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline for mAbs is analyzed on the basis of phase distribution, program type and molecular target, as is the entire pipeline for all molecule types.
• Detailed analysis of pipeline drug clinical trials by trial size, trial duration and program failure rate for each molecule type and mechanism of action. Additionally, a detailed analysis of clinical trial endpoints is provided, detailing their importance in this disease area and their commercial relevance to currently marketed products.
• Multi-scenario forecast data for the market is provided to 2019, which takes into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Japan, Germany, the UK, France, Italy and Spain.
• Discussion of the drivers and barriers for market growth
• Complete analysis of licensing and co-development deals in this market, by year, value, molecule type, Phase and mechanism of action. Additionally, the international network of licensing deals in breast cancer is mapped out by geography.

Reasons to Buy

• Understand the different indications for breast cancer, from early-stage to the metastatic disease
• Grasp the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent, and the context of mAbs in the pipeline
• Pinpoint the trends in clinical trial duration and size amongst clinical Phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for breast cancer therapeutics. Determine the risk associated with the development of mAbs compared to other molecule types.
• Observe the shift in clinical trial endpoints by clinical Phase, and use this data to potentially influence any future developmental programs. Understand the importance of selecting the correct endpoints in the study of drugs for this disease.
• Assess the potential clinical and commercial impact of recently-approved molecules on the breast cancer market and determine the potential revenues associated with the launch of a novel product, in addition to the level of competitiveness in the market.

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Monoclonal Antibodies Market in Breast Cancer to 2019 - Introduction 9

2.1 Symptoms 9

2.2 Etiology 9

2.3 Epidemiology 10

2.4 Pathophysiology 10

2.5 Diagnosis 11

2.6 Prognosis and Disease Staging 11

2.6.1 Classification 13

2.7 Treatment Options 13

2.7.1 Surgery and Radiation Therapy 13

2.7.2 Chemotherapy 14

2.7.3 Hormonal Therapies 15

2.7.4 Targeted Therapies 15

2.7.5 Resistance to Pharmacological Therapies 16

2.7.6 Treatment Guidelines 17

2.7.7 Measuring the Effectiveness of Treatment 19

3 Marketed Products 20

3.1 Herceptin (Trastuzumab) - Hoffmann La Roche 20

3.2 Avastin (Bevacizumab) - Hoffmann La Roche 23

3.3 Kadcyla (Trastuzumab Emtansine) - Hoffmann La Roche 25

3.4 Perjeta (Pertuzumab) - Hoffmann La Roche 26

3.5 Xgeva (denosumab) - Amgen 27

3.6 Heat Map for Marketed Products 28

3.7 Conclusion 30

4 Pipeline for Breast Cancer Monoclonal Antibody Therapeutics 31

4.1 Overall Pipeline 32

4.2 Mechanisms of Action 34

4.3 Clinical Trials 37

4.3.1 Attrition Rate 37

4.3.2 Clinical Trial Size 38

4.3.3 Duration 40

4.3.4 Clinical Trial End-points 42

4.4 Promising Drug Candidates in the Pipeline 44

4.4.1 CDX-011 (glembatumumab vedotin) - Celldex Therapeutics 44

4.4.2 Metmab (onartuzumab) - Hoffman La Roche 44

4.4.3 Hu3S193 - Recepta Biopharma 44

4.4.4 MM-121 - Merrimack Pharmaceuticals 45

4.4.5 IMC-18F1 (Icrucumab) - Eli Lilly 45

4.4.6 Rexomun (Ertumaxomab) - Fresenius Biotech 45

4.4.7 Medi-573 (Dusigitumab) - Medimmune 45

4.4.8 MK-0646 (Dalotuzumab) - Merck and Co 46

4.4.9 LY3012217 (Cixutumumab) - Eli Lilly 46

4.5 Conclusion 46

5 Market Forecast to 2019 48

5.1 Global 48

5.1.1 Treatment Usage Patterns 48

5.1.2 Market Size 49

5.2 US 50

5.2.1 Treatment Usage Patterns 50

5.2.2 Market Size 51

5.3 Canada 52

5.3.1 Treatment Usage Patterns 52

5.3.2 Market Size 53

5.4 Europe 54

5.4.1 Treatment Usage Patterns 54

5.4.2 Annual Cost of Therapy 55

5.4.3 Market Size 56

5.5 Japan 57

5.5.1 Treatment Usage Patterns 57

5.5.2 Market Size 58

5.6 Drivers and Barriers 59

5.6.1 Drivers 59

5.6.2 Barriers 59

6 Deals and Strategic Consolidations 60

6.1 R&D Licensing Agreements 60

6.1.1 Key Licensing Deals 63

6.2 Co-development Agreements 65

6.2.1 Key Deals 65

7 Appendix 68

7.1 References 68

7.2 References for Heat Map 73

7.3 All Pipeline Products, by Phase 74

7.3.1 Discovery 74

7.3.2 Preclinical 77

7.3.3 IND/CTA Filed and Phase I 89

7.3.4 Phase II 95

7.3.5 Phase III and Pre-Registration 102

7.4 Market Definitions 104

7.5 Abbreviations 105

7.6 Tabular Forecast Data 106

7.6.1 Global 106

7.6.2 US 106

7.6.3 Canada 106

7.6.4 UK 107

7.6.5 France 107

7.6.6 Germany 107

7.6.7 Italy 107

7.6.8 Spain 108

7.6.9 Japan 108

7.7 Research Methodology 109

7.7.1 Coverage 109

7.7.2 Secondary Research 109

7.8 Therapeutic Landscape 110

7.9 Epidemiology-Based Forecasting 110

7.10 Market Size by Geography 111

7.11 Geographical Landscape 112

7.12 Pipeline Analysis 112

7.13 Competitive Landscape 112

7.13.1 Expert Panel Validation 112

7.14 Contact Us 112

7.15 Disclaimer 112

List of Tables

Table 1: Market for mAbs in Breast Cancer, Global, TNM Staging, 2010-2013 11

Table 2: Market for mAbs in Breast Cancer, US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013 12

