The 2016 and 2017 FDA approvals of multiple immune checkpoint inhibitors for advanced bladder cancer have greatly altered the treatment landscape for this disease. The FDA’s (2020) and EC’s (2021) approvals of Bavencio (Merck KGaA / Pfizer) as a maintenance treatment for first-line locally advanced or metastatic disease and the FDA’s approval of Keytruda (Merck & Co.) for non-muscle-invasive BCG-unresponsive disease highlight the expanded use of immune checkpoint inhibitors across lines of therapy. The FDA’s approval of Padcev (Seagen / Astellas) will have a significant impact on the market, and label expansions will follow across the G7 for use in combination with Keytruda for muscle-invasive and metastatic disease. Given the intense Phase II/III pipeline activity, we anticipate the approval of several new therapies for various populations by 2030.

QUESTIONS ANSWERED

  • What are the sizes of the clinically and commercially relevant drug-treatable bladder cancer populations, and how will drug-treatment rates change over time?
  • How is bladder cancer currently treated, and what are the key advantages and disadvantages of existing drugs? What is the expected market impact of recent approvals?
  • Which of the emerging therapies are viewed as most promising, and what sales / uptake could they secure in the bladder cancer market?
  • What are the drivers of and constraints in the bladder cancer market, and how will the market evolve over the ten-year forecast period?

PRODUCT DESCRIPTION

Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

SOLUTION ENHANCEMENT

Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.

Table of contents

  • Bladder Cancer - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q3 2021
        • Q2 2021
          • April 2021
        • Q1 2021
          • March 2021
          • February 2021
          • January 2021
        • Q4 2020
          • December 2020
          • November 2020
        • Q3 2020
          • December 2020
          • November 2020
        • Q2 2020
          • June 2020
      • Key Findings
        • Bladder Cancer - Key Findings
          • June 2020
      • Market Outlook
        • Key Findings
          • Market Share of Drug Classes for Bladder Cancer: 2020
          • Market Share of Drug Classes for Bladder Cancer: 2030
          • Drug-Treatable Population Share and Major-Market Sales Share in Bladder Cancer: 2020
          • Drug-Treatable Population Share and Major-Market Sales Share in Bladder Cancer: 2030
          • Population Positioning of Therapies in Bladder Cancer: United States
          • Population Positioning of Therapies in Bladder Cancer: Europe
          • Population Positioning of Therapies in Bladder Cancer: Japan
          • Bladder Cancer SWOT Analysis
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Bladder Cancer?
          • What Factors Are Constraining the Market for Bladder Cancer?
          • U.S. Sales of Key Therapies (Excluding Immune Checkpoint Inhibitors) in the Bladder Cancer Market: 2020-2030
          • U.S. Sales of Immune Checkpoint Inhibitors in the Bladder Cancer Market: 2020-2030
        • Segment-Specific Trends
          • Patient-Share Dynamics for Key Treatments for Non-Muscle-Invasive Bladder Cancer in the United States: 2020-2030
          • Patient-Share Dynamics for Key Treatments for Non-Muscle-Invasive Bladder Cancer in Europe: 2020-2030
          • Patient-Share Dynamics of Key Treatments for Localized and Resectable Locally Advanced Muscle-Invasive Bladder Cancer in the Major Markets: 2020-2030
          • Patient-Share Dynamics of Key Treatments in First-Line Unresectable Locally Advanced or Metastatic Bladder Cancer in the United States: 2020-2030
          • Patient-Share Dynamics of Key Treatments for First-Line Metastatic Bladder Cancer in Europe: 2020-2030
          • Patient-Share Dynamics of Key Treatments for Second-Line Metastatic Bladder Cancer in the United States: 2020-2030
          • Patient-Share Dynamics of Key Treatments for Third-Line Metastatic Bladder Cancer in the United States: 2020-2030
      • Forecast
        • Market Forecast Downloads
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Disease Pathophysiology
            • Staging and Classification
              • Definitions of the TNM Staging System for Bladder Cancer
              • AJCC / UICC TNM Staging Classification System for Bladder Cancer
            • Key Pathways and Drug Targets
              • Key Pathways and Drug Targets for Bladder Cancer
          • Epidemiology
            • Key Findings
              • Epidemiology Populations
                • Disease Definition
                • Methods
                • Sources Used for Diagnosed Incidence of Bladder Cancer
                • Diagnosed Incident Cases of Bladder Cancer: 2020-2030
                • Disease Definition
                • Methods
                • Sources Used for Stage Distribution of Bladder Cancer
                • Diagnosed Incident Cases of Bladder Cancer by Stage: 2020-2030
                • Diagnosed Incident Cases of Bladder Cancer by Muscle-Invasiveness at Diagnosis: 2020-2030
                • Definition
                • Methods
                • Sources Used for Locally Recurrent Incident Cases of Bladder Cancer
                • Locally Recurrent Incident Cases of Bladder Cancer: 2020-2030
                • Definition
                • Methods
                • Sources Used for Metastatic Recurrent Incident Cases of Bladder Cancer
                • Metastatic Recurrent Incident Cases of Bladder Cancer: 2020-2030
                • Bladder Cancer Patient Flow
                • Sources Used for Drug-Treatable Populations of Bladder Cancer
                • Drug-Treatable Cases of Bladder Cancer: 2020-2030
                • Drug-Treated Cases of Bladder Cancer: 2020-2030
            • Current Treatment
              • Key Findings
                • Treatment Goals
                  • Key Endpoints Used in Clinical Trials for Bladder Cancer
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drug Classes Used for Bladder Cancer
                  • Current Treatments Used for Bladder Cancer
                  • Market Events Impacting the Use of Key Current Therapies in Bladder Cancer
                  • Key Results from Select Clinical Trials Investigating Tecentriq for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Tecentriq
                  • Key Ongoing Clinical Trials of Tecentriq in the Treatment of Bladder Cancer
                  • Expert Insight: Tecentriq
                  • Key Results from Select Clinical Trials Investigating Opdivo for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Opdivo
                  • Key Ongoing Clinical Trials of Opdivo in the Treatment of Bladder Cancer
                  • Expert Insight: Opdivo
                  • Key Results from Select Clinical Trials Investigating Keytruda for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Keytruda
                  • Key Ongoing Clinical Trials of Keytruda in the Treatment of Bladder Cancer
                  • Expert Insight: Keytruda
