Global Metastatic Urothelial Carcinoma Market Size, Share, and COVID-19 Impact Analysis, By Treatment (Chemotherapy, Targeted Therapy, Immunotherapy, and Others), By End User (Hospitals, Specialty Cancer Centers, and Research Institutions), and By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2025 - 2035

Industry: Healthcare

RELEASE DATE Oct 2025
REPORT ID SI16154
PAGES 273
REPORT FORMAT PathSoft

Global Metastatic Urothelial Carcinoma Market Size Insights Forecasts to 2035

  • The Global Metastatic Urothelial Carcinoma Market Size Was Estimated at USD 1.16 Billion in 2024
  • The Market Size is Expected to Grow at a CAGR of around 19.65% from 2025 to 2035
  • The Worldwide Metastatic Urothelial Carcinoma Market Size is Expected to Reach USD 8.35 Billion by 2035
  • Asia Pacific is expected to grow the fastest during the forecast period.

Global Metastatic Urothelial Carcinoma Market

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According to a Research Report Published by Spherical Insights and Consulting, The Global Metastatic Urothelial Carcinoma Market Size was worth around USD 1.16 Billion in 2024 and is predicted to Grow to around USD 8.35 Billion by 2035 with a compound annual growth rate (CAGR) of 19.65% from 2025 and 2035. The market for metastatic urothelial carcinoma has a number of opportunities to grow due to the emergence of novel therapeutic agents with the advancement in biological and genetic knowledge & technologies.

 

Market Overview

The global metastatic urothelial carcinoma industry refers to the treatments and therapies used for managing urothelial carcinoma that has spread to other parts of the body, particularly the bladder. Metastatic urothelial cancer refers to an incurable condition with a limited life expectancy, and platinum-based chemotherapy is the mainstay of treatment. Further, immunotherapy, antibody drug conjugates, and targeted agents are showing encouraging results in several recent practice-changing trials. With the growing prevalence of bladder cancer worldwide, accounting for 614k new cases in 2022, there is increased research, with an estimated 1000 trials in the United States, further driven by regulatory innovation and technological progress.

 

Innovation and market expansion are anticipated as a result of major players' growing R&D expenditures and the expanding partnerships for evaluating the safety and tolerability of novel drugs.  For instance, in march 2021, Exelixis, Inc. announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate XL092 and Avelumab in various forms of locally advanced or metastatic urothelial carcinoma. The new advances in urothelial cancer care, including the incorporation of biomarkers for personalized treatment approaches and combination therapy, are driving a huge surge in the global metastatic urothelial carcinoma market.    

 

Report Coverage

This research report categorizes the metastatic urothelial carcinoma market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the metastatic urothelial carcinoma market. Recent market developments and competitive strategies such as expansion, type launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the metastatic urothelial carcinoma market. 

 

Global Metastatic Urothelial Carcinoma Market Report Coverage

Report CoverageDetails
Base Year:2024
Market Size in 2024:USD 1.16 Billion
Forecast Period:2025-2035
Forecast Period CAGR 2025-2035 :19.65%
2035 Value Projection:USD 8.35 Billion
Historical Data for:2020-2023
No. of Pages:273
Tables, Charts & Figures:126
Segments covered:By Treatment, By End User and COVID-19 Impact Analysis
Companies covered::Pfizer Inc., Johnson & Johnson Services Inc., F. Hoffmann-La Roche Ltd., Merck & Co., Inc., AbbVie Inc., Bayer AG, Bristol-Myers Squibb Company, AstraZeneca PLC, Eli Lilly and Company, Gilead Sciences Inc., Merck KGaA, Astellas Pharma Inc., Genentech Inc., Exelixis Inc., EMD Serono, Zymeworks Inc., Mirati Therapeutics Inc., UroGen Pharma Ltd., and Others
Pitfalls & Challenges:COVID-19 Impact, Challenges, Future, Growth, & Analysis

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Driving Factors

The metastatic urothelial cancer market is driven by the increased prevalence of bladder cancer, with an estimated 614,298 cases in the year 2022 worldwide. In the United States, there are 84,870 new cases (4.2% of all new cancer cases) and an estimated 17,420 deaths in the year 2025. The increasing advancement in immunotherapy for treating bladder cancer is propelling the market growth. For instance, nivolumab was approved by the FDA for adjuvant therapy of high-risk muscle-invasive urothelial cancer and for patients with cisplatin ineligibility. Additionally, the personalized medicine approach towards advanced urothelial cancer is anticipated to promote market growth.

