Brensocatib Sales Forecast, and Market Size Analysis - 2034
상품코드:1855036
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
Brensocatib의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 확보
브렌소카팁은 현재 비낭포성 섬유화 기관지확장증(NCFB)에 대한 최초의 승인된 치료제로서, 지금까지 승인된 치료제가 없었던 질환 영역에서 조기에 시장 점유율을 확보할 수 있는 위치에 있습니다.
Insmed는 2025년 중반 미국 시장 출시 계획과 더 광범위한 상업적 확장을 시사했습니다.
Insmed의 상업적 전략(호흡기 센터에 대한 의사의 접근, 환자 지원, 특수 유통)과 우선 심사를 통한 규제 흐름이 빠른 시장 진입을 뒷받침하고 있습니다.
2. 주요 적응증 확대
비낭포성섬유증성 기관지확장증(NCFB) : 승인된 적응증이자 주요 상업적 초점인 ASPEN의 임상 3상 데이터에 따르면, 폐 악화율이 위약 대비 통계적으로 유의하게 감소했습니다.
폐 기능 및 증상: ASPEN 임상에서 브렌소카팁(25mg)은 FEV1의 감소를 지연시키고, 호흡기 QOL의 수치적 개선 효과를 나타내어 악화 억제 외의 임상적 유용성을 뒷받침하고 있습니다.
호흡기 적응증 추가 가능성: Insmed는 초기 개발 단계에서 다른 호중구 관련 질환(만성 부비동염, 화농성 땀샘염 등)을 탐색하고 있으며, 임상시험이 잘 진행되면 이 분자의 유용성이 확대될 수 있습니다.
3. 지리적 확장
미국 승인(FDA)을 통해 미국이 첫 번째 상업적 시장이 될 것입니다. Insmed는 미국 승인 후 유럽과 일본에서의 승인 신청 및 출시를 계획하고 있으며, 이들 시장에서는 2026년 상반기 출시를 목표로 하고 있습니다.
아시아태평양과 유럽은 현지 승인과 보험사의 접근성에 따라 주요 시장이 될 것으로 예상됩니다.
4. 신규 적응증 승인(규제 상황/기대)
브렌소카팁은 NCFB(10mg과 25mg 두 가지 용량)로 FDA 승인을 받았습니다. 이는 기관지확장증에 대한 DPP-1 억제제로는 최초의 승인입니다.
Insmed의 개발 계획에는 다른 호중구 매개 염증성 질환에 대한 탐색도 포함되어 있지만, 아직 초기 단계에 있으며 승인되지 않은 상태입니다.
5. 강력한 수량 모멘텀
ASPEN 임상 3상(nࣈ:1,721)에서 브렌소카팁은 위약 대비 연간 악화율을 낮추고(용량별 비율 대비 -0.79-0.81), 첫 악화까지 걸리는 시간을 개선하는 것으로 나타났습니다.
ASPEN 결과 발표와 후속 하위 그룹 분석은 임상 사례를 강화하여 임상의의 강한 관심과 시장의 긍정적인 반응을 이끌어 냈습니다.
6. 경쟁사와의 차별화와 시장 동향
퍼스트 인 클래스 DPP-1 억제제: 브렌소카팁의 기전(경구용 DPP-1 억제에 의한 호중구 세린 프로테아제 활성화 억제)은 기존 지지요법과는 다른 기전으로, 브렌소카팁은 호중구 구동성 폐질환의 표적 항염증 치료제가 되고 있습니다.
임상적 차별성: ASPEN은 악화 빈도가 감소하고 폐 기능 저하가 더디게 진행됨을 입증했습니다. 이는 보험사와 임상의가 만성폐질환 관리에서 중요하게 여기는 결과이며, 이는 강력한 가치 논리를 뒷받침합니다.
시장 동향 : 기관지확장증에 대한 높은 미충족 수요, 기전 기반 치료에 대한 관심 증가, 만성질환 관리에 대한 실제 임상 증거에 대한 신뢰는 이 분야에서 최초로 승인된 치료제의 채택을 촉진할 것으로 보입니다.
위험과 역풍: 남은 과제로는 장기 안전성 확립(시판 후 장기간 노출 필요), 보험자 범위 및 가격 협상(ICER 및 보험자의 비용효과성 평가), 호중구 생물학 관련 모니터링 요건 가능성(DPP-1 저해 문헌에서 지적된 피부과적/치주질환 등), 미래의 대체 전략과의 경쟁 등이 있습니다. 학적 검토 등), 미래의 약물 및 대체 치료 전략과의 경쟁 등이 있습니다.
브렌소카팁(Brensocatib)의 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본) 시장을 조사 분석했으며, 매출 예측, 작용기전(MoA), 용법·용량, 연구개발(R&D)에 관한 정보를 전해드립니다.
목차
제1장 보고서 소개
제2장 Brensocatib 개요 : 비낭포성섬유증성 기관지확장증(NCFBE) 등의 승인된 적응증, 비용종을 동반하지 않는 만성 부비동염이나 화농성 한선염 등의 잠재적 적응증
제품 상세
Brensocatib 임상 개발
Brensocatib 임상 연구
Brensocatib 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 프로파일
제3장 Brensocatib 경쟁 구도(출시약)
제4장 경쟁 구도(후기 단계의 새로운 Brensocatib 요법)
제5장 Brensocatib 시장 평가
승인된/잠재적 적응증의 Brensocatib 시장 전망
주요 7개 시장 분석
주요 7개 시장 승인된/잠재적 적응증용 Brensocatib 시장 규모
시장 분석 : 국가별
미국의 승인된/잠재적 적응증용 Brensocatib 시장 규모
독일의 승인된/잠재적 적응증용 Brensocatib 시장 규모
영국의 승인된/잠재적 적응증용 Brensocatib 시장 규모
제6장 Brensocatib SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 보고서 구입 옵션
KSM
영문 목차
영문목차
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
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
