Global Bladder Cancer Diagnosis and Treatment Market 2025-2035
Description
Bladder Cancer Diagnosis and Treatment Market Size, Share & Trends Analysis Report by Product (Urothelial Carcinoma, Squamous Cell Bladder Cancer, Adenocarcinoma, and Others) by Stage (Non-Muscle-Invasive (NMIBC) (Stage 0a, 0is, I.), and Muscle-Invasive (MIBC) (Stage II, III, IV (metastatic)) by Diagnosis (Cystoscopy, Biopsy, Urine Cytology, Intravenous Pyelogram, and Others), and By Treatment (Surgery, Chemotherapy, Immunotherapy, Radiation Therapy, and Others) Forecast Period (2026-2035)
Industry Overview
Bladder cancer diagnosis and treatment market was valued at $5,920 million in 2025 and is projected to reach $10,928 million by 2035, growing at a CAGR of 6.4% during the forecast period (2026-2035). The increasing global prevalence of bladder cancer is increasing the need for enhanced diagnostic and therapeutic options, thus propelling market development. With current treatments in place, high rates of recurrence, disease progression, and poor long-term survival emphasize significant unmet medical needs. Meeting these challenges through novel therapies and enhanced diagnostics is core to increased patient improvement and growing market opportunities. As per the National Center for Biotechnology Information Org., in March 2025, bladder cancer is the fourth most frequent cancer in men, accounting for 6% of new cases and 4% of deaths due to cancer.
Approximately 25% are muscle-invasive at diagnosis and have a higher metastatic risk, and the rest are mostly non-muscle-invasive. Urothelial carcinoma comprises around 90% of all cases, with the rest predominantly squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma. Radical cystectomy with lymph node dissection is the treatment of choice for muscle-invasive bladder cancer, although approximately 50% of the patients can develop distant metastases after treatment. Pathologic complete response, which means no tumor or lymph node involvement remains, is associated with better overall survival. Despite treatment, recurrence occurs in roughly 30% of patients within a year, underscoring ongoing challenges in management.
Market Dynamics
Advancing Bladder Cancer Survival with Novel Therapies
Market growth is largely attributed to the development of new immunotherapies and targeted therapies that enhance survival and minimize recurrence. Several current clinical breakthrough developments illustrate this trend, showing the possibility of new combination therapies to revolutionize treatment outcomes. For instance, in August 2025, Pfizer Inc. and Astellas Pharma Inc. reported positive results from their Phase 3 EV-303 clinical trial, additionally referred to as KEYNOTE-905. This study is examining the combination of PADCEV (enfortumab vedotin), an antibody-drug conjugate targeting Nectin-4, and KEYTRUDA (pembrolizumab), a PD-1 inhibitor, as treatments before and after surgery compared to surgery alone for patients with muscle-invasive bladder cancer (MIBC) individuals are unable or unwilling to receive chemotherapy based to a chemotherapy drug. The trial's interim analysis indicated a significant improvement in event-free survival (EFS) and overall survival (OS) with the combination therapy compared to surgery alone. Additionally, it achieved the secondary goal of pathologic complete response (pCR) rate, marking the first regimen to enhance survival in this patient group.
Market Segmentation
Urothelial carcinoma is a cancer originating from urothelial cells in the urinary tract, affecting the upper or lower tracts. The global rise in urothelial carcinoma cases is causing a surge in the need for advanced diagnostic and treatment methods. As per the National Center for Biotechnology Information Org., in December 2024, Urothelial cancer is the fifth most prevalent cancer in Canada, with about 13,400 new cases and 2,600 deaths projected in 2023. These cancers can occur anywhere along the urinary tract; however, are most frequently found in the urinary bladder. At the time of diagnosis, 70% of individuals present with non-muscle invasive disease, 25% with muscle-invasive disease, and 5% with locally advanced or metastatic disease that is incurable. Despite definitive treatment, outcomes for urothelial cancer are not optimal, with relapse rates as high as 40-50% in patients with muscle-invasive disease, and real-world data indicating a median overall survival of only 20 months for those with metastatic disease.
Regional Outlook
The global bladder cancer diagnosis and treatment market is further divided by region, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).
Regulatory Approvals and Supportive Policies In Europe
Global regulatory bodies' favorable decisions for new therapies are boosting market adoption, fostering innovation, and driving market growth. For instance, in July 2025, the European Commission approved Imfinzi as the first and only perioperative immunotherapy for muscle-invasive bladder cancer. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use and results from the NIAGARA Phase III trial. The Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared to neoadjuvant chemotherapy with radical cystectomy.
North America Maintains Strong Market Position
North America holds a significant share, owing to the market growth is primarily driven by the increasing US cases of bladder cancer are driving the demand for advanced diagnostic tools and treatment modalities, driving market growth. As per the American Cancer Society’s estimates for bladder cancer in the US for 2025, Bladder cancer is more common in men than women.
The major companies operating in the global bladder cancer diagnosis and treatment market include AstraZeneca Plc, Bristol-Myers Squibb Co., F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Pfizer Inc., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Developments
Industry Overview
Bladder cancer diagnosis and treatment market was valued at $5,920 million in 2025 and is projected to reach $10,928 million by 2035, growing at a CAGR of 6.4% during the forecast period (2026-2035). The increasing global prevalence of bladder cancer is increasing the need for enhanced diagnostic and therapeutic options, thus propelling market development. With current treatments in place, high rates of recurrence, disease progression, and poor long-term survival emphasize significant unmet medical needs. Meeting these challenges through novel therapies and enhanced diagnostics is core to increased patient improvement and growing market opportunities. As per the National Center for Biotechnology Information Org., in March 2025, bladder cancer is the fourth most frequent cancer in men, accounting for 6% of new cases and 4% of deaths due to cancer.
Approximately 25% are muscle-invasive at diagnosis and have a higher metastatic risk, and the rest are mostly non-muscle-invasive. Urothelial carcinoma comprises around 90% of all cases, with the rest predominantly squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma. Radical cystectomy with lymph node dissection is the treatment of choice for muscle-invasive bladder cancer, although approximately 50% of the patients can develop distant metastases after treatment. Pathologic complete response, which means no tumor or lymph node involvement remains, is associated with better overall survival. Despite treatment, recurrence occurs in roughly 30% of patients within a year, underscoring ongoing challenges in management.
Market Dynamics
Advancing Bladder Cancer Survival with Novel Therapies
Market growth is largely attributed to the development of new immunotherapies and targeted therapies that enhance survival and minimize recurrence. Several current clinical breakthrough developments illustrate this trend, showing the possibility of new combination therapies to revolutionize treatment outcomes. For instance, in August 2025, Pfizer Inc. and Astellas Pharma Inc. reported positive results from their Phase 3 EV-303 clinical trial, additionally referred to as KEYNOTE-905. This study is examining the combination of PADCEV (enfortumab vedotin), an antibody-drug conjugate targeting Nectin-4, and KEYTRUDA (pembrolizumab), a PD-1 inhibitor, as treatments before and after surgery compared to surgery alone for patients with muscle-invasive bladder cancer (MIBC) individuals are unable or unwilling to receive chemotherapy based to a chemotherapy drug. The trial's interim analysis indicated a significant improvement in event-free survival (EFS) and overall survival (OS) with the combination therapy compared to surgery alone. Additionally, it achieved the secondary goal of pathologic complete response (pCR) rate, marking the first regimen to enhance survival in this patient group.
Market Segmentation
- Based on the type, the market is segmented into urothelial carcinoma, squamous cell bladder cancer, adenocarcinoma, and others (small cell carcinoma).
- Based on the stage, the market is segmented into non-muscle-invasive (NMIBC) (Stage 0a, 0is, I), and Muscle-Invasive (MIBC) (Stage II, III, IV (metastatic).
- Based on the diagnosis, the market is segmented into cystoscopy, biopsy, urine cytology, intravenous pyelogram, and others.
- Based on the treatment, the market is segmented into surgery, chemotherapy, immunotherapy, radiation therapy, and others (intravesical therapies, systemic chemotherapy, targeted therapies & small molecules, and antibody-drug conjugates (ADCs)).
Urothelial carcinoma is a cancer originating from urothelial cells in the urinary tract, affecting the upper or lower tracts. The global rise in urothelial carcinoma cases is causing a surge in the need for advanced diagnostic and treatment methods. As per the National Center for Biotechnology Information Org., in December 2024, Urothelial cancer is the fifth most prevalent cancer in Canada, with about 13,400 new cases and 2,600 deaths projected in 2023. These cancers can occur anywhere along the urinary tract; however, are most frequently found in the urinary bladder. At the time of diagnosis, 70% of individuals present with non-muscle invasive disease, 25% with muscle-invasive disease, and 5% with locally advanced or metastatic disease that is incurable. Despite definitive treatment, outcomes for urothelial cancer are not optimal, with relapse rates as high as 40-50% in patients with muscle-invasive disease, and real-world data indicating a median overall survival of only 20 months for those with metastatic disease.
Regional Outlook
The global bladder cancer diagnosis and treatment market is further divided by region, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).
Regulatory Approvals and Supportive Policies In Europe
Global regulatory bodies' favorable decisions for new therapies are boosting market adoption, fostering innovation, and driving market growth. For instance, in July 2025, the European Commission approved Imfinzi as the first and only perioperative immunotherapy for muscle-invasive bladder cancer. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use and results from the NIAGARA Phase III trial. The Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared to neoadjuvant chemotherapy with radical cystectomy.
North America Maintains Strong Market Position
North America holds a significant share, owing to the market growth is primarily driven by the increasing US cases of bladder cancer are driving the demand for advanced diagnostic tools and treatment modalities, driving market growth. As per the American Cancer Society’s estimates for bladder cancer in the US for 2025, Bladder cancer is more common in men than women.
- About 84,870 new cases of bladder cancer (about 65,080 in men and 19,790 in women)
- About 17,420 deaths from bladder cancer (about 12,640 in men and 4,780 in women)
The major companies operating in the global bladder cancer diagnosis and treatment market include AstraZeneca Plc, Bristol-Myers Squibb Co., F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Pfizer Inc., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Developments
- In February 2025, Pfizer and Astellas' PADCEV plus KEYTRUDA showed long-term efficacy in the first-line treatment of locally advanced or metastatic urothelial cancer. The Phase 3 EV-302 clinical trial showed sustained overall survival and progression-free survival benefits after an additional 12 months of follow-up.
- In May 2025, UroGen reported the outcome of the FDA's Oncologic Drugs Advisory Committee's vote 4 to 5 in favor of UGN-102 (mitomycin) for intravesical solution treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), a treatment option for urothelial and specialty cancers.
- Market value data analysis of 2024 and forecast to 2035.
- Annualized market revenues ($ million) for each market segment.
- Country-wise analysis of major geographical regions.
- Key companies operating in the global bladder cancer diagnosis and treatment market. Based on the availability of data, information related to new products and relevant news is also available in the report.
- Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
- Analysis of market-entry and market expansion strategies.
- Competitive strategies by identifying ‘who-stands-where’ in the market.
Table of Contents
225 Pages
- 1. Report Summary
- Current Industry Analysis and Growth Potential Outlook
- Global Bladder Cancer Diagnosis and Treatment Market Sales Analysis - Type | Stage | Diagnosis| Form | Treatment ($ Million)
- Bladder Cancer Diagnosis and Treatment Market Sales Performance of Top Countries
- 1.1. Research Methodology
- Primary Research Approach
- Secondary Research Approach
- 1.2. Market Snapshot
- 2. Market Overview and Insights
- 2.1. Scope of the Study
- 2.2. Analyst Insight & Current Market Trends
- 2.2.1. Key Bladder Cancer Diagnosis and Treatment Market Trends
- 2.2.2. Market Recommendations
- 3. Market Determinants
- 3.1. Market Drivers
- 3.1.1. Drivers For Global Bladder Cancer Diagnosis and Treatment Market: Impact Analysis
- 3.2. Market Pain Points and Challenges
- 3.2.1. Restraints For Global Bladder Cancer Diagnosis and Treatment Market: Impact Analysis
- 3.3. Market Opportunities
- 3.3.1. Opportunities For Global Bladder Cancer Diagnosis and Treatment Market: Impact Analysis
- 4. Competitive Landscape
- 4.1. Competitive Dashboard - Bladder Cancer Diagnosis and Treatment Market Revenue and Share by Manufacturers
- Bladder Cancer Diagnosis and Treatment Product Comparison Analysis
- Top Market Player Ranking Matrix
- 4.2. Key Company Analysis
- 4.2.1. AstraZeneca Plc
- 4.2.1.1. Overview
- 4.2.1.2. Product Portfolio
- 4.2.1.3. Financial Analysis
- 4.2.1.4. SWOT Analysis
- 4.2.1.5. Business Strategy
- 4.2.2. Bristol-Myers Squibb Co.
- 4.2.2.1. Overview
- 4.2.2.2. Product Portfolio
- 4.2.2.3. Financial Analysis
- 4.2.2.4. SWOT Analysis
- 4.2.2.5. Business Strategy
- 4.2.3. F. Hoffmann-La Roche Ltd.
- 4.2.3.1. Overview
- 4.2.3.2. Product Portfolio
- 4.2.3.3. Financial Analysis
- 4.2.3.4. SWOT Analysis
- 4.2.3.5. Business Strategy
- 4.2.4. Merck & Co., Inc.
- 4.2.4.1. Overview
- 4.2.4.2. Product Portfolio
- 4.2.4.3. Financial Analysis
- 4.2.4.4. SWOT Analysis
- 4.2.4.5. Business Strategy
- 4.2.5. Pfizer Inc.
- 4.2.5.1. Overview
- 4.2.5.2. Product Portfolio
- 4.2.5.3. Financial Analysis
- 4.2.5.4. SWOT Analysis
- 4.2.5.5. Business Strategy
- 4.3. Top Winning Strategies by Market Players
- 4.3.1. Merger and Acquisition
- 4.3.2. Product Launch
- 4.3.3. Partnership And Collaboration
- 5. Global Bladder Cancer Diagnosis and Treatment Market Sales Analysis By Type ($ Million)
- 5.1. Urothelial Carcinoma
- 5.2. Squamous Cell Bladder Cancer
- 5.3. Adenocarcinoma
- 5.4. Others (Small Cell Carcinoma)
- 6. Global Bladder Cancer Diagnosis and Treatment Market Sales Analysis By Stage ($ Million)
- 6.1. Non-Muscle-Invasive (NMIBC) (Stage 0a, 0is, I)
- 6.2. Muscle-Invasive (MIBC) (Stage II, III, IV (metastatic)
- 7. Global Bladder Cancer Diagnosis and Treatment Market Sales Analysis By Diagnosis ($ Million)
- 7.1. Cystoscopy
- 7.2. Biopsy
- 7.3. Urine Cytology
- 7.4. Intravenous Pyelogram
- 7.5. Others
- 8. Global Bladder Cancer Diagnosis and Treatment Market Sales Analysis By Treatment ($ Million)
- 8.1. Surgery
- 8.2. Chemotherapy
- 8.3. Immunotherapy
- 8.4. Radiation Therapy
- 8.5. Others (Intravesical therapies, Systemic chemotherapy, Targeted therapies & small molecules, and Antibody-drug conjugates (ADCs))
- 9. Regional Analysis
- 9.1. North American Bladder Cancer Diagnosis and Treatment Market Sales Analysis - Type | Stage | Diagnosis| Form | Treatment ($ Million)
- Macroeconomic Factors for North America
- 9.1.1. United States
- 9.1.2. Canada
- 9.2. European Bladder Cancer Diagnosis and Treatment Market Sales Analysis - Type | Stage | Diagnosis| Form | Treatment ($ Million)
- Macroeconomic Factors for Europe
- 9.2.1. UK
- 9.2.2. Germany
- 9.2.3. Italy
- 9.2.4. Spain
- 9.2.5. France
- 9.2.6. Russia
- 9.2.7. Rest of Europe
- 9.3. Asia-Pacific Bladder Cancer Diagnosis and Treatment Market Sales Analysis - Type | Stage | Diagnosis| Form | Treatment ($ Million)
- Macroeconomic Factors for Asia-Pacific
- 9.3.1. China
- 9.3.2. Japan
- 9.3.3. South Korea
- 9.3.4. India
- 9.3.5. Australia & New Zealand
- 9.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
- 9.3.7. Rest of Asia-Pacific
- 9.4. Rest of the World Bladder Cancer Diagnosis and Treatment Market Sales Analysis - Type | Stage | Diagnosis| Form | Treatment ($ Million)
- Macroeconomic Factors for the Rest of the World
- 9.4.1. Latin America
- 9.4.2. Middle East and Africa
- 10. Company Profiles
- 10.1. Asieris Pharmaceuticals
- 10.1.1. Quick Facts
- 10.1.2. Company Overview
- 10.1.3. Product Portfolio
- 10.1.4. Business Strategies
- 10.2. Astellas Pharma Inc.
- 10.2.1. Quick Facts
- 10.2.2. Company Overview
- 10.2.3. Product Portfolio
- 10.2.4. Business Strategies
- 10.3. AstraZeneca Plc
- 10.3.1. Quick Facts
- 10.3.2. Company Overview
- 10.3.3. Product Portfolio
- 10.3.4. Business Strategies
- 10.4. BASS Medical Group
- 10.4.1. Quick Facts
- 10.4.2. Company Overview
- 10.4.3. Product Portfolio
- 10.4.4. Business Strategies
- 10.5. Boston Scientific Corp.
- 10.5.1. Quick Facts
- 10.5.2. Company Overview
- 10.5.3. Product Portfolio
- 10.5.4. Business Strategies
- 10.6. Bristol-Myers Squibb Co.
- 10.6.1. Quick Facts
- 10.6.2. Company Overview
- 10.6.3. Product Portfolio
- 10.6.4. Business Strategies
- 10.7. CG Oncology, Inc.
- 10.7.1. Quick Facts
- 10.7.2. Company Overview
- 10.7.3. Product Portfolio
- 10.7.4. Business Strategies
- 10.8. F. Hoffmann-La Roche Ltd.
- 10.8.1. Quick Facts
- 10.8.2. Company Overview
- 10.8.3. Product Portfolio
- 10.8.4. Business Strategies
- 10.9. ImmunityBio, Inc.
- 10.9.1. Quick Facts
- 10.9.2. Company Overview
- 10.9.3. Product Portfolio
- 10.9.4. Business Strategies
- 10.10. Johnson & Johnson
- 10.10.1. Quick Facts
- 10.10.2. Company Overview
- 10.10.3. Product Portfolio
- 10.10.4. Business Strategies
- 10.11. Max Healthcare
- 10.11.1. Quick Facts
- 10.11.2. Company Overview
- 10.11.3. Product Portfolio
- 10.11.4. Business Strategies
- 10.12. Merck & Co., Inc.
- 10.12.1. Quick Facts
- 10.12.2. Company Overview
- 10.12.3. Product Portfolio
- 10.12.4. Business Strategies
- 10.13. Novartis AG
- 10.13.1. Quick Facts
- 10.13.2. Company Overview
- 10.13.3. Product Portfolio
- 10.13.4. Business Strategies
- 10.14. Olympus Europa SE & Co. KG
- 10.14.1. Quick Facts
- 10.14.2. Company Overview
- 10.14.3. Product Portfolio
- 10.14.4. Business Strategies
- 10.15. Pacific Edge Ltd.
- 10.15.1. Quick Facts
- 10.15.2. Company Overview
- 10.15.3. Product Portfolio
- 10.15.4. Business Strategies
- 10.16. Pfizer Inc.
- 10.16.1. Quick Facts
- 10.16.2. Company Overview
- 10.16.3. Product Portfolio
- 10.16.4. Business Strategies
- 10.17. Photocure ASA
- 10.17.1. Quick Facts
- 10.17.2. Company Overview
- 10.17.3. Product Portfolio
- 10.17.4. Business Strategies
- 10.18. Reliance General Insurance Co. Ltd.
- 10.18.1. Quick Facts
- 10.18.2. Company Overview
- 10.18.3. Product Portfolio
- 10.18.4. Business Strategies
- 10.19. Teleflex Inc.
- 10.19.1. Quick Facts
- 10.19.2. Company Overview
- 10.19.3. Product Portfolio
- 10.19.4. Business Strategies
- 10.20. UroGen Pharma, Ltd.
- 10.20.1. Quick Facts
- 10.20.2. Company Overview
- 10.20.3. Product Portfolio
- 10.20.4. Business Strategies
- 10.21. Veracyte, Inc.
- 10.21.1. Quick Facts
- 10.21.2. Company Overview
- 10.21.3. Product Portfolio
- 10.21.4. Business Strategies
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