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December 17, 2021updated 11 Mar 2022 7:40am

Major unmet needs in overactive bladder unlikely to be addressed in the near future

GlobalData expects there will still be a considerable level of unmet need remaining in the overactive bladder segment by 2030.

By GlobalData Healthcare

Unmet needs within the overactive bladder (OAB) market are significant and largely expected to persist throughout the next decade, according to GlobalData’s recent Overactive Bladder: Global Drug Forecast and Market Analysis to 2030 report.

OAB is a symptom complex characterised by urinary urgency, with or without incontinence. It is a highly prevalent condition that affects around 335 million adults across the eight major markets covered in the report, namely the US, France, Germany, Italy, Spain, the UK, Japan and China. Due to remarkably low diagnosis and treatment rates, however, only a small minority of this population is currently receiving pharmacotherapy.

There is much misinformation and stigma surrounding OAB, which often deters patients from seeking medical help and limits the treatment pool. This may be compounded by a lack of knowledge of OAB and the options available to treat this condition among general practitioners. In addition, the drug therapies commonly used to treat OAB, including antimuscarinics such as Astellas’ Vesicare (solifenacin succinate) and beta 3 adrenergic receptor agonists such as Astellas’ Myrbetriq (mirabegron), have considerable limitations in terms of their safety and efficacy profiles. In particular, antimuscarinics have come under increased scrutiny in recent years due to accumulating evidence that they can increase the risk of cognitive impairments and dementia.

Dissatisfaction with current therapies also leads to poor persistence and adherence to drug treatment, as tolerability is often deemed insufficient to justify the limited efficacy benefits. Key opinion leaders interviewed by GlobalData emphasised that the majority of patients treated with these therapies do not remain on long-term treatment.

Despite the clear need for novel drug therapies with improved safety and efficacy profiles, the late-stage pipeline is scarce, with no products in Phase III development or the pre-registration stage of development. This is indicative of a period of stagnation over the next few years, with little opportunity for addressing the unmet needs that constrain the market. Several innovative products have, however, reached Phase II development, including Urovant Sciences’ gene therapy URO-902, which is in development for the US market, and Bayer’s P2X purinoceptor 3 (P2RX3) antagonist eliapixant, which is in development for the global market. As these pipeline candidates employ novel mechanisms of action, they have the potential to address aspects of OAB pathophysiology that are not targeted by any currently available therapies.

Despite this, clinical data relating to these therapies is limited, and much uncertainty remains regarding their likelihood of regulatory approval, future impacts on the market in the event of approval, and potential to address unmet needs. Due to the limitations of the late-stage pipeline, GlobalData expects that there will still be a considerable level of unmet need remaining in OAB by 2030, providing ample opportunities for new players to enter the market.

Figure 1 outlines the major unmet needs and opportunities in OAB, along with current and future levels of attainment.

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