Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM

Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM", which provides in-depth analysis of the Glioblastoma Multiforme (GBM) therapeutics market within the Asia-Pacific (APAC) region, covering Australia, China, India and Japan. The report provides estimates of market size for 2013, along with market forecasts until 2020. It also covers disease epidemiology, treatment algorithms, treatment patterns, and in-depth analysis of the marketed and pipeline products.

The value of the GBM market in the APAC region amounted to an estimated $49.4m in 2013, and is expected to register a Compound Annual Growth Rate (CAGR) of 11.5%, to reach $105.8m by 2020. The GBM market in India was the smallest of the APAC markets in 2013, but is expected to experience the highest growth rate in the forecast period, at a CAGR of 14.4%, due to having the highest number of promising candidates in the pipeline. Japan currently has the largest share of GBM market in the APAC region, at 48%, and is expected to experience healthy growth during the forecast period at a CAGR of 13.8%.

The existing treatment landscape is bleak for both newly diagnosed and recurrent GBM, with temozolomide alone serving as the standard of care after surgery and radiation. For first-line treatment Rindopepimut, a novel vaccine, is in late-stage development in India and Australia, but it is limited to EGFRvIII patients. There are two strong candidates in the current pipeline for second-line treatment: Avastin and Cotara. Avastin is the first and only targeted therapy for newly diagnosed GBM, is already approved as second-line treatment in Australia and Japan, and is in Phase III development in China and India. Cotara is a single-infusion drug with a novel delivery route, which is in Phase II development in India. The expected launch of these three drugs is the key driver for growth in APAC GBM market. As all are expensive, even a modest uptake will increase the annual cost of therapy, and subsequently the market size.

Scope

- A brief introduction to GBM, including disease pathogenesis, risk factors, diagnosis, treatment options and algorithm
- In-depth analysis of major marketed products, covering product performance, life-cycle, and a heat map depicting comparative analysis of safety and efficacy parameters
- A comprehensive review of the GBM pipeline – including individual analysis of promising late-stage pipeline drugs that are likely to enter the market during the forecast period – analyzed on the basis of phase distribution, molecule types and molecular targets
- Additional clinical trial analysis by phase, trial size, trial duration and program failure rate analyses, for each molecule type and mechanism of action
- Multi-scenario forecasts of the GBM market from 2013 to 2020 in the four APAC countries
- An overview of key licensing and co-development agreements that could have an impact on growth trends
- Analysis of the key drivers and restraints that have had and are expected to have a significant impact on the market

Reasons to buy

- Align your product portfolio to the markets with high growth potential
- Develop market entry and expansion strategies by identifying the potential regions and therapeutic segments poised for strong growth
- Devise a more effectively tailored strategy through the understanding of key drivers and barriers in the GBM market
- Develop key strategic initiatives based on an understanding of key focus areas and leading companies
- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 9
2 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Introduction 10
2.1 Disease Introduction 10
2.2 Classification of Brain Tumors 11
2.3 Tumor Grading 13
2.4 Subtypes of Glioblastoma Multiforme 14
2.5 Etiology 14
2.6 Pathophysiology 15
2.6.1 Loss of Heterozygosity of Chromosome 10 16
2.6.2 Epidermal Growth Factor Receptor Amplification 16
2.6.3 Phosphatase and Tensin Homolog Mutation 16
2.6.4 Loss of p53 Function 17
2.6.5 p16INK4a Alteration and Loss of Normal Retinoblastoma 1 Function 17
2.6.6 Isocitrate Dehydrogenase 1 or Isocitrate Dehydrogenase 2 Mutation 17
2.7 Symptoms 18
2.8 Diagnosis 19
2.9 Prognosis 20
2.10 Epidemiology 21
2.11 Treatment Options 22
2.11.1 Surgery 22
2.11.2 Radiation Therapy 22
2.11.3 Chemotherapy 23
2.11.4 Targeted Therapy 24
2.11.5 Drugs for Symptom Relief 24
2.11.6 Other Alternative Therapies 24
2.12 Treatment Algorithm 25
3 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Marketed Products 29
3.1 Key Marketed Products 29
3.2 Temodar (temozolomide) – Merck 29
3.3 Avastin (bevacizumab) – Roche 31
3.4 BiCNU (carmustine) and Gliadel Wafer (carmustine in polifeprosan) 33
3.4.1 BiCNU (carmustine) – Bristol-Myers Squibb 34
3.4.2 Gliadel Wafer (carmustine in polifeprosan) – Eisai 34
3.5 Unlicensed/Off-Label Use in Glioblastoma Multiforme 36
3.5.1 Lomustine 36
3.5.2 Carboplatin 37
3.5.3 Teniposide 37
3.6 Comparative Efficacy and Safety 37
3.7 Unmet Needs 40
4 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Pipeline 42
4.1 Overall Pipeline 42
4.2 Molecular Targets 44
4.3 Clinical Trials 46
4.3.1 Clinical Trial Size 46
4.3.2 Clinical Trial Duration 48
4.3.3 Failure Rate of Developmental Pipeline 50
4.3.4 Summary of Clinical Trial and Risk Analysis 51
4.4 Promising Pipeline Candidates 52
4.4.1 Rindopepimut (CDX-110) – Celldex Therapeutics 52
4.4.2 Avastin (bevacizumab) – Roche 52
4.4.3 Cotara – Peregrine Pharmaceuticals 53
4.4.4 BIOMAb (nimotuzumab) – BioCon 54
4.5 Heat Map of Safety and Efficacy and Product Competitiveness Framework for Glioblastoma Multiforme Pipeline 55
5 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Market Forecast to 2020 59
5.1 Asia-Pacific Market 59
5.1.1 Treatment Use Patterns 59
5.1.2 Market Size 59
5.2 Australia 61
5.2.1 Treatment Use Patterns 61
5.2.2 Annual Cost of Therapy 61
5.2.3 Market Size 62
5.3 China 63
5.3.1 Treatment Use Patterns 63
5.3.2 Annual Cost of Therapy 64
5.3.3 Market Size 65
5.4 India 66
5.4.1 Treatment Use Patterns 66
5.4.2 Annual Cost of Therapy 67
5.4.3 Market Size 68
5.5 Japan 69
5.5.1 Treatment Use Patterns 69
5.5.2 Annual Cost of Therapy 70
5.5.3 Market Size 71
5.6 Drivers and Barriers for the Glioblastoma Multiforme Therapeutics in the Asia-Pacific Market to 2020 72
5.6.1 Drivers 72
5.6.2 Barriers 74
6 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Deals and Strategic Consolidations 75
6.1 Major Co-Development Deals 75
6.1.1 Del Mar Pharmaceuticals Enters into Agreement with Guangxi Wuzhou Pharmaceutical 75
6.1.2 Immatics Biotechnologies Enters into Agreement with Cancer Research UK 75
6.2 Major Licensing Deals 76
6.2.1 Eisai Received Marketing Authorization Holder License with Nobelpharma for Gliadel in Japan 76
6.2.2 Teva Pharma Enters into Agreement with Perrigo for Generic Temozolomide 76
6.2.3 SOM Biotech Enters into Licensing Agreement with Argon Pharma for SOM0777 76
6.2.4 ImmunoCellular Therapeutics Enters into Agreement with University of Pennsylvania 76
6.2.5 Bexion Pharmaceuticals Enters into Agreement with Cincinnati Children’s Hospital Medical Center 76
6.2.6 Celldex Therapeutics Enters into Agreement with Duke University Brain Tumor Cancer Center 77
7 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 – Appendix 78
7.1 Market Definitions 78
7.2 Abbreviations 78
7.3 Bibliography 80
7.4 All Pipeline Products by Phase 90
7.4.1 Discovery 90
7.4.2 Preclinical 91
7.4.3 Phase I 95
7.4.4 Phase II 97
7.4.5 Phase III and Pre-Registration 100
7.4.6 Undisclosed stage of development 100
7.5 Market Forecasts to 2020 100
7.5.1 Asia-Pacific 100
7.5.2 Australia 101
7.5.3 China 101
7.5.4 India 102
7.5.5 Japan 102
7.6 Research Methodology 102
7.6.1 Coverage 103
7.6.2 Secondary Research 103
7.6.3 Therapeutic Landscape 103
7.6.4 Forecasting 104
7.6.5 Geographical Landscape 104
7.6.6 Pipeline Analysis 104
7.7 Competitive Landscape 105
7.8 Expert Panel Validation 105
7.9 Contact Us 105
7.10 Disclaimer 105

1.1 List of Tables
Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons, 2014 12
Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma, 2005 14
Table 3: Glioblastoma Multiforme, Karnofsky Performance Status Score (%), 1984 21
Table 4: Discovery 90
Table 5: Preclinical and IND/CTA-filed 91
Table 6: Phase I 95
Table 7: Phase II 97
Table 8: Phase III and pre-registration 100
Table 9: Undisclosed stage of development 100
Table 10: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Forecast Data, 2013–2020 100
Table 11: Glioblastoma Multiforme Therapeutics, Australia, Forecast Data, 2013–2020 101
Table 12: Glioblastoma Multiforme Therapeutics, China, Forecast Data, 2013–2020 101
Table 13: Glioblastoma Multiforme Therapeutics, India, Forecast Data, 2013–2020 102
Table 14: Glioblastoma Multiforme Therapeutics, Japan, Forecast Data, 2013–2020 102

1.2 List of Figures
Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations, 2014 15
Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme, 2014 26
Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme, 2014 28
Figure 4: Glioblastoma Multiforme, Global, Historical Sales of Temodar ($m), 2008–2013 30
Figure 5: Glioblastoma Multiforme, Global, Historical Sales of Avastin ($bn), 2004–2013 32
Figure 6: Glioblastoma Multiforme, Global, Historical Sales of Gliadel Wafer ($m), 2003–2006 35
Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013 38
Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013 43
Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013 46
Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type, 2006–2013 48
Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006–2013 49
Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type and Reasons for Failure, 2006–2013 51
Figure 13: Glioblastoma Multiforme, Asia-Pacific, Heat Map for Pipeline Products, 2013 56
Figure 14: Glioblastoma Multiforme, Asia-Pacific, Product Competitiveness Framework, 2013 57
Figure 15: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Treatment Use Patterns (‘000), 2013–2020 59
Figure 16: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Market Size ($m), 2013–2020 60
Figure 17: Glioblastoma Multiforme Therapeutics, Australia, Treatment Use Patterns (‘000), 2013–2020 61
Figure 18: Glioblastoma Multiforme Therapeutics, Australia, Annual Cost of Therapy ($), 2013–2020 62
Figure 19: Glioblastoma Multiforme Therapeutics, Australia, Market Size ($m), 2013–2020 63
Figure 20: Glioblastoma Multiforme Therapeutics, China, Treatment Use Patterns (‘000), 2013–2020 64
Figure 21: Glioblastoma Multiforme Therapeutics, China, Annual Cost of Therapy ($), 2013–2020 65
Figure 22: Glioblastoma Multiforme Therapeutics, China, Market Size ($m), 2013–2020 66
Figure 23: Glioblastoma Multiforme Therapeutics, India, Treatment Use Patterns (‘000), 2013–2020 67
Figure 24: Glioblastoma Multiforme Therapeutics, India, Annual Cost of Therapy ($), 2013–2020 68
Figure 25: Glioblastoma Multiforme Therapeutics, India, Market Size ($m), 2013–2020 69
Figure 26: Glioblastoma Multiforme Therapeutics, Japan, Treatment Use Patterns (‘000), 2013–2020 70
Figure 27: Glioblastoma Multiforme Therapeutics, Japan, Annual Cost of Therapy ($), 2013–2020 71
Figure 28: Glioblastoma Multiforme Therapeutics, Japan, Market Size ($m), 2013–2020 72