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市場調查報告書

OpportunityAnalyzer:特發性肺纖維化 (IPF) - 機會分析與預測

OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis - Opportunity Analysis and Forecast to 2025

出版商 GlobalData 商品編碼 270217
出版日期 內容資訊 英文 186 Pages
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OpportunityAnalyzer:特發性肺纖維化 (IPF) - 機會分析與預測 OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis - Opportunity Analysis and Forecast to 2025
出版日期: 2016年06月06日 內容資訊: 英文 186 Pages
簡介

主要7個國家 (美國、法國、德國、義大利、西班牙、英國、日本) 的特發性肺纖維化 (IPF)的治療藥市場,預計從2015年的9億730萬美元,擴大到2025年的32億美元,以13.6%的年複合成長率 (CAGR) 年複合成長率成長。

本報告提供特發性肺纖維化 (IPF)的治療藥市場相關調查分析,疾病概要,流行病學,目前治療選項,未滿足需求和機會,研究開發策略,開發平台評估等相關的系統性資訊。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理生理學
  • 分類/分期
  • 預後
  • QOL
  • 症狀

第4章 流行病學

  • 疾病的背景
  • 危險因素和合併症
  • 全球趨勢
  • 預測手法
    • 利用之資訊來源
    • 預測的前提條件與手法
    • 未利用之資訊來源
  • 特發性肺纖維化 (IPF)的流行病學預測
    • 確診的發病數量
    • 確診的患者數
    • 死亡率
  • 議論
    • 流行病學預測的考察
    • 分析的限制
    • 分析的優勢

第5章 目前治療選項

  • 概要
  • 產品簡介:領導品牌

第6章 未滿足需求評估與機會分析

  • 概要
  • 缺乏有效的藥物
  • 高價的治療
  • 對早期迅速的診斷
  • 未認識的疾病
  • 缺乏疾病後期的治療選項
  • 患者的QOL的提高
  • 副作用和給藥計劃的改善

第7章 研究開發 (R&D) 策略

  • 概要
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床實驗階段的有前途藥物
  • 初期階段的創新方法

第9章 開發平台評估分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的10年預測
    • 美國
    • EU5個國家
    • 日本

第10章 附錄

圖表

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目錄
Product Code: GDHC059POA

The IPF therapeutic market is currently dominated by the only two drugs that have gained marketing approval for IPF - Roche's Esbriet and Boehringer Ingelheim's Ofev. Esbriet was the first drug to gain approval for IPF in 2011 when it was approved for use in Europe, a full four years before rival Ofev. However, both gained approval into the largest IPF market of the US on the same day in October 2014. The top-selling drug in IPF in value terms is Roche's Esbriet, which GlobalData estimates generated approximately $572m in 2015 from the seven major markets. There is high R&D activity for the development of new therapies for IPF and eight promising therapies can potentially enter the market from 2015 to 2025. Numerous novel targets are being studied in the IPF pipeline, with major pharmaceutical players Roche, Sanofi, Bristol-Myers Squibb, and Biogen all active in the development process. Other promising pipeline candidates include FibroGen's CTGF inhibitor, Promedior's PTX2 protein, Afferent's P2X3 receptor antagonist, and MediciNova's 5-LO/LT pathway inhibitor. The continued uptake of Esbriet and Ofev, combined with the introduction of new novel drugs will shape the future competitive landscape and drive growth in the IPF market.

Highlights

Key Questions Answered

  • What was the impact of Esbriet and Ofev on the IPF market following their FDA approval in 2014 and what is their future outlook within this market?
  • What do physicians think about Esbriet and Ofev, and how they will be used for IPF during the forecast period?
  • What is the significance of late-phase pipeline products and how will their launch shape the future treatment landscape in IPF?
  • What are the unmet needs within the IPF market?
  • What are the remaining opportunities within the IPF market?

Key Findings

  • The main drivers of growth for the IPF market include the increasing uptake of Esbriet and Ofev, the launch of new novel treatment options during the second half of the forecast period, and the increasing number of prevalent cases of IPF.
  • R&D strategies include the development of novel therapies, partnerships and acquisitions, combination of therapies, and targeting niche patient subpopulations.
  • The IPF therapeutic market is characterized by significant unmet needs. The most pressing unmet need is the development of a product capable of either stabilizing or reversing progression of IPF. Current therapies Esbriet and Ofev do not address this need and are only capable of slowing disease progression.
  • With high R&D activity in the IPF therapeutic market, physicians are looking forward to pipeline products becoming available, which will enable them to improve patients' treatment.

Scope

  • Overview of IPF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
  • Annualized IPF therapeutic market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the IPF therapeutics markets.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-stage pipeline drugs.
  • Analysis of the current and future market competition in the global IPF therapeutics markets. 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 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 IPF therapeutic markets.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IPF therapeutic markets 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.
  • Track drug sales in the global IPF therapeutic markets from 2015-2025.
  • Organize 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

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Classification or Staging System
  • 3.3. Prognosis
  • 3.4. Quality of Life
  • 3.5. Symptoms

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Incidence
    • 4.3.2. Prevalence
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Forecast Assumptions and Methods
    • 4.4.3. Sources Not Used
  • 4.5. Epidemiological Forecast for IPF (2015-2025)
    • 4.5.1. Diagnosed Incident Cases
    • 4.5.2. Diagnosed Prevalent Cases
    • 4.5.3. IPF Mortality
  • 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. Esbriet (Pirfenidone)
    • 5.2.2. Ofev (Nintedanib)
    • 5.2.3. Fluimucil (N-acetylcysteine)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Lack of an Efficacious Drug
    • 6.2.1. Overview
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Patient Access to Costly Treatments
    • 6.3.1. Overview
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Early and Prompt Diagnosis
    • 6.4.1. Overview
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Unrecognized Disease
    • 6.5.1. Overview
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity
  • 6.6. Lack of Treatment Options for Patients with Late Stage Disease
    • 6.6.1. Overview
    • 6.6.2. Gap Analysis
    • 6.6.3. Opportunity
  • 6.7. Improvement in Patient Quality Of Life
    • 6.7.1. Overview
    • 6.7.2. Gap Analysis
    • 6.7.3. Opportunity
  • 6.8. Improved Side Effects and Dosing Regimen
    • 6.8.1. Overview
    • 6.8.2. Gap Analysis
    • 6.8.3. Opportunity

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Drug Development Strategy: Combination Therapy
    • 7.1.2. Improving Understanding of Disease Mechanism
    • 7.1.3. Licensing and Alliances
    • 7.1.4. Niche Patient Subgroups
  • 7.2. Clinical Trial Design
    • 7.2.1. Selection of Appropriate Clinical Trial Endpoints

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. FG-3019
    • 8.2.2. PRM-151
    • 8.2.3. Lebrikizumab
    • 8.2.4. SAR-156597
    • 8.2.5. BG-00011
    • 8.2.6. BMS-986020
    • 8.2.7. AF-219
    • 8.2.8. Tipelukast
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Combination Therapy
    • 8.3.2. Biomarkers
    • 8.3.3. Stem Cell Therapy

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking of Key Pipeline Drugs
    • 9.1.1. Standards of Care - Esbriet and Ofev
    • 9.1.2. PRM-151
    • 9.1.3. FG-3019
    • 9.1.4. Other Pipeline Products
  • 9.2. Commercial Benchmarking of Key Pipeline Drugs
    • 9.2.1. Standards of Care - Esbriet and Ofev
    • 9.2.2. PRM-151
    • 9.2.3. FG-3019
    • 9.2.4. Other Pipeline Products
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Ten-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 IPF 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. Physicians and Specialists Included in this Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Author
    • 10.7.2. Therapy Area Director
    • 10.7.3. Epidemiologist
    • 10.7.4. Global Director of Therapy Analysis and Epidemiology
    • 10.7.5. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Idiopathic Interstitial Pneumonias and Associated Histological Patterns
  • Table 2: The GAP Index
  • Table 3: The GAP Index and Staging System
  • Table 4: Risk Factors and Comorbidities of IPF
  • Table 5: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IPF
  • Table 6: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IPF
  • Table 7: 7MM, except Japan, Sources Used to Forecast Severity Segmentation of Diagnosed Incident Cases and Diagnosed Prevalent Cases of IPF
  • Table 8: 7MM, Sources Used to Forecast IPF Deaths
  • Table 9: 7MM, Sources Not Used in the Epidemiological Analysis of IPF
  • Table 10: 7MM, Diagnosed Incident Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025
  • Table 11: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N (Row %), 2015
  • Table 12: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages ≥18 Years, N (Row %), 2015
  • Table 13: 7MM, Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025
  • Table 14: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N (Row %), 2015
  • Table 15: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, N (Row %), 2015
  • Table 16: 7MM, IPF Deaths, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025
  • Table 17: 7MM, Age-Specific IPF Deaths, Both Sexes, N (Row %), 2015
  • Table 18: 7MM, Sex-Specific IPF Deaths, Ages ≥18 Years, N (Row %), 2015
  • Table 19: Leading Treatments for IPF, 7MM 2016
  • Table 20: Product Profile - Esbriet
  • Table 21: Safety of Esbriet
  • Table 22: Esbriet SWOT Analysis, 2016
  • Table 23: Product Profile - Ofev
  • Table 24: Safety of Ofev
  • Table 25: Ofev SWOT Analysis, 2016
  • Table 26: Product Profile - Fluimucil
  • Table 27: Fluimucil SWOT Analysis, 2016
  • Table 28: Unmet Need and Opportunities in IPF, 2016
  • Table 29: IPF - Late-Stage Pipeline, May 2016
  • Table 30: Product Profile - FG-3019
  • Table 31: FG-3019 SWOT Analysis, 2016
  • Table 32: Product Profile - PRM-151
  • Table 33: PRM-151 SWOT Analysis, 2016
  • Table 34: Product Profile - Lebrikizumab
  • Table 35: Lebrikizumab SWOT Analysis, 2016
  • Table 36: Product Profile - SAR-156597
  • Table 37: SAR-156597 SWOT Analysis, 2016
  • Table 38: Product Profile - BG-00011
  • Table 39: BG-00011 SWOT Analysis, 2016
  • Table 40: Product Profile - BMS-986020
  • Table 41: BMS-986020 SWOT Analysis, 2016
  • Table 42: Product Profile - AF-219
  • Table 43: AF-219 SWOT Analysis, 2016
  • Table 44: Product Profile -Tipelukast
  • Table 45: Tipelukast SWOT Analysis, 2016
  • Table 46: Early-stage pipeline products in IPF, May 2016
  • Table 47: Clinical Benchmark of Key Pipeline Drugs in IPF
  • Table 48: Commercial Benchmark of Key Pipeline Drugs in IPF
  • Table 49: Top-Line Sales Forecast ($m) for IPF, 2015-2025
  • Table 50: Key Events Impacting Sales for IPF, 2015-2025
  • Table 51: IPF Market - Drivers and Barriers, 2015-2025
  • Table 52: Key Launch Dates
  • Table 53: Key Patent Expiries
  • Table 54: Key Historical and Projected Launch Dates
  • Table 55: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: The Induction and Progression of IPF
  • Figure 2: Classifications of Idiopathic Interstitial Pneumonia
  • Figure 3: 7MM, Diagnosed Incident Cases of IPF, Ages ≥18 Years, Both Sexes, N, 2015-2025
  • Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N, 2015
  • Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages ≥18 Years, 2015
  • Figure 6: 7MM, Age-Standardized Diagnosed Incidence of IPF, Ages ≥18 Years, N, 2015
  • Figure 7: US and 5EU, Diagnosed Incident Cases of IPF by Severity, Both Sexes, Ages ≥18, 2015
  • Figure 8: 7MM, Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025
  • Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N, 2015
  • Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, 2015
  • Figure 11: 7MM, Age-Standardized Diagnosed Prevalence of IPF, Ages ≥18 Years, N, 2015
  • Figure 12: US and 5EU, Diagnosed Prevalent Cases of IPF by Severity, Both Sexes, Ages ≥18 Years, 2015
  • Figure 13: 7MM, IPF Deaths, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025
  • Figure 14: 7MM, Age-Specific IPF Deaths, Both Sexes, N, 2015
  • Figure 15: 7MM, Sex-Specific IPF Deaths, Ages ≥18 Years, 2015
  • Figure 16: Competitive Assessment of Late-Stage Pipeline Agents in IPF, 2015-2025
  • Figure 17: Global Sales for IPF by Region, 2015-2025
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