Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020

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Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020

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Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany

The Glioblastoma Multiforme (GBM) treatment market is forecast to grow rapidly from $301 million in 2013 to $623 million by 2020, at a Compound Annual Growth Rate (CAGR) of 10.9%. Such significant growth comes despite the patent expiration of Temodar (temozolomide) and will be driven primarily by the market entry of the DCVax-L vaccine. This follows clinical trials showing that DCVax-L produces an Overall Survival (OS) of around 2.3 times longer than the current standard of care for newly diagnosed patients. Report Information

Angel Wong, Analyst for GBI Research, says: "The current standard treatment of surgery, radiotherapy and chemotherapy, in combination with Temodar, has an OS of less than 15 months. As DCVax-L has been shown to extend OS substantially, the vaccine will demand a premium price once it hits the market."

GBI Research expects DCVax-L, which has recently received early approval in Germany, to be approved in the US and EU in 2015 and 2016, respectively, ahead of less efficacious treatments Cotara and Rindopepimut (CDX-110), which will enter the global GBM treatment market in 2016 and 2017, respectively. DCVax-L has the added advantage of facing few other active competitors in the current high-risk GBM therapeutics market.

"Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany" assesses the current GBM therapeutics market and forecasts market trends to 2020. It analyzes key drivers and barriers, and includes an in-depth analysis of the drugs available for the treatment of GBM, a comprehensive review of the developmental pipelines and additional in-depth analysis of GBM clinical trials by Phase, molecule type, trial size, trial duration and program failure rate.

Scope

- The report assesses the current GBM market and forecasts market trends to 2020, analyzing key drivers and barriers

- 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 2020, 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

Reasons to Buy

- The report will assist business development and enable marketing executives who wish to strategize their product launches

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


List of Figures

Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations
Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme
Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme
Figure 4: Glioblastoma Multiforme, Global, Historical Sales of Temodar ($m), 2008–2013
Figure 5: Glioblastoma Multiforme, Global, Historical Sales of Avastin ($bn), 2004–2013
Figure 6: Glioblastoma Multiforme, Global, Historical Sales of Gliadel Wafer ($m), 2003–2006
Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013
Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013
Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013
Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type (participants), 2006–2013
Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006–2013
Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type, and Reasons for Failure, 2006–2013
Figure 13: Glioblastoma Multiforme, Global, Sales Forecast for DCVax-L ($m), 2014–2020
Figure 14: Glioblastoma Multiforme, Global, Sales Forecast for Rindopepimut ($m), 2017–2020
Figure 15: Glioblastoma Multiforme, Global, Sales Forecast for Cotara ($m), 2016–2019
Figure 16: Glioblastoma Multiforme, Global, Heat Map for Pipeline Products, 2013
Figure 17: Glioblastoma Multiforme, Global, Product Competitiveness Framework, 2013
Figure 18: Glioblastoma Multiforme, Global, Treatment Usage Patterns and Market Size, 2013-2020
Figure 19: Glioblastoma Multiforme, North America, Treatment Usage Patterns ('000), 2013-2020
Figure 20: Glioblastoma Multiforme, North America, Annual Cost of Treatment ($),2013-2020
Figure 21: Glioblastoma Multiforme, North America, Market Size ($m), 2013-2020
Figure 22: Glioblastoma Multiforme, Top Five Countries of Europe, Treatment Usage Patterns ('000), 2013-2020
Figure 23: Glioblastoma Multiforme, Top Five Countries of Europe, Annual Cost of Treatment ($),2013-2020
Figure 24: Glioblastoma Multiforme, Top Five Countries of Europe, Market Size ($m), 2013-2020
Figure 25: Glioblastoma Multiforme, Japan, Treatment Usage Patterns and Annual Cost of Treatment, 2013-2020
Figure 26: Glioblastoma Multiforme, Japan, Market Size ($m), 2013-2020


List of Tables

Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons
Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma
Table 3: Glioblastoma Multiforme, Glioblastoma Multiforme, Karnofsky Performance Status Score (%)
Table 4: Glioblastoma Multiforme, Top Five Countries of Europe, Changes in Demographics, 1999–2013
Table 5: Discovery
Table 6: Preclinical and IND/CTA-filed
Table 7: Phase I
Table 8: Phase II
Table 9: Phase III and pre-registration
Table 10: Undisclosed stage of development
Table 11: Glioblastoma Multiforme, Global, Market Forecast, 2013-2020
Table 12: Glioblastoma Multiforme, US, Market Forecast, 2013-2020
Table 13: Glioblastoma Multiforme, Canada, Market Forecast, 2013-2020
Table 14: Glioblastoma Multiforme, UK, Market Forecast, 2013-2020
Table 15: Glioblastoma Multiforme, France, Market Forecast, 2013-2020
Table 16: Glioblastoma Multiforme, Germany, Market Forecast, 2013-2020
Table 17: Glioblastoma Multiforme, Italy, Market Forecast, 2013-2020
Table 18: Glioblastoma Multiforme, Spain, Market Forecast, 2013-2020
Table 19: Glioblastoma Multiforme, Japan, Market Forecast, 2013-2020


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Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020

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