Erectile Dysfunction (ED) Drugs Market: Introduction
According to the report, the global erectile dysfunction drugs market was valued at US$ 3.4 Bn in 2017 and is projected to contract at a CAGR of -3.1% from 2021 to 2028. Oral phosphodiesterase type 5 inhibitors are one of the most commonly used erectile dysfunction drugs across the globe. Viagra (sildenafil citrate) and other PDE 5 inhibitors such as Cialis (tadalafil) and Levitra/Staxyn (vardenafil) are the most consumed drugs for ED treatment across the world. On losing patent and marketing exclusivity, these drugs will become available in the public domain in the form of low cost generics.
The loss of patent exclusivity of a branded drug results in revenue reduction by around 40% in the first year, which goes on decreasing to 30% and 20% in the following years. This can be attributed to generic equivalents of these drugs are manufactured and marketed at 1/10th of the price of the original branded drug, thereby resulting in much higher consumption of the drugs since efficacy and demand remains high. Consequently, the generics segment is anticipated to be a promising investment area even for original molecule manufacturers, since it is a mode of sustenance and offsetting expenditure.
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For instance, in 2011, Pfizer developed a chewable form of Viagra called Viagra Jet and started marketing it in Mexico. Pfizer also plans to market it in other countries in the developing world. Bayer AG introduced the orally disintegrating tablet for its Levitra (vardenafil) drug in Germany, France, Austria, Hungary, Spain, Sweden, Poland, Denmark, and Britain, in March 2011.
Furthermore, Asia Pacific and Rest of the World are favorable regions for generic companies to initiate, establish, and expand business due to fewer entry barriers and shorter legal hurdles. Large populations, availability of raw materials, and cheaper workforce have enhanced the manufacturing capabilities of these companies.
The global erectile dysfunction drugs market is set to experience a patent cliff toward the end of the forecast period. The market is highly genericized through 2019 all over due to patent expiration of Viagra in these countries. However, it still consists of blockbuster drugs such as Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra/Staxyn (vardenafil) in the U.S. that has been driving the market in the past few years. Cialis (tadalafil) and Levitra/Staxyn (vardenafil) are set to lose marketing and patent exclusivity in 2017 and 2018, respectively, while Viagra (sildenafil citrate) is scheduled to expire in the U.S. by October 2020. This event is expected to have a profound effect on the overall market for erectile dysfunction drugs, causing a drastic dip in market revenue by the end of the forecast period. Moreover, approved ANDAs for these molecules will lead to intense generic competition.
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Increase in Incidence of Various Diseases and Sedentary Lifestyles
The number of patients suffering from diabetes mellitus, hypertension, hypercholesterolemia, spinal cord injuries, cardiovascular diseases, and various other conditions is rising globally. Increase in incidence rates of diseases and their associated drug treatments affect the normal functioning of erection in men, thereby contributing to the rise in demand for erectile dysfunction drugs. For instance, chlorthalidone, propanolol, diazepam, cimetidine, and naproxen are some of the drugs that could cause ED. These drugs could help in treating a particular disease condition; however, these can also cause hormonal imbalance, affect nerves, and blood circulation, thereby increasing the risk of ED in men.
According to the United Nations Economic and Social Commission for Asia and the Pacific, around 60% of the world’s geriatric population lives in Asia Pacific. The number of elderly people is estimated to double from 547 million in 2016 to 1.3 billion by 2050. Hence, increase in use of such drugs to treat the above mentioned disease conditions will continue to encourage the use of erectile dysfunction drugs, thereby driving the market.
Moreover, obesity has been linked to increased risk of erectile dysfunction. Sedentary lifestyle and increase in incidence of obesity are expected to boost the ED market in the long term. Smoking and alcoholism have both been shown to increase the risk of ED.
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Development of New Formulations to Drive Global Market
Localized drug delivery techniques for erectile dysfunction treatment such as the use of creams and pellets that show better efficacy and performance will be frequently sought after by medical professionals and facilities who have been dogged by severe shortcomings of current drugs. Successful observations of combination therapy have been encouraging and market leaders should focus on combination molecules such as PDE 5 inhibitors to gain a significant advantage due to several benefits such as lower drug doses and reduced incidence of adverse effects.
Cialis Segment to Dominate Market
In terms of drug, the global erectile dysfunction drugs market has been classified into Viagra, Cialis, Staxyn/Levitra, Stendra/Spedra, and others. The others segment includes Zydena (medicated urethral system for erection), Mvix, Helleva, Vitaros, Caverject Impulse, generic products, and pipeline products. Cialis (tadalafil) sales exceeded that of Viagra (sildenafil citrate) due to patent expiration of Viagra (sildenafil citrate) in major countries in Europe. Entry of generic competition into these markets following the loss of exclusivity will cause a rapid and severe decline in revenue for the product. Cialis (tadalafil) and Adcirca (tadalafil) went off patent in major markets in Europe and the U.S. in November 2020.
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North America to Dominate Global Market
In terms of region, the global erectile dysfunction (ED) drugs market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global erectile dysfunction (ED) drugs market in 2020, followed by Asia Pacific. High prevalence and increase in incidence of erectile dysfunction in the U.S. and Canada and high adoption of branded treatment for ED ca be attributed to the U.S.'s market dominance. However, decrease in healthcare cost and decrease in hospitalization rates are likely to restrain the market in North America during the forecast period.
The global erectile dysfunction (ED) drugs market is fragmented in terms of number of players. Key players in the global market include Pfizer, Inc., Dong-A ST Co., Ltd., Eli Lilly and Company, Bayer AG, Vivus, Inc., and Teva Pharmaceutical Industries Ltd. Manufacturers are launching new products in the international market to tap the unmet needs of erectile dysfunction. Other prominent players operating in the global market include SK Chemicals, Meda Pharmaceuticals, Inc., Cristalia Produtos Quimicos Farmaceuticos Ltda., Apricus Biosciences, Inc., and Futura Medical plc.
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