Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant

Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant

Summary

GBI Research, the leading business intelligence provider, has released its latest research,‘Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant’, which provides in-depth analysis of pancreatic adenocarcinoma market within the eight major developed markets of the US, UK, France, Germany, Italy, Spain, Japan and Canada. The report provides an estimation of the market size for 2012, along with market forecasts to 2019. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of the pipeline, and deal analysis.

The global pancreatic adenocarcinoma therapeutics market is expected to grow from approximately $856m in 2012 to $1.2 billion in 2019, with growth driven by small changes in multiple factors. These include the impact of the drugs approved in the forecast period, but also the increase in the prevalence of the disease and minor improvements in diagnostics that result in more patients being eligible for pharmacological.

Scope

- A brief introduction to pancreatic adenocarcinoma, including the disease’s pathogenesis, risk factors, diagnosis, staging and treatment algorithms for each stage.
- In-depth analysis of drugs available for the treatment of pancreatic adenocarcinoma, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map comparing the drugs in terms of safety and efficacy.
- Comprehensive review of the pipeline for pancreatic adenocarcinoma therapies, 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, program type.
- Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, 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, Japan, Germany, the UK, France, Italy and Spain.
- Discussion of the drivers and barriers for market growth.
- Discussion of the licensing and co-development deals landscape in pancreatic adenocarcinoma, Includes an analysis of licensing deals by stage of development, molecule type and mechanism of action. Also includes an analysis of both licensing and co-development deals by year and value and network maps of licensing and co-development deals.

Reasons to buy

- Understand the vast scope and diversity 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, between molecule types and mechanisms of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for pancreatic adenocarcinoma therapeutics.
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the pancreatic adenocarcinoma therapeutics market.

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Overview 9
2.1.1 Pancreatic Neuroendocrine Tumors 10
2.2 Pathophysiology 11
2.2.1 Inherited Disease 11
2.2.2 Somatic Mutations 11
2.3 Signs and Symptoms 12
2.4 Risk Factors 13
2.4.1 Smoking 13
2.4.2 Pancreatitis and Other Medical Conditions 13
2.4.3 Obesity 13
2.4.4 Infections 13
2.5 Diagnosis 13
2.6 Treatment Algorithm 14
2.6.1 Surgery 14
2.6.2 Radiation Therapy 14
2.6.3 Chemotherapy 15
2.6.4 Algorithm of Chemotherapeutic Treatment for Pancreatic Cancer 16
3 Marketed Products 33
3.1 Approved Products 33
3.1.1 Gemcitabine 33
3.1.2 IV Fluorouracil 34
3.1.3 Tarceva 34
3.1.4 Abraxane 35
3.1.5 Teysuno/TS-1 36
3.2 Off-Label Products 36
3.2.1 Xeloda 36
3.2.2 Eloxatin 37
3.3 Marketed Products – Discussion 37
4 Product Pipeline 39
4.1 Pipeline Overview 39
4.2 Overview of Pipeline by Phase, Route of Administration, Molecule Type and Molecular Target 39
4.3 Key Trends in Drug Development within the Pancreatic Cancer Pipeline 44
4.3.1 Enhancing Drug Delivery 44
4.3.2 Targeted Therapies 44
4.3.3 Immunotherapy 45
4.4 Clinical Trial Duration and Size 47
4.5 Clinical Trial Failure Rate 50
4.6 Clinical Trial Discussion 51
4.7 Promising Drug Candidates in Pipeline 53
4.7.1 Masivet/Kinavet (US) – AB Science 53
4.7.2 Glufosfamide – Eleison Pharmaceuticals Incorporated 54
4.7.3 Tertomotide – Kael-GemVax Co., Ltd 55
4.7.4 TH-302 – Threshold Pharmaceuticals 56
4.7.5 HyperAcute Pancreas – NewLink Genetics Corporation 58
4.7.6 MM-398 – Merrimack Pharmaceuticals Inc. 60
4.8 Pipeline Discussion 62
5 Market Forecast 67
5.1 Introduction 67
5.2 Global Market 67
5.3 North America 70
5.3.1 Treatment Usage Patterns 70
5.3.2 Annual Cost of Therapy 71
5.3.3 Market Size 73
5.4 Top Five European Countries 75
5.4.1 Treatment Usage Patterns 75
5.5 Annual Cost of Therapy 77
5.6 Market Size 79
5.7 Japan 81
5.7.1 Treatment Usage Patterns 81
5.7.2 Annual Cost of Therapy 82
5.7.3 Market Size 82
5.8 Drivers and Barriers 83
5.8.1 Drivers 83
5.8.2 Barriers 84
6 Deals 87
6.1 Licensing Deals 87
6.1.1 Clavis Enters Licensing and Development Agreement with Clovis 89
6.1.2 Baxter Enters Licensing Agreement with Onconova for Rigosertib 90
6.1.3 Lorus Therapeutics Enters Into Licensing Agreement with Zor Pharma 90
6.1.4 Novogen Enters Into Licensing Agreement with Marshall Edwards For NV-196 And NV-143 90
6.2 Co-Development Deals 90
6.2.1 Merck Serono Enters Into Co-Development Agreement with Threshold Pharma for TH-302 92
7 Appendix 93
7.1 All Pipeline Drugs by Phase 93
7.1.1 Discovery 93
7.1.2 Preclinical 95
7.1.3 IND/CTA-Filed 103
7.1.4 Phase I 103
7.1.5 Phase II 105
7.1.6 Phase III 110
7.1.7 Pre-Registration 111
7.2 Market Forecasts to 2019 111
7.2.1 Global 111
7.2.2 US 112
7.2.3 Canada 112
7.2.4 UK 113
7.2.5 France 113
7.2.6 Germany 114
7.2.7 Italy 114
7.2.8 Spain 115
7.2.9 Japan 115
7.3 Abbreviations 116
7.4 References 117
7.5 Methodology 122
7.6 Secondary Research 122
7.7 Contact Us 122
7.8 Disclaimer 122

