Melanoma Therapeutics Market to 2020 - Rising Prevalence and Evolving Treatment Algorithms to Drive Market Growth

Melanoma Therapeutics Market to 2020 - Rising Prevalence and Evolving Treatment Algorithms to Drive Market Growth

Summary

GBI Research, a leading business intelligence provider, has released its latest research report, "Melanoma Therapeutics Market to 2020 - Rising Prevalence and Evolving Treatment Algorithms to Drive Market Growth” Melanoma is a highly heterogeneous disease comprising Cutaneous Melanoma (CM), Ocular Melanoma (OM), Mucosal Melanoma (MM), melanoma of the internal organs, and, according to some classifications, melanoma of the soft parts (non-bony and non-cartilaginous tissues) of the body. CM is by far the most common form of melanoma, accounting for approximately 90–95% of all melanomas.

Historically, melanoma has been considered as a very challenging disease to treat with pharmacotherapy. However, in recent years, understanding of the pathophysiology and heterogeneity of melanoma, and particularly CM, has developed considerably. This has led to the approval of several new drug agents indicated for CM since 2011, namely Sylatron (peginterferon alfa-2b), Yervoy (ipilimumab), Opdivo, (nivolumab), Keytruda (pembrolizumab), Zelboraf (vemurafenib), Tafinlar (dabrafenib) and Mekinist (trametinib). These drugs have dramatically improved the treatment options for CM patients, leading to unprecedented market growth.

Rapid market growth is also anticipated over the forecast period due to the expanding melanoma treatment population and the continued uptake of recently approved drugs. The melanoma pipeline is currently strong, with several promising molecules in development including, Polynoma’s seviprotimut-L, Amgen’s talimogene laherparepvec (T-VEC) and Roche and Genentech’s cobimetinib in combination with Zelboraf, which are in development for CM, as well as AstraZeneca’s selumetinib which is in development for OM. Consequently, the melanoma therapeutics market is projected to grow from $1.3 billion in 2013 to $3.6 billion in 2020, at a CAGR of 15.4%.

Scope

The report analyzes treatment usage patterns, drug types available and pipeline and market forecasts across indications for melanoma.The report covers and includes -
- An introduction to the melanoma indication, including disease symptoms, epidemiology, etiology, pathophysiology, staging, diagnosis and treatment.
- In-depth analysis of the current melanoma marketed products landscape including product profiles of the main drugs used in melanoma and heat maps that compare safety and efficacy parameters of the various drugs.
- Comprehensive analysis of the melanoma pipeline by phase of development, molecule type, molecular target and novelty. A comparative analysis of late-stage pipeline drugs that are likely to enter the market in the forecast period is also provided alongside heat maps.
- Additional in-depth analysis of melanoma clinical trials by size, duration, failure rates and primary and secondary endpoints.
- Multi-scenario forecast data for the market to 2020, taking into account how it will be affected by the introduction of new drugs and changes in disease epidemiology across the key developed markets, the US, Canada, the UK, France, Germany, Italy, Spain and Japan.
- Discussion of the licensing and co-development strategic consolidations landscape in melanoma, by Phase of development and molecule type, as well as an analysis of both licensing and co-development deals by year, and network maps of licensing and co-development deals.

Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to
- Gain a comprehensive understanding of the melanoma indication including segmentation of disease and treatment algorithms.
- Understand the current melanoma marketed products landscape and recognize the dominant therapeutic agents and pharmaceutical players involved.
- Identify trends and developments within the melanoma pipeline including which molecule types and molecular targets are prominent.
- Consider market opportunities and potential risks by examining trends in melanoma clinical trial duration and size, as well as clinical trial failure rates, amongst clinical trial Phases and molecule types.
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the melanoma therapeutics market.

