브렌소카팁(Brensocatib) 판매 예측, 시장 규모 분석(2034년)

Key Factors Driving Brensocatib Growth

1. Market Share Gains and New Patient Starts

• Brensocatib is now the first approved therapy for non-cystic fibrosis bronchiectasis (NCFB), positioning it to capture early market share in a disease area that previously had no approved treatments.
• Early uptake indicators and analyst models project strong new-patient starts given high unmet need and the lack of alternatives; Insmed has signaled mid-2025 US launch planning and broader commercial roll-out.
• Insmed's commercial strategy (physician outreach to pulmonology centres, patient support, and specialty distribution) and priority-review regulatory pathing are supporting rapid market entry.

2. Expansion Across Key Indications

• Non-Cystic Fibrosis Bronchiectasis (NCFB): Approved indication and the primary commercial focus - ASPEN Phase III data showed a statistically significant reduction in pulmonary exacerbation rate versus placebo.
• Lung function & symptoms: In ASPEN, brensocatib (25 mg) also slowed FEV1 decline and produced numerical improvements in respiratory quality-of-life measures, supporting clinical benefit beyond exacerbation reduction.
• Potential additional respiratory indications: Insmed is exploring other neutrophil-driven conditions (e.g., chronic rhinosinusitis, hidradenitis suppurativa) in earlier development efforts which could broaden the molecule's utility if trials are positive.

3. Geographic Expansion

• US approval (FDA) makes the US the initial commercial market; Insmed had planned regulatory filings and launches in Europe and Japan following US approval, targeting first-half 2026 for those markets.
• Global trial footprint (ASPEN included sites across many countries) and Insmed's manufacturing/supply planning support a multi-region roll-out; Asia-Pacific and Europe are expected to be key markets contingent on local approvals and payer access.

4. New Indication Approvals (Regulatory status/expectations)

• Brensocatib received FDA approval for NCFB (two doses: 10 mg and 25 mg); this is the first regulatory approval for a DPP-1 inhibitor in bronchiectasis.
• Additional regulatory filings for other indications would require positive trial data; Insmed's development plans include exploring other neutrophil-mediated inflammatory diseases, but those are at earlier stages and not yet approved.

5. Strong Volume Momentum

• The Phase III ASPEN trial (n≈1,721) showed brensocatib reduced annual exacerbation rates vs placebo (rate ratios ~0.79-0.81 depending on dose) and improved time to first exacerbation - results that underpin volume projections and payer discussions.
• Publication of the ASPEN results and subsequent subgroup analyses strengthened the clinical case, generating strong clinician interest and positive market reaction; investor sentiment and forecasts project rapid uptake in the eligible NCFB population.

6. Competitive Differentiation and Market Trends

• First-in-class DPP-1 inhibitor: Brensocatib's mechanism (oral DPP-1 inhibition reducing neutrophil serine protease activation) is mechanistically distinct from existing supportive care and positions it as a targeted anti-inflammatory treatment for neutrophil-driven lung disease.
• Clinical differentiation: ASPEN demonstrated reductions in exacerbation frequency and slower lung-function decline - outcomes payers and clinicians emphasize for chronic lung-disease management, supporting a strong value narrative.
• Market trends enabling uptake: High unmet need in bronchiectasis, growing emphasis on mechanism-based therapies, and reliance on real-world evidence for chronic disease management all support adoption of a first approved therapy in this space.
• Risks & headwinds: Remaining issues include establishing long-term safety (larger/longer post-marketing exposure needed), payer coverage and pricing negotiations (ICER and payers will assess cost-effectiveness), potential monitoring requirements tied to neutrophil biology (e.g., dermatologic/periodontal considerations noted in literature for DPP-1 inhibition), and competition from future agents or alternative treatment strategies.

Brensocatib Recent Developments

• In August 2025, Insmed Incorporated announced that the US Food and Drug Administration (FDA) approved first-in-class BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. BRINSUPRI is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the US an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline.
• In May 2025, Insmed Incorporated presented 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference, which took place in San Francisco, including three prespecified subgroup analyses from the Phase III ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis (NCFBE), signalling the consistency of efficacy and safety outcomes across diverse clinical profiles.
• In February 2025, Insmed Incorporated announced that the US FDA accepted the Company's New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis. In its Day 60 communication to Insmed, the FDA granted Priority Review to the NDA and set a target action date of August 2025, under the Prescription Drug User Fee Act (PDUFA).

"Brensocatib Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Brensocatib for approved indication Non-cystic fibrosis bronchiectasis (NCFBE); as well as potential indications like Chronic Rhinosinusitis Without Nasal Polyps and Hidradenitis Suppurativa in the 7MM. A detailed picture of Brensocatib's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Brensocatib for approved and potential indications. The Brensocatib market report provides insights about Brensocatib's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Brensocatib performance, future market assessments inclusive of the Brensocatib market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Brensocatib sales forecasts, along with factors driving its market.

