Wednesday 18 April 2012, Amsterdam
After Strong Growth in 2002-2011, Patent Expiries or Loss of Orphan Drug Exclusivities Expected to Cause Negative Growth in Market
GlobalData estimated the global Pulmonary Arterial Hypertension (PAH) therapeutics market to be worth $3.3 billion in 2011. This estimate represents the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, India and Russia, collectively. Between 2002 and 2011, the global PAH therapeutics market grew at a Compound Annual Growth Rate (CAGR) of 38.6%. PAH is a rare indication, yet despite its small patient volume, the PAH therapeutics market showed tremendous growth in the historic period. This growth was due to the significant drug development activity which corresponds to the launch of around eight premium priced drugs in the PAH therapeutics market during 2002 to 2011. Patient volume also increased during this period due to the increasing awareness of PAH. The various drugs used to treat PAH are: Tracleer (bosentan), Letairis (ambrisentan), Remodulin (treprostinil), Ventavis (iloprost), Revatio (sildenafil), Adcirca (tadalafil), Tyvaso (inhaled treprostinil), and Veletri (epoprostenol). The uptake of these drugs drove the market because of an increase in the Annual Cost of Therapy (ACOT) for PAH. In 2011, the leading drugs in the key markets (the US, France, Germany, Italy, Spain, the UK and Japan) were Tracleer, Revatio, Letairis/Volibris and Remodulin, with sales of $1,303.3m, $439.0m, $364.3m and $363.7m, respectively.
The global PAH therapeutics market is estimated to be worth $3.1 billion in 2020. It is forecast to show a negative CAGR of 0.6% during 2011 to 2020. This trend is on the account of significant number of patent expiries or loss of ODE in the forecast period. The majority of the marketed drugs (Tracleer, Letairis, Remodulin, Ventavis, Revatio and Adcirca) will lose either their patent protection or ODE during 2011 to 2020. Several pipeline drugs such as macitentan, selexipag, riociguat and imatinib, are also expected to enter the market in forecast period. Imatinib, riociguat and selexipag are First-In-Class (FIC) while macitentan is a me-too with enhanced safety and efficacy. However, the loss of patent protection or ODE will have a strong impact and will result in negative growth. In 2020, the three leading drugs in the major PAH therapeutics market will be riociguat, macitentan and Tyvaso with estimated sales of $700.5m, $437.7m and $421.3m, respectively.
Pulmonary Arterial Hypertension, Global, Pipeline by Mechanism of Action, 2011: See figure.
Pulmonary Arterial Hypertension Therapeutics Market has Strong Competition with Several Marketed Products
The current competition in the global PAH therapeutics market is strong in spite of low patient numbers; this is due to the high competitive intensity in the PAH therapeutics market. There are three main classes of drugs present in the market: Endothelin Receptor Antagonist (ERA), prostacyclins, and Phosphodiesterase-5 (PDE-5) inhibitors. The drugs in the ERA class are Tracleer and Letairis; in the prostacyclin class the drugs are Remodulin, Tyvaso, Ventavis and Veletri, and in the PDE-5 class they are Revatio and Adcirca. All of these drugs have demonstrated satisfactory efficacy. The safety profiles of these drug classes is in the following order: PDE-5 inhibitors (safe options), followed by prostacyclins, then ERAs. The ERA class is the leading class in the PAH therapeutics market; however, it is associated with liver toxicity. Drugs from different classes are also used as combination therapies. Therefore, there is strong competition for a me-too drug in the global PAH therapeutics. However simultaneously there is a need for a drug which improves the disease pathogenesis.
Pulmonary Arterial Hypertension Pipeline is Strong with Several First-in-class Drugs in Development
The PAH therapeutics pipeline is strong with 31 drugs in different phases of development. In the total pipeline, around 71% of the drugs are FIC. These FIC drugs have some distinct advantages over the currently marketed products which may bring a change in the safety and efficacy benchmarks. In addition to this, around 13% of pipeline drugs are classified as me-too and 16% are product extensions. There is one drug in Pre-registration, eight drugs in Phase III, 11 in Phase II, three in Phase I and eight in the Preclinical stage.
The Pre-registration drug is an oral treprostinil and it is a product extension. Phase III contains four FICs, two me-too and two product extensions. The launch of these products in the market may change or improve the treatment paradigm of PAH. The FICs are imatinib, riociguat, selexipag and ranolazine and the me-too drugs are macitentan and vardenafil. The product extensions are MD-0701 and beraprost sodium-MR. Of these drugs in Phase III, vardenafil and ranolazine are being evaluated in center-sponsored trials while all others are evaluated in company-sponsored trials.
Oral treprostinil is a prostacyclin receptor agonist. Imatinib is a tyrosine kinase inhibitor and may have some effect on disease pathogenesis; riociguat is a soluble Guanylate Cyclase (sGC) inhibitor and selexipag is an IP receptor agonist. Macitentan is an ERA with increased safety and efficacy relative to the currently marketed Tracleer. MD-0701 and beraprost sodium-MR are prostacyclin receptor agonist.
The PAH pipeline is diverse with different types of mechanism of action. These mechanisms are prostacyclin receptor agonist, NO based vasodilation, PDE-5 inhibitor, tyrosine kinase inhibitor, endothelin receptor agonist, IP receptor agonist, late sodium current inhibitor, Rho-kinase inhibitor, repair of lung vasculature and sGC inhibitor.
Significant Unmet Needs Exists in the Pulmonary Arterial Hypertension Therapeutics Market
The PAH therapeutics market has high unmet need in terms of efficacy and safety. Based on the safety, efficacy and ACOT assessment, the unmet need in the PAH therapeutics market was found to be high. This infers that despite the availability of a significant number of treatment options, there is a need for the new products with improved safety and efficacy.
The drug classes currently used have certain limitations. ERA such as Tracleer is an oral therapy associated with liver toxicity and teratogenicity. Prostacyclins are limited by their route of administration such as intravenous (IV) or subcutaneous injections can result in pain or other infusion reactions; there is also a requirement for an inhalation device for inhalations. These therapies only provide symptomatic relief and improve functional capacity; there is limited data regarding the effect of these therapies on the improvement of long term survival.
There is a need in the PAH therapeutics market for products which can reverse pulmonary vascular remodeling, further improve survival rates, and can delay disease progression.
“Pulmonary Arterial Hypertension (PAH) Therapeutics - Global Drug Forecasts and Treatment Analysis to 2020”, is an essential and comprehensive source of information and analysis on the global Pulmonary Arterial Hypertension (PAH) therapeutics market. The report identifies and analyzes the key trends shaping and driving the global PAH therapeutics market, as well as treatment usage patterns in the global PAH therapeutics market. The competitive landscape is also covered, with insights into the emerging players expected to significantly alter the positions of the existing market leaders. An in-depth analysis of current pipeline products offers up valuable insights, and the report quantifies the unmet need in the global PAH therapeutics market as well as in the markets of the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, India and Russia, highlighting opportunities for future players.
