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市場調查報告書

肺動脈高血壓:機會分析與預測 2024年

OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecast to 2024

出版商 GlobalData 商品編碼 356221
出版日期 內容資訊 英文 182 Pages
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肺動脈高血壓:機會分析與預測 2024年 OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecast to 2024
出版日期: 2016年01月01日 內容資訊: 英文 182 Pages
簡介

全球主要7個市場 (美國、歐盟五國、日本 的肺動脈高血壓 (PAH) 的2014年的銷售額規模,約34億5,000萬美金。該市場預計在預測的10年期間以3.20%的年複合成長率緩慢成長,2024年終生成約47億5,000萬美元的銷售額。主要7個市場的成長的主要推動因素,是Actelion公司的Uptravi的銷售和2重、3重聯合療法的利用擴大。

本報告提供肺動脈高血壓 (PAH) 相關臨床研究最新趨勢相關分析,PAH概要,市場資料 (收益、治療成本、治療的利用模式、預測) 、未滿足需求,臨床實驗製圖,市場預測,開發平台分析,及競爭分析等系統性資訊。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因及病理學
  • 症狀
  • 診斷
  • 預後
  • QL (生活品質)

第4章 流行病學

  • 疾病的背景
  • 風險因素和合併症
  • 全球的趨勢
    • 發病率、盛行率
  • 預測手法
    • 使用來源
    • 未使用來源
    • 預測的前提條件、手法
  • PAH的流行病學的預測
  • 討論
    • 流行病學預測的考察
    • 分析的限制
    • 分析的優勢

第5章 競爭評估

  • 概要
  • 診斷、治療
  • 臨床業務
  • 產品簡介:內皮素受體拮抗劑
  • 產品簡介:PDE5抑制劑
  • 產品簡介:可溶性鳥苷酸環化酶 (sGC) 刺激藥
  • 產品簡介:前列環素衍生物

第6章 未滿足需求評估與機會分析

  • 概要
    • 新的治療藥或穩定化治療
    • 有效性的提高
    • 調整治療的生物標記、化驗
    • 右心衰竭的預防藥

第7章 研究開發策略

  • 概要
    • 現有PAH藥物的改性
    • 在其他的治療領域被知道的藥物的再利用
    • 新的抗發炎、抗增生劑治療目標
    • 授權協定、收購
  • 臨床實驗設計
    • 目前臨床實驗設計
    • 未來臨床實驗設計

第8章 開發平台評估

  • 概要
  • 後期階段臨床實驗的有潛力的藥劑
  • 創新的早期方法

第9章 開發平台價值分析

  • 主要開發平台藥物的臨床性基準
  • 主要開發平台藥物的商業性基準
  • 競爭評估
  • top line:10年預測
    • 美國
    • 歐盟五國
    • 日本

第10章 附錄

圖表清單

目錄
Product Code: GDHC050POA

GlobalData estimates the 2014 sales for pulmonary arterial hypertension (PAH) at approximately $3.45 billion across the 7MM covered in this report, which include the US, 5EU and Japan. The market will grow moderately at a CAGR of 3.20% during the 10-year forecast period, generating sales of approximately $4.75 billion at the end of 2024. The US market is expected to grow the fastest of the three regions, recording a CAGR of 3.70% and generating around 75% of global sales in 2024. The major drivers for this growth across the 7MM will be the launch of Actelion's Uptravi and the increased use of double and triple combination therapy.

Highlights

Key Questions Answered

  • The level of unmet needs in the PAH market is significantly high. Will the pipeline drugs fulfil these unmet needs of the market? Key Opinion Leaders (KOLs) interviewed by GlobalData provide insights and highlight opportunities for drug developers.
  • The 10-year forecast period will mark the launch of two late-stage pipeline drugs and the patent expirations of seven marketed drugs. How will the market be impacted? Which of the marketed and pipeline drugs will have the highest peak sales at the highest CAGR, and why?
  • Is combination therapy the new standard-of-care in the PAH market? How will reimbursement affect the adoption of combination therapy in the different markets?

