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OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2025

Published By :

GlobalData

Published Date : Apr 2017

Category :

Pharmaceutical

No. of Pages : 229 Pages

OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2025

Summary

The bladder cancer market in the seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, and Japan) 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 during the forecast period. 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 newer immunotherapies, specifically, PD-1 checkpoint modulators, of which five are expected to launch by 2025. These drugs will provide much-needed alternatives to bladder cancer patients who have not benefitted from traditional treatments.

Key Questions Answered

- How will the bladder cancer market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) change from 2015-2025?
- What are the most promising late-stage pipeline drugs in bladder cancer?
- How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?
- What are the unmet needs in bladder cancer treatment management?
- What drivers and barriers will affect bladder cancer therapeutics sales in the 7MM over the forecast period?

Scope

- Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline Bladder cancer market revenue from 2015-2025. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting bladder cancer therapeutics sales in the 7MM.
- 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 products.
- 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.
- 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 bladder cancer therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Bladder Cancer: Executive Summary 10
2.1 Bladder Cancer Market in the 7MM Expected To Triple in Size From 2015 to 2025 11
2.2 Big Pharma Focuses on Label Expansion, While Smaller Companies Focus on Developing Drugs with Novel Mechanisms of Action 12
2.3 The Levels of Unmet Need Remain High Across Bladder Cancer Settings 13
2.4 Pipeline Agents Will Reduce Unmet Need, but Opportunities Remain 13
2.5 NMIBC Settings Are Not Expected to Change Significantly, While PD-1 Checkpoint Inhibitors Are Expected to Gain Stronghold in Advanced Disease Settings 14
2.6 What Do Physicians Think? 17
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Classification or Staging Systems 21
3.3 Symptoms 24
3.4 Prognosis 25
3.5 Quality of Life 25
4 Epidemiology 27
4.1 Disease Background 27
4.2 Risk Factors and Comorbidities 27
4.3 Global Trends 28
4.3.1 Incidence 29
4.3.2 Relative Survival 31
4.4 Forecast Methodology 32
4.4.1 Sources Used Tables 32
4.4.2 Forecast Assumptions and Methods 36
4.4.3 Sources Not Used 39
4.5 Epidemiological Forecast for Bladder Cancer (2015-2025) 40
4.5.1 Diagnosed Incident Cases of Bladder Cancer 40
4.5.2 Age-Specific Diagnosed Incident Cases of Bladder Cancer 41
4.5.3 Sex-Specific Diagnosed Incident Cases of Bladder Cancer 43
4.5.4 Age-Standardized Diagnosed Incidence Rates of Bladder Cancer 44
4.5.5 Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis 45
4.5.6 Five-Year Diagnosed Prevalent Cases of Bladder Cancer 46
4.6 Discussion 48
4.6.1 Epidemiological Forecast Insight 48
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 Diagnosis and Treatment 51
5.2.1 Diagnosis 51
5.2.2 Treatment Guidelines and Leading Prescribed Drugs 53
5.3 Clinical Practice 54
5.4 Product Profiles - Major Brands, Immunotherapies 56
5.4.1 Bacillus Calmette-Gurin (BCG) 56
5.4.2 Tecentriq (atezolizumab) 63
5.4.3 Opdivo (nivolumab) 72
5.5 Product Profiles - Major Brands, Chemotherapies 79
5.5.1 GemCis (gemcitabine/cisplatin) 79
5.5.2 Mitomycin C 83
5.5.3 Valstar (valrubicin) 84
5.5.4 Javlor (vinflunine ditartrate) 88
6 Unmet Needs Assessment and Opportunity Analysis 93
6.1 Overview 93
6.2 Improved Treatments for Patients with BCG-Relapsed/Refractory NMIBC 93
6.2.1 Unmet Need 93
6.2.2 Gap Analysis 94
6.2.3 Opportunity 94
6.3 Prevention of Disease Progression in Patients with NMIBC 95
6.3.1 Unmet Need 95
6.3.2 Gap Analysis 95
6.3.3 Opportunity 96
6.4 Therapies for Advanced Disease Beyond Immune Checkpoint Inhibitors 96
6.4.1 Unmet Need 96
6.4.2 Gap Analysis 97
6.4.3 Opportunity 97
6.5 Predictive Biomarkers to Drive Drug Discovery 97
6.5.1 Unmet Need 97
6.5.2 Gap Analysis 98
6.5.3 Opportunity 98
6.6 Improved Diagnostic Methods 98
6.6.1 Unmet Need 98
6.6.2 Gap Analysis 99
6.6.3 Opportunity 99
7 Research and Development Strategies 100
7.1 Overview 100
7.1.1 Drug Development by Small Pharmaceutical Companies 100
7.1.2 Intravesical Approaches for NMIBC May Give Way to Systemic Approaches in the Future 101
7.1.3 Identification of Prognostic Markers for PD-1 Checkpoint Inhibitors 101
7.1.4 Conversion of PD-1 Checkpoint Inhibitor Nonresponders to Responders 102
7.2 Clinical Trial Design 103
7.2.1 Registrational Studies: Open-Label, Non-Comparative Trial Designs Still Prevalent 108
7.2.2 Variability of Trial Endpoints in Both the NMIBC and Advanced Disease Settings 108
8 Pipeline Assessment 110
8.1 Overview 110
8.2 Promising Drugs in Clinical Development 111
8.2.1 CG-0070 112
8.2.2 Instiladrin (rAD-Interferon (IFN)/Syn3) 118
8.2.3 Vicinium (oportuzumab monatox) 121
8.2.4 Apatorsen 126
8.2.5 Cyramza (ramucirumab) 132
8.2.6 PD-1 Immune Checkpoint Inhibitors 138
8.3 Innovative Early-Stage Approaches 157
8.3.1 ALT-803 158
8.3.2 Cometriq (cabozantinib) 158
8.3.3 BC-819 160
8.3.4 IMMU-132 (sacituzumab govitecan) 162
9 Pipeline Valuation Analysis 164
9.1 Clinical Benchmark of Key Pipeline Drugs 164
9.2 Commercial Benchmark of Key Pipeline Drugs 169
9.3 Competitive Assessment 172
9.4 Top-Line 10-Year Forecast 174
9.4.1 US 178
9.4.2 5EU 181
9.4.3 Japan 184
10 Appendix 187
10.1 Bibliography 187
10.2 Abbreviations 206
10.3 Methodology 210
10.4 Forecasting Methodology 210
10.4.1 Diagnosed Bladder Cancer Patients 210
10.4.2 Percent Drug-Treated Patients 210
10.4.3 Drugs Included in Each Therapeutic Class 211
10.4.4 Launch and Patent Expiry Dates 211
10.4.5 General Pricing Assumptions 212
10.4.6 Individual Drug Assumptions 213
10.4.7 Generic Erosion 222
10.4.8 Pricing of Pipeline Agents 222
10.5 Primary Research - KOLs Interviewed for this Report 223
10.5.1 KOLs 223
10.6 Primary Research - Prescriber Survey 225
10.7 About the Authors 226
10.7.1 Analyst 226
10.7.2 Therapy Area Director 226
10.7.3 Epidemiologist 226
10.7.4 Managing Epidemiologist 227
10.7.5 Global Director of Therapy Analysis and Epidemiology 227
10.7.6 Global Head and EVP of Healthcare Operations and Strategy 228
10.8 About GlobalData 229
10.9 Contact Us 229
10.10 Disclaimer 229

