Market Overview
The global genital dysfunction drugs market reached US$ 4.15 billion in 2023 and is expected to reach US$ 7.16 billion by 2031 growing with a CAGR of 7% during the forecast period 2024-2031.
Genital dysfunction is a type of sexual dysfunction that affects an individual's ability to engage in sexual activity effectively. It encompasses a variety of conditions that can interfere with the sexual response cycle, which includes desire, arousal, orgasm, and resolution.
Key players in the industry product launches and approvals that would drive the genital dysfunction drugs market growth. For instance, in June 2023, Futura Medical plc announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) marketing authorization for MED3000, an innovative topical gel formulation designed for the treatment of erectile dysfunction (ED).
Market Scope
Metrics | Details |
CAGR | 7% |
Size Available for Years | 2022-2031 |
Forecast Period | 2024-2031 |
Data Availability | Value (US$ Mn) |
Segments Covered | Product Type, Route of Administration, and Distribution Channels |
Regions Covered | North America, Europe, Asia-Pacific, South America, and Middle East & Africa |
Largest Region | North America |
Fastest Growing Region | Asia-Pacific |
Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and Acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, Porter’s Analysis, Pricing Analysis, Regulatory Analysis, Supply-Chain Analysis, and Other Key Insights. |
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Market Dynamics: Drivers
Increasing prevalence of erectile dysfunction
The demand for the global genital dysfunction drugs market is driven by multiple factors. One of the key factors is the increasing prevalence of erectile dysfunction. The increasing prevalence of conditions like post-menopausal sexual dysfunction and hypoactive sexual desire disorder, alongside a growing awareness of sexual wellness drugs.
Erectile dysfunction (ED) is often linked to various chronic health conditions such as diabetes, hypertension, and cardiovascular diseases. As these chronic conditions become more prevalent due to lifestyle factors and aging populations, the incidence of ED is likely to rise.
As per NCBI research publication in January 2024, studies indicate that nearly 50% of men with known coronary artery disease (CAD) experience significant ED. This correlation suggests that ED may be an early indicator of underlying cardiovascular issues. A meta-analysis involving over 90,000 men found that those with ED had a 44% higher risk of cardiovascular events, 62% more myocardial infarctions (heart attacks), 39% more strokes, and a 25% increased risk of death compared to men without ED. This highlights the serious implications of ED beyond sexual health.
Hypertension was about 40% of men with ED also have hypertension, while approximately 35% of all hypertensive men experience ED. Hyperlipidemia condition is present in about 42% of men with ED. Men with undiagnosed diabetes are up to three times more likely to have ED (28%) compared to non-diabetic men (10%). Among men over 50, those with diabetes are roughly twice as likely to experience ED (46%) compared to those without diabetes (24%). All these above factors demand for the genital dysfunction drugs market.
Furthermore, key players in the industry product launches and approvals that would drive the genital dysfunction drugs market growth. For instance, in February 2023, Astellas Pharma announced the launch of Vyleesi (bremelanotide) in the United States, a significant development in treatment options for women experiencing low sexual desire. Vyleesi is an injectable medication specifically designed for premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD).
Moreover, the growing aging population, technological advancements, and the rise in lifestyle-related health issues contribute to the demand for male genital dysfunction medications, and premature ejaculation treatments are the factors expected to drive the global genital dysfunction drugs market over the forecast period.
Market Restraints
Adverse effects associated with the drugs
The main treatment for genital dysfunction includes PDF5 inhibitors and side effects of PDE5 inhibitors include both common and severe reactions. The potential side effects associated with genital dysfunction medications, such as headaches, flushing, nasal congestion, and indigestion are mild and temporary, the potential for serious complications such as vision changes, priapism, and sudden hearing loss cannot be overlooked.
Patients should be informed about these risks when considering PDE5 inhibitors for genital dysfunction treatment. It is essential for anyone experiencing severe side effects to seek immediate medical attention to mitigate potential long-term consequences. Concerns about these side effects may lead individuals to avoid seeking prescriptions altogether, thereby limiting the market's potential growth.
Market Segment Analysis
The global genital dysfunction drugs market is segmented based on product type, route of administration, distribution channels, and region.
The sildenafil segment accounted for approximately XX% of the global genital dysfunction drugs market share
The sildenafil segment is expected to hold the largest market share over the forecast period. Sildenafil (Viagra) has been widely recognized as the first-line therapy for ED. Its long-standing presence in the market has built a strong reputation among both healthcare providers and patients. Studies indicate that it is the most commonly prescribed medication for ED, making it a go-to option for many men seeking genital dysfunction treatment.
Sildenafil works by inhibiting phosphodiesterase type 5 (PDE5), an enzyme that breaks down cyclic guanosine monophosphate (cGMP) in the corpus cavernosum of the penis. By preventing this breakdown, sildenafil increases the levels of cGMP, which promotes smooth muscle relaxation and enhances blood flow to the penis during sexual stimulation. This mechanism is crucial for achieving and maintaining an erection.
Furthermore, the rising number of clinical trials, key players' product launches, and innovative treatment options would propel this segment's growth in the genital dysfunction drugs market. For instance, in July 2024, Aspargo Labs announced promising data regarding ASP-001, the first oral spray formulation for erectile dysfunction (ED) that utilizes sildenafil citrate. This innovative product demonstrates a significantly faster absorption rate compared to traditional Viagra tablets, achieving absorption within five minutes twice as fast as the pill form.
Similarly, in September 2024, Viatris announced the launch of PrViagra ODF (sildenafil citrate orodispersible film) in Canada, introducing a new formulation for the treatment of erectile dysfunction (ED). This innovative product dissolves in the mouth, offering a convenient and discreet option for men seeking treatment for ED.
Also, in July 2024, DongKoo Bio announced the launch of a new combination drug designed to address both erectile dysfunction (ED) and premature ejaculation (PE). This innovative medication, which combines clomipramine (used for treating premature ejaculation) and sildenafil (the active ingredient in Viagra for erectile dysfunction), is set to enter the market under the name GuSeJeong in South Korea, while CTC Bio will market it as WonTuJeong.
Market Geographical Share
North America accounted for approximately XX% of the global genital dysfunction drugs market share
North America region is expected to hold the largest market share over the forecast period owing to the high prevalence of erectile dysfunction, rising aging population, and the prevalence of chronic diseases, including hypertension, diabetes, and obesity, driving the market growth.
These conditions are closely linked to erectile dysfunction, studies show that men with diabetes are at least twice as likely to experience ED compared to those without diabetes. The increasing rates of these comorbidities contribute to a higher demand for effective treatment options driving the genital dysfunction drugs market growth.
Erectile dysfunction (ED) is a significant health concern among men with diabetes mellitus (DM), with studies indicating that the prevalence of ED in this population is approximately 3.5 times higher than in men without diabetes. This elevated prevalence can be attributed to several physiological and psychological factors associated with diabetes.
As per Diabetic Medicine research publication in September 2023, research shows that about 52.5% of men with diabetes experience erectile dysfunction, which varies across different types of diabetes 37.5% in Type 1 and 66.3% in Type 2 diabetes. The odds ratio for developing ED in diabetic men compared to non-diabetic controls is approximately 3.62, indicating a substantially higher risk. Diabetic men are significantly more likely to experience difficulties achieving or maintaining an erection.
Similarly, the integration of telehealth and telemedicine for sexual health further enhances access to these therapies, facilitating better management of conditions like impotence and genitourinary syndrome of menopause. As a result, the global sexual dysfunction drug market is poised for continued growth, driven by both innovations in treatment options and changing societal attitudes towards sexual health.
Furthermore, in this region, a major number of key players' presence, well-advanced healthcare infrastructure, government initiatives & regulatory support, technological advancements, and product launches & approvals would propel the genital dysfunction drugs market growth. For instance, in September 2023, the FDA approved Eroxon, a new over-the-counter (OTC) gel designed to treat erectile dysfunction (ED). This marks a significant development in the treatment landscape for ED, as Eroxon is the first topical gel of its kind to be available without a prescription in the United States.
Also, in September 2024, Haleon announced the launch of Eroxon, the first and only FDA-cleared over-the-counter (OTC) gel for the treatment of erectile dysfunction (ED). This innovative product is now available for pre-order in the United States. Thus, the above factors are expected to drive the genital dysfunction drugs market in this region.
Market Segmentation
By Product Type
- Sildenafil
- Tadalafil
- Avanafil
- Udenafil
- Vardenafil
- Alprostadil
- Others
By Route of Administration
- Oral
- Injectable
- Topical
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- U.K.
- France
- Spain
- Italy
- Rest of Europe
- South America
- Brazil
- Argentina
- The rest of South America
- Asia-Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
- Middle East and Africa
Market Companies
The major global players in the genital dysfunction drugs market include Pfizer Inc., Eli Lilly and Company, Bayer, Teva Pharmaceutical Industries Ltd., Lupin, Viatris Inc. (Mylan Inc.), Futura Medical, 23andMe (Lemonaid Health), Hims & Hers Health, Inc., and BlueChew among others.
Key Developments
- In September 2023, Akums Drugs and Pharmaceuticals launched the Tamsulosin + Tadalafil Capsule in the Indian market, a significant advancement aimed at treating both benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). This combination therapy represents a notable achievement as Akums is the first contract development and manufacturing organization (CDMO) to receive approval from the Drug Controller General of India (DCGI) for this unique formulation.
Why Purchase the Report?
- To visualize the global genital dysfunction drugs market segmentation based on product type, route of administration, distribution channels, and region and understand key commercial assets and players.
- Identify commercial opportunities by analyzing trends and co-development.
- Excel data sheet with numerous data points of the genital dysfunction drugs market with all segments.
- PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
- Product mapping is available in excel consisting of key products of all the major players.
The global genital dysfunction drugs market report would provide approximately 62 tables, 56 figures, and 184 pages.
Target Audience 2024
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
