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

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

Key Highlights

According to DelveInsight’s estimates, in 2023, there were approximately 1,028,651 diagnosed prevalent cases of Non-Cystic Fibrosis Bronchiectasis (NCFB) in the 7MM. Of these, the US accounted for approximately 37% of the cases, EU4 and the UK countries accounted for around 54%, followed by Japan which represented nearly 9%.

The NCFB market is set for steady growth, with a robust compound annual growth rate (CAGR) anticipated from 2024 to 2034. This expansion in the 7MM is driven by the introduction of innovative therapies such as Brensocatib, and CMS I-neb as well as advances in diagnostic techniques and the rising prevalence of NCFB.

According to DelveInsight’s analysis, the NCFB market in the 7MM was valued at approximately USD 1,455.1 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 14.5%.

A major market barrier for NCFB is the complexity of its diagnosis. Misdiagnosis or delayed diagnosis due to overlapping symptoms with other respiratory conditions limits timely treatment, reducing market penetration of therapies and impacting overall patient management and outcomes.

A critical unmet need in NCFB is the lack of approved, disease-specific therapies. Current treatments primarily focus on symptom management rather than addressing the underlying pathology, creating a significant gap in effective long-term solutions and driving demand for targeted, innovative drug development.

In October 2024, Insmed shared positive late-breaking subgroup data from the Phase III ASPEN study of brensocatib for patients with NCFB at the CHEST 2024 Annual Meeting.

DelveInsight’s “Non-Cystic Fibrosis Bronchiectasis (NCFB) – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of NCFB, historical and forecasted epidemiology, as well as the NCFB market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The NCFB market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM NCFB market size from 2020 to 2034. The report also covers NCFB treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Non-Cystic Fibrosis Bronchiectasis Understanding and Treatment Algorithm

Non-Cystic Fibrosis Bronchiectasis overview

NCFB is a chronic inflammatory lung condition characterized by irreversible bronchial dilation, resulting in persistent sputum production and compromised bacterial clearance. This dysfunction establishes a detrimental cycle where ineffective pathogen elimination leads to recurrent infections, chronic inflammation, and progressive pulmonary damage. Symptoms commonly include cough, excessive sputum production, and frequent respiratory infections, alongside additional manifestations such as shortness of breath, wheezing, hemoptysis, and chest pain. The severity of these symptoms can vary considerably among individuals, with some experiencing mild, sporadic episodes while others endure daily, debilitating symptoms, often exacerbated by infectious triggers. NCFB is frequently associated with comorbidities like anxiety, depression, and fatigue, which significantly diminish patients’ quality of life and contribute to longer hospital stays and increased outpatient visits. The etiology of NCFB is multifaceted, with a considerable proportion of cases attributed to idiopathic factors, post-infective complications, and associations with conditions such as COPD and asthma, underscoring the complexity of its management.

Non-Cystic Fibrosis Bronchiectasis diagnosis

The diagnosis of NCFB is primarily established through chest computed tomography scans, which provide detailed imaging of bronchial dilation and associated abnormalities. Complementary diagnostic modalities, including chest X-rays, bronchoscopy, lung function tests, blood tests, and sputum cultures, are utilized to identify potential underlying conditions and assess microbial colonization. Given the heterogeneous nature of bronchiectasis and its multifactorial origins, no single diagnostic measure can comprehensively evaluate disease severity or prognosis. To address this complexity, two validated scoring systems—the Bronchiectasis Severity Index (BSI) and the FACED score—are employed to systematically assess disease severity. These tools integrate clinical and radiological parameters, enabling a more nuanced understanding of the condition and informing individualized management strategies.

Further details related to country-based variations are provided in the report…

Non-Cystic Fibrosis Bronchiectasis treatment

The treatment of NCFB is focused on symptom management, slowing the decline in lung function, and preventing exacerbations. Chest physiotherapy is a cornerstone of management due to its effectiveness and minimal side effects, while some patients derive additional benefit from specialized interventions, including regular administration of low-dose macrolides as prophylactic antibiotics. The current treatment regimen encompasses a multifaceted approach, incorporating antibiotics, corticosteroids, bronchodilators, acid suppression medications, active mucolytic agents, and strategies to enhance bronchial hygiene. Elevated neutrophil levels in the airways underscore the potential efficacy of anti-inflammatory therapies, such as corticosteroids and macrolides, in mitigating inflammation. However, the heterogeneity of NCFB necessitates a personalized treatment approach, as existing therapies can be labor-intensive and may induce side effects, contributing to rising resistance to current medications. This complexity emphasizes the critical need for novel drug development to provide more effective and streamlined treatment options tailored to individual patient profiles.

Non-Cystic Fibrosis Bronchiectasis Epidemiology

As the market is derived using a patient-based model, the NCFB epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of NCFB, severity-specific diagnosed prevalent cases of NCFB, gender-specific diagnosed prevalent cases of NCFB, etiology-specific diagnosed prevalent cases of NCFB, and microbiology of NCFB patients in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

According to DelveInsight’s epidemiology model, in the 7MM, the total diagnosed prevalent cases of NCFB were approximately 1,028,651 in 2023. This number is anticipated to rise during the forecast period (2024-2034), driven by increased awareness and screening, along with advancements in diagnostic techniques.

In 2023, the US accounted for the highest number of diagnosed prevalent cases of NCFB, with approximately 380,711 cases, while France accounted for the least, with only 37,576 cases.

Among EU4 and the UK, the UK accounted for the highest number of diagnosed prevalent cases of NCFB, with approximately 224,976 cases in 2023, followed by Spain with approximately 149,236 cases, and Italy with nearly 89,584 cases.

Among the severity-specific diagnosed prevalent cases of NCFB in EU4 and the UK in 2023, there were approximately 235,481 moderate cases, around 163,649 severe cases, and 152,230 mild cases.

Among the gender-specific cases of NCFB in the UK in 2023, there were approximately 130,486 cases for females and around 94,490 cases for males.

In Japan in 2023, the majority of etiology-specific diagnosed prevalent cases of NCFB were attributed to unknown or idiopathic causes, accounting for 32,837 cases.

In 2023, Japan had approximately 96,580 diagnosed prevalent cases of NCFB.

Non-Cystic Fibrosis Bronchiectasis Drug Chapters

Emerging Drugs

Brensocatib: Insmed/AstraZeneca

Brensocatib, an oral small-molecule inhibitor targeting dipeptidyl peptidase 1 (DPP1), is being developed by Insmed for the treatment of bronchiectasis, CRSsNP, and other neutrophil-driven conditions. By inhibiting DPP1, brensocatib aims to reduce inflammation by blocking the activation of neutrophil serine proteases (NSPs), such as neutrophil elastase, during neutrophil formation in the bone marrow. Insmed reported positive topline results from the Phase III ASPEN study of brensocatib in patients with NCFB, leading to plans for a New Drug Application (NDA) submission to the US FDA in late 2024. If approved, brensocatib is expected to launch in the US by mid-2025, followed by launches in Europe and Japan in the first half of 2026. In October 2024, Insmed shared positive late-breaking subgroup data from the Phase III ASPEN study of brensocatib for patients with NCFB at the CHEST 2024 Annual Meeting. Furthermore, the EMA approved a Pediatric Investigational Plan for brensocatib in NCFB patients, and brensocatib has gained access to the PRIME scheme and Breakthrough Therapy Designation for adult NCFB patients.

Inhaled Colistimethate Sodium (CMS I-neb): Zambon

CMS I-neb is an investigational inhaled therapy for adults with NCFB colonized by P. aeruginosa, potentially offering a first-in-class treatment option. It uses colistimethate sodium, a prodrug of colistin, a polymyxin antibiotic targeting aerobic Gram-negative pathogens, including drug-resistant P. aeruginosa. By disrupting the bacterial cell membrane, colistin causes cell death and serves as a last-resort treatment for infections like carbapenem-resistant P. aeruginosa. In September 2024, Zambon released the results of the Phase III PROMIS-I and PROMIS-II studies in The Lancet Respiratory Medicine journal. The Phase III PROMIS-I trial demonstrated a significant reduction in pulmonary exacerbation rates. Although the PROMIS-II trial was terminated early due to the pandemic, pre-pandemic data showed consistency with PROMIS-I outcomes. Zambon is working with regulatory authorities to expedite patient access. The US FDA has granted CMS I-neb Breakthrough Therapy Designation (BTD), as well as QIDP and Fast Track Designation (FTD).

FASENRA (benralizumab): AstraZeneca

FASENRA (benralizumab) is a monoclonal antibody that targets the IL-5 receptor alpha on eosinophils, facilitating the recruitment of natural killer cells to induce apoptosis, resulting in rapid and near-complete depletion of blood and tissue eosinophils in most patients. FASENRA is currently under investigation for treating adult patients with Non-Cystic Fibrosis Bronchiectasis associated with eosinophilic inflammation (NCFB + EI). According to clinicaltrials.gov, FASENRA completed Phase III clinical trials for this indication in April 2024.

Drug Class Insights

The treatment of NCFB involves several drug classes tailored to manage symptoms, reduce exacerbations, and control underlying inflammation. Antibiotics, both oral and inhaled, are essential for managing chronic bacterial colonization, particularly against pathogens like P. aeruginosa. Macrolides, often used for their anti-inflammatory properties, are beneficial in reducing exacerbation frequency. Bronchodilators, including beta-agonists and anticholinergics, help alleviate airway obstruction, while corticosteroids are used to address inflammation, although their role remains limited due to potential side effects. Mucolytic agents improve mucus clearance, and emerging anti-inflammatory agents targeting neutrophilic inflammation, such as DPP1 inhibitors, represent innovative approaches. Together, these drug classes form a comprehensive yet evolving treatment landscape for NCFB, addressing its multifaceted pathophysiology.

Continued in report…

Market Outlook

The market for NCFB is poised for significant growth due to the evolving landscape of pharmacological and non-pharmacological interventions addressing the complex pathophysiology of the disease. Current therapeutic strategies encompass a range of drug classes, including antibiotics, corticosteroids, bronchodilators, and mucolytics, with inhaled antibiotics demonstrating efficacy in managing chronic bacterial infections and reducing exacerbation rates. Emerging therapies, such as Brensocatib, a Dipeptidyl Peptidase 1 (DPP1) inhibitor, and BI 1291583, a cathepsin C inhibitor, target neutrophilic inflammation through distinct mechanisms, thereby offering novel approaches to improve patient outcomes. Additionally, investigational therapies like CMS I-neb and monoclonal antibodies such as FASENRA and Itepekimab present further options by directly targeting specific inflammatory pathways associated with eosinophilic inflammation. The incorporation of non-pharmacological approaches, particularly Airway Clearance Techniques (ACTs), complements pharmacological regimens, enhancing mucus clearance and preventing infection. However, the market faces challenges, including a lack of consensus guidelines and under-researched therapies like mucolytics and hyperosmolar agents, which may hinder optimal patient management.

Nonetheless, ongoing clinical trials and advancements in drug development highlight the potential for innovative treatments to fill existing gaps in NCFB management, ultimately improving the quality of life for patients and reducing the burden on healthcare systems. With a promising pipeline of therapies in various stages of development, the future of NCFB treatment appears increasingly optimistic, underscoring the need for continued research and clinical validation to fully realize these opportunities.

Continued in report…

Key players Insmed, Zambon, AstraZeneca, Renovion, Sanofi, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat NCFB.

The total market size of NCFB in the 7MM was approximately USD 1,455.1 million in 2023 and is projected to increase during the forecast period (2024–2034), with a CAGR of approximately 14.5%.

The total market size of NCFB in the US was approximately USD 664.3 million in 2023, accounting for approximately 46% of the total market revenue for the 7MM.

The total market size of NCFB in EU4 and the UK was calculated to be approximately USD 722.9 million in 2023. Among the EU4 and the UK, the UK accounted for the highest market with approximately USD 295.0 million, followed by Spain with approximately USD 195.7 million in the respective year, and Italy with nearly USD 117.5 million.

The total market size of NCFB in Japan was approximately USD 67.8 million in 2023.

Among the currently used therapies, the majority of the market share was of Bronchodilators, with a revenue of approximately USD 1,010.8 million in 2023 among the 7MM.

Non-Cystic Fibrosis Bronchiectasis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. For example Brensocatib is expected to enter the US market in 2025 and is projected to have a medium-fast uptake during the forecast period.

Further detailed analysis of emerging therapies drug uptake in the report…

Non-Cystic Fibrosis Bronchiectasis Pipeline Development Activities

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

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for NCFB.

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 NCFB evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, San Antonio, Harvard Medical School, Boston, US, The Freeman Hospital, Newcastle upon Tyne, and the Fukujuji Hospital, Tokyo, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or NCFB market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician’s View

As per the KOLs from the US, the prevalence of NCFB is rising, especially among women and the elderly, likely driven by increased physician awareness and the expanded use of CT imaging, the diagnostic gold standard. CT imaging not only facilitates the identification of underlying causes but also provides a precise assessment of the extent and severity of NCFB.

As per the KOLs from the UK, previous severe respiratory infections, allergic bronchopulmonary aspergillosis, impaired ciliary clearance, primary or secondary immunodeficiency, and other illnesses linked with bronchiectasis, such as COPD and severe asthma, are only a few of the predisposing factors that may be found. Despite following the suggestions in the guidelines, 40% of patients cannot determine the cause of their bronchiectasis, and only 13% of those cases result in a change in how the patients are managed.

As per the KOLs from Japan, surgery is most effective for symptomatic bronchiectasis, caused by a localized structural alteration in the airway in otherwise healthy people. The most common causes of airway damage include childhood infections such as TB, measles, pertussis, and post-infectious bronchiectasis.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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 analyzes multiple 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.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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

DelveInsight’s ‘Non-Cystic Fibrosis Bronchiectasis (NCFB) – Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of NCFB.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

Further details will be provided in the report.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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, and a descriptive overview of NCFB explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.

Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.

Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.

A detailed review of the NCFB 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 preferences that help shape and drive the 7MM NCFB market.

Non-Cystic Fibrosis Bronchiectasis report insights

Patient Population

Therapeutic Approaches

NCFB Pipeline Analysis

NCFB Market Size and Trends

Existing and Future Market Opportunity

Non-Cystic Fibrosis Bronchiectasis report key strengths

11 years Forecast

The 7MM Coverage

NCFB Epidemiology Segmentation

Key Cross Competition

Attribute analysis

Drugs Uptake and Key Market Forecast Assumptions

Non-Cystic Fibrosis Bronchiectasis report assessment

Current Treatment Practices

Unmet Needs

Pipeline Product Profiles

Market Attractiveness

Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions

Market Insights

What was the total market size of NCFB, the market size of NCFB by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?

How will Brensocatib affect the treatment paradigm of NCFB?

Which drug is going to be the largest contributor by 2034?

What are the pricing variations among different geographies for marketed therapies?

How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

What are the disease risks, burdens, and unmet needs of NCFB? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to NCFB?

What is the historical and forecasted NCFB patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?

Out of the countries mentioned above, which country would have the highest diagnosed prevalent NCFB population during the forecast period (2024–2034)?

What factors are contributing to the growth of NCFB cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

What are the current options for the treatment of NCFB? What are the current clinical and treatment guidelines for treating NCFB?

How many companies are developing therapies for the treatment of NCFB?

How many emerging therapies are in the mid-stage and late stage of development for treating NCFB?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?

What is the cost burden of current treatment on the patient?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What is the 7MM historical and forecasted market of NCFB?

Reasons to Buy

The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the NCFB 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.

Understand the existing market opportunities in varying geographies and the growth potential over the coming years.

The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Identifying upcoming solid players in the market will help devise strategies to help get 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 for NCFB, barriers to accessibility of approved therapy, and patient assistance programs.

To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.

Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.