2023년 주요 7개국에서 진단된 비낭포성 섬유증 기관지확장증(NCFB) 유병자 수는 약 102만 8,651명으로 집계됐습니다. 이 중 미국이 약 37%, EU 4개국과 영국이 약 54%, 일본이 약 9%를 차지합니다.
NCFB 시장은 꾸준한 성장세를 보이며 2024년부터 2034년까지 연평균 성장률(CAGR)이 견조할 것으로 예상됩니다. 주요 7개국에서 이러한 확장은 브렌소카팁(Brensocatib), CMS I-neb과 같은 혁신적인 치료법의 도입, 진단 기술의 발전, NCFB의 유병률 증가에 기인합니다.
주요 7개국 NCFB 시장 규모는 2023년 약 14억 5,510만 달러로 2024년부터 2034년까지 예측 기간 동안 연평균 14.5%의 성장률을 기록할 것으로 예상됩니다.
NCFB의 주요 시장 장벽은 진단의 복잡성입니다. 다른 호흡기질환과 중복되는 증상으로 인한 오진 및 진단 지연은 적시 치료를 제한하고 치료제의 시장 침투를 감소시켜 전체 환자 관리 및 결과에 영향을 미칩니다.
미충족 수요 중 가장 중요한 것은 승인된 질환 특이적 치료제가 없다는 것입니다. 현재 치료는 근본적인 병태생리를 다루기보다는 증상 관리에만 초점을 맞추고 있어 효과적인 장기적 해결책에 대한 큰 공백이 존재하며, 이에 따라 표적화된 혁신적 의약품 개발에 대한 수요가 증가하고 있습니다.
이 보고서는 주요 7개국 비낭포성 섬유증 기관지확장증(NCFB) 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등을 제공합니다.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Non-Cystic Fibrosis Bronchiectasis report insights
Non-Cystic Fibrosis Bronchiectasis report key strengths
Non-Cystic Fibrosis Bronchiectasis report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies