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Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2019 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany
Publication Date Jun 2014
Publisher GBI Research
Product Type Report
Pages 112
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Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2019 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany

Summary

GBI Research, a leading business intelligence provider, has released its latest research report, “Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2019 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany�.Due to the poor prognosis under currently available treatments, therapies with high potency are in strong demand in the Glioblastoma Multiforme (GBM) market. In newly diagnosed patients, the current standard of care, comprising resection surgery, radiation therapy and chemotherapy with Merck’s Temodar (temozolomide), has a maximum Overall Survival (OS) of 15 months and almost inevitable tumor recurrence. Current therapeutic options for recurrent GBM are Roche’s Avastin (bevacizumab), carmustine and other chemotherapy drugs used off-label. However, they only offer limited OS benefit, leaving high unmet need in this patient segment.

During the 2012-2019 forecast period, the GBM market is expected to grow rapidly from $305m to $583m. The market entry of Northwest Biotherapeutics’ DCVax-L, a dendritic cell-based therapeutic vaccine that acts as an add-on to the standard treatment in newly diagnosed patients, will account for much of this growth. Having demonstrated superior OS improvement compared with the standard treatment alone in clinical trials, it is expected to bear high market potential, given that its efficacy is translated into larger Phase III trials. The cancer vaccine Rindopepimut (CDX-110) and targeted therapy Cotara will also enter the GBM market, but will drive growth to a lesser extent. However, unmet needs are likely to remain in the relapsed setting over the forecast period due to the lack of superior OS benefits in the late-stage pipeline.

Scope

A brief introduction to GBM, including the disease pathogenesis, risk factors and diagnosis
- In-depth analysis of the drugs available for the treatment of GBM, including safety, efficacy, treatment patterns, and strengths and weaknesses, as well as a heat map comparing drugs in terms of safety and efficacy
- A comprehensive review of the developmental pipeline for GBM, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period, with the pipeline analyzed by Phase distribution, molecule type and molecular target
- Additional in-depth analysis of GBM clinical trials by Phase, molecule type, trial size, trial duration and program failure rate
- Multi-scenario forecast data for the GBM market to 2019, taking into account the introduction of new drugs, the expiry of key patents and the changes in disease epidemiology across the key developed markets of the US, Canada, Japan, Germany, the UK, France, Italy and Spain
- Discussion of the drivers of and barriers to market growth
- Discussion of the licensing and co-development deals landscape in GBM

Reasons to buy

- Understand the different levels of GBM therapies for newly diagnosed and recurrent GBM
- Understand the vast scope of the pipeline and determine which molecule types and mechanisms of action are prominent
- Observe the trends in clinical trial duration and size by clinical Phase and molecule type, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for GBM therapeutics
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the GBM therapeutics market

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 Disease Introduction 8
2.2 Classification of Brain Tumors 9
2.3 Tumor Grading 11
2.4 Subtypes of Glioblastoma Multiforme 12
2.5 Etiology 12
2.6 Pathophysiology 13
2.6.1 Loss of Heterozygosity of Chromosome 10 14
2.6.2 Epidermal Growth Factor Receptor Amplification 14
2.6.3 Phosphatase and Tensin Homolog Mutation 14
2.6.4 Loss of p53 Function 15
2.6.5 p16INK4a Alteration and Loss of Normal Retinoblastoma 1 Function 15
2.6.6 Isocitrate Dehydrogenase 1 or Isocitrate Dehydrogenase 2 Mutation 15
2.7 Symptoms 16
2.8 Diagnosis 17
2.9 Prognosis 18
2.10 Epidemiology 19
2.11 Treatment options 20
2.11.1 Surgery 20
2.11.2 Radiotherapy 20
2.11.3 Chemotherapy 21
2.11.4 Targeted Therapy 22
2.11.5 Drugs for symptoms relief 22
2.11.6 Other alternative therapies 22
2.12 Treatment algorithm 23
3 Marketed drugs 26
3.1 Temodar (temozolomide) - Merck 26
3.2 Avastin (bevacizumab) - Roche 28
3.3 BiCNU (carmustine) and Gliadel Wafer (carmustine in polifeprosan) 30
3.3.1 BiCNU (carmustine) - Bristol-Myers Squibb 31
3.3.2 Gliadel Wafer (carmustine in polifeprosan) - Eisai 32
3.4 Unlicensed/Off-label Use in Glioblastoma Multiforme 34
3.4.1 Lomustine 34
3.4.2 Carboplatin 34
3.4.3 Cyclophosphamide 34
3.4.4 Etoposide 35
3.4.5 Irinotecan 35
3.5 Comparative Efficacy and Safety 35
3.6 Unmet needs 38
4 Glioblastoma Pipeline 40
4.1 Overall Pipeline 40
4.2 Molecular Targets 42
4.3 Clinical Trials 44
4.3.1 Clinical Trial Size 44
4.3.2 Clinical Trial Duration 46
4.3.3 Failure Rate of Developmental Pipeline 48
4.3.4 Summary of Clinical Trial and Risk Analysis 50
4.4 Promising Pipeline Candidates 50
4.4.1 DCVax-L - Northwest Biotherapeutics 50
4.4.2 Rindopepimut (CDX-110) - Celldex Therapeutics 52
4.4.3 Avastin (bevacizumab)- Roche 53
4.4.4 ICT-107 - ImmunoCellular Therapeutics 55
4.4.5 Cotara- Peregrine Pharmaceuticals 56
4.4.6 Eir-060- EirGen Pharma 57
4.4.7 Heat Map of Safety and Efficacy and Competitor Matrix for Glioblastoma Multiforme Pipeline 57
5 Market forecasts 62
5.1 Geographical Markets 62
5.1.1 Global Market 63
5.1.2 North America 64
5.1.3 Top Five Countries of Europe 69
5.1.4 Japan 73
5.2 Drivers and Barriers 76
5.2.1 Drivers 76
5.2.2 Barriers 77
6 Deals and Strategic Consolidations 79
6.1 Major Co-Development Deals 79
6.1.1 Del Mar Pharmaceuticals Enters into Agreement with Guangxi Wuzhou Pharmaceutical 79
6.1.2 Immatics Biotechnologies Enters into Agreement with Cancer Research UK 79
6.2 Major Licensing Deals 79
6.2.1 ImmunoCellular Therapeutics Enters into Agreement with University of Pennsylvania 79
6.2.2 Bexion Pharmaceuticals Enters into Agreement with Cincinnati Children’s Hospital Medical Center 80
6.2.3 Celldex Therapeutics Enters into Agreement with Duke University Brain Tumor Cancer Center 80
7 Appendix 81
7.1 Sources 81
7.2 Market Definition 90
7.3 Abbreviations 90
7.4 All Pipeline Products, by Phase 93
7.4.1 Discovery 93
7.4.2 Preclinical 95
7.4.3 Phase I 99
7.4.4 Phase II 101
7.4.5 Phase III and Pre-registration 105
7.4.6 Undisclosed stage of development 105
7.5 Tabular Forecast Data 105
7.5.1 Global 105
7.5.2 US 106
7.5.3 Canada 106
7.5.4 UK 107
7.5.5 France 107
7.5.6 Germany 108
7.5.7 Italy 108
7.5.8 Spain 109
7.5.9 Japan 109
7.6 Research Methodology 110
7.7 Coverage 110
7.7.1 Secondary Research 110
7.8 Therapeutic Landscape 110
7.8.1 Forecasting 111
7.9 Geographical Landscape 112
7.10 Pipeline Analysis 112
7.11 Competitive Landscape 112
7.11.1 Expert Panel Validation 112
7.12 Contact Us 112
7.13 Disclaimer 112

