Advanced Renal Cell Carcinoma Market
- According to DelveInsight, Advanced Renal Cell Carcinoma market is expected to grow at a decent CAGR by 2034.
- A notable advancement occurred in December 2023, when the FDA approved Merck’s WELIREG, reflecting ongoing efforts to expand and improve therapeutic options for this challenging condition.
- Renal cell carcinoma is the most common type of kidney cancer accounting for around 90 percent of all kidney cancers. It is among the top ten most common cancers in the world. Patients with advanced RCC have five-year survival rates of approximately 11-12 percent.
- RCC occurs most often in people older than 50. It is more common in men than in women. Several factors which to an increased risk of RCC, include smoking, obesity, high blood pressure, and having a family history of certain conditions, such as von Hippel–Lindau disease.
- The diagnosis and treatment of both localized ad metastatic RCC have evolved in recent years. The use of abdominal computed tomography or magnetic resonance imaging has contributed to an increased incidence of the disease with identification of asymptomatic lesions.
- Metastasis, the spread of cancer cells from the kidney, can occur in various locations in the body. These include the lymph nodes surrounding the kidney, the renal vein, and the vena cava. Additionally, metastasis may affect the other kidney and the adrenal glands.
- The landscape of advanced RCC treatment has undergone a transformative shift with the introduction of immune checkpoint inhibitors and targeted therapies. These innovations, whether administered individually or in combination, have significantly broadened therapeutic choices and enhanced survival rates for patients. By leveraging a deeper comprehension of the molecular and genetic underpinnings of RCC, targeted therapies have emerged as potent tools, substantially enhancing patient outcomes. This dual approach marks a pivotal advancement in RCC management, promising improved efficacy and prognosis for those facing this challenging disease.
- Regulatory bodies and key pharmaceutical companies are actively engaged in enhancing the treatment landscape for advanced renal cell carcinoma.
- The competitive landscape for advanced RCC is intense, with multiple established and emerging therapies challenging each other’s market share, particularly with the rise of combination treatments involving immunotherapy and tyrosine kinase inhibitors.
- Advanced Renal Cell Carcinoma Companies like Exelixis, Bristol-Myers Squibb (BMS), AstraZeneca, HUTCHMED, and others are actively advancing their pipelines to develop new treatments for advanced renal cell carcinoma (aRCC). These efforts highlight a robust commitment within the pharmaceutical industry to innovate and improve therapeutic options for patients battling this aggressive cancer
To know Advanced RCC Market CAGR and Trends, click here @ Advanced Renal Cell Carcinoma Market Report
DelveInsight's “ Advanced Renal Cell Carcinoma Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of advanced renal cell carcinoma, historical and forecasted epidemiology as well as the advanced renal cell carcinoma market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
Advanced renal cell carcinoma market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted market size of 7MM advanced renal cell carcinoma from 2020 to 2034. The report also covers current advanced renal cell carcinoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.
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Study Period |
2020–2034 |
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Forecast Period |
2024–2034 |
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Geographies Covered |
US, EU4 (Germany, France, Italy, and Spain) the UK, and Japan |
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Advanced Renal Cell Carcinoma Epidemiology
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Segmented by:
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Advanced Renal Cell Carcinoma key companies |
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Advanced Renal Cell Carcinoma therapies/drug |
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Advanced Renal Cell Carcinoma Market |
Segmented by:
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Analysis |
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Key Factors Driving the Advanced Renal Cell Carcinoma Market
Rising advanced renal cell carcinoma incidence & disease burden
Kidney cancer incidence is growing worldwide (≈400,000 new cases/year; ~175,000 deaths/year), which increases the advanced-RCC patient pool and demand for therapies.
Emergence of novel targeted classes — HIF-2α inhibitors
HIF-2α inhibitors (e.g., Merck’s WELIREG) are now validated for RCC and represent a new oral targeted class entering later-line and possibly earlier-line settings, creating additional revenue and shifting treatment algorithms. Additionally, NiKang Therapeutics is also working with its candidate NKT2152 to improve the treatment landscape.
