NEW YORK, Sept. 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Global Pulmonary Arterial Hypertension (PAH) Therapeutics Industry
http://www.reportlinker.com/p0960405/Global-Pulmonary-Arterial-Hypertens...
This report analyzes the worldwide markets for Pulmonary Arterial Hypertension (PAH) Therapeutics in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. European market for PAH Therapeutics is further analyzed by the following countries/regions - France, Germany, Italy, UK, Spain, and Rest of Europe. Annual estimates and forecasts are provided for the period 2010 through 2018. Also, a six-year historic analysis is provided for these markets. The report profiles 26 companies including many key and niche players such as Actelion Pharmaceuticals Ltd., Arena Pharmaceuticals, Inc., Bayer HealthCare Pharmaceuticals, Cipla Limited, Daiichi Sankyo Co., Ltd., Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline Plc, Nippon Shinyaku Co., Ltd., Pfizer, Inc., Sanofi S.A, The Novartis Group, United Therapeutics Corp., and YM BioSciences, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW II-1
Global PAH Market on a Growth Trajectory II-1
Evolution of the PAH Market II-1
Table 1: Global PAH Market by Drug Class: 2011 (includes
corresponding Graph/Chart) II-2
The PAH Classification by WHO and NYHA II-2
PAH Patient Groupings as per World Health Organization II-2
Classification of PAH patients As per New York Heart
Association (NYHA) II-3
Market Outlook II-3
Competitive Scenario II-3
Table 2: Leading Drugs in the PAH Market by Sales: 2011
(includes corresponding Graph/Chart) II-4
Market Trends & Issues II-4
PAH Drug Market on a Steady Growth Trajectory II-4
Tracleer Remains the Undisputed Leader II-5
Table 3: Market Share of Leading PAH Oral Drugs (2012):
Percentage Breakdown of Value Sales for Tracleer, Revatio,
Letairis/Volibris and Others (includes corresponding
Graph/Chart) II-5
Tracleer to lose ground to Letairis over ERA Receptors II-6
Oral Therapies lead the Global PAH Therapeutics Market II-6
Table 4: Global PAH Market by Mode of Drug Usage (2012):
Percentage Share Breakdown for Oral, Inhaled, and
Injectables (includes corresponding Graph/Chart) II-6
Thelin Exits PAH Market II-6
Pipeline Drugs to Give Tough Competition to Tracleer II-7
An Insight into Different PAH Drug Classes II-7
Table 5: Global PAH Market (2011): Percentage Share Breakdown
by Cost Effectiveness of PAH Drugs (includes corresponding
Graph/Chart) II-7
Table 6: Global PAH Market (2011): Percentage Breakdown for
Patients on Single Therapy - PDE5 Inhibitor, ERA, Inhaled
Prostacyclin Analog, Injectable Prostacyclin Analog, and
Others (includes corresponding Graph/Chart) II-8
Table 7: Global PAH Market (2011): Percentage Share Breakdown
for Patients on Combination Therapies (includes corresponding
Graph/Chart) II-8
Comparative Cost Analysis II-8
Table 8: Annual Costs Involved in Major Approved PAH Drugs
(includes corresponding Graph/Chart) II-9
Key Statistics II-10
Leading Approved Drugs as Per Mode of Administration II-10
Leading PAH Drugs by Mechanism II-10
Leading PAH Drugs by Year of Approval/Launch II-10
Patent Expiries of Select Major PAH Drugs II-11
An Insight into Select PAH Drugs II-11
Tracleer (Bosentan) II-11
Future Dominance Likely, Even as New Drugs Line up for Launch II-11
Revatio (Sildenafil) II-12
Ventavis (Iloprost) II-12
Letairis (Ambrisentan) II-12
Veletri (Epoprostenol) II-12
Flolan (Epoprostenol) II-13
Remodulin (Treprostinil) II-13
Tyvaso (Treprostinil) II-13
Adcirca (Tadalafil) II-13
Pipeline Drugs II-14
Select Promising Imminent Drugs II-14
