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市場調査レポート
商品コード
1605431
気管支拡張症 - 市場考察、疫学、市場予測(2034年)Bronchiectasis - Market Insight, Epidemiology And Market Forecast - 2034 |
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気管支拡張症 - 市場考察、疫学、市場予測(2034年) |
出版日: 2024年10月01日
発行: DelveInsight
ページ情報: 英文 203 Pages
納期: 2~10営業日
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気管支拡張症市場は、複雑な病態生理に対応する薬理学的/非薬理学的介入の進化により、大きな成長が見込まれています。現在の治療戦略には、薬物療法、胸部理学療法、水分補給、重症例では抗生物質の吸入による酸素療法などのさまざまな治療オプションがあり、慢性細菌感染の管理や増悪率の減少に有効であることが実証されています。ジペプチジルペプチダーゼ1(DPP1)阻害薬であるBrensocatibやカテプシンC阻害薬であるBI 1291583などの新治療法は、それぞれ異なるメカニズムで好中球性炎症を標的とし、患者の転帰を改善する新しいアプローチを提供します。さらに、CMS i-nebやFASENRAやItepekimabのようなモノクローナル抗体などの治験中の治療薬は、好酸球性炎症に関連する特定の炎症経路を直接標的とすることで、さらなる選択肢を提示しています。非薬理学的アプローチ、特にACT(Airway Clearance Techniques)を取り入れることは、薬理学的レジメンを補完し、粘液クリアランスを高め、感染を予防します。しかし、この市場は、コンセンサスガイドラインの欠如や、粘液溶解薬や高浸透圧薬のような研究が不十分な治療法など、最適な患者管理を妨げる可能性のある課題に直面しています。
しかし、進行中の臨床試験や医薬品開発の進歩は、気管支拡張症管理における既存のギャップを埋める革新的な治療法の可能性を浮き彫りにしており、最終的には患者のQOLを改善し、医療システムの負担を軽減します。さまざまな開発段階にある有望な治療薬のパイプラインにより、気管支拡張症治療の将来はますます楽観的になっているように見えますが、これらの機会を完全に実現するためには、継続的な研究と臨床検証が必要であることを明示しています。
主要企業であるInsmed、Zambon、AstraZeneca、Renovion、Sanofiなどは、臨床開発のさまざまな段階で主力候補薬を評価しています。これらの企業は、気管支拡張症を治療する自社製品を研究することを目指しています。
当レポートでは、気管支拡張症の主要7市場(米国、ドイツ、スペイン、イタリア、フランス、英国、日本)について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。
DelveInsight's "Bronchiectasis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of bronchiectasis, historical and forecasted epidemiology, as well as the bronchiectasis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The bronchiectasis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM bronchiectasis market size from 2020 to 2034. The report also covers bronchiectasis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Bronchiectasis overview
Bronchiectasis is a chronic, progressive lung disease characterized by irreversible bronchial airway dilation and impaired mucociliary function, resulting in persistent mucus buildup and heightened bacterial colonization. Although historically linked to childhood respiratory infections, the disease is now understood to have multifactorial origins, including idiopathic, acquired, or infection-related causes. A productive cough is the hallmark symptom, yet in nearly 40% of cases, the cause remains unidentified. Bronchiectasis frequently develops secondary to pulmonary conditions such as cystic fibrosis, COPD, autoimmune diseases, immunodeficiencies, and airway obstructions, or through recurrent infections, including pneumonia and tuberculosis. The disease presents with gradually worsening airflow obstruction, marked by chronic cough, thick mucus production, shortness of breath, and systemic signs like fever, fatigue, and chest pain. As the condition advances, complications such as hemoptysis and nail clubbing may arise, underscoring the impact of recurrent infections, airway blockages, and peribronchial fibrosis on disease progression.
Bronchiectasis diagnosis
The diagnosis of bronchiectasis 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. The definitive diagnostic tool for bronchiectasis is High-Resolution Computed Tomography (HRCT) of the chest, optimally conducted when the patient is clinically stable to ensure accuracy. HRCT provides detailed imaging of the bronchial structure, with tubular bronchiectasis emerging as the most frequently observed subtype. This imaging modality allows for precise identification of bronchial dilation and related abnormalities, facilitating early intervention and improved disease management.
Bronchiectasis treatment
The management of Bronchiectasis centers on identifying and addressing underlying causes, such as prior severe respiratory infections, allergic bronchopulmonary aspergillosis, ciliary clearance impairment, immunodeficiency, COPD, and severe asthma. Treatment strategies focus primarily on symptomatic relief and optimizing lung function through mucus clearance techniques, infection control with antibiotics, and the use of bronchodilators or corticosteroids to alleviate airflow obstruction. Supportive measures, including smoking cessation and vaccinations, play a key role, while advanced cases may require surgical intervention or lung transplantation. However, the absence of disease-modifying therapies highlights a critical gap in treatment, as current approaches primarily manage symptoms without addressing the root causes of Bronchiectasis. Although inhaled corticosteroids and long-term macrolide therapies show promise, efficacy evidence remains limited by small cohorts and brief trial durations, underscoring the urgent need for more robust research to develop targeted therapies capable of reversing structural damage and improving long-term patient outcomes.
As the market is derived using a patient-based model, the bronchiectasis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, total diagnosed prevalent cases of cystic fibrosis bronchiectasis, gender-specific diagnosed prevalent cases of cystic fibrosis bronchiectasis, age-specific diagnosed prevalent cases of cystic fibrosis bronchiectasis, and microbiology of cystic fibrosis bronchiectasis 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 bronchiectasis, 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 bronchiectasis at the CHEST 2024 Annual Meeting. Furthermore, the EMA approved a Pediatric Investigational Plan for brensocatib in bronchiectasis patients, and brensocatib has gained access to the PRIME scheme and Breakthrough Therapy Designation for adult bronchiectasis patients.
Inhaled Colistimethate Sodium (CMS I-neb): Zambon
CMS I-neb is an investigational inhaled therapy for adults with bronchiectasis 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 NCFB associated with eosinophilic inflammation (bronchiectasis + EI). According to clinicaltrials.gov, FASENRA completed Phase III clinical trials for this indication in April 2024.
Drug Class Insights
The treatment of bronchiectasis 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 bronchiectasis, addressing its multifaceted pathophysiology.
The market for bronchiectasis 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 treatment options which includes medications, chest physical therapy, hydration, and in severe cases, oxygen therapy 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 bronchiectasis 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 bronchiectasis 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 bronchiectasis.
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.
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 bronchiectasis.
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 bronchiectasis 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 Chicago, Chicago, USA, Georgetown University Hospital, Washington, DC, US, Hospital Universitari Vall d'Hebron, Barcelona, Spain, and the Fukujuji Hospital, Tokyo, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or bronchiectasis 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, Exacerbations are critical events in the course of bronchiectasis, often triggered by bacterial or viral infections. Beyond worsening symptoms, they can significantly reduce quality of life, impair lung function, and increase the risk of hospitalization and mortality. Understanding the impact of these episodes is essential to improving prevention strategies and developing more effective interventions for patients.
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 'Bronchiectasis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of bronchiectasis.
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.
Bronchiectasis report insights
Bronchiectasis report key strengths
Bronchiectasis report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies