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Opportunity Analyzer: Glioblastoma - Opportunity Analysis and Forecasts to 2024

Summary

Glioblastoma multiforme (GBM) is characterized as a disease with some of the highest unmet needs in oncology, with patients having a median overall survival (OS) of between one and two years. The lack of therapies is primarily due to the inability of drugs to penetrate the blood-brain barrier (BBB). The GBM market is currently dominated by temozolomide and Avastin which are considered as standards of care in newly diagnosed and recurrent settings, respectively. Between 2014 and 2024, the market is set to undergo substantial growth due to a number companies developing therapies in the late-stage pipeline, which is dominated by immunotherapies. On one hand, the main drivers of growth will be the launch of EGFR-targeting therapies such as Rintega and ABT-414, as well as the checkpoint inhibitor Opdivo. Furthermore, the launch of autologous cell vaccines such as ICT-107 and DCVax-L will also impact the GBM market. On the other hand, the GBM market constrainers remain modest with the increasing cost-consciousness of healthcare providers, and the launch of biosimilar bevacizumab in the 7MM (US, France, Germany, Italy, Spain, UK and Japan).

Highlights

Key Questions Answered

- The GBM market is marked by the presence of a number of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of GBM market?
- The late-stage GBM pipeline has therapies targeting different GBM populations. Which late-stage drugs will have the biggest impact in each patient population? Which of these drugs will have the highest peak sales at the highest CAGR, and why?
- Current therapies used to treat GBM include temozolomide, Gliadel and Avastin. How will the advent of new therapies change the drug treatment landscape for GBM? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Key Findings

- The main driver of the enormous expansion of the GBM market will be the launch of Opdivo for newly diagnosed and recurrent GBM. GlobalData forecasts significant patient uptake for Opdivo which will supersede Avastin to become the SoC in the recurrent setting.
- The second largest driver will be the launch of Rintega for EGFRvIII positive GBM. Rintega uptake would be partially facilitated by the availability of EGFRvIII companion diagnostics, which help to identify patients most likely to respond to the treatment.
- The approval of Rintega and Opdivo will partially fulfil key unmet needs in the GBM space: however, many of these unmet needs will still remain even after these agents are launched.
- Another driver of the GBM market is the increasing incidence of GBM cases within the 7MM. The biggest constrainer of the GBM market is the launch of biosimilar bevacizumab in the 7MM.

Scope

- Overview of GBM, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized GBM therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the GBM therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global GBM therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global GBM therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global GBM therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global GBM therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

Opportunity Analyzer: Glioblastoma - Opportunity Analysis and Forecasts to 2024
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
2.3 Upcoming Related Reports 19
3 Disease Overview 20
3.1 Etiology and Pathophysiology 20
3.1.1 Etiology 20
3.1.2 Pathophysiology 20
3.2 Symptoms 23
4 Epidemiology 24
4.1 Disease Background 24
4.2 Risk Factors and Comorbidities 25
4.3 Global Trends 26
4.3.1 7MM Incidence Trends 26
4.3.2 7MM Trends in Relative Survival 28
4.4 Forecast Methodology 29
4.4.1 Sources Used 29
4.4.2 Sources Not Used 33
4.4.3 Forecast Assumptions and Methods 34
4.5 Epidemiological Forecast for Brain Cancer (2014-2024) 36
4.5.1 Diagnosed Incident Cases of Brain Cancer 36
4.5.2 Age-Specific Diagnosed Incidence of Brain Cancer 38
4.5.3 Sex-Specific Diagnosed Incident Cases of Brain Cancer 40
4.5.4 Age-Standardized Diagnosed Incidence of Brain Cancer 42
4.5.5 Five-Year Diagnosed Prevalent Cases of Brain Cancer 44
4.5.6 Diagnosed Incident Cases of Brain Cancer by Type 45
4.6 Discussion 46
4.6.1 Epidemiological Forecast Insight 46
4.6.2 Limitations of the Analysis 47
4.6.3 Strengths of the Analysis 48
5 Current Treatment Options 49
5.1 Overview 49
5.2 Product Profiles- Major Brands 50
5.2.1 Avastin (bevacizumab) 50
5.2.2 Temozolomide 57
5.2.3 Gliadel (carmustine wafer) 59
5.2.4 Optune (NovoTTF-100A) 61
6 Unmet Needs Assessment and Opportunity Analysis 64
6.1 Overview 64
6.2 Identification of New Treatment Options for Patients with rGBM Refractory to Avastin 65
6.2.1 Unmet Need 65
6.2.2 Gap Analysis 66
6.2.3 Opportunity 66
6.3 More Efficacious Treatment for Patients with MGMT-Unmethylated Promoters 67
6.3.1 Unmet Need 67
6.3.2 Gap Analysis 67
6.3.3 Opportunity 68
6.4 Criteria to Evaluate Tumor Response 68
6.4.1 Unmet Need 68
6.4.2 Gap Analysis 69
6.4.3 Opportunity 69
6.5 Reduce Use of Steroids in GBM Patients 70
6.5.1 Unmet Need 70
6.5.2 Gap Analysis 70
6.5.3 Opportunity 71
6.6 Identification of Biomarkers Predictive of Therapeutic Efficacy 71
6.6.1 Unmet Need 71
6.6.2 Gap Analysis 71
6.6.3 Opportunity 72
7 RandD Strategies 73
7.1 Overview 73
7.1.1 Assessment of Immunotherapy Efficacy in GBM 73
7.1.2 Increased Use of Biomarkers to Better Predict Treatment Efficacy 75
7.1.3 Moving Towards Less Cumbersome Cancer Vaccines to Facilitate Approval 76
7.1.4 Local Administration of Therapeutics During Surgery 77
7.2 Clinical Trial Design 78
7.2.1 Clinical Endpoints 78
7.2.2 Comparator Arms 81
7.2.3 Combinatory Approach 82
8 Pipeline Assessment 84
8.1 Overview 84
8.2 Promising Drugs in Clinical Development 84
8.2.1 Rintega (rindopepimut) 86
8.2.2 Opdivo (nivolumab) 93
8.2.3 ABT-414 100
8.2.4 ICT-107 106
8.2.5 VB-111 113
8.2.6 DCVax-L 118
8.2.7 Toca 511 and Toca FC 123
8.2.8 Veliparib 128
8.2.9 ITK-1 132
8.2.10 Prophage G-100 and G-200 135
8.2.11 TVI-Brain-1 140
8.2.12 Cotara (Iodine I 131 Derlotuximab Biotin) 142
8.3 Innovative Early-stage Approaches 144
8.3.1 Checkpoint Inhibitors 148
8.3.2 Vaccines 149
8.3.3 Small Molecules 150
9 Pipeline Valuation Analysis 152
9.1 Clinical Benchmark of Key Pipeline Drugs 152
9.2 Commercial Benchmark of Key Pipeline Drugs 156
9.3 Competitive Assessment 159
9.4 Top Line 10-Year Forecast 161
9.4.1 US 166
9.4.2 5EU 167
9.4.3 Japan 168
10 Appendix 169
10.1 Bibliography 169
10.2 Abbreviations 188
10.3 Methodology 192
10.4 Forecasting Methodology 192
10.4.1 Diagnosed GBM Patients 192
10.4.2 Percent Drug-treated Patients 193
10.4.3 Drugs Included in Each Therapeutic Class 193
10.4.4 Launch and Patent Expiry Dates 193
10.4.5 General Pricing Assumptions 194
10.4.6 General Forecast Assumptions 195
10.4.7 Individual Drug Assumptions 196
10.4.8 Generic and Biosimilar Erosion 197
10.4.9 Pricing of Pipeline Agents 197
10.5 Physicians and Specialists Included in this Study 200
10.5.1 High-Prescribing Physician Survey 201
10.6 About the Authors 202
10.6.1 Author 202
10.6.2 Epidemiologist 202
10.6.3 Therapy Director 203
10.6.4 Global Director of Therapy Analysis and Epidemiology 203
10.6.5 Global Head of Healthcare 204
10.7 About GlobalData 205
10.8 Disclaimer 205

1.1 List of Tables
Table 1: Symptoms of Glioblastoma 23
Table 2: Description of Brain Cancer Types 25
Table 3: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of Brain Cancer 30
Table 4: 7MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of Brain Cancer 31
Table 5: 7MM, Diagnosed Incident Cases of Brain Cancer, All Ages, Both Sexes, N, 2014-2024 37
Table 6: 7MM, Age-Specific Diagnosed Incident Cases of Brain Cancer, Both Sexes, N (Row %), 2014 39
Table 7: 7MM, Sex-Specific Diagnosed Incident Cases of Brain Cancer, All Ages, N (Row %), 2014 41
Table 8: 7MM, Five-Year Diagnosed Prevalent Cases of Brain Cancer, All Ages, Both Sexes, N, 2014?2024 44
Table 9: Leading Treatments for Glioblastoma 50
Table 10: Product Profile - Avastin 51
Table 11: Efficacy of Avastin in Phase II Trials 53
Table 12: Efficacy of Avastin Compared to Nitrosureas 54
Table 13: Efficacy of Avastin in Newly Diagnosed GBM 55
Table 14 Avastin SWOT Analysis 57
Table 15: Product Profile - Temozolomide 58
Table 16: Efficacy of Temozolomide in Newly Diagnosed GBM 59
Table 17: Product Profile - Gliadel 60
Table 18: Efficacy of Gliadel in Newly Diagnosed Malignant Glioma Patients 61
Table 19 Overall Unmet Needs - Current Level of Attainment 65
Table 20: Design of Current Phase III Trials in GBM 80
Table 21: Glioblastoma - Late Stage Pipeline, 2015 85
Table 22: Product Profile - Rintega 87
Table 23: Efficacy of Rintega in rGBM 90
Table 24: Rintega SWOT Analysis 92
Table 25: Global Sales Forecast ($m) for Rintega, 2014-2024 93
Table 26: Product Profile - Opdivo 94
Table 27: Preliminary Efficacy of Opdivo Monotherapy and Opdivo + Yervoy Combination Therapy 97
Table 28: Opdivo SWOT Analysis 99
Table 29: Global Sales Forecast ($m) for Opdivo, 2014-2024 100
Table 30: Product Profile - ABT-414 101
Table 31: Preliminary Efficacy of ABT-414 + Temozolomide Rechallenge and ABT-414 Monotherapy 103
Table 32: Safety of ABT-414 104
Table 33: ABT-414 SWOT Analysis 105
Table 34: Global Sales Forecast ($m) for ABT-414, 2014-2024 106
Table 35: Product Profile - ICT-107 107
Table 36: Efficacy of ICT-107 in Phase II Study, Months (N) 110
Table 37: Safety of ICT-107 111
Table 38: ICT-107 SWOT Analysis 112
Table 39: Global Sales Forecast ($m) for ICT-107, 2014-2024 113
Table 40: Product Profile - VB-111 114
Table 41: Efficacy of VB-111 116
Table 42: VB-111 SWOT Analysis 117
Table 43: Global Sales Forecast ($m) for VB-111, 2014-2024 118
Table 44: Product Profile - DCVax-L 119
Table 45: DCVax-L SWOT Analysis 122
Table 46: Global Sales Forecast ($m) for DCVax-L, 2014-2024 123
Table 47: Product Profile - Toca 511 and Toca FC 124
Table 48 Toca 511 and Toca FC SWOT Analysis 127
Table 49: Global Sales Forecast ($m) for Toca 511, 2014-2024 128
Table 50: Global Sales Forecast ($m) for Toca FC, 2014-2024 128
Table 51: Product Profile - Veliparib 129
Table 52 Veliparib SWOT Analysis 131
Table 53: Global Sales Forecast ($m) for Veliparib, 2014-2024 131
Table 54: Product Profile - ITK-1 132
Table 55: Efficacy of ITK-1 in a Phase I trial 134
Table 56: ITK-1 SWOT Analysis 134
Table 57: Global Sales Forecast ($m) for ITK-1, 2014-2024 135
Table 58: Product Profile - Prophage 136
Table 59: Preliminary Efficacy of Prophage G-100 + Temozolomide Combination Therapy 138
Table 60: Prophage G-100 and G-200 SWOT Analysis 139
Table 61: Product Profile - TVI-Brain-1 140
Table 62: TVI-Brain-1 SWOT Analysis 142
Table 63: Product Profile - Cotara 143
Table 64: Cotara SWOT Analysis 144
Table 65: Key Early-Stage Pipeline Products in GBM 145
Table 66 Clinical Benchmark of Key Marketed and Pipeline Drugs - Newly Diagnosed GBM 153
Table 67: Commercial Benchmark of Key Marketed and Pipeline Drugs - Newly Diagnosed GBM 156
Table 68: Commercial Benchmark of Key Marketed and Pipeline Drugs - Recurrent GBM 157
Table 69: Global Sales Forecast ($m) for GBM, 2014-2024 163
Table 70: Key Events Impacting Sales for Glioblastoma, 2014?2024 165
Table 71: GBM Market - Drivers and Barriers, 2014-2024 166
Table 72: Key Launch Dates in the GBM Market, 2014-2024 193
Table 73: Key Patent Expiries in the GBM Market, 2014-2024 194
Table 74: Average Body Weight and Surface Area Across the 7MM 195
Table 75: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 201

1.2 List of Figures
Figure 1: 7MM, Age-Standardized Diagnosed Incidence Rate of Brain Cancer (Cases per 100,000 Population), All Ages, Men, 1998-2007 27
Figure 2: 7MM, Age-Standardized Diagnosed Incidence Rate of Brain Cancer (Cases per 100,000 Population), All Ages, Women, 1998-2007 28
Figure 3: 7MM, Diagnosed Incident Cases of Brain Cancer, All Ages, Both Sexes, N, 2014-2024 38
Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of Brain Cancer, Both Sexes, N, 2014 40
Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of Brain Cancer, All Ages, N, 2014 42
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of Brain Cancer, All Ages, N, 2014 43
Figure 7: 7MM, Five-Year Diagnosed Prevalent Cases of Brain Cancer, All Ages, Both Sexes, N, 2014?2024 45
Figure 8: 7MM, Diagnosed Incident Cases of Brain Cancer by Type, All Ages, Both Sexes, N, 2014 46
Figure 9: Rintega's Phase II and III Development in Glioblastoma 89
Figure 10: Opdivo's Phase II and III Development in Glioblastoma 96
Figure 11: ABT-414's Phase II and III Development in Glioblastoma 102
Figure 12: ICT-107's Phase II and III Development in Glioblastoma 108
Figure 13: VB-111's Phase II and III Development in Glioblastoma 115
Figure 14: DCVax-L's Phase II and III Development in Glioblastoma 120
Figure 15: Toca 511 and Toca FC's Phase II and III Development in Glioblastoma 125
Figure 16: Veliparib's Phase II and III Development in Glioblastoma 129
Figure 17: ITK-1's Phase II and III Development in Glioblastoma 133
Figure 18: Prophage (G-100 and G-200)'s Phase II and III Development in Glioblastoma 137
Figure 19: TVI-Brain 1's Phase II and III Development in Glioblastoma 141
Figure 20: Cotara's Phase II and III Development in Glioblastoma 143
Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in Newly Diagnosed GBM, 2014-2024 160
Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in Recurrent GBM, 2014-2024 161
Figure 23: GBM Sales by Product, 2014-2024 164

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