흑색종 : 신규 요법, 미충족 수요 및 TPP 인사이트 보고서(2026년)

Melanoma Emerging Therapy and TPP Insights

Thelansis's "Melanoma 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.

Melanoma Overview

Melanoma is an aggressive malignancy arising from melanocytes - pigment-producing cells residing predominantly in the skin but also in ocular and mucosal sites - representing the most lethal form of skin cancer due to its pronounced metastatic potential. Ultraviolet radiation-induced DNA damage, particularly cyclobutane pyrimidine dimer formation, drives mutagenesis in sporadic melanoma, while germline CDKN2A mutations underlie familial predisposition. Somatic driver mutations - BRAF V600 in approximately 50%, NRAS in 15-20%, and NF1 or KIT alterations in the remaining subtypes - activate MAPK and PI3K survival pathways. Patients present with evolving pigmented lesions characterised by the ABCDE criteria - asymmetry, border irregularity, colour variation, diameter, and evolution - with diagnosis established by excisional biopsy and histopathological assessment, including Breslow thickness, ulceration, and mitotic rate. Sentinel lymph node biopsy guides locoregional staging, while PET-CT and brain MRI are essential for metastatic evaluation. Surgical excision with appropriate margins remains the cornerstone for localised disease. Adjuvant therapy - pembrolizumab, nivolumab, or BRAF-MEK inhibitor combinations in BRAF-mutated disease - reduces recurrence risk in high-risk resected melanoma. Advanced disease management mirrors metastatic cutaneous melanoma - immune checkpoint inhibitors, BRAF-MEK targeted combinations, and lifileucel TIL therapy for refractory disease. Prognosis is stage-dependent; multidisciplinary management, dermoscopic surveillance, sun protection education, and patient-centred care are integral to optimising outcomes.

Key Highlights

• In France, survival-adjusted prevalent Melanoma cases are projected to increase from 1,356,791 in 2025 to 1,454,815 by 2035.
• Rising awareness and improved screening are contributing to earlier melanoma diagnosis.
• Immune checkpoint inhibitors and targeted therapies have significantly improved survival outcomes.
• Unmet need persists in advanced, resistant, and metastatic melanoma cases.

Market Overview

• The France Melanoma market is projected to grow from USD 270 million in 2025 to USD 840 million by 2035.
• Growth is supported by expanding adoption of immunotherapies and precision oncology approaches.
• Emerging cell therapies and next-generation immunotherapies are expected to drive future market expansion.

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

• Regeneron Pharmaceuticals
• Amgen
• Binhui Biopharmaceutical Co., Ltd.
• Hoffmann-La Roche
• Innovent Biologics (Suzhou) Co. Ltd.
• Bristol-Myers Squibb
• AstraZeneca
• Biocad
• Pfizer
• Novartis Pharmaceuticals
• Merck Sharp & Dohme LLC
• Incyte Corporation
• Sandoz
• ModernaTX, Inc.
• Genentech, Inc.
• Alaunos Therapeutics
• BioNTech SE
• Actelion
• BioAtla, Inc.
• Toray Industries, Inc.
• Eucure (Beijing) Biopharma Co., Ltd.
• Bio-Thera Solutions
• Eisai Inc.
• C4 Therapeutics, Inc.
• Seagen Inc.
• TILT Biotherapeutics Ltd.
• ImmVira Pharma Co. Ltd.
• Shandong Boan Biotechnology Co., Ltd.
• Syndax Pharmaceuticals
• AgonOx, Inc.
• MacroGenics
• Ipsen
• Inhibrx Biosciences, Inc.
• Tvardi Therapeutics, Incorporated
• GlaxoSmithKline

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)