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OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017
OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017
Bladder cancer is a urologic malignancy arising from the epithelial lining of the urinary bladder. Although it is the ninth most common cancer worldwide in men and women, with the highest recurrence rate of any malignancy, relatively little is known about its etiology. There has been little development over the past 20 years in bladder cancer, with a huge void of unmet met needs which are yet to be filled.
The disease can be spilt into three main categories; NMIBC (non-muscle invasive bladder cancer), muscle invasive disease and metastatic disease. The standards of care within all of these settings are generics; BCG immunotherapy/ mitomycin c (NMIBC) and the off label use of GemCis (muscle invasive disease and metastatic disease).
Progression and recurrence rates are relative to clinical stage, but are generally high, especially for patients with the aggressive carcinoma in situ (CIS) classification. This is one patient subgroup which has particularly high unmet needs.
There are clear unmet needs for higher efficacious drugs that can reduce progression and recurrence rates as well as cure the disease, surprisingly big pharma seems to have taken a back seat in development, instead collaborating with independent researchers to head trials with their already marketed drugs. Most of the current pipeline is being investigated by small-medium sized biotech's.
Key Questions Answered
- Which bladder cancer patient segments have the greatest unmet needs?
- What are the R&D strategies companies are pursuing in the bladder cancer space?
- Why has there been a void of interest from big pharma in this highly underserved market?
- What are the most promising pipeline agents for bladder cancer? How do their clinical and commercial attributes compare to one another?
- What opportunities will remain for future players following the launch of these pipeline agents?
- What is the potential for predictive biomarkers and targeted therapies in the bladder cancer setting?
- GlobalData forecasts the bladder cancer market in the 6MM to grow modestly from $239.3m in 2012 to $297.5m in 2017, at a CAGR of 4%. The main driver of growth in the global bladder cancer market will be the increase in number of incident cases across the study period in the 6MM and the entrance of EOquin into the market towards the end of the forecast period.
- Although the level of unmet need in the bladder cancer market is high, KOLs are generally not impressed by any of the pipeline products and they do not expect any of them to drastically change the treatment landscape. The unmet needs will hence remain after the forecast period in turn rendering the bladder cancer market as highly lucrative and commercially viable for developers.
- GlobalData believes that with the unmet needs being so high, regulatory authorities may offer a more flexible approach to what is required to satisfy approval requirements. GlobalData believes small biotech's are taking a risk-reward gamble tilted towards high risks for high rewards in the bladder cancer market. However, GlobalData also expects big pharma to gradually start taking a more proactive role in bladder cancer drug development because very few cancer settings provide the relatively low regulatory hurdles that bladder cancer does, in turn making it an alluring prospect for drug development.
- GlobalData expects future efforts to focus on predictive biomarkers which will pave the way for desperately needed targeted therapies in this space.
- Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Topline bladder cancer therapeutics market revenue from 2012–2017. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the bladder cancer therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global bladder cancer 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
- 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.
- Develop business strategies by understanding the trends shaping and driving the global bladder cancer market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global bladder cancer therapeutics market in the 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 13
1.2 List of Figures 15
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.1.3 Clinical Staging 19
3.1.4 Prognosis 22
3.1.5 Quality of Life 23
3.1.6 Symptoms 24
3.1.7 Diagnosis 24
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 26
4.2.1 Smoking is the most significant risk factor for bladder cancer 27
4.2.2 Up to 25% of male bladder cancer cases are due to occupational exposure to aromatic amines 28
4.3 Global Trends 29
4.3.1 Incidence, Mortality, and Five-Year Prevalence 30
4.3.2 Relative Survival 32
4.3.3 Disability-Adjusted Life Years (DALYs) and Years of Life Lost (YLLs) 33
4.4 Forecast Methodology 34
4.4.1 Sources Used 34
4.4.2 Sources Not Used 36
4.4.3 Forecast Assumptions and Methods 37
4.5 Epidemiological Forecast for Bladder Cancer (2012-2022) 38
4.5.1 Incident Cases of Bladder Cancer 38
4.5.2 Age-Specific Incident Cases of Bladder Cancer 40
4.5.3 Sex-Specific Incident Cases of Bladder Cancer 41
4.5.4 Age-Standardized Incidence Rates of Bladder Cancer 43
4.5.5 Incident Cases of Bladder Cancer by Stage at Diagnosis 44
4.5.6 Five-Year Prevalent Cases of Bladder Cancer 45
4.6 Discussion 47
4.6.1 Epidemiological Forecast Insight 47
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 Valstar (valrubicin) 50
5.2.2 Javlor (vinflunine ditartrate) 54
5.2.3 Intravesical Bacillus Calmette-Guérin (BCG) 58
5.2.4 Mitomycin C 60
5.2.5 GemCis 62
6 Unmet Needs Assessment and Opportunity Analysis 64
6.1 Overview 64
6.2 Unmet Needs Analysis 66
6.2.1 Unmet Need: Better Cure Rate for Patients with NMIBC 66
6.2.2 Unmet Need: Therapies that Prevent Disease Progression in Patients with NMIBC 67
6.2.3 Unmet Need: More Efficacious Therapies for Muscle-Invasive and Metastatic Bladder Cancer 68
6.2.4 Unmet Need: Treatment Options for Platinum-Refractory/Intolerant Metastatic Patients 69
6.2.5 Unmet Need: Lack of Predictive Biomarkers 69
6.2.6 Unmet Need: Better Initial Diagnosis and Resection Success Rates 70
6.3 Opportunity Analysis 71
6.3.1 Opportunity: Replacement for BCG Therapy in NMIBC Setting 71
6.3.2 Opportunity: Salvage Therapy after BCG Failure in High-Grade Patients 71
6.3.3 Opportunity: Redefining the Standard of Care for First-Line Muscle-Invasive and Metastatic Patients 72
6.3.4 Opportunity: Novel Treatments for Platinum-Refractory Patients 73
6.3.5 Opportunity: Leveraging the Immune System to Fight Bladder Cancer 73
6.3.6 Opportunity: Identification of Predictive Biomarkers 73
6.3.7 Opportunity: Neoadjuvant Therapy 74
7 R&D Strategies 75
7.1 Overview 75
7.1.1 Drug Development Dominated by Small Pharmaceutical Companies 75
7.1.2 Large Pharmaceutical Company and Academic Group Cooperation 76
7.1.3 Companies Primarily Focus on the NMIBC Segment 77
7.1.4 Success of BCG Therapy Is a Signal for Further Immunotherapy Strategies 78
7.1.5 Intravesicular Approaches for NMIBC Are Still Strategically Relevant 78
7.2 Clinical Trial Design 79
7.2.1 Registration Studies: Moving Towards More Robust Design 79
7.2.2 No Treatment Options Solid Enough to Constitute a Standard Comparative Arm 80
7.2.3 Variety of the Endpoints Used in Metastatic and NMIBC Settings 81
7.2.4 Contribution of Investigator-Initiated Trials to the Development of Treatment Algorithms 82
8 Pipeline Assessment 85
8.1 Overview 85
8.2 Promising Drugs in Clinical Development 86
8.2.1 EOquin (Apaziquone) 87
8.2.2 Jevtana (cabazitaxel) 90
8.2.3 CG-0070 94
8.2.4 Apatorsen (OGX-427) 98
8.2.5 Abraxane (nab-paclitaxel) 102
8.3 Innovative Early-Stage Approaches 106
8.3.1 Immunotherapies 107
8.3.2 Targeted Therapies 111
9 Pipeline Valuation Analysis 114
9.1 Clinical Benchmark of Key Pipeline Drugs 115
9.2 Commercial Benchmark of Key Pipeline Drugs 119
9.3 Competitive Assessment 122
9.4 Top-Line Five-Year Forecast 123
9.4.1 US 126
9.4.2 5EU 127
10 Appendix 128
10.1 Bibliography 128
10.2 Abbreviations 145
10.3 Methodology 147
10.4 Forecasting Methodology 147
10.4.1 Diagnosed Bladder Cancer Patients 147
10.4.2 Percent Drug-Treated Patients 148
10.4.3 Drugs Included in Each Therapeutic Class 148
10.4.4 Launch Dates 148
10.4.5 General Pricing Assumptions 149
10.4.6 Individual Drug Assumptions 150
10.4.7 Generic Erosion 152
10.5 Physicians and Specialists Included in this Study 153
10.6 About the Authors 154
10.6.1 Authors 154
10.6.2 Epidemiologist 155
10.6.3 Global Head of Healthcare 156
10.7 About GlobalData 157
10.8 Disclaimer 157
1.1 List of Tables
Table 1: Definitions of Stages 21
Table 2: Bladder Cancer Prognosis by Stage 23
Table 3: Symptoms of Bladder Cancer by Phase 24
Table 4: Bladder Cancer Risk Factors 27
Table 5: 6MM, GLOBOCAN Incidence, Five-Year Prevalence, and Mortality of Bladder Cancer, Ages ?15 Years, Men and Women, 2008 31
Table 6: 6MM, Relative Survival of Bladder Cancer (%), Men and Women 32
Table 7: 6MM, GLOBOCAN Disability-Adjusted Life Years (DALYs) and Years of Life Lost (YLLs) Due to Bladder Cancer, Men and Women, N, 2008 33
Table 8: 6MM, Sources of Bladder Cancer Incidence Data 34
Table 9: 6MM, Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Select Years 2012-2022 39
Table 10: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N (Row %), 2012 40
Table 11: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N (Row %), 2012 42
Table 12: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ?15 Years, Men and Women, N (Row %), 2012 44
Table 13: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Select Years 2012-2022 46
Table 14: Leading Treatments for Bladder Cancer 50
Table 15: Product Profile - Valstar 52
Table 16: Bladder Cancer - Local Adverse Side Effects Observed before and during Treatment 53
Table 17: Valstar SWOT Analysis 54
Table 18: Product Profile - Javlor 56
Table 19: Javlor SWOT Analysis 58
Table 20: BCG SWOT Analysis 60
Table 21: Mitomycin C SWOT Analysis 61
Table 22: GemCis SWOT Analysis 63
Table 23: Overall Unmet Needs - Current Level of Attainment 66
Table 24: Design of Current and Pipeline Therapy Trials in Bladder Cancer 83
Table 25: Bladder Cancer - Late-Stage Pipeline, 2012 86
Table 26: Product Profile - EOquin 88
Table 27: EOquin SWOT Analysis 90
Table 28: Product Profile - Jevtana 92
Table 29: Jevtana SWOT Analysis 94
Table 30: Product Profile - CG-0070 96
Table 31: CG-0070 SWOT Analysis 97
Table 32: Product Profile - Apatorsen 100
Table 33: Apatorsen SWOT Analysis 102
Table 34: Product Profile - Abraxane (nab-paclitaxel) 104
Table 35: Abraxane SWOT Analysis 106
Table 36: Early-Stage Pipeline Products in Bladder Cancer 106
Table 37: Clinical Benchmark of Key Pipeline Drugs - NMIBC 115
Table 38: Clinical Benchmark of Key Pipeline Drugs - Metastatic Disease 116
Table 39: Commercial Benchmark of Key Pipeline Drugs - NMIBC Setting 119
Table 40: Commercial Benchmark of Key Pipeline Drugs - Metastatic Setting 120
Table 41: Top-Line Sales Forecasts ($m) for Bladder Cancer, 2012-2017 124
Table 42: Key Events Impacting Sales for Bladder Cancer, 2017 125
Table 43: Bladder Cancer - Drivers and Barriers, US and EU 125
Table 44: Key Launch Dates 148
1.2 List of Figures
Figure 1: Reconciliation of Bladder Cancer Staging Systems 20
Figure 2: Primary Tumor Development 22
Figure 3: 6MM, Incidence Rates of Bladder Cancer, Ages ?15 Years, Men, Rate per 100,000 Population, 1993-2002 30
Figure 4: 6MM, Incidence Rates of Bladder Cancer, Ages ?15 Years, Women, Rate per 100,000 Population, 1993-2002 31
Figure 5: 6MM, Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Select Years 2012-2022 39
Figure 6: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, 2012 41
Figure 7: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, 2012 42
Figure 8: 6MM, Age-Standardized Bladder Cancer Incidence, Ages ?15 Years, Men and Women, Cases per 100,000 Population, 2012 43
Figure 9: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ?15 Years, Men and Women, N, 2012 45
Figure 10: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, 2012-2022 46
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Bladder Cancer, 2012-2017 122
Figure 12: Global Sales for Bladder Cancer by Region, 2012-2017 124
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