진행성 신세포암 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the advanced renal cell carcinoma market size was valued at USD 9.32 billion in 2025 and is estimated to grow from USD 9.96 billion in 2026 to reach USD 13.89 billion by 2031, at a CAGR of 6.88% during the forecast period (2026-2031).

This report is Segmented by Therapy Type (Immunotherapy, Targeted Therapy, Combination, Others), Line of Therapy (First-Line, Second-Line, Third-Line+, Maintenance), Disease Subtype (Clear Cell, Papillary, Other), Route of Administration (Oral, IV, Subcutaneous, Other), End User (Hospitals, Institutes, Others), and Geography (North America, Europe, APAC, MEA, South America). Forecasts in Value (USD).

Global Advanced Renal Cell Carcinoma Market Trends and Insights

Rising Incidence and Diagnosis of RCC

Kidney cancer incidence is rising, expanding the addressable patient pool for systemic treatment. A 2025 analysis found that incident kidney cancer cases among adults aged 65 years and older increased from 70,003 in 1990 to 203,022 in 2024. Older patients often require closer monitoring and may continue treatment across multiple lines of care. Between 20% and 30% of patients present with metastatic disease at diagnosis, while another 30% to 50% progress after local treatment. In the United States, Merck projected more than 80,000 new kidney cancer cases and more than 15,000 deaths in 2026, supporting sustained demand for advanced disease therapies.

Durable Survival Benefit From Combination Immunotherapy

Combination immunotherapy has shifted many first-line advanced RCC settings away from single-agent approaches. Pembrolizumab plus axitinib has demonstrated sustained survival benefit across IMDC risk groups in long-term follow-up. Longer survival increases the number of patients eligible for subsequent therapy after first-regimen failure, extending demand across the treatment pathway. The advanced renal cell carcinoma market benefits as effective first-line care helps patients reach later treatment settings in better clinical condition.

Treatment-Related Toxicity and Discontinuation

Treatment-related toxicity can limit the practical use of new combinations in the advanced renal cell carcinoma market. HIF-2a inhibition can cause anemia and hypoxia, requiring monitoring that specialist oncology centers may manage more effectively than less-resourced settings. Checkpoint inhibitors can trigger immune-related adverse events, including pneumonitis, colitis, and endocrine disorders, and patients may need coordinated care across multiple medical teams. In a U.S. real-world study, inpatient admissions increased from 22% in second-line care to 32.7% in fourth-line care after immunotherapy and VEGF-based treatment failure. Dose reductions, treatment interruptions, and discontinuation can reduce the clinical and commercial value of later-line therapy.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Later-Line Treatment Options and Sequential Use
2. Biomarker-Enabled HIF-2a Segmentation
3. High Cost and Unequal Reimbursement

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Immunotherapy accounted for 58.88% of global revenue in 2025. PD-1 and PD-L1 inhibitors remained widely used, especially in established first-line combinations. Pembrolizumab-, nivolumab-, and ipilimumab-based regimens retained a durable role, supported by clinical evidence across risk groups. Targeted therapy is the fastest-growing segment, with the advanced renal cell carcinoma market size projected to rise at an 8.15% CAGR from 2026 to 2031.

Targeted therapy growth reflects the role of HIF-2a inhibitors and the continued use of next-generation VEGFR-TKIs. The February 2025 European approval of WELIREG for previously treated advanced clear cell RCC gave this category a defined role in European later-line care. Cytokine-based treatments retained limited use where access to newer therapies was restricted, while cytotoxic and other systemic therapies remained relevant for select refractory patients. Oral and subcutaneous forms may shift more treatment away from infusion centers, changing the balance between specialty pharmacy and hospital channels in the advanced renal cell carcinoma industry.

First-line treatment held 64.34% of global revenue in 2025. This position reflected the high cost of initial treatment and the broad use of immunotherapy combinations when clinicians first managed advanced disease. First-line regimens shaped subsequent care because earlier exposure to immunotherapy and VEGF-targeted agents influenced later treatment choices. Third-line and later treatment is the fastest-growing category, with the advanced renal cell carcinoma market size in this segment forecast to expand at a 9.80% CAGR from 2026 to 2031.

Later-line growth increased as survival improved in earlier stages of care. A systematic review presented at ASCO 2026 found that TKI-based regimens remained a reliable second-line option after immune checkpoint inhibitor failure. The June 2026 approval of pembrolizumab plus belzutifan in adjuvant care blurred the boundary between perioperative and metastatic treatment. Patients exposed to immunotherapy before metastatic recurrence may require different sequencing strategies, creating demand for prospective evidence after adjuvant therapy.

Complete Report Scope:

• By Therapy Type
  • Immunotherapy
    • PD-1 and PD-L1 Inhibitors
    • CTLA-4 Inhibitors
    • Cytokine-Based Immunotherapy
  • Targeted Therapy
    • VEGFR Tyrosine Kinase Inhibitors
    • HIF-2- Inhibitors
    • mTOR Inhibitors
    • Multikinase and MET Inhibitors
  • Combination Therapy
    • IO-IO Combinations
    • IO-TKI Combinations
    • Targeted-Therapy Combinations
  • Cytotoxic and Other Systemic Therapy
• By Line of Therapy
  • First-Line Treatment
  • Second-Line Treatment
  • Third-Line and Later Treatment
  • Maintenance and Treatment Sequencing
• By Disease Subtype
  • Clear Cell RCC
  • Papillary RCC
  • Other
• By Route of Administration and Form
  • Oral
  • Intravenous
  • Subcutaneous
  • Combination and Sequential Administration
• By End User
  • Hospitals and Hospital Pharmacies
  • Cancer Research Institutes
  • Ambulatory Surgical Centers
  • Academic and Research Institutes
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 39.89% of global advanced renal cell carcinoma market revenue in 2025. The region benefited from high disease incidence, early access to new medicines, and public and private reimbursement systems that supported treatment adoption. U.S. women had an age-standardized kidney cancer incidence rate of 8.7 per 100,000, among the highest rates reported globally. The United States received FDA approval for pembrolizumab plus belzutifan in adjuvant clear cell RCC in June 2026, while Canada and Mexico contributed less revenue but continued to expand access.

Europe was the second-largest regional area in the advanced renal cell carcinoma market, with approval pathways supporting access across 27 European Union member states after national reimbursement decisions. The European Commission conditionally approved WELIREG for advanced clear cell RCC in February 2025 and approved subcutaneous nivolumab in May 2025. Germany remained a major revenue center, while South America had lower but improving access. Brazil and Argentina expanded procurement and insurance coverage, although drug costs and fragmented reimbursement continued to limit regional uptake.

Asia-Pacific was the fastest-growing region in the advanced renal cell carcinoma market and is forecast to expand at an 8.58% CAGR from 2026 to 2031. China remained central to this growth due to rising incidence, expanding infrastructure, and locally developed regimens. In May 2026, China's NMPA approved sintilimab plus fruquintinib for locally advanced or metastatic RCC after prior VEGFR-TKI treatment. Japan's accelerated pathways and expanding oncology networks in India, South Korea, and Australia supported access, although South Korea still had reimbursement gaps. The Middle East and Africa remained split between early adoption in GCC states and infrastructure and supply barriers across many Sub-Saharan markets, while the Africa Medicines Agency framework offered a longer-term path to alignment.

1. Abbvie
2. Arcus Biosciences, Inc.
3. Astellas Pharma
4. AstraZeneca
5. AVEO Oncology, Inc.
6. Bayer
7. BeiGene, Ltd.
8. Bristol-Myers Squibb
9. Eisai
10. Exelixis, Inc.
11. Roche
12. HUTCHMED (China) Limited
13. Ipsen Pharma SAS
14. Johnson & Johnson
15. Merck
16. Novartis
17. Ono Pharmaceutical
18. Pfizer
19. Regeneron Pharmaceuticals
20. Sanofi
21. Takeda Pharmaceuticals
22. Telix Pharmaceuticals Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Incidence and Diagnosis of RCC
  • 4.2.2 Durable Survival Benefit From Combination Immunotherapy
  • 4.2.3 Expansion of Later-Line Treatment Options
  • 4.2.4 Biomarker-Enabled HIF-2- Segmentation
  • 4.2.5 Longer Treatment Duration and Sequential Regimen Use
  • 4.2.6 Increasing Recognition of Oligometastatic and Site-Specific Management
• 4.3 Market Restraints
  • 4.3.1 Treatment-Related Toxicity and Discontinuation
  • 4.3.2 High Cost and Unequal Reimbursement
  • 4.3.3 Treatment Sequencing Uncertainty After IO-TKI Failure
  • 4.3.4 Limited Prospective Evidence in Non-Clear Cell RCC and Rare Hereditary Subtypes
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Rivalry Among Existing Competitors

5 MARKET SIZE AND GROWTH FORECASTS ( VALUE, USD)

• 5.1 By Therapy Type
  • 5.1.1 Immunotherapy
    • 5.1.1.1 PD-1 and PD-L1 Inhibitors
    • 5.1.1.2 CTLA-4 Inhibitors
    • 5.1.1.3 Cytokine-Based Immunotherapy
  • 5.1.2 Targeted Therapy
    • 5.1.2.1 VEGFR Tyrosine Kinase Inhibitors
    • 5.1.2.2 HIF-2- Inhibitors
    • 5.1.2.3 mTOR Inhibitors
    • 5.1.2.4 Multikinase and MET Inhibitors
  • 5.1.3 Combination Therapy
    • 5.1.3.1 IO-IO Combinations
    • 5.1.3.2 IO-TKI Combinations
    • 5.1.3.3 Targeted-Therapy Combinations
  • 5.1.4 Cytotoxic and Other Systemic Therapy
• 5.2 By Line of Therapy
  • 5.2.1 First-Line Treatment
  • 5.2.2 Second-Line Treatment
  • 5.2.3 Third-Line and Later Treatment
  • 5.2.4 Maintenance and Treatment Sequencing
• 5.3 By Disease Subtype
  • 5.3.1 Clear Cell RCC
  • 5.3.2 Papillary RCC
  • 5.3.3 Other
• 5.4 By Route of Administration and Form
  • 5.4.1 Oral
  • 5.4.2 Intravenous
  • 5.4.3 Subcutaneous
  • 5.4.4 Combination and Sequential Administration
• 5.5 By End User
  • 5.5.1 Hospitals and Hospital Pharmacies
  • 5.5.2 Cancer Research Institutes
  • 5.5.3 Ambulatory Surgical Centers
  • 5.5.4 Academic and Research Institutes
  • 5.5.5 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 AbbVie Inc.
  • 6.3.2 Arcus Biosciences, Inc.
  • 6.3.3 Astellas Pharma Inc.
  • 6.3.4 AstraZeneca PLC
  • 6.3.5 AVEO Oncology, Inc.
  • 6.3.6 Bayer AG
  • 6.3.7 BeiGene, Ltd.
  • 6.3.8 Bristol-Myers Squibb Company
  • 6.3.9 Eisai Co., Ltd.
  • 6.3.10 Exelixis, Inc.
  • 6.3.11 F. Hoffmann-La Roche Ltd.
  • 6.3.12 HUTCHMED (China) Limited
  • 6.3.13 Ipsen Pharma SAS
  • 6.3.14 Johnson & Johnson
  • 6.3.15 Merck & Co., Inc.
  • 6.3.16 Novartis AG
  • 6.3.17 Ono Pharmaceutical Co., Ltd.
  • 6.3.18 Pfizer Inc.
  • 6.3.19 Regeneron Pharmaceuticals, Inc.
  • 6.3.20 Sanofi
  • 6.3.21 Takeda Pharmaceutical Company Limited
  • 6.3.22 Telix Pharmaceuticals Limited

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment