The NCFB market is entering a new phase as Insmed’s BRINSUPRI has achieved a major regulatory breakthrough, securing FDA approval as the first therapy and the first-ever DPP1 inhibitor.
DelveInsight’s Non-cystic Fibrosis Bronchiectasis Market Report 2034 includes a comprehensive understanding of current treatment practices, emerging non-cystic fibrosis bronchiectasis drugs, market share of individual therapies, and current and forecasted non-cystic fibrosis bronchiectasis market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Non-cystic Fibrosis Bronchiectasis Market Summary
- The total NCFB market size across major regions—the US, EU4, the UK, and Japan—reached approximately USD 1.5 billion in 2024. In the US, the NCFB market is projected to expand at a CAGR of 11.7% over 2020–2034, maintaining its position as the largest of the major markets.
- Around 1 million diagnosed prevalent NCFB cases across the 7MM in 2024, with numbers expected to rise steadily from 2025 to 2034.
- Several leading companies, including Zambon, Renovion, Haisco Pharmaceutical Group, Chiesi Farmaceutici, Armata Pharmaceuticals, Verona Pharma, Sanofi, Regeneron, Boehringer Ingelheim, CSL, Fosun Pharma, Expedition Therapeutics, Melodia Therapeutics, and Alivexis, are developing innovative therapies targeting NCFB.
- Prominent NCFB drugs currently in clinical development include Inhaled Colistimethate Sodium (CMS I-neb), ARINA-1 (RVN-301), HSK31858, AP-PA02, Ensifentrine (Nebulized), Itepekimab, BI 1291583, CHF 6333, CSL787, XH-S004, and MDI-0151. These emerging treatments are expected to enter the market over the forecast period and potentially reshape the therapeutic landscape for NCFB.
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What is Non-cystic Fibrosis Bronchiectasis?
Non-cystic fibrosis bronchiectasis is a chronic respiratory disorder characterized by irreversible dilation of the airways, persistent mucus buildup, and impaired bacterial clearance, leading to recurring infections and gradual lung deterioration. Individuals typically experience chronic coughing and repeated respiratory infections, while comorbidities like anxiety, depression, and fatigue further impact their overall well-being. The condition frequently necessitates prolonged hospitalizations and regular outpatient care, placing a significant strain on healthcare resources.
Non-cystic Fibrosis Bronchiectasis Epidemiology Segmentation
By 2034, the prevalence of non-cystic fibrosis bronchiectasis is expected to rise significantly, driven by improved diagnostic imaging, heightened disease awareness, and aging populations worldwide. The growing burden of chronic respiratory conditions such as COPD and asthma will also contribute to a higher incidence. The NCFB market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Diagnosed Prevalent Cases of NCFB
- Gender-specific Diagnosed Prevalent Cases of NCFB
- Severity-specific Diagnosed Prevalent Cases of NCFB
- Etiology-specific Diagnosed Prevalent Cases of NCFB
- Microbiology of NCFB Patients
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NCFB Market Analysis
Bronchodilators have so far dominated the NCFB market; however, Insmed’s BRINSUPRI approval has reshaped the landscape by introducing the first DPP1 inhibitor in this space. Its entry has spurred other major NCFB players, such as Boehringer Ingelheim, Fosun Pharma, Expedition Therapeutics, Haisco Pharmaceutical Group, Melodia Therapeutics, and Alivexis, to accelerate development of their own DPP1 inhibitor programs.
As the first DPP1 inhibitor available for respiratory care, BRINSUPRI’s unique mechanism and first-mover advantage could make it the standard of care for NCFB. Insmed is expected to commercialize the therapy independently and has already begun preparing for launch. Recently, the company raised roughly USD 750 million through an offering of 7.81 million shares at USD 96 each to fuel commercial readiness. Following FDA approval, Insmed’s stock climbed about 15%, including an 8% jump on the day of the announcement.
Insmed has also submitted BRINSUPRI for review to both the EMA and MHRA, with European and UK launches anticipated in 2026—underscoring a strong global commercialization push. Early regulatory momentum and the advantage of being first to market are projected to support rapid adoption and substantial revenue growth, potentially making BRINSUPRI a multi-billion-dollar asset. With no other approved therapies in the category, Insmed is expected to retain significant pricing leverage. The company is also exploring BRINSUPRI’s use in various conditions, including hidradenitis suppurativa and chronic rhinosinusitis without nasal polyps, both of which are currently in mid-stage trials.
