Published Date : 2023-04-07
Published Date : 2023-04-07
Updated On : 2024-02-16
Pages : 153
Thelansis’s “Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Chronic Rhinosinusitis without Nasal Polyps treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Chronic rhinosinusitis without nasal polyposis (CRSsNP) manifests as the persistence of at least two out of four key symptoms over a period of 12 weeks or more: nasal obstruction, anterior or posterior nasal discharge, reduction or loss of smell, and facial pain/pressure/fullness. Additional symptoms may include rhinorrhea and facial discomfort. Conditions predisposing individuals to CRSsNP comprise acute rhinosinusitis, often triggered by viral respiratory infections, as well as allergic and non-allergic rhinitis, asthma, bronchitis, pneumonia, gastroesophageal reflux disease, adenotonsillitis, sleep apnea, and otitis media. Moreover, the likelihood of allergic conjunctivitis, atopic dermatitis, asthma, urinary tract infections, and skin/soft tissue infections increases with a diagnosis of CRSsNP. Traditionally, CRSsNP, typically associated with microbacterial colonization, has been presumed to arise from unresolved or insufficiently treated acute rhinosinusitis. However, this scenario is uncommon, as most cases of acute rhinosinusitis stem from viral respiratory infections that typically resolve without intervention. Therefore, when CRSsNP is present, various underlying predisposing factors should be considered, including primary and secondary immunodeficiencies such as common variable immunodeficiency and HIV, genetic anomalies like cystic fibrosis (CF), and mucociliary disorders such as ciliary dyskinesia. For instance, HIV-infected individuals exhibit a heightened prevalence of CRS, likely attributable to diminished cellular and humoral immunity—thirty-six percent of patients with common variable immunodeficiency present with CRSsNP. Additionally, some individuals with both CRS phenotypes have low serum IgA levels, with 6.2% exhibiting selective IgA deficiency. However, the connection between selective IgA deficiency and both types of chronic rhinosinusitis remains uncertain. CRSsNP is characterized by fibrosis, thickening of the basement membrane, and hyperplasia of goblet cells. Elevated levels of TGF-β are observed in the early stages of CRSsNP, while pro-inflammatory neutrophils and Th1 markers, along with the T cell profile, remain unaffected. The remodeling process appears to proceed concurrently with inflammation during the initial stages of CRSsNP, indicating its pivotal role in the condition's onset. Mucus secretion, goblet cell hyperplasia, and glandular hyperplasia represent hallmark features of upper airway remodeling in CRSsNP. The primary objectives of medical treatment for CRS involve reducing mucosal swelling, improving sinus drainage, and eliminating infections. This typically necessitates a combination of topical or oral glucocorticoids, oral antibiotics, and nasal saline irrigation. Although the role of bacteria in chronic sinusitis pathogenesis remains unclear, prompt diagnosis and appropriate treatment often alleviate symptoms in most patients, with many achieving a cure. Functional endoscopic sinus surgery (FESS) may be recommended when medical therapy proves ineffective.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | XHANCE® (fluticasone propionate) nasal spray | Optinose US Inc. | Phase 3 |
2 | Brensocatib | Insmed Incorporated | Phase 2 |
3 | Dupilumab SAR231893 | Sanofi | Phase 2 |
4 | Tezepelumab | AstraZeneca | Phase 3 |
5 | HV-3000 (Rimegepant) | Pfizer | Phase 3 |
6 | Airiver Nasal Drug Coated Balloon (DCB) Catheter. | Airiver Medical, Inc. | Early Phase 1 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) market scenario 2023 |
1.2.2. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) market scenario 2028 |
1.2.3. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) market scenario 2033 |
2. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) management |
2.16. Market Opportunity for Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market Forecast 2023-2033 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |