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The urinary incontinence drugs market was valued at USD 2170.44 Million in 2025, driven by growing aging population and increasing awareness and diagnosis rates of urinary incontinence expenditure across the 8 major markets. The market is anticipated to grow at a CAGR of 7.00% during the forecast period of 2026-2035, with the values likely to reach USD 4269.58 Million by 2035. The market is driven by the increasing elderly population and the introduction of advanced drug formulations with improved efficacy and fewer side effects. Rising healthcare spending and expanding reimbursement policies are also expected to support market value during the forecast period.
Base Year
Historical Period
Forecast Period
Bladder and continence issues affect an estimated 1 in 5 people in the UK, with 14 million affected, according to NHS . This rising prevalence significantly fuels demand for urinary incontinence drugs across global markets.
In April 2024, Zydus launched generic Mirabegron Extended-Release Tablets in the U.S., expanding access to affordable treatment for overactive bladder with symptoms of urge urinary incontinence. This strategic entry is expected to positively influence market growth across key regions.
A key trend in the urinary incontinence drugs market is the shift toward device-based and mRNA therapies. For instance, in 2024, UroMems reported positive trial results for its UroActive implant using MyoElectroMechanical technology.
Compound Annual Growth Rate
7%
Value in USD Million
2026-2035
*this image is indicative*
Urinary incontinence drugs are pharmaceutical treatments designed to manage involuntary urine leakage by improving bladder control and reducing urinary urgency. These medications include anticholinergics, beta-3 adrenergic agonists, and hormone therapies, commonly used for stress, urge, and mixed incontinence. The market is poised to grow at a CAGR of 7.00% during the forecast period of 2026–2035, driven by the rising geriatric population, increasing prevalence of chronic conditions like diabetes and obesity, and growing awareness about urinary health. Advancements in drug formulations and expanding access to healthcare further support market expansion.
Generic Drug Penetration to Strengthen Market Growth
The rising demand for affordable and effective therapies continues to drive growth in the urinary incontinence drugs market across the eight major regions. For instance, in June 2019, Lupin received U.S. FDA approval for its Mirabegron Extended-Release Tablets, 25 mg and 50 mg, indicated for overactive bladder (OAB) with symptoms such as urge urinary incontinence and urgency. Following this, in April 2024, Lupin launched Mirabegron Extended-Release Tablets, 25 mg in the United States, after final FDA approval, as a generic version of Astellas Pharma’s Myrbetriq®. This strategic development strengthens treatment access and reinforces the growing role of generics in global market expansion.
The market is witnessing several trends including expanding indications for beta-3 agonists and rapidly aging population, among others.
Expanding Indications for Beta-3 Agonists to Elevate the Market Value
The market is increasingly driven by the expansion of approved indications for beta-3 adrenergic receptor agonists, targeting broader patient populations. In May 2024, Sumitomo Pharma America advanced this trend by submitting a supplemental New Drug Application (sNDA) for vibegron (GEMTESA®) to the U.S. FDA, aiming to treat overactive bladder symptoms such as urge urinary incontinence, urgency, and urinary frequency, in men receiving pharmacological therapy for benign prostatic hyperplasia. Supported by successful Phase 3 results, this strategic development highlights a shift toward more tailored and combination-targeted therapies, reinforcing the upward trajectory of market growth.
Rapidly Aging Global Population Expected to Boost Urinary Incontinence Drugs Market Demand
The growing prevalence of an aging population is emerging as a key factor in the expansion of the urinary incontinence drugs market. This trend reflects the increasing need for effective bladder control therapies as older individuals face higher risks of incontinence. In October 2023, the World Health Organization (WHO) highlighted tha t the population aged 60 years and older will double by 2050, reaching 2.1 billion, with the number of individuals aged 80 years and above projected to triple to 426 million. Furthermore, the Population Reference Bureau reported that the number of Americans aged 65 and older will rise from 58 million in 2022 to 82 million by 2050, increasing their share of the population from 17% to 23%. These developments underscore the expanding patient base and are expected to significantly propel the urinary incontinence drugs market forward.
Stress Incontinence to Lead the Market Segmentation Based on Incontinence Type
The market, by incontinence type, is categorized into urge incontinence, overflow incontinence, stress incontinence, mixed incontinence, and others. Among these, the stress incontinence segment is projected to lead the market in the coming years. This trend is primarily driven by the high prevalence of stress urinary incontinence (SUI), particularly among aging women, and the growing demand for safer, non-surgical treatment alternatives. In July 2024, a clinical trial published in The Journal of Urology® introduced TAS-303, an investigational drug that demonstrated significant efficacy and safety in treating women with SUI. Unlike other drugs, which are associated with gastrointestinal and neurological side effects, TAS-303 is a highly selective noradrenaline reuptake inhibitor that avoids these adverse reactions. The study showed a 58% reduction in SUI episode frequency in the TAS-303 group, with benefits observed as early as four weeks into treatment. Such promising developments are expected to reinforce the dominance of the stress incontinence segment, supported by an aging global population and the increasing preference for pharmacological therapies over surgical procedures.
The report covers key regions including the United States, United Kingdom, Germany, France, Italy, Spain, Japan, and India, with market expansion driven by an aging population and evolving regulatory frameworks. The United States is expected to lead the market due to its high disease prevalence and supportive regulatory environment. According to Stephen W. Leslie et al. (2024), approximately 13 million individuals in the U.S. are affected by urinary incontinence, with prevalence rates exceeding 75% among long-term care residents. Regulatory advancements also support market growth, for example, in December 2024, the U.S. FDA approved GEMTESA® (vibegron) by Sumitomo Pharma America, the first β3 agonist approved for men with overactive bladder symptoms u ndergoing treatment for benign prostatic hyperplasia. These developments underscore the region’s momentum in addressing unmet needs and advancing therapeutic options.
The key features of the market report comprise clinical trials analysis, patent analysis, grant analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Pfizer Inc., a leading global biopharmaceutical company, actively contributes to the market through its product TOVIAZ® (fesoterodine fumarate). Approved for the treatment of overactive bladder in adults and neurogenic detrusor overactivity in pediatric patients, TOVIAZ® is available as extended-release tablets in 4 mg and 8 mg strengths. With ongoing updates and rigorous medical review, Pfizer strengthens its presence across major regions by addressing both adult and pediatric incontinence treatment needs.
Astellas Pharma, a global leader in urology, has maintained a strong presence in the market across key regions through its well-established treatments for overactive bladder (OAB) and lower urinary tract symptoms (LUTS) linked to benign prostatic hyperplasia (BPH). With a focus on improving quality of life, Astellas continues to expand its OAB portfolio and awareness initiatives, including annual campaigns and digital tools like OAB.ie, reinforcing its commitment to underserved patient needs.
Merck is actively involved in the urinary incontinence drugs market. MSD offers a broad portfolio addressing various types of incontinence, such as oxybutynin, solifenacin, tolterodine, and mirabegron, which target detrusor overactivity. These drugs support the company’s commitment to advancing treatment for overactive bladder and related conditions through evidence-based therapies and global medical outreach.
Kissei Pharmaceutical Co., Ltd., launched Beova® Tablets 50mg in Japan for the treatment of overactive bladder (OAB), a key segment in the urinary incontinence drugs market. Approved in 2018, Beova®, containing vibegron, is a once-daily β3-adrenergic receptor agonist that effectively reduces urinary urgency, frequency, and urge urinary incontinence. This strategic entry strengthens company’s urology portfolios and contributes to addressing the rising global burden of OAB, particularly in aging populations across major regions.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market are Astellas Pharma, Sanofi S.A., Kyorin Holding, Urovant Sciences, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, and Ferring Pharmaceuticals.
"Urinary Incontinence Drugs Market Report and Forecast 2026-2035" offers a detailed analysis of the market based on the following segments:
Market Breakup by Incontinence Type
Market Breakup by Drug Type
Market Breakup by Gender
Market Breakup by Distribution Channel
Market Breakup by Region
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Incontinence Type |
|
| Breakup by Drug Type |
|
| Breakup by Gender |
|
| Breakup by Distribution Channel |
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| Breakup by Region |
|
| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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