Published Date : 2023-12-26
Published Date : 2023-12-26
Updated On : 2024-10-01
Pages : 158
Thelansis’s “Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Head and neck squamous cell carcinoma (HNSCC) represents a diverse disease originating from the mucosal linings of the upper aerodigestive tract. Despite the implementation of multimodal therapies, approximately half of all patients diagnosed with locally advanced disease experience relapse, and the prognosis for those with recurrent or metastatic HNSCC remains bleak. Notably, tobacco smoking remains a predominant risk factor for the development of HNSCC, with a demonstrable escalation in risk correlating with both increased frequency and prolonged duration of smoking habits. Several molecular biomarkers have been proposed for HNSCC, among which CD44, CD133, and ALDH1 have garnered extensive validation and are associated with prognostic significance. Diagnosis of HNSCC typically relies on routine histopathological examination, commonly employing hematoxylin and eosin staining. First-line treatment strategies often incorporate pembrolizumab, an immune checkpoint inhibitor. Pembrolizumab, an IgG4 humanized antibody targeting PD1, is recommended particularly for patients exhibiting PDL1 expression in their tumors or demonstrating microsatellite instability unless contraindicated due to an underlying autoimmune disorder.
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 | ALE.P02 | Alentis Therapeutics | Phase 1/2 |
2 | FID007 | Fulgent Pharma LLC. | Phase 2 |
3 | Evorpacept (ALX148)+Pembrolizumab | ALX Oncology Inc. | Phase 2 |
4 | HLX10 | Shanghai Henlius Biotech | Phase 2 |
5 | SI-B001+SI-B003 | Sichuan Baili Pharmaceutical Co., Ltd. | Phase 2 |
6 | TransCon (TC) TLR7/8 Agonist | Ascendis Pharma A/S | Phase 2 |
7 | ASP-1929 Plus Pembrolizumab | Rakuten Medical, Inc. | Phase 2 |
8 | CyPep-1 | Cytovation AS | Phase 2 |
9 | NBTXR3 | Nanobiotix | Phase 3 |
10 | HMBD-001 | Hummingbird Bioscience | Phase 2 |
Continued...
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. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) – 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. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2023 |
1.2.2. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2028 |
1.2.3. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2033 |
2. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
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. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) management |
2.16. Market Opportunity for Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) |
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 Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) 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 |