Bladder Cancer – Opportunity Analysis and Forecasts to 2028

Pages: 139 Published: November 30, 2020 Report Code: GDHC106POA

Report Overview
Key Players
Table of Contents
Tables
Figures

The bladder cancer market in the 7 major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is expected to experience a high growth between 2018 and 2028. The main drivers of growth will be an increased incident patient population, continued uptake of immunotherapy drug and targeted therapy regimen in the metastatic patient, and the launch and uptake of 11 new premium-priced therapies along with label expansion of PD-1/PD-L1 inhibitors, including the newly approved Balversa (erdafitinib), and Padcev (enfortumab vedotin)
Until recently, BCG has been dominating non-muscle invasive bladder cancer across all segments, and generic chemotherapy dominating locally advanced and metastatic patient population. The bladder cancer competitive landscape is experiencing a substantial change during the forecast period owing to the launch of targeted therapies, increased use and label expansion for immune checkpoint inhibitor (ICI), into non muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) across all 7MM. Additionally, companies are moving towards introducing novel therapies with innovative MOAs for BCG relapse and refractory patients as well as platinum-ineligible patients in advanced stage disease condition. GlobalData expects these new drugs to enrich treatment options for different patient populations and add complexity to the bladder cancer treatment algorithm.
Key Questions Answered
How will the earlier use of immune checkpoint inhibitors and targeted therapy agent in NMIBC, MIBC and locally advanced and metastatic setting 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 these unmet needs?
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.

Key Highlights

The main driver of the growth of the bladder cancer market will be the approval of new drugs with novel MOAs in the NMIBC setting and anti-PD-1/PD-L1 based combination approvals for treating various different stages of the disease. The second strongest driver will be the increasing number of incident cases.

To gain approval and obtain reimbursement, it is essential for pipeline drugs to demonstrate greater efficacy (overall survival), better safety or treatment adherence when compared with available agents. For this reason, agents positioned as first-line NMIBC treatments are being investigated in combination with BCG the current standard of care (SOC), to limit the “standard-of-care hurdle“. In the advanced stage disease, various combinations and agents with novel MOAs are being investigataed for treating patients with muscle-invasive bladder cancer as well as unresectable or cisplatin-ineligible patients.

Due to concerns related to the high annual cost of therapy, GlobalData expects to have some market access restrictions in the EU and Japan.

Generic erosion is very negligible in the forecast as the first ICI looses its patent in 2028.

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.

Key Players

AstraZeneca
Astellas Pharma/ Seattle Genetics
Bristol-Myers Squibb
CG Oncology
Ferring Pharmaceuticals
Immunity Bio
Immunomedics
Janssen/J&J
Merck & Co.
Merck KGaA/ Pfizer
Nectar Therapeutics
QED Therapeutics
Roche (Genentech)
Sesen Bio

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

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 – 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

List of Figures

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

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Bladder Cancer – Opportunity Analysis and Forecasts to 2028

Scope

Key Highlights

Reasons to Buy

Key Players

Table of Contents

List of Tables

List of Figures

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Get in touch to find out about our multi-purchase discounts

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