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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 Forecasts to 2026

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 Forecasts to 2026
出版日期: 2017年10月09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

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目錄
Product Code: GDHC076POA

Pulmonary arterial hypertension (PAH) is a rare, fatal cardiopulmonary disease with an annual mortality rate of 15%. The disease is a subset (Group 1) within the World Health Organization's (WHO's) classification of the different types of pulmonary hypertension (PH). PAH is characterized by an abnormal rise in the resting mean pulmonary artery pressure (PAP) (>25mmHg compared with normal levels of around 14mmHg), a pulmonary vascular resistance of more than 3 Wood units, and a pulmonary capillary wedge pressure less than 15mmHg (Foshat and Boroumand, 2017).

Pulmonary arterial hypertension (PAH) market has generated much interest and investment from drug developers over the past several years, despite PAH being a rare disease. Current treatments include 13 marketed drugs from five different therapeutics classes, while there are four drugs in late-stage development. The forecast period from 2016-2026 will be marked by the patent expirations of several of these marketed drugs, including Volibris/Letairis, Opsumit, Adcirca, Adempas, Remodulin, Tyvaso, and Uptravi.

It is estimated that the 2016 sales for the pulmonary arterial hypertension (PAH) market was approximately $3.8B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2026, it is expected that the overall market will grow at a moderate compound annual growth rate (CAGR) of 2.2% over the 10-year period.

Major drivers to this growth in the PAH market during the forecast period will include -

  • Increased use of combination therapy following the positive outcomes from recent clinical trials will boost PAH sales due to higher treatment costs of drug combinations.
  • Launch of Reata Pharmaceuticals' first-in-class antioxidant inflammation modulator, bardoxolone methyl, will provide an effective oral therapy for PAH patients with the potential of being used in combination with other therapies.
  • Patient assistance programs by manufacturers will provide reimbursement support to the patients.
  • Launch of Arena Pharmaceuticals' pipeline drug, ralinepag, will provide an effective oral alternative to parenteral prostacyclin therapy.

The report "OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecasts to 2026", provideoverview of pulmonary arterial hypertension, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

In particular, this report provides the following -

  • Annualized PAH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
  • 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.

Companies mentioned in this report: Actelion Pharmaceuticals (now key subsidiary of Johnson & Johnson), Arena Pharmaceuticals Bayer, EigerBioPharmaceuticals, Eli Lilly, Gilead, GlaxoSmithKline, Merck, Mochida Pharmaceutical.

Scope

  • Overview of pulmonary arterial hypertension, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized PAH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
  • 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 global PAH therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global 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 global PAH therapeutics market from 2016-2026.
  • 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 Table of Contents 2

  • 1.1 List of Tables 7
  • 1.2 List of Figures 8

2 Executive Summary 10

  • 2.1 PAH Market Will Exhibit Moderate Growth Between 2016 and 2026 10
  • 2.2 Upfront and Sequential Dual and Triple Combination Therapies and Launch of Bardoxolone Methyl Will Fuel Market Growth 12
  • 2.3 Bardoxolone Methyl Has the Potential to Become a Blockbuster Therapy and Fulfill an Unmet Need 13
  • 2.4 Reformulation of Existing Drugs Will Continue to Dominate the PAH Pipeline 14
  • 2.5 What Do Physicians Think? 14

3 Introduction 18

  • 3.1 Catalyst 18
  • 3.2 Related Reports 18

4 Disease Overview 19

  • 4.1 Etiology and Pathophysiology 19
    • 4.1.1 Etiology 19
    • 4.1.2 Pathophysiology 19
  • 4.2 Symptoms 22
  • 4.3 Diagnosis 23
  • 4.4 Prognosis 25
  • 4.5 Quality of Life 25

5 Epidemiology 27

  • 5.1 Disease Background 27
  • 5.2 Risk Factors and Comorbidities 28
  • 5.3 Global and Historical Trends 29
  • 5.4 Forecast Methodology 31
    • 5.4.1 Sources 31
    • 5.4.2 Forecast Assumptions and Methods 39
  • 5.5 Epidemiological Forecast for PAH (2016-2026) - Based on Registry Data 51
    • 5.5.1 Diagnosed Incident Cases of PAH (Forecast Based on Registry Data) 51
    • 5.5.2 Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data) 52
    • 5.5.3 Diagnosed Prevalent Cases of PAH by NYHA Functional Classes (Forecast Based on Registry Data) 53
    • 5.5.4 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data) 53
  • 5.6 Epidemiological Forecast for PAH (2016-2026) - Adjusted for Underestimation of Registry Data 54
    • 5.6.1 Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 54
    • 5.6.2 Age-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 56
    • 5.6.3 Sex-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 57
    • 5.6.4 Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 58
    • 5.6.5 Age-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 59
    • 5.6.6 Sex-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 60
    • 5.6.7 Diagnosed Prevalent Cases of PAH by NYHA Functional Class I-IV (Forecast Adjusted for Underestimation of Registry Data) 61
    • 5.6.8 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 62
  • 5.7 Discussion 63
    • 5.7.1 Epidemiological Forecast Insight 63
    • 5.7.2 Limitations of Analysis 64
    • 5.7.3 Strengths of Analysis 64

6 Current Treatment Options 66

  • 6.1 Overview 66
  • 6.2 Diagnosis and Treatment 66
  • 6.3 Clinical Practice 68
  • 6.4 Product Profiles - Endothelin Receptor Antagonists 71
    • 6.4.1 Tracleer and Generics (bosentan) 71
    • 6.4.2 Volibris/Letairis (ambrisentan) 74
    • 6.4.3 Opsumit (macitentan) 77
  • 6.5 Product Profiles - Phosphodiesterase Type 5 Inhibitors 80
    • 6.5.1 Revatio and Generics (sildenafil citrate) 80
    • 6.5.2 Adcirca (tadalafil) 83
  • 6.6 Product Profiles - Soluble Guanylate Cyclase Stimulators 85
    • 6.6.1 Adempas (riociguat) 85
  • 6.7 Product Profiles - Prostacyclin Derivatives 89
    • 6.7.1 Flolan and Generics (epoprostenol) 89
    • 6.7.2 Veletri (epoprostenol) 92
    • 6.7.3 Ventavis (iloprost) 94
    • 6.7.4 Remodulin (treprostinil) 96
    • 6.7.5 Tyvaso (treprostinil) 99
    • 6.7.6 Orenitram (treprostinil) 101
  • 6.8 Product Profiles - Prostacyclin IP Receptor Agonists 104
    • 6.8.1 Uptravi (selexipag) 104

7 Unmet Needs and Opportunity Assessment 109

  • 7.1 Overview 109
  • 7.2 Novel Curative or Stabilizing Therapeutics 110
    • 7.2.1 Unmet Need 110
    • 7.2.2 Gap Analysis 112
    • 7.2.3 Opportunity 112
  • 7.3 Improved Efficacy 113
    • 7.3.1 Unmet Need 113
    • 7.3.2 Gap Analysis 113
    • 7.3.3 Opportunity 114
  • 7.4 Biomarkers and Assays to Tailor Treatment 114
    • 7.4.1 Unmet Need 114
    • 7.4.2 Gap Analysis 115
    • 7.4.3 Opportunity 115
  • 7.5 Drugs to Prevent Right Heart Failure 115
    • 7.5.1 Unmet Need 115
    • 7.5.2 Gap Analysis 116
    • 7.5.3 Opportunity 116
  • 7.6 Anti-inflammatory Therapies 117
    • 7.6.1 Unmet Need 117
    • 7.6.2 Gap Analysis 117
    • 7.6.3 Opportunity 117

8 R&D Strategies 118

  • 8.1 Overview 118
    • 8.1.1 Reformulation of Existing PAH Drugs 118
    • 8.1.2 Repurposing of Known Drugs from Other Therapy Areas 119
    • 8.1.3 Novel Anti-inflammatory and Anti-proliferative Therapeutic Targets 119
    • 8.1.4 Licensing Agreements and Acquisitions 120
  • 8.2 Clinical Trials Design 121
    • 8.2.1 Current Clinical Trial Design 121
    • 8.2.2 Future Clinical Trial Design 122

9 Pipeline Assessment 124

  • 9.1 Overview 124
  • 9.2 Promising Drugs in Clinical Development 126
  • 9.3 Promising Drugs in Clinical Development, Prostacyclin Derivatives 126
    • 9.3.1 Trevyent (treprostinil diolamine) 126
    • 9.3.2 Tysuberprost (esuberaprost sodium + treprostinil) 128
  • 9.4 Promising Drugs in Clinical Development, Prostacyclin IP Receptor Agonists 131
    • 9.4.1 Ralinepag 131
  • 9.5 Promising Drugs in Clinical Development, Antioxidant Inflammation Modulators 133
    • 9.5.1 Bardoxolone Methyl 133
  • 9.6 Innovative Early-Stage Approaches 136

10 Pipeline Valuation Analysis 139

  • 10.1 Clinical Benchmark of Key Pipeline Drugs 139
  • 10.2 Commercial Benchmark of Key Pipeline Drugs 141
  • 10.3 Competitive Assessment 143
  • 10.4 Top-Line 10-Year Forecast 145
    • 10.4.1 US 149
    • 10.4.2 5EU 151
    • 10.4.3 Japan 151

11 Appendix 153

  • 11.1 Bibliography 153
  • 11.2 Abbreviations 161
  • 11.3 Methodology 164
    • 11.3.1 Forecasting Methodology 164
    • 11.3.2 Diagnosed Patients 164
    • 11.3.3 Percent Drug-Treated Patients 164
    • 11.3.4 Drugs Included in Each Therapeutic Class 165
    • 11.3.5 Launch and Patent Expiry Dates 165
    • 11.3.6 General Pricing Assumptions 166
    • 11.3.7 Individual Drug Assumptions 167
    • 11.3.8 Generic Erosion 171
    • 11.3.9 Pricing of Pipeline Agents 171
  • 11.4 Primary Research - KOLs Interviewed for This Report 173
  • 11.5 Primary Research - Prescriber Survey 176
  • 11.6 About the Authors 177
    • 11.6.1 Analyst 177
    • 11.6.2 Therapy Area Director 177
    • 11.6.3 Epidemiologist 178
    • 11.6.4 Director of Epidemiology 178
    • 11.6.5 Global Director of Therapy Analysis and Epidemiology 179
    • 11.6.6 Global Head of Healthcare 180
  • 11.7 About GlobalData 181
  • 11.8 Contact Us 181
  • 11.9 Disclaimer 182

List of Tables

1.1 List of Tables

  • Table 1: Pulmonary Arterial Hypertension Key Metrics in the 7MM 10
  • Table 2: NYHA/WHO Functional Classification of PAH 23
  • Table 3: WHO Guidelines, Modified NYHA Functional Classes I-IV 28
  • Table 4: Risk Factors and Comorbidities for PAH 29
  • Table 5: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Based on Registry Data) 51
  • Table 6: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Based on Registry Data). 52
  • Table 7: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data) 55
  • Table 8: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data) 58
  • Table 9: Treatment Guidelines for PAH 67
  • Table 10: Most Prescribed Drugs for PAH by Class in the Global Markets, 2017 68
  • Table 11: Product Profile - Tracleer 72
  • Table 12: Tracleer SWOT Analysis, 2017 74
  • Table 13: Product Profile - Volibris/Letairis 75
  • Table 14: Volibris/Letairis SWOT Analysis, 2017 77
  • Table 15: Product Profile - Opsumit 78
  • Table 16: Opsumit SWOT Analysis, 2017 80
  • Table 17: Product Profile - Revatio 81
  • Table 18: Revatio SWOT Analysis, 2017 82
  • Table 19: Product Profile - Adcirca 84
  • Table 20: Adcirca SWOT Analysis, 2017 85
  • Table 21: Product Profile - Adempas 87
  • Table 22: Adempas SWOT Analysis, 2017 88
  • Table 23: Product Profile - Flolan 90
  • Table 24: Flolan SWOT Analysis, 2017 91
  • Table 25: Product Profile - Veletri 93
  • Table 26: Veletri SWOT Analysis, 2017 94
  • Table 27: Product Profile - Ventavis 95
  • Table 28: Ventavis SWOT Analysis, 2017 96
  • Table 29: Product Profile - Remodulin 98
  • Table 30: Remodulin SWOT Analysis, 2017 99
  • Table 31: Product Profile - Tyvaso 100
  • Table 32: Tyvaso SWOT Analysis, 2017 101
  • Table 33: Product Profile - Orenitram 103
  • Table 34: Orenitram SWOT Analysis, 2017 104
  • Table 35: Product Profile - Uptravi 107
  • Table 36: Uptravi SWOT Analysis, 2017 108
  • Table 37: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH 122
  • Table 38: PAH - Late-Stage Clinical Pipeline, 2017 126
  • Table 39: Product Profile - Trevyent 127
  • Table 40: Trevyent SWOT Analysis, 2017 128
  • Table 41: Product Profile - Tysuberprost 130
  • Table 42: Tysuberprost SWOT Analysis, 2017 131
  • Table 43: Product Profile - Ralinepag 132
  • Table 44: Ralinepag SWOT Analysis, 2017 133
  • Table 45: Product Profile - Bardoxolone Methyl 134
  • Table 46: Bardoxolone Methyl SWOT Analysis, 2017 136
  • Table 47: Drugs in Development for PAH, 2016 138
  • Table 48: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives 139
  • Table 49: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists 140
  • Table 50: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives 141
  • Table 51: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists 142
  • Table 52: Key Events Impacting Sales for PAH, 2016-2026 148
  • Table 53: PAH Market - Global Drivers and Barriers, 2016-2026 149
  • Table 54: Key Historical and Projected Launch Dates for PAH 165
  • Table 55: Key Historical and Projected Patent Expiry Dates for PAH 166
  • Table 56: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 176
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