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 11
2.1 Disease Introduction 11
2.2 Types of Melanoma 12
2.3 Symptoms 13
2.3.1 Cutaneous Melanoma 13
2.3.2 Ocular Melanoma 14
2.3.3 Mucosal Melanomas 14
2.3.4 Melanomas of the Internal Organs and Soft Parts 14
2.3.5 Advanced Melanoma 15
2.4 Etiology and Risk Factors 15
2.4.1 Phenotypic Characteristics 15
2.4.2 Exposure to Ultraviolet Radiation 16
2.4.3 Personal or Family History of Melanoma 17
2.4.4 Xeroderma Pigmentosum 18
2.4.5 Parkinson’s Disease 18
2.5 Pathophysiology 18
2.5.1 Cutaneous Melanoma 18
2.5.2 Ocular Melanoma 19
2.5.3 Mucosal Melanoma 20
2.5.4 Underlying Molecular Pathways 20
2.6 Melanoma Staging 22
2.7 Diagnosis 25
2.7.1 Cutaneous Melanoma 25
2.7.2 Ocular Melanoma 25
2.7.3 Mucosal Melanoma 26
2.8 Epidemiology 26
2.8.1 Cutaneous Melanoma 26
2.8.2 Ocular Melanoma 27
2.8.3 Mucosal Melanoma 28
2.9 Treatment Options 28
2.9.1 Surgery 29
2.9.2 Radiation Therapy 29
2.9.3 Pharmacotherapy 30
2.10 Treatment Algorithms 31
2.10.1 Cutaneous Melanoma 31
2.10.2 Ocular Melanoma 32
2.10.3 Mucosal Melanoma 33
2.11 Treatment Segments 34
2.11.1 Adjuvant Therapy for CM (All Mutations) 35
2.11.2 Advanced Therapy for CM (All Mutations) 37
2.11.3 Advanced Therapy for CM (BRAF Mutated Patients Only) 44
3 Marketed Products 49
3.1 Overview 49
3.2 Adjuvant therapy 50
3.2.1 Immunotherapy 50
3.3 Therapy for Advanced (Unresectable or Metastatic) Melanoma 52
3.3.1 Chemotherapy 52
3.3.2 Immunotherapy 54
3.3.3 Targeted Therapies 59
3.4 Heat Maps for Marketed Products 62
4 Melanoma Pipeline 68
4.1 Overview 68
4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 70
4.3 Pipeline Distribution by Molecular Target 76
4.4 Clinical Trial Landscape 82
4.4.1 Clinical Trial Failure Rates 82
4.4.2 Clinical Trial Duration 86
4.4.3 Clinical Trial Size 89
4.4.4 Primary and Secondary Endpoints 91
4.5 Promising Pipeline Molecules 97
4.5.1 Adjuvant Immunotherapy 97
4.5.2 Advanced Disease Immunotherapy 101
4.5.3 Advanced Disease Targeted Therapy 103
4.6 Heat Map and Competitor Matrix for Pipeline Products 110
5 Market Forecast to 2020 117
5.1 Geographical Markets 117
5.2 Global Market 118
5.3 North America 121
5.3.1 Treatment Usage Patterns 121
5.3.2 Annual Cost of Therapy 123
5.3.3 Market Size 124
5.4 Top Five EU Markets 126
5.4.1 Treatment Usage Patterns 126
5.4.2 Annual Cost of Therapy 127
5.4.3 Market Size 129
5.5 Japan 130
5.5.1 Treatment Usage Patterns 130
5.5.2 Annual Cost of Therapy 131
5.5.3 Market Size 132
5.6 Driver and Barriers for the Melanoma Therapeutics Market 132
5.6.1 Drivers 132
5.6.2 Barriers 134
6 Strategic Consolidations 135
6.1 Overview 135
6.2 Co-development Deals 135
6.2.1 GlaxoSmithKline Enters into Co-development Agreement with Synta Pharma for elesclomol (STA-4783) – Deal Now Terminated 140
6.2.2 Exelixis Enters into Co-development Agreement with Genentech for cobimetinib 140
6.2.3 Roche Enters into Co-development Agreement with Bristol-Myers Squibb for Zelboraf/Yervoy Combination Drug - No Longer Under Development for Melanoma 141
6.3 Licensing Deals 141
6.3.1 Chugai Pharma Enters into Licensing Agreement with Roche for Zelboraf 146
6.3.2 Colby Enters into Licensing Agreement with MannKind for Cancer Immunotherapy Products – No Longer Under Development for Melanoma 146
6.3.3 Molecular Insight Enters into Licensing Agreement with Bayer Schering Pharma for Solazed – No Longer Under Development for Melanoma - No Longer Under Development for Melanoma 146
7 Appendix 147
7.1 All Pipeline Drugs by Phase of Development 149
7.1.1 Discovery 149
7.1.2 Preclinical 151
7.1.3 IND/CTA-filed 157
7.1.4 Phase I 157
7.1.5 Phase II 160
7.1.6 Phase III 165
7.1.7 Pre-registration 166
7.2 Market Forecasts to 2020 166
7.2.1 Global 166
7.2.2 US 166
7.2.3 Canada 167
7.2.4 UK 167
7.2.5 France 168
7.2.6 2.2.6 Germany 168
7.2.7 Italy 169
7.2.8 Spain 169
7.2.9 Japan 170
7.3 References 170
7.3.1 References for Heat Maps 180
7.4 Abbreviations 183
7.5 Research Methodology 185
7.5.1 Secondary Research 186
7.5.2 Marketed Product Profiles 186
7.5.3 Late-Stage Pipeline Candidates 186
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 186
7.5.5 Product Competitiveness Framework 187
7.5.6 Pipeline Analysis 187
7.5.7 Forecasting Model 188
7.5.8 Deals Data Analysis 189
7.6 Contact Us 189
7.7 Disclaimer 189

1.1 List of Tables
Table 1: Characteristics of Types of Melanoma 13
Table 2: Staging of Cutaneous Melanoma 24
Table 3: Melanoma Clinical Trial Endpoint Definitions 34
Table 4: Melanoma Therapeutics Market, Global, Pipeline, Groups of Molecular Targets, 2014 77
Table 5: Breakdown of ‘Other’ Molecular Targets 147
Table 6: Breakdown of Molecular Target Combinations 148
Table 7: Melanoma Therapeutics, Global, All Pipeline Products, Discovery Phase, 2014 149
Table 8: Melanoma Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 151
Table 9: Melanoma Therapeutics, Global, All Pipeline Products, IND/CTA-filed Phase, 2014 157
Table 10: Melanoma Therapeutics, Global, All Pipeline Products, Phase I, 2014 157
Table 11: Melanoma Therapeutics, Global, All Pipeline Products, Phase II, 2014 160
Table 12: Melanoma Therapeutics, Global, All Pipeline Products, Phase III, 2014 165
Table 13: Melanoma Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2014 166
Table 14: Melanoma Therapeutics Market, Global, Market Forecast, 2013–2020 166
Table 15: Melanoma Therapeutics Market, US, Market Forecast, 2013–2020 166
Table 16: Melanoma Therapeutics Market, Canada, Market Forecast, 2013–2020 167
Table 17: Melanoma Therapeutics Market, UK, Market Forecast, 2013–2020 167
Table 18: Melanoma Therapeutics Market, France, Market Forecast, 2013–2020 168
Table 19: Melanoma Therapeutics Market, Germany, Market Forecast, 2013–2020 168
Table 20: Melanoma Therapeutics Market, Italy, Market Forecast, 2013–2020 169
Table 21: Melanoma Therapeutics Market, Spain, Market Forecast, 2013–2020 169
Table 22: Melanoma Therapeutics Market, Japan, Market Forecast, 2013–2020 170
Table 23: List of Abbreviations 183

1.2 List of Figures
Figure 1: Melanoma Therapeutics Market, Global, Heat Map for Adjuvant Marketed Products, 2014 65
Figure 2: Melanoma Therapeutics Market, Global, Heat Map for Advanced Marketed Products, 2014 66
Figure 3: Melanoma Therapeutics Market, Global, Heat Map for Advanced Marketed Products, 2014 (continued) 67
Figure 4: Melanoma Therapeutics Market, Global, Pipeline, 2014 71
Figure 5: Melanoma Therapeutics Market, Global, Pipeline, Breakdown of Biologics and Gene/Cell Therapies, 2014 73
Figure 6: Melanoma Therapeutics Market, Global, Pipeline, Repositioned Molecules by Original Indication, 2014 74
Figure 7: Melanoma Therapeutics Market, Global, Pipeline by Molecular Target, 2014 76
Figure 8: Melanoma Therapeutics Market, Global, Pipeline, Breakdown of Protein Kinase Molecular Targets by Phase of Development, 2014 78
Figure 9: Melanoma Therapeutics Market, Global, Pipeline, Breakdown of Antigens/Antigen Ligands Molecular Targets by Phase of Development, 2014 80
Figure 10: Melanoma Therapeutics Market, Global, Pipeline, Breakdown of Cytokine/Cytokine Receptor Molecular Targets by Phase of Development, 2014 81
Figure 11: Melanoma Therapeutics Market, Global, Clinical Trial Failure Rates by Phase of Development and Overall Clinical Trial Attrition Rate, 2006–2013 (%) 82
Figure 12: Melanoma Therapeutics Market, Global, Clinical Trial Failure Rates (Phases I, II and III) and Clinical Trial Attrition Rate by Molecule Type (%), 2006–2013 83
Figure 13: Melanoma Therapeutics Market, Global, Clinical Trial Failure Rates (Phases I, II and III) and Clinical Trial Attrition Rate by Molecular Target (%), 2006–2013 85
Figure 14: Melanoma Therapeutics Market, Global, Pipeline, Clinical Trial Duration by Molecule Type (months), 2006–2013 87
Figure 15: Melanoma Therapeutics Market, Global, Clinical Trial Size by Molecule Type (participants), 2006–2013 89
Figure 16: Melanoma Therapeutics Market, Global, Failure Rate, Average Trial Duration and Average Trial Recruitment Size by Molecule Type, 2006–2013 91
Figure 17: Melanoma Therapeutics Market, Global, Pipeline, Primary Clinical Trial Endpoints by Phase of Development (%), 2006–2013 92
Figure 18: Melanoma Therapeutics Market, Global, Breakdown of Safety/drug Biochemistry and Efficacy Clinical Trial Primary Endpoints by Phase of Development, 2006–2013 93
Figure 19: Melanoma Therapeutics Market, Global, Secondary Clinical Trial Endpoints by Phase of Development (%), 2006–2013 94
Figure 20: Melanoma Therapeutics Market, Global, Breakdown of Safety/drug biochemistry, Efficacy and ‘Other’ Clinical Trial Secondary Endpoints by Phase of Development, 2006–2013 96
Figure 21: Melanoma Therapeutics Market, Global Sales Forecast for Seviprotimut-L ($m), 2017–2020 99
Figure 22: Melanoma Therapeutics Market, Global, Sales Forecast for Yervoy (Adjuvant Setting) ($m), 2016–2020 101
Figure 23: Melanoma Therapeutics Market, Global Sales Forecast for Talimogene Laherparepvec (T-Vec) ($m), 2015–2020 103
Figure 24: Melanoma Therapeutics Market, Global, Sales Forecast for Selumetinib ($m), 2016–2020 106
Figure 25: Melanoma Therapeutics Market, Global Sales Forecast for Binimetinib ($m), 2016–2020 108
Figure 26: Melanoma Therapeutics Market, Global, Sales Forecast for Cobimetinib ($m), 2015–2020 110
Figure 27: Melanoma Therapeutics Market, Global, Heat Map for Adjuvant Pipeline Products, 2014 111
Figure 28: Melanoma Therapeutics Market, Global, Heat Map for Advanced Pipeline Products, 2014 112
Figure 29: Melanoma Therapeutics Market, Global, Heat Map for Advanced Pipeline Products, 2014 (continued) 113
Figure 30: Melanoma Therapeutics Market, Global, Competitor Matrix for Advanced Products, 2014 114
Figure 31: Melanoma Therapeutics Market, Global, Treatment Patterns (‘000) and Market Size ($bn), 2013–2020 118
Figure 32: Melanoma Therapeutics Market, North America, Treatment Patterns, 2013–2020 122
Figure 33: Melanoma Therapeutics Market, North America, Annual Cost of Therapy ($), 2013–2020 123
Figure 34: Melanoma Therapeutics Market, North America, Market Size, 2013–2020 125
Figure 35: Melanoma Therapeutics Market, Five EU Countries, Treatment Patterns (‘000), 2013–2020 126
Figure 36: Melanoma Therapeutics Market, Top Five EU Countries, Annual Cost of Therapy ($), 2013–2020 128
Figure 37: Melanoma Therapeutics Market, Top Five EU Countries, Market Size ($m), 2013–2020 129
Figure 38: Melanoma Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2013–2020 130
Figure 39: Melanoma Therapeutics Market, Japan, Annual Cost of Therapy ($), 2013–2020 131
Figure 40: Melanoma Therapeutics Market, Japan, Market Size ($m), 2013–2020 132
Figure 41: Melanoma Therapeutics Market, Global, Co-development Deals by Region, 2006–2014 135
Figure 42: Melanoma Therapeutics Market, Global, Co-development Deals by Deal Value, 2006–2014 136
Figure 43: Melanoma Therapeutics Market, Global, Co-development Deals by Year, 2006–2014 137
Figure 44: Melanoma Therapeutics Market, Global, Co-development Deals by Phase of Development, Deal Value and Upfront Payment ($m), 2006–2014 138
Figure 45: Melanoma Therapeutics Market, Co-development Deals by Phase of Development, Molecule Type and Aggregate Deal Value ($m), 2006–2014 139
Figure 46: Melanoma Therapeutics Market, Global, Licensing Deals by Region, 2006–2014 141
Figure 47: Melanoma Therapeutics Market, Global, Licensing Deals by Deal Value, 2006–2014 142
Figure 48: Melanoma Therapeutics Market, Global, Licensing Deals by Year, 2006–2014 143
Figure 49: Melanoma Therapeutics Market, Global, Licensing Deals by Phase of Development, Deal Value and Upfront Payment ($m), 2006–2014 144
Figure 50: Melanoma Therapeutics Market, Licensing Deals by Phase of Development, Molecule Type and Aggregate Deal Value ($m), 2006–2014 145