OpportunityAnalyzer: Bladder Cancer – Opportunity Analysis and Forecasts to 2025

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Bladder Cancer: Executive Summary

2.1 Bladder Cancer Market in the 7MM Expected To Triple in Size From 2015 to 2025

2.2 Big Pharma Focuses on Label Expansion, While Smaller Companies Focus on Developing Drugs with Novel Mechanisms of Action

2.3 The Levels of Unmet Need Remain High Across Bladder Cancer Settings

2.4 Pipeline Agents Will Reduce Unmet Need, but Opportunities Remain

2.5 NMIBC Settings Are Not Expected to Change Significantly, While PD-1 Checkpoint Inhibitors Are Expected to Gain Stronghold in Advanced Disease Settings

2.6 What Do Physicians Think?

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Classification or Staging Systems

3.3 Symptoms

3.4 Prognosis

3.5 Quality of Life

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global Trends

4.3.1 Incidence

4.3.2 Relative Survival

4.4 Forecast Methodology

4.4.1 Sources Used Tables

4.4.2 Forecast Assumptions and Methods

4.4.3 Sources Not Used

4.5 Epidemiological Forecast for Bladder Cancer (2015–2025)

4.5.1 Diagnosed Incident Cases of Bladder Cancer

4.5.2 Age-Specific Diagnosed Incident Cases of Bladder Cancer

4.5.3 Sex-Specific Diagnosed Incident Cases of Bladder Cancer

4.5.4 Age-Standardized Diagnosed Incidence Rates of Bladder Cancer

4.5.5 Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis

4.5.6 Five-Year Diagnosed Prevalent Cases of Bladder Cancer

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 Limitations of the Analysis

4.6.3 Strengths of the Analysis

5 Current Treatment Options

5.1 Overview

5.2 Diagnosis and Treatment

5.2.1 Diagnosis

5.2.2 Treatment Guidelines and Leading Prescribed Drugs

5.3 Clinical Practice

5.4 Product Profiles – Major Brands, Immunotherapies

5.4.1 Bacillus Calmette-Guérin (BCG)

5.4.2 Tecentriq (atezolizumab)

5.4.3 Opdivo (nivolumab)

5.5 Product Profiles – Major Brands, Chemotherapies

5.5.1 GemCis (gemcitabine/cisplatin)

5.5.2 Mitomycin C

5.5.3 Valstar (valrubicin)

5.5.4 Javlor (vinflunine ditartrate)

6 Unmet Needs Assessment and Opportunity Analysis

6.1 Overview

6.2 Improved Treatments for Patients with BCG-Relapsed/Refractory NMIBC

6.2.1 Unmet Need

6.2.2 Gap Analysis

6.2.3 Opportunity

6.3 Prevention of Disease Progression in Patients with NMIBC

6.3.1 Unmet Need

6.3.2 Gap Analysis

6.3.3 Opportunity

6.4 Therapies for Advanced Disease Beyond Immune Checkpoint Inhibitors

6.4.1 Unmet Need

6.4.2 Gap Analysis

6.4.3 Opportunity

6.5 Predictive Biomarkers to Drive Drug Discovery

6.5.1 Unmet Need

6.5.2 Gap Analysis

6.5.3 Opportunity

6.6 Improved Diagnostic Methods

6.6.1 Unmet Need

6.6.2 Gap Analysis

6.6.3 Opportunity

7 Research and Development Strategies

7.1 Overview

7.1.1 Drug Development by Small Pharmaceutical Companies

7.1.2 Intravesical Approaches for NMIBC May Give Way to Systemic Approaches in the Future

7.1.3 Identification of Prognostic Markers for PD-1 Checkpoint Inhibitors

7.1.4 Conversion of PD-1 Checkpoint Inhibitor Nonresponders to Responders

7.2 Clinical Trial Design

7.2.1 Registrational Studies: Open-Label, Non-Comparative Trial Designs Still Prevalent

7.2.2 Variability of Trial Endpoints in Both the NMIBC and Advanced Disease Settings

8 Pipeline Assessment

8.1 Overview

8.2 Promising Drugs in Clinical Development

8.2.1 CG-0070

8.2.2 Instiladrin (rAD-Interferon (IFN)/Syn3)

8.2.3 Vicinium (oportuzumab monatox)

8.2.4 Apatorsen

8.2.5 Cyramza (ramucirumab)

8.2.6 PD-1 Immune Checkpoint Inhibitors

8.3 Innovative Early-Stage Approaches

8.3.1 ALT-803

8.3.2 Cometriq (cabozantinib)

8.3.3 BC-819

8.3.4 IMMU-132 (sacituzumab govitecan)

9 Pipeline Valuation Analysis

9.1 Clinical Benchmark of Key Pipeline Drugs

9.2 Commercial Benchmark of Key Pipeline Drugs

9.3 Competitive Assessment

9.4 Top-Line 10-Year Forecast

9.4.1 US

9.4.2 5EU

9.4.3 Japan

10 Appendix

10.1 Bibliography

10.2 Abbreviations

10.3 Methodology

10.4 Forecasting Methodology

10.4.1 Diagnosed Bladder Cancer Patients

10.4.2 Percent Drug-Treated Patients

10.4.3 Drugs Included in Each Therapeutic Class

10.4.4 Launch and Patent Expiry Dates

10.4.5 General Pricing Assumptions

10.4.6 Individual Drug Assumptions

10.4.7 Generic Erosion

10.4.8 Pricing of Pipeline Agents

10.5 Primary Research – KOLs Interviewed for this Report

10.5.1 KOLs

10.6 Primary Research – Prescriber Survey

10.7 About the Authors

10.7.1 Analyst

10.7.2 Therapy Area Director

10.7.3 Epidemiologist

10.7.4 Managing Epidemiologist

10.7.5 Global Director of Therapy Analysis and Epidemiology

10.7.6 Global Head and EVP of Healthcare Operations and Strategy

10.8 About GlobalData

10.9 Contact Us

10.10 Disclaimer

Table 1: Bladder Cancer: Key Metrics in the 7MM

Table 2: Bladder Cancer Staging System

Table 3: AJCC TNM Staging System for Bladder Cancer – Definitions of Stages

Table 4: Symptoms of Bladder Cancer

Table 5: Bladder Cancer Prognosis by Stage

Table 6: Bladder Cancer Risk Factors

Table 7: 5EU, Relative Survival of Bladder Cancer (%), Men and Women

Table 8: 7MM, Sources of Bladder Cancer Incidence Data

Table 9: 7MM, Sources of Bladder Cancer Stage at Diagnosis Data

Table 10: 7MM, Sources of Bladder Cancer Relative Survival Data

Table 11: 7MM, Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N, Select Years 2015–2025

Table 12: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N (Row %), 2015

Table 13: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, N (Row %), 2015

Table 14: 7MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, N (Row %), 2015

Table 15: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N, Select Years 2015–2025

Table 16: Treatment Guidelines for Bladder Cancer

Table 17: Leading Treatments for Bladder Cancer, 2015

Table 18: Product Profile – TICE BCG

Table 19: Efficacy of TICE BCG in CIS Bladder Cancer

Table 20: Efficacy of TICE BCG in Preventing Recurrence of Ta/T1 Bladder Cancer in the US

Table 21: Efficacy of TICE BCG in preventing recurrence of Ta/T1 bladder cancer in The Netherlands

Table 22: Safety of TICE BCG

Table 23: TICE BCG SWOT Analysis, 2016

Table 24: Product Profile – Tecentriq

Table 25: Efficacy of Tecentriq in Metastatic Bladder Cancer (Cohort 2 of IMvigor210)

Table 26: Efficacy of Tecentriq in First-line, Cisplatin-Ineligible, Metastatic Bladder Cancer (IMvigor210 Cohort 1)

