Urothelial Carcinoma - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Urothelial cancer is a malignant tumor that arises from the urothelial (transitional) cells lining the urinary tract, including the bladder, ureters, and renal pelvis. These specialized cells can stretch and contract, and cancer in this tissue most commonly affects the bladder.
• The majority of urothelial carcinoma occurs in males and has approximately a two to threefold greater incidence than in females.
• The current treatment of urothelial carcinoma involves a multimodal approach that includes surgical interventions like Transurethral Resection (TUR) for diagnosis, staging, and initial control of non-muscle invasive disease, with re-TUR and radical cystectomy indicated for more advanced or recurrent cases.
• For locally advanced and metastatic disease, cisplatin-based chemotherapy remains the first-line standard, while targeted therapies (like FGFR inhibitors) and immune checkpoint inhibitors (targeting PD-1/PD-L1) offer additional options, particularly in patients with specific genetic mutations or refractory disease.
• Currently, the major key players, contributing heavily in the market, include UroGen Pharma (JELMYTO), Pfizer, Astellas Pharma (PADCEV), Johnson & Johnson Innovative Medicine (BALVERSA), Merck (KEYTRUDA), and others.
• 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.
• 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 initiated the Phase III trial of UGN-104 for the treatment of patients with low-grade upper tract urothelial cancer.
• In a nutshell, it is estimated that the urothelial carcinoma treatment space will experience significant growth during the forecast period of 2025-2034. The future is brighter for patients with urothelial carcinoma. Targeted agents and biomarker-driven therapies hold promise for improved outcomes both as single agents and in combinations.

DelveInsight's "Urothelial Carcinoma - Market Insights, Epidemiology, and Market Forecast - 2034" report 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, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The urothelial carcinoma market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM urothelial carcinoma market size from 2020 to 2034. The report also covers current urothelial carcinoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Urothelial Carcinoma Understanding and Treatment Algorithm

Urothelial Carcinoma Overview

Urothelial carcinoma spans a broad clinical spectrum. At one end, it presents as a low-grade, non-muscle-invasive disease that, while rarely life-threatening, is prone to recurrence and requires long-term surveillance. At the other extreme, it manifests as high-grade disease, either non-muscle-invasive or muscle-invasive, with significantly higher risks. Muscle-invasive bladder cancer (MIBC) is life-threatening and demands prompt treatment. High-grade non-muscle-invasive disease carries a notable risk of progression to muscle-invasive or metastatic stages, often with poor outcomes. Metastatic progression occurs in approximately 25% of pT2, 50% of pT3, and 80% of pT4 tumors, with corresponding five-year survival rates of 67%, 35%, and 27%. Due to the heterogeneity of urothelial carcinoma, particularly in intermediate cases, standard treatment approaches may not be effective for up to 25% of patients.

Urothelial Carcinoma Diagnosis

Urine cytology is the most widely used noninvasive test to detect urothelial tumors. However, it is limited by its low sensitivity. On the other hand, cystoscopy is the gold standard procedure to follow patients with a history of bladder cancer, but this test is invasive and costly. Another approach to diagnosing urothelial cancer is via biomarkers. Currently, Bladder Tumor Antigen (BTA) stat, BTA TRAK, Nuclear Matrix Protein 22 (NMP-22), ImmunoCyt/uCyt, and UroVysion have either Food and Drug Administration (FDA) clearance or approval. The US Preventive Services Task Force (USPSTF) recommends against routine screening for bladder carcinoma in adults. Although several currently available noninvasive urine tests can detect bladder carcinoma in asymptomatic individuals, their positive predictive value is low, and they have not been demonstrated to enhance long-term clinical outcomes. Urinary tract imaging studies are used to define the location and extent of the tumor and to detect sites of multifocal disease. Computed tomography is a simple and noninvasive imaging study and has generally replaced Intravenous Pyelography (IVP).

Urothelial Carcinoma Treatment

Management of urothelial carcinoma focuses on preventing progression and minimizing unnecessary procedures. Transurethral resection delays diagnosis of invasive disease, requiring repeat resection for complete eradication. Intravesical therapy complements surgical resection, reducing recurrence and progression, especially in high-risk cases. Early cystectomy is contentious but considered in cases of rapid recurrence or residual disease. Lymphadenectomy during cystectomy remains debated, with extended lymphadenectomy potentially offering survival advantages. Cisplatin-based chemotherapy shows survival benefits, with proponents debating the timing of neoadjuvant versus adjuvant use.

Urothelial Carcinoma Epidemiology

The urothelial carcinoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and line-wise treated cases of urothelial carcinoma and in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. The total cases of urothelial carcinoma in the 7MM comprised approximately 205,500 cases in 2024 and are projected to increase during the forecast period.

• Among 7MM, the US accounted for the highest number of incident cases of urothelial carcinoma, i.e., around 87,100 in 2024.
• In EU4 and the UK, males accounted for more incident cases of urothelial carcinoma, i.e., nearly 73,000, as compared to females with incident cases of nearly 22,700, in 2024.
• As per the analysis, the median age of diagnosis of urothelial carcinoma is 69 years in men and 71 years in women.
• More than 90% of bladder carcinomas are classified as urothelial carcinoma, which arise from the urothelium.
• Among all the mutations observed in urothelial carcinoma, approximately 50% of the patients had a TP53 mutation, followed by a FGFR3 mutation (nearly 30%) in the US.

Urothelial Carcinoma Drug Chapters

The drug chapter segment of the urothelial carcinoma report encloses a detailed analysis of urothelial carcinoma emerging drugs or late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into urothelial carcinoma pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

PADCEV (enfortumab vedotin): Pfizer and Astellas Pharma

PADCEV (enfortumab vedotin-ejfv) is a first-in-class Antibody-drug Conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells, followed by the internalization and release of the anti-tumor agent Monomethyl Auristatin E (MMAE) into the cell, which results in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).

In December 2019, the US FDA approved PADCEV for the treatment of locally advanced or metastatic urothelial carcinoma who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. In April 2023, the US FDA approved the combination of PADCEV with KEYTRUDA for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

OPDIVO (nivolumab): Bristol-Myers Squibb

OPDIVO targets the PD1 receptor, an immune checkpoint, thus embodying a potent form of immunotherapy. This action obstructs the signal that impedes the activation of T-cells against cancerous cells. This activity discusses the drug's indications, mechanism of action, dosing and administration, and adverse event profile, providing essential insights for healthcare professionals involved in treating patients with metastatic melanoma and related conditions.

In August 2021, the US FDA approved OPDIVO for adjuvant treatment in patients with urothelial carcinoma at high risk of recurrence following radical surgery. More recently, in March 2024, OPDIVO received approval for use in combination with cisplatin and gemcitabine, as a first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

Emerging Drugs

UGN-104: UroGen Pharma

UGN-104 is an innovative mitomycin formulation in development by UroGen for the treatment of low-grade upper tract urothelial cancer. It utilizes UroGen's RTGel technology for prolonged mitomycin exposure. It is designed for treating low-grade upper tract urothelial cancer, and its Phase III evaluation has been started, offering a non-surgical treatment option with similar intellectual property protection.

TYRA-300: Tyra Biosciences

It is an investigational inhibitor of FGFR3 that is designed to be potent and selective to address two critical limitations of current approved and investigational FGFR inhibitors: activity in the presence of treatment-emergent resistance mutations such as the V555 gatekeeper mutation, and selectivity for FGFR3 over FGFR1 and other FGFR isoforms to avoid off-target side effects. It is currently being evaluated in Phase I/II for advanced urothelial carcinoma. In February 2024, the FDA granted rare pediatric disease (RPD) designation to TYRA-300.

Drug Class Insights

Currently, the market holds a diverse range of therapeutic alternatives for treatment, including FGFR inhibitors, PD-1 inhibitors, and others in different lines of treatment.

PD-1/PD-L1 provides a mechanism of immune escape, the blockade of which has already been accomplished in various cancers and has reinvigorated interest in the treatment of metastatic urothelial cancer. Currently, the market holds potential PD-1/PD-L1 inhibitors including KEYTRUDA, OPDIVO, BAVENCIO, and others. TECENTRIQ (atezolizumab), a PD-L1 inhibitor approved in 2016 for urothelial carcinoma, was withdrawn in November 2022. Specifically, the withdrawal applied to patients ineligible for cisplatin-containing chemotherapy, regardless of PD-L1 status, and those with tumors expressing PD-L1.

Apart from this, there are drugs in the class of FGFR inhibitors like BALVERSA, an oral pan-FGFR (FGFR1-4) Tyrosine Kinase Inhibitor (TKI) which causes prolonged inhibition of the FGFR pathway signaling owing to uptake in intracellular lysosomes. The drugs in these classes have been observed to have a fine efficacy, encouraging the upcoming drugs to take similar approaches.

Urothelial Carcinoma Market Outlook

Several treatment protocols used for urothelial carcinoma include chemotherapy, immunotherapy, radiation therapy, target-specific therapy, and surgical treatment. Urothelial carcinoma has shown poor survival when treated with chemotherapy; however, due to the advancements in the treatment of new immunotherapies, more alternatives are available. There is also a patient categorization observed, dividing the treatment into first-line and second-line therapies. For cisplatin-ineligible patients, carboplatin and its combinations, KEYTRUDA, OPDIVO, and other therapies are marketed. The pipeline has some potential therapies like UGN-104, utilizing RTGel technology for prolonged mitomycin exposure, and TYRA-300, an inhibitor of FGFR3.

Key Findings

• 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 Drugs Uptake

The market of urothelial carcinoma is segmented into cisplatin-eligible and ineligible patients within the line of therapies. On a greater overview, it has been observed that KEYTRUDA had the greatest uptake in 2024. This is due to its existence as a monotherapy as well as its availability in combination with PADCEV (a successful approval).

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players 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.

Urothelial Carcinoma Activities

The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for urothelial carcinoma therapies.

KOL Views

To keep up with the real-world scenario in current and emerging 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, including Medical/scientific Writers, Professors, and others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Emory University School of Medicine, Anderson Cancer Center, Southwestern Medical Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or urothelial carcinoma market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT 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.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated. 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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are

overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present. The report further 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 Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of urothelial 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, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the urothelial 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 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 shape and drive the 7MM urothelial carcinoma Market.

Urothelial Carcinoma Report Insights

• Patient Population
• Therapeutic Approaches
• Urothelial Carcinoma Pipeline Analysis
• Urothelial Carcinoma Market Size and Trends
• Existing and future Market Opportunity

Urothelial Carcinoma Report Key Strengths

• Ten-Year Forecast
• The 7MM Coverage
• Urothelial Carcinoma Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Urothelial Carcinoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the historical and forecasted Urothelial carcinoma patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What was the total urothelial carcinoma market size, the market size by therapies, the market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors 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 market dynamics and subsequent analysis of the associated trends?
• Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for treating urothelial carcinoma?
• How many companies are developing therapies to treat urothelial carcinoma?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the urothelial 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 market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current 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 players in the market will help devise strategies to help get ahead of competitors.
• 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 market so that the upcoming players can strengthen their development and launch strategy.