List of Tables
1.1 List of Tables
Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons 10
Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma 12
Table 3: Glioblastoma Multiforme, Glioblastoma Multiforme, Karnofsky Performance Status Score (%) 19
Table 4: Glioblastoma Multiforme, Top Five Countries of Europe, Changes in Demographics, 1999-2013 70
Table 5: Discovery 93
Table 6: Preclinical and IND/CTA-filed 95
Table 7: Phase I 99
Table 8: Phase II 101
Table 9: Phase III and pre-registration 105
Table 10: Undisclosed stage of development 105
Table 11: Glioblastoma Multiforme, Global, Market Forecast, 2012-2019 105
Table 12: Glioblastoma Multiforme, US, Market Forecast, 2012-2019 106
Table 13: Glioblastoma Multiforme, Canada, Market Forecast, 2012-2019 106
Table 14: Glioblastoma Multiforme, UK, Market Forecast, 2012-2019 107
Table 15: Glioblastoma Multiforme, France, Market Forecast, 2012-2019 107
Table 16: Glioblastoma Multiforme, Germany, Market Forecast, 2012-2019 108
Table 17: Glioblastoma Multiforme, Italy, Market Forecast, 2012-2019 108
Table 18: Glioblastoma Multiforme, Spain, Market Forecast, 2012-2019 109
Table 19: Glioblastoma Multiforme, Japan, Market Forecast, 2012-2019 109

List of Figures
1.2 List of Figures
Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations 13
Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme 24
Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme 25
Figure 4: Glioblastoma Multiforme, Global, Historical Sales of Temodar ($m), 2008-2013 27
Figure 5: Glioblastoma Multiforme, Global, Historical Sales of Avastin ($bn), 2004-2013 29
Figure 6: Glioblastoma Multiforme, Global, Historical Sales of Gliadel Wafer ($m), 2003-2006 32
Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013 36
Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013 41
Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013 44
Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type (participants), 2006-2013 46
Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006-2013 48
Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type, and Reasons for Failure, 2006-2013 49
Figure 13: Glioblastoma Multiforme, Global, Sales Forecast for DCVax-L ($m), 2014-2019 52
Figure 14: Glioblastoma Multiforme, Global, Sales Forecast for Rindopepimut ($m), 2017-2019 53
Figure 15: Glioblastoma Multiforme, Global, Sales Forecast for Cotara ($m), 2016-2019 57
Figure 16: Glioblastoma Multiforme, Global, Heat Map for Pipeline Products, 2013 59
Figure 17: Glioblastoma Multiforme, Global, Competitor Matrix, 2013 60
Figure 18: Glioblastoma Multiforme, Global, Treatment Usage Patterns and Market Size, 2012-2019 64
Figure 19: Glioblastoma Multiforme, North America, Treatment Usage Patterns ('000), 2012-2019 65
Figure 20: Glioblastoma Multiforme, North America, Annual Cost of Treatment ($), 2012-2019 67
Figure 21: Glioblastoma Multiforme, North America, Market Size ($m), 2012-2019 68
Figure 22: Glioblastoma Multiforme, Top Five Countries of Europe, Treatment Usage Patterns ('000), 2012-2019 69
Figure 23: Glioblastoma Multiforme, Top Five Countries of Europe, Annual Cost of Treatment ($), 2012-2019 71
Figure 24: Glioblastoma Multiforme, Top Five Countries of Europe, Market Size ($m), 2012-2019 73
Figure 25: Glioblastoma Multiforme, Japan, Treatment Usage Patterns and Annual Cost of Treatment, 2012-2019 74
Figure 26: Glioblastoma Multiforme, Japan, Market Size ($m), 2012-2019 76

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