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Opportunity Analyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017

Summary

The bladder cancer market has remained largely unchanged in the past 10-20 years. However, significant expansion is expected starting in 2016, with the introduction of several new therapies that are projected to fuel market growth. In addition, bladder cancer has a robust early-stage pipeline that will contribute to market growth beyond the forecast period of 2012-2017. Currently, the bladder cancer market is dominated by generic chemotherapy and immunotherapy. Though initially effective, toxicity and lack of clinical efficacy in improving overall survival have left the door open for more tolerable and effective drugs to be developed. In the past, bladder cancer has not been an area of focus for pharmaceutical companies, but that is rapidly changing as more companies focus on the bladder cancer market, recognizing the high level of unmet need and relatively clear regulatory path. During the forecast period, the market landscape will begin to change dramatically with the introduction of targeted immunotherapies. These drugs will provide much-needed alternatives to bladder cancer patients who have not benefitted from traditional treatments.

Highlights

Key Questions Answered

- The bladder cancer market is poised to undergo rapid expansion during the forecast period and beyond. What are the main drivers of this expansion? What are the main barriers that could dampen this expansion?
- The bladder cancer market is plagued by the presence of high unmet needs not addressed by current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the bladder cancer market?
- The current bladder cancer market is highly generic. How will the introduction of targeted immunotherapies, including the much-anticipated PD-1/PD-L1 class of immune checkpoint inhibitors, change the market landscape?

Key Findings

- The main driver of the rapid expansion of the bladder market will be the launch of several highly anticipated drugs into the market starting in 2016.
- The second largest driver will be the forecast increase in number of incident cases in bladder cancer.
- To gain approval, it is essential for companies to demonstrate efficacy in delaying recurrence, but not necessarily improvement in overall survival. Thus, the bar for approval in bladder cancer is low.
- In the future, companies will have to differentiate their drugs from others in the same class in order to successfully compete for patient share.
- The number of pipeline agents being developed by small to mid-sized companies represents an opportunity for large pharma to enter this highly lucrative market through licensing and marketing partnerships.

Scope

- Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized bladder cancer therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for 5 years to 2017.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the bladder cancer 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 bladder cancer 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 bladder cancer therapeutics 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 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 bladder cancer therapeutics market from 2012-2017.
- 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: Bladder Cancer - Opportunity Analysis and Forecasts to 2017
1 Table of Contents
1 Table of Contents 11
1.1 List of Tables 16
1.2 List of Figures 20
2 Introduction 21
2.1 Catalyst 21
2.2 Related Reports 21
2.3 Upcoming Related Reports 21
3 Disease Overview 22
3.1 Etiology and Pathophysiology 22
3.1.1 Etiology 22
3.1.2 Pathophysiology 23
3.1.3 Clinical Staging 24
3.2 Prognosis 27
3.3 Quality of Life 28
3.4 Symptoms 29
3.5 Diagnosis 29
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Co-morbidities 31
4.2.1 Smoking is the most significant risk factor for bladder cancer 32
4.2.2 Up to 25% of male bladder cancer cases are due to occupational exposure to aromatic amines 33
4.3 Global and Historical Trends 33
4.3.1 Incidence, Mortality, and Five-Year Prevalence 34
4.3.2 Relative Survival 36
4.3.3 Disability-Adjusted Life Years and Years of Life Lost 37
4.4 Forecast methodology 37
4.4.1 Sources used 38
4.4.2 Forecast assumptions and methods 40
4.4.3 Sources not used 41
4.5 Incident/Prevalent Cases of Bladder Cancer 42
4.5.1 Incident Cases of Bladder Cancer 42
4.5.2 Age-Specific Incident Cases of Bladder Cancer 43
4.5.3 Sex-Specific Incident Cases of Bladder Cancer 44
4.5.4 Age-Standardized Incidence Rates of Bladder Cancer 45
4.5.5 Incident Cases of Bladder Cancer by Stage at Diagnosis 46
4.5.6 Five-Year Prevalent Cases of Bladder Cancer 47
4.6 Discussion 49
4.6.1 Epidemiological Forecast Insight 49
4.6.2 Limitations of the Analysis 49
4.6.3 Strengths of the Analysis 50
5 Current Treatment Options 51
5.1 Overview 51
5.2 Product Profiles- Major Brands 52
5.2.1 Intravesical Bacillus Calmette-Guerin 52
5.2.2 GemCis (Gemcitabine/Cisplatin) 56
5.2.3 Mitomycin c 60
5.2.4 Valstar (Valrubicin) 62
5.2.5 Javlor (Vinfluinine Ditartrate) 66
6 Unmet Needs Assessment and Opportunity Analysis 72
6.1 Overview 72
6.2 Unmet Needs Analysis 73
6.2.1 Higher Cure Rate for Patients with NMIBC 73
6.2.2 Therapies that Prevent Disease Progression in Patients with NMIBC 73
6.2.3 More Efficacious Therapies for Muscle-Invasive and Metastatic Bladder Cancer 74
6.2.4 Treatment Options for Platinum-Refractory/Intolerant Metastatic Patients 76
6.2.5 Lack of Predictive Biomarkers 76
6.2.6 Improved Initial Diagnosis and Resection Success Rates 77
6.3 Opportunity Analysis 78
6.3.1 Replacement for BCG Therapy in the NMIBC Setting 78
6.3.2 Salvage Therapy after BCG Failure in High-Grade Patients 79
6.3.3 Redefining the Standard of Care for First-Line Muscle-Invasive and Metastatic Patients 79
6.3.4 Novel Treatments for Platinum-Refractory Patients 80
6.3.5 Leveraging the Immune System to Fight Bladder Cancer 81
6.3.6 Identification of Predictive Biomarkers and Targeted Drugs 81
6.3.7 Neoadjuvant Therapy 81
6.3.8 Companion Diagnostic Tests 82
7 RandD Strategies 84
7.1 Overview 84
7.1.1 Drug Development by Small Pharmaceutical Companies 84
7.1.2 Success of BCG Therapy is a Signal for Further Immunotherapy Strategies 84
7.1.3 Intravesical Approaches for NMIBC May Give Way to Systemic Approaches in the Future 85
7.2 Clinical trial design 85
7.2.1 Registrational Studies: Open-Label, Non-Comparative Trial Designs Still Prevalent 89
7.2.2 A Variety of Trial Endpoints are Used in the NMIBC and Metastatic Settings 89
8 Pipeline Assessment 91
8.1 Overview 91
8.2 Promising drugs in clinical development 92
8.2.1 MCNA 92
8.2.2 Apaziquone 98
8.2.3 Keytruda (Pembrolizumab) 102
8.2.4 Atezolizumab 107
8.2.5 Cyramza (Ramucirumab) 113
8.2.6 Vicinium (Oportuzumab Monatox) 118
8.2.7 Durvalumab 121
8.2.8 CG-0070 124
8.2.9 Apatorsen 129
8.2.10 Opdivo (Nivolumab) 135
8.3 Innovative Early-stage Approaches 139
8.3.1 Immunotherapies 140
8.3.2 Targeted Therapies 142
9 Pipeline Valuation Analysis 145
9.1 Clinical Benchmark of Key Pipeline Drugs 145
9.2 Commercial Benchmark of Key Pipeline Drugs 148
9.3 Competitive Assessment 151
9.4 Top Line Five Year Forecast 151
9.4.1 US 154
9.4.2 5EU 154
10 Appendix 156
10.1 Bibliography 156
10.2 Abbreviations 176
10.3 Methodology 180
10.4 Forecasting Methodology 180
10.4.1 Diagnosed Bladder Cancer patients 180
10.4.2 Percent Drug-treated Patients 180
10.4.3 Drugs Included in Each Therapeutic Class 181
10.4.4 Reconciliation of Epidemiological Staging with Clinical Staging 181
10.4.5 Launch and Patent Expiry Dates 181
10.4.6 General Pricing Assumptions 182
10.4.7 Individual Drug Assumptions 182
10.4.8 Generic Erosion 186
10.5 Physicians and Specialists Included in this Study 187
10.6 About the Authors 188
10.6.1 Author 188
10.6.2 Therapy Area Director 188
10.6.3 Epidemiologist 188
10.6.4 Global Director of Therapy Analysis and Epidemiology 189
10.6.5 Global Head of Healthcare 189
10.7 About GlobalData 190
10.8 Disclaimer 190

1.1 List of Tables
Table 1: AJCC TNM Staging System for Bladder Cancer - Definitions of Stages 26
Table 2: Bladder Cancer Prognosis by Stage 28
Table 3: Symptoms of Bladder Cancer 29
Table 4: Bladder Cancer Risk Factors 32
Table 5: 6MM, GLOBOCAN Incidence, Five-Year Prevalence, and Mortality for Bladder Cancer, Ages ?15 Years, Men and Women, 2008 36
Table 6: 6MM, Relative Survival of Bladder Cancer (%), Men and Women 36
Table 7: 6MM, GLOBOCAN DALYs and YLLs Due to Bladder Cancer, Men and Women, N, 2008 37
Table 8: 6MM, Sources of Bladder Cancer Incidence Data 38
Table 9: 6MM, Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Selected Years, 2012-2022 42
Table 10: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N (Row %), 2012 43
Table 11: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N (Row %), 2012 44
Table 12: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ?15 Years, Men and Women, N (Row %), 2012 47
Table 13: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Selected Years, 2012-2022 48
Table 14: Leading Treatments for Bladder Cancer 52
Table 15: Product Profile - TICE-BCG 54
Table 16: Efficacy of BCG (TheraCys) 55
Table 17: Safety of BCG 56
Table 18: BCG SWOT Analysis 56
Table 19: Product Profile - GemCis 57
Table 20: Efficacy of GemCis 58
Table 21: Safety of GemCis 59
Table 22: GemCis SWOT Analysis 59
Table 23: Product Profile - Mitomycin C 60
Table 24: Efficacy of Mitomycin C 61
Table 25: Safety of Mitomycin C 61
Table 26: Mitomycin C SWOT Analysis 62
Table 27: Product Profile - Valstar 64
Table 28: Efficacy of Valstar 65
Table 29: Safety of Valstar 66
Table 30: Valstar SWOT Analysis 66
Table 31: Product Profile - Javlor 68
Table 32: Efficacy of Javlor 69
Table 33: Safety of Javlor 70
Table 34: Javlor SWOT Analysis 71
Table 35: Overall Unmet Needs - Current Level of Attainment 72
Table 36: Clinical Trial Design of Key Pipeline Drugs in the NMIBC Setting 87
Table 37: Clinical Trial Design of Key Pipeline Drugs in the MIBC and Metastatic Settings 88
Table 38: Bladder Cancer - Late-Stage Pipeline, 2015 92
Table 39: Product Profile - MCNA 95
Table 40: Efficacy of MCNA 96
Table 41: Safety of MCNA 97
Table 42: MCNA SWOT Analysis 97
Table 43: Product Profile - Apaziquone 99
Table 44: Efficacy of Apaziquone 100
Table 45: Safety of Apaziquone 101
Table 46: EOquin SWOT Analysis 102
Table 47: Product Profile -Keytruda 104
Table 48: Efficacy of Keytruda 105
Table 49: Safety of Keytruda 106
Table 50: Keytruda SWOT Analysis 107
Table 51: Product Profile - Atezolizumab 109
Table 52: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer 110
Table 53: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Chemotherapy 111
Table 54: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer 112
Table 55: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Platinum-Based Chemotherapy 112
Table 56: Atezolizumab SWOT Analysis 113
Table 57: Product Profile - Cyramza 115
Table 58: Efficacy of Cyramza 116
Table 59: Safety of Cyramza in Combination with Docetaxel 117
Table 60: Cyramza SWOT Analysis 118
Table 61: Product Profile -Vicinium 119
Table 62: Efficacy of Vicinium 120
Table 63: Safety of Vicinium 121
Table 64: Vicinium SWOT Analysis 121
Table 65: Product Profile - Durvalumab 122
Table 66: Efficacy of Durvalumab 123
Table 67: Durvalumab SWOT Analysis 124
Table 68: Product Profile - CG-0070 125
Table 69: Efficacy of CG-0070 127
Table 70: Safety of CG-0070 128
Table 71: CG-0070 SWOT Analysis 129
Table 72: Product Profile - Apatorsen 131
Table 73: Efficacy of Apatorsen 133
Table 74: Safety of Apatorsen 134
Table 75: Apatorsen SWOT Analysis 135
Table 76: Product Profile - Opdivo 137
Table 77: Efficacy of Opdivo 138
Table 78: Opdivo SWOT Analysis 139
Table 79: Early-Stage Pipeline Products in Bladder Cancer 139
Table 80: Clinical Benchmarking of Key Pipeline Drugs - NMIBC setting 147
Table 81: Clinical Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings 148
Table 82: Commercial Benchmarking of Key Pipeline Drugs - NMIBC setting 149
Table 83: Commercial Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings 150
Table 84: Top Line Sales Forecasts ($) for Bladder Cancer, 2012-2017 152
Table 85: Key Events Impacting Sales for Bladder Cancer, 2012-2017 153
Table 86: Bladder Cancer Market - Drivers and Barriers, US and EU, 2012-2017 153
Table 87: Key Launch Dates 181

1.2 List of Figures
Figure 1: Bladder Cancer Staging Systems 25
Figure 2: Primary Tumor Development in Bladder Cancer 27
Figure 3: 6MM, Incidence Rates of Bladder Cancer, Ages ?15 Years, Men, Rate per 100,000 Population, 1993-2002 35
Figure 4: 6MM, Incidence Rates of Bladder Cancer, Ages ?15 Years, Women, Rate per 100,000 Population, 1993-2002 35
Figure 5: 6MM, Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Selected Years, 2012-2022 43
Figure 6: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, 2012 44
Figure 7: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, 2012 45
Figure 8: 6MM, Age-Standardized Bladder Cancer Incidence Rate, Ages ?15 Years, Men and Women, Cases per 100,000 Population, 2012 46
Figure 9: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ?15 Years, Men and Women, N, 2012 47
Figure 10: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ?15 Years, Men and Women, N, Selected Years, 2012-2022 48
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Bladder Cancer, 2012-2017 151
Figure 12: Sales for Bladder Cancer by Region, 2012 and 2017 152

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