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市場調查報告書

OpportunityAnalyzer:全球囊狀纖維化症(CF)治療藥物市場:市場機會分析與未來預測

OpportunityAnalyzer: Cystic Fibrosis - Opportunity Analysis and Forecasts to 2018 - Event-Driven Update

出版商 GlobalData 商品編碼 270218
出版日期 內容資訊 英文 149 Pages
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OpportunityAnalyzer:全球囊狀纖維化症(CF)治療藥物市場:市場機會分析與未來預測 OpportunityAnalyzer: Cystic Fibrosis - Opportunity Analysis and Forecasts to 2018 - Event-Driven Update
出版日期: 2014年07月07日 內容資訊: 英文 149 Pages
簡介

本報告提供囊狀纖維化症(以下CF)治療法研究以及開發的最新趨勢調查,相關的市場預測,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年的發病數量預測值,臨床試驗的進展,新制治療藥物的開發平台評估,今後的市場趨勢等的調查預測,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因與病情
    • 病因
    • 病情
    • 預測
    • 生活品質(QOL)
  • 徵兆

第4章 免疫學

  • 風險要素和併發症
  • 全球各國到現在為止的趨勢
    • 美國
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 預測手法
    • 利用的資訊來源
    • 預測的假設·手法
    • 沒利用的資訊來源
  • 免疫學的預測
    • 得病率(整體)
    • 得病率(各年齡)
    • 得病率(男女)
    • 得病率(突變的各類型)
  • 議論
    • 免疫學的趨勢相關結論
    • 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,吸入式抗生素
    • TOBI(Tobramycin)
    • TOBI Podhaler(Tobramycin吸入用粉末式)
    • Bramitob (Tobramycin)
    • Colistimethate Sodium(噴霧式:以各種學名藥名流通)
    • Colobreathe(colistimethate·鈉乾燥粉末式)
    • Cayston(Aztreonam)
  • 產品簡介:領導品牌,粘液溶解藥
    • Pulmozyme(dornase alfa)
    • Bronchitol(mannitol)
  • 產品簡介:領導品牌,CFTR(囊狀纖維化症膜電導控制因素)調製器
    • Kalydeco (ivacaftor, VX-770)
  • 產品簡介:領導品牌,其他治療方法
    • 胰臟酵素替代療法(PERTs)

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
    • 根治性治療的開發
    • CF相關的肺感染疾病的改善療法
    • 粘液溶解藥的呼吸道沖洗改善
    • 治療方法的遵守相關改善
    • 安全的抗炎治療開發
  • 市場機會分析
    • CFTR蛋白質功能作為標的療法
    • 吸入式抗生素的新層級與處方
    • 新的粘液溶解藥
    • 新的抗發炎醫藥品

第7章 研究開發(R&D)策略

  • 概要
    • 最配合策略
    • 個人化醫療的方法
    • 想法實現的各種研究
    • 許可證給予與產業合作
  • 臨床實驗的設計

第8章 開發平台分析

  • 概要
  • 臨床實驗階段的有潛力的藥劑
  • 臨床實驗階段的有潛力的藥劑:吸入式抗生素
    • Aeroquin (levofloxacin, MP-376)
    • Arikace (amikacin) 85
  • 臨床實驗階段的有潛力藥劑:CFTR調製器
    • Lumacaftor (VX-809)/Kalydeco (VX-770)
    • Ataluren (PTC124)
  • 臨床實驗階段的有潛力的藥劑:PERTs
    • Liprotamase (LY3031642)
  • 初期階段的創新方法

第9章 開發平台評估分析

  • 主要的開發平台藥物臨床方面的標準
  • 主要的開發平台藥物的商業方面的標準
  • 競爭力的評估
  • 今後5年的銷售額的預測
    • 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: GDHC003EPIDR

Cystic Fibrosis (CF) is an autosomal recessive disease characterized by the secretion of thick, sticky mucus which clogs the lungs and leads to life-threatening lung infections; and obstructs pancreatic enzyme secretions that are essential for the body to break down and absorb nutrients. CF patients have a limited number of available treatment options and significant unmet needs still exist. Opportunities are significant for new therapies that will improve symptoms, change the course of this disease, as well as increase therapy options. The introduction of the first disease modifying therapy, Kalydeco (ivacaftor), by Vertex in 2012, paved the way for a new class of therapies known as cystic fibrosis transmembrane conductance regulator (CFTR) modulators. On June 24, 2014, Vertex announced positive Phase III clinical trial data for lumacaftor in combination with Kalydeco in patients with CF who have two copies of the F508del mutation. This novel combination therapy of CFTR modulators has the potential to treat the underlying cause of the disease for approximately 50% of all CF patients and drive rapid growth in the CF market.

Highlights

Key Questions Answered

  • What are the pressing unmet needs and remaining opportunities in the CF market?
  • What R&D strategies are drug developers pursuing in the CF therapeutics space?
  • What is the significance of CFTR modulators in the CF market?
  • What is the clinical and commercial positioning of key pipeline products in the CF market?
  • What are the innovative early-stage treatment approaches in the CF market?

Key Findings

  • Rapid growth in the CF market is expected from 2012 to 2018.
  • Emerging market players are employing diverse R&D strategies to gain entry in the CF market.
  • A curative therapy is the most pressing unmet need in CF.
  • Significant opportunities exist for novel disease modifying drugs.

Scope

  • Overview of CF, including epidemiology, etiology, pathophysiology, symptoms and current treatment options
  • Annualized CF therapeutics market revenue, annual cost of therapies and forecasts for five years to 2018.
  • Key topics covered include strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design and implications for the CF therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging trends and mechanisms of action under development, including inhaled antibiotics, CFTR modulators and pancreatic enzyme products.
  • Analysis of the current and future market competition in the US and five major EU CF therapeutics market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies. Insightful review of the key industry drivers, restraints and challenges.

Reasons to buy

  • Identify the unmet needs and remaining opportunities in the CF therapeutics market.
  • Develop business strategies by understanding the trends shaping and driving the US and five major EU CF therapeutics market.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Assess the clinical and commercial viability of promising pipeline products.
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various emerging therapies.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  • Drive revenues by understanding the key trends, innovative products and technologies, market and segments likely to impact the US and five major EU CF therapeutics market in future.

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. Prognosis
    • 3.1.4. Quality of Life
  • 3.2. Symptoms

4. Epidemiology

  • 4.1. Risk Factors and Co-morbidities
  • 4.2. Global and Historical Trends
    • 4.2.1. US
    • 4.2.2. France
    • 4.2.3. Germany
    • 4.2.4. Italy
    • 4.2.5. Spain
    • 4.2.6. UK
  • 4.3. Forecast Methodology
    • 4.3.1. Sources Used
    • 4.3.2. Forecast Assumptions and Methods
    • 4.3.3. Sources Not Used
  • 4.4. Epidemiology Forecast
    • 4.4.1. Total Prevalent Cases of Cystic Fibrosis
    • 4.4.2. Total Prevalent Cases of Cystic Fibrosis Segmented by Age
    • 4.4.3. Total Prevalent Cases of Cystic Fibrosis Segmented by Sex
    • 4.4.4. Total Prevalent Cases of Cystic Fibrosis by Mutation Type
  • 4.5. Discussion
    • 4.5.1. Conclusion on Epidemiology Trends
    • 4.5.2. Limitations of the Analysis
    • 4.5.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles - Major Brands, Inhaled Antibiotics
    • 5.2.1. TOBI (tobramycin)
    • 5.2.2. TOBI Podhaler (tobramycin inhalation powder)
    • 5.2.3. Bramitob (tobramycin)
    • 5.2.4. Colistimethate Sodium (nebulized; numerous generic names)
    • 5.2.5. Colobreathe (colistimethate sodium dry powder)
    • 5.2.6. Cayston (aztreonam)
  • 5.3. Product Profiles - Major Brands, Mucolytics
    • 5.3.1. Pulmozyme (dornase alfa)
    • 5.3.2. Bronchitol (mannitol)
  • 5.4. Product Profiles - Major Brands, CFTR Modulators
    • 5.4.1. Kalydeco (ivacaftor, VX-770)
  • 5.5. Product Profiles - Major Brands, Other Therapies
    • 5.5.1. Pancreatic Enzyme Replacement Therapies (PERTs)

6. Unmet Needs Assessment and Oppportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. The Development of Curative Therapies
    • 6.2.2. Improving Treatment of CF-related Lung Infections
    • 6.2.3. Improving Airway Clearance with Mucolytic Agents
    • 6.2.4. Improving Treatment Compliance
    • 6.2.5. The Development of Safe Anti-inflammatory Therapies
  • 6.3. Opportunity Analysis
    • 6.3.1. Therapies that Target CFTR Protein Function
    • 6.3.2. New Classes and Formulations of Inhaled Antibiotics
    • 6.3.3. Novel Mucolytic Agents
    • 6.3.4. Novel Anti-inflammatory Agents

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Reformulation Strategies
    • 7.1.2. Personalized Treatment Approach
    • 7.1.3. Diverse Proof-of-Concept Research
    • 7.1.4. Licensing and Alliances
  • 7.2. Clinical Trial Design

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
  • 8.3. Promising Drugs in Clinical Development, Inhaled Antibiotics
    • 8.3.1. Arikayce (amikacin)
  • 8.4. Promising Drugs in Clinical Development, CFTR Modulators
    • 8.4.1. Lumacaftor (VX-809)/Kalydeco (VX-770)
    • 8.4.2. Ataluren (PTC124)
  • 8.5. Innovative Early-Stage Approaches

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 Six-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 CF 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. Drug Assumptions
    • 10.4.7. Generic Erosion
    • 10.4.8. Pricing of Pipeline Agents
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Analyst
    • 10.6.2. Reviewer
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Classes of the CFTR Gene Mutations in Cystic Fibrosis
  • Table 2: Symptoms of Cystic Fibrosis
  • Table 3: Six Major Markets, Sources of Cystic Fibrosis Prevalence Data
  • Table 4: Six Major Markets, Sources of Cystic Fibrosis-Causing Mutation Data
  • Table 5: Six Major Markets, Total Prevalent Cases of Cystic Fibrosis, Ages 0-35 Years, Men and Women, Selected Years, 2012-2022
  • Table 6: Six Major Markets, Total Prevalent Cases of Cystic Fibrosis, Ages 0-35 Years, By Sex, 2012, N (%)
  • Table 7: Six Major Markets, Cystic Fibrosis Prevalent Cases Segmented by Mutation Type, Ages 0-35 Years, Men and Women, 2012
  • Table 8: Leading Treatments for Cystic Fibrosis, 2014
  • Table 9: Product Profile - TOBI
  • Table 10: Product Profile - TOBI Podhaler
  • Table 11: Product Profile - Bramitob
  • Table 12: Product Profile - Colistimethate Sodium
  • Table 13: Product Profile - Colobreathe
  • Table 14: Product Profile - Cayston
  • Table 15: Product Profile - Pulmozyme
  • Table 16: Product Profile - Bronchitol
  • Table 17: Product Profile - Kalydeco
  • Table 18: Overall Unmet Needs - Current Level of Attainment
  • Table 19: Cystic Fibrosis - Late-Stage Pipeline, 2014
  • Table 20: Product Profile - Arikayce
  • Table 21: Product Profile - Lumacaftor/Kalydeco
  • Table 22: Product Profile - Ataluren
  • Table 23: Early-Stage Pipeline Products in Cystic Fibrosis, 2014
  • Table 24: Clinical Benchmark of Key Pipeline Drugs - Inhaled Antibiotics
  • Table 25: Clinical Benchmark of Key Pipeline Drugs - CFTR Modulators
  • Table 26: Commercial Benchmark of Key Pipeline Drugs - Inhaled Antibiotics
  • Table 27: Commercial Benchmark of Key Pipeline Drugs - CFTR Modulators
  • Table 28: Top-Line Sales Forecasts ($m) for Cystic Fibrosis, 2012-2018
  • Table 29: Key Events Impacting Sales for Cystic Fibrosis, 2012-2018
  • Table 30: Cystic Fibrosis Market - Drivers and Barriers, 2012-2018
  • Table 31: Key Launch Dates
  • Table 32: Key Patent Expiries

List of Figures

  • Figure 1: Six Major Markets, Total Prevalent Cases of Cystic Fibrosis, Ages 0-35 Years, Men and Women, Selected Years, 2012-2022
  • Figure 2: Six Major Markets, Total Prevalent Cases of Cystic Fibrosis, By Age, Men and Women, 2012
  • Figure 3: Six Major Markets, Cystic Fibrosis Prevalent Cases Segmented by Mutation Type, Ages 0-35 Years, Men and Women, 2012
  • Figure 4: Competitive Assessment of Late-Stage Pipeline Inhaled Antibiotics in Cystic Fibrosis, 2012-2018
  • Figure 5: Competitive Assessment of Late-Stage Pipeline CFTR Modulators in Cystic Fibrosis, 2012-2018
  • Figure 6: Sales for Cystic Fibrosis by Region, 2012-2018
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