Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - Market Insights, Epidemiology, and Market Forecast - 2032

Key Highlights:

• In 2022, the market size of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) was the highest in the US among the 7MM and China, accounting for approximately USD 1,317 million, and is expected to increase further by 2032.

The products, which are likely to hit the market during the forecast period 2023-2032, include FASENRA (benralizumab), TEZSPIRE (tezepelumab), and Depemokimab/GSK3511294, among others.

This “Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - Market Insights, Epidemiology, and Market Forecast - 2032” report delivers an in-depth understanding of the CRSwNP, historical and forecasted epidemiology as well as the CRSwNP market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan and China.

The CRSwNP market report provides current treatment practices, emerging drugs, market size, market share of individual therapies, and current and forecasted 7MM and China from 2019 to 2032. The report also covers current CRSwNP treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan
• China

Study Period: 2019-2032

CRSwNP Understanding and Treatment Algorithm

Nasal Polyposis is characterized by a runny or stuffy nose, loss or reduced sense of smell, headache or facial pain, sinus pressure, snoring, and postnatal drip, and the standard treatment for nasal polyps includes a combination of pharmacological and surgical approaches depending on individual case assessment.

CRSwNP Diagnosis

For the diagnosis of nasal polyps, an ENT specialist or any other physician first looks into the nasal passages with a special lighted instrument known as a nasoscope. The most preferred techniques are confirming the location, size, and severity of polyps nasal endoscopy, and radiological imaging. Further allergy tests and blood tests can be done to determine other disease-related components.

Further details related to country-based variations are provided in the report.

CRSwNP Treatment

Corticosteroids are considered the first-line therapy for the treatment of NP. Initially, nasal corticosteroids are recommended for treatment. If the patient does not progress, they may be shifted to oral corticosteroids and then to injectable corticosteroids. If the corticosteroids do not show progress in the condition, surgical intervention is the next treatment of choice. Biologics can be given to treat severe polyps, treat post-surgery reoccurrence cases, and treat patients who cannot undergo surgery. Anti-allergic NSAIDs can be added to the regimen depending on the condition.

The currently recommended range of pharmacological treatments includes mainly biologics and corticosteroids, including NUCALA (mepolizumab), DUPIXENT (dupilumab), XOLAIR (omalizumab), XHANCE (fluticasone propionate), SINUVA (mometasone furoate) Sinus Implant, and PROPEL (mometasone furoate) as currently approved for treating NP and CRSwNP. With many treatment options already present, the market anticipates the launch of emerging products with novel MoA targets and the onset of action.

CRSwNP is a complex and frequent respiratory condition that poses significant challenges to both the patients who experience it and the physicians who treat them. Treatment aims to eliminate or significantly reduce the size of the nasal polyps, resulting in relief of nasal obstruction, improvement in sinus drainage, and restoration of olfaction and taste. A handful of clinical trials are expected to change the landscape of the emerging therapeutic market in the forecast period. Profound disease understanding, development of novel therapeutic agents, and patient-centered treatment approaches will improve patient outcomes in the coming years.

CRSwNP Epidemiology

As the market is derived using a patient-based model, the CRSwNP epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of Chronic Rhinosinusitis (CRS), diagnosed prevalent cases of CRS, diagnosed prevalent cases of CRSwNP, and Gender-specific diagnosed prevalent cases of CRSwNP in the 7MM and China covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, Japan, and China from 2019 to 2032.

• There were 17,014,061 diagnosed prevalent cases of CRSwNP estimated to have occurred in the 7MM and China in 2022, of which 2,191,303 of the accounted cases were estimated to be from the US alone, and these cases are anticipated to increase during the forecast period.
• The diagnosed prevalent cases of CRSwNP were further divided into Gender-specific cases. The Gender-specific diagnosed prevalent cases of CRSwNP are categorized into Males and Females, with 1,205,216 and 986,086 cases, respectively, in the US in 2022, which is expected to further increase by 2032.

CRSwNP Drug Chapters

The drug chapter segment of the CRSwNP report encloses a detailed analysis of CRSwNP pipeline drugs. It also helps understand the CRSwNP clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs (Included Information)

NUCALA (mepolizumab): GlaxoSmithKline

GSK's NUCALA (mepolizumab) is the first IL-5 therapy approved as an add-on treatment in the US for adults with CRSwNP to target eosinophilic inflammation in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. The recommended dosage of mepolizumab is 100 mg, administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.

Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. By inhibiting IL-5 signaling, mepolizumab reduces the production and survival of eosinophils; however, the mechanism of mepolizumab action in asthma, CRSwNP, EGPA, and HES has not been definitively established.

The US FDA approved NUCALA in July 2021 based on positive results from the pivotal SYNAPSE study.

Emerging Drugs

TEZSPIRE (tezepelumab): AstraZeneca/Amgen

TEZSPIRE (tezepelumab) is a potential human monoclonal antibody (immunoglobulin [Ig] G2?) that inhibits the action of thymic stromal lymphopoietin (TSLP). TSLP expression is elevated in the airways of patients with asthma compared with healthy individuals and in nasal polyp tissue from patients with CRSwNP compared with healthy sinus tissue or patients with CRS without NP. Tezepelumab binds specifically to TSLP, preventing its interaction with its heterodimeric receptor.

Tezepelumab is currently under Phase III clinical trials to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP. This trial is based on positive results of tezepelumab from the PATHWAY and NAVIGATOR trials in patients with severe, uncontrolled asthma and comorbid nasal polyps.

