Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019 – Crowded Late-Stage Pipelines and Favorable Market Conditions Encourage Robust Growth

Publisher Name :
Date: 15-Dec-2013
No. of pages: 106

GBI Research has released the pharma report “Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019 Crowded Late-Stage Pipelines and Favorable Market Conditions Encourage Robust Growth” Gastric and esophageal cancers are two orphan cancers of the gastrointestinal tract. They are often diagnosed at advanced, incurable stages due to a late onset of symptoms, but are also associated with low survival rates in the early stages of disease.

Currently the primary treatment options are chemotherapy and surgery, which are used wherever possible. One monoclonal Antibody (mAb), Herceptin (trastuzumab) is marketed for use in suitable patients with advanced gastric or gastro-esophageal junction cancer.

However, the late-stage pipelines for these indications include many promising mAb candidates which are anticipated to enter the market during the forecast period. Additionally, current market conditions are favorable for new mAbs, with high pricing patterns and weak impact from biosimilar exposure. As a result of this, GBI Research believes the global market has the potential to grow to a value of $766m by 2019.

Scope

  • A brief introduction to the two indications, including the disease’s pathogenesis, risk factors, diagnosis and treatment algorithms.
  • In-depth analysis of Herceptin, including analysis of its safety, efficacy, treatment patterns and strengths/weaknesses.
  • A comprehensive review of the pipeline for mAbs in gastric and esophageal cancer, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets.
  • Additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action.
  • Multi-scenario forecast data of the market to 2019, taking 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, Canada, Japan, Germany, the UK, France, Italy and Spain.
  • Discussion of the drivers and barriers for market growth.

Reasons to buy

  • Understand the unmet need in the treatment of these cancers, the role of Herceptin and the areas of opportunity for other mAbs to enter the market.
  • Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent.
  • Observe the trends in clinical trial duration, size and molecule types across the phases of development and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for mAbs in gastric and esophageal cancers.
  • Observe the shift in clinical trial endpoints with clinical phase, and use this data to potentially influence any future developmental programs.
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the market for mAbs in gastric and esophageal cancers.

Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019 – Crowded Late-Stage Pipelines and Favorable Market Conditions Encourage Robust Growth

Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7

2 Introduction 9
2.1 Symptoms 9
2.1.1 Early Gastric Cancer 9
2.1.2 Early Esophageal Cancer 10
2.1.3 Advanced Gastric or Esophageal Cancer 10
2.2 Etiology 10
2.2.1 Esophageal Cancer 10
2.2.2 Gastric Cancer 11
2.3 Epidemiology 11
2.4 Pathophysiology 12
2.5 Diagnosis 13
2.6 Prognosis and Disease Staging 13
2.7 Treatment Options 16
2.7.1 Chemotherapy 16
2.7.2 Targeted Therapies 16
2.7.3 Treatment Guidelines 17
2.7.4 Resistance to Pharmacological Therapies 19

3 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Marketed Products 20
3.1 Herceptin (Trastuzumab) - Hoffman La Roche 20

4 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Developmental Pipeline 22
4.1 Gastric Cancer 22
4.1.1 Overall Pipeline 22
4.1.2 Molecular Targets 24
4.1.3 Clinical Trials 26
4.1.4 Conclusion 33
4.2 Esophageal Cancer 34
4.2.1 Overall Pipeline 34
4.2.2 Molecular Targets 36
4.2.3 Clinical Trials 37
4.2.4 Conclusion 43
4.3 Key Late-Stage Pipeline Products 43
4.3.1 AMG 102 (rilotumumab) - Amgen 43
4.3.2 IMC-1121B (Ramucirumab) - Eli Lilly and Company 43
4.3.3 Theraloc (Nimotuzumab) - YM Biosciences 44
4.3.4 MetMAb (Onartuzumab) - F. Hoffmann-La Roche 44
4.3.5 Perjeta (pertuzumab) - F. Hoffmann-La Roche 44
4.3.6 Kadcyla (ado-trastuzumab emtansine) - F. Hoffmann-La Roche 45
4.4 Conclusion 46

5 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Market Forecast to 2019 47
5.1 Gastric Cancer 48
5.1.1 Global 48
5.1.2 US 51
5.1.3 Canada 53
5.1.4 Europe 55
5.1.5 Japan 58
5.2 Esophageal Cancer 60
5.2.1 Global 60
5.2.2 US 62
5.2.3 Canada 64
5.2.4 Europe 66
5.2.5 Japan 69
5.3 Drivers and Barriers 70
5.3.1 Drivers 70
5.3.2 Barriers 72

6 Deals and Strategic Consolidations 74
6.1 Licensing Agreements 74
6.1.1 Gastric Cancer 74
6.1.2 Esophageal Cancer 77
6.2 Co-Development Agreements 77
6.2.1 Gastric Cancer 77
6.2.2 Esophageal Cancer 78

7 Appendix 79
7.1 Market Definitions 79
7.2 Abbreviations 79
7.3 References 80
7.4 All Pipeline Products, by Stage of Development 84
7.4.1 Gastric Cancer 84
7.4.2 Esophageal Cancer 93
7.5 Tabular Forecast Data 97
7.5.1 Gastric Cancer 97
7.5.2 Esophageal Cancer 100
7.6 Research Methodology 102
7.6.1 Coverage 102
7.6.2 Secondary Research 103
7.6.3 Therapeutic Landscape 103
7.6.4 Epidemiology-Based forecasting 103
7.6.5 Market Size by Geography 105
7.6.6 Geographical Landscape 106
7.6.7 Pipeline Analysis 106
7.6.8 Competitive Landscape 106
7.6.9 Expert Panel Validation 106
7.7 Contact Us 106
7.8 Disclaimer 106

List of Tables

Table 1: Market for mAbs in Gastrointestinal Tract Cancer, US, Epidemiology, 2008 11
Table 2: Market for mAbs in Gastrointestinal Tract Cancer, US, Diagnosis by Stage, 2008 12
Table 3: Market for mAbs in Gastrointestinal Tract Cancer, US, Five-Year Relative Survival by Stage, 2003-2009 14
Table 4: Market for mAbs in Gastric Cancer, Global, TNM Staging, 2010-2013 15
Table 5: Gastric Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 84
Table 6: Gastric Cancer Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 85
Table 7: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 87
Table 8: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 89
Table 9: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-registration), 2013 92
Table 10: Gastric Cancer Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 93
Table 11: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 93
Table 12: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 94
Table 13: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 94
Table 14: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 95
Table 15: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-registration), 2013 97
Table 16: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 97
Table 17: Market for mAbs in Gastric Cancer, Global, Forecast Data, 2012-2019 97
Table 18: Market for mAbs in Gastric Cancer, US, Forecast Data, 2012-2019 98
Table 19: Market for mAbs in Gastric Cancer, Canada, Forecast Data, 2012-2019 98
Table 20: Market for mAbs in Gastric Cancer, UK, Forecast Data, 2012-2019 98
Table 21: Market for mAbs in Gastric Cancer, France, Forecast Data, 2012-2019 98
Table 22: Market for mAbs in Gastric Cancer, Germany, Forecast Data, 2012-2019 99
Table 23: Market for mAbs in Gastric Cancer, Italy, Forecast Data, 2012-2019 99
Table 24: Market for mAbs in Gastric Cancer, Spain, Forecast Data, 2012-2019 99
Table 25: Market for mAbs in Gastric Cancer, Japan, Forecast Data, 2012-2019 99
Table 26: Market for mAbs in Esophageal Cancer, Global, Forecast Data, 2012-2019 100
Table 27: Market for mAbs in Esophageal Cancer, US, Forecast Data, 2012-2019 100
Table 28: Market for mAbs in Esophageal Cancer, Canada, Forecast Data, 2012-2019 100
Table 29: Market for mAbs in Esophageal Cancer, UK, Forecast Data, 2012-2019 101
Table 30: Market for mAbs in Esophageal Cancer, France, Forecast Data, 2012-2019 101
Table 31: Market for mAbs in Esophageal Cancer, Germany, Forecast Data, 2012-2019 101
Table 32: Market for mAbs in Esophageal Cancer, Italy, Forecast Data, 2012-2019 101
Table 33: Market for mAbs in Esophageal Cancer, Spain, Forecast Data, 2012-2019 102
Table 34: Market for mAbs in Esophageal Cancer, Japan, Forecast Data, 2012-2019 102

