Erectile Dysfunction - Pipeline Assessment and Market Forecasts to 2017

01 Sep 2010 • by Natalie Aster

GlobalData’s report, “Erectile Dysfunction - Pipeline Assessment and Market Forecasts to 2017” is an essential source of information and analysis on the global Erectile Dysfunction (ED) therapeutics market. The report identifies the key trends shaping and driving the ED market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring a significant shift in the positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global ED therapeutics sector.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

The ED market is currently very competitive and is expected to become more competitive in the future. The market is dominated by three major cyclic Guanosine Monophosphate (cGMP)-specific Phosphodiesterase type 5 (PDE5 inhibitors) including Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl). The market is expected to witness a decline between 2011 and 2014 due to patent expiry of the blockbuster drug Viagra. Viagra’s patent expires in early 2012 and the market is expected to decline due to erosions of margins with the entry of generics. Post 2014, the market is expected to grow due to an increase in the number of ED patients. GlobalData’s analysis revealed that the market grew at a CAGR of 9.8% from 2001 to 2009. The growth rate was moderate due lack of ED awareness and reluctance among the male general population to discuss their sexual problems. With the patent expiry of Viagra in 2012, the market is expected to decline after 2011, with a CAGR of 3.2% from 2009 to 2017.

GlobalData’s analysis showed that the ED pipeline is weak. The products in the ED pipeline comprise of me-too molecules. Some of the promising me-too class drugs/molecules are in Phase III trials and are likely to get approval in coming years. One of the promising molecules is Avanafil, which is unlikely to have much impact as the market has high competition among similar products and will experience generic erosion after 2012 due to patent expiry of Viagra.

The Erectile Dysfunction Market is forecast to decline until 2017

The Erectile Dysfunction (ED) market is currently very competitive and is expected to become more competitive in the future. The market is dominated by three major cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5 inhibitors) including Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil HCl). However the market is expected to witness a decline between 2011 and 2014 due to patent expiry of the blockbuster drug Viagra. Viagra’s patent expires in early 2012 and the market is expected to decline due to the erosion of margins with the entry of generics. Post 2014, the market is expected to grow due to an increase in the number of ED patients. The currently marketed products for the treatment of ED have high efficacy and safety standards. The market also has three other modes of treatment, which are Vacuum Constriction Devices (VCDs), penile prosthesis, and vascular reconstructive surgery. The ED diagnosis rate is low due to the non availability of formal tests. The other important factors are a lack of knowledge among patients regarding ED and a reluctance to share sexual problems with physicians and partners. The unmet need in ED is low to moderate as a significant number of patients do not respond to the currently available treatment. Therefore, patients not responding to current treatment would still remain an untapped area of research and development for pharmaceutical companies to bring novel drugs into the market. It would, therefore, be sufficient for newer entrants to demonstrate a superior efficacy and safety profile in order to capture value in the market over the currently used branded treatments.

GlobalData’s analysis estimates that Avanafil is likely to gain market approval as the drug is expected to bring higher efficacy and safety measures in the treatment of ED. Avanafil is a PDE5 inhibitor, which is already available in the market in the form of Viagra, Cialis and Levitra. Therefore Avanafil is expected to face stiff competition in the market. Increases in the treatment seeking population, prescription rates and the ageing global population are considered to be important drivers for this market. GlobalData’s analysis shows that the market grew at a Compound Annual Growth Rate (CAGR) of 9.8% from $1,366m in 2001 to $2,884m in 2009. The market is predicted to decline at a CAGR of 3.2% and reach a total value of $2,210m by 2017. The decline in the market is primarily attributed to the patent expiry of a major marketed product, Viagra, in 2012. The decline in the market can also be attributed to a weak pipeline, as no major product is likely to surpass the efficacy of the currently marketed products.

Erectile Dysfunction Market is Set to Witness High Market Competition

GlobalData found the current competition in the ED market to be strong as the market is governed mainly by three major branded drugs that have comparable safety and efficacy profiles. Most of the revenue for this market is generated by these three PDE5 inhibitors, which are Viagra, Cialis and Levitra. The PDE5 inhibitors are expected to remain dominant in the market as no novel drugs are in the pipeline. The most promising among the pipeline drugs is also a PDE5 inhibitor. The ED market is set to witness intensified competition after 2011 due to the patent expiry of Viagra in 2012. Because of the absence of novel drugs following this patent expiry, the ED market is expected to head towards market share competition and generic erosion. There are also a significant numbers of ED patients not responding to the currently available treatment. Therefore the market is long overdue for a novel therapy, but research companies have failed to provide any major drugs. Two major drugs received US Food and Drug Administration (FDA) approval in 2003, but since then no major drug has been launched.

New Entrants Unlikely to Bring Change in Treatment of Erectile Dysfunction

GlobalData found that that the currently available treatment options are successful in meeting the market demand. The market still has enough room for new entrants as there are significant numbers of ED patients not responding to the currently available treatments. The ED pipeline drugs in Phase III belong to a me-too class of drugs. The pipeline drug Avanafil (a PDE5 inhibitor) is in Phase III clinical trials and is expected to be launched in the near future. However, it may not be able to bring any change in the market dynamics as it will be competing against the popular PDE5 inhibitors already available in the market. New entrants are also likely to face stiff competition due to market erosion by generics after 2011. Therefore, no change in the market dynamics is predicted in this market.

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