Brensocatib Drug Summary

BRINSUPRI (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in other neutrophil-mediated diseases. The report provides Brensocatib's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Brensocatib is in the Phase II stage of clinical development for the treatment of patients with Chronic Rhinosinusitis Without Nasal Polyps (NCT06013241) and Hidradenitis Suppurativa (NCT06685835).

Scope of the Brensocatib Market Report

The report provides insights into:

• A comprehensive product overview including the Brensocatib MoA, description, dosage and administration, research and development activities in approved indication Non-cystic fibrosis bronchiectasis (NCFBE); as well as potential indications like Chronic Rhinosinusitis Without Nasal Polyps and Hidradenitis Suppurativa.
• Elaborated details on Brensocatib regulatory milestones and other development activities have been provided in Brensocatib market report.
• The report also highlights Brensocatib's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The Brensocatib market report also covers the patents information, generic entry and impact on cost cut.
• The Brensocatib market report contains current and forecasted Brensocatib sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Brensocatib market report also features the SWOT analysis with analyst views for Brensocatib in approved and potential indications.

Methodology:

The Brensocatib market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Brensocatib Analytical Perspective by DelveInsight

• In-depth Brensocatib Market Assessment

This Brensocatib sales market forecast report provides a detailed market assessment of Brensocatib for approved indication Non-cystic fibrosis bronchiectasis (NCFBE); as well as potential indications like Chronic Rhinosinusitis Without Nasal Polyps and Hidradenitis Suppurativa in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Brensocatib sales data uptil 2034.

• Brensocatib Clinical Assessment

The Brensocatib market report provides the clinical trials information of Brensocatib for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Brensocatib Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Brensocatib Market Potential & Revenue Forecast

• Projected market size for the Brensocatib and its key indications
• Estimated Brensocatib sales potential (Brensocatib peak sales forecasts)
• Brensocatib Pricing strategies and reimbursement landscape

Brensocatib Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Brensocatib Market positioning compared to existing treatments
• Brensocatib Strengths & weaknesses relative to competitors

Brensocatib Regulatory & Commercial Milestones

• Brensocatib Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Brensocatib Clinical Differentiation

• Brensocatib Efficacy & safety advantages over existing drugs
• Brensocatib Unique selling points

Brensocatib Market Report Highlights

• In the coming years, the Brensocatib market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Brensocatib companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Brensocatib's dominance.
• Other emerging products for Non-cystic fibrosis bronchiectasis (NCFBE); Chronic Rhinosinusitis Without Nasal Polyps, and Hidradenitis Suppurativa are expected to give tough market competition to Brensocatib and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Brensocatib in approved and potential indications.
• Analyse Brensocatib cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Brensocatib sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Brensocatib in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Brensocatib? How strong is Brensocatib's clinical and commercial performance?
• What is Brensocatib's clinical trial status in each individual indications such as Non-cystic fibrosis bronchiectasis (NCFBE); as well as potential indications like Chronic Rhinosinusitis Without Nasal Polyps and Hidradenitis Suppurativa and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Brensocatib Manufacturers?
• What are the key designations that have been granted to Brensocatib for approved and potential indications? How are they going to impact Brensocatib's penetration in various geographies?
• What is the current and forecasted Brensocatib market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Brensocatib in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to Brensocatib for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Brensocatib? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Brensocatib Overview in approved indications Non-cystic fibrosis bronchiectasis (NCFBE); as well as potential indications like Chronic Rhinosinusitis Without Nasal Polyps and Hidradenitis Suppurativa

• 2.1. Product Detail
• 2.2. Brensocatib Clinical Development
  • 2.2.1. Brensocatib Clinical studies
  • 2.2.2. Brensocatib Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Brensocatib Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Brensocatib Therapies)

5. Brensocatib Market Assessment

• 5.1. Brensocatib Market Outlook in approved and potential indications
• 5.2. 7MM Analysis
  • 5.2.1. Brensocatib Market Size in the 7MM for approved and potential indications
• 5.3. Country-wise Market Analysis
  • 5.3.1. Brensocatib Market Size in the United States for approved and potential indications
  • 5.3.2. Brensocatib Market Size in Germany for approved and potential indications
  • 5.3.3. Brensocatib Market Size in France for approved and potential indications
  • 5.3.4. Brensocatib Market Size in Italy for approved and potential indications
  • 5.3.5. Brensocatib Market Size in Spain for approved and potential indications
  • 5.3.6. Brensocatib Market Size in the United Kingdom for approved and potential indications
  • 5.3.7. Brensocatib Market Size in Japan for approved and potential indications

6. Brensocatib SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options