OpportunityAnalyzer: Glioblastoma – Opportunity Analysis and Forecast to 2024

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).

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.

Key Highlights

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?

Companies mentioned

Arbor Pharmaceuticals

AbbVie

Agenus

AstraZeneca

Boehringer Ingelheim

Bristol-Myers Squibb Company

Celldex Therapeutics

Chugai

Eisai

Fujifilm

GreenPeptide

Immunocellular Therapeutics

Merck & Co.

Northwest Biotherapeutics

Novartis

Novocure ...

Arbor Pharmaceuticals

AbbVie

Agenus

AstraZeneca

Boehringer Ingelheim

Bristol-Myers Squibb Company

Celldex Therapeutics

Chugai

Eisai

Fujifilm

GreenPeptide

Immunocellular Therapeutics

Merck & Co.

Northwest Biotherapeutics

Novartis

Novocure

Ono Pharmaceuticals

Peregrine Pharmaceuticals

Pfizer

Roche

Tocagen

TVAX Biomedical

VBL Therapeutics

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.17MM Incidence Trends

4.3.27MM Trends in Relative Survival

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast for Brain Cancer (2014–2024)

4.5.1Diagnosed Incident Cases of Brain Cancer

4.5.2Age-Specific Diagnosed Incidence of Brain Cancer

4.5.3Sex-Specific Diagnosed Incident Cases of Brain Cancer

4.5.4Age-Standardized Diagnosed Incidence of Brain Cancer

4.5.5Five-Year Diagnosed Prevalent Cases of Brain Cancer

4.5.6Diagnosed Incident Cases of Brain Cancer by Type

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2Product Profiles- Major Brands

5.2.1Avastin (bevacizumab)

5.2.2Temozolomide

5.2.3Gliadel (carmustine wafer)

5.2.4Optune (NovoTTF-100A)

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Identification of New Treatment Options for Patients with rGBM Refractory to Avastin

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3More Efficacious Treatment for Patients with MGMT-Unmethylated Promoters

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Criteria to Evaluate Tumor Response

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Reduce Use of Steroids in GBM Patients

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Identification of Biomarkers Predictive of Therapeutic Efficacy

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

7R&D Strategies

7.1Overview

7.1.1Assessment of Immunotherapy Efficacy in GBM

7.1.2Increased Use of Biomarkers to Better Predict Treatment Efficacy

7.1.3Moving Towards Less Cumbersome Cancer Vaccines to Facilitate Approval

7.1.4Local Administration of Therapeutics During Surgery

7.2Clinical Trial Design

7.2.1Clinical Endpoints

7.2.2Comparator Arms

7.2.3Combinatory Approach

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Rintega (rindopepimut)

8.2.2Opdivo (nivolumab)

8.2.3ABT-414

8.2.4ICT-107

8.2.5VB-111

8.2.6DCVax-L

8.2.7Toca 511 and Toca FC

8.2.8Veliparib

8.2.9ITK-1

8.2.10Prophage G-100 and G-200

8.2.11TVI-Brain-1

8.2.12Cotara (Iodine I 131 Derlotuximab Biotin)

8.3Innovative Early-stage Approaches

8.3.1Checkpoint Inhibitors

8.3.2Vaccines

8.3.3Small Molecules

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed GBM Patients

10.4.2Percent Drug-treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6General Forecast Assumptions

10.4.7Individual Drug Assumptions

10.4.8Generic and Biosimilar Erosion

10.4.9Pricing of Pipeline Agents

10.5Physicians and Specialists Included in this Study

10.5.1High-Prescribing Physician Survey

10.6About the Authors

10.6.1Author

10.6.2Epidemiologist

10.6.3Therapy Director

10.6.4Global Director of Therapy Analysis and Epidemiology

10.6.5Global Head of Healthcare

10.7About GlobalData

10.8Disclaimer

List of Tables

Table 1: Symptoms of Glioblastoma

Table 2: Description of Brain Cancer Types

Table 3: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of Brain ...

Table 1: Symptoms of Glioblastoma

Table 2: Description of Brain Cancer Types

Table 3: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of Brain Cancer

Table 4: 7MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of Brain Cancer

Table 5: 7MM, Diagnosed Incident Cases of Brain Cancer, All Ages, Both Sexes, N, 2014–2024

Table 6: 7MM, Age-Specific Diagnosed Incident Cases of Brain Cancer, Both Sexes, N (Row %), 2014

Table 7: 7MM, Sex-Specific Diagnosed Incident Cases of Brain Cancer, All Ages, N (Row %), 2014

Table 8: 7MM, Five-Year Diagnosed Prevalent Cases of Brain Cancer, All Ages, Both Sexes, N, 2014-2024

Table 9: Leading Treatments for Glioblastoma

Table 10: Product Profile – Avastin

Table 11: Efficacy of Avastin in Phase II Trials

Table 12: Efficacy of Avastin Compared to Nitrosureas

Table 13: Efficacy of Avastin in Newly Diagnosed GBM

Table 14 Avastin SWOT Analysis

Table 15: Product Profile – Temozolomide

Table 16: Efficacy of Temozolomide in Newly Diagnosed GBM

Table 17: Product Profile – Gliadel

Table 18: Efficacy of Gliadel in Newly Diagnosed Malignant Glioma Patients

Table 19 Overall Unmet Needs – Current Level of Attainment

Table 20: Design of Current Phase III Trials in GBM

Table 21: Glioblastoma – Late Stage Pipeline, 2015

Table 22: Product Profile – Rintega

Table 23: Efficacy of Rintega in rGBM

Table 24: Rintega SWOT Analysis

Table 25: Global Sales Forecast ($m) for Rintega, 2014–2024

Table 26: Product Profile – Opdivo

Table 27: Preliminary Efficacy of Opdivo Monotherapy and Opdivo + Yervoy Combination Therapy

Table 28: Opdivo SWOT Analysis

Table 29: Global Sales Forecast ($m) for Opdivo, 2014–2024

Table 30: Product Profile — ABT-414

Table 31: Preliminary Efficacy of ABT-414 + Temozolomide Rechallenge and ABT-414 Monotherapy

Table 32: Safety of ABT-414

Table 33: ABT-414 SWOT Analysis

Table 34: Global Sales Forecast ($m) for ABT-414, 2014–2024

Table 35: Product Profile – ICT-107

Table 36: Efficacy of ICT-107 in Phase II Study, Months (N)

Table 37: Safety of ICT-107

Table 38: ICT-107 SWOT Analysis

Table 39: Global Sales Forecast ($m) for ICT-107, 2014–2024

Table 40: Product Profile – VB-111

Table 41: Efficacy of VB-111

Table 42: VB-111 SWOT Analysis

Table 43: Global Sales Forecast ($m) for VB-111, 2014–2024

Table 44: Product Profile – DCVax-L

Table 45: DCVax-L SWOT Analysis

Table 46: Global Sales Forecast ($m) for DCVax-L, 2014–2024

Table 47: Product Profile – Toca 511 and Toca FC

Table 48 Toca 511 and Toca FC SWOT Analysis

Table 49: Global Sales Forecast ($m) for Toca 511, 2014–2024

Table 50: Global Sales Forecast ($m) for Toca FC, 2014–2024

Table 51: Product Profile – Veliparib

Table 52 Veliparib SWOT Analysis

Table 53: Global Sales Forecast ($m) for Veliparib, 2014–2024

Table 54: Product Profile – ITK-1

Table 55: Efficacy of ITK-1 in a Phase I trial

Table 56: ITK-1 SWOT Analysis

Table 57: Global Sales Forecast ($m) for ITK-1, 2014–2024

Table 58: Product Profile – Prophage

Table 59: Preliminary Efficacy of Prophage G-100 + Temozolomide Combination Therapy

Table 60: Prophage G-100 and G-200 SWOT Analysis

Table 61: Product Profile – TVI-Brain-1

Table 62: TVI-Brain-1 SWOT Analysis

Table 63: Product Profile – Cotara

Table 64: Cotara SWOT Analysis

Table 65: Key Early-Stage Pipeline Products in GBM

Table 66 Clinical Benchmark of Key Marketed and Pipeline Drugs - Newly Diagnosed GBM

Table 67: Commercial Benchmark of Key Marketed and Pipeline Drugs - Newly Diagnosed GBM

Table 68: Commercial Benchmark of Key Marketed and Pipeline Drugs - Recurrent GBM

Table 69: Global Sales Forecast ($m) for GBM, 2014–2024

Table 70: Key Events Impacting Sales for Glioblastoma, 2014-2024

Table 71: GBM Market – Drivers and Barriers, 2014-2024

Table 72: Key Launch Dates in the GBM Market, 2014–2024

Table 73: Key Patent Expiries in the GBM Market, 2014–2024

Table 74: Average Body Weight and Surface Area Across the 7MM

Table 75: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: 7MM, Age-Standardized Diagnosed Incidence Rate of Brain Cancer (Cases per 100,000 Population), All Ages, Men, 1998–2007

Figure 2: 7MM, Age-Standardized Diagnosed ...

Figure 1: 7MM, Age-Standardized Diagnosed Incidence Rate of Brain Cancer (Cases per 100,000 Population), All Ages, Men, 1998–2007

Figure 2: 7MM, Age-Standardized Diagnosed Incidence Rate of Brain Cancer (Cases per 100,000 Population), All Ages, Women, 1998–2007

Figure 3: 7MM, Diagnosed Incident Cases of Brain Cancer, All Ages, Both Sexes, N, 2014–2024

Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of Brain Cancer, Both Sexes, N, 2014

Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of Brain Cancer, All Ages, N, 2014

Figure 6: 7MM, Age-Standardized Diagnosed Incidence of Brain Cancer, All Ages, N, 2014

Figure 7: 7MM, Five-Year Diagnosed Prevalent Cases of Brain Cancer, All Ages, Both Sexes, N, 2014-2024

Figure 8: 7MM, Diagnosed Incident Cases of Brain Cancer by Type, All Ages, Both Sexes, N, 2014

Figure 9: Rintega’s Phase II & III Development in Glioblastoma

Figure 10: Opdivo’s Phase II & III Development in Glioblastoma

Figure 11: ABT-414’s Phase II & III Development in Glioblastoma

Figure 12: ICT-107’s Phase II & III Development in Glioblastoma

Figure 13: VB-111’s Phase II & III Development in Glioblastoma

Figure 14: DCVax-L’s Phase II & III Development in Glioblastoma

Figure 15: Toca 511 and Toca FC’s Phase II & III Development in Glioblastoma

Figure 16: Veliparib’s Phase II & III Development in Glioblastoma

Figure 17: ITK-1’s Phase II & III Development in Glioblastoma

Figure 18: Prophage (G-100 and G-200)’s Phase II & III Development in Glioblastoma

Figure 19: TVI-Brain 1’s Phase II & III Development in Glioblastoma

Figure 20: Cotara’s Phase II & III Development in Glioblastoma

Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in Newly Diagnosed GBM, 2014–2024

Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in Recurrent GBM, 2014–2024

Figure 23: GBM Sales by Product, 2014–2024

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