Monoclonal Antibodies Market in Colorectal Cancer to 2019 - Favorable Pricing Policy in the US and Rising Prevalence in Europe and Japan Ensures Market Growth


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GBI Research

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GBI Research, has released the pharma report - “Monoclonal Antibodies Market in Colorectal Cancer to 2019 - Favorable Pricing Policy in the US and Rising Prevalence in Europe and Japan Ensures Market Growth”. There are currently three monoclonal Antibody (mAb) treatments approved for metastatic colorectal cancer with the purpose of extending the patient’s lifespan; Avastin, Erbitux and Vectibix. The current market leader is Avastin, which generated revenues of $6.2 billion in 2012 across a number of oncology indications. While compelling late-stage candidates are absent from the current pipeline, the anticipated rise in total prevalence of colorectal cancer in the top eight markets may inspire further investment. Pricing patterns for mAbs are highly favorable in the US, the largest market for colorectal cancer, and patent expirations are not expected to have a substantial effect on any of the featured markets. As a result of this, GBI Research believes the global market has the potential to grow to a value of $5.5 billion by 2019.

Scope

  • A brief introduction to colorectal cancer, including the disease’s pathogenesis, etiology, diagnosis and treatment algorithms.
  • In-depth analysis of the three mAbs marketed for colorectal cancer, including analysis of their safety, efficacy, treatment patterns and strengths/weaknesses. Including a heat map comparing the drugs in terms of safety and efficacy.
  • A comprehensive review of the pipeline for colorectal 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 is analyzed on the basis of phase distribution, molecule types, program types, mechanisms of action and molecular targets.
  • Additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration and program failure rate for each molecule type, in addition to an in-depth analysis of clinical trial primary endpoints.
  • Multi-scenario forecast data of the market to 2019, taking into account how the market may 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.
  • Discussion of the drivers and barriers for market growth.
  • In-depth analysis of all licensing and co-development deals that have occurred in the colorectal cancer market since 2006.

Reasons to Buy

  • Understand the role of mAbs in the treatment of colorectal cancer and their relation to chemotherapies and targeted small molecule therapies.
  • Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent.
  • Observe the trends in clinical trial duration and size amongst clinical phases and molecule types. Use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for colorectal cancer therapeutics.
  • Observe the shift in clinical trial endpoints throughout clinical phases of development, and use this data to potentially influence any future developmental programs.
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the colorectal cancer mAbs market.
Table of Contents

1 Table of Contents 1
1.1 List of Tables 3
1.2 List of Figures 4

2 Executive Summary 5
2.1 Monoclonal Antibodies Favored in the Market for Metastatic Colorectal Cancer 5
2.2 Strong Pipeline to Drive Growth to 2019 5

3 Monoclonal Antibodies in Colorectal Cancer Market to 2019 – Introduction 7
3.1 Symptoms 7
3.2 Etiology 7
3.3 Epidemiology 8
3.4 Pathophysiology 9
3.5 Diagnosis 9
3.6 Prognosis and Disease Staging 10
3.7 Treatment Options 11
3.7.1 Chemotherapy 11
3.7.2 Targeted Therapies 12
3.7.3 Resistance to Pharmacological Therapies 13
3.7.4 Treatment Guidelines 13
3.8 GBI Research Report Guidance 15

4 Monoclonal Antibodies in Colorectal Cancer Market to 2019 – Marketed Products 16
4.1 Avastin (Bevacizumab) – Hoffman La Roche 16
4.2 Erbitux (Cetuximab) – Bristol-Myers Squibb, Eli Lilly, and Merck KGaA 18
4.3 Vectibix (Panitumumab) – Amgen and Takeda 19
4.4 Heat Map for Marketed Products 20
4.5 Conclusion 22