1.1 List of Tables
Table 1: Bladder Cancer: Key Metrics in the 7MM 10
Table 2: Bladder Cancer Staging System 22
Table 3: AJCC TNM Staging System for Bladder Cancer - Definitions of Stages 23
Table 4: Symptoms of Bladder Cancer 25
Table 5: Bladder Cancer Prognosis by Stage 25
Table 6: Bladder Cancer Risk Factors 28
Table 7: 5EU, Relative Survival of Bladder Cancer (%), Men and Women 32
Table 8: 7MM, Sources of Bladder Cancer Incidence Data 33
Table 9: 7MM, Sources of Bladder Cancer Stage at Diagnosis Data 34
Table 10: 7MM, Sources of Bladder Cancer Relative Survival Data 35
Table 11: 7MM, Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N, Select Years 2015-2025 40
Table 12: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N (Row %), 2015 42
Table 13: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, N (Row %), 2015 43
Table 14: 7MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages 15 Years, Men and Women, N (Row %), 2015 46
Table 15: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N, Select Years 2015-2025 47
Table 16: Treatment Guidelines for Bladder Cancer 53
Table 17: Leading Treatments for Bladder Cancer, 2015 54
Table 18: Product Profile - TICE BCG 58
Table 19: Efficacy of TICE BCG in CIS Bladder Cancer 60
Table 20: Efficacy of TICE BCG in Preventing Recurrence of Ta/T1 Bladder Cancer in the US 61
Table 21: Efficacy of TICE BCG in preventing recurrence of Ta/T1 bladder cancer in The Netherlands 61
Table 22: Safety of TICE BCG 62
Table 23: TICE BCG SWOT Analysis, 2016 62
Table 24: Product Profile - Tecentriq 65
Table 25: Efficacy of Tecentriq in Metastatic Bladder Cancer (Cohort 2 of IMvigor210) 68
Table 26: Efficacy of Tecentriq in First-line, Cisplatin-Ineligible, Metastatic Bladder Cancer (IMvigor210 Cohort 1) 69
Table 27: Safety of Tecentriq in Second-Line Metastatic Bladder Cancer (IMvigor210 Cohort 2) 70
Table 28: Safety of Tecentriq in First-Line, Cisplatin-Ineligible, Metastatic Bladder Cancer (IMvigor210 Cohort 1) 71
Table 29: Tecentriq SWOT Analysis, 2016 72
Table 30: Product Profile - Opdivo 74
Table 31: Efficacy of Opdivo in Second-Line Advanced Bladder Cancer 76
Table 32: Efficacy of Opdivo + Yervoy in Second-Line Advanced Bladder Cancer 77
Table 33: Safety of Opdivo in SecondLline Metastatic Bladder Cancer (CheckMate-275) 78
Table 34: Opdivo SWOT Analysis 78
Table 35: Product Profile - GemCis 80
Table 36: Efficacy of GemCis in the First-Line Metastatic Setting 81
Table 37: Safety of GemCis 82
Table 38: GemCis SWOT Analysis, 2016 82
Table 39: Product Profile - Mitomycin C 83
Table 40: Mitomycin C SWOT Analysis, 2016 84
Table 41: Product Profile - Valstar 85
Table 42: Efficacy of Valstar 86
Table 43: Safety of Valstar 87
Table 44: Valstar SWOT Analysis, 2016 88
Table 45: Product Profile - Javlor 89
Table 46: Efficacy of Javlor 90
Table 47: Safety of Javlor 91
Table 48: Javlor SWOT Analysis, 2016 92
Table 49: Unmet Needs in Bladder Cancer, 2016 93
Table 50: Clinical Trial Design of Key Registrational Trials in the NMIBC Setting 104
Table 51: Clinical Trial Design of Key Registrational Trials in the MIBC and Metastatic Settings 105
Table 52: Key Late-Stage Pipeline Agents for Bladder Cancer, 2016 111
Table 53: Product Profile - CG-0070 113
Table 54: Efficacy of CG-0070 (Phase I) 116
Table 55: Efficacy of CG-0070 (Phase II/III BOND trial) 116
Table 56: Safety of CG-0070 117
Table 57: CG-0070 SWOT Analysis 118
Table 58: Product Profile - Instiladrin 119
Table 59: Efficacy of Instiladrin (Phase II) 120
Table 60: Safety of CG-0070 121
Table 61: Instiladrin SWOT Analysis 121
Table 62: Product Profile - Vicinium 123
Table 63: Efficacy of Vicinium (Phase II) 125
Table 64: Safety of Vicinium 125
Table 65: Vicinium SWOT Analysis 126
Table 66: Product Profile - Apatorsen 127
Table 67: Efficacy of Apatorsen (Borealis-1 Trial) 130
Table 68: Safety of Apatorsen (Borealis-1 Trial) 131
Table 69: Apatorsen SWOT Analysis 132
Table 70: Product Profile - Cyramza 134
Table 71: Efficacy of Cyramza in Second-Line, Metastatic Bladder Cancer 136
Table 72: Safety of Cyramza in Combination with Docetaxel 137
Table 73: Cyramza SWOT Analysis 138
Table 74: Product Profile - Avelumab 141
Table 75: Efficacy of Avelumab (Phase 1b JAVELIN Solid Tumor) 143
Table 76: Safety of Avelumab 144
Table 77: Avelumab SWOT Analysis 144
Table 78: Product Profile - Durvalumab 146
Table 79: Efficacy of Durvalumab in Advanced BC (Bladder Cohort of Study 1108) 148
Table 80: Safety of Durvalumab (Bladder Cohort of Study 1108) 149
Table 81: Durvalumab SWOT Analysis 150
Table 82: Product Profile - Keytruda 151
Table 83: Efficacy of Keytruda in Second-Line, Metastatic Bladder Cancer (Phase III KEYNOTE-045) 154
Table 84: Efficacy of Keytruda in First-Line, Cisplatin-Ineligible Bladder Cancer (Phase II KEYNOTE-052) 155
Table 85: Safety of Keytruda in second-line treatment of advanced bladder cancer (Phase III KEYNOTE-045) 156
Table 86: Keytruda SWOT Analysis 157
Table 87: Innovative Early-Stage Approaches for Bladder Cancer, 2016 157
Table 88: Efficacy of BC-819 161
Table 89: Safety of BC-819 162
Table 90: Clinical Benchmark of Key Pipeline Drugs - NMIBC 164
Table 91: Clinical Benchmark of Key Pipeline Drugs - MIBC and Metastatic Disease 166
Table 92: Commercial Benchmark of Key Pipeline Drugs - NMIBC 169
Table 93: Commercial Benchmark of Key Pipeline Drugs - MIBC and Metastatic Disease 170
Table 94: Top-Line Sales Forecasts ($M) for Bladder Cancer, 2015-2025 175
Table 95: Key Events Impacting Sales for Bladder Cancer, 2015-2025 177
Table 96: Bladder Cancer Market - Global Drivers and Barriers, 20152025 178
Table 97: Sales Forecast ($M) for Bladder Cancer in the US, 2015-2025 179
Table 98: Sales Forecast ($M) for Bladder Cancer in the 5EU, 2015-2025 182
Table 99: Sales Forecast ($M) for Bladder Cancer in Japan, 2015-2025 185
Table 100: Key Historical and Projected Launch Dates for Bladder Cancer 211
Table 101: Key Historical and Projected Patent Expiry Dates for Bladder Cancer 212
Table 102: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 225

1.2 List of Figures
Figure 1: Global Sales for Bladder Cancer by Country/Region, 2015 and 2025 12
Figure 2: Competitive Assessment of Marketed and Pipeline Agents in NMIBC, 2015-2025 15
Figure 3: Competitive Assessment of Marketed and Pipeline Agents in MIBC/Metastatic Disease, 2015-2025 16
Figure 4: Primary Tumor Development in Bladder Cancer 24
Figure 5: 7MM, Age-Adjusted Diagnosed Incidence Rates of Bladder Cancer (Cases per 100,000 Population), Ages 15 Years, Men, 1998-2007 30
Figure 6: 7MM, Incidence Rates of Bladder Cancer (Cases per 100,000 Population), Ages 15 Years, Women, 1998-2007 31
Figure 7: 7MM, Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N, Select Years 2015-2025 41
Figure 8: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N, 2015 43
Figure 9: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Ages 15 Years, N, 2015 44
Figure 10:7MM, Age-Standardized Diagnosed Incidence of Bladder Cancer (Cases per 100,000 Population), Ages 15 Years, Both Sexes, 2015 45
Figure 11: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Ages 15 Years, Both Sexes, N, 2015-2025 47
Figure 12: NMIBC Treatment Algorithm 55
Figure 13: MIBC/Metastatic Disease Treatment Algorithm 56
Figure 14: Tecentriqs Development in Bladder Cancer 66
Figure 15: Opdivos Development in Bladder Cancer 74
Figure 16: CG-0070s Development in Bladder Cancer 114
Figure 17: Instiladrins Development in Bladder Cancer 119
Figure 18: Viciniums Development in Bladder Cancer 123
Figure 19: Apatorsens Development in Bladder Cancer 128
Figure 20: Cyramzas Development in Bladder Cancer 134
Figure 21: Avelumabs Development in Bladder Cancer 142
Figure 22: Durvalumabs Development in Bladder Cancer 146
Figure 23: Keytrudas Development in Bladder Cancer 152
Figure 24: Competitive Assessment of Marketed and Pipeline Agents in NMIBC, 2015-2025 172
Figure 25: Competitive Assessment of Marketed and Pipeline Agents in MIBC/Metastatic Disease, 2015-2025 173
Figure 26: Top-Line Sales for Bladder Cancer by Country/Region, 2015 and 2025 175
Figure 27: Global Sales for Bladder Cancer by Drug Class, 2015 and 2025 176
Figure 28: Sales for Bladder Cancer by Drug Class in the US, 2015 and 2025 180
Figure 29: Sales for Bladder Cancer by Drug Class in the 5EU, 2015 and 2025 183
Figure 30: Sales for Bladder Cancer by Drug Class in Japan, 2015 and 2025 186

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