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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

Published By :

GBI Research

Published Date : Jun 2014

Category :

Therapeutic Area

No. of Pages : 112 Pages

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
Table of Content

1 Table of Contents 1
1.1 List of Tables 3
1.2 List of Figures 4

2 Executive Summary 5
2.1 Significant Market Growth Driven by Personalized Vaccine DCVax-L 5
2.2 Challenging Clinical Trial Landscape Poses Barrier to Market Entrants 5
2.3 Significant Presence of Targeted Therapies from Phase II to Phase III of the Pipeline 5

3 Introduction 5
3.1 Disease Introduction 6
3.2 Classification of Brain Tumors 6
3.3 Tumor Grading 9
3.4 Subtypes of Glioblastoma Multiforme 10
3.5 Etiology 10
3.6 Pathophysiology 11
3.6.1 Loss of Heterozygosity of Chromosome 10 12
3.6.2 Epidermal Growth Factor Receptor Amplification 12
3.6.3 Phosphatase and Tensin Homolog Mutation 12
3.6.4 Loss of p53 Function 13
3.6.5 p16INK4a Alteration and Loss of Normal Retinoblastoma 1 Function 13
3.6.6 Isocitrate Dehydrogenase 1 or Isocitrate Dehydrogenase 2 Mutation 13
3.7 Symptoms 14
3.8 Diagnosis 15
3.9 Prognosis 16
3.10 Epidemiology 17
3.11 Treatment options 18
3.11.1 Surgery 18
3.11.2 Radiotherapy 18
3.11.3 Chemotherapy 19
3.11.4 Targeted Therapy 20
3.11.5 Drugs for symptoms relief 20
3.11.6 Other alternative therapies 20
3.12 Treatment algorithm 21
3.13 GBI Research Report Guidance 24

4 Marketed drugs 24
4.1 Temodar (temozolomide) – Merck 24
4.2 Avastin (bevacizumab) – Roche 26
4.3 BiCNU (carmustine) and Gliadel Wafer (carmustine in polifeprosan) 29
4.3.1 BiCNU (carmustine) – Bristol-Myers Squibb 29
4.3.2 Gliadel Wafer (carmustine in polifeprosan) – Eisai 31
4.4 Unlicensed/Off-label Use in Glioblastoma Multiforme 33
4.4.1 Lomustine 33
4.4.2 Carboplatin 33
4.4.3 Cyclophosphamide 33
4.4.4 Etoposide 34
4.4.5 Irinotecan 34
4.5 Comparative Efficacy and Safety 34
4.6 Unmet needs 36

5 Glioblastoma Pipeline 38
5.1 Overall Pipeline 38
5.2 Molecular Targets 40
5.3 Clinical Trials 42
5.3.1 Clinical Trial Size 42
5.3.2 Clinical Trial Duration 44
5.3.3 Failure Rate of Developmental Pipeline 46
5.3.4 Summary of Clinical Trial and Risk Analysis 48
5.4 Promising Pipeline Candidates 48
5.4.1 DCVax-L – Northwest Biotherapeutics 48
5.4.2 Rindopepimut (CDX-110) – Celldex Therapeutics 50
5.4.3 Avastin (bevacizumab)- Roche 51
5.4.4 ICT-107 – ImmunoCellular Therapeutics 53
5.4.5 Cotara- Peregrine Pharmaceuticals 54
5.4.6 Eir-060- EirGen Pharma 55
5.4.7 Heat Map of Safety and Efficacy and Competitor Matrix for Glioblastoma Multiforme Pipeline 55

6 Market forecasts 58
6.1 Geographical Markets 58
6.1.1 Global Market 60
6.1.2 North America 61
6.1.3 Top Five Countries of Europe 66
6.1.4 Japan 70
6.2 Drivers and Barriers 73
6.2.1 Drivers 73
6.2.2 Barriers 74

7 Deals and Strategic Consolidations 75
7.1 Major Co-Development Deals 76
7.1.1 Del Mar Pharmaceuticals Enters into Agreement with Guangxi Wuzhou Pharmaceutical 76
7.1.2 Immatics Biotechnologies Enters into Agreement with Cancer Research UK 76
7.2 Major Licensing Deals 76
7.2.1 ImmunoCellular Therapeutics Enters into Agreement with University of Pennsylvania 76
7.2.2 Bexion Pharmaceuticals Enters into Agreement with Cincinnati Children’s Hospital Medical Center 76
7.2.3 Celldex Therapeutics Enters into Agreement with Duke University Brain Tumor Cancer Center 76

