OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2025

  • ID: 4331289
  • Drug Pipelines
  • 229 pages
  • GlobalData
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OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2025


Summary

Bladder cancer is a urologic malignancy arising primarily from epithelial cells lining the bladder. In the vast majority of cases (>90%), bladder cancer manifests as transitional (urothelial) cell carcinoma (TCC). The remaining cases manifest as squamous cell carcinoma, adenocarcinoma, and in rare instances, carcinosarcoma. Bladder cancer is classified under the International Classification of Diseases, Tenth Revision (ICD-10) code C67. It is the ninth most common cancer in men and women worldwide, with the highest recurrence rate of any malignancy.

It is estimated that the bladder cancer market in the 7MM was valued at $360M in 2015. This market includes sales of approved, branded therapies and those of off-label drugs. Of the countries/regions in the 7MM, the 5EU contributed 45% of sales, while the US and Japan contributed 39% and 16%, respectively. By 2025, it is expected that the bladder cancer market in the 7MM to reach $1.17B, tripling in size, at a Compound Annual Growth Rate (CAGR) of 12.5%.

In 2025, the US will contribute 49% of sales, while the 5EU and Japan will contribute 35% and 16%, respectively. During the forecast period, the US market is expected to grow the fastest, at a CAGR of 15.2%, owing to the earlier and more widespread usage of programmed cell death protein 1 (PD-1) modulators. The 5EU market will grow the slowest, at a CAGR of 9.5%, and the Japanese market will grow at a CAGR of 12.7%.

Major drivers of growth in the bladder cancer market in the 7MM during 2015-2025 are expected to be the following:
  • Immunotherapies, specifically PD-1 modulators, will see entry and/or increased incorporation into treatment algorithms.
  • The launch of IO + IO combination therapies will fuel sales growth due to the premium pricing of these combination regimens.
  • Increased incident cases of bladder cancer across the 7MM will increase the drug treatable patient population.
  • Introduction of pipeline agents CG-0070, Vicinium, and Cyramza will expand treatment options for bladder cancer patients.
Historically, the bladder cancer market has been highly generic, with BCG and chemotherapies dominating the landscape. However, with the launch of Tecentriq and the subsequent launches of other PD-1 modulators, the bladder cancer treatment algorithms are expected to change during the forecast period. Though these PD-1 modulators are expected to have a significant impact on the treatment of bladder cancer, the reality is that a majority of patients (estimated to be upwards of 70%) will not respond to these drugs. Thus, pharmaceutical companies are looking at various ways to expand the treatable patient population.

While big pharma companies are focused on “me-too” PD-1 modulators, smaller companies are developing drugs with novel mechanisms of action (MOAs). Cold Genesys, Eleven Biotherapeutics, and FKD Therapies Oy all have late-stage candidates in the NMIBC setting that have distinctive MOAs. The author believes that the bladder cancer market is an attractive prospect for these companies due to the combination of a high level of unmet need and relatively low regulatory hurdles, which provides a suitable risk-reward balance for developers with limited financial resources.

The report "OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2025" provides overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

In particular, this report provides the following:
  • Topline Bladder cancer market revenue from 2015-2025. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting bladder cancer therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global bladder cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Companies mentioned in this report: Altor Bioscience, AstraZeneca, BioCancell, Bristol-Myers Squibb, Chugai, Cold Genesys, Eleven Biotherapeutics, Eli Lilly & Co., Endo Pharmaceuticals, Exelixis, FKD Therapies Oy, Immunomedics, MedImmune, Merck & Co., Merck KgAa, OncoGenex, Ono Pharmaceutical, Pfizer, Pierre Fabre Medicament, Roche.

Scope
  • Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline Bladder cancer market revenue from 2015-2025. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
  • Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting bladder cancer therapeutics sales in the 7MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global bladder cancer therapeutics 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 therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the bladder cancer therapeutics 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.
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1 Table of Contents
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
10.9 Contact
10.10 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: 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

List of Figures
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
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