The market for erectile dysfunction
In 2019, the number of men around the world with erectile dysfunction was estimated at approximately 409 million, corresponding to about 15.3% of the male adult population. Furthermore, the problem is expected to increase by more than 1 percent per year between 2020 and 2026. The increase is mainly due to change in demographics (more men and more people over the age of 50) and prevalence levels. This matters since the condition has shown to be age-dependent in most studies. The older the population, the higher the prevalence level.
Arizton, 2018; European Association of Urology, 2016; Prevalence (MMAS, 1989); Prevalence (MSAM-7, 2003)
Erectile dysfunction has several different underlying causes, including stress, chronic diseases and psychological disorders. Stress is estimated to be more common in Europe and North America. Diabetes is one of the chronic diseases that can cause erectile dysfunction and is an important factor behind the increase in erectile dysfunction in the population. Erectile dysfunction caused by type 2 diabetes is estimated to increase the prevalence by 1% per year until 2040. Globally, diagnosed depression increased by approximately 18% between 2005 and 2015 and the increase is expected to continue, thereby being a contributing factor to the increase in erectile dysfunction in the population.
Arizton, 2018; UN, 2017; JP Mulhall, 2016
PDE5 inhibitors are prescription drugs available in several variants, of which Viagra developed by Pfizer, Cialis developed by Eli Lilly and Levitra developed by Bayer AG and GlaxoSmithKline are market leaders in drug development in the treatment of erectile dysfunction.
Drugs with PDE5 inhibitors have to be taken a short time before intercourse. The effect takes place approximately 30 to 60 minutes after ingestion, which requires planning. The mechanism of action of PDE5 inhibitors is dilation of the blood vessels in the erectile tissue of the penis, which leads to a stronger erection. However, the dilation of the blood vessels is not only limited to this area, so PDE5 inhibitors also affect blood vessels in other parts of the body.
Common side effects of PDE5 inhibitors include runny nose, headache, blushing, abdominal pain, back pain, indigestion, temporary visual impairment, fatigue and dizziness. They have also been reported to cause other major side effects, including severe drop in blood pressure. This means that PDE5 inhibitors are contraindicated in patients with cardiovascular disease and in patients treated with nitro-drugs.
Furthermore, up to 30 to 40% of patients with erection problems do not respond to treatment with this substance.
Park NC, Kim TN, Park HJ. Treatment Strategy for NonResponders to PDE5 Inhibitor. World J Mens Health. 2013 Apr; 31 (1): 31–35.
Jackson G, Rosen RC, Kloner RA, Kostis JB. The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med. 2006 Jan; 3 (1): 28-36;
Gratzke C, Angulo J, Chitaley K, Dai YT, Kim NN, Paick JS, Simonsen U, Uckert S, Wespes E, Andersson KE, Lue
Summary of important competitors
Viagra. PDE5 inhibitor. First on the market, ”the golden standard". Global registration.
Cialis. PDE5 inhibitor. Today higher sale volumes than Viagra. Global registration.
Limitations with current therapeutics
- 30 to 40% of patients experience little or no effect, which also affects 70% of diabetic patients
- Side effects such as nausea, headache, dizziness and drop in blood pressure
- Short duration of action, which requires unwanted planning of sexual activity