A detailed emerging therapies list will be provided in the final report.

CRSwNP Market Outlook

The market of CRSwNP is anticipated to evolve largely due to the quick approvals of new therapies by regulatory agencies like the European Commission and the US FDA. The current market for CRSwNP is undergoing a boom with the approval of biologics that target uncontrolled severe NP cases and can be given post-surgery in the recurrence of NP cases.

Various FDA-approved therapies by major key pharmaceutical players are available in the market, including branded biologics that include NUCALA (mepolizumab), DUPIXENT (dupilumab), and XOLAIR (omalizumab), along with other treatment options like XHANCE (fluticasone propionate), SINUVA (mometasone furoate) Sinus Implant, and PROPEL (mometasone furoate). Among the 7MM and China, the major share of the market was captured by Corticosteroids.

With a handful number of clinical trials in the CRSwNP emerging pipeline, TEZSPIRE is under development by AstraZeneca and Amgen for treating CRSwNP and is currently in Phase III of development for CRSwNP treatment along with other emerging options. Considering the treatment paradigm for CRSwNP, a substantial market has been designated toward biologics where many potential candidates like DUPIXENT and others have marked their coveted entries; the market looks forward to catering to other biologics under development.

The total market size of CRSwNP in the 7MM and China was approximately USD 2,368 million in 2022 and is projected to increase during the forecast period (2023-2032).

• The market size of CRSwNP in the 7MM and China is expected to increase at a CAGR of about 9.36% due to the advancing treatment landscape and the launch of the emerging drugs under development.
• Among the EU4 and the UK, Germany accounted for the maximum market size of USD 144 million in 2022, whereas both the United Kingdom and France accounted for the same market size in 2022, which was USD 95 million, while Spain occupied the bottom of the ladder in the same year with USD 40 million.
• Japan accounted for a market size of USD 82 million in 2022, but these dynamics are expected to change in the forecast period.
• The market size of CRSwNP in China was USD 532 million in 2022 and is anticipated to change in the forecast period.

CRSwNP Drug Uptake

This section focuses on the uptake rate of the potential drug expected to be launched in the market during the study period 2019-2032. For example, we estimate the drug FASENRA is anticipated to be launched in the US by 2025. In 2021, the US FDA approved NUCALA (mepolizumab) to treat CRSwNP in adults.

Further detailed analysis of emerging therapies drug uptake is in the report.

CRSwNP Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I clinical trials. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on designations, collaborations, mergers and acquisitions, licensing, and patent details for CRSwNP emerging therapies.

KOL-Views

To keep up with the 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 CRSwNP's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake along with challenges related to accessibility, include Wright State University Boonshoft School of Medicine, University of California San Diego, University of Siena, University of Southampton, University of Fukui, Fudan University, and The Third Affiliated Hospital of Sun Yat-sen University.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM and China. Centers such as the Wright State University Boonshoft School of Medicine, University of California San Diego, University of Siena, University of Southampton, University of Fukui, Fudan University, and The Third Affiliated Hospital of Sun Yat-sen University were contacted. Their opinions help understand and validate current and emerging therapies and treatment patterns for CRSwNP market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT 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.

Market Access and Reimbursement

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of CRSwNP, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the CRSwNP market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM and China drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM and China CRSwNP market.

CRSwNP Report Insights

• Patient Population
• Therapeutic Approaches
• Pipeline Analysis
• CRSwNP Market Size and Trends
• Existing and Future Market Opportunity

CRSwNP Report Key Strengths

• Ten Years Forecast
• The 7MM and China Coverage
• CRSwNP Epidemiology Segmentation
• Key Cross Competition
• Drug Uptake and Key Market Forecast Assumptions

CRSwNP Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT Analysis)

Key Questions Answered

Market Insights

• What was the CRSwNP total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• What will impact the market with the launch of TEZSPIRE, FASENRA, and other emerging drugs?
• How much of the market will be captured by TEZSPIRE, FASENRA, and other emerging drugs after their launch?
• What are the pricing variations among different geographies for NUCALA (mepolizumab), DUPIXENT (dupilumab), XOLAIR (omalizumab), XHANCE (fluticasone propionate), SINUVA (mometasone furoate) Sinus Implant, and PROPEL (mometasone furoate)?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

What are the disease risks, burdens, and unmet needs of CRSwNP? What will be the growth opportunities across the 7MM and China with respect to the patient population pertaining to CRSwNP?

• What is the historical and forecasted CRSwNP patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan and China?
• How many male and female patients are of CRSwNP?
• What factors are affecting the diagnosis of CRSwNP?

Current Treatment Scenario, Marketed Drug, and Emerging Therapies

• What are the current options for the standard of care for CRSwNP? What are the current treatment guidelines for treating CRSwNP in the US and Europe?
• How many companies are developing therapies for the treatment of CRSwNP?
• How many emerging therapies are in the mid-stage and late stage of development to treat CRSwNP?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the patents of emerging therapies for CRSwNP?
• What will impact the market after the expected patent expiry of the emerging drug?
• What is the cost burden of marketed therapies on patients?
• What is the patient acceptability regarding preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of recommended therapies?
• What are the 7MM and China historical and forecasted market of CRSwNP?

Reasons to Buy

The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the CRSwNP market.

• Insights on patient burden/disease prevalence, accuracy/evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data and reported sales of current products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and potential of current and emerging therapies to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies for NUCALA (mepolizumab), DUPIXENT (dupilumab), XOLAIR (omalizumab), and others.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.