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

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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 Actelions 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?

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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 treprostinils market position.
- The highest revenue generators in the 7MM market at the end of 2024 will be Actelions Veletri, Opsumit and Uptravi and Bayers 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.

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Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Symptoms 22
3.3 Diagnosis 23
3.4 Prognosis 24
3.5 Quality of Life 25
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 28
4.3 Global Trends 29
4.3.1 Incidence and Prevalence 29
4.4 Forecast Methodology 31
4.4.1 Sources Used 34
4.4.2 Sources Not Used 39
4.4.3 Forecast Assumptions and Methods 40
4.5 Epidemiological Forecast for PAH (2014-2024) 46
4.5.1 Epidemiological Forecast for PAH - Based on Registry Data 46
4.5.2 Epidemiological Forecast for PAH - Adjusted for Underestimation 61
4.6 Discussion 74
4.6.1 Epidemiological Forecast Insight 74
4.6.2 Limitations of the Analysis 75
4.6.3 Strengths of the Analysis 76
5 Competitive Assessment 78
5.1 Overview 78
5.2 Diagnosis and Treatment 78
5.3 Clinical Practice 81
5.4 Product Profiles - Endothelin Receptor Antagonists 83
5.4.1 Tracleer (bosentan) 83
5.4.2 Volibris/Letairis (Ambrisentan) 87
5.4.3 Opsumit (macitentan) 91
5.5 Product Profiles - Phosphodiesterase Type 5 Inhibitors 94
5.5.1 Revatio (sildenafil citrate) 94
5.5.2 Adcirca (tadalafil) 96
5.6 Product Profile - Soluble Guanylate Cyclase Stimulator 99
5.6.1 Adempas (riociguat) 99
5.7 Product Profiles - Prostacyclin Derivatives 103
5.7.1 Flolan and Generics (epoprostenol) 103
5.7.2 Veletri (epoprostenol) 106
5.7.3 Ventavis (iloprost) 108
5.7.4 Remodulin (treprostinil) 111
5.7.5 Tyvaso (Treprostinil) 114
5.7.6 Orenitram (treprostinil) 117
6 Unmet Needs Assessment and Opportunity Analysis 121
6.1 Overview 121
6.1.1 Novel Curative or Stabilizing Therapeutics 122
6.1.2 Improved Efficacy 124
6.1.3 Biomarkers and Assays to Tailor Treatment 126
6.1.4 Drugs to Prevent Right Heart Failure 127
7 R&D Strategies 129
7.1 Overview 129
7.1.1 Reformulation of Existing PAH Drugs 129
7.1.2 Repurposing of Known Drugs from Other Therapy Areas 130
7.1.3 Novel Anti-inflammatory and Anti-Proliferative Therapeutic Targets 130
7.1.4 Licensing Agreements and Acquisitions 131
7.2 Clinical Trial Design 132
7.2.1 Current Clinical Trial Design 132
7.2.2 Future Clinical Trial Design 133
8 Pipeline Assessment 135
8.1 Overview 135
8.2 Promising Drugs in Late-Stage Clinical Development 136
8.2.1 Uptravi (selexipag) 136
8.2.2 Beraprost Sodium 314d (Beraprost sodium) 140
8.3 Innovative Early-Stage Approaches 144
9 Pipeline Valuation Analysis 146
9.1 Clinical Benchmark of Key Pipeline Drugs 146
9.2 Commercial Benchmark of Key Pipeline Drugs 148
9.3 Competitive Assessment 149
9.4 Top Line 10-Year Forecast 150
9.4.1 US 153
9.4.2 5EU 154
9.4.3 Japan 155
10 Appendix 156
10.1 Bibliography 156
10.2 Abbreviations 164
10.3 Methodology 167
10.4 Forecasting Methodology 167
10.4.1 Diagnosed PAH patients 167
10.4.2 Percent Drug-Treated Patients 167
10.4.3 Drugs Included in Each Therapeutic Class 168
10.4.4 General Pricing Assumptions 169
10.4.5 Individual Drug Assumptions 170
10.4.6 Pricing of Pipeline agents 175
10.5 Physicians Included in This Study 176
10.6 Primary Research - Prescriber Survey 178
10.7 About the Authors 179
10.7.1 Analyst 179
10.7.2 Epidemiologist 179
10.7.3 Therapy Director - CVMD 180
10.7.4 Global Head of Healthcare 180
10.8 About GlobalData 181
10.9 Disclaimer 181

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