Pulmonary Arterial Hypertension (PAH) Therapeutics: Market Research Report

December 2017 | 161 pages | ID: P22FBE06122EN
Global Industry Analysts, Inc

Abstracts

This report analyzes the worldwide markets for Pulmonary Arterial Hypertension (PAH) Therapeutics in US$ Million. The Global market is analyzed by the following Drug Class and Brands: Endothelin Receptor Antagonist (Letairis/Volibris, Macitentan, Thelin, & Tracleer), Prostacyclin and Prostacyclin Analogs (Epoprostenol/Veletri*, Flolan, Remodulin, Selexipag, Tyvaso, Ventavis, & Orenitram), PDE-5 Inhibitors (Cialis/Adcirca, & Revatio), and Soluble Guanylate Cyclase (sGC) Stimulator (Riociguat). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022.

Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research.

Company profiles are primarily based on public domain information including company URLs.

The report profiles 31 companies including many key and niche players such as -

• Actelion Pharmaceuticals Ltd.
• Bayer AG
• Gilead Sciences, Inc.
• Pfizer, Inc.
• United Therapeutics Corporation

Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

Pulmonary Arterial Hypertension (PAH) – A Prelude
Current & Future Analysis
PAH Drugs Market by Class

Table 1. Global PAH Market by Drug Class (2016 & 2018): Percentage Share Breakdown of Sales by Drug Class (includes corresponding Graph/Chart)

The PAH Classification
PH Patient Groupings as per World Health Organization
Classification of PAH patients as per New York Heart Association (NYHA)
Oral Therapies lead the Global PAH Therapeutics Market

Table 2. Global PAH Market by Mode of Drug Usage (2016): Percentage Share Breakdown for Oral, Inhaled, and Injectables (includes corresponding Graph/Chart)

Combination Therapy Favored over Monotherapy for PAH
Pediatric PAH - A Potential Market with Unmet Need
Inflammation: New Target for PAH Therapeutics
Aging Population & PAH

Table 3. Global Aging Population (in Thousands) by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Table 4. Global Population by Age-Group: Percentage Change Over the Period 2010-2050 (includes corresponding Graph/Chart)

2. COMPETITIVE SCENARIO

Leading Players

Table 5. Leading Drugs for PAH (2016): Percentage Share Breakdown of Revenue by Brand (includes corresponding Graph/Chart)

Table 6. Leading Players in the Global PAH Therapeutics Market: Percentage Share Breakdown of Revenues by Company (includes corresponding Graph/Chart)

Leading Approved Drugs as Per Mode of Administration
Major Drug Brands by Class
Prostacyclin receptor agonist/ Prostacyclin Analogue
Flolan (Epoprostenol)
Ventavis (Iloprost)
Remodulin (Treprostinil)
Orenitram
Tyvaso
Uptravi (Selexipag)
Veletri (Epoprostenol for Injection)
Phosphodiesterase 5 inhibitor
Revatio
Adcirca (Tadalafil)
Endothelin receptor antagonists (ERAs)
Opsumit
Tracleer (Bosentan)
Letairis (Ambrisentan)
Loss of Market exclusivity Tones Down Growth
Patent Expiry of Leading PAH Drugs
Opsumit & Uptravi: Game-changers for Actelion
Selexipag – Latest Entrant in PAH Therapeutics
United Therapeutics - A Major Player
Gilead Sciences
GlaxoSmithKline
Bayer

3. PAH PIPELINE

Pulmokine Investigates PDGF Receptor Pathway
Reata Pharmaceuticals Completes Phase 3 Study for Bardoxolone methyl
Eiger BioPharmaceuticals Commences Phase 2 Trials for Bestatin
Insmed Investigates INS 1009
LTT Bio-Pharma Focuses on LT-2004
Ascendis Investigates TransCon Treprostinil in a Phase I trial
Arena Initiates Phase II Trial for Ralinepeg,
TheraSilence nanoparticles Found to Reduce Pulmonary Arterial Thickness
CXA-10 to Undergo Phase II Study
Atu111 Undergoes Preclinical Trial for PH
RP5063 - A NCE for PAH
SteadyMed to File NDA for Trevyent
Pluristem’s PLX-PAD
Sagene Pharmaceuticals, Inc.
Select PAH Therapeutics under Pipeline: 2016

4. PRODUCT OVERVIEW

5. PRODUCT INNOVATIONS & APPROVALS

Nippon Shinyaku Receives Marketing Approval for Uptravi
Actelion to Initiate Phase III Study for Pediatric Formulation of Opsumit
Actelion Announces USFDA Approval of Uptravi
Reata Pharmaceuticals’ Bardoxolone Methyl Receives Orphan Drug Designation
Actelion Receives Approval for Opsumit from Japan’s MHLW
Bayer Healthcare Receives Approval for Adempas from Japan’s MHLW
Silence Therapeutics Develops Gene Toolkit for PAH Research
Arena Pharmaceuticals’ APD811 Receives Orphan Drug Status for PAH Treatment
Bayer’s Adempas Approved for Two Rare Types of PAH
Actelion’s Opsumit Receives Approval from Australia’s TGA

6. RECENT INDUSTRY ACTIVITY

Arena Pharmaceuticals Initiates Phase 2 Clinical Trial for Ralinepag
Gilead Reports Top-Line Phase 2 Results for GS-4997 (Selonsertib) in Pulmonary Arterial Hypertension (PAH)
Gilead Sciences Accelerates its PAH Portfolio
Mallinckrodt Pharmaceuticals Acquires Ikaria
Supernus Pharmaceuticals Receives US$2 million Milestone Payment from United Therapeutics
Vectura Group plc Acquires Activaero GmbH
Mast Therapeutics Completes Acquisition of Aires Pharmaceuticals

7. FOCUS ON SELECT GLOBAL PLAYERS

Actelion Pharmaceuticals Ltd (Switzerland)
Bayer AG (Germany)
Gilead Sciences, Inc. (US)
Pfizer, Inc. (US)
United Therapeutics Corporation (US)
Lung Biotechnology PBC (US)

8. GLOBAL MARKET PERSPECTIVE

Table 7. World Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 8. World Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 9. World 14-Year Perspective for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

Table 10. World Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics by Drugs - Endothelin Receptor Antagonist (ERA) (Letairis/Volibris, Macitentan, & Tracleer), Prostacyclin and Prostacyclin Analogs (Epoprostenol/Veletri, Flolan, Remodulin, Selexipag, Tyvaso, Ventavis and Orenitram), PDE-5 Inhibitors (Cialis/Adcirca & Revatio (Sildenafil)) and Soluble Guanylate Cyclase (sGC) Stimulators (Riociguat) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2018 (includes corresponding Graph/Chart)

Table 11. World Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics by Drugs - Endothelin Receptor Antagonist (ERA) (Letairis/Volibris, Macitentan, & Tracleer), Prostacyclin and Prostacyclin Analogs (Epoprostenol/Veletri, Flolan, Remodulin, Selexipag, Tyvaso, Ventavis and Orenitram), PDE-5 Inhibitors (Cialis/Adcirca & Revatio (Sildenafil)) and Soluble Guanylate Cyclase (sGC) Stimulators (Riociguat) Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 12. World 10-Year Perspective for Pulmonary Arterial Hypertension (PAH) Therapeutics Market by Drugs - Percentage Breakdown of Dollar Sales for Endothelin Receptor Antagonist (ERA) (Letairis/Volibris, Macitentan, & Tracleer), Prostacyclin and Prostacyclin Analogs (Epoprostenol/Veletri, Flolan, Remodulin, Selexipag, Tyvaso, Ventavis and Orenitram), PDE-5 Inhibitors (Cialis/Adcirca & Revatio (Sildenafil)) and Soluble Guanylate Cyclase (sGC) Stimulators (Riociguat) Markets for Years 2009, 2016 & 2018 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
High PAH Incidence: Major Market Booster
High Costs: Major Challenge for R&D of PAH Therapeutics
Aging Population Statistics: Key Opportunity Indicator

Table 13. Aging Population in the US (2015 & 2030): 60 Years and Above Population (in Thousands) and Percentage of Population (includes corresponding Graph/Chart)

Prospective Market for Combination Therapies in the US

Table 14. PAH Market in the US (2011): Percentage Share Breakdown by Volume for Class of PAH Patients - Class II, Class III, Class I and Class IV (includes corresponding Graph/Chart)

Leading Drugs
FDA Approved PAH Drugs in the US
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 15. US Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 16. US Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

2. CANADA

Market Analysis

Table 17. Canadian Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 18. Canadian Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

3. JAPAN

A. Market Analysis
Select Approved and Pipeline Drugs in Japanese PAH market
Product Approval
LTT Bio-Pharma Co. Ltd.: Key Japan- based Player
B. Market Analytics

Table 19. Japanese Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 20. Japanese Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4. EUROPE

Market Analysis

Table 21. European Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region/Country - France, Germany, Italy, UK, Spain, and Rest of European Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 22. European Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region/Country - France, Germany, Italy, UK, Spain, and Rest of European Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

Table 23. European 14-Year Perspective for Pulmonary Arterial Hypertension (PAH) Therapeutics by Geographic Region/Country - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, and Rest of European Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)

4A. FRANCE

Market Analysis

Table 24. French Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 25. French Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4B. GERMANY

A. Market Analysis
Bayer AG: Key Germany-based Player
B. Market Analytics

Table 26. German Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 27. German Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4C. ITALY

Market Analysis

Table 28. Italian Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 29. Italian Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4D. UNITED KINGDOM

A. Market Analysis
Product Launch
Strategic Corporate Development
Silence Therapeutics plc: Key UK-Based Player
B. Market Analytics

Table 30. UK Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 31. UK Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4E. SPAIN

Market Analysis

Table 32. Spanish Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 33. Spanish Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4F. REST OF EUROPE

A. Market Analysis
Product Launches/Developments
Strategic Corporate Development
Select Key Players
B. Market Analytics

Table 34. Rest of European Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 35. Rest of European Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC

Market Analysis

Table 36. Asia-Pacific Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 37. Asia-Pacific Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

6. LATIN AMERICA

Market Analysis

Table 38. Latin American Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 39. Latin American Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

7. REST OF WORLD

Market Analysis

Table 40. Rest of World Recent Past, Current & Future Analysis for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

Table 41. Rest of World Historic Review for Pulmonary Arterial Hypertension (PAH) Therapeutics Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 31 (including Divisions/Subsidiaries - 33)
The United States (18)
Japan (3)
Europe (10)
  France (1)
  Germany (3)
  The United Kingdom (3)
  Rest of Europe (3)
Asia-Pacific (Excluding Japan) (1)
Middle East (1)