5 Monoclonal Antibodies in Colorectal Cancer Market to 2019 – Developmental Pipeline 23
5.1 Overall Pipeline 23
5.2 Molecular Targets and Mechanisms of Action 25
5.3 Clinical Trials 26
5.3.1 Failure Rate 26
5.3.2 Clinical Trial Size 27
5.3.3 Duration 30
5.3.4 Primary Endpoints 31
5.4 Conclusion 33
5.5 Key Late-Stage Pipeline Products 33
5.5.1 IMC-1121B (Ramucirumab) – Eli Lilly and Company 33
5.5.2 Xilonix – XBiotech 34
5.5.3 MetMAb (Onartuzumab) – Hoffmann-La Roche 34
5.5.4 Anti-DR5 MoAb (Tigatuzumab) – Daiichi Sankyo 34
5.5.5 MK0646 (Dalotuzumab) – Merck 35
5.5.6 AMG-655 (Conatumumab) – Amgen 36
5.6 Conclusion 36

6 Monoclonal Antibodies in Colorectal Cancer Market to 2019- Market Forecast to 2019 36
6.1 Global 38
6.1.1 Treatment Usage Patterns 38
6.1.2 Market Size 39
6.2 North America 40
6.2.1 US 40
6.2.2 Canada 42
6.3 Europe 43
6.3.1 Treatment Usage Patterns 43
6.3.2 Annual Cost of Therapy 44
6.3.3 Market Size 46
6.4 Japan 47
6.4.1 Treatment Usage Patterns 47
6.4.2 Market Size 48
6.5 Drivers and Barriers 48
6.5.1 Drivers 48
6.5.2 Barriers 49

7 Monoclonal Antibodies in Colorectal Cancer Market to 2019- Deals and Strategic Consolidations 51
7.1 R&D Licensing Agreements 51
7.1.1 Key Licensing Deals 54
7.2 Co-Development Agreements 56
7.2.1 Key Co-Development Agreements 57

8 Monoclonal Antibodies in Colorectal Cancer Market to 2019- Appendix 58
8.1 Market Definitions 58
8.2 Abbreviations 58
8.3 References 60
8.4 Sources for Heat Map 65
8.5 All Pipeline Products, by Stage of Development 66
8.5.1 Discovery 66
8.5.2 Preclinical and IND/CTA-filed 67
8.5.3 Phase I 72
8.5.4 Phase II 75
8.5.5 Phase III and Pre-registration 80
8.5.6 Undisclosed 80
8.6 Tabular Forecast Data 82
8.6.1 Global 82
8.6.2 US 82
8.6.3 Canada 82
8.6.4 UK 82
8.6.5 France 83
8.6.6 Germany 83
8.6.7 Italy 83
8.6.8 Spain 83
8.6.9 Japan 84
8.7 Research Methodology 84
8.7.1 Coverage 84
8.7.2 Secondary Research 84
8.7.3 Primary Research 85
8.7.4 Therapeutic Landscape 85
8.7.5 Epidemiology-Based Forecasting 85
8.7.6 Market Size by Geography 87
8.7.7 Geographical Landscape 88
8.7.8 Pipeline Analysis 88
8.8 Contact Us 88
8.9 Disclaimer 88
Table 1: Market for mAbs in Colorectal Cancer, US, Epidemiology, 2008 8
Table 2: Market for mAbs in Colorectal Cancer, US, Diagnosis by Stage, 2009 8
Table 3: Market for mAbs in Colorectal Cancer, US, Five-Year Survival by Stage, 2009 10
Table 4: Market for mAbs in Colorectal Cancer, Global, TNM Staging, 2013 11
Table 5: Market for mAbs in Colorectal Cancer, Sources for Heat Map 63
Table 6: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 64
Table 7: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 65
Table 8: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 70
Table 9: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 73
Table 10: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Phase III), 2013 78
Table 11: Colorectal Cancer Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 78
Table 12: Market for mAbs in Colorectal Cancer, Global, Forecast Data, 2012–2019 80
Table 13: Market for mAbs in Colorectal Cancer, US, Forecast Data, 2012–2019 80
Table 14: Market for mAbs in Colorectal Cancer, Canada, Forecast Data, 2012–2019 80
Table 15: Market for mAbs in Colorectal Cancer, UK, Forecast Data, 2012–2019 80
Table 16: Market for mAbs in Colorectal Cancer, France, Forecast Data, 2012–2019 81
Table 17: Market for mAbs in Colorectal Cancer, Germany, Forecast Data, 2012–2019 81
Table 18: Market for mAbs in Colorectal Cancer, Italy, Forecast Data, 2012–2019 81
Table 19: Market for mAbs in Colorectal Cancer, Spain, Forecast Data, 2012–2019 81
Table 20: Market for mAbs in Colorectal Cancer, Japan, Forecast Data, 2012–2019 82
Figure 1: Market for mAbs in Colorectal Cancer, Developmental Pipeline 5
Figure 2: Market for mAbs in Colorectal Cancer, US, Market Size ($bn), 2012–2019 6
Figure 3: Market for mAbs in Colorectal Cancer, Global, ESMO Treatment Guidelines (Colorectal Cancer at Stage I to III) 14
Figure 4: Market for mAbs in Colorectal Cancer, Global, ESMO Treatment Guidelines (Colorectal Cancer at Stage IV) 15
Figure 5: Market for mAbs in Colorectal Cancer, Global, Sales of Avastin ($bn), 2004–2012 17
Figure 6: Market for mAbs in Colorectal Cancer, Global, Sales of Vectibix ($m), 2006–2012 19
Figure 7: Market for mAbs in Colorectal Cancer, Global, Heat Map of Safety and Efficacy for Marketed Products, 2013 21
Figure 8: Market for mAbs in Colorectal Cancer, Global, Overall Pipeline, 2013 24
Figure 9: Market for mAbs in Colorectal Cancer, Global, Pipeline mAbs by Mechanism of Action and Molecular Target, 2013 25
Figure 10: Market for mAbs in Colorectal Cancer, Global, Developmental Pipeline Failure Rate, 2006–2013 26
Figure 11: Market for mAbs in Colorectal Cancer, Global, Developmental Pipeline Failure Rate, 2006–2013 27
Figure 12: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Sizes, 2006–2013 28
Figure 13: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Sizes by Molecule Type, 2006–2013 29
Figure 14: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Durations, 2006–2013 30
Figure 15: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Durations by Molecule Type, 2006–2013 31
Figure 16: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Primary Endpoints, 2006–2012 32
Figure 17: Market for mAbs in Colorectal Cancer, Global, Clinical Trial Primary Endpoints, 2006–2012 33
Figure 18: Market for mAbs in Colorectal Cancer, Global, Market Growth and Size, 2012–2019 37
Figure 19: Market for mAbs in Colorectal Cancer, Global, Treatment Patterns, 2012–2019 38
Figure 20: Market for mAbs in Colorectal Cancer, Global, Market Size ($bn), 2012–2019 39
Figure 21: Market for mAbs in Colorectal Cancer, US, Treatment Usage Patterns, 2012–2019 40
Figure 22: Market for mAbs in Colorectal Cancer, US, Market Size ($m), 2012–2019 41
Figure 23: Market for mAbs in Colorectal Cancer, Canada, Treatment Usage Patterns, 2012–2019 42
Figure 24: Market for mAbs in Colorectal Cancer, Canada, Market Size ($m), 2012–2019 43
Figure 25: Market for mAbs in Colorectal Cancer, Leading Five European Markets, Treatment Patterns, 2012–2019 44
Figure 26: Market for mAbs in Colorectal Cancer, Leading Five European Markets, Annual Cost of Therapy, 2012–2019 45
Figure 27: Market for mAbs in Colorectal Cancer, Leading Five European Markets, Market Size ($m), 2012–2019 46
Figure 28: Market for mAbs in Colorectal Cancer, Japan, Treatment Usage Patterns, 2012–2019 47
Figure 29: Market for mAbs in Colorectal Cancer, Japan, Market Size ($m), 2012–2019 48
Figure 30: Market for mAbs in Colorectal Cancer, Global, Licensing Deals (All Molecule Types), 2006–2012 51
Figure 31: Market for mAbs in Colorectal Cancer, Global, Licensing Deals (All Molecule Types), 2006–2012 52
Figure 32: Market for mAbs in Colorectal Cancer, Global, Licensing Deals (All Molecule Types), 2006–2012 53
Figure 33: Market for mAbs in Colorectal Cancer, Global, Co-development Deals Global Network, 2006–2013 56
Figure 34: Market for mAbs in Colorectal Cancer, Global, Co-development Deals by Year and Value, 2006–2013 57
Figure 35: GBI Research Market Forecasting Model 87