Underactive Bladder - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The majority of Underactive Bladder (UAB) patients either remain undiagnosed or get misdiagnosed leading to the progression of the disease to severe conditions.
• In 2023, the market size of UAB was highest in the US among the 7MM accounting for approximately USD 359 million that is further expected to increase by 2034.
• While the larger market is covered by Catheterization, the available pharmacotherapy treatment options for UAB accounted for the total market of around USD 117 million in 2023, in the US.
• Despite of high prevalence with total diagnosed cases of around 1.79 million in 2023 in the 7MM, the treatment market of UAB lacks approved therapy specific to UAB treatment.

Emerging therapies have the potential to create a significant positive shift in the Underactive Bladder (UAB) market size.

This report delivers an in-depth understanding of the Underactive Bladder (UAB), historical and forecasted epidemiology as well as the Underactive Bladder (UAB) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Underactive Bladder (UAB) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM UAB market size from 2020 to 2034. The report also covers current UAB treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Underactive Bladder (UAB) Disease Understanding and Treatment Algorithm

Underactive Bladder (UAB) Overview

Underactive bladder (UAB) is a condition marked by diminished bladder contractions, leading to incomplete emptying. Its causes range from nerve damage and diabetes to aging and specific medications. Risk factors include neurological disorders, pelvic surgeries, and chronic diseases. The burden of UAB is profound, encompassing recurrent urinary tract infections, potential kidney damage, and significantly diminished quality of life due to urinary retention and frequent catheterization. Early diagnosis and targeted management are crucial to alleviating these impacts and improving patient outcomes.

Underactive Bladder (UAB) Diagnosis

Diagnosing UAB involves urodynamic testing, bladder scans, and patient history evaluations to assess bladder function, identify incomplete emptying, and determine underlying causes.

Accuracy in diagnosis of UAB remains a significant challenge within the clinical setting, leading to widespread misdiagnosis or underdiagnoses. UAB is often erroneously interpreted as BOO or overactive bladder OAB due to overlapping symptoms. This diagnostic ambiguity significantly hampers the identification and appropriate management of UAB, resulting in inadequate treatment for many patients.

The overlap in clinical presentation - such as urinary frequency, urgency, and hesitancy - between UAB, BOO, and OAB contributes to this confusion. Healthcare providers may mistakenly attribute symptoms to more commonly diagnosed conditions like BOO or OAB, overlooking the possibility of UAB. This misinterpretation is compounded by the lack of standardized diagnostic criteria and tools specifically tailored for UAB, further exacerbating the issue.

Underactive Bladder (UAB) Treatment

Treatment of UAB includes behavioral therapies, pelvic floor muscle exercises, medications to enhance bladder contractions, and, in severe cases, intermittent catheterization or sacral nerve stimulation to improve bladder emptying and alleviate symptoms.

The therapeutic market for UAB faces significant challenges, characterized by a scarcity of effective treatment options and considerable challenges in managing this condition. UAB, which is particularly prevalent among the elderly, remains underdiagnosed and poorly addressed, underscoring a substantial medical necessity.

Currently, there is no approved therapy for UAB, the available supportive care treatments are limited, and very few have demonstrated validated outcomes. This is in stark contrast to the advancements seen in therapies for OAB, highlighting a critical gap in effective treatment options for UAB. UAB patients frequently experience feelings of helplessness due to difficulties in voiding or inadequate bladder emptying, emphasizing the urgent need for more effective therapies.

Underactive Bladder (UAB) Epidemiology

As the market is derived using the patient-based model, the Underactive Bladder (UAB) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of LUTS - Moderate to Severe, Total Diagnosed Prevalent Cases of Underactive Bladder (UAB), Gender-specific Diagnosed Prevalent Cases of Underactive Bladder (UAB), Classification-specific Diagnosed Prevalent Cases of Underactive Bladder (UAB), and Etiology-specific Diagnosed Prevalent Cases of Underactive Bladder (UAB) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. As per the analyst's estimations, the total prevalent cases of LUTS - Moderate to Severe, in the 7MM were approximately 81.73 million cases in 2023 and are projected to increase during the forecast period. The anticipated rise in prevalent cases of moderate to severe LUTS in the US is attributed to an aging population, increased prevalence of obesity, and sedentary lifestyles.

• The overall count of individuals diagnosed with UAB in the United States was approximately 642 thousand in 2023. Given the increasing prevalence of risk factors, increased awareness and diagnosis, higher occurrence of chronic conditions, improved healthcare access, and enhanced data collection for UAB in the United States population, the diagnosed prevalence is estimated to increase during the forecast period (2024-2034).
• Among the 7MM, EU4 and the UK accounted for nearly 51% diagnosed prevalent cases of Underactive Bladder (UAB) in 2023.
• Among EU4 and the UK, Germany had the highest diagnosed prevalent population of UAB, with nearly 257 thousand cases, followed by Italy and the UK in 2023. On the other hand, France had the lowest diagnosed prevalent population in EU4 and the UK in 2023.
• In Japan, there were around 240 thousand diagnosed prevalent cases of UAB in 2022. These cases are expected to increase at a significant CAGR.
• Gender-specific diagnosed prevalent cases of Underactive Bladder (UAB) showed that males were more affected by UAB than females in the 7MM in 2023.
• Men are more frequently affected by UAB due to a higher prevalence of prostate-related issues, such as benign prostatic hyperplasia, which can obstruct bladder outflow and impair bladder muscle function.
• Etiology-specific diagnosed prevalent cases of Underactive Bladder (UAB) were distributed in Idiopathic, Neurogenic, Myogenic, and Others.
• As per the assessments done by the analyst's analysts, diagnosed prevalent cases of neurogenic sub-type are more than the other etiology-specific diagnosed cases of UAB. In 2023, there were 1.07 million cases of neurogenic, 366 thousand cases of idiopathic, 233 thousand cases of others, and 119 thousand cases of myogenic in the 7MM.
• As per the analyst's model, the classification-specific diagnosed prevalent UAB cases were categorized into Detrusor Underactivity, Detrusor Hyperactivity with impaired contractility (DHIC), Acontractile Detrusor (AcD). In 2023, there were highest cases of Detrusor Underactivity (~353 thousand), followed by AcD (~161 thousand) in the US.

Underactive Bladder (UAB) Drug Chapters

The drug chapter segment of the Underactive Bladder (UAB) report encloses a detailed analysis of Underactive Bladder (UAB) marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the UAB clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

TAC-302: Taiho Pharmaceutical

TAC-302, developed by Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an orally administered small molecule under clinical development for treating detrusor underactivity with OAB. It stimulates neurite outgrowth in cultured peripheral neurons, showing beneficial effects on bladder denervation and storage/voiding dysfunctions. Currently, in Phase II trials, TAC-302 has demonstrated significant improvement in bladder contractility index (BCI) in males and bladder voiding efficiency (BVE) in both sexes, though efficacy for OAB remains inconclusive. Despite promising preclinical and Phase II results, further studies are required to establish its therapeutic potential fully.

Drug Class Insights

The existing Underactive Bladder (UAB) treatment mainly include different off-label drugs targeting the symptoms of UAB.

In the realm of pharmacological interventions for Underactive Bladder (UAB), therapeutic options remain scant and heterogeneous. While parasympathomimetics and alpha-1 adrenoceptor antagonists offer potential, their efficacy fluctuates, often accompanied by notable adverse effects. Cholinesterase inhibitors also emerge as a preferred choice, yet challenges persist in achieving consistent outcomes, urging further exploration and refinement of treatment modalities.

Moreover, the upcoming treatment landscape is poised to see further expansion after the emergence of emerging drug TAC-302, which is an orally administered small molecule, currently advancing through clinical development with the ambitious aim of addressing detrusor underactivity coupled with Overactive Bladder (OAB).

Underactive Bladder (UAB) Market Outlook

The current market outlook for underactive bladder (UAB) treatments reveals a complex landscape with a significant need for advanced therapeutic options. UAB, characterized by weak or insufficient bladder contractions, leads to slow or incomplete emptying. Effective management necessitates thorough neurologic and urodynamic evaluations, with primary goals including the prevention of upper urinary tract injury, avoidance of bladder overdistension, and reduction of residual urine.

Lifestyle modifications and conservative management form the cornerstone of initial UAB treatment. Techniques such as scheduled voiding and double voiding aim to improve bladder emptying efficiency. Intermittent self-catheterization (ISC) remains the gold standard for ensuring complete bladder emptying, although it requires extensive patient training and support due to its complexity and potential discomfort. Alpha-blockers like tamsulosin and doxazosin are commonly prescribed to reduce urethral resistance, facilitating easier bladder emptying.

Pharmacological treatments for UAB are currently limited, with no drugs universally validated for the condition. Parasympathomimetics, such as bethanechol, are intended to stimulate bladder contractions, but they often show inconsistent efficacy and can cause serious side effects like bradycardia and bronchospasm. Alpha-1 adrenoceptor antagonists, including urapidil, indoramin, and doxazosin, are sometimes used off-label to reduce urethral resistance. Cholinesterase inhibitors, such as distigmine, work by increasing acetylcholine levels, which may enhance bladder contractions and are the choice of many physicians. Muscarinic receptor agonists like bethanechol have produced mixed results in clinical trials.

Advanced and emerging therapies offer promising avenues for UAB management. Neuromodulation techniques, such as sacral neuromodulation, are being explored to improve bladder function by modulating neural pathways. Botulinum toxin injections, used to relax the external sphincter in cases of functional bladder outlet obstruction, can reduce resistance to urine flow. Few new drugs are being developed and tested as potential treatments for UAB; the emerging drugs include TAC-302 (in Japan), and others.

• The total market size of Underactive Bladder (UAB) in the 7MM was approximately USD 976 million in 2023 and is projected to increase during the forecast period (2023-2034)
• The market size in the 7MM will increase at a constant CAGR due to increasing awareness of the disease, better diagnosis, and the launch of the emerging target therapy for UAB .
• Among EU4 countries, Germany with about USD 153 million accounted for the maximum market size in 2023 while France occupied the bottom of the ladder with around USD 73 million in 2023.
• Japan accounted for 5% of the total market in the 7MM, with USD 49 million in 2023.

Underactive Bladder (UAB) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2020-2034. For example, for TAC-302, we expect the drug uptake to be medium with a probability-adjusted peak share of around 10%, and years to the peak is expected to be 7 years from the year of launch.

Underactive Bladder (UAB) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Underactive Bladder (UAB) emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on UAB evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, include Massachusetts General Hospital, Boston; Department of Urologic Surgery, Nashville, Tennessee, US; Department of Child and Adolescent Psychiatry, Saarland University Hospital, Homburg, Germany; Southmead Hospital, United Kingdom; Department of Urology, University Hospital of Rennes, Rennes, France; Department of Urology, Sakurajyuji Hospital, Japan, and others.

The analysts connected with 50+ KOLs to gather insights, however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the University of Palermo and CNR Institute of Biomedicine and Molecular Immunology (IBIM), Division of Behavioral Sleep Medicine, Iwate Medical University School of Medicine, etc. were contacted. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Underactive Bladder (UAB) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis, and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis is done to analyze multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement is a crucial point for any drug after its approval. Many drugs or therapies are not properly recognized by the reimbursement body and may fail to get reimbursed or their reimbursement process gets delayed. CPAP being the first-line therapy for UAB is currently included in the list of products and services qualifying for reimbursements and funded under the indications established because of the clinical symptoms reported (with the exclusion of any other sleep disorder) and an AHI score that must be =15.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Underactive Bladder (UAB), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression along with treatment guidelines
• Additionally, an all-inclusive account of both the current and emerging therapies along with the elaborative profiles of late-stage and prominent therapies will have an impact on the current treatment landscape
• A detailed review of the Underactive Bladder (UAB) market; historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preference that help in shaping and driving the 7MM Underactive Bladder (UAB) market

Underactive Bladder (UAB) Report Insights

• Patient Population
• Therapeutic Approaches
• Underactive Bladder (UAB) Pipeline Analysis
• Underactive Bladder (UAB) Market Size and Trends
• Existing and future Market Opportunity

Underactive Bladder (UAB) Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Underactive Bladder (UAB) Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Underactive Bladder (UAB) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights:

• What was the Underactive Bladder (UAB) total market size, the market size by therapies, and market share (%) distribution in 2020, and how it would all look in 2034? What are the contributing factors for this growth?
• What are the unmet needs are associated with the current treatment market of UAB ?
• How is TAC-302 going to compete with the first line of therapy for UAB after approval?
• Which drug is going to be the largest contributor in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Underactive Bladder (UAB) ? What will be the growth opportunities across the 7MM concerning the patient population of Underactive Bladder (UAB) ?
• What is the historical and forecasted Underactive Bladder (UAB) patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis? Why is the current year diagnosis rate not high?
• Which severity stage is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Underactive Bladder (UAB) ? What are the current treatment guidelines for the treatment of Underactive Bladder (UAB) in the US and Europe?
• How many companies are developing therapies for the treatment of Underactive Bladder (UAB) ?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Underactive Bladder (UAB) ?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Underactive Bladder (UAB) ?
• What is the cost burden of current therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of Underactive Bladder (UAB) ?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Underactive Bladder (UAB) Market
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Conjoint analysis section to provide visibility around leading classes
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs
• To understand the perspective of Key Opinion Leaders’ around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy