Chronic Rhinosinusitis With Nasal Polyps Market Assessment, By Treatment Type [Medications, Surgical Methods], By Route of Administration [Nasal, Oral, Others], By Distribution Channel [Hospital Pharmacies, Retail Pharmacies, Online Pharmacies], By Region

Chronic Rhinosinusitis With Nasal Polyps Market Assessment, By Treatment Type [Medications, Surgical Methods], By Route of Administration [Nasal, Oral, Others], By Distribution Channel [Hospital Pharmacies, Retail Pharmacies, Online Pharmacies], By Region, Opportunities and Forecast, 2017-2031F

Chronic rhinosinusitis with nasal polyps (CRSwNP) market is projected to witness a CAGR of 6.33% during the forecast period 2024-2031, growing from USD 3.54 billion in 2023 to USD 5.78 billion in 2031F.

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 the treatment of chronic rhinosinusitis with nasal polyps and their regulatory approvals have significantly enhanced the growth of the market. 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 FASENRA (benralizumab), TEZSPIRE (tezepelumab), and Depemokimab/GSK3511294 among other factors. The development and manufacturing of proficient sinusitis drugs, despite the stringent approval process and time-consuming clinical trials are some of the major factors hampering the growth of the market.

In March 2023, Optinose 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 both physical and mental health, including the quality of sleep. 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 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 in 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).

Dominance of Medications Segment

Medications are generally preferred over surgery for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), thus the segment dominates the market landscape. Medication allows for long-term management, helping to maintain remission and prevent recurrences. They minimize invasive procedures, especially when patients do not meet strict surgical requirements or if their symptoms remain controlled with pharmacotherapy. Medical treatment improves quality of life by allowing patients to manage their symptoms while avoiding complications associated with surgery. Medications are less expensive and easily available, and they are cost-effective options.

Although surgery may be required in several cases as medication dominates the market. The government initiatives to reduce the disease burden through subsidies and reimbursements might help in further expansion of the market.

For instance, in April 2023, Nucala became the first monoclonal antibody to be PBS-subsidized by the Australian government for the treatment of CRSwNP. Nucala is the product of GSK plc marketed since 2015. The initiative by the Australian government is anticipated to provide subsidized access to this new treatment option for CRSwNP patients.

Nasal Route of Administration to be the Leading Segment

The nasal route of administration is preferred for medications of chronic rhinosinusitis with nasal polyposis (CRSwNP) as it provides an easy and fast route for local treatment of nose and sinus diseases with lower doses than systemic administration and fewer adverse effects. For instance, intranasal corticosteroids, such as mometasone furoate nasal spray (MFNS), are the preferred treatment for CRSwNP. Other treatments that can be administered intranasally for CRSwNP include intranasal anticholinergic agents, intranasal cromones, and nasal saline. Several marketed products in the form of nasal inhalation and sprays are available for the treatment of CRSwNP. Expanding the scope of indication for already approved drugs for CRSwNP, promising a step of revenue generation for key players.

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 of age 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 be the Dominating Region

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 the lead position of North America. 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

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 is expected to be completed in the early months of 2025.

Key Players Landscape and Outlook

Market players like Sanofi, Regeneron Pharmaceuticals, and GlaxoSmithKline have several promising products in the clinical pipeline which shows the market readiness of these companies. 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 and Aiolos Bio, Inc. announced an agreement under which GSK acquired Aiolos. Aiolos is 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.