Overall, BRINSUPRI’s outlook is highly favorable, as it breaks new ground in an area of significant unmet need. DelveInsight projects that peak global sales could exceed USD 5 billion, positioning the drug as a significant blockbuster opportunity.
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Key Factors Driving the Non-Cystic Fibrosis Bronchiectasis Market
Launch of Insmed’s BRINSUPRI
Insmed’s BRINSUPRI (brensocatib) has reached a major regulatory milestone as the first FDA-approved DPP1 inhibitor and the first therapy authorized explicitly for non-cystic fibrosis bronchiectasis (NCFB). As the only treatment developed exclusively for this disease, its approval represents a significant scientific step forward, addressing a therapeutic area with long-standing unmet needs. By introducing a novel mechanism to reduce underlying inflammation, BRINSUPRI provides patients with a much-needed new treatment option.
Expanding Diagnosed NCFB Population
Recent prevalence data and meta-analyses indicate that bronchiectasis is more common than previously believed, with incidence rising sharply with age. Advances in imaging and clinical awareness are increasing diagnosis rates, broadening the potential NCFB patient base. In 2024, an estimated 390,000 people in the US were diagnosed with NCFB, with millions more affected globally. This number is projected to surpass 470,000 by 2034.
Competitive Landscape in NCFB Market
BRINSUPRI’s entry into the market has intensified competition among companies developing therapies for NCFB. Several leading players, including Boehringer Ingelheim (Verducatib/BI 1291583), Fosun Pharma/Expedition Therapeutics (XH-S004), Haisco Pharmaceutical Group/Chiesi (HSK31858), and Melodia Therapeutics/Alivexis (MDI-0151, currently in preclinical development), are progressing their DPP1 inhibitor pipelines in an effort to reshape the therapeutic landscape.
Other Therapeutic Classes in NCFB Clinical Development
Beyond DPP1 inhibitors such as BRINSUPRI, ongoing research is evaluating multiple therapeutic classes for NCFB. These include cell membrane modulators (CMS I-neb; Zambon), immunomodulators (ARINA-1; Renovion), and other emerging approaches aimed at addressing the disease’s complex inflammatory pathways.
Non-cystic Fibrosis Bronchiectasis Competitive Landscape
Leading NCFB developers, including Boehringer Ingelheim (Verducatib; BI 1291583), Fosun Pharma/Expedition Therapeutics (XH-S004), Haisco Pharmaceutical Group (HSK31858), and Melodia Therapeutics/Alivexis (MDI-0151), continue to advance DPP1 inhibitor programs for NCFB, COPD, and related respiratory conditions. Alongside DPP1 candidates such as BRINSUPRI, researchers are also investigating alternative therapeutic approaches, including inhaled cell-membrane–targeting agents (CMS I-neb; Zambon) and immunomodulators (ARINA-1; Renovion).
Zambon’s CMS I-neb is positioned as a potential first-in-class inhaled treatment for adults with NCFB infected with Pseudomonas aeruginosa. Colistimethate sodium targets aerobic Gram-negative bacteria, including resistant strains, by disrupting cell membranes, aiming to reduce and prevent pulmonary exacerbations. The therapy has received Breakthrough Therapy, QIDP, and Fast Track designations from the US FDA, underscoring its promise in addressing a major unmet need. In the PROMIS-I Phase III trial, CMS I-neb significantly lowered annual exacerbation rates in NCFB patients. Although PROMIS-II was halted early due to COVID-19 and loss of equipoise following PROMIS-I’s strong results, a pre-pandemic sub-analysis aligned with PROMIS-I outcomes. Zambon now intends to work closely with regulators to expedite approval. The PROMIS data were published in The Lancet Respiratory Medicine in September 2024 and presented at the 6th World Bronchiectasis Conference.
Renovion’s ARINA-1 (RVN-301) is an at-home nebulized therapy designed to improve lung function by clearing mucus, reducing inflammation, and lowering the bacterial burden. In April 2024, the company reported positive topline Phase II CLIMB results in NCFB, supporting continued development. Renovion plans to evaluate the data further, engage with regulators, and advance to Phase III testing.
Verducatib (BI 1291583), Boehringer Ingelheim’s DPP1/CatC inhibitor, aims to improve symptoms and quality of life in bronchiectasis by reducing neutrophil-driven inflammation, a core driver of disease progression. Its mechanism may help preserve airway structure, enhance pathogen clearance, rebalance mucus, and minimize chronic inflammatory damage. Boehringer is currently running AIRTIVITY (NCT06872892), a Phase III, global, randomized, double-blind, placebo-controlled trial assessing verducatib’s efficacy, safety, and tolerability over 12–18 months, with annualized pulmonary exacerbation rates through week 76 as the primary endpoint.
Collectively, these emerging therapies are expected to redefine the NCFB treatment landscape. As they advance toward approval, they have the potential to set new standards of care, stimulate innovation, and significantly expand opportunities within the NCFB market over the next several years.
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Recent Developments in the Non-cystic Fibrosis Bronchiectasis Market
- In August 2025, the FDA approved Insmed’s BRINSUPRI (brensocatib), the first oral therapy for non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older.
- In June 2025, Insmed Inc. announced that it intends to launch a $650 million underwritten public offering of its common stock, with underwriters receiving a 30-day option to buy up to an additional $97.5 million in shares. All shares will be issued and sold by the company. The offering’s final terms, size, and completion will depend on market conditions and other factors, and there is no assurance it will proceed.
- In May 2025, Insmed shared 11 new abstracts at the ATS 2025 International Conference, including three prespecified subgroup analyses from the Phase III ASPEN study investigating brensocatib in non-cystic fibrosis bronchiectasis (NCFB).
| Non-cystic Fibrosis Bronchiectasis Report Metrics | Details |
| Study Period | 2020–2034 |
| Non-cystic Fibrosis Bronchiectasis Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Non-cystic Fibrosis Bronchiectasis Market Size in 2024 | USD 1.5 Billion |
| Key Non-cystic Fibrosis Bronchiectasis Companies | Zambon, Renovion, Haisco Pharmaceutical Group, Chiesi Farmaceutici S.p.A, Armata Pharmaceuticals, Verona Pharma, Sanofi, Regeneron Pharmaceuticals, Boehringer Ingelheim, Chiesi Farmaceutici S.p.A., CSL, Fosun Pharma, Expedition Therapeutics, Melodia Therapeutics, Alivexis, Insmed, AstraZeneca, and others |
| Key Non-cystic Fibrosis Bronchiectasis Therapies in Clinical Trials | Inhaled Colistimethate Sodium (CMS I-neb), ARINA-1 (RVN-301), HSK31858, AP-PA02, Ensifentrine (Nebulizer), Itepekimab, BI 1291583, CHF 6333, CSL787, XH-S004, MDI-0151, BRINSUPRI, and others |
Scope of the Non-cystic Fibrosis Bronchiectasis Market Report
- Non-cystic Fibrosis Bronchiectasis Therapeutic Assessment: Non-cystic Fibrosis Bronchiectasis current marketed and emerging therapies
- Non-cystic Fibrosis Bronchiectasis Market Dynamics: Conjoint Analysis of Emerging Non-cystic Fibrosis Bronchiectasis Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- NCFB Market Unmet Needs, KOL’s views, Analyst’s views, Non-cystic Fibrosis Bronchiectasis Market Access and Reimbursement
Discover more about NCFB drugs in development @ Non-cystic Fibrosis Bronchiectasis Clinical Trials
Table of Contents
| 1 | Key Insights on NCFB Market |
| 2 | Report Introduction |
| 3 | Non-cystic Fibrosis Bronchiectasis Market Overview at a Glance |
| 3.1 | Non-cystic Fibrosis Bronchiectasis Market Share (%) Distribution in 2024 |
| 3.2 | Non-cystic Fibrosis Bronchiectasis Market Share (%) Distribution in 2034 |
| 4 | Epidemiology and Non-cystic Fibrosis Bronchiectasis Market Forecast Methodology |
| 5 | Executive Summary |
| 6 | Key Events |
| 7 | Non-cystic Fibrosis Bronchiectasis Disease Background and Overview |
| 7.1 | Introduction |
| 7.2 | Etiology and Manifestations |
| 7.3 | Non-cystic Fibrosis Bronchiectasis Symptoms |
| 7.4 | Non-cystic Fibrosis Bronchiectasis Pathophysiology |
| 7.5 | Non-cystic Fibrosis Bronchiectasis Diagnosis |
| 7.5.1 | Non-cystic Fibrosis Bronchiectasis Diagnostic Algorithm |
| 7.5.2 | Non-cystic Fibrosis Bronchiectasis Diagnostic Guidelines |
| 7.6 | Non-cystic Fibrosis Bronchiectasis Prognosis |
| 7.7 | Non-cystic Fibrosis Bronchiectasis Treatment and Management |
| 7.7.1 | Non-cystic Fibrosis Bronchiectasis Treatment Guidelines |
| 8 | Non-cystic Fibrosis Bronchiectasis Patient Journey |
| 9 | Non-cystic Fibrosis Bronchiectasis Epidemiology and Patient Population |
| 9.1 | Key Findings |
| 9.2 | Assumption and Rationale: The 7MM |
| 9.2.1 | Total Diagnosed Prevalent Cases of NCFB |
| 9.2.2 | Gender-specific Diagnosed Prevalent Cases of NCFB |
| 9.2.3 | Severity-specific Diagnosed Prevalent Cases of NCFB |
| 9.2.4 | Etiology-specific Diagnosed Prevalent Cases of NCFB |
| 9.2.5 | Microbiology of NCFB Patients |
| 9.3 | Total Diagnosed Prevalent Cases of NCFB in the 7MM |
| 9.4 | The US |
| 9.5 | EU4 and the UK |
| 9.6 | Japan |
| 10 | Non-cystic Fibrosis Bronchiectasis Marketed Drugs |
| 10.1 | Key Cross Competition |
| 10.2 | BRINSUPRI (Brensocatib): Insmed/AstraZeneca |
| 10.2.1 | Drug Description |
| 10.2.2 | Other Developmental Activities |
| 10.2.3 | Clinical Trials Information |
| 10.2.4 | Safety and Efficacy |
| 10.2.5 | Analysts’ View |
| 11 | Non-cystic Fibrosis Bronchiectasis Emerging Drugs |
| 11.1 | Key Cross Competition |
| 11.2 | Inhaled Colistimethate Sodium (CMS I-neb): Zambon |
| 11.2.1 | Drug Description |
| 11.2.2 | Other Developmental Activities |
| 11.2.3 | Clinical Trials Information |
| 11.2.4 | Safety and Efficacy |
| 11.2.5 | Analysts’ View |
| 11.4 | ARINA-1 (RVN-301): Renovion |
| 11.5 | HSK31858: Haisco Pharmaceutical Group/Chiesi Farmaceutici S.p.A |
| 11.6 | AP-PA02: Armata Pharmaceuticals |
| 11.7 | Ensifentrine (Nebulizer): Verona Pharma |
| 11.8 | Itepekimab: Sanofi/Regeneron Pharmaceuticals |
| 11.9 | BI 1291583: Boehringer Ingelheim |
| 11.10 | CHF 6333: Chiesi Farmaceutici S.p.A. |
| 11.11 | CSL787: CSL |
| To be continued in the final report. | |
| 12 | Non-cystic Fibrosis Bronchiectasis: The 7MM Analysis |
| 12.1 | Key Findings |
| 12.2 | Key Non-cystic Fibrosis Bronchiectasis Market Forecast Assumptions |
| 12.2.1 | Cost Assumptions and Rebates |
| 12.2.2 | Pricing Trends |
| 12.2.3 | Analogue Assessment |
| 12.2.4 | Launch Year and NCFB Therapy Uptake |
| 12.3 | Non-cystic Fibrosis Bronchiectasis Market Outlook |
| 12.4 | Attribute Analysis |
| 12.5 | Total Non-cystic Fibrosis Bronchiectasis Market Size in the 7MM |
| 12.6 | Total Non-cystic Fibrosis Bronchiectasis Market Size by Therapies in the 7MM |
| 12.7 | Non-cystic Fibrosis Bronchiectasis Market Size in the US |
| 12.7.1 | Total Non-cystic Fibrosis Bronchiectasis Market Size in the US |
| 12.7.2 | The Non-cystic Fibrosis Bronchiectasis Market Size by Therapies in the US |
| 12.8 | Non-cystic Fibrosis Bronchiectasis Market Size in EU4 and the UK |
| 12.9 | Non-cystic Fibrosis Bronchiectasis Market Size in Japan |
| 13 | Key Opinion Leaders’ Views |
| 14 | Non-cystic Fibrosis Bronchiectasis Market SWOT Analysis |
| 15 | Non-cystic Fibrosis Bronchiectasis Market Unmet Needs |
| 16 | Non-cystic Fibrosis Bronchiectasis Market Access and Reimbursement |
| 16.1 | The US |
| 16.2 | In EU4 and the UK |
| 16.3 | Japan |
| 17 | Acronyms and Abbreviations |
| 18 | Bibliography |
| 19 | Non-cystic Fibrosis Bronchiectasis Market Report Methodology |
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