Untapped potential within the overactive bladder (OAB) market remains considerable due to under-diagnosis and under-treatment of this highly prevalent condition, according to GlobalData, a leading data and analytics company.

Key opinion leaders (KOLs) interviewed by GlobalData verified that only a minority of patients with OAB, a symptom complex characterized by urinary urgency, with or without incontinence, receive a formal diagnosis. This reflects factors such as insufficient awareness and understanding of OAB among both general practitioners and patients.

Diagnosed patients have several pharmaceutical therapies available to them, including anticholinergics, such as Vesicare (solifenacin succinate), and beta 3 adrenergic receptor agonists, such as Myrbetriq (mirabegron). However, KOLs affirmed that long-term adherence to OAB medication is poor, as efficacy is limited and patients are often unwilling to accept the side effects associated with these drugs. For example, anticholinergics, which represent first-line pharmacotherapies, are associated with adverse effects such as dry mouth, constipation, as well as anticholinergic-induced adverse cognitive effects.

Fiona Chisholm, Pharma Analyst at GlobalData, comments: “Coupled with the low diagnosis rates, the limitations of current therapies mean that the treatment pool is small, with most patients discontinuing treatment in the long-term. There is a clear need for alternative therapies with novel mechanisms of action and improved safety and efficacy profiles.”

The established drug classes continue to dominate the R&D landscape. According to GlobalData’s clinical trial database, among 115 OAB clinical trials initiated over the past five years, 91 investigated established drug classes such as anticholinergics*. Additionally, among 10 strategic alliances that took place over the same time period, eight related to established drug classes.

Chisholm adds: “There is a trend for pharma companies to invest most significantly in established drug classes, but such R&D strategies are unlikely to lead to the development of therapies capable of transforming the landscape by significantly increasing treatment rates or improving patient quality of life. Unlocking the potential of this market will likely require more innovative approaches.

“However, there are some drugs with novel mechanisms of action under investigation in OAB trials. One such candidate is Urovant’s Sciences’ URO-902, a gene therapy currently in Phase II development in the US. In Phase I trials, URO-902 demonstrated statistically significant improvements in OAB symptoms compared to placebo. Bayer’s eliapixant, a P2X purinoceptor 3 (P2RX3) antagonist, represents another notable contender. The drug is being investigated in a Phase II trial for OAB-wet patients specifically (patients with urge incontinence), which has a projected completion date of Q1 2022. Nonetheless, due to the high prevalence and level of unmet need, considerable space remains for additional innovative therapies that can capitalize on gaps within the OAB market landscape.”

*Includes Phase I–III clinical trials initiated between June 16, 2016, and June 15, 2021, including ongoing, completed, terminated, and withdrawn trials, sponsored by pharma companies, government bodies, and institutions such as universities, hospitals, and not-for-profit institutes.