1.1 List of Tables
Table 1: Pancreatic Cancer Therapeutics, Inherited Cancer Syndromes Associated with an Increased Risk of Pancreatic Cancer 11
Table 2: Pancreatic Cancer Therapeutics, Common Mutations in Pancreatic Cancer 12
Table 3: Pancreatic Cancer Therapeutics, Tumor Staging in Pancreatic Cancer 14
Table 4: Pancreatic Cancer Therapeutics, ECOG Performance Status Scores and Description 15
Table 5: Pancreatic Cancer Therapeutics, Common Endpoints in Oncology Clinical Trials and their Description 16
Table 6: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy 17
Table 7: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy 18
Table 8: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Eloxatin 22
Table 9: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Cisplatin 23
Table 10: Pancreatic Cancer Therapeutics, Typical Dosing of Teysuno based on Body Surface Area (BSA) of Patient 27
Table 11: Pancreatic Cancer Therapeutics, Adverse Events Associated with Gemcitabine Monotherapy, Teysuno Monotherapy, and with their Combination 27
Table 12: Pancreatic Cancer Therapeutics, Improvements in Overall Survival with Gemcitabine Drug Combinations 29
Table 13: Pancreatic Cancer Therapeutics, Key Molecular Targets of the Developmental Pipeline 42
Table 14: Pancreatic Cancer Therapeutics, Global, Average Clinical Trial Duration (months) 47
Table 15: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Masivet 53
Table 16: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with TH-302 57
Table 17: Pancreatic Cancer Therapeutics, Top Five European Markets, Europe Age-Standardized Incidence Rates of Pancreatic Cancer, 2008 75
Table 18: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Discovery Phase 93
Table 19: Pancreatic Cancer Therapeutics, Developmental Pipeline, Preclinical Phase 95
Table 20: Pancreatic Cancer Therapeutics, Developmental Pipeline, IND/CTA-Filed Phase 103
Table 21: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase I 103
Table 22: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase II I 105
Table 23: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase III 110
Table 24: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration 111
Table 25: Pancreatic Cancer Therapeutics, Global, Market Forecast, 2012–2019 111
Table 26: Pancreatic Cancer Therapeutics, US, Market Forecast, 2012–2019 112
Table 27: Pancreatic Cancer Therapeutics, Canada, Market Forecast, 2012–2019 112
Table 28: Pancreatic Cancer Therapeutics, UK, Market Forecast, 2012–2019 113
Table 29: Pancreatic Cancer Therapeutics, France, Market Forecast, 2012–2019 113
Table 30: Pancreatic Cancer Therapeutics, Germany, Market Forecast, 2012–2019 114
Table 31: Pancreatic Cancer Therapeutics, Italy, Market Forecast, 2012–2019 114
Table 32: Pancreatic Cancer Therapeutics, Spain, Market Forecast, 2012–2019 115
Table 33: Pancreatic Cancer Therapeutics, Japan, Market Forecast, 2012–2019 115
Table 34: Pancreatic Cancer Therapeutics, Abbreviations 116

1.2 List of Figures
Figure 1: Pancreatic Cancer Therapeutics, Global, World-Age Standardized Incidence Rates (rate per 100,000), 2008 10
Figure 2: Pancreatic Cancer Therapeutics, Efficacy Results For Key Parameters – Marketed Products 31
Figure 3: Pancreatic Cancer Therapeutics, Safety Results for Key Parameters – Marketed Products 32
Figure 4: Pancreatic Cancer Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration 40
Figure 5: Pancreatic Cancer Therapeutics, Global, Pipeline by Molecule Type and Mechanism of Action 43
Figure 6: Pancreatic Cancer Therapeutics, Global, Pipeline by Molecular Target 46
Figure 7: Pancreatic Cancer Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006–2013 48
Figure 8: Pancreatic Cancer Therapeutics, Global, Clinical Trial Sizes by Phase and Molecule Type, 2006–2013 49
Figure 9: Pancreatic Cancer Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure, 2006–2013 50
Figure 10: Pancreatic Cancer Therapeutics, Cross Analysis of Clinical Trial Failure Rate, Duration and Size by Molecule Type and Phase, Global, 2006–2013 52
Figure 11: Pancreatic Cancer Therapeutics, Global, Estimated Sales of TH-302 ($m), 2017–2019 58
Figure 12: Pancreatic Cancer Therapeutics, Global, Estimated Sales of HyperAcute Pancreas ($m), 2015–2019 60
Figure 13: Pancreatic Cancer Therapeutics, Global, Estimated Sales of MM-398 ($m), 2016–2019 61
Figure 14: Pancreatic Cancer Therapeutics, Efficacy Results for Key Parameters – Pipeline Products 63
Figure 15: Pancreatic Cancer Therapeutics, Safety results for Key Parameters – Pipeline Products 64
Figure 16: Pancreatic Cancer Therapeutics, Product Competitiveness Framework in First-line treatment in Metastatic Disease – Efficacy 65
Figure 17: Pancreatic Cancer Therapeutics, Product Competitiveness Framework in First-line treatment in Metastatic Disease – Safety Parameters 66
Figure 18: Pancreatic Cancer Therapeutics Market, Global, Treatment Patterns and Market Revenues ($m), 2012–2019 69
Figure 19: Pancreatic Cancer Therapeutics, US and Canada, Treatment Usage Patterns, 2012–2019 71
Figure 20: Pancreatic Cancer Therapeutics, US and Canada, Annual Cost of Therapy ($), 2012–2019 72
Figure 21: Pancreatic Cancer Therapeutics Market, US and Canada, Market Revenues ($m), 2012–2019 74
Figure 22: Pancreatic Cancer Therapeutics, Top Five European Markets, Treatment Usage Patterns, 2012–2013 76
Figure 23: Pancreatic Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy ($), 2012–2019 78
Figure 24: Pancreatic Cancer Therapeutics, Top Five European Markets, Market Revenues ($m), 2012–2019 80
Figure 25: Pancreatic Cancer Therapeutics, Japan, Treatment Usage Patterns, 2012–2019 81
Figure 26: Pancreatic Cancer Therapeutics, Japan, Annual Cost of Therapy ($), 2012–2019 82
Figure 27: Pancreatic Cancer Therapeutics, Japan, Market Size ($m), 2012–2019 83
Figure 28: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Region, Value ($m) and Year, 2006–2013 88
Figure 29: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Phase, Value ($m) and Molecule Type, 2006–2013 89
Figure 30: Pancreatic Cancer Therapeutics, Global, Co-Development Deals by Region, Value ($m) and Year, 2006–2013 91