Sildenafil Citrate Market Trends

Growth Drivers

• Increasing awareness of disease detection: There is a fast-rising prevalence of erectile dysfunction that increases diagnostic awareness, driving growth in the sildenafil citrate market.  In this regard, NLM data in April 2025 states that PAH cases have increased by 13.9% in high socio‐demographic index countries, highlighting the demand for the market. Besides, USPSTF now highly recommends ED screening for diabetes in men, broadening the patient pool for phosphodiesterase-5 inhibitors. Hence, these factors, which increase awareness and accessibility to affordable therapeutics, are expected to propel market growth.
• Patent expirations and affordable therapeutics: The demand for generics and patent expirations is another major driver for the sildenafil citrate market. In this regard, the U.S. FDA orange book reported that there have been 92 sildenafil approvals till date, reflecting the exceptional regulatory support. Besides, the lowered prices when compared to branded therapeutics are expanding business in emerging nations. Furthermore, the WHO report stated that its prequalification accelerated generic adoption in developing countries. Therefore, this further drags the interest of global players to invest in effective therapeutics.
• Health care cost containment and generic substitution: Payer pressure to keep costs down decisively favors generic sildenafil citrate. Multiple Abbreviated New Drug Applications (ANDAs) approved by the FDA have established a price-cutting, competitive market. AHRQ studies on cost-effective interventions always point to generic medications as critical to preventing runaway healthcare spending without sacrifice of quality. This driver forces manufacturers to compete on price and supply chain efficiency, making sildenafil one of the most cost-effective treatments in its class, which in turn expands access and volume.

Summary of Key Clinical Trials of Sildenafil Citrate

Source: AHA Journal May 2024, NLM June 2023, ClinicalTrials August 2025,

Challenges

• Patent litigation risks: One of the most significant hurdles experienced by the sildenafil citrate market is the legal challenges that potentially delay the product’s market entry. In this context, the USPTO in 2024 reported that paragraph IV filings lead to an average legal cost, acting as a major market restraint. Besides, once patents expire or are invalidated, it results in highly competitive pressures in the sector, making it restrictive for the manufacturer to opt for sildenafil citrate products.
• Patient affordability and out-of-pocket expenses: Even if a product is approved and reimbursed, excessive patient co-payments can curtail adherence and demand. In the U.S., even with Medicare Part D coverage, out-of-pocket expenses for branded products can be prohibitive. The CDC reports that cost-related non-adherence with prescription medication is a serious public health problem. This problem is particularly seen in developing markets without any strong insurance system, where the major share of the expense is paid directly by patients, which tightly limits the addressable market for all but the lowest-cost generics.