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Pancreatic Cancer Therapeutics in Major Developed Markets to 2021-Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape

Pancreatic Cancer Therapeutics in Major Developed Markets to 2021-Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape


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Executive Summary

Pancreatic Cancer Therapeutics in Major Developed Markets to 2021-Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape

Pancreatic Cancer (PC) is a disease predominately of the elderly with ~75% of PC cases being diagnosed in patient's over 75 years old. PC proliferates rapidly, is asymptomatic at its earliest stages and when symptoms do present themselves they are non-specific. There are currently no early detection methods in use for PC. Currently the best option for patient survival is resection which can triple five year survival rate to 15% compared to the unresectable stages of PC. Regrettably ~83% of patients present with advanced unresectable disease and patient prognosis is extremely poor. The majority of patients ultimately develop resistant disease, for whom treatment options have historically been limited, with treatment involving fluorouracil as a monotherapy or used in a combination therapy being standard. The recent approval of Onivyde for gemcitabine refractory disease in 2015 has improved survival of resistant patients, but there is a clear clinical need to diversify the treatment options for this patient cohort.

The current late-stage drugs in development for PC address this clinical need; however, results so far have been limited in their efficacy, with none demonstrating clinically transformative efficacy or safety. As a result, the growth in PC prevalence as a result of a global aging population, increasing diabetes and obesity prevalence is expected to be the key driver of this market throughout the forecast period.

Scope

Global revenues for the PC market are forecast to rise at a moderate CAGR of 7.6% from USD 1.746bn in 2014 to USD 2.92bn in 2021.

-What factors are driving the market growth?

-How can the factors limiting growth be overcome in the future?

The variation in mechanism of action has shifted away from the traditional chemotherapies, which dominate the marketed products, but account for only 7% of the pipeline. 44% of the pipeline are drugs inhibiting signal transduction.

-What are the dynamics of the remaining 49% of the pipeline?

-How does this reflect the need for novel targeted therapies?

Key mechanisms of action across the pipeline include cancer immunotherapies against IAP repeat containing proteins, whole cell vaccines and targeted therapies against the PI3K/Akt/mTOR pathway.

-What is the scientific rationale behind these targets?

Several drugs are expected to be approved during the forecast period: TH-302, ruxolitinib phosphate, HyperAcute Pancreas, G17DT and clivatuzumab tetraxetan. However, their sales will be limited by their expected high costs.

-Where will these novel therapies fit into the current treatment algorithm for PC?

The pipeline therapies, G17DT is expected to have the strongest performance, with revenues of USD 141m by 2021.

-How will the other late stage pipeline drugs perform commercially?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis.

Visualize the composition of the pancreatic cancer market in terms of dominant molecule types and targets, highlighting the current unmet needs and how they can be addressed to allow a competitive understanding of gaps in the current market.

Analyze the pancreatic cancer pipeline and stratify by stage of development, molecule type, and molecular target.

Visualize the clinical safety and efficacy of late-stage pipeline drugs via a detailed heat map, outlining the results across major clinical trial endpoints.

Understand the growth in patient epidemiology, annual therapy costs, and market revenues for the pancreatic cancer market globally and across the US, UK, France, Germany, Italy, Spain, Japan, and Canada.

Identify commercial opportunities in the pancreatic cancer deals landscape by analyzing trends in licensing and co-development deals.

