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市場調查報告書

OpportunityAnalyzer:膀胱癌的全球市場 - 市場機會分析與未來預測

OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017

出版商 GlobalData 商品編碼 293248
出版日期 內容資訊 英文 191 Pages
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OpportunityAnalyzer:膀胱癌的全球市場 - 市場機會分析與未來預測 OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017
出版日期: 2015年12月19日 內容資訊: 英文 191 Pages
簡介

膀胱癌市場在這10∼20年並沒有發生重大的變化,但一般認為由於重新導入了各種新治療方法,從2016年開始該市場將達到急速成長。再加上多數開發中產品進入了臨床實驗的初期階段,預計其對今後市場成長將具有重大貢獻。現在雖然主要用於學名藥的化療·免疫療法,但這些在初期階段雖然有效,但仍有其毒性及提升整體生存率等課題。大型製藥企業至今雖然未關注膀胱癌領域,但上述之新治療方法開發上的可能性,巨大未滿足需求的存在,將持續提升企業對之的注目。

本報告提供膀胱癌治療方法的研究以及開發的最新趨勢調查、進行相關的市場未來預測、提供疾病概要和目前的治療方法、未滿足需求、市場機會的評估、今後10年的發病數量的預測值、臨床試驗的進展、新治療藥的開發平台評估、今後的市場趨勢等調查、預測。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病情和病因
    • 病因
    • 病理生理學
    • 臨床階段
  • 預後
  • QoL (生活品質)
  • 症狀
  • 診斷

第4章 流行病學

  • 疾病的背景情況
  • 風險要素和共生病症
    • 抽煙是膀胱癌症最大的風險要素
    • 男性膀胱癌症患者中最大的25%佔有率,是導因於業務中暴露於芳香族胺
  • 全球的趨勢
    • 患病人數,死亡率,今後5年的發病數量預測
    • 相對的存活率
    • 失能調整後存活年 (DALY) 和平均生命年數損失 (YLL)
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法
  • 膀胱癌的流行病學預測
    • 膀胱癌的發病數量 (全體)
    • 膀胱癌的發病數量 (各年齡)
    • 膀胱癌的發病數量 (男女)
    • 已調整年齡的膀胱癌發病數量
    • 膀胱癌的發病數量 (診斷時的各階段)
    • 膀胱癌的5年患病人數
  • 議論
    • 流行病學的趨勢相關考察
    • 分析的限制
    • 分析的優勢

第5章 目前治療選擇

  • 概要
  • 產品簡介:領導品牌
    • Intravesical Bacillus Calmette-Guerin
    • GemCis (Gemcitabine/Cisplatin)
    • Mitomycin c
    • Valstar (Valrubicin)
    • Javlor (Vinfluinine Ditartrate)

第6章 未滿足需求的評估與機會分析

  • 概要
  • 未滿足需求分析
    • 改善NMIBC (肌層非浸潤性膀胱癌) 的治療率
    • 防止NMIBC患者惡化的治療
    • NMIBC的更有效治療方法
    • 鉑類化合物無效/不耐症轉移患者的治療選擇
    • 缺乏預測用生物標記
    • 改善初診·切除成功率
  • 市場機會分析
    • NMIBC環境下BCG療法的替代手段
    • 重病患者的BCG療法失敗時的補救性治療
    • 重新定義第一線肌層浸潤·轉移患者的治療標準
    • 對鉑類化合物無效患者的新治療方法
    • 強化治療膀胱癌的免疫系統
    • 預測用生物標記·標靶治療藥的選擇
    • 新佐劑療法 (術前補助化療)
    • 搭配診斷檢驗

第7章 研究開發 (R&D) 策略

  • 概要
    • 小規模製藥企業的藥物開發
    • BCG療法的成功:進一步免疫療法策略的徵兆
    • NMIBC的膀胱內方法今後,被組織性方法取代的可能性
  • 臨床實驗的設計
    • 登記趨勢的研究:開放標籤,非對照臨床試驗設計依然盛行
    • 用於NMIBC和設置轉移的各種臨床實驗的試驗指標

第8章 開發平台分析

  • 概要
  • 臨床實驗中的有潛力藥劑
    • MCNA
    • Apaziquone
    • Keytruda (Pembrolizumab)
    • Atezolizumab
    • Cyramza (Ramucirumab)
    • Vicinium (Oportuzumab Monatox)
    • Durvalumab
    • CG-0070
    • Apatorsen
    • Opdivo (Nivolumab)
  • 早期階段的創新的方法
    • 免疫療法
    • 標靶治療

第9章 開發平台評估分析

  • 主要開發平台上藥物臨床方面的標準
  • 主要開發平台上藥物的商業方面的標準
  • 競爭力的評估
  • 今後5年的銷售額預測
    • 美國
    • 歐洲主要5個國家

第10章 附錄

圖表一覽

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目錄
Product Code: GDHC015EPOA

The bladder cancer market has remained largely unchanged in the past 10-20 years. However, significant expansion is expected starting in 2016, with the introduction of several new therapies that are projected to fuel market growth. In addition, bladder cancer has a robust early-stage pipeline that will contribute to market growth beyond the forecast period of 2012-2017. Currently, the bladder cancer market is dominated by generic chemotherapy and immunotherapy. Though initially effective, toxicity and lack of clinical efficacy in improving overall survival have left the door open for more tolerable and effective drugs to be developed. In the past, bladder cancer has not been an area of focus for pharmaceutical companies, but that is rapidly changing as more companies focus on the bladder cancer market, recognizing the high level of unmet need and relatively clear regulatory path. During the forecast period, the market landscape will begin to change dramatically with the introduction of targeted immunotherapies. These drugs will provide much-needed alternatives to bladder cancer patients who have not benefitted from traditional treatments.

Highlights

Key Questions Answered

  • The bladder cancer market is poised to undergo rapid expansion during the forecast period and beyond. What are the main drivers of this expansion? What are the main barriers that could dampen this expansion?
  • The bladder cancer market is plagued by the presence of high unmet needs not addressed by current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the bladder cancer market?
  • The current bladder cancer market is highly generic. How will the introduction of targeted immunotherapies, including the much-anticipated PD-1/PD-L1 class of immune checkpoint inhibitors, change the market landscape?

Key Findings

  • The main driver of the rapid expansion of the bladder market will be the launch of several highly anticipated drugs into the market starting in 2016.
  • The second largest driver will be the forecast increase in number of incident cases in bladder cancer.
  • To gain approval, it is essential for companies to demonstrate efficacy in delaying recurrence, but not necessarily improvement in overall survival. Thus, the bar for approval in bladder cancer is low.
  • In the future, companies will have to differentiate their drugs from others in the same class in order to successfully compete for patient share.
  • The number of pipeline agents being developed by small to mid-sized companies represents an opportunity for large pharma to enter this highly lucrative market through licensing and marketing partnerships.

Scope

  • Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized bladder cancer therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for 5 years to 2017.
  • 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 split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • 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. Additionally a list of acquisition targets included in the pipeline product company list.
  • 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 global bladder cancer therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global bladder cancer therapeutics market from 2012-2017.
  • 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 Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
    • 3.1.3. Clinical Staging
  • 3.2. Prognosis
  • 3.3. Quality of Life
  • 3.4. Symptoms
  • 3.5. Diagnosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Co-morbidities
    • 4.2.1. Smoking is the most significant risk factor for bladder cancer
    • 4.2.2. Up to 25% of male bladder cancer cases are due to occupational exposure to aromatic amines
  • 4.3. Global and Historical Trends
    • 4.3.1. Incidence, Mortality, and Five-Year Prevalence
    • 4.3.2. Relative Survival
    • 4.3.3. Disability-Adjusted Life Years and Years of Life Lost
  • 4.4. Forecast methodology
    • 4.4.1. Sources used
    • 4.4.2. Forecast assumptions and methods
    • 4.4.3. Sources not used
  • 4.5. Incident/Prevalent Cases of Bladder Cancer
    • 4.5.1. Incident Cases of Bladder Cancer
    • 4.5.2. Age-Specific Incident Cases of Bladder Cancer
    • 4.5.3. Sex-Specific Incident Cases of Bladder Cancer
    • 4.5.4. Age-Standardized Incidence Rates of Bladder Cancer
    • 4.5.5. Incident Cases of Bladder Cancer by Stage at Diagnosis
    • 4.5.6. Five-Year 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. Product Profiles- Major Brands
    • 5.2.1. Intravesical Bacillus Calmette-Guerin
    • 5.2.2. GemCis (Gemcitabine/Cisplatin)
    • 5.2.3. Mitomycin c
    • 5.2.4. Valstar (Valrubicin)
    • 5.2.5. Javlor (Vinfluinine Ditartrate)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Higher Cure Rate for Patients with NMIBC
    • 6.2.2. Therapies that Prevent Disease Progression in Patients with NMIBC
    • 6.2.3. More Efficacious Therapies for Muscle-Invasive and Metastatic Bladder Cancer
    • 6.2.4. Treatment Options for Platinum-Refractory/Intolerant Metastatic Patients
    • 6.2.5. Lack of Predictive Biomarkers
    • 6.2.6. Improved Initial Diagnosis and Resection Success Rates
  • 6.3. Opportunity Analysis
    • 6.3.1. Replacement for BCG Therapy in the NMIBC Setting
    • 6.3.2. Salvage Therapy after BCG Failure in High-Grade Patients
    • 6.3.3. Redefining the Standard of Care for First-Line Muscle-Invasive and Metastatic Patients
    • 6.3.4. Novel Treatments for Platinum-Refractory Patients
    • 6.3.5. Leveraging the Immune System to Fight Bladder Cancer
    • 6.3.6. Identification of Predictive Biomarkers and Targeted Drugs
    • 6.3.7. Neoadjuvant Therapy
    • 6.3.8. Companion Diagnostic Tests

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Drug Development by Small Pharmaceutical Companies
    • 7.1.2. Success of BCG Therapy is a Signal for Further Immunotherapy Strategies
    • 7.1.3. Intravesical Approaches for NMIBC May Give Way to Systemic Approaches in the Future
  • 7.2. Clinical trial design
    • 7.2.1. Registrational Studies: Open-Label, Non-Comparative Trial Designs Still Prevalent
    • 7.2.2. A Variety of Trial Endpoints are Used in the NMIBC and Metastatic Settings

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising drugs in clinical development
    • 8.2.1. MCNA
    • 8.2.2. Apaziquone
    • 8.2.3. Keytruda (Pembrolizumab)
    • 8.2.4. Atezolizumab
    • 8.2.5. Cyramza (Ramucirumab)
    • 8.2.6. Vicinium (Oportuzumab Monatox)
    • 8.2.7. Durvalumab
    • 8.2.8. CG-0070
    • 8.2.9. Apatorsen
    • 8.2.10. Opdivo (Nivolumab)
  • 8.3. Innovative Early-stage Approaches
    • 8.3.1. Immunotherapies
    • 8.3.2. Targeted Therapies

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 Five Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

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. Reconciliation of Epidemiological Staging with Clinical Staging
    • 10.4.5. Launch and Patent Expiry Dates
    • 10.4.6. General Pricing Assumptions
    • 10.4.7. Individual Drug Assumptions
    • 10.4.8. Generic Erosion
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Therapy Area Director
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Director of Therapy Analysis and Epidemiology
    • 10.6.5. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: AJCC TNM Staging System for Bladder Cancer - Definitions of Stages
  • Table 2: Bladder Cancer Prognosis by Stage
  • Table 3: Symptoms of Bladder Cancer
  • Table 4: Bladder Cancer Risk Factors
  • Table 5: 6MM, GLOBOCAN Incidence, Five-Year Prevalence, and Mortality for Bladder Cancer, Ages ≥15 Years, Men and Women, 2008
  • Table 6: 6MM, Relative Survival of Bladder Cancer (%), Men and Women
  • Table 7: 6MM, GLOBOCAN DALYs and YLLs Due to Bladder Cancer, Men and Women, N, 2008
  • Table 8: 6MM, Sources of Bladder Cancer Incidence Data
  • Table 9: 6MM, Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Table 10: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 11: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 12: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 13: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Table 14: Leading Treatments for Bladder Cancer
  • Table 15: Product Profile - TICE-BCG
  • Table 16: Efficacy of BCG (TheraCys)
  • Table 17: Safety of BCG
  • Table 18: BCG SWOT Analysis
  • Table 19: Product Profile - GemCis
  • Table 20: Efficacy of GemCis
  • Table 21: Safety of GemCis
  • Table 22: GemCis SWOT Analysis
  • Table 23: Product Profile - Mitomycin C
  • Table 24: Efficacy of Mitomycin C
  • Table 25: Safety of Mitomycin C
  • Table 26: Mitomycin C SWOT Analysis
  • Table 27: Product Profile - Valstar
  • Table 28: Efficacy of Valstar
  • Table 29: Safety of Valstar
  • Table 30: Valstar SWOT Analysis
  • Table 31: Product Profile - Javlor
  • Table 32: Efficacy of Javlor
  • Table 33: Safety of Javlor
  • Table 34: Javlor SWOT Analysis
  • Table 35: Overall Unmet Needs - Current Level of Attainment
  • Table 36: Clinical Trial Design of Key Pipeline Drugs in the NMIBC Setting
  • Table 37: Clinical Trial Design of Key Pipeline Drugs in the MIBC and Metastatic Settings
  • Table 38: Bladder Cancer - Late-Stage Pipeline, 2015
  • Table 39: Product Profile - MCNA
  • Table 40: Efficacy of MCNA
  • Table 41: Safety of MCNA
  • Table 42: MCNA SWOT Analysis
  • Table 43: Product Profile - Apaziquone
  • Table 44: Efficacy of Apaziquone
  • Table 45: Safety of Apaziquone
  • Table 46: EOquin SWOT Analysis
  • Table 47: Product Profile -Keytruda
  • Table 48: Efficacy of Keytruda
  • Table 49: Safety of Keytruda
  • Table 50: Keytruda SWOT Analysis
  • Table 51: Product Profile - Atezolizumab
  • Table 52: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer
  • Table 53: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Chemotherapy
  • Table 54: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer
  • Table 55: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Platinum-Based Chemotherapy
  • Table 56: Atezolizumab SWOT Analysis
  • Table 57: Product Profile - Cyramza
  • Table 58: Efficacy of Cyramza
  • Table 59: Safety of Cyramza in Combination with Docetaxel
  • Table 60: Cyramza SWOT Analysis
  • Table 61: Product Profile -Vicinium
  • Table 62: Efficacy of Vicinium
  • Table 63: Safety of Vicinium
  • Table 64: Vicinium SWOT Analysis
  • Table 65: Product Profile - Durvalumab
  • Table 66: Efficacy of Durvalumab
  • Table 67: Durvalumab SWOT Analysis
  • Table 68: Product Profile - CG-0070
  • Table 69: Efficacy of CG-0070
  • Table 70: Safety of CG-0070
  • Table 71: CG-0070 SWOT Analysis
  • Table 72: Product Profile - Apatorsen
  • Table 73: Efficacy of Apatorsen
  • Table 74: Safety of Apatorsen
  • Table 75: Apatorsen SWOT Analysis
  • Table 76: Product Profile - Opdivo
  • Table 77: Efficacy of Opdivo
  • Table 78: Opdivo SWOT Analysis
  • Table 79: Early-Stage Pipeline Products in Bladder Cancer
  • Table 80: Clinical Benchmarking of Key Pipeline Drugs - NMIBC setting
  • Table 81: Clinical Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings
  • Table 82: Commercial Benchmarking of Key Pipeline Drugs - NMIBC setting
  • Table 83: Commercial Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings
  • Table 84: Top Line Sales Forecasts ($) for Bladder Cancer, 2012-2017
  • Table 85: Key Events Impacting Sales for Bladder Cancer, 2012-2017
  • Table 86: Bladder Cancer Market - Drivers and Barriers, US and EU, 2012-2017
  • Table 87: Key Launch Dates

List of Figures

  • Figure 1: Bladder Cancer Staging Systems
  • Figure 2: Primary Tumor Development in Bladder Cancer
  • Figure 3: 6MM, Incidence Rates of Bladder Cancer, Ages ≥15 Years, Men, Rate per 100,000 Population, 1993-2002
  • Figure 4: 6MM, Incidence Rates of Bladder Cancer, Ages ≥15 Years, Women, Rate per 100,000 Population, 1993-2002
  • Figure 5: 6MM, Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Figure 6: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 7: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 8: 6MM, Age-Standardized Bladder Cancer Incidence Rate, Ages ≥15 Years, Men and Women, Cases per 100,000 Population, 2012
  • Figure 9: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 10: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Bladder Cancer, 2012-2017
  • Figure 12: Sales for Bladder Cancer by Region, 2012 and 2017
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