Table 27: Safety of Tecentriq in Second-Line Metastatic Bladder Cancer (IMvigor210 Cohort 2)

Table 28: Safety of Tecentriq in First-Line, Cisplatin-Ineligible, Metastatic Bladder Cancer (IMvigor210 Cohort 1)

Table 29: Tecentriq SWOT Analysis, 2016

Table 30: Product Profile – Opdivo

Table 31: Efficacy of Opdivo in Second-Line Advanced Bladder Cancer

Table 32: Efficacy of Opdivo + Yervoy in Second-Line Advanced Bladder Cancer

Table 33: Safety of Opdivo in SecondLline Metastatic Bladder Cancer (CheckMate-275)

Table 34: Opdivo SWOT Analysis

Table 35: Product Profile – GemCis

Table 36: Efficacy of GemCis in the First-Line Metastatic Setting

Table 37: Safety of GemCis

Table 38: GemCis SWOT Analysis, 2016

Table 39: Product Profile – Mitomycin C

Table 40: Mitomycin C SWOT Analysis, 2016

Table 41: Product Profile – Valstar

Table 42: Efficacy of Valstar

Table 43: Safety of Valstar

Table 44: Valstar SWOT Analysis, 2016

Table 45: Product Profile – Javlor

Table 46: Efficacy of Javlor

Table 47: Safety of Javlor

Table 48: Javlor SWOT Analysis, 2016

Table 49: Unmet Needs in Bladder Cancer, 2016

Table 50: Clinical Trial Design of Key Registrational Trials in the NMIBC Setting

Table 51: Clinical Trial Design of Key Registrational Trials in the MIBC and Metastatic Settings

Table 52: Key Late-Stage Pipeline Agents for Bladder Cancer, 2016

Table 53: Product Profile – CG-0070

Table 54: Efficacy of CG-0070 (Phase I)

Table 55: Efficacy of CG-0070 (Phase II/III BOND trial)

Table 56: Safety of CG-0070

Table 57: CG-0070 SWOT Analysis

Table 58: Product Profile – Instiladrin

Table 59: Efficacy of Instiladrin (Phase II)

Table 60: Safety of CG-0070

Table 61: Instiladrin SWOT Analysis

Table 62: Product Profile – Vicinium

Table 63: Efficacy of Vicinium (Phase II)

Table 64: Safety of Vicinium

Table 65: Vicinium SWOT Analysis

Table 66: Product Profile – Apatorsen

Table 67: Efficacy of Apatorsen (Borealis-1 Trial)

Table 68: Safety of Apatorsen (Borealis-1 Trial)

Table 69: Apatorsen SWOT Analysis

Table 70: Product Profile – Cyramza

Table 71: Efficacy of Cyramza in Second-Line, Metastatic Bladder Cancer

Table 72: Safety of Cyramza in Combination with Docetaxel

Table 73: Cyramza SWOT Analysis

Table 74: Product Profile – Avelumab

Table 75: Efficacy of Avelumab (Phase 1b JAVELIN Solid Tumor)

Table 76: Safety of Avelumab

Table 77: Avelumab SWOT Analysis

Table 78: Product Profile – Durvalumab

Table 79: Efficacy of Durvalumab in Advanced BC (Bladder Cohort of Study 1108)

Table 80: Safety of Durvalumab (Bladder Cohort of Study 1108)

Table 81: Durvalumab SWOT Analysis

Table 82: Product Profile – Keytruda

Table 83: Efficacy of Keytruda in Second-Line, Metastatic Bladder Cancer (Phase III KEYNOTE-045)

Table 84: Efficacy of Keytruda in First-Line, Cisplatin-Ineligible Bladder Cancer (Phase II KEYNOTE-052)

Table 85: Safety of Keytruda in second-line treatment of advanced bladder cancer (Phase III KEYNOTE-045)

