Erectile dysfunction is the inability to attain or maintain penile erection in men, sufficient for successful sexual intercourse. Erectile dysfunction is a common medical disorder primarily affecting men older than 40 years of age. In addition, other than the typical causes of erectile dysfunction, such as diabetes and hypertension, a number of common lifestyle related factors are also associated with development of the condition. These include obesity, excessive alcohol consumption, smoking, use of recreational drugs, and poor physical and psychological health. Commonly, oral drugs belonging to the PDE 5 inhibitors class form the mainstay of erectile dysfunction treatment. Other treatment options include lifestyle modification, testosterone therapy, penile devices, injection therapies and psychotherapy.
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The global market for erectile dysfunction drugs has been studied from the perspective of currently marketed branded drugs and pipeline drugs. Branded drugs include Viagra (sildenafil citrate), Cialis (tadalafil), Levitra/Staxyn (vardenafil), Stendra/Spedra (avanafil), Zydena (udenafil), MUSE (medicated urethral systems for erection), Mvix (mirodenafil) and Helleva (lodenafil). The drugs in the pipeline for erectile dysfunction treatment primarily consist of two major drugs, namely Vitaros (alprostadil) and Uprima (apomorphine) currently in later phases of clinical trials.
In 2012, Viagra (sildenafil citrate) accounted for the largest share (45%) by revenue of the total erectile dysfunction drugs market. However, due to the loss of the drug’s patent exclusivity in Europe and other countries in 2013, the overall market revenue is expected to decline during the forecast period as international markets contribute considerably to the overall market revenue of the drug. In the U.S. market, Viagra will continue to maintain a major revenue share due to its extended patent exclusivity till 2020. The market for Cialis (tadalafil) accounted for the second largest share at USD 1,926.8 million, in 2012. However, it is expected to witness a decline in market revenue at a CAGR of (12.6%) from 2013 to 2019, owing to loss of patent exclusivity in 2017. In addition, the patent for Bayer’s Levitra/Staxyn (vardenafil) is scheduled to expire in 2018 and is thus expected to contribute to the declining market revenue.
A few novel compounds are currently under investigation in both preclinical and clinical settings, for the treatment of impotency. These studies are majorly focused on medications with improved efficacy, shorter onset of action and fewer side effects as compared to the currently available treatments. Such pipeline drugs include Vitaros (alprostadil), Uprima (apomorphine) and Topiglan (alprostadil), amongst others.
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Geographically, North America dominated the global market for erectile dysfunction drugs in terms of revenue generation and is expected to maintain its position throughout the forecast period. The extended patent exclusivity for Pfizer’s Viagra (sildenafil citrate) in the U.S., till 2020, will be responsible for the leadership of the North American market. Europe was the second largest regional market for erectile dysfunction drugs in 2012, owing to the increased demand for ED drugs. Market growth will also be facilitated by the expected marketing approvals for a few promising drug candidates such as Stendra/Spedra (avanafil) and Zydena (udenafil) by mid 2014.
The global erectile dysfunction dugs market is dominated by few major players including Pfizer, Inc. Eli Lilly & Co., and Bayer AG. Post patent expiration of the major branded drugs and intense genericization of the market, the competition in this market is expected to be characterized by consolidation activities, partnerships, and intensive mergers and acquisitions. The other key players in the erectile dysfunction drugs market include Dong-A Pharmaceutical Co. Ltd., Vivus, Inc., Apricus Biosciences, Inc. and Meda Pharmaceuticals.