Emerging advanced renal cell carcinoma therapies
Some of the advanced renal cell carcinoma drugs in clinical trials include TLX250-CDx (Telix Pharmaceuticals), Ciforadenant (Corvus Pharmaceuticals), Temferon (Genenta Science), NKT2152 (NiKang Therapeutics), Abexinostat (Xynomic Pharmaceuticals), NGM707 (NGM Biopharmaceuticals), TLX250-CDx (Telix), and others.
Advanced Renal Cell Carcinoma Treatment Market
Advanced Renal Cell Carcinoma Overview, Country-Specific Treatment Guidelines and Diagnosis
Renal cell carcinoma (RCC) is the most common type of kidney cancer, originating in the tiny tubules within the kidneys. These tubules play a crucial role in directing essential substances like water and nutrients to the bloodstream while filtering waste through urine. When RCC spreads beyond the kidneys to other parts of the body, such as the lungs, spine, and lymphatic system, it becomes metastatic renal cell carcinoma. It's also called stage IV renal cell cancer. The progression rate of mRCC can vary, but advancements in treatment have significantly improved the management of the disease, offering patients better outcomes and quality of life.
Symptoms may include blood in the urine, pain on one side of the lower back, a lump or fullness in the back or side, weight loss, fatigue, fever, night sweats, a general feeling of being unwell, and high blood pressure. When the cancer becomes advanced, the symptoms can vary depending on where it has spread. Common symptoms of advanced renal cell carcinoma include weight loss, pain, breathing problems or shortness of breath, weakness, and fatigue.
The advanced renal cell carcinoma market report provides an overview of advanced renal cell carcinoma pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.
Further details related to country-based variations in diagnosis are provided in the report
Advanced Renal Cell Carcinoma Treatment
The management of advanced renal cell carcinoma has significantly evolved over the past decade, with the introduction of new treatments and advances in surgery and ablative techniques. Therapies for advanced patients have become more personalized, with different prognostic groups established to tailor treatment to the disease's severity. For patients with isolated metastasis in good condition, surgical excision, radiotherapy, or ablative therapy may be proposed to delay the initiation of systemic therapy. For those not eligible for surgical resection, alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy are recommended. Additionally, targeted therapies using tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become widely used in both first- and second-line treatments, providing effective management options for advanced renal cell carcinoma.
Advanced Renal Cell Carcinoma Epidemiology
The advanced renal cell carcinoma epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The advanced renal cell carcinoma epidemiology is segmented with detailed insights into Incident Cases of Kidney Cancer, Incident Cases of Renal Cell Carcinoma, Subtype-specific Incident of Renal Cell Carcinoma, Stage-specific Incident of Renal Cell Carcinoma, Gender-specific Incident of advanced Renal Cell Carcinoma, Diagnosed and Treated Cases of advanced Renal Cell Carcinoma
- According to findings, renal cell carcinoma accounts for 90% of all kidney cancers.
- One in three people with renal cell carcinoma receive a diagnosis at the metastatic stage.
- RCC predominantly affects the male population, with men being significantly more susceptible as compared to women.
- There are several types of RCC, but 75% of patients have a type called clear cell.
- Several factors can be attributed to an increased risk of RCC, including smoking, obesity, and high blood pressure and having a family history of certain conditions, such as von Hippel-Lindau disease, a rare genetic multi-system disorder characterized by abnormal blood vessel growth.
- RCC is difficult to detect in its early stages, and >30% patients with RCC have metastatic, or advanced, cancer at the time of diagnosis, meaning the cancer cells have spread beyond the kidney to other parts of the body.
Advanced Renal Cell Carcinoma Recent Developments
- In February 2025, Telix Pharmaceuticals announced the FDA accepted the Biologics License Application for TLX250-CDx, a novel imaging agent for kidney cancer, granting it Priority Review. This brings Telix closer to potentially launching the first imaging agent to accurately diagnose clear cell renal cell carcinoma.
- In January 2025, INNOVATE Corp. announced that the U.S. FDA has approved the MediBeacon® TGFR for assessing kidney function in patients with normal or impaired renal function.
Advanced Renal Cell Carcinoma Drug Chapters
The drug chapter segment of the advanced renal cell carcinoma market report encloses a detailed analysis of advanced renal cell carcinoma marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the advanced renal cell carcinoma clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.
Marketed Advanced Renal Cell Carcinoma Drugs
KEYTRUDA (pembrolizumab): Merck
It is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells. In April 2019, the FDA approved pembrolizumab plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma
WELIREG (belzutifan): Merck
Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α). HIF-2α is a transcription factor that plays a role in oxygen sensing by regulating genes that promote adaptation to hypoxia. Under normal oxygen levels, HIF-2α is targeted for ubiquitin-proteasomal degradation by VHL protein. In December 2023, the US FDA WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma.
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Therapy Name |
Company Name |
ROA |
MOA |
Phases |
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Zanzalintinib (XL092) + Nivolumab |
Exelixis/ BMS |
Oral |
Tyrosine kinases inhibitor |
III |
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Savolitinib + Durvalumab |
AstraZeneca/ HUTCHMED |
Oral |
MET inhibitor |
III |
Note: Detailed current therapies assessment will be provided in the full report of advanced renal cell carcinoma
Emerging Advanced Renal Cell Carcinoma Drugs
Zanzalintinib (XL092) + Nivolumab: Exelixis/BMS
Zanzalintinib represents a next‐generation oral TKI designed to inhibit the activity of receptor tyrosine kinases associated with cancer growth and spread. These include VEGF receptors, MET, AXL, and MER, which play crucial roles in various cellular functions and pathological processes such as oncogenesis, metastasis, and tumor angiogenesis. Zanzalintinib builds upon Exelixis' extensive experience with cabozantinib, their flagship medicine, aiming to enhance key characteristics like pharmacokinetic half‐life.
Savolitinib + Durvalumab: AstraZeneca/HUTCHMED
Savolitinib is an investigational inhibitor of the mesenchymal–epithelial transition factor, or MET receptor tyrosine kinase, an enzyme that has been shown to function abnormally in many types of solid tumors. We designed savolitinib through chemical structure modification to specifically address kidney toxicity, the primary issue that halted the development of several other selective MET inhibitors.
Note: Detailed emerging therapies assessment will be provided in the final report.
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Therapy Name |
Company Name |
ROA |
MOA |
Phases |
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Zanzalintinib (XL092) + Nivolumab |
Exelixis/ BMS |
Oral |
Tyrosine kinases inhibitor |
III |
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Savolitinib + Durvalumab |
AstraZeneca/ HUTCHMED |
Oral |
MET inhibitor |
III |
Advanced Renal Cell Carcinoma Market Outlook
Key Advanced Renal Cell Carcinoma companies, including Exelixis, Bristol-Myers Squibb (BMS), AstraZeneca, and HUTCHMED, are actively evaluating their lead candidates at various stages of clinical development, focusing on the treatment of advanced renal cell carcinoma. The Advanced Renal Cell Carcinoma market outlook appears promising, driven by these companies' efforts to innovate and expand the therapeutic arsenal. As these investigational therapies progress through clinical trials, they hold the potential to significantly improve patient outcomes and address unmet needs in advanced renal cell carcinoma management. The competitive landscape is poised for dynamic growth, with advancements in targeted therapies, immunotherapies, and combination treatments, ultimately aiming to enhance survival rates and quality of life for patients.
Advanced Renal Cell Carcinoma Drugs Uptake
This section focuses on the uptake rate of potential Advanced Renal Cell Carcinoma drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key Advanced Renal Cell Carcinoma companies evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.
Further detailed analysis of emerging therapies drug uptake in the report…
Advanced Renal Cell Carcinoma Pipeline Activities
The Advanced Renal Cell Carcinoma market report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key Advanced Renal Cell Carcinoma companies involved in developing targeted therapeutics.
Pipeline Development Activities
The Advanced Renal Cell Carcinoma market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for advanced Renal Cell Carcinoma emerging therapies.
Advanced Renal Cell Carcinoma KOL Views
To keep up with the real-world scenario in current and emerging Advanced Renal Cell Carcinoma market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.
DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of advanced renal cell carcinoma. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Advanced Renal Cell Carcinoma market and the unmet needs.