 

Restraining Factors

The metastatic urothelial carcinoma market is restricted by strict regulations and competition with alternative treatments. Furthermore, the immune-related adverse events associated with immunotherapies are hampering the market growth.

 

Market Segmentation

The metastatic urothelial carcinoma market share is classified into treatment and end user.   

 

  • The immunotherapy segment dominated the market with the largest share of nearly 45.0% in 2024 and is projected to grow at a substantial CAGR during the forecast period.

Based on the treatment, the metastatic urothelial carcinoma market is divided into chemotherapy, targeted therapy, immunotherapy, and others. Among these, the immunotherapy segment dominated the market with the largest share of nearly 45.0% in 2024 and is projected to grow at a substantial CAGR during the forecast period. An ongoing development of new immunotherapy by the use of specially engineered immune cells is contributing to drive the segmental market growth. For instance, in august 2024, the European Commission (EC) has granted marketing authorization to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for the frontline treatment of adult patients with unresectable or metastatic urothelial cancer.

 

Global Metastatic Urothelial Carcinoma Market

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  • The hospital segment dominated the market with a significant share between range of 50-70% in 2024 and is anticipated to grow at a significant CAGR during the forecast period.

Based on the end user, the metastatic urothelial carcinoma market is divided into hospital, specialty cancer centers, and research institutions. Among these, the hospital segment dominated the market with a significant share between range of 50-70% in 2024 and is anticipated to grow at a significant CAGR during the forecast period. This is attributed to the availability of multidisciplinary teams for providing personalized treatment plans and advanced therapies. Further, the increasing significance of individualized treatment approach, ongoing research, and collaboration for improving patient outcomes are contributing to promote the segmental market growth.

 

Regional Segment Analysis of the Metastatic Urothelial Carcinoma Market

  • North America (U.S., Canada, Mexico) 
  • Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
  • Asia-Pacific (China, Japan, India, Rest of APAC)
  • South America (Brazil and the Rest of South America) 
  • The Middle East and Africa (UAE, South Africa, Rest of MEA)

 

North America is anticipated to hold the largest share of the metastatic urothelial carcinoma market over the predicted timeframe.

 

Global Metastatic Urothelial Carcinoma Market

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North America is anticipated to hold the largest share of about 38-47% in the metastatic urothelial carcinoma market over the predicted timeframe. The market ecosystem in North America is strong, with the presence of leading companies like Astellas Pharma, Inc. and Bristol-Myers Squibb Company that are developing therapies for metastatic bladder cancer. Further, advancements in genomics and AI-driven drug discovery for developing effective personalized treatments, along with an investment among cancer biotech companies and pharmaceutical firms, are contributing to propel the market growth. For instance, in march 2023, Merck announced that it has strengthened its oncology franchise by securing exclusive worldwide rights to Anti-PD-L1 antibody BAVENCIO (avelumab). The United States is leading the North America metastatic urothelial cancer, with a major share of about 70-90%, driven by the presence of the largest patient pool for urothelial carcinoma, along with the growing awareness and treatment availability.

 

Asia Pacific is expected to grow at a rapid CAGR in the metastatic urothelial carcinoma market during the forecast period. The Asia Pacific area has a thriving market for metastatic urothelial carcinoma due to the growing ageing population and increasing bladder cancer rates. Furthermore, an increasing technological advancements and sophisticated solutions approach for early diagnosis of bladder cancer are promoting the market growth. For instance, in January 2025, Advanced Genomics APAC Co., Ltd. announced the signing of an exclusive service provider agreement with Cancer Precision Medicine Inc. for the bladder cancer screening test GALEAS Bladder in Japan. China is leading the metastatic urothelial carcinoma market in the Asia Pacific region, with an estimated market share of nearly 43%, driven by the ongoing research on treatment related biomarkers of locally advanced/mUC patients. In march 2023, China’s National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for enfortumab vedotin for urothelial cancer.

 

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the metastatic urothelial carcinoma market, along with a comparative evaluation primarily based on their type of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes type development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

 

List of Key Companies

  • Pfizer Inc.
  • Johnson & Johnson Services Inc.
  • F. Hoffmann-La Roche Ltd.
  • Merck & Co., Inc.
  • AbbVie Inc.
  • Bayer AG
  • Bristol-Myers Squibb Company
  • AstraZeneca PLC
  • Eli Lilly and Company
  • Gilead Sciences Inc.
  • Merck KGaA
  • Astellas Pharma Inc.
  • Genentech Inc.
  • Exelixis Inc.
  • EMD Serono
  • Zymeworks Inc.
  • Mirati Therapeutics Inc.
  • UroGen Pharma Ltd.
  • Others

 

Key Target Audience

  • Market Players
  • Investors
  • End-users
  • Government Authorities 
  • Consulting And Research Firm
  • Venture capitalists
  • Value-Added Resellers (VARs) 

 

Recent Development

  • In October 2025, DATROWAY Plus Rilvegostomig showed promising tumor responses in patients with metastatic urothelial cancer in TROPION-PanTumor03 phase 2 trial. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

 

  • In January 2025, FDA approved Balversa for locally advanced, metastatic urothelial carcinoma. The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.

 

  • In December 2024, Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. announced that Ono has received a supplemental approval of Opdivo Intravenous Infusion, an anti-PD-1 antibody, in combination with cisplatin and gemcitabine for the treatment of unresectable urothelial carcinoma in Japan.

 

  • In August 2024, Mabwell, an innovative biopharmaceutical company, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved.

 

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the metastatic urothelial carcinoma market based on the below-mentioned segments:  

 

Global Metastatic Urothelial Carcinoma Market, By Treatment

  • Chemotherapy
  • Targeted Therapy
  • Immunotherapy
  • Others

 

Global Metastatic Urothelial Carcinoma Market, By End User

  • Hospitals
  • Specialty Cancer Centers
  • Research Institutions

 

Global Metastatic Urothelial Carcinoma Market, By Regional Analysis

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of the Middle East & Africa

Frequently Asked Questions (FAQ)

  • 1. What is the market size of the metastatic urothelial carcinoma market?
    The global metastatic urothelial carcinoma market size is expected to grow from USD 1.16 Billion in 2024 to USD 8.35 Billion by 2035, at a CAGR of 19.65% during the forecast period 2025-2035.
  • 2. Which region holds the largest share of the metastatic urothelial carcinoma market?
    North America is anticipated to hold the largest share of the metastatic urothelial carcinoma market over the predicted timeframe.
  • 3. What is the forecasted CAGR of the Global Metastatic urothelial carcinoma Market from 2024 to 2035?
    The market is expected to grow at a CAGR of around 19.65% during the period 2024–2035.
  • 4. Who are the top companies operating in the Global Metastatic Urothelial Carcinoma Market?
    Key players include Pfizer Inc., Johnson & Johnson Services Inc., F. Hoffmann-La Roche Ltd., Merck & Co., Inc., AbbVie Inc., Bayer AG, Bristol-Myers Squibb Company, AstraZeneca PLC, Eli Lilly and Company, Gilead Sciences Inc., Merck KGaA, Astellas Pharma Inc., Genentech Inc., Exelixis Inc., EMD Serono, Zymeworks Inc., Mirati Therapeutics Inc., and UroGen Pharma Ltd.
  • 5. Can you provide company profiles for the leading metastatic urothelial carcinoma manufacturers?
    Yes. For example, Pfizer Inc. is one of the world’s largest research-based pharmaceutical and biomedical companies, known for developing, manufacturing, and marketing medications and vaccines. Johnson & Johnson Services Inc. is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange.
  • 6. What are the main drivers of growth in the metastatic urothelial carcinoma market?
    The growing prevalence of bladder cancer, advancement in immunotherapy, and personalized medical approach are major market growth drivers of the metastatic urothelial carcinoma market.
  • 7. What challenges are limiting the metastatic urothelial carcinoma market?
    Strict regulations, competition with alternative treatments, and adverse effects of immunotherapies remain key restraints in the metastatic urothelial carcinoma market.

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