                  • Key Results from Select Clinical Trials Investigating Bavencio for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Bavencio
                  • Key Ongoing Clinical Trials of Bavencio in the Treatment of Bladder Cancer
                  • Expert Insight: Bavencio
                  • Balversa
                  • Key Results from Select Clinical Trials Investigating Balversa for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Balversa
                  • Key Ongoing Clinical Trials of Balversa in Bladder Cancer
                  • Expert Insight: Balversa
                  • Key Results from Select Clinical Trials Investigating Padcev for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Padcev
                  • Key Ongoing Clinical Trials of Padcev in the Treatment of Bladder Cancer
                  • Expert Insight: Padcev
                  • Trodelvy
                  • Key Results from Select Clinical Trials Investigating Trodelvy for the Treatment of Bladder Cancer
                  • Ongoing Clinical Development of Trodelvy
                  • Key Ongoing Clinical Trials of Trodelvy in the Treatment of Bladder Cancer
                  • Expert Insight: Trodelvy
                • Medical Practice
                  • Non-Muscle-Invasive Bladder Cancer
                  • Localized and Resectable Locally Advanced Muscle-Invasive Bladder Cancer
                  • First-Line Unresectable Locally Advanced or Metastatic Bladder Cancer
                  • Second- and Third-Line Metastatic Bladder Cancer
                  • Bladder Cancer Treatment Guidelines
                  • Patient Characteristics Influencing Drug Selection in Bladder Cancer
                  • Region-Specific Treatment Practices
                  • Treatment Decision Tree for Bladder Cancer: United States
                  • Treatment Decision Tree for Bladder Cancer: Europe
                  • Treatment Decision Tree for Bladder Cancer: Japan
              • Unmet Need
                • Attainment of Unmet Needs
                  • Current and Future Attainment of Unmet Needs in Bladder Cancer
                  • Top Unmet Needs in Bladder Cancer: Current and Future Attainment
              • Emerging Therapies
                • Key Findings
                  • Key Emerging Therapies
                    • Key Therapies in Development for Bladder Cancer
                    • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of Bladder Cancer
                    • Lenvima
                    • Key Results from Select Clinical Trials Investigating Lenvima for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Lenvima
                    • Key Ongoing Clinical Trials of Lenvima in the Treatment of Bladder Cancer
                    • Expert Insight: Lenvima
                    • Expectations for Market Authorization and Sales Opportunity of Lenvima in Bladder Cancer
                    • Key Results from Select Clinical Trials Investigating Cyramza for the Treatment of Bladder Cancer
                    • Analysis of Clinical Development Program for Cyramza
                    • Key Ongoing Clinical Trials of Cyramza in the Treatment of Bladder Cancer
                    • Expert Insight: Cyramza
                    • Expectations for Market Authorization and Sales Opportunity of Cyramza in Bladder Cancer
                    • Sasanlimab
                    • Key Results from Select Clinical Trials Investigating Sasanlimab for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Sasanlimab
                    • Key Ongoing Clinical Trials of Sasanlimab in the Treatment of Bladder Cancer
                    • Expert Insight: Sasanlimab
                    • Expectations for Market Authorization and Sales Opportunity of Sasanlimab in Bladder Cancer
                    • Cetrelimab
                    • Key Results of Select Clinical Trials Investigating Cetrelimab in Bladder Cancer
                    • Analysis of the Clinical Development Program for Cetrelimab
                    • Key Ongoing Clinical Trials of Cetrelimab in Bladder Cancer
                    • Expert Insight: Cetrelimab
                    • Expectation for Market Authorization and Sales Opportunity of Cetrelimab in Bladder Cancer
                    • Key Results from Select Clinical Trials Investigating Imfinzi for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Imfinzi
                    • Key Ongoing Clinical Trials of Imfinzi in the Treatment of Bladder Cancer
                    • Expert Insight: Imfinzi
                    • Expectations for Market Authorization and Sales Opportunity of Imfinzi in Bladder Cancer
                    • Linrodostat
                    • Key Results from Select Clinical Trials Investigating Linrodostat for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Linrodostat
                    • Key Ongoing Clinical Trials of Linrodostat in the Treatment of Bladder Cancer
                    • Expert Insight: Linrodostat
                    • Expectations for Market Authorization and Sales Opportunity of Linrodostat in Bladder Cancer
                    • Key Results from Select Clinical Trials Investigating Oportuzumab Monatox for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Oportuzumab Monatox
                    • Key Ongoing Clinical Trials of Oportuzumab Monatox in the Treatment of Bladder Cancer
                    • Expert Insight: Oportuzumab Monatox
                    • Expectations for Market Authorization and Sales Opportunity of Oportuzumab Monatox in Bladder Cancer
                    • Key Results from Select Clinical Trials Investigating Nadofaragene Firadenovec for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Nadofaragene Firadenovec
                    • Key Ongoing Clinical Trials of Nadofaragene Firadenovec in Bladder Cancer
                    • Expert Insight: Nadofaragene Firadenovec
                    • Expectations for Market Authorization and Sales Opportunity of Nadofaragene Firadenovec in Bladder Cancer
                    • CG0070
                    • Key Results from Select Clinical Trials Investigating CG0070 in Bladder Cancer
                    • Analysis of the Clinical Development Program for CG0070
                    • Key Ongoing Clinical Trials of CG0070 in Bladder Cancer
                    • Expert Insight: CG0070
                    • Expectation for Market Authorization and Sales Opportunity of CG0070 in Bladder Cancer
                    • Bempegaldesleukin
                    • Key Results from Select Clinical Trials Investigating Bempegaldesleukin for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Bempegaldesleukin
                    • Key Ongoing Clinical Trials of Bempegaldesleukin in the Treatment of Bladder Cancer
                    • Expert Insight: Bempegaldesleukin
                    • Expectations for Market Authorization and Sales Opportunity of Bempegaldesleukin in Bladder Cancer
                    • Nogapendekin Alfa Inbakicept
                    • Key Results from Select Clinical Trials Investigating Nogapendekin Alfa Inbakicept in Bladder Cancer
                    • Analysis of the Clinical Development Program for Nogapendekin Alfa Inbakicept
                    • Key Ongoing Clinical Trials of Nogapendekin Alfa Inbakicept in Bladder Cancer
                    • Expectation for Market Authorization and Sales Opportunity of Nogapendekin Alfa Inbakicept in Bladder Cancer
                    • Key Results from Select Clinical Trials Investigating Apaziquone for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Apaziquone
                    • Key Ongoing Clinical Trials of Apaziquone in the Treatment of Bladder Cancer
                    • Expert Insight: Apaziquone
                    • Expectations for Market Authorization and Sales Opportunity of Apaziquone in Bladder Cancer
                    • TAR-200
                    • Key Results from Select Clinical Trials Investigating TAR-200 in Bladder Cancer
                    • Analysis of the Clinical Development Program for TAR-200
                    • Key Ongoing Clinical Trials of TAR-200 in Bladder Cancer
                    • Expert Insight: TAR-200
                    • Expectation for Market Authorization and Sales Opportunity of TAR-200 in Bladder Cancer
                    • UGN-102
                    • Key Results From Select Clinical Trials Investigating UGN-102 in Bladder Cancer
                    • Ongoing Clinical Development of UGN-102
                    • Key Ongoing Clinical Trials of UGN-102 in Bladder Cancer
                    • Expectation for Market Authorization and Sales Opportunity of UGN-102 in Bladder Cancer
                    • Infigratinib
                    • Key Results from Select Clinical Trials Investigating Infigratinib for the Treatment of Bladder Cancer
                    • Analysis of the Clinical Development Program for Infigratinib
                    • Key Ongoing Clinical Trials of Infigratinib in the Treatment of Bladder Cancer
                    • Expert Insight: Infigratinib
                    • Expectations for Market Authorization and Sales Opportunity of Infigratinib in Bladder Cancer
                  • Early-Phase Pipeline Analysis
                    • Select Compounds in Early-Phase Development for Bladder Cancer
                • Access & Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                    • Key Market Access Considerations in Bladder Cancer: United States
                    • General Reimbursement Environment: United States
                    • Key Market Access Considerations in Bladder Cancer: EU5
                    • General Reimbursement Environment: EU5
                    • Key Market Access Considerations in Bladder Cancer: Japan
                    • General Reimbursement Environment: Japan
                • Appendix
                  • Brands, Marketers, and Generic Availability of Key Therapies for Bladder Cancer by Market
                  • Bladder Cancer Bibliography

              Author(s): Grace Mitchell, M.Res.; Narendra Parihar

              Grace Mitchell, M.Res., is an analyst on the Oncology team at Clarivate. She has authored content on immune checkpoint inhibitors, bladder cancer, and ovarian cancer. She obtained her master’s degree in cancer sciences, with a focus on the expression of immune checkpoints in diffuse large B-cell lymphoma, from the University of Birmingham. She also holds an Honor’s degree in biomedical science from the University of Reading.

              Narendra Parihar, M.P.H., is a principal epidemiologist at Clarivate. His areas of interest are cancer epidemiology, rare disease epidemiology, and targeted therapies in cancer. A former dentist, he earned his M.P.H. from the Tata Institute of Social Sciences in Mumbai.


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