List of Figures

Figure 1: Gastric Cancer: Treatment Algorithm 17
Figure 2: Esophageal Cancer: Treatment Algorithm (Locoregional Tumor) 18
Figure 3: Market for mAbs in Gastrointestinal Tract Cancer, Global, Sales of Herceptin ($bn), 1999-2012 20
Figure 4: Market for mAbs in Gastric Cancer, Global, Overall Pipeline, 2013 23
Figure 5: Market for mAbs in Gastric Cancer, Global, Pipeline mAbs by Mechanism of Action and Molecular Target, 2013 25
Figure 6: Market for mAbs in Gastric Cancer, Global, Developmental Pipeline Failure Rate, 2006-2013 26
Figure 7: Market for mAbs in Gastric Cancer, Global, Clinical Trial Sizes, 2006-2013 27
Figure 8: Market for mAbs in Gastric Cancer, Global, Clinical Trial Sizes by Molecule Type, 2006-2013 28
Figure 9: Market for mAbs in Gastric Cancer, Global, Clinical Trial Durations, 2006-2013 29
Figure 10: Market for mAbs in Gastric Cancer, Global, Clinical Trial Durations by Molecule Type, 2006-2013 30
Figure 11: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints (All Molecule Types), 2006-2013 31
Figure 12: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints (mAbs Only), 2006-2013 32
Figure 13: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints by Developmental Program (mAbs Only), 2006-2013 33
Figure 14: Market for mAbs in Esophageal Cancer, Global, Overall Pipeline, 2013 35
Figure 15: Market for mAbs in Esophageal Cancer, Global, Pipeline mAbs by Mechanism of Action, 2013 36
Figure 16: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Sizes, 2006-2013 37
Figure 17: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Sizes by Molecule Type, 2006-2013 38
Figure 18: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Durations, 2006-2013 39
Figure 19: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Durations by Molecule Type, 2006-2013 40
Figure 20: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints (All Molecule Types), 2006-2012 41
Figure 21: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints (mAbs Only), 2006-2012 42
Figure 22: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints by Developmental Program (mAbs Only), 2006-2012 42
Figure 23: Market for mAbs in Gastric Cancer, Global, Market Size and Growth, 2012-2019 47
Figure 24: Market for mAbs in Esophageal Cancer, Global, Market Size and Growth, 2012-2019 48
Figure 25: Market for mAbs in Gastric Cancer, Global, Treatment Usage Patterns, 2012-2019 49
Figure 26: Market for mAbs in Gastric Cancer, Global, Market Size ($m), 2012-2019 50
Figure 27: Market for mAbs in Gastric Cancer, US, Treatment Patterns, 2012-2019 51
Figure 28: Market for mAbs in Gastric Cancer, US, Market Size ($m), 2012-2019 52
Figure 29: Market for mAbs in Gastric Cancer, Canada, Treatment Usage Patterns, 2012-2019 53
Figure 30: Market for mAbs in Gastric Cancer, Canada, Market Size ($m), 2012-2019 54
Figure 31: Market for mAbs in Gastric Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019 55
Figure 32: Market for mAbs in Gastric Cancer, Top Five European Markets, Annual Cost of Therapy, 2012-2019 56
Figure 33: Market for mAbs in Gastric Cancer, Top Five European Markets, Market Size ($m), 2012-2019 57
Figure 34: Market for mAbs in Gastric Cancer, Japan, Treatment Usage Patterns, 2012-2019 59
Figure 35: Market for mAbs in Gastric Cancer, Japan, Market Size ($m), 2012-2019 60
Figure 36: Market for mAbs in Esophageal Cancer, Global, Treatment Usage Patterns, 2012-2019 61
Figure 37: Market for mAbs in Esophageal Cancer, Global, Market Size ($m), 2012-2019 61
Figure 38: Market for mAbs in Esophageal Cancer, US, Treatment Patterns, 2012-2019 62
Figure 39: Market for mAbs in Esophageal Cancer, US, Market Size ($m), 2012-2019 63
Figure 40: Market for mAbs in Esophageal Cancer, Canada, Treatment Patterns, 2012-2019 64
Figure 41: Market for mAbs in Esophageal Cancer, Canada, Market Size ($m), 2012-2019 65
Figure 42: Market for mAbs in Esophageal Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019 66
Figure 43: Market for mAbs in Esophageal Cancer, Top Five European Markets, Annual Cost of Therapy ($), 2012-2019 67
Figure 44: Market for mAbs in Esophageal Cancer, Top Five European Markets, Market Size ($m), 2012-2019 68
Figure 45: Market for mAbs in Esophageal Cancer, Japan, Treatment Patterns, 2012-2019 69
Figure 46: Market for mAbs in Esophageal Cancer, Japan, Market Size ($m), 2012-2019 70
Figure 47: Market for mAbs in Gastric Cancer, Global, Licensing Deals (Countries), 2006-2013 74
Figure 48: Market for mAbs in Gastric Cancer, Global, Licensing Deals by Year and Value, 2006-2013 75
Figure 49: Market for mAbs in Gastrointestinal Tract Cancers, Global, Licensing Deals, 2006-2013 75
Figure 50: Market for mAbs in Gastric Cancer, Global, Co-Development Deals, 2006-2013 77
Figure 51: GBI Research Market Forecasting Model 105

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