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Region |
KOL Views |
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United States |
“With a richer understanding of renal cell carcinoma (RCC) tumor biology and the addition of immune checkpoint inhibitors (ICIs) to the treatment landscape, the prognosis for many patients with metastatic disease has improved. Still, resistance to checkpoint inhibition is common and contributes to the poor 5-year survival rate of 10% in the metastatic RCC setting.” |
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UK |
“Advances in renal cell carcinoma (RCC) treatment algorithms, fostered by a better understanding of molecular and genomic aberrations underlying kidney cancer pathogenesis and the addition of immune checkpoint inhibitors (ICIs) to frontline advanced RCC management, have led to significant improvements in patient response rates and survival outcomes. Several immunotherapies, such as ICI-ICI combinations or combined with tyrosine kinase inhibitors (TKIs) targeting VEGF, are now approved for the management of metastatic RCC (mRCC).” |
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging Advanced Renal Cell Carcinoma therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Advanced Renal Cell Carcinoma Market Access and Reimbursement
The Advanced Renal Cell Carcinoma market report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Scope of the Advanced Renal Cell Carcinoma Market Report
- The Advanced Renal Cell Carcinoma market report covers a segment of key events, an executive summary, descriptive overview of advanced renal cell carcinoma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
- Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
- A detailed review of the advanced renal cell carcinoma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
- The Advanced Renal Cell Carcinoma market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM advanced renal cell carcinoma market.
Advanced Renal Cell Carcinoma Market Report Insights
- Advanced Renal Cell Carcinoma Patient Population
- Advanced Renal Cell Carcinoma Therapeutic Approaches
- Advanced Renal Cell Carcinoma Pipeline Analysis
- Advanced Renal Cell Carcinoma Market Size
- Advanced Renal Cell Carcinoma Market Trends
- Existing and future Advanced Renal Cell Carcinoma Market Opportunity
Advanced Renal Cell Carcinoma Market Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- Advanced Renal Cell Carcinoma Epidemiology Segmentation
- Inclusion of Country specific treatment guidelines
- KOL’s feedback on approved and emerging Advanced Renal Cell Carcinoma therapies
- Key Cross Competition
- Conjoint analysis
- Advanced Renal Cell Carcinoma Drugs Uptake
- Key Advanced Renal Cell Carcinoma Market Forecast Assumptions
Advanced Renal Cell Carcinoma Market Report Assessment
- Current Advanced Renal Cell Carcinoma Treatment Practices
- Advanced Renal Cell Carcinoma Unmet Needs
- Advanced Renal Cell Carcinoma Pipeline Product Profiles
- Advanced Renal Cell Carcinoma Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
- What is the growth rate of the 7MM advanced renal cell carcinoma treatment market?
- What was the advanced renal cell carcinoma market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
- What are the pricing variations among different geographies for approved and off-label therapies?
- How would the market drivers, barriers, and future opportunities affect the Advanced Renal Cell Carcinoma market dynamics and subsequent analysis of the associated trends?
- What are the current and emerging options for the treatment of advanced renal cell carcinoma?
- How many Advanced Renal Cell Carcinoma companies are developing therapies for the treatment of advanced renal cell carcinoma?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
- Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios.
- What are the country-specific accessibility issues of expensive, recently approved Advanced Renal Cell Carcinoma therapies?
- How will the patent expiry of KEYTRUDA affect the advanced RCC market?
Reasons to buy
- The Advanced Renal Cell Carcinoma market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the advanced renal cell carcinoma Market.
- Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
- Understand the existing Advanced Renal Cell Carcinoma market opportunities in varying geographies and the growth potential over the coming years.
- Distribution of historical and current Advanced Renal Cell Carcinoma patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identifying strong upcoming Advanced Renal Cell Carcinoma companies in the market will help devise strategies to help get ahead of competitors.
- Detailed analysis, ranking of class-wise potential current, and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
- Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
- To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
- Detailed insights on the unmet needs of the existing Advanced Renal Cell Carcinoma market so that the upcoming Advanced Renal Cell Carcinoma companies can strengthen their development and launch strategy.