1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 8

1.2 List of Figures 9

2 Introduction 11

2.1 Disease Introduction 11

2.2 Epidemiology 11

2.3 Symptoms 12

2.4 Risk Factors 13

2.4.1 Age 13

2.4.2 Smoking 13

2.4.3 Obesity 13

2.4.4 Diet 13

2.4.5 Inherited Mutations 14

2.4.6 Chronic Pancreatitis 14

2.4.7 Diabetes 14

2.4.8 Infectious Diseases Risk Factors 14

2.4.9 Precursor Lesions 15

2.5 Pathophysiology 15

2.5.1 Somatic Mutations 15

2.6 Disease Stages 17

2.7 Diagnosis 18

2.8 Disease Prognosis 19

2.9 Treatment Algorithm 19

2.9.1 Adjuvant Therapy, Resected Cancer 20

2.9.2 First-Line Treatment, Unresectable 21

2.9.3 Second-Line Treatment, Unresectable 22

3 Commercial and Clinical Prospects of Marketed Products 24

3.1 Approved Products 24

3.1.1 Gemcitabine 24

3.1.2 IV Fluorouracil 25

3.1.3 Abraxane 26

3.1.4 Tarceva 27

3.1.5 Teysuno/TS-1/S-1 28

3.1.6 Onivyde 29

3.2 Off-Label Products 30

3.2.1 Capecitabine 30

3.2.2 Oxaliplatin 30

3.3 Marketed Products-Discussion 31

4 Pipeline for Pancreatic Cancer Therapeutics 36

4.1 Overview by Phase and Molecule Type 37

4.2 Overview by Molecular Target 38

4.3 Clinical Trials 42

4.3.1 Clinical Trial Failure Rates 42

4.3.2 Clinical Trial Duration 46

4.3.3 Clinical Trial Size 50

4.3.4 Discussion 55

4.4 Promising Pipeline Molecules 55

4.4.1 Evofosfamide (TH-302)-Threshold Pharmaceuticals. 55

4.4.2 Tertomotide-Kael-GemVax 58

4.4.3 Ruxolitinib phosphate-Incyte Corporation 59

4.4.4 HyperAcute Pancreas/ Algenpantucel-L-NewLink Genetics Corporation 61

4.4.5 G17DT-Cancer Advances 64

4.4.6 Nimotuzumab-InnoMab 65

4.4.7 Clivatuzumab Tetraxetan-Immunomedics. 66

4.5 Pipeline Discussion 68

5 Market Forecast to 2021 72

5.1 Global Market 73

5.2 North America 74

5.2.1 US 74

5.2.2 Canada 77

5.3 Top Five European Markets 80

5.3.1 Treatment Usage Patterns 80

5.3.2 Annual Cost of Treatment 81

5.3.3 Market Size 82

5.3.4 Japan 84

6 Drivers and Barriers 87

6.1 Drivers 87

6.1.1 Rising prevalence across all target markets 87

6.1.2 Orphan Indication Incentives 87

6.1.3 Growing Disease Awareness 88

6.1.4 Better Diagnostics 88

6.1.5 All Treatment Segments Have an Unmet Need 88

6.1.6 High Number of Candidates in Late-Stage Drug Development 88

6.2 Barriers 89

6.2.1 Generics Will Restrict Premium Pricing 89

6.2.2 High Failure Rates 89

6.2.3 The High Genetic Heterogeneity of PC 89

6.2.4 Typical Late Stage of Diagnosis 89

7 Strategic Consolidations 91

7.1 Major Co-Development Deals 91

7.1.1 Merck Serono Enters into Co-development Agreement with Threshold Pharma for TH-302 93

7.1.2 GSK Enters into Co-development Agreement with OncoMed Pharmaceuticals for Novel Antibody Therapeutics 94

7.1.3 OncoMed Pharma Enters into Co-development Agreement with Celgene Corporation for Anti-Cancer Stem Cell Therapies 94

7.2 Major Licensing Deals 95

7.2.1 Baxter International Enters into a Licensing Agreement with Onconova Therapeutics for Rigosertib 97

7.2.2 Janssen Biotech Enters into Worldwide Licensing Agreement with Pharmacyclics for PCI-32765 98

7.2.3 AVEO Pharmaceuticals Enters into a License and Development Agreement with Schering-Plough Corporation for AV-299 98

7.2.4 Ardea Biosciences Enters Into a Licensing Agreement with Bayer HealthCare to Develop MEK Inhibitors 99

8 Appendix 100

8.1 All Pipeline Drugs by Phase 100

8.1.1 Discovery 100

8.1.2 Preclinical 103

8.1.3 Phase I 106

8.1.4 Phase II 109

8.1.5 Phase III 113

8.1.6 Pre-Registration 114

8.2 Market Forecasts to 2020 114

8.2.1 Global 114

8.2.2 The US 115

8.2.3 Canada 115

8.2.4 The UK 116

8.2.5 France 116

8.2.6 Germany 116

8.2.7 Italy 117

8.2.8 Spain 117

8.2.9 Japan 117

8.3 References 118

8.4 Abbreviations 132

8.5 Methodology 134

8.6 Coverage 134

8.7 Secondary Research 135

8.8 Therapeutic Landscape 135

8.9 Epidemiology-Based Forecasting 135

8.9.1 Analogous Forecasting Methodology 136

8.10 Market Size by Geography 136

8.10.1 Forecasting Model for Therapeutic Areas 137

8.11 Geographical Landscape 137

8.12 Pipeline Analysis 137

8.13 Competitive Landscape 138

8.14 Contact Us 138

8.15 Disclaimer 138

1.1 List of Tables

Table 1: Pancreatic Cancer Therapeutics, Symptoms and Causes 13

Table 2: Pancreatic Cancer Therapeutics, Inherited Mutation Information 14

Table 3: Pancreatic Cancer Therapeutics, Common Mutations in Pancreatic Cancer 17

Table 4: Pancreatic Cancer Therapeutics, TNM Classification System 18

Table 5: Pancreatic Cancer Therapeutics, Survival by Stage 19

Table 6: Pancreatic Cancer Therapeutics: Common Endpoints in Oncology Clinical Trials and their Description 20

Table 7: Pancreatic Cancer Therapeutics, Key Molecular Targets in the Pipeline 39

Table 8: Pancreatic Cancer Therapeutics, Global, Average Clinical Trial Duration (Months), 2015 46

Table 9: Pancreatic Cancer Therapeutics, Global, Cross Analysis of Clinical Trial Failure Rate, Duration and Size by Molecule Type or Mechanism of Action and Phase, 2006-2015 55

Table 10: Pancreatic Cancer Therapeutics, Efficacy of TH-302 & Gemcitabine Combination Therapy 56

Table 11: Pancreatic Cancer Therapeutics, Efficacy of Ruxolitinib & Capecitabine Combination Therapy 60

Table 12: Pancreatic Cancer Therapeutics, Top Five European Markets, Europe Age-Standardized Incidence Rates of Pancreatic Cancer (per 100,000), 2012 80

Table 13: Pancreatic Cancer Therapeutics, Top Five European Markets, Market Revenue Table (USD m), 2014-2021 83

Table 14: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Discovery, 2015 100

Table 15: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Preclinical 2015 103

Table 16: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Phase I, 2015 106

Table 17: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Phase II, 2015 109

Table 18: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Phase III, 2015 113

Table 19: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration, 2015 114

Table 20: Pancreatic Cancer Market, Global, Market Forecasts, 2014-2021 114

Table 21: Pancreatic Cancer Market, The US, Market Forecasts, 2014-2021 115

Table 22: Pancreatic Cancer Market, Canada, Market Forecasts, 2014-2021 115

Table 23: Pancreatic Cancer Market, The UK, Market Forecasts, 2014-2021 116

Table 24: Pancreatic Cancer Market, France, Market Forecasts, 2014-2021 116

Table 25: Pancreatic Cancer Market, Germany, Market Forecasts, 2014-2021 116

Table 26: Pancreatic Cancer Market, Italy, Market Forecasts, 2014-2021 117

Table 27: Pancreatic Cancer Market, Spain, Market Forecasts, 2014-2021 117

Table 28: Pancreatic Cancer Market, Japan, Market Forecasts, 2014-2021 117

Table 29: Abbreviations 132

1.2 List of Figures

Figure 1: Pancreatic Cancer Therapeutics, Five-Year Survival by Age 19

Figure 2: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Marketed Products, Adjuvant Therapies Post-Disease Resection 33

Figure 3: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Marketed Products, First-Line Treatment Unresectable Disease 34

Figure 4: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Marketed Products, Second-Line Treatment Unresectable Disease 35

Figure 5: Pancreatic Cancer Therapeutics, Global, Pipeline by Stage of Development, Molecule Type and Program Type 38

Figure 6: Pancreatic Cancer Therapeutics, Global, Pipeline by Mechanism of Action, 2015 41

Figure 7: Pancreatic Cancer Therapeutics, Global, Pipeline by Mechanism of Action and Stage of Development, 2015 42

Figure 8: Pancreatic Cancer Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2015 43

Figure 9: Pancreatic Cancer Therapeutics, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015 44

Figure 10: Pancreatic Cancer Therapeutics, Global, Clinical Trial Failure Rate by Mechanism of Action, 2006-2015 45

Figure 11: Pancreatic Cancer Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2015 47

Figure 12: Pancreatic Cancer Therapeutics, Global, Clinical Trial Duration by Phase and Mechanism of Action, 2006-2015 49

Figure 13: Pancreatic Cancer Therapeutics, Global, Clinical Trial Size by Molecule Type, 2006-2015 51

Figure 14: Pancreatic Cancer Therapeutics, Global, Clinical Trial Size by Mechanism of Action, 2006-2015 52

Figure 15: Pancreatic Cancer Therapeutics, Global, Cumulative Clinical Trial Size by Molecule Type, 2006-2015 53

Figure 16: Pancreatic Cancer Therapeutics, Global, Cumulative Clinical Trial Size by Mechanism of Action, 2006-2015 54

Figure 17: Pancreatic Cancer Therapeutics, Global, Estimated Sales of TH-302 (USD m), 2019-2021 57

Figure 18: Pancreatic Cancer Therapeutics, Global, Estimated Sales of Ruxolitinib Phosphate (USD m), 2018-2021 61

Figure 19: Pancreatic Cancer Therapeutics, Global, Estimated Sales of HyperAcute Pancreas (USD m), 2019-2021 63

Figure 20: Pancreatic Cancer Therapeutics, Global, Estimated Sales of G17DT (USD m), 2018-2021 65

Figure 21: Pancreatic Cancer Therapeutics, Global, Estimated Sales of Clivatuzumab Tetraxetan (USD m), 2019-2021 68

Figure 22: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Pipeline and Marketed Products (Light Blue), Adjuvant Therapies Post-Disease Resection 69

Figure 23: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Pipeline and Marketed Products (Light Blue), First-Line Treatment of Unresectable Disease 70

Figure 24: Pancreatic Cancer Therapeutics, Efficacy and Safety Results for Key Parameters-Pipeline and Marketed Products (Light Blue), Second-Line Treatment of Unresectable Disease 71

Figure 25: Pancreatic Cancer Therapeutics, Product Competitiveness Framework in Metastatic Disease 71

Figure 26: Pancreatic Cancer Therapeutics Market, Global, Treatment Usage Patterns ('000 patients) and Market Revenues (USD m), 2014-2021 74

Figure 27: Pancreatic Cancer Therapeutics, US, Treatment Usage Patterns ('000 patients) and Annual Cost of Therapy (USD ), 2014-2021 75

Figure 28: Pancreatic Cancer Therapeutics Market, US, Market Revenues (USD m), 2014-2021 76

Figure 29: Pancreatic Cancer Therapeutics, Canada, Treatment Usage Patterns ('000 patients) and Annual Cost of Therapy (USD ), 2014-2021 78

Figure 30: Pancreatic Cancer Therapeutics Market, Canada, Market Revenues (USD m), 2014-2021 79

Figure 31: Pancreatic Cancer Therapeutics, Top Five European Markets, Treatment Usage Patterns ('000 patients), 2014-2021 81

Figure 32: Pancreatic Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy (USD ), 2014-2021 82

Figure 33: Pancreatic Cancer Therapeutics, Top Five European Markets, Market Size (USD m), 2014-2021 84

Figure 34: Pancreatic Cancer Therapeutics, Japan, Treatment Usage Patterns ('000) and Annual Cost of Therapy (USD ), 2014-2021 85

Figure 35: Pancreatic Cancer Therapeutics, Japan, Market Size (USD m), 2014-2021 86

Figure 36: Pancreatic Cancer Therapeutics, Global, Co-Development Deals by Region, Value (USD m), Year and by Phase, 2006-2014 92

Figure 37: Pancreatic Cancer Therapeutics, Global, Co-Development Deals by Molecule Type and Mechanism of Action 2006-2014 93

Figure 38: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Region, Value (USD m), Year and by Phase, 2006-2014 96

Figure 39: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Molecule Type and Mechanism of Action, 2006-2014 97

Figure 40: GBI Research Market Forecasting Model 137

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