Urothelial Carcinoma emerging therapies such as KEYTRUDA (pembrolizumab), OPDIVO (nivolumab), BT8009, Erdafitinib and Cetrelimab, and others are expected to boost the Urothelial Carcinoma Market in the upcoming years.
DelveInsight has launched a new report on “Urothelial Carcinoma – Market Insights, Epidemiology, and Market Forecast-2034” that delivers an in-depth understanding of the Urothelial Carcinoma, historical and forecasted epidemiology as well as the Urothelial Carcinoma market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
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Recent advancements in the Urothelial Carcinoma Market:
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In May 2022, Exelixis, Inc. released detailed findings from multiple cohorts of the Phase Ib COSMIC-021 trial, evaluating cabozantinib (CABOMETYX^®) both as a monotherapy and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The company announced plans to present data from Urothelial Carcinoma (UC) cohorts 3, 4, and 5, as well as Non-Small Cell Lung Cancer (NSCLC) cohorts 7 and 20, during oral abstract sessions at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 3–7.
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In May 2022, Kinnate Biopharma Inc. unveiled the design and rationale for its Phase I trial-in-progress (KIN-4802, NCT05242822) assessing KIN-3248, a pan-FGFR inhibitor. The company planned to present details during a poster session on June 6, 2022, at the ASCO Annual Meeting.
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In April 2022, Ikena Oncology, Inc. announced it would present two trial-in-progress posters at ASCO 2022, providing insights into clinical trials for its TEAD inhibitor, IK-930, and aryl hydrocarbon receptor (AHR) antagonist, IK-175.
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In March 2022, Juniper Biologics Pte Ltd and Helsinn Group entered into an exclusive licensing agreement for the development and commercialization of infigratinib (INN) in Australia, New Zealand, Southeast Asia, and select Middle Eastern and African markets. This agreement focuses on treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangements.
Some of the key facts of the Urothelial Carcinoma Market Report:
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In 2023, the Urothelial Carcinoma market was valued at approximately USD 900 million in the 7MM and is projected to grow by 2034 during the study period (2020–2034).
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Urothelial Carcinoma is a type of cancer that originates in the urothelial cells lining the urinary tract. The term “urothelium” refers to the epithelial lining found on the mucosal surfaces of the renal collecting tubules, calyces, pelvis, ureter, bladder, and urethra.
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The majority (~90%) of Urothelial Carcinoma cases are Urothelial Bladder Cancer (UBC), while Upper Tract Urothelial Carcinoma (UTUC) accounts for only 5–10% of all urothelial malignancies.
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This cancer primarily affects males (70–80%), likely due to the higher prevalence of smoking among men compared to women. Smoking is a significant risk factor, with nearly half of Urothelial Carcinoma cases linked to a history of smoking.
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In 2023, the United States had the highest incidence of Urothelial Carcinoma, accounting for approximately 40% of all reported cases.
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The risk of developing Urothelial Carcinoma increases with age, with approximately 90% of patients being over 60. This may also be because the disease is often diagnosed at later stages, with around 30% of cases identified at muscle-invasive or metastatic stages.
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According to the World Health Organization (2016), bladder cancers are classified based on differentiation, ranging from low grade (grades 1 and 2) to high grade (grade 3). These classifications influence risk assessment and patient management strategies.
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Several major pharmaceutical companies, including Johnson & Johnson, AstraZeneca, and Astellas Pharma/Seagen/Merck, are actively engaged in developing treatments for Urothelial Carcinoma. The anticipated introduction of new and emerging therapies is expected to drive substantial market growth throughout the forecast period (2024–2034).
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Promising Urothelial Carcinoma pipeline therapies in various stages of development include KEYTRUDA (pembrolizumab), OPDIVO (nivolumab), BT8009, Erdafitinib and Cetrelimab, and others.
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Key benefits of the Urothelial Carcinoma market report:
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Urothelial Carcinoma market report covers a descriptive overview and comprehensive insight of the Urothelial Carcinoma Epidemiology and Urothelial Carcinoma market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
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The Urothelial Carcinoma market report provides insights on the current and emerging therapies.
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Urothelial Carcinoma market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Urothelial Carcinoma market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Urothelial Carcinoma market.
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Urothelial Carcinoma Overview
Urothelial Carcinoma is the most common cancer affecting the urinary tract, typically arising from the urothelial cells and predominantly diagnosed in individuals over the age of 50. It is significantly more frequent in men, with incidence rates two to three times higher than in women.
The disease is marked by the invasion of neoplastic urothelial cells into the basement membrane or lamina propria. Approximately 90% of cases are Urothelial Bladder Cancer (UBC), while Upper Tract Urothelial Carcinoma (UTUC) makes up just 5–10% of all urothelial cancers. Major risk factors for both UBC and UTUC include cigarette smoking, occupational exposure to carcinogens, along with various environmental and genetic influences.
Urothelial Carcinoma Treatment Market
Around 70% of patients are diagnosed with non-muscle-invasive bladder cancer (NMIBC), though 10–30% of these cases eventually progress to a more invasive form despite localized therapies. The remaining 30% present with muscle-invasive bladder cancer (MIBC), which has a high likelihood of metastasis and disease advancement, even after aggressive treatment such as radical surgery and systemic therapy.
Chemotherapy, particularly with cisplatin-based combinations, remains the primary treatment strategy. In cases where the disease advances following initial systemic therapy, immunotherapy options—such as atezolizumab and pembrolizumab—offer alternative treatment pathways. Surgical interventions like nephroureterectomy may also be required depending on disease progression.
Since the 1970s and 1980s, chemotherapy has served as a foundation in the management of urothelial carcinoma. Platinum-based regimens, including MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin) and GC (gemcitabine and cisplatin), remain the standard first-line treatments for advanced or metastatic stages of the disease.
Urothelial Carcinoma Market Outlook
The urothelial carcinoma market is expected to undergo significant transformation in the coming years, driven by the anticipated introduction of novel therapies from leading pharmaceutical companies including Pfizer, Merck, Eisai Inc., AstraZeneca, Seagen Inc., Bayer, Incyte Corporation, Acerta Pharma BV, and others over the forecast period 2020–2034.
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Urothelial Carcinoma Marketed Therapies
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KEYTRUDA (pembrolizumab): Merck
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OPDIVO (nivolumab): Bristol Myers Squibb
Urothelial Carcinoma Emerging Therapies
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BT8009: Bicycle Therapeutics
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Erdafitinib and Cetrelimab: Johnson & Johnson
Scope of the Urothelial Carcinoma Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Urothelial Carcinoma Companies: Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, and others
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Key Urothelial Carcinoma Therapies: KEYTRUDA (pembrolizumab), OPDIVO (nivolumab), BT8009, Erdafitinib and Cetrelimab, and others
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Urothelial Carcinoma Therapeutic Assessment: Urothelial Carcinoma current marketed and Urothelial Carcinoma emerging therapies
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Urothelial Carcinoma Market Dynamics: Urothelial Carcinoma market drivers and Urothelial Carcinoma market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
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Urothelial Carcinoma Unmet Needs, KOL’s views, Analyst’s views, Urothelial Carcinoma Market Access and Reimbursement
Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Urothelial Carcinoma Patient Share (%) Overview at a Glance
5. Urothelial Carcinoma Market Overview at a Glance
6. Urothelial Carcinoma Disease Background and Overview
7. Urothelial Carcinoma Epidemiology and Patient Population
8. Country-Specific Patient Population of Urothelial Carcinoma
9. Urothelial Carcinoma Current Treatment and Medical Practices
10. Unmet Needs
11. Urothelial Carcinoma Emerging Therapies
12. Urothelial Carcinoma Market Outlook
13. Country-Wise Urothelial Carcinoma Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Urothelial Carcinoma Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Related Reports:
Urothelial Carcinoma Pipeline Insights, DelveInsight
“Urothelial Carcinoma Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Urothelial Carcinoma market. A detailed picture of the Urothelial Carcinoma pipeline landscape is provided, which includes the disease overview and Urothelial Carcinoma treatment guidelines.
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