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

Press Release   •   Jan 02, 2016 15:09 IST

Pancreatic Cancer Therapeutics in Major Developed Markets to 2021 - Strong Late Stage Pipeline Holds Promise for Increasingly Diverse Market Landscape Summary 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 $1.746bn in 2014 to $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 $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.

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Table of Contents

.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

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