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

Renal Cell Carcinoma (RCC) Emerging Therapy and TPP Insights

Thelansis's "Renal Cell Carcinoma (RCC) 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.

Renal Cell Carcinoma (RCC) Overview

Renal cell carcinoma (RCC) is the most common malignancy of the kidney, with clear cell RCC representing approximately 75% of cases - characterised by biallelic VHL tumour suppressor gene inactivation, driving constitutive HIF-mediated VEGF and mTOR pathway upregulation and angiogenic programme activation. Papillary and chromophobe subtypes constitute the principal non-clear cell histologies, each harbouring distinct molecular drivers. Tobacco smoking, obesity, hypertension, and hereditary syndromes - Von Hippel-Lindau, hereditary papillary RCC, and Birt-Hogg-Dube - represent established risk factors. Patients present with the classical triad of haematuria, flank pain, and palpable mass - increasingly incidentally detected on cross-sectional imaging - alongside paraneoplastic manifestations including hypercalcaemia, polycythaemia, and stauffer syndrome. Diagnosis integrates CT or MRI characterisation, with biopsy reserved for diagnostically uncertain or metastatic cases alongside molecular profiling. Surgical resection - radical or nephron-sparing nephrectomy - remains curative for localised disease. Metastatic RCC management has been transformed by combination immunotherapy - nivolumab-ipilimumab for intermediate and poor-risk disease - and VEGFR tyrosine kinase inhibitor combinations with checkpoint inhibitors - pembrolizumab-axitinib, nivolumab-cabozantinib, and lenvatinib-pembrolizumab - as first-line standards. Belzutifan, a HIF-2a inhibitor, represents a paradigm-shifting targeted advance in VHL-driven and refractory RCC. Prognosis varies with stage and risk stratification; multidisciplinary management, surveillance imaging, and patient-centred supportive care are integral to optimising long-term outcomes.

Key Highlights

• In France, survival-adjusted prevalent RCC cases are projected to increase from 610,586 in 2025 to 654,698 by 2035.
• RCC remains a major kidney malignancy with growing reliance on biomarker-driven treatment approaches.
• Combination immunotherapies and VEGF-targeted therapies continue to transform patient outcomes.
• Significant unmet need persists in resistant and metastatic RCC cases.

Market Overview

• The Italy RCC market is projected to grow from USD 210 million in 2025 to USD 490 million by 2035.
• Growth is supported by increasing adoption of immune checkpoint inhibitors and targeted therapies.
• Pipeline innovation in combination regimens is expected to create additional commercial opportunities.

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

• Zhejiang Haichang Biotech Co., Ltd.
• Bristol-Myers Squibb
• Merck Sharp & Dohme LLC
• Oncorena AB
• Novartis Pharmaceuticals
• HiberCell, Inc.
• Hoffmann-La Roche
• Xynomic Pharmaceuticals, Inc.
• Exelixis
• Eisai Inc.
• AVEO Pharmaceuticals, Inc.
• Imbioray (Hangzhou) Biomedicine Co., Ltd.
• Incyte Corporation
• Daiichi Sankyo
• Akeso
• BeiGene
• Shanghai Henlius Biotech
• Compass Therapeutics
• AstraZeneca
• HiFiBiO Therapeutics
• Janux Therapeutics

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)