Bladder Cancer – Opportunity Analysis and Forecasts to 2028

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 Is Expected to Grow Exponentially in Size from 2018 to 2028

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

2.3 The Level of Unmet Need Will Still Remain Across Bladder Cancer Setting with the Opportunity for New Drug Entrants to Address Needs

2.4 Introduction of Novel Drugs Along with Greater Adoption Among PD-1/PD-L1 Checkpoint Inhibitor Drugs in Advanced-Stage Disease Setting

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

4.2.1 Symptoms

4.2.2 Prognosis

4.2.3 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors

5.3 Global and Historical Trends

5.3.1 7MM Trends in Diagnosed Incidence

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for Bladder Cancer (2018–2028)

5.5.1 Diagnosed Incident Cases of Bladder Cancer

5.5.2 Age-Specific Diagnosed Incident Cases of Bladder Cancer

5.5.3 Sex-Specific Diagnosed Incident Cases of Bladder Cancer

5.5.4 Five-Year Diagnosed Prevalent Cases of Bladder Cancer

5.5.5 Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis

5.5.6 Diagnosed Incident Cases of Bladder Cancer by Stage Ta by Grade

5.5.7 Diagnosed Incident Cases of Bladder Cancer by Tumor Location

5.5.8 Diagnosed Incident Cases of Bladder Cancer by Stage T4 Metastasis

5.5.9 Diagnosed Incident Cases of Bladder Cancer with FGFR3 Mutations

5.5.10 Diagnosed Incident Cases of Bladder Cancer (Stages T2, T3, and T4) with PD-L1 Expression

5.5.11 Diagnosed Incident Cases of Bladder Cancer with HER-2 Overexpression

5.5.12 Two-Year Recurrence of Diagnosed Incident Cases of Bladder Cancer

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Additional Therapeutic Modalities Across the Disease Spectrum

7.3 Evaluation of Novel MOAs for Advanced Disease Stage

7.4 Improved Drugs in NMIBC Patients with Tumor Recurrence and BCG Recurrent and Refractory Patients

7.5 Improved Diagnostic and Drug Delivery Methods for Later Disease Stages

8 R&D Strategies

8.1 Overview

8.1.1 Orphan and Regulatory Designations Accelerate Drug Development in Bladder Cancer

8.1.2 Involvement of Both Big and Small Biotech Companies in Drug Development

8.1.3 Novel Immunotherapy Combinations and Label Expansions

8.2 Clinical Trials Design

8.2.1 Registrational Studies: Open-Label, Non-comparative Trial Designs Still Prevalent

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

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early-Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Agents

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.4.2 Payers

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 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: Risk Factors for Bladder Cancer

Table 6: 7MM, Two-Year Recurrence of Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018, N

Table 7: Treatment Guidelines for Bladder Cancer

Table 8: Leading Treatments for Bladder Cancer Along with Launch Dates in Different Countries

Table 9: Comparison of Therapeutic Classes in Development for Bladder Cancer, 2018–2028

Table 10: Innovative Early-Stage Approaches for Bladder Cancer, 2020

Table 11: Drugs in Development for Bladder Cancer, 2020

Table 12: Clinical Benchmark of Key Pipeline Drugs – NMIBC

Table 13: Clinical Benchmark of Key Pipeline Drugs – MIBC and Locally Advanced and Metastatic Bladder Cancer

Table 14: Commercial Benchmark of Key Pipeline Drugs – NMIBC

Table 15: Commercial Benchmark of Key Pipeline Drugs – MIBC and Locally Advanced and Metastatic Bladder Cancer

Table 16: Key Events Impacting Sales for Bladder Cancer, 2018–2028

Table 17: Bladder Cancer Market – Global Drivers and Barriers, 2018–2028

Table 18: Key Historical and Projected Launch Dates for Bladder Cancer

Table 19: Key Historical and Projected Patent Expiry Dates for Bladder Cancer

Table 20: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for Bladder Cancer in 2018 and 2028

Figure 2: Competitive Assessment of the Pipeline Drugs for NMIBC Benchmarked Against the SOC, BCG

Figure 3: Competitive Assessment of the Pipeline Drugs for MIBC or Locally Advanced/Metastatic Bladder Cancer Benchmarked Against the SOC, Gemcitabine + Cisplatin

Figure 4: Primary Tumor Development in Bladder Cancer

Figure 5: 7MM, Diagnosed Incidence of Bladder Cancer, Men, Ages ≥18 Years, 2008–2028, Cases per 100,000 Population

Figure 6: 7MM, Diagnosed Incidence of Bladder Cancer, Women, Ages ≥18 Years, 2008–2028, Cases per 100,000 Population

Figure 7: Sources Used and Not Used for Diagnosed Incident Cases of Bladder Cancer

Figure 8: Sources Used for Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis

Figure 9: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage Ta by Grade

Figure 10: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage by Tumor Location

Figure 11: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage T4 by Metastasis

Figure 12: Sources Used for Five-Year Diagnosed Prevalent Cases of Bladder Cancer

Figure 13: Sources Used for Diagnosed Incident Cases of Bladder Cancer by Mutations and Biomarkers

Figure 14: Sources Used for Two-Year Recurrence of Diagnosed Incident Cases of Bladder Cancer

Figure 15: 7MM, Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018

Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018, N

Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018, N

Figure 18: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018

Figure 19: 7MM, Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis, Both Sexes, Ages ≥18 Years, 2018, N

Figure 20: 7MM, Diagnosed Incident Cases of Bladder Cancer Stage Ta by Grade, Both Sexes, Ages ≥18 Years, 2018, N

Figure 21: 7MM, Diagnosed Incident Cases of Bladder Cancer by Tumor Location, Both Sexes, Ages ≥18 Years, 2018, N

Figure 22: 7MM, Diagnosed Incident Cases of Bladder Cancer by Stage T4 Metastasis, Both Sexes, Ages ≥18 Years, 2018, N

Figure 23: 7MM, Diagnosed Incident Cases of Bladder Cancer with FGFR3 Mutations, Both Sexes, Ages ≥18 Years, 2018, N

Figure 24: 7MM, Diagnosed Incident Cases of Bladder Cancer (Stages T2, T3, and T4) with PD-L1 Expression, Both Sexes, Ages ≥18 Years, 2018, N

Figure 25: 7MM, Diagnosed Incident Cases of Bladder Cancer with HER-2 Overexpression, Both Sexes, Ages ≥18 Years, 2018, N

Figure 26: Treatment Flow for NMIBC

Figure 27: Treatment Flow for Advanced-Stage Bladder Cancer

Figure 28: Unmet Needs and Opportunities in Bladder Cancer

Figure 29: Overview of the Development Pipeline in Bladder Cancer

Figure 30: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for Bladder Cancer in the 7MM During the Forecast Period

Figure 31: Competitive Assessment of the Pipeline Drugs in NMIBC Benchmarked Against the SOC, BCG

Figure 32: Competitive Assessment of the Pipeline Drugs in MIBC Benchmarked Against the SOC, Gemcitabine + Cisplatin

Figure 33: Global (7MM) Sales Forecast by Country for Bladder Cancer in 2018 and 2028

Figure 34: Global Sales Forecast by Class for Bladder Cancer in 2018 and 2028

Figure 35: Sales Forecast by Class for Bladder Cancer in the US in 2018 and 2028

Figure 36: Sales Forecast by Class for Bladder Cancer in the 5EU in 2018 and 2028

Figure 37: Sales Forecast by Class for Bladder Cancer in Japan in 2018 and 2028