Erectile Dysfunction Treatment Market

Market Overview

The global erectile dysfunction treatment market size is expected to grow at a CAGR of 3.38% over the forecast period (2023–2031). The global market is anticipated to grow due to the widespread availability of the Internet and the increasing prevalence of e-commerce deliveries in various areas.

Penile erection is a physiological condition in which the penis becomes firm, engorged, and enlarged. It occurs due to the interaction of psychological, vascular, neural, and endocrine factors and is often associated with sexual arousal or sexual attraction. A man is said to have erectile dysfunction (ED) if he has persistent trouble getting or keeping an erection to engage in sexual activity or if it affects other aspects of his sexual life. It is the most common male sexual condition which can arise due to stress or emotional reasons.

Additionally, it may serve as a first indication of more severe ailments such as atherosclerosis (the narrowing or obstruction of arteries), cardiovascular disease, hypertension, or hyperglycemia resulting from diabetes. The most common conditions for the illness to manifest are restricted blood flow or damaged nerves in the penis. Moreover, it can result from serious health conditions, emotional issues, or both. Some risk factors include age above 50, diabetes, high blood pressure, cardiac diseases, high cholesterol, Smoking, and lack of exercise.

Market Dynamics

Market Drivers

Emergence of Innovative ED Treatment Technologies

In order to provide cutting-edge solutions for impotence and erectile dysfunction, market participants are concentrating on technical developments and upgrades. Several new device technologies for ED treatment have been introduced in the market. One of the technologies is low-intensity shock wave extracorporeal therapy (LI-ESWT), a promising method for treating erectile dysfunction. This treatment has shown recent effectiveness in treating fractures and reversible ischemia tissues of the heart. It has also demonstrated efficacy in the treatment of kidney stones in cardiology. The LI-ESWT is a device that resembles a wand that is applied to various parts of the penis. It works by releasing acoustic waves interacting with the tissues and releasing components promoting blood circulation.

Additionally, gene therapy, tissue engineering, nanotechnology, and endovascular tools are emerging future therapies for the treatment of ED. Tissue engineering will be used in the biological reconstruction of the phallus, and nanotechnology will be a novel local therapy for ED in the future. We can cure ED caused by focal vascular lesions with further innovations in endovascular technology. Therefore, the future of technological advancements in men's health problems is bright, and the acceptance of technology will entirely depend upon their safety, efficacy, and patient satisfaction. These technological modalities are further anticipated to augment the growth of the ED treatment market in the upcoming years.

Increasing E-Commerce Delivery of ED Drugs and Devices

The development of information and communication technologies (ICTs) as a tool has led to many cultural and social changes. The availability and accessibility of updated information regarding ED drugs and devices help reduce the gap between vendors and consumers. This will bring awareness among the patient population and boost the market's demand. A cross-sectional study conducted to investigate the treatment of ED through online platforms between May and November 2019 revealed that 11,456 members received treatment through online platforms, and the majority of them were from rural regions, i.e., 69%. The study confirmed that social stigma and reluctance to consult a physician for the treatment of ED are contributing to the rising online pharmacy practice. Thus, easy internet access and the emergence of e-commerce delivery in regions worldwide are expected to drive the growth of the global market during the forecast period.

Market Restraint

Threat from Counterfeit Drugs in Treating Erectile Dysfunction

Medicines with varying amounts of active ingredients can lead to various serious health conditions. Drug overdose and drug interactions can result in a variety of adverse outcomes. An example of a specific interaction is with nitrates, which can lead to a significant drop in blood pressure, known as severe hypotension. Some counterfeit pharmaceuticals may contain hidden ingredients that can harm consumers. Some undisclosed substances that are generally considered safe may provide a risk when combined with erectile dysfunction medication. For instance, diabetes medicines were found to be counterfeit in ED medications, which could cause fatal hypoglycemia.

Moreover, in 2006, the World Health Organization established the International Medicine Products Anti-Counterfeiting Task Force (IMPACT) to end selling fake medicines and cap counterfeit versions of prescription-based pharmaceuticals. PDE-5 inhibitors manufacturers came forward and started working with law enforcement and regulatory authorities by producing holographic security foil, radio frequency identification tags, and 2D barcodes for the identification of the genuine version of products.

The Food Drug Administration (FDA) has also developed public education through magazines, news articles, education leaflets, consumer websites, and pharmacy education programs. Therefore, difficulties in quantifying the falsified product versions and differentiating counterfeit products from genuine ones result in overall problems with counterfeit versions. This has become a key restraint in the global erectile dysfunction treatment market.

Market Opportunities

Increasing Incidence of Erectile Dysfunction and Other Chronic Diseases

Pharmaceutical companies and research scientists are continuously putting efforts into innovations and new drug formulations as well as drug delivery systems to meet the unmet needs of patients. These advancements in the research enhanced patient convenience, bioavailability, drug safety and efficacy, and increased onset and duration of action. The rising prevalence of ED is observed not only in men aged > 40 but also in men under 40. This, in turn, has increased the demand for the treatment of ED.

The initial ED drug therapy launched was semi-solid intraurethral suppositories, followed by oral drug therapies. Since the emergence of oral therapies, this treatment modality has dominated the global ED market. Nowadays, PDE-5 inhibitors are used as first-line treatment and have shown 70% results with patient satisfaction. But it was found to have 11–44% failure in therapy. There are a lot of factors limiting the use of PDE-5 inhibitors, such as the fact that they must be taken two hours before sexual intercourse, the fact that they interact negatively with alcohol and food, and the fact that they are contraindicated with nitrates.

Moreover, the latest advancements in the administration of PDE-5 inhibitors are through an orodispersible dosage system. This system disintegrates when placed in the mouth without the need for water. This was found to offer convenience in administering, limiting the need for chewing and difficulties in swallowing, which can be more favorable for the elderly population and people with dysphasia. Such advancements in ED drug formulations and delivery systems will likely enhance the patient experience, further boosting the growth of the erectile dysfunction treatment market.

Regional Analysis

Region-wise, the global erectile dysfunction treatment market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global erectile dysfunction treatment market shareholder and is anticipated to expand significantly during the forecast period. This dominance is due to factors like improved access to prescription and generic erectile dysfunction drugs, reimbursement coverage for ED surgeries, improved healthcare infrastructure, rising R&D innovations, and rising demand for ED drugs. The US is the major revenue contributor in the region. The overall prevalence of erectile dysfunction in US males aged 20 to more than 70 years age was found to be 18.4%. More than 30 million men in the US suffer from erectile dysfunction, according to this estimate. This solely depends on age, which shows the highest prevalence values for people over 70 years, i.e., 70.2%.

In Canada, a cross-sectional epidemiology study stated that the overall prevalence of ED was 49.4%, which states that the condition affects an estimated 3 million Canadian men over 40. With the increase in chronic diseases, the prevalence of ED will also be influenced. Research has shown that erectile dysfunction is common in men with cardiovascular disease (51.3%) and diabetes (51.3%). Such instances drive regional market growth.

In Europe, countries like the UK, Germany, Italy, France, and Spain are the major revenue contributors. Factors like increasing adoption of a sedentary lifestyle, increase in chronic diseases, investments in R&D activities, government funding, high healthcare investments, and biosimilar and orphan drugs development are increasing regulatory expertise, which, in turn, propels the erectile dysfunction drugs market growth in the region. Research conducted by the Massachusetts Male Aging Study (MMAS) showed that the epidemiology of ED in Europe ranges from 10–to 76.5%.

Another study conducted by the European Male Ageing Study (EMAS) in men aged 40−79 years reported that the prevalence of erectile dysfunction was 6−64% for different age groups, and the average range was found to be 30%. Results from investigational male sexual dysfunctions reported that the overall prevalence of erectile dysfunction in European countries was found to be in the range of 5–17.2% in men aged 18–29 years, 3–26.9% in 30–39 years, 4–52% in men 40–49. Moreover, a significant risk factor for ED is the rise in chronic illnesses like diabetes, heart disease, high blood pressure, and obesity, which may be brought on by switching to a secondary lifestyle. Among all these diseases, diabetes was the established risk factor for ED, and as men with diabetes age, ED becomes even more common, which drives the market growth.

In Asia-Pacific, the market witnessed sustainable growth with increasing low-cost generic ED medicines and increasing prevalence of ED. It was observed that the prevalence of ED ranges widely in the Asia-Pacific region, with 8% - 50% in China and 13% - 81.1% in Japan. The major factors resulting in increasing cases of ED in the Asia-Pacific region were diabetes, hypertension, cardiovascular diseases, and the aging population. Socio-economic factors were also the major contributors to increasing ED. As per the Global Better Sex Survey, many men mentioned that sex is important in life but did not recognize ED as a treatable medical condition. As per the published studies on erectile dysfunction, the overall prevalence in the Asia-Pacific was 35% to 38%.

Moreover, the availability of low-cost generics in the Asia-Pacific region significantly contributes to market growth. Expirations of patents for branded drugs for erectile dysfunction, such as Pfizer's Viagra, Eli Lilly, and Company's Cialis, and Bayer's Levitra, are creating opportunities for generic manufacturers to develop their generic versions, which they can sell in the market at low cost. In addition, countries like China and India offer opportunities for the leading vendors in the market to conduct disease awareness campaigns, as these countries account for the largest pool of untreated patients. Such initiatives by different countries can enhance the consumption of ED drugs in the future, ultimately driving market growth in the region.

Segmental Analysis

The global erectile dysfunction treatment market has been segmented into drugs, devices, route of administration, and distribution channels.

Based on drugs, the global erectile dysfunction treatment market is categorized into Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Stendra (avanafil), Zydena (udenafil), and Mvix (sildenafil).

The Viagra segment dominates the global market. Viagra (sildenafil) is the primary medication for erectile dysfunction (ED) and holds the biggest market share among all other ED medications. The medicine is expected to enhance penile blood circulation, hence facilitating the attainment of a rigid erection for sexual performance. Generic copies of sildenafil are increasing, and Pfizer's original Viagra generics are still available, so the drug maintains its market dominance even after the patent expires, outselling competing PDE-5 inhibitors.

Based on devices, the global erectile dysfunction treatment market is categorized into penile implants, vacuum constriction devices, shock wave therapy, and others.

The penile implants segment owns the highest market share and is expected to exhibit a CAGR of 2.9% during the forecast period. The penile implant or penile prosthesis has increased preference among the patient population due to its high efficacy. The implantation method is used when the first-line therapy, i.e., oral PDE-5 inhibitors, is ineffective. Inflatable and malleable penile implants are the two main varieties. Boston Scientific and Coloplast are the leading market players in the penile implant market.

Moreover, VCD is an external pump that aids the penis to become erect, and a band connected to the pump further helps to maintain the erection. The patient population prefers VCD due to its invasive nature, ease of use, and government coverage. According to a study, the efficacy of VCD was reported to be 50–80%, contributing to its increasing utilization worldwide.

By route of administration, the global erectile dysfunction treatment market is categorized into oral drugs, penile injections and suppositories, and topical formulations. 

The oral drugs segment dominates the global market and is expected to expand substantially during the forecast period. These drugs available for the treatment of ED include PDE-5 inhibitors such as Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Stendra (avanafil), Zydena (udenafil), and Mvix (sildenafil). Among all these drugs, Viagra (sildenafil) is the first drug for ED, covering the largest share of the ED drugs market.

In addition, the increased sales of Revatio (sildenafil) by Teva Pharmaceuticals make it a key player in the market. A new drug such as Stendra (avanafil) was observed to have several advantages compared to the old drugs, such as decreased incidence of side effects and interactions and rapid onset of action. At present, Stendra is the only drug that is available as a Branded drug version for ED. All such developments drive segment growth.

Based on the distribution channel, the global erectile dysfunction treatment market is categorized into retail pharmacies, hospital pharmacies, and online portals.

The retail pharmacies segment owns the highest market share and is estimated to expand substantially during the forecast period. Due to their easy access, these pharmacies are considered the first healthcare contact for ED treatment. Moreover, the expiration of patent protection for blockbuster drugs, including Viagra, Cialis, and Levitra, is increasing their generic sales through retail pharmacies, where they can be purchased easily without any prescription. It was also observed that more than 50% of males prefer ED treatment by consulting pharmacists rather than physicians due to social stigma toward the sexual disease.

Recent Developments

• September 2023 -A brand-new, non-prescription treatment for erectile dysfunction (ED) will soon be offered to men. It is said to perform more quickly than standard ED medicine. In June, the FDA authorized MED3000 (Eroxon), a topical gel therapy for ED, for over-the-counter sales. The container for MED3000 is a single-use tube. The ingredients are applied to the penis' head right before a sexual encounter.