Prevalence of OAB

According to Statistic Brain, an estimated 183 million people worldwide suffer from overactive bladder (OAB), with North America having the highest prevalence. In the U.S. alone, around 66.6 million people experience OAB symptoms, suggesting a significant market potential for OAB treatment.The overactive bladder treatment market is projected to have a compound annual growth rate (CAGR) of 3.4% over the forecast period, according to Statistic Brain.

Outpatient Rate

From the National Center for Biotechnology Information, a budget impact model (BIM) with a 5-year time horizon was developed. This model utilized a top-down, prevalence-based approach and projected market shares for 1-million-member US commercial and Medicare plans. The purpose of the model was to assess the effectiveness and safety of mirabegron for treating overactive bladder in adults. Here is the results:

For a 1-million-member plan, the estimated number of patients with OAB treated with prescription medication was 31,456 from the commercial payor perspective and 56,684 from the Medicare perspective . The estimated number of patients with incontinence, a subset of patients with OAB, receiving prescription medication for OAB was 20,936 and 37,276 from the US commercial payor and Medicare perspectives, respectively.Based on the given information, the utilization rate of prescription medication for OAB is estimated to be around 29.4% on average.

Dosage

Vibegron, marketed as Gemtesa, is an oral tablet taken once daily, with each tablet containing 75 mg of vibegron.

API reference price (USD/KG): $ 4,439

Treatment Period

The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in UUI episodes. Additionally, 40.8% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.The medication may improve your symptoms within one or two weeks, but it may take several weeks or months to achieve maximum benefit. Therefore，we decide to choose 180days as average.

Market share of Vibegron

The product (Mirabegron) accounted for half of the U.S. OAB market in 2018(47%).

Mirabegron and Vibegron are both β3 adrenergic receptor agonists, which work by stimulating the β3 receptors to relax the smooth muscle of the bladder, thereby reducing symptoms caused by bladder overactivity. Therefore we speculate  the market share of Vibegron  is about 23.5%

API Demand

Based on the given information, the calculated API demand of Vibegron is around $757.7 million based on the estimated prevalence rate, utilization rate, dosage, treatment period, and market share.

Reference

https://www.statisticbrain.com/overactive-bladder-statistics/

https://www.urologytimes.com/view/vibegron-officially-launched-in-us-oab-market

Chen JV, Gahn JC, Nesheim J, Mudd PN Jr. Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder in the USA. Pharmacoeconomics. 2022 Oct;40(10):979-988. doi: 10.1007/s40273-022-01163-5. Epub 2022 Jul 26. PMID: 35881325; PMCID: PMC9522665.