두경부 편평상피암 : 신규 요법, 미충족 수요 및 TPP 인사이트 리포트(2026년)

Head and Neck Squamous Cell Carcinoma (HNSCC) Emerging Therapy and TPP Insights

Thelansis's "Head and Neck Squamous Cell Carcinoma (HNSCC) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Head and Neck Squamous Cell Carcinoma (HNSCC) Overview

Head and Neck Squamous Cell Carcinoma (HNSCC) is a biologically heterogeneous and highly aggressive group of malignancies arising from the mucosal epithelium of the oral cavity, pharynx, and larynx. It represents one of the most prevalent cancers globally and is driven by two primary etiological pathways: chronic exposure to tobacco and alcohol, and infection with high-risk human papillomavirus (HPV).

HPV-positive HNSCC, particularly in the oropharynx, has emerged as a distinct clinical subtype with improved prognosis and greater responsiveness to treatment compared to HPV-negative disease, despite often presenting with advanced nodal involvement. Most patients are diagnosed at a locally advanced stage, requiring multidisciplinary, function-preserving treatment approaches, including surgery, radiation therapy, and platinum-based chemoradiation. However, recurrence rates remain high, with a significant proportion progressing to recurrent or metastatic (R/M) disease.

The treatment paradigm for R/M HNSCC has evolved significantly with the introduction of immune checkpoint inhibitors targeting PD-1, which have become a cornerstone of therapy, either as monotherapy or in combination with chemotherapy. Despite these advances, overall prognosis remains poor, highlighting the need for more effective and durable treatment strategies.

Key Highlights

• In the US, prevalence (survival-adjusted cases) is projected to increase from 404.1K in 2025 to 432.3K by 2035, reflecting steady growth (0.7% CAGR).
• High rates of recurrence and progression to metastatic disease remain a major clinical challenge, with limited long-term survival in advanced stages.
• Increasing adoption of immunotherapy and biomarker-driven treatment approaches is reshaping the therapeutic landscape, particularly in recurrent/metastatic settings.

Market Overview

• The France HNSCC market is projected to grow from $105M in 2025 to $335M by 2035, reflecting strong double-digit growth driven by expanding use of immunotherapies.
• Market expansion is supported by:
• Increased uptake of immune checkpoint inhibitors (PD-1 inhibitors)
• Broader use of combination regimens in advanced disease
• Despite relatively stable patient growth, market value is driven by high-cost oncology therapies and extended treatment duration.
• Future growth will depend on advancements in immuno-oncology, targeted therapies, and personalized treatment strategies to improve survival outcomes.

Insights driven by surveys* with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Fulgent Pharma LLC.
• CSPC Megalith Biopharmaceutical Co., Ltd.
• Gilead Sciences
• Merck Sharp & Dohme LLC
• Sichuan Baili Pharmaceutical Co., Ltd.
• Transgene
• Regeneron Pharmaceuticals
• Inhibrx Biosciences, Inc
• AstraZeneca
• Coherus Oncology, Inc.
• Ipsen
• Radiopharm Theranostics, Ltd
• KaliVir Immunotherapeutics
• IDEAYA Biosciences
• ImmunityBio, Inc.
• Rondo Therapeutics
• AbbVie
• Sutro Biopharma, Inc.
• SystImmune Inc.
• Zumutor Biologics Inc.
• Arcus Biosciences, Inc.
• Normunity AccelCo, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

6. Regulatory and Reimbursement Environments (by country and payer insights)

7. Appendix (e.g., bibliography, methodology)