Urothelial Carcinoma Market Set to Expand During the Forecast Period (2025-2034) Amid Rising Incidence and Evolving Therapeutic Landscape | DelveInsight

The dynamics of the urothelial carcinoma market are anticipated to change due to the demand for innovative therapies, particularly in chemotherapy and immunotherapy, and increased awareness about bladder cancer and government initiatives aimed at promoting early detection and treatment.

LAS VEGAS, Aug 6, 2025 /PRNewswire/ -- DelveInsight's Urothelial Carcinoma Market Insights report includes a comprehensive understanding of current treatment practices, urothelial carcinoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Takeaways from the Urothelial Carcinoma Market Report

• According to DelveInsight's analysis, the market size for urothelial carcinoma in the 7MM is expected to grow significantly by 2034.
• The United States accounted for the highest urothelial carcinoma treatment market size in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Among 7MM, the US accounted for the highest number of incident cases of urothelial carcinoma, i.e., around  87K in 2024.
• Leading urothelial carcinoma companies developing emerging therapies, such as UroGen Pharma, Tyra Biosciences, Taiho Oncology, and others, are developing new urothelial carcinoma treatment drugs that can be available in the urothelial carcinoma market in the coming years.
• The promising urothelial carcinoma therapies in the pipeline include UGN-104, TYRA-300, Futibatinib + pembrolizumab, and others.

Discover the urothelial carcinoma new treatment @ New Treatments for Urothelial Carcinoma

Urothelial Carcinoma Market Dynamics

The urothelial carcinoma market dynamics are expected to change in the coming years. Advancements in computational and bioinformatics platforms, along with various R&D practices, are enabling the development of the urothelial carcinoma market, where drug combination therapies offer more effective disease control. The proven efficacy of available drug classes, used either as monotherapy or in combination, is further driving market growth. Additionally, the rising frequency of germline mutations in bladder and upper urinary tract cancers over the past decade underscores the importance of germline testing in guiding treatment decisions. As a result, ongoing efforts to develop and validate biomarkers increasingly rely on such tools to identify patients who may benefit from targeted therapies.

As potential therapies are being investigated for the treatment of urothelial carcinoma, it is safe to predict that the treatment space will significantly impact the urothelial carcinoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the urothelial carcinoma market in the 7MM.

However, several factors may impede the growth of the urothelial carcinoma market. Around 50% of patients with metastatic urothelial cancer are ineligible for standard cisplatin-based chemotherapy due to comorbidities, highlighting a significant unmet need for tolerable therapies that can extend survival in older, frail populations. Additionally, up to half of bladder cancer patients experience recurrence within a year post-surgery, with no effective measures currently available to prevent it, leaving many patients fearful of relapse. This underscores the urgent demand for new treatment options in the adjuvant setting, where novel approaches such as cancer vaccines are emerging as potential competitors to traditional therapies like chemotherapy.

Moreover, urothelial carcinoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the urothelial carcinoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Urothelial Carcinoma market growth.

Urothelial Carcinoma Treatment Market

The current management of urothelial carcinoma relies on a comprehensive, multimodal strategy. For non-muscle invasive disease, surgical procedures such as Transurethral Resection (TUR) are commonly used for diagnosis, staging, and initial control. In more advanced or recurrent cases, repeat TUR or radical cystectomy may be warranted.

For patients with locally advanced or metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the standard first-line therapy. However, targeted treatments such as FGFR inhibitors and immune checkpoint inhibitors (targeting PD-1/PD-L1) have emerged as valuable alternatives, especially for individuals with specific genetic alterations or treatment-resistant disease.

Several pharmaceutical companies are at the forefront of this therapeutic area, including UroGen Pharma (JELMYTO), Pfizer, Astellas Pharma (PADCEV), Johnson & Johnson Innovative Medicine (BALVERSA), and Merck (KEYTRUDA).

PADCEV (enfortumab vedotin-ejfv) is a pioneering Antibody-Drug Conjugate (ADC) that targets Nectin-4, a cell surface protein abundantly expressed in bladder cancer. Preclinical studies indicate that PADCEV exerts its anti-tumor effects by binding to Nectin-4-positive cells, leading to internalization and release of the cytotoxic agent Monomethyl Auristatin E (MMAE). This results in cell cycle arrest and apoptosis.

PADCEV received FDA approval in December 2019 for patients with locally advanced or metastatic urothelial cancer who had previously been treated with both a PD-1/PD-L1 inhibitor and platinum-based chemotherapy, either before or after surgery or in the metastatic setting. In April 2023, the FDA further approved the combination of PADCEV with KEYTRUDA for patients ineligible for cisplatin-containing regimens.

OPDIVO, an immune checkpoint inhibitor targeting the PD-1 receptor, enhances T-cell activity against tumor cells, thereby acting as a powerful immunotherapeutic agent. Its clinical utility includes indications, mechanism of action, dosing protocols, and known side effects, especially relevant to clinicians treating metastatic melanoma and similar cancers.

In August 2021, OPDIVO was approved by the FDA as an adjuvant therapy for patients with high-risk urothelial carcinoma following radical surgery. Most recently, in March 2024, it received approval in combination with cisplatin and gemcitabine as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma.

To know more about FDA-approved drugs for urothelial carcinoma, visit @ Approved Urothelial Carcinoma Treatment

Urothelial Carcinoma Pipeline Therapies and Key Companies

The urothelial carcinoma pipeline seems to be quite strong. The most promising ones include UGN-104 by UroGen Pharma, ACR-368 by Acrivon Therapeutics, and TYRA-300 by Tyra Biosciences.

UGN-104 is a novel mitomycin-based therapy being developed by UroGen for the treatment of low-grade upper tract urothelial carcinoma. Leveraging UroGen's RTGel® technology it allows for extended exposure to mitomycin, potentially enabling effective, non-surgical treatment. The drug is currently undergoing Phase III trials and benefits from similar intellectual property protections.

Meanwhile, TYRA-300 is an experimental FGFR3 inhibitor engineered to be both highly potent and selective. It is specifically designed to overcome key challenges associated with existing FGFR-targeted therapies, such as resistance due to mutations like the V555 gatekeeper mutation, and to minimize off-target effects by favoring FGFR3 over FGFR1 and other FGFR isoforms. TYRA-300 is under Phase I/II clinical evaluation for advanced urothelial carcinoma, and in February 2024, it received the FDA's Rare Pediatric Disease (RPD) designation.

The anticipated launch of these emerging therapies are poised to transform the urothelial carcinoma market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the urothelial carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about urothelial carcinoma marketed and pipeline drugs @ Urothelial Carcinoma Clinical Trials

Recent Developments in the Urothelial Carcinoma Market

• In June 2025, the data of OPDIVO + YERVOY for cisplatin-ineligible metastatic urothelial carcinoma, presented at the ASCO 2025, failed to improve the overall survival.
• In April 2025, UroGen Pharma highlighted the duration of response of nearly four years from a long-term follow-up study with JELMYTO for pyelocalyceal solution, which is FDA-approved for the treatment of low-grade upper tract urothelial cancer in adult patients.
• In February 2025, Pfizer and Astellas Pharma announced additional follow-up results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV + KEYTRUDA in patients with previously untreated locally advanced or metastatic urothelial cancer.
• In February 2025, first-line maintenance treatment data of the Phase III JAVELIN Bladder 100 trial of BAVENCIO in patients with advanced urothelial carcinoma with or without diabetes mellitus were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium 2025.

Urothelial Carcinoma Overview

Urothelial carcinoma exhibits a wide range of clinical behaviors. On the less severe end, it can appear as low-grade, non-muscle-invasive disease, typically not life-threatening but characterized by frequent recurrence and requiring ongoing monitoring. On the more severe end, the cancer may be high-grade, either non-muscle-invasive or muscle-invasive, both associated with a significantly elevated risk profile. Muscle-invasive bladder cancer (MIBC) is a serious condition that requires immediate intervention, while high-grade non-muscle-invasive forms have a substantial likelihood of advancing to muscle-invasive or metastatic disease, often resulting in poor prognosis. The chances of metastasis increase with tumor stage, about 25% in pT2, 50% in pT3, and 80% in pT4, correlating with five-year survival rates of 67%, 35%, and 27%, respectively. Due to the disease's heterogeneity, particularly in intermediate cases, standard treatment strategies may be ineffective for roughly one-quarter of patients.

Urine cytology is the most commonly used noninvasive method for detecting urothelial tumors, though its sensitivity is limited. Cystoscopy, while considered the gold standard for follow-up in bladder cancer patients, is invasive and expensive. Biomarker-based tests such as Bladder Tumor Antigen (BTA) stat, BTA TRAK, Nuclear Matrix Protein 22 (NMP-22), ImmunoCyt/uCyt, and UroVysion have received FDA clearance or approval as alternative diagnostic tools. However, the U.S. Preventive Services Task Force advises against routine bladder cancer screening in adults, as current noninvasive urine tests, despite their ability to identify the disease in asymptomatic individuals, offer low positive predictive value and have not been shown to improve long-term outcomes. Imaging studies of the urinary tract help determine tumor location, assess disease extent, and identify multifocal involvement. Computed tomography (CT) has largely replaced intravenous pyelography (IVP) due to its simplicity and noninvasive nature.

Urothelial Carcinoma Epidemiology Segmentation

The urothelial carcinoma epidemiology section provides insights into the historical and current urothelial carcinoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The urothelial carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:

• Total Incident Cases of Urothelial Carcinoma
• Gender-specific Incident Cases of Urothelial Carcinoma
• Age-specific Incident Cases of Urothelial Carcinoma
• Mutation-specific Incident Cases of Urothelial Carcinoma
• Stage-specific Incident Cases of Urothelial Carcinoma
• Line-wise Treated Cases of Urothelial Carcinoma

Scope of the Urothelial Carcinoma Market Report

• Therapeutic Assessment: Urothelial Carcinoma current marketed and emerging therapies
• Urothelial Carcinoma Market Dynamics: Key Market Forecast Assumptions of Emerging Urothelial Carcinoma Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Urothelial Carcinoma Market Access and Reimbursement

Download the report to understand which factors are driving urothelial carcinoma treatment market trends @ Urothelial Carcinoma Market Forecast

Table of Contents

Related Reports

Urothelial Carcinoma Pipeline

Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others.

Metastatic Urothelial Carcinoma Market

Metastatic Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic urothelial carcinoma companies, including Bausch Health Companies Inc., GlaxoSmithKline PLC, Nestle SA, Pfizer Inc., Regeneron Pharmaceuticals Inc., Evelo Biosciences, AbbVie Inc., Allergan PLC, Cara Therapeutics, Bristol-Myers Squibb Company, Sanofi S.A., LEO Pharma, among others.

Metastatic Urothelial Carcinoma Pipeline

Metastatic Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic urothelial carcinoma companies, including PharmaMar, Ectin Research AG, Exelixis, Eli Lilly and Company, Merck Sharp & Dohme LLC, Astellas Pharma Inc., Seagen Inc., Shanghai Miracogen Inc., Advaxis, Inc., among others.

Advanced Urothelial Carcinoma Pipeline

Advanced Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced urothelial carcinoma companies, including Jiangsu Hengrui Pharmaceuticals Co., Ltd., Evopoint Biosciences Inc., Bicycle Therapeutics, Bristol-Myers Squibb, Sichuan Baili Pharmaceutical Co., Ltd., BeiGene, Aurigene Discovery Technologies Limited, Mabwell (Shanghai) Bioscience Co., Ltd., Tyra Biosciences, Inc., Klus Pharma Inc., among others.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Contact Us
Shruti Thakur
info@delveinsight.com
+14699457679
www.delveinsight.com

Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg