Pulmonary Arterial Hypertension (PAH) - Pipeline Assessment and Market Forecasts to 2016

Pulmonary Arterial Hypertension (PAH) - Pipeline Assessment and Market Forecasts to 2016

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GlobalData, the industry analysis specialist, has released its latest research, "Pulmonary Arterial Hypertension (PAH) - Pipeline Analysis and Market Forecasts to 2016", which provides key data, information and analysis on the PAH market. The report provides a comprehensive overview of the annualized market data from 2005 to 2009, and forecasts forward seven years to 2016. The research also includes market characterization, opportunities, the unmet needs, competitive assessments, the product profiles of major marketed products and promising drugs in the pipeline, an overview on discontinued projects, implications for future market competition, and the key players of the PAH market.

The Pulmonary Arterial Hypertension Market is Forecast to Show a High Growth Rate to 2015 but will Diminish in 2016

GlobalData valued the global Pulmonary Arterial Hypertension (PAH) market to be worth $2,653m in 2009. According to the Venice 2003 revised classification system, PAH is categorized as World Health Organization (WHO) Group I - PAH. Prior to 2001, no drug was approved for the treatment of PAH. Only supportive care medication such as anticoagulants, diuretics, oxygen, digoxin and calcium channel blockers was given to the patients. In 2001, the US Food and Drug Administration (FDA) approved Tracleer as the treatment for patients with PAH. This drug is a registered trademark of Actelion Ltd. The sales of Tracleer grew rapidly due to a high patient switch over from off-label drugs to Tracleer. The drug has a better efficacy profile compared to the previously used off-label drugs. The FDA also approved three more drugs, Remodulin, Ventavis, and Revatio in 2002, 2004 and 2005 respectively for the treatment of PAH. However, these three drugs accounted for only a 24% market share to PAH market in 2005. Between 2005 and 2009, the PAH market grew at a Compound Annual Growth Rate (CAGR) of 39.2% and recorded revenues of $2,653m in 2009. According to GlobalData analysis, the PAH market is forecast to grow at a CAGR of 5% annually over the next six years to reach $3,569m by 2015. Tracleer, the major revenue generating drug of the PAH market is expected to go off patent by 2015. The patent expiry of this drug will be a major barrier for the market growth. Until this time, the growth of the PAH market is primarily attributed to increased competition among existing products, the release of new and enhanced treatment options, and the development of safer and more efficacious therapies. In 2009, Actelion Ltd, with its key drug Tracleer, was the leading player in the global PAH market.

Global Pulmonary Arterial Hypertension Market Revenues and Forecast, 20052016

Source: GlobalData

Competition in the Pulmonary Arterial Hypertension Market is Expected to Intensify

The leading companies in the global PAH market are Actelion Ltd., Eli Lilly & Co., Gilead Sciences, Inc., United Therapeutics Corporation, Pfizer, Inc., Genentech, Inc. (Roche), Bayer Schering Pharma AG, and Quadrant Technologies Limited. Together these companies accounted for more than 99% of the global PAH market in 2009. Actelion Ltd, with its blockbuster drug Tracleer, was the market leader with a share of more than 50% followed by Revatio and Remodulin with 15% each. However, companies such as Actelion Ltd., United Therapeutics Corporation, Bayer AG, Gilead Sciences, Pfizer Inc., Novartis AG, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline Plc., and Cogentus Pharmaceuticals have some of the most technologically advanced products in their pipeline portfolios and are expected to play a key role in the PAH market between 2009 and 2016. The global PAH market has seen intense competition in recent times, which is expected to further intensify in the coming years.

The Current Competition In the PAH Market is Strong Owing to Similar Efficacy and Safety Profiles of Marketed Products

GlobalData evaluated the current competition in the PAH market and concluded that the competition is strong. The market is dominated by endothelin receptor antagonists such as Tracleer and Letairis. These two products have a similar efficacy profiles. However, the safety profile of Letairis is better than that of Tracleer. The competition is expected to increase further as many promising drugs such as ACT-064992, Oral treprostinil, Riociguat (BAY63-2521) are going to be launched in the coming years. In June 2009, inhaled treprostinil (Tyvaso) was approved by the FDA for the treatment of PAH. Therefore, the current competition in the PAH market is strong and the available treatment options have proven to be effective against PAH. The products currently available in the market have disease modifying properties and show relief from disease associated symptoms. Symptomatic relief for the patient varies according to the dosage and type of therapy. The current PAH market is projected to record revenues worth $3,569m by 2015. In 2016, the market is expected to witness a decline due to the patent expiry of the blockbuster drug Tracleer.

Opportunity and Unmet Need in Pulmonary Arterial Hypertension Market, 2010

Source: GlobalData

First-In-Class Pipeline Candidates Raise Hope for PAH Treatment

GlobalData analysis shows that the PAH therapeutics pipeline is strong and contains 67 molecules. Although the pipeline is small, majority of the molecules are first-in-class. These first-in-class molecules have distinct advantages over the currently marketed products in terms of overall survival rates, better efficacy and safety profiles, and have the potential to satisfy the market's unmet needs. If approved, these products will stimulate intense competition in the market, and the existing market leaders will need to respond quickly in the race to develop a new blockbuster drug. GlobalData found that 67 therapies were in different developmental stages in 2009. Approximately 64% of the pipeline is first-in-class drugs and the rest are either me-too versions of the marketed drugs, product extensions, or combination therapies. Majority of the late-stage pipeline are first-in-class drugs and these drugs will offer better treatment options to PAH patients in terms of safety and efficacy. As a result, once these drugs enter the PAH market, they would make the existing market leaders to plan new strategies to withhold their market shares in the PAH market. Essentially, the global PAH market is heading towards an increasingly competitive landscape with more dynamism expected.

Expected Entry of Late-Stage Pipeline Drugs Likely to Intensify Future Competition

GlobalData found that there were 67 products in different stages of clinical development in 2009. Treprostinil, sitaxentan, and tadalafil are undergoing life cycle management activities and currently, clinical trials are being conducted to evaluate the efficacy and safety of these drugs in new patient-base or new geographical location. There are many other products in Phase III such as imatinib mesylate (Gleevec), QTI571, BAY63-2521 and combination therapies such as hypoglycemic agents plus antihypertensive agents. The majority of the pipeline products differ from the marketed ones in terms of addressing the unmet clinical needs. The pipeline products are being developed to have improved features such as reduced risks associated with intake, better efficacy regardless of the degree and length of illness, ability to slow down the progression of the disease, and less side effects. If successfully launched, these products are expected to meet most of the patients' unmet needs. For more details, please vist http://www.reportreserve.com/reportdet.php?company=GlobalData&reportid=10327

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