Published Date : 2022-09-26
Published Date : 2022-09-26
Updated On : 2023-11-04
Pages : 155
Thelansis’s “Head and Neck Squamous Cell Carcinoma (HNSCC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" 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 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) presents a multifaceted array of malignancies, creating formidable challenges for medical practitioners. The majority of patients receive diagnoses at an advanced local disease stage, necessitating treatment regimens that encompass surgery, chemotherapy, and radiotherapy. Regrettably, approximately 50% of these individuals will undergo disease recurrence. In cases of recurrent or metastatic HNSCC, the prognosis is notably grim, with a median survival rate ranging from 12 to 15 months despite treatment efforts. Head and neck cancer stands as the seventh most prevalent cancer globally, constituting 3% of all cancer cases, with an annual incidence of roughly 900,000 new cases and half a million fatalities. Human papillomavirus (HPV) infection is now recognized as the primary causative factor for HNSCC, particularly in the oropharynx (OPSCC), responsible for approximately 60-70% of OPSCC cases in the United States. HPV-positive (HPV+) HNSCC exhibits distinct disparities in both epidemiology and pathophysiology when compared to HPV-negative (HPV-) or HPV-unrelated HNSCC. Demographically, patients with HPV+ OPSCC tend to be younger males, typically diagnosed in their 40s to 50s and are often non-smokers or light smokers. HPV infection is characterized by a latency period of 10-30 years between the initial infection and the clinical manifestation of HPV+ OPSCC.
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 | Pembrolizumab and Lenvatinib | Merck Sharp & Dohme LLC | Phase 3 |
2 | SCT-I10A | Sinocelltech Ltd. | Phase 3 |
3 | Monalizumab and Cetuximab | AstraZeneca | Phase 3 |
4 | Ficlatuzumab and Cetuximab | AVEO Pharmaceuticals, Inc. | Phase 3 |
5 | Nivolumab and Ipilimumab | Bristol-Myers Squibb | Phase 3 |
6 | Atezolizumab | Hoffmann-La Roche | Phase 3 |
7 | Zanzalintinib and Pembrolizumab | Exelixis | Phase 3 |
8 | MRG003 | Shanghai Miracogen Inc. | Phase 3 |
9 | NBTXR3 and Cetuximab | Nanobiotix | Phase 3 |
10 | Buparlisib and Paclitaxel | Adlai Nortye Biopharma Co., Ltd. | Phase 3 |
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. 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. Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2022 |
1.2.2. Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2025 |
1.2.3. Head and Neck Squamous Cell Carcinoma (HNSCC) market scenario 2032 |
2. 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 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. 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 Head and Neck Squamous Cell Carcinoma (HNSCC) management |
2.16. Market Opportunity for Head and Neck Squamous Cell Carcinoma (HNSCC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Head and Neck Squamous Cell Carcinoma (HNSCC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of 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. Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of 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. Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of 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. Head and Neck Squamous Cell Carcinoma (HNSCC) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of 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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 Head and Neck Squamous Cell Carcinoma (HNSCC) Market Forecast 2022-2032 |
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 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 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 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 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 |