市场调查报告书
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1604482
慢性鼻窦炎伴随鼻息肉市场:各治疗类型,各给药途径,各流通管道,各地区,机会,预测,2017年~2031年Chronic Rhinosinusitis with Nasal Polyps Market Assessment, By Treatment Type, By Route of Administration, By Distribution Channel, By Region, Opportunities and Forecast, 2017-2031F |
2024-2031年预测期间,全球慢性鼻窦炎伴随鼻息肉市场规模将以6.95%的复合年增长率扩大,从2023年的35.4亿美元增至2031年的62.46亿美元。 10.95亿美元。
慢性鼻窦炎伴随鼻息肉(CRSwNP)是一种以鼻窦持续发炎和存在称为鼻息肉的良性发炎病变为特征的疾病。鼻息肉通常发生在筛窦,可阻塞鼻腔气道,导致脸部压力和疼痛、鼻塞、嗅觉减退或嗅觉丧失(嗅觉减少或完全消失),鼻涕会引起各种症状。
由于人口老化、空气污染、过度吸烟等诸多原因,慢性鼻窦炎的盛行率正在上升,并且预计将继续上升,市场预计将因此增长。针对特定发炎途径治疗与鼻息肉相关的慢性鼻窦炎的生物製剂的开发和监管批准正在显着推动市场成长。由于人们对该疾病及其治疗方法的认识不断增强,预计该市场将会成长。特别是 TEZSPIRE (tezepelumab) 和 Depemokimab/GSK3511294 等新药预计将推动市场发展。
2023年3月,OptiNose US, Inc.宣布XHANCE的补充新药申请(sNDA)被美国FDA接受。 XHANCE 利用呼气输送系统 (EDS) 将丙酸氟替卡松(一种广泛使用的鼻腔抗炎药)输送到难以进入的鼻窦和鼻窦引流通道。 sNDA 备案是根据 ReOpen 计划中两项 3 期临床试验的结果,该计划研究了慢性鼻窦炎的治疗。
本报告提供全球慢性鼻窦炎伴随鼻息肉市场相关调查,提供市场概要,以及各治疗类型,各给药途径,各流通管道,各地区趋势,及加入此市场的主要企业简介等资讯。
Global chronic rhinosinusitis with nasal polyps market is projected to witness a CAGR of 6.95% during the forecast period 2024-2031, growing from USD 3,540.00 million in 2023 to USD 6246.16 million by 2031.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition characterized by persistent inflammation of the sinuses and the presence of benign inflammatory lesions called nasal polyps. These polyps typically develop in the ethmoid sinuses and can obstruct the nasal airways, leading to various symptoms such as facial pressure or pain, nasal congestion, hyposmia or anosmia (reduced or complete lack of smell), and postnasal drip.
The market is anticipated to grow under the influence of the growing prevalence of chronic rhinosinusitis, which is anticipated to keep rising due to the increasing geriatric population, air pollution, excessive smoking, and many other reasons. The development of biologic therapies targeting specific inflammatory pathways for treating chronic rhinosinusitis with nasal polyps and their regulatory approvals have significantly enhanced the market's growth. The market is expected to grow due to the increasing awareness about disease and its available treatments. The market is expected to be driven by emerging drugs such as TEZSPIRE (tezepelumab) and Depemokimab/GSK3511294, among other factors. The development and manufacturing of me of the major factors hampering the growth of the market.
In March 2023, OptiNose US, Inc. announced that its supplemental new drug application (sNDA) for XHANCE has been accepted for review by the US FDA. XHANCE is a drug-device combination product that utilizes the Exhalation Delivery System (EDS) to deliver fluticasone propionate, a widely used nasal anti-inflammatory drug, high and deep into difficult-to-access sinuses and sinonasal drainage tracts. The sNDA submission is based on the results of two phase 3 clinical trials from the ReOpen Program, which studied the treatment of chronic sinusitis.
Growing Prevalence of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
The prevalence of CRSwNP is consistently increasing. The disease burden is particularly high in patients with comorbid asthma and/or nonsteroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD) and in patients who need repeated treatment with systemic corticosteroids and/or surgery. Symptoms in CRSwNP patients include rhinorrhea, nasal congestion, and loss of smell. These symptoms impair physical and mental health, including sleep quality. Targeted treatment of nasal polyps and the underlying processes of chronic sinus inflammation are medically necessary. Novel, well-tolerated therapies that provide effective symptom control minimize recurrence rates of nasal polyps, which are being promoted and marketed by key players to cater to the requirements.
According to an article published in 'Allergy, Asthma & Clinical Immunology' journal in December 2023, chronic rhinosinusitis is estimated to affect about 2 to 14% of the United States population, out of which about 25 to 30% of cases are associated with the presence of nasal polyps (CRSwNP).
Clinical Developments for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Chronic rhinosinusitis with nasal polyps (CRSwNP) is usually associated with asthma and allergic rhinitis. Diagnosis of CRSwNP is done by bilateral endoscopic visualization of polyps in the nasal area. Treatment options for CRSwNP include topical irrigation and intranasal corticosteroids, systemic corticosteroids, monoclonal antibodies, surgery, and biological therapies targeting underlying inflammatory processes. Additionally, targeting the underlying inflammatory pathways involved in the pathophysiology of CRSwNP and offering new treatment options for patients with more severe or unresponsive diseases have been significant milestones for the treatment of CRSwNP. The role of biologics and corticosteroids in the market and advancements in these drug categories are anticipated to drive growth in the market. Various promising products in the clinical pipeline seem to contribute to the market expansion.
For instance, GSK's Depemokimab (GSK3511294) is a pipeline drug that is expected to complete phase III clinical trials in the third quarter of the year 2024 and has shown significant efficacy in phase I and II clinical trials. Similarly, in January 2024, Upstream Bio announced the entry of a phase II clinical trial and the beginning of dosing the first patients with Verekitug (UPB-101) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
Biologics Segment Holds Dominance in Chronic Rhinosinusitis with Nasal Polyps Market
The biologics segment leads the chronic rhinosinusitis with nasal polyps (CRSwNP) market, as it promotes one of the most directed forms of treatment available. Biologics precisely modulates specific inflammatory pathways that drive the disease, resulting in significant symptom relief and fewer interventions through surgery. In chronic cases, biologics are predominantly beneficial for patients who cannot respond to conventional therapies. The high efficacy and safety of biologics make them a preferred option among healthcare providers, thus fueling their adoption. Consequently, the growing success of this targeted therapy underpins its market dominance in managing CRSwNP symptoms and improving patient outcomes.
For instance, in April 2023, Nucala became the first monoclonal antibody to be PBS-subsidized by the Australian government to treat CRSwNP. Nucala is the product of GSK plc marketed since 2015. The Australian government's initiative is anticipated to provide subsidized access to this new treatment option for CRSwNP patients.
Parenteral Route of Administration to be the Leading Segment
The predominance of parenteral administration of biologics in the treatment of chronic rhinosinusitis with nasal polyps is mainly because of its efficacy in delivering those drugs that exert their action instantaneously and have a high bioavailability. Biologics, such as dupilumab and mepolizumab, specifically target pathways of the inflammatory processes associated with CRSwNP, and optimum dosing can only be accomplished through parenteral administration. This route bypasses gastrointestinal absorption issues, so drug levels reach systemic circulation quickly and effectively, critical in managing acute symptoms and controlling inflammation in these patients. Additionally, many of the patients with CRSwNP may have gastrointestinal side effects that make oral delivery less feasible.
For instance, in January 2024, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the US Food and Drug Administration approved Dupixent (dupilumab) for the treatment of pediatric patients aged 1 to 11 years and weight of at least 15 kg suffering from eosinophilic esophagitis (EoE). Dupixent became the first medication approved in the United States specifically to treat these patients. The approval expands the approved indication of Dupixent, including atopic dermatitis, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, asthma, and EoE.
North America to Hold the Dominating Share in the Global Market
North America is anticipated to be the leading region in the market with a higher value share. The prevalence of chronic rhinosinusitis with nasal polyps (CRSwNP) in the United States is estimated to be around 2-14% as per various studies. The prevalence of CRSwNP is greater in men than in women. Asthma, allergy, and allergic rhinitis are the most common comorbidities associated with CRSwNP, and the high occurrence of these conditions in North America increases the risk of CRSwNP. Obesity is one of the major risk factors for CRSwNP, and more than 40% of the United States population is obese, further increasing the risk of CRSwNp. Additionally, the strong presence of key market players in the region and the strong clinical pipeline for the treatment option for CRSwNP strengthens North America's lead position. Regulatory emphasis on reducing the disease burden of CRSwNP is expected to expand the market.
For instance, in June 2023, the US Food and Drug Administration made its final industry guidelines titled "Developing Drugs for Treatment of Chronic Rhinosinusitis with Nasal Polyps" public. The guideline is intended to support sponsors in the creation of pharmaceuticals or biological products intended to treat nasal polyps and chronic rhinosinusitis (CRSwNP).
Future Market Scenario (2024-2031F)
The major factor driving the future market scenario is the growing prevalence of chronic rhinosinusitis due to the rising aging population, pollution levels, and smoking tendencies of individuals. Aging and other comorbidities like asthma significantly increase the risk of disease occurrence.
The development of medications for CRSwNP by exploring alternative inflammatory pathways such as interleukins 4, 5, 13, 33, ILC2 cells, and IgE along with other pathogenic mechanisms involved in CRS pathogenesis such as arachidonic acid pathway, extravascular fibrin deposition (coagulation cascade), and B-cell dysregulation, can open the market with newer and more effective drug candidates. For instance, Benralizumab is a promising drug candidate for AstraZeneca undergoing phase III clinical investigations, which are expected to be completed in the early months of 2025.
Key Players Landscape and Outlook
Market players like Sanofi-Aventis US LLC, Regeneron Pharmaceuticals Inc., and GlaxoSmithKline (GSK) plc have several promising products in the clinical pipeline, which shows their market readiness. The regulatory approvals and expansion in approved indications for biologics are anticipated to divert the attention of key players for the development of further biologics and biosimilar products in the forecast years.
In January 2024, GSK plc completed the acquisition of Aiolos Bio, Inc., a clinical-stage biopharmaceutical company focused on the unmet treatment needs of patients with specific respiratory and inflammatory conditions. The deal was valued at USD 1.4 billion. The acquisition enables GSK with access to Aiolos' AIO-001, which is a long-acting anti-thymic stromal lymphopoietin monoclonal antibody prepared to enter phase 2 clinical trials for the treatment of adult asthma patients, with the potential for additional indications, including chronic rhinosinusitis with nasal polyps.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.