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Published Date: 2015-04-06Number of Pages: 73

Pulmonary Arterial Hypertension (PAH) Market (Prostacyclin and Prostacyclin Analogs, ERAs, PDE-5 Inhibitors, sGC Stimulators and Selexipag) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020

Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by high blood pressure in pulmonary arteries that carry blood from the heart to the lungs. PAH is a very rare condition that occurs when pulmonary arteries become narrow in diameter or get blocked. Based on information gathered from various sources including WHO and CDC, the worldwide prevalence of PAH has been estimated to be between 100,000 – 200,000, approximately 15 - 50 cases per million people. Although, there is no cure for PAH, treatments are available to reduce symptoms, improve the quality of life, and slow down disease progression. Prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), and phosphodiesterase-5 (PDE-5) inhibitors are the most-prescribed drug classes for the treatment of PAH. Recently, a new drug class, soluble guanylate cyclase (sGC) stimulators, has been identified to treat people suffering from PAH.

The recent approval of drugs and the anticipated approval of new PAH drugs in the coming years have been identified as the major growth drivers of the PAH market during the forecast period between 2014 and 2020. Opsumit (macitentan), Orenitram (treprostinil extended release tablet), and Adempas (riociguat) are the PAH drugs that received approval from various regulatory agencies across the world in the recent years (2013 and 2014). A new therapeutic agent Uptravi (selexipag) is anticipated to be introduced in the first half of 2016. In addition, governments of various countries providing incentives to companies engaged in the development and manufacturing of PAH drugs are also expected to contribute to the market growth.

On the other hand, the patent expiry of major PAH drugs such as Tracleer, Letairis, Adcirca, and Tyvaso is expected to affect the market revenue during the forecast period, as their generic versions would be sold at prices 70% to 80% lower than that of the branded ones. Development of breakthrough therapy for the treatment of PAH is expected to be a growth opportunity for drug manufacturers, as the currently available drugs are not enough to meet the medical needs of people suffering from PAH.

The global PAH market has been segmented into prostacyclin and prostacyclin analogs, ERAs, PDE-5 inhibitors, and sGC stimulators, based on the commercially-available drug classes, to treat PAH. Of these, ERAs represented the largest segment in 2013 with a revenue share of 55.8%. However, during the forecast period, the prostacyclin and prostacyclin analogs segment is expected to record the highest growth, mainly due to the approval of Orenitram (treprostinil extended release tablet) in December 2013 and the anticipated approval of Uptravi (selexipag) in the first quarter of 2016. Adempas (riociguat) is the only approved sGC stimulator for the treatment of PAH. Adempas was first approved by the U.S. FDA in October 2013.

In terms of geography, the global pulmonary arterial hypertension (PAH) market has been segmented into four major regions: North America, Europe, Asia-Pacific, and Rest of the World (RoW). North America, with a share of 44.6%, represented the largest regional market for PAH in terms of revenue in 2013, followed by Europe. These two developed regions are expected to witness substantial growth during the forecast period, primarily due to the recently approved PAH drugs in the market and products that are anticipated to receive approval during the next few years. In the Asia Pacific region, Japan, China, India, Australia, and New Zealand exhibit immense opportunities for the companies operating in the PAH market. In RoW, the low level of awareness regarding the diagnosis and treatment of PAH is one of the prime reasons restraining the market growth. However, during the forecast period, growing awareness regarding PAH would drive growth of the market.

Actelion Pharmaceuticals, Ltd., Bayer HealthCare, Gilead Sciences, Inc., GlaxoSmithKline plc, Novartis International AG, Pfizer, Inc. and United Therapeutics Corporation are the key players operating in the global PAH market.

pulmonary-arterial-hypertension-therapeutics-market


Chapter 1 Preface
1.1 Report Description
1.2 Market Segmentation
1.3 Research Methodology
      1.3.1 Assumptions
      1.3.2 Sources
              1.3.2.1 Secondary Research
              1.3.2.2 Primary Research
      1.3.3 Models
1.4 List of Abbreviations

Chapter 2 Executive Summary
2.1 Market Snapshot: Global Pulmonary Arterial Hypertension Market (2013 & 2020)
2.2 Global Pulmonary Arterial Hypertension Market, by Drug Class, 2019 (USD Million)
2.3 Comparative Analysis: Global Pulmonary Arterial Hypertension Market Revenue, by Geography, 2013 & 2020 (Value %)

Chapter 3 Global Pulmonary Arterial Hypertension (PAH) Market Overview
3.1 Introduction
3.2 Epidemiology
3.3 Annual Treatment Cost with Various PAH Drugs in the United States
3.4 Drivers
      3.4.1 Newly-approved therapeutic agents will significantly contribute to the growth of the PAH market
      3.4.2 Governments encouraging development of orphan drugs to propel growth of the PAH market
3.5 Restraints
      3.5.1 Patent expirations of major PAH drugs during the forecast period
3.6 Opportunities
      3.6.1 Emphasis on developing breakthrough therapy for the treatment of PAH
3.7 Even Impact Analysis
3.8 Competitive Landscape
      3.8.1 Global Pulmonary Arterial Hypertension Market Share Analysis, by Key Players, 2013 (Value %)

Chapter 4 Global Pulmonary Arterial Hypertension (PAH) Market Revenue, by Drug Class
4.1 Overview
      4.1.1 Global Pulmonary Arterial Hypertension Market Revenue, by Drug Class, 2012 – 2020 (USD Million)
      4.1.2 Comparative Analysis: Global Pulmonary Arterial Hypertension Market Revenue, by Drug Class, 2013 & 2020 (Value %)
4.2 Prostacyclin and Prostacyclin Analogs
      4.2.1 Global Prostacyclin and Prostacyclin Analogs Market Revenue, 2012 – 2020 (USD Million)
      4.2.2 Historical Sales Data: Prostacyclin and Prostacyclin Analog Brands
4.3 Endothelin Receptor Antagonists (ERAs)
      4.3.1 Global Endothelin Receptor Antagonists Market Revenue, 2012 – 2020 (USD Million)
      4.3.2 Historical Sales Data: Endothelin Receptor Antagonist Brands
4.4 Phosphodiesterase 5 (PDE-5) Inhibitors
      4.4.1 Global Phosphodiesterase 5 Inhibitors Market Revenue, 2012 – 2020 (USD Million)
      4.4.2 Historical Sales Data: Phosphodiesterase 5 Inhibitor Brands
4.5 Soluble Guanylate Cyclase (sGC) Stimulators
      4.5.1 Global Soluble Guanylate Cyclase Stimulators Market Revenue, 2014 – 2020 (USD Million)

Chapter 5 Pipeline Analysis: Global Pulmonary Arterial Hypertension (PAH) Market
5.1 Overview
      5.1.1 Major Steps: Drug Development and Commercialization
5.2 Early-stage Drug Candidates (Phase I & Phase II)
      5.2.1 Pulmonary Arterial Hypertension: Phase I & Phase II Molecules
5.3 Late-stage Drug Candidates (Phase III & Registration Phase)
      5.3.1 Uptravi (selexipag)
              5.3.1.1 Global Uptravi (selexipag) Market Revenue, 2016 – 2020 (USD Million)

Chapter 6 Global Pulmonary Arterial Hypertension (PAH) Market, By Geography
6.1 Overview
      6.1.1 Global Pulmonary Arterial Hypertension Market Revenue, by Geography, 2012 – 2020 (USD Million)
6.2 North America
      6.2.1 North America Pulmonary Arterial Hypertension Market Revenue, 2012 - 2020 (USD Million)
6.3 Europe
      6.3.1 Europe Pulmonary Arterial Hypertension Market Revenue, 2012 - 2020 (USD Million)
6.4 Asia Pacific
      6.4.1 Asia Pacific Pulmonary Arterial Hypertension Market Revenue, 2012 - 2020 (USD Million)
6.5 Rest of the World (RoW)
      6.5.1 RoW Pulmonary Arterial Hypertension Market Revenue, 2012 - 2020 (USD Million)

Chapter 7 Recommendations
7.1 Focus on research and development
7.2 Collaboration
7.3 Targeting developing nations

Chapter 8 Company Profiles
8.1 Actelion Pharmaceuticals, Ltd.
      8.1.1 Company Overview
      8.1.2 Financial Overview
      8.1.3 Product Portfolio
      8.1.4 Business Strategies
      8.1.5 Recent Developments
8.2 Bayer HealthCare
      8.2.1 Company Overview
      8.2.2 Financial Overview
      8.2.3 Product Portfolio
      8.2.4 Business Strategies
      8.2.5 Recent Developments
8.3 Gilead Sciences, Inc.
      8.3.1 Company Overview
      8.3.2 Financial Overview
      8.3.3 Product Portfolio
      8.3.4 Business Strategies
      8.3.5 Recent Developments
8.4 GlaxoSmithKline plc
      8.4.1 Company Overview
      8.4.2 Financial Overview
      8.4.3 Product Portfolio
      8.4.4 Business Strategies
      8.4.5 Recent Developments
8.5 Novartis International AG
      8.5.1 Company Overview
      8.5.2 Financial Overview
      8.5.3 Product Portfolio
      8.5.4 Business Strategies
      8.5.5 Recent Developments
8.6 Pfizer, Inc.
      8.6.1 Company Overview
      8.6.2 Financial Overview
      8.6.3 Product Portfolio
      8.6.4 Business Strategies
      8.6.5 Recent Developments
8.7 United Therapeutics Corporation
      8.7.1 Company Overview
      8.7.2 Financial Overview
      8.7.3 Product Portfolio
      8.7.4 Business Strategies
      8.7.5 Recent Developments

List of Figures
 
FIG. 1 Pulmonary Arterial Hypertension (PAH): Market Segmentation
FIG. 2 Global Pulmonary Arterial Hypertension Market, by Drug Class, 2019 (USD Million)
FIG. 3 Comparative Analysis: Global Pulmonary Arterial Hypertension Market Revenue, by Geography, 2013 & 2020 (Value %)
FIG. 4 Global Pulmonary Arterial Hypertension Market Share Analysis, by Key Players, 2013 (Value %)
FIG. 5 Comparative Analysis: Global Pulmonary Arterial Hypertension Market Revenue, by Drug Class, 2013 & 2020 (Value %)
FIG. 6 Global Prostacyclin and Prostacyclin Analogs Market Revenue, 2012 – 2020 (USD Million)
FIG. 7 Global Endothelin Receptor Antagonists Market Revenue, 2012 – 2020 (USD Million)
FIG. 8 Global Phosphodiesterase 5 Inhibitors Market Revenue, 2012 – 2020 (USD Million)
FIG. 9 Global Soluble Guanylate Cyclase Stimulators Market Revenue, 2014 – 2020 (USD Million)
FIG. 10 Major Steps: Drug Development and Commercialization
FIG. 11 Global Uptravi (selexipag) Market Revenue, 2016 – 2020 (USD Million)
FIG. 12 North America Pulmonary Arterial Hypertension Market Revenue, 2012 – 2020 (USD Million)
FIG. 13 Europe Pulmonary Arterial Hypertension Market Revenue, 2012 – 2020 (USD Million)
FIG. 14 Asia Pacific Pulmonary Arterial Hypertension Market Revenue, 2012 – 2020 (USD Million)
FIG. 15 RoW Pulmonary Arterial Hypertension Market Revenue, 2012 – 2020 (USD Million)
FIG. 16 Actelion Pharmaceuticals, Ltd.: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 17 Bayer HealthCare: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 18 Gilead Sciences, Inc.: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 19 GlaxoSmithKline plc: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 20 Novartis International AG: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 21 Pfizer, Inc.: Annual Revenue, 2011 – 2013 (USD Million)
FIG. 22 United Therapeutics Corporation: Annual Revenue, 2011 – 2013 (USD Million)

List of Tables

TABLE 1 List of Abbreviations
TABLE 2 Market Snapshot: Global Pulmonary Arterial Hypertension Market (2013 & 2020)
TABLE 3 Annual Treatment Cost with Various PAH Drugs in the United States
TABLE 4 Event Impact Analysis: Global PAH Market
TABLE 5 Global Pulmonary Arterial Hypertension Market Revenue, by Drug Class, 2012 – 2020 (USD Million)
TABLE 6 Historical Sales Data: Prostacyclin and Prostacyclin Analog Brands
TABLE 7 Historical Sales Data: Endothelin Receptor Antagonist Brands
TABLE 8 Historical Sales Data: Phosphodiesterase 5 Inhibitor Brands
TABLE 9 Pulmonary Arterial Hypertension: Phase I & Phase II Molecules
TABLE 10 Global Pulmonary Arterial Hypertension Market Revenue, by Geography, 2012 – 2020 (USD Million)
TABLE 11 List of Major Countries in North America
TABLE 12 List of Major Countries in Europe
TABLE 13 List of Major Countries in Asia Pacific
TABLE 14 List of Major Countries in Rest of the World

Pulmonary arterial hypertension (PAH) is a progressive disorder, characterized by high blood pressure in pulmonary arteries that carry blood from the heart to the lungs. PAH is a very rare condition that occurs when pulmonary arteries become narrow in diameter or get blocked. This report on the global pulmonary arterial hypertension (PAH) market offers an insightful and in-depth assessment of the current and future market potential of PAH drugs. The research study has been divided into eight chapters namely, preface, executive summary, global PAH market overview, global PAH market revenue by drug class, PAH market pipeline analysis, global PAH market revenue by geography, recommendations, and company profiles.

The executive summary chapter covers a market snapshot representing key findings from the study on the global PAH market. The market overview chapter of the report comprises qualitative analysis of the overall PAH market, considering factors determining market dynamics such as growth drivers, restraints, and opportunities. This chapter also includes a section on epidemiology of PAH. A section on the event impact analysis has also been provided in the market overview chapter of the report on the PAH market. In the competitive landscape section, the market revenue share of key players operating in the PAH market in terms of percentage in 2013 has been provided. The market share analysis of key players involved a study of the company’s product/service portfolio and sales revenue along with the geographical presence.

In chapter four, the global PAH market has been segmented into prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE-5) inhibitors, and soluble guanylate cyclase (sGC) stimulators, based on the commercially-available drug classes, to treat PAH. The market revenue size for each segment has been provided in terms of USD million in the chapter for the period from 2012 to 2020, along with the CAGR for the forecast period between 2014 and 2020, considering 2012 and 2013 as the base years. The chapter also provides qualitative analysis for each segment, based on factors such as market trends, recent developments, future outlook, and opportunities.

Chapter five deals with the pipeline analysis of the PAH market and comprises information such as major steps involved in the development and commercialization of a drug, tabular presentation of early-stage drug candidates, and extensive analysis and future sales projection of the late-stage drug candidate, Uptravi (selexipag).

Geographically, the global PAH market has been classified into four major regions namely, North America, Europe, Asia-Pacific, and Rest of the World (RoW). The market size and forecast for each of these regions along with the CAGR has been provided in the report.

The study on the global PAH market also suggests a list of recommendations for new companies aspiring to enter the market and existing companies willing to accentuate revenue shares. The report concludes with the profiles of major players in the global PAH market such as Actelion Pharmaceuticals, Ltd., Bayer HealthCare, Gilead Sciences, Inc., GlaxoSmithKline plc, Novartis International AG, Pfizer, Inc., and United Therapeutics Corporation. Each company profile in the report provides information under the heads: company overview, financial overview, product portfolio, business strategies, and recent developments.

The company overview section comprises basic information about the company such as major business areas, company’s brief history and its establishment year, number of employees, and geographical presence. In the financial overview section, annual revenue for the last three consecutive years (2011, 2012, and 2013) has been provided. The business strategies section mentions key strategies adopted by a company in the past to strengthen its position in the PAH market. The recent developments section shares information about the recent activities of the companies operating in the PAH market.
 
The global PAH market is segmented as follows:

Global Pulmonary Arterial Hypertension Market, by Drug Class
  • Prostacyclin and Prostacyclin Analogs
  • Endothelin Receptor Antagonists (ERAs)
  • Phosphodiesterase-5 (PDE-5) Inhibitors
  • Soluble Guanylate Cyclase (sGC) Stimulators
Pipeline Analysis: Pulmonary Arterial Hypertension Market
  • Early-stage Drug Candidates (Phase I & Phase II)
  • Late-stage Drug Candidates (Phase III & Registration Phase)
Global Pulmonary Arterial Hypertension Market, by Geography
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World (RoW)


 
 
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