Macitentan II-14
Riociguat II-14
Selexipag II-14
Clinical Trials in the Pipeline II-15
United Therapeutics Completes FREEDOM - M Trial for Oral
Remodulin II-15
Actelion Completes SERAPHIN Phase III Trial II-15
GeNO LLC Begins PHiano Trial for NITROSYL™ II-15
Arena Completes Phase I trial for APD811 II-15
Gilead Starts Phase II of Cicletanine II-16
AMBITION Phase IV Trial to Begin II-16
Bayer Begins Phase III for Oral Riociguat II-16
Phase III Results Out for PHIRST-1 Trial II-16
Phase III IMPRES trial Ends on a Positive Note II-16
Selexipag under Phase III GRIPHON Trial II-17
2. PRODUCT OVERVIEW II-18
Introduction II-18
PAH Subgroups II-18
Table 9: Global PAH Market (2011): Gender-wise Percentage
Share Breakdown by Incidence of Occurrence (includes
corresponding Graph/Chart) II-19
Causes and Development of PAH II-19
Symptoms of PAH II-19
Diagnosis of PAH II-20
Identification of patients on clinical grounds II-20
Detection of PAH II-20
Evaluation and classification of PAH II-22
Treatments for PAH II-22
Novel Therapies for PAH II-24
3. STRATEGIC CORPORATE DEVELOPMENTS II-25
FDA Revises Boxed Warning for Letairis Tablets II-25
Pfizer Secures Approval for Revatio® from European Commission
for Treating PAH in Pediatric Patients II-25
Sanofi-Aventis Changes Name to Sanofi II-25
Novartis Secures Regulatory Approval for Onbrez® Inhalation
Capsules II-25
Nippon Shinyaku and Actelion Pharmaceuticals Ink License
Agreement for Macitentan II-26
Pfizer Receives European Regulators Approval for Viagra to
Treat PAH in Children II-26
Ergonex Pharma and Pfizer Sign Agreement for Terguride II-26
Aires Pharmaceuticals and Novartis International
Pharmaceutical Sign Agreement II-26
Lee's Pharmaceutical Receives Exclusive Rights to Market
Remodulin II-27
Invida Group and Actelion Pharmaceuticals Extend Contract II-27
Immune Control Merges with Arginetix II-27
Pfizer Signs Agreement with Ergonex Pharma to Acquire
Terguride Investigational PAH Treatment II-27
Pulmokine Receives NIH SBIR Grants for PAH Treatment Development II-28
FDA Grants Orphan Drug Designation to Clinical Data PRX-8066
Serotonin 2B Receptor Antagonist II-28
US FDA Approves VELETRI® Brand Name for Epoprostenol for
Injection Therapy of Actelion Pharmaceuticals US II-28
US Food and Drug Administration Approves Additional Guidelines
for Veletri Administration II-29
Actelion Pharmaceuticals US Selects Accredo Health Group as
Exclusive Specialty Pharmacy Provider of Epoprostenol for
Injection II-29
European Commission Approves Revatio IV Formulation for
Treating Pulmonary Arterial Hypertension II-30
United Therapeutics Withdraws Marketing Authorization
Application for Tyvaso II-30
Navitas Assets and Gilead Sciences Ink Agreement II-30
Actelion Pharmaceuticals Receives FDA Approval for Tracleer® II-30
United Therapeutics Secures US FDA Approval for TYVASO
Inhalation Solution II-31
Eli Lilly Inks License and Supply Agreement with United
Therapeutics II-31
United Therapeutics Secures US FDA Approval for ADCIRCA™ Tablets II-31
Actelion Signs Definitive Agreement with GeneraMedix II-32
Eli Lilly Japan Obtains Approval to Commercialize Adcirca Tablet II-32
Proteo's Drug Candidate Elafin Obtains Orphan Drug Status for
Treating Esophagus Carcinoma II-32
Pfizer to Withdraw Thelin from Market II-32
Actelion Acquires Improved Epoprosterol Sodium formulation
from GeneraMedix II-33
United Therapeutics' Tyvaso Receives FDA Approval II-33
United Therapeutics' Adcirca Receives US FDA Approval II-33
Actelion's Tracleer Drug Receives Approval from EU II-33
Pfizer's Revatio Receives US-FDA Approval II-34
Actelion's new Ventavis® formulation Receives Approval from US
FDA II-34
Gilead Sciences and GlaxoSmithKline Enter into Collaboration II-34
United Therapeutics Inks Licensing Deal with Supernus
Pharmaceuticals II-34
Lung to Fund Aradigm Study of Treprostinil in AERx Inhaler II-35
Aires Pharmaceuticals Inks Exclusive License Agreement with
National Institutes of Health II-35
United Therapeutics and Lung Rx Submit New Drug Application to
FDA II-35
GlaxoSmithKline Receives Marketing Authorization for Volibris®
from European Commission II-35
4. PRODUCT/SERVICE LAUNCHES II-36
United Therapeutics Introduces Adcirca™ in Canada II-36
GlaxoSmithKline Introduces Volibris Oral Tablets for PAH II-36
Cipla Introduces BOSENTAS II-36
Actelion Pharmaceuticals US Introduces Pulmonary Arterial
Hypertension Mobile Reference Guide II-36
Actelion Pharmaceuticals US Introduces Ventavis in New
Formulation II-37
Nippon Shinyaku Introduces Adcirca® Tablets 20mg II-37
5. FOCUS ON SELECT PLAYERS II-38
Actelion Pharmaceuticals Ltd. (Switzerland) II-38
Arena Pharmaceuticals, Inc. (US) II-38
Bayer HealthCare Pharmaceuticals (Germany) II-38
Cipla Limited (India) II-39
Daiichi Sankyo Co., Ltd. (Japan) II-39
Eli Lilly and Company (US) II-39
Gilead Sciences, Inc. (US) II-39
GlaxoSmithKline Plc (UK) II-40
Nippon Shinyaku Co., Ltd. (Japan) II-40
Pfizer, Inc. (US) II-40
Sanofi S.A (France) II-41
The Novartis Group (Switzerland) II-41
United Therapeutics Corp. (US) II-41
YM BioSciences, Inc. (Canada) II-42
6. GLOBAL MARKET PERSPECTIVE II-43
Table 10: World Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics by
Geographic Region - US, Europe, and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2010 through 2018 (includes corresponding
Graph/Chart) II-43
Table 11: 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 2004 through 2009 (includes
corresponding Graph/Chart) II-44
Table 12: World 15-Year Perspective for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market by Geographic Region -
Percentage Breakdown of Dollar Sales for US, Europe and Rest
of World Markets for Years 2004, 2011 & 2018 (includes
corresponding Graph/Chart) II-45
Table 13: World Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics by Drugs -
Endothelin Receptor Antagonist (ERA) (Letairis/Volibris,
Macitentan, Thelin (Sitaxentan) & Tracleer), Prostacyclin
(Epoprostenol/Veletri, Flolan, Remodulin, Selexipag, Tyvaso &
Ventavis), 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 2010 through 2018 (includes
corresponding Graph/Chart) II-46
Table 14: World Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics by Drugs - Endothelin Receptor
Antagonist (ERA) (Letairis/Volibris, Macitentan, Thelin
(Sitaxentan) & Tracleer), Prostacyclin (Epoprostenol/Veletri,
Flolan, Remodulin, Selexipag, Tyvaso & Ventavis), 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 2004 through 2009 (includes corresponding
Graph/Chart) II-47
Table 15: World 15-Year Perspective for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market by Drugs - Percentage
Breakdown of Dollar Sales for Endothelin Receptor Antagonist
(ERA) (Letairis/Volibris, Macitentan, Thelin (Sitaxentan) &
Tracleer), Prostacyclin (Epoprostenol/Veletri, Flolan,
Remodulin, Selexipag, Tyvaso & Ventavis), PDE-5 Inhibitors
(Cialis/Adcirca & Revatio (Sildenafil)) and Soluble Guanylate
Cyclase (sGC) Stimulators (Riociguat) Markets for Years 2004
through 2009 for Years 2004, 2011 & 2018 (includes
corresponding Graph/Chart) II-48
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
US PAH Drug Market Treads on a Growth Path III-1
FDA Approved PAH Drugs in the US III-1
Table 16: PAH Market in the US (2011): Market Share
Breakdown for Leading Oral PAH Drugs by Value (includes
corresponding Graph/Chart) III-2
Prospective Market for Combination Therapies in the US III-2
Table 17: PAH Market in the US by Drug Class (2011):
Percentage Share Breakdown for ERA, PDE5, PGI2, PDE5+ERA,
PGI2+PDE5, PGI2+ERA, PGI2+PDE5+ERA and Others (includes
corresponding Graph/Chart) III-2
Oral Remodulin Likely to Emerge as a Niche Market for Class
II and III Market in the US III-2
Table 18: PAH Market in the US (2011): Class of PAH
Patients - Class II, Class III, Class I and Class IV
(includes corresponding Graph/Chart) III-3
Table 19: 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) III-3
Strategic Corporate Developments III-3
Product/Service Launches III-11
Focus on Select Key Players III-12
B.Market Analytics III-14
Table 20: The US Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension Market Analyzed with Annual
Sales Figures in US$ Million for Years 2010 through 2018
(includes corresponding Graph/Chart) III-14
Table 21: The US Historic Review for Pulmonary Arterial
Hypertension Market Analyzed with Annual Sales Figures in
US$ Million for Years 2004 through 2009 (includes
corresponding Graph/Chart) III-15
2. CANADA III-16
A.Market Analysis III-16
Current & Future Analysis III-16
Product/Service Launch III-16
Focus on Select Player III-16
B.Market Analytics III-17
Table 22: Canadian Recent Past, Current & Future Analysis
for Pulmonary Arterial Hypertension (PAH) Therapeutics
Market Analyzed with Annual Sales Figures in US$ Million for
Years 2010 through 2018 (includes corresponding Graph/Chart) III-17
Table 23: Canadian Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-18
3. JAPAN III-19
A.Market Analysis III-19
Current & Future Analysis III-19
Select Approved and Pipeline Drugs in Japanese PAH market III-19
Strategic Corporate Developments III-19
Product/Service Launches III-20
Focus on Select Players III-21
B.Market Analytics III-22
Table 24: Japanese Recent Past, Current & Future Analysis
for Pulmonary Arterial Hypertension (PAH) Therapeutics
Market Analyzed with Annual Sales Figures in US$ Million for
Years 2010 through 2018 (includes corresponding Graph/Chart) III-22
Table 25: Japanese Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-23
4. EUROPE III-24
A.Market Analysis III-24
Current & Future Analysis III-24
Strategic Corporate Developments III-24
Focus on Select Major Players III-26
B.Market Analytics III-28
Table 26: European Recent Past, Current & Future Analysis
for Pulmonary Arterial Hypertension (PAH) Therapeutics
Market Analyzed with Annual Sales Figures in US$ Million for
Years 2010 through 2018 (includes corresponding Graph/Chart) III-28
Table 27: European Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-29
Table 28: European 15-Year Perspective for Pulmonary
Arterial Hypertension (PAH) Therapeutics Market by
Geographic Region - Percentage Breakdown of Dollar Sales for
France, Germany, Italy, the UK, Spain and the Rest of Europe
for Years 2004, 2011 & 2018 (includes corresponding
Graph/Chart) III-30
4a. FRANCE III-31
A.Market Analysis III-31
Current & Future Analysis III-31
B.Market Analytics III-31
Table 29: France Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-31
Table 30: France Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-32
4b. GERMANY III-33
A.Market Analysis III-33
Current & Future Analysis III-33
Bayer Healthcare Pharmaceuticals - A Key Player III-33
B.Market Analytics III-34
Table 31: German Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-34
Table 32: German Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-35
4c. ITALY III-36
A.Market Analysis III-36
Current & Future Analysis III-36
B.Market Analytics III-36
Table 33: Italian Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-36
Table 34: Italian Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-37
4d. THE UNITED KINGDOM III-38
A.Market Analysis III-38
Current & Future Analysis III-38
B.Market Analytics III-38
Table 35: The UK Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-38
Table 36: The UK Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-39
4e. SPAIN III-40
A.Market Analysis III-40
Current & Future Analysis III-40
B.Market Analytics III-40
Table 37: Spanish Recent Past, Current & Future Analysis for
Pulmonary Arterial Hypertension (PAH) Therapeutics Market
Analyzed with Annual Sales Figures in US$ Million for Years
2010 through 2018 (includes corresponding Graph/Chart) III-40
Table 38: Spanish Historic Review for Pulmonary Arterial
Hypertension (PAH) Therapeutics Market Analyzed with Annual
Sales Figures in US$ Million for Years 2004 through 2009
(includes corresponding Graph/Chart) III-41
4f. REST OF EUROPE III-42
A.Market Analysis III-42
Current & Future Analysis III-42
B.Market Analytics III-42
Table 39: Rest of European Recent Past, Current & Future
Analysis for Pulmonary Arterial Hypertension (PAH)
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-42
Table 40: Rest of European Historic Review for Pulmonary
Arterial Hypertension (PAH) Therapeutics Market Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-43
5. ASIA-PACIFIC III-44
A.Market Analysis III-44
Current & Future Analysis III-44
Strategic Corporate Developments III-44
Product/Service Launch III-44
Focus on Select Player III-45
B.Market Analytics III-45
Table 41: Asia-Pacific Recent Past, Current & Future
Analysis for Pulmonary Arterial Hypertension (PAH)
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-45
Table 42: Asia-Pacific Historic Review for Pulmonary
Arterial Hypertension (PAH) Therapeutics Market Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-46
6. LATIN AMERICA III-47
A.Market Analysis III-47
Current & Future Analysis III-47
B.Market Analytics III-47
Table 43: Latin American Recent Past, Current & Future
Analysis for Pulmonary Arterial Hypertension (PAH)
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-47
Table 44: Latin American Historic Review for Pulmonary
Arterial Hypertension (PAH) Therapeutics Market Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-48
7. REST OF WORLD III-49
A.Market Analysis III-49
Current & Future Analysis III-49
B.Market Analytics III-49
Table 45: Rest of World Recent Past, Current & Future
Analysis for Pulmonary Arterial Hypertension (PAH)
Therapeutics Market Analyzed with Annual Sales Figures in
US$ Million for Years 2010 through 2018 (includes
corresponding Graph/Chart) III-49
Table 46: Rest of World Historic Review for Pulmonary
Arterial Hypertension (PAH) Therapeutics Market Analyzed
with Annual Sales Figures in US$ Million for Years 2004
through 2009 (includes corresponding Graph/Chart) III-50
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 26 (including Divisions/Subsidiaries - 29)
The United States (14)
Canada (1)
Japan (2)
Europe (8)
- France (1)
- Germany (2)
- The United Kingdom (2)
- Rest of Europe (3)
Asia-Pacific (Excluding Japan) (4)
To order this report:
Therapy Industry: Global Pulmonary Arterial Hypertension (PAH) Therapeutics Industry
Contact Nicolas: nicolasbombourg@reportlinker.com
US: (805)-652-2626
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