Table 86: Keytruda SWOT Analysis

Table 87: Innovative Early-Stage Approaches for Bladder Cancer, 2016

Table 88: Efficacy of BC-819

Table 89: Safety of BC-819

Table 90: Clinical Benchmark of Key Pipeline Drugs – NMIBC

Table 91: Clinical Benchmark of Key Pipeline Drugs – MIBC and Metastatic Disease

Table 92: Commercial Benchmark of Key Pipeline Drugs – NMIBC

Table 93: Commercial Benchmark of Key Pipeline Drugs – MIBC and Metastatic Disease

Table 94: Top-Line Sales Forecasts ($M) for Bladder Cancer, 2015–2025

Table 95: Key Events Impacting Sales for Bladder Cancer, 2015–2025

Table 96: Bladder Cancer Market – Global Drivers and Barriers, 2015‒2025

Table 97: Sales Forecast ($M) for Bladder Cancer in the US, 2015–2025

Table 98: Sales Forecast ($M) for Bladder Cancer in the 5EU, 2015–2025

Table 99: Sales Forecast ($M) for Bladder Cancer in Japan, 2015–2025

Table 100: Key Historical and Projected Launch Dates for Bladder Cancer

Table 101: Key Historical and Projected Patent Expiry Dates for Bladder Cancer

Table 102: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales for Bladder Cancer by Country/Region, 2015 and 2025

Figure 2: Competitive Assessment of Marketed and Pipeline Agents in NMIBC, 2015–2025

Figure 3: Competitive Assessment of Marketed and Pipeline Agents in MIBC/Metastatic Disease, 2015–2025

Figure 4: Primary Tumor Development in Bladder Cancer

Figure 5: 7MM, Age-Adjusted Diagnosed Incidence Rates of Bladder Cancer (Cases per 100,000 Population), Ages ≥15 Years, Men, 1998–2007

Figure 6: 7MM, Incidence Rates of Bladder Cancer (Cases per 100,000 Population), Ages ≥15 Years, Women, 1998–2007

Figure 7: 7MM, Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N, Select Years 2015–2025

Figure 8: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N, 2015

Figure 9: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Ages ≥15 Years, N, 2015

Figure 10:7MM, Age-Standardized Diagnosed Incidence of Bladder Cancer (Cases per 100,000 Population), Ages ≥15 Years, Both Sexes, 2015

Figure 11: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Both Sexes, N, 2015–2025

Figure 12: NMIBC Treatment Algorithm

Figure 13: MIBC/Metastatic Disease Treatment Algorithm

Figure 14: Tecentriq’s Development in Bladder Cancer

Figure 15: Opdivo’s Development in Bladder Cancer

Figure 16: CG-0070’s Development in Bladder Cancer

Figure 17: Instiladrin’s Development in Bladder Cancer

Figure 18: Vicinium’s Development in Bladder Cancer

Figure 19: Apatorsen’s Development in Bladder Cancer

Figure 20: Cyramza’s Development in Bladder Cancer

Figure 21: Avelumab’s Development in Bladder Cancer

Figure 22: Durvalumab’s Development in Bladder Cancer

Figure 23: Keytruda’s Development in Bladder Cancer

Figure 24: Competitive Assessment of Marketed and Pipeline Agents in NMIBC, 2015–2025

Figure 25: Competitive Assessment of Marketed and Pipeline Agents in MIBC/Metastatic Disease, 2015–2025

Figure 26: Top-Line Sales for Bladder Cancer by Country/Region, 2015 and 2025

Figure 27: Global Sales for Bladder Cancer by Drug Class, 2015 and 2025

Figure 28: Sales for Bladder Cancer by Drug Class in the US, 2015 and 2025

Figure 29: Sales for Bladder Cancer by Drug Class in the 5EU, 2015 and 2025

Figure 30: Sales for Bladder Cancer by Drug Class in Japan, 2015 and 2025