8 Appendix 77
8.1 Sources 77
8.2 Market Definition 86
8.3 Abbreviations 86
8.4 All Pipeline Products, by Phase 89
8.4.1 Discovery 89
8.4.2 Preclinical 91
8.4.3 Phase I 95
8.4.4 Phase II 97
8.4.5 Phase III and Pre-registration 101
8.4.6 Undisclosed stage of development 101
8.5 Tabular Forecast Data 101
8.5.1 Global 101
8.5.2 US 102
8.5.3 Canada 102
8.5.4 UK 103
8.5.5 France 103
8.5.6 Germany 104
8.5.7 Italy 104
8.5.8 Spain 105
8.5.9 Japan 105
8.6 Research Methodology 106
8.7 Coverage 106
8.7.1 Secondary Research 106
8.8 Therapeutic Landscape 106
8.8.1 Forecasting 107
8.9 Geographical Landscape 108
8.10 Pipeline Analysis 108
8.11 Competitive Landscape 108
8.11.1 Expert Panel Validation 108
8.12 Contact Us 108
8.13 Disclaimer 108

List of Table

Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons 7
Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma 9
Table 3: Glioblastoma Multiforme, Glioblastoma Multiforme, Karnofsky Performance Status Score (%) 17
Table 4: Glioblastoma Multiforme, Top Five Countries of Europe, Changes in Demographics, 1999–2013 67
Table 5: Discovery 89
Table 6: Preclinical and IND/CTA-filed 91
Table 7: Phase I 95
Table 8: Phase II 97
Table 9: Phase III and pre-registration 101
Table 10: Undisclosed stage of development 101
Table 11: Glioblastoma Multiforme, Global, Market Forecast, 2012-2019 101
Table 12: Glioblastoma Multiforme, US, Market Forecast, 2012-2019 102
Table 13: Glioblastoma Multiforme, Canada, Market Forecast, 2012-2019 102
Table 14: Glioblastoma Multiforme, UK, Market Forecast, 2012-2019 103
Table 15: Glioblastoma Multiforme, France, Market Forecast, 2012-2019 103
Table 16: Glioblastoma Multiforme, Germany, Market Forecast, 2012-2019 104
Table 17: Glioblastoma Multiforme, Italy, Market Forecast, 2012-2019 104
Table 18: Glioblastoma Multiforme, Spain, Market Forecast, 2012-2019 105
Table 19: Glioblastoma Multiforme, Japan, Market Forecast, 2012-2019 105

List of Chart

Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations 11
Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme 22
Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme 23
Figure 4: Glioblastoma Multiforme, Global, Historical Sales of Temodar ($m), 2008–2013 25
Figure 5: Glioblastoma Multiforme, Global, Historical Sales of Avastin ($bn), 2004–2013 28
Figure 6: Glioblastoma Multiforme, Global, Historical Sales of Gliadel Wafer ($m), 2003–2006 31
Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013 35
Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013 39
Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013 42
Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type (participants), 2006–2013 44
Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006–2013 46
Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type, and Reasons for Failure, 2006–2013 47
Figure 13: Glioblastoma Multiforme, Global, Sales Forecast for DCVax-L ($m), 2014–2019 50
Figure 14: Glioblastoma Multiforme, Global, Sales Forecast for Rindopepimut ($m), 2017–2019 51
Figure 15: Glioblastoma Multiforme, Global, Sales Forecast for Cotara ($m), 2016–2019 55
Figure 16: Glioblastoma Multiforme, Global, Heat Map for Pipeline Products, 2013 56
Figure 17: Glioblastoma Multiforme, Global, Competitor Matrix, 2013 57
Figure 18: Glioblastoma Multiforme, Global, Treatment Usage Patterns and Market Size, 2012–2019 61
Figure 19: Glioblastoma Multiforme, North America, Treatment Usage Patterns (\'000), 2012–2019 62
Figure 20: Glioblastoma Multiforme, North America, Annual Cost of Treatment ($), 2012–2019 64
Figure 21: Glioblastoma Multiforme, North America, Market Size ($m), 2012–2019 65
Figure 22: Glioblastoma Multiforme, Top Five Countries of Europe, Treatment Usage Patterns (\'000), 2012–2019 66
Figure 23: Glioblastoma Multiforme, Top Five Countries of Europe, Annual Cost of Treatment ($), 2012–2019 68
Figure 24: Glioblastoma Multiforme, Top Five Countries of Europe, Market Size ($m), 2012–2019 70
Figure 25: Glioblastoma Multiforme, Japan, Treatment Usage Patterns and Annual Cost of Treatment, 2012–2019 71
Figure 26: Glioblastoma Multiforme, Japan, Market Size ($m), 2012–2019 73

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