Table 3: Market for mAbs in Breast Cancer, References for Heat Map (Figure 6) 73

Table 4: Breast Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 74

Table 5: Breast Cancer Therapeutics, Global, All Pipeline Products (Preclinical), 2013 77

Table 6: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase I and IND/CTA filed), 2013 89

Table 7: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 95

Table 8: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-Registration), 2013 102

Table 9: Market for mAbs in Breast Cancer, Global, Forecast Data, 2012-2019 106

Table 10: Market for mAbs in Breast Cancer, US, Forecast Data, 2012-2019 106

Table 11: Market for mAbs in Breast Cancer, Canada, Forecast Data, 2012-2019 106

Table 12: Market for mAbs in Breast Cancer, UK, Forecast Data, 2012-2019 107

Table 13: Market for mAbs in Breast Cancer, France, Forecast Data, 2012-2019 107

Table 14: Market for mAbs in Breast Cancer, Germany, Forecast Data, 2012-2019 107

Table 15: Market for mAbs in Breast Cancer, Italy, Forecast Data, 2012-2019 107

Table 16: Market for mAbs in Breast Cancer, Spain, Forecast Data, 2012-2019 108

Table 17: Market for mAbs in Breast Cancer, Japan, Forecast Data, 2012-2019 108

List of Figures

Figure 1 Market for mAbs in Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stages I to III 17

Figure 2: Market for mAbs in Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV 18

Figure 3: Market for mAbs in Breast Cancer, Global, Sales of Herceptin ($bn), 1999-2012 21

Figure 4: Market for mAbs in Breast Cancer, Global, Sales of Avastin ($bn), 2004-2012 24

Figure 5: Market for mAbs in Breast Cancer, Global, Aggregate Sales of Xgeva and Prolia ($m), 2010-2012 27

Figure 6: Market for mAbs in Breast Cancer, Global, Heat Map (Marketed Products) 29

Figure 7: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013 32

Figure 8: Market for mAbs in Breast Cancer, Global, mAbs by Mechanism of Action, 2013 34

Figure 9: Market for mAbs in Breast Cancer, Global, mAbs by Mechanism of Action (Growth Factor Inhibitors), 2013 35

Figure 10: Market for mAbs in Breast Cancer, Global, mAbs by Molecular Target (Targeted Cytotoxic), 2013 36

Figure 11: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013 37

Figure 12: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013 38

Figure 13: Market for mAbs in Breast Cancer, Global, Clinical Trial Size, 2013 39

Figure 14: Market for mAbs in Breast Cancer, Global, Clinical Trial Duration, 2006-2013 40

Figure 15: Market for mAbs in Breast Cancer, Global, Clinical Trial Durations, 2006-2013 41

Figure 16: Market for mAbs in Breast Cancer, Global, Clinical Trial Endpoints for Phases II and III, 2006-2012 42

Figure 17: Market for mAbs in Breast Cancer, Global, Clinical Trial Endpoints for Phases II and III per Product, 2006-2012 43

Figure 18: Market for mAbs in Breast Cancer, Global, Treatment Usage Patterns, 2012-2019 48

Figure 19: Market for mAbs in Breast Cancer, Global, Market Size ($bn), 2012-2019 49

Figure 20: Market for mAbs in Breast Cancer, US, Treatment Patterns, 2012-2019 50

Figure 21: Market for mAbs in Breast Cancer, US, Market Size ($bn), 2012-2019 51

Figure 22: Market for mAbs in Breast Cancer, Canada, Treatment Usage Patterns, 2012-2019 52

Figure 23: Market for mAbs in Breast Cancer, Canada, Market Size ($m), 2012-2019 53

Figure 24: Market for mAbs in Breast Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019 54

Figure 25: Market for mAbs in Breast Cancer, Top Five European Markets, Annual Cost of Therapy ($), 2012-2019 55

Figure 26: Market for mAbs in Breast Cancer, Top Five European Markets, Market Size ($m), 2012-2019 56

Figure 27: Market for mAbs in Breast Cancer, Japan, Treatment Usage Patterns, 2012-2019 57

Figure 28: Market for mAbs in Breast Cancer, Japan, Market Size ($m), 2012-2019 58

Figure 29: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (A) 60

Figure 30: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (B) 61

Figure 31: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (C) 62

Figure 32: Market for mAbs in Breast Cancer, Global, Co-development Deals (All Molecule Types) by Partner Country, 2006-2012 65

Figure 33: Market for mAbs in Breast Cancer, Global, Co-development Deals by Molecule Type, 2006-2012 66

Figure 34: GBI Research Market Forecasting Model 111