Bladder Cancer: Opportunity Analysis and Forecasts to 2028
Summary:
The Bladder Cancer market is expected to significantly grow from $733m in 2018 to $4.0bn by 2028 across the seven major markets (7MM - US, France, Germany, Italy, Spain, UK, and Japan) at a compound annual growth rate (CAGR) of 18.5%. The exponential growth of the bladder cancer market will be driven by an increasing incident patient population and the approval and launch of new branded therapies with different MOAs: Balversa, Padcev, Vofatamab, Vicinium, Qapzola, N-803 and Instilidrin.
In addition, the label expansion of currently marketed therapies: PD-1/PD-L1 checkpoint inhibitors in combination with chemotherapies or other immuno-oncology agents will promote market growth during the forecast period. PD-1/PD-L1 checkpoint inhibitors are highly anticipated in bladder cancer and they are expected to have greater adoption and usage in different lines of therapy across the 7MM (US, France, Germany, Italy, Spain, UK, and Japan), especially in the areas where unmet need is the highest.
However, a major barrier for market growth in bladder cancer will be identifying the patient population with specific mutations for targeted therapy regimens, which is not feasible for all patients as costs for identification would be expensive for the payers, and will limit the usage of these drugs. In the EU and Japan, the usage of checkpoint inhibitors other than Keytruda and Tecentriq is currently difficult due to reimbursement restrictions. Competition from other drugs and reimbursement restriction will tamper the growth of the market significantly.
Among the pipeline candidates, PD-1/PD-L1 inhibitors as monotherapy or as a combination regimen are expected to result in significant revenues due to premium pricing and clinical benefit in BCG-relapsed and refractory patients, as well as in platinum based chemotherapy ineligible patients.
The usage of PD-1/PD-L1 inhibitors in bladder cancer is expanding, translating to the major contributor of increased revenue in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) over the forecast period. Label expansion of PD-1/PD-L1 inhibitors and the launch of novel drugs such as Vicinium, N-803, Instiladrin for non-muscle invasive bladder cancer population are major drivers of the US market.
Key opinion leaders (KOLs) across the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) are very enthusiastic about Padcev and sales revenues for this drug is set to increase at a CAGR of 18.8% from the time of launch in 2020 over the forecast period. In addition, evaluating targeted therapy regimens in combination with immune checkpoint inhibitors will aid in better product adoption across all type of bladder cancer patients.
The latest report “Bladder Cancer: Opportunity Analysis and Forecasts to 2028”, provides an overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management. The report further brings in annualized bladder cancer therapeutics market revenue, strategic competitor assessment, clinical trial mapping, pipeline drug analysis and analysis of the current and future market competition in the global bladder cancer market.
Key Questions Answered by the report:
Scope:
Reasons to buy:
The report will enable you to:
Summary:
The Bladder Cancer market is expected to significantly grow from $733m in 2018 to $4.0bn by 2028 across the seven major markets (7MM - US, France, Germany, Italy, Spain, UK, and Japan) at a compound annual growth rate (CAGR) of 18.5%. The exponential growth of the bladder cancer market will be driven by an increasing incident patient population and the approval and launch of new branded therapies with different MOAs: Balversa, Padcev, Vofatamab, Vicinium, Qapzola, N-803 and Instilidrin.
In addition, the label expansion of currently marketed therapies: PD-1/PD-L1 checkpoint inhibitors in combination with chemotherapies or other immuno-oncology agents will promote market growth during the forecast period. PD-1/PD-L1 checkpoint inhibitors are highly anticipated in bladder cancer and they are expected to have greater adoption and usage in different lines of therapy across the 7MM (US, France, Germany, Italy, Spain, UK, and Japan), especially in the areas where unmet need is the highest.
However, a major barrier for market growth in bladder cancer will be identifying the patient population with specific mutations for targeted therapy regimens, which is not feasible for all patients as costs for identification would be expensive for the payers, and will limit the usage of these drugs. In the EU and Japan, the usage of checkpoint inhibitors other than Keytruda and Tecentriq is currently difficult due to reimbursement restrictions. Competition from other drugs and reimbursement restriction will tamper the growth of the market significantly.
Among the pipeline candidates, PD-1/PD-L1 inhibitors as monotherapy or as a combination regimen are expected to result in significant revenues due to premium pricing and clinical benefit in BCG-relapsed and refractory patients, as well as in platinum based chemotherapy ineligible patients.
The usage of PD-1/PD-L1 inhibitors in bladder cancer is expanding, translating to the major contributor of increased revenue in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) over the forecast period. Label expansion of PD-1/PD-L1 inhibitors and the launch of novel drugs such as Vicinium, N-803, Instiladrin for non-muscle invasive bladder cancer population are major drivers of the US market.
Key opinion leaders (KOLs) across the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) are very enthusiastic about Padcev and sales revenues for this drug is set to increase at a CAGR of 18.8% from the time of launch in 2020 over the forecast period. In addition, evaluating targeted therapy regimens in combination with immune checkpoint inhibitors will aid in better product adoption across all type of bladder cancer patients.
The latest report “Bladder Cancer: Opportunity Analysis and Forecasts to 2028”, provides an overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management. The report further brings in annualized bladder cancer therapeutics market revenue, strategic competitor assessment, clinical trial mapping, pipeline drug analysis and analysis of the current and future market competition in the global bladder cancer market.
Key Questions Answered by the report:
- How will the earlier use of immune checkpoint inhibitors and targeted therapies agent in NMIBC, MIBC, and locally advanced and metastatic settings affect the bladder cancer treatment algorithm?
- The bladder cancer market is characterized by a number of unmet needs. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil them?
- Eight late-stage pipeline agents are going to enter the bladder cancer market from 2018 onwards. Will the late-stage drugs make a significant impact on the bladder cancer market? Which of these drugs will have the highest peak sales, and why?
Scope:
- Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized bladder cancer therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven patient segments, forecast from 2018 to 2028.
- 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 assessing emerging trends and mechanisms of action under development for bladder cancer. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global bladder cancer 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 market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global bladder cancer 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.
Table of Contents
1 Table of Contents1.1 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 Drug 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/BCG Recurrence and Refractory
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 Commercial Benchmark of Key Pipeline Drugs
10.2 Competitive Assessment
10.3 Top-Line 10-Year Forecast
10.3.1 US
10.3.2 5EU
10.3.3 Japan
11 Appendix
List of Tables
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 - Bladder Cancer
Table 13: Clinical Benchmark of Key Pipeline Drugs - Bladder Cancer
Table 14: Clinical Benchmark of Key Pipeline Drugs - Bladder Cancer
Table 15: Commercial Benchmark of Key Pipeline Drugs - Bladder Cancer
Table 16: Commercial Benchmark of Key Pipeline Drugs - Bladder Cancer
Table 17: Commercial Benchmark of Key Pipeline Drugs - Bladder Cancer
Table 18: Key Events Impacting Sales for Bladder Cancer, 2018-2028
Table 19: Bladder Cancer Market - Global Drivers and Barriers, 2018-2028
Table 20: Key Historical and Projected Launch Dates for Bladder Cancer
Table 21: Key Historical and Projected Patent Expiry Dates for Bladder Cancer
Table 22:High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for Bladder Cancer in 2018 and 2028
Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs, BCG and Keytruda
Figure 3: Primary Tumor Development in Bladder Cancer
Figure 4: 7MM, Diagnosed Incidence of Bladder Cancer, Men, Ages ≥18 Years, 2008-2028, Cases per 100,000 Population
Figure 5: 7MM, Diagnosed Incidence of Bladder Cancer, Women, Ages ≥18 Years, 2008-2028, Cases per 100,000 Population
Figure 6: Sources Used and Not Used for Diagnosed Incident Cases of Bladder Cancer
Figure 7: Sources Used for Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis
Figure 8: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage Ta by Grade
Figure 9: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage by Tumor Location
Figure 10: Sources Used for Diagnosed Incident Cases of Bladder Cancer Stage T4 by Metastasis
Figure 11: Sources Used for Five-Year Diagnosed Prevalent Cases of Bladder Cancer
Figure 12: Sources Used for Diagnosed Incident Cases of Bladder Cancer by Mutations and Biomarkers
Figure 13: Sources Used for Two-Year Recurrence of Diagnosed Incident Cases of Bladder Cancer
Figure 14: 7MM, Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018
Figure 15: 7MM, Age-Specific Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018, N
Figure 16: 7MM, Sex-Specific Diagnosed Incident Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018, N
Figure 17: 7MM, Five-Year Diagnosed Prevalent Cases of Bladder Cancer, Both Sexes, Ages ≥18 Years, 2018
Figure 18: 7MM, Diagnosed Incident Cases of Bladder Cancer by Stage at Diagnosis, Both Sexes, Ages ≥18 Years, 2018, N
Figure 19: 7MM, Diagnosed Incident Cases of Bladder Cancer Stage Ta by Grade, Both Sexes, Ages ≥18 Years, 2018, N
Figure 20: 7MM, Diagnosed Incident Cases of Bladder Cancer by Tumor Location, Both Sexes, Ages ≥18 Years, 2018, N
Figure 21: 7MM, Diagnosed Incident Cases of Bladder Cancer by Stage T4 Metastasis, Both Sexes, Ages ≥18 Years, 2018, N
Figure 22: 7MM, Diagnosed Incident Cases of Bladder Cancer with FGFR3 Mutations, Both Sexes, Ages ≥18 Years, 2018, N
Figure 23: 7MM, Diagnosed Incident Cases of Bladder Cancer (Stages T2, T3, and T4) with PD-L1 Expression, Both Sexes, Ages ≥18 Years, 2018, N
Figure 24: 7MM, Diagnosed Incident Cases of Bladder Cancer with HER-2 Overexpression, Both Sexes, Ages ≥18 Years, 2018, N
Figure 25: Treatment Flow for NMIBC
Figure 26: Treatment Flow for Advanced-Stage Bladder Cancer
Figure 27: Unmet Needs and Opportunities in Bladder Cancer
Figure 28: Overview of the Development Pipeline in Bladder Cancer
Figure 29: Key Phase II/III Trials for the Promising Pipeline Agents that The Publisher Expects to Be Licensed for Bladder Cancer in the 7MM During the Forecast Period
Figure 30: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs, BCG and Keytruda
Figure 31: Global (7MM) sales forecast by Country for Bladder Cancer in 2018 and 2028
Figure 32: Global Sales Forecast by Class for Bladder Cancer in 2018 and 2028
Figure 33: Sales Forecast by Class for Bladder Cancer in the US in 2018 and 2028
Figure 34: Sales Forecast by Class for Bladder Cancer in the EU in 2018 and 2028
Figure 35: Sales Forecast by Class for Bladder Cancer in Japan in 2018 and 2028
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- AstraZeneca
- Astellas Pharma/ Seattle Genetics
- Bristol-Myers Squibb
- Ferring Pharmaceuticals
- Immunity Bio
- Janssen/J&J
- Merck & Co.
- Merck KGaA/ Pfizer
- Rainier Therapeutics
- Roche (Genentech)
- Sesen Bio
- Spectrum Pharmaceuticals