Key Findings

  • The major drivers for growth across the 7MM in the PAH market during the forecast period will be the launch of the first-in-class prostacyclin receptor agonist, Uptravi marketed by Actelion and the increased use of combination therapy.
  • KOLs interviewed by GlobalData opined that Uptravi has a promising future as a second-line therapy in the PAH market, and has the potential to displace oral treprostinil's market position.
  • The highest revenue generators in the 7MM market at the end of 2024 will be Actelion's Veletri, Opsumit and Uptravi and Bayer's Adempas.
  • In other interviews, KOLs highlighted that the greatest unmet need in the PAH disease space is the need to develop novel drugs with curative or disease-stabilizing properties.
  • Low disease awareness, declining population in the 5EU and Japan, high cost of drugs and patent expirations of branded drugs are the major barriers for growth in the PAH market during the forecast period.

Scope

  • Overview of PAH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized PAH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the PAH 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 PAH 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 PAH therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the PAH 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 7MM PAH therapeutics market from 2014-2024.
  • 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

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Diagnosis
  • 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 and Prevalence
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast for PAH (2014-2024)
    • 4.5.1. Epidemiological Forecast for PAH - Based on Registry Data
    • 4.5.2. Epidemiological Forecast for PAH - Adjusted for Underestimation
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Competitive Assessment

  • 5.1. Overview
  • 5.2. Diagnosis and Treatment
  • 5.3. Clinical Practice
  • 5.4. Product Profiles - Endothelin Receptor Antagonists
    • 5.4.1. Tracleer (bosentan)
    • 5.4.2. Volibris/Letairis (Ambrisentan)
    • 5.4.3. Opsumit (macitentan)
  • 5.5. Product Profiles - Phosphodiesterase Type 5 Inhibitors
    • 5.5.1. Revatio (sildenafil citrate)
    • 5.5.2. Adcirca (tadalafil)
  • 5.6. Product Profile - Soluble Guanylate Cyclase Stimulator
    • 5.6.1. Adempas (riociguat)
  • 5.7. Product Profiles - Prostacyclin Derivatives
    • 5.7.1. Flolan and Generics (epoprostenol)
    • 5.7.2. Veletri (epoprostenol)
    • 5.7.3. Ventavis (iloprost)
    • 5.7.4. Remodulin (treprostinil)
    • 5.7.5. Tyvaso (Treprostinil)
    • 5.7.6. Orenitram (treprostinil)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
    • 6.1.1. Novel Curative or Stabilizing Therapeutics
    • 6.1.2. Improved Efficacy
    • 6.1.3. Biomarkers and Assays to Tailor Treatment
    • 6.1.4. Drugs to Prevent Right Heart Failure

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Reformulation of Existing PAH Drugs
    • 7.1.2. Repurposing of Known Drugs from Other Therapy Areas
    • 7.1.3. Novel Anti-inflammatory and Anti-Proliferative Therapeutic Targets
    • 7.1.4. Licensing Agreements and Acquisitions
  • 7.2. Clinical Trial Design
    • 7.2.1. Current Clinical Trial Design
    • 7.2.2. Future Clinical Trial Design

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Late-Stage Clinical Development
    • 8.2.1. Uptravi (selexipag)
    • 8.2.2. Beraprost Sodium 314d (Beraprost sodium)
  • 8.3. 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 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 PAH patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. General Pricing Assumptions
    • 10.4.5. Individual Drug Assumptions
    • 10.4.6. Pricing of Pipeline agents
  • 10.5. Physicians Included in This Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Analyst
    • 10.7.2. Epidemiologist
    • 10.7.3. Therapy Director - CVMD
    • 10.7.4. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: NYHA/WHO Functional Classification of PAH
  • Table 2: WHO Guidelines, Modified New York Heart Association Functional Classes I-IV
  • Table 3: Risk Factors and Comorbidities for PAH
  • Table 4: 7MM, Global Trends for the Diagnosed Incidence of PAH
  • Table 5: 7MM, Global Trends for the Diagnosed Prevalence of PAH
  • Table 6: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Incident Cases (Based on Registry Data)
  • Table 7: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Prevalent Cases (Based on Registry Data)
  • Table 8: 7MM Sources of Epidemiological Data Used for the Classification of Diagnosed Prevalent Cases* According to the NYHA Functional Classes I-IV
  • Table 9: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data)
  • Table 10: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data)
  • Table 11: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data)
  • Table 12: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data)
  • Table 13: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data)
  • Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data)
  • Table 15: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation)
  • Table 16: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation)
  • Table 17: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation)
  • Table 18: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation)
  • Table 19: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation)
  • Table 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation)
  • Table 21: PAH Diagnosis and Treatment Guidelines
  • Table 22: Leading Treatments for PAH
  • Table 23: Product Profile - Tracleer
  • Table 24: Tracleer SWOT Analysis, 2015
  • Table 25: Product Profile - Volibris/Letairis
  • Table 26: Volibris/Letairis SWOT Analysis, 2015
  • Table 27: Product Profile - Opsumit
  • Table 28: Opsumit SWOT Analysis, 2015
  • Table 29: Product Profile - Revatio
  • Table 30: Revatio SWOT Analysis, 2015
  • Table 31: Product Profile - Adcirca
  • Table 32: Adcirca SWOT Analysis, 2015
  • Table 33: Product Profile - Adempas
  • Table 34: Adempas SWOT Analysis, 2015
  • Table 35: Product Profile - Flolan
  • Table 36: Flolan SWOT Analysis, 2015
  • Table 37: Product Profile - Veletri
  • Table 38: Veletri SWOT Analysis, 2015
  • Table 39: Product Profile - Ventavis
  • Table 40: Ventavis SWOT Analysis, 2015
  • Table 41: Product Profile - Remodulin
  • Table 42: Remodulin SWOT Analysis, 2015
  • Table 43: Product Profile - Tyvaso
  • Table 44: Tyvaso SWOT Analysis, 2015
  • Table 45: Product Profile - Orenitram
  • Table 46: Orenitram SWOT Analysis, 2015
  • Table 47: Unmet Needs in PAH
  • Table 48: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH
  • Table 49: PAH - Late-Stage Clinical Pipeline, 2015
  • Table 50: Product Profile - Uptravi
  • Table 51: Uptravi SWOT Analysis, 2015
  • Table 52: Product Profile - Beraprost Sodium 314d
  • Table 53: Beraprost Sodium 314d SWOT Analysis, 2015
  • Table 54: Innovative Early-Stage Pipeline Products in PAH
  • Table 55: Clinical Benchmark of Key Pipeline Drugs for PAH
  • Table 56: Commercial Benchmark of Key Pipeline Drugs for PAH
  • Table 57: Top-Line Sales Forecasts ($m) for PAH, 2014-2024
  • Table 58: Key Events Impacting Sales for PAH, 2014-2024
  • Table 59: Pulmonary Arterial Hypertension Market - Drivers and Barriers, 2014-2024
  • Table 60: Key Launch Dates
  • Table 61: Key Patent Expiration Dates
  • Table 62: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Target Pathways of the Currently Marketed Drugs for PAH
  • Figure 2: Diagnostic Approach to PAH
  • Figure 3: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data)
  • Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data)
  • Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Based on Registry Data)
  • Figure 6: 7MM, Age-Standardized Diagnosed Incidence of PAH (Cases per 100,000 Population), All Ages, by Sex, 2014 (Based on Registry Data)
  • Figure 7: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data)
  • Figure 8: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data)
  • Figure 9: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Based on Registry Data)
  • Figure 10: 7MM, Age-Standardized Diagnosed Prevalence of PAH (%), All Ages, by Sex, 2014 (Based on Registry Data)
  • Figure 11: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Based on Registry Data)
  • Figure 12: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation)
  • Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation)
  • Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation)
  • Figure 15: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation)
  • Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation)
  • Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation)
  • Figure 18: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Adjusted for Underestimation)
  • Figure 19: PAH Treatment Algorithm
  • Figure 20: Competitive Assessment of Key Pipeline Drugs for PAH, 2014-2024
  • Figure 21: Sales for PAH in the US, 5EU, and Japan, 2014-2024
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