PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933365
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1933365
Bladder Cancer Vaccines Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034
Growth Factors of bladder cancer vaccines Market
The global bladder cancer vaccines market was valued at USD 350.46 billion in 2025 and is projected to grow to USD 417.43 billion in 2026, eventually reaching USD 2,423.37 billion by 2034, exhibiting a CAGR of 24.59% during the forecast period. Europe dominated the market in 2025 with a 36.31% share, driven by the high prevalence of bladder cancer, established healthcare infrastructure, and increased adoption of therapeutic vaccines. Bladder cancer, one of the most prevalent cancers worldwide, can be treated effectively with Bacillus Calmette-Guerin (BCG) vaccines, primarily for non-muscle invasive bladder cancers (NMIBCs). Rising incidence rates and lifestyle-related risk factors, such as prolonged exposure to carcinogens and smoking, are fueling the demand for bladder cancer vaccines globally.
Leading players, including Merck & Co., Inc., Shionogi & Co., Ltd., and ImmunityBio, Inc., are investing heavily in research and development (R&D) and expanding their global presence to strengthen their market positions. Continuous innovations and new pipeline candidates are driving growth, ensuring a robust market outlook for the coming decade.
Market Dynamics
Drivers: The increasing prevalence of bladder cancer is the primary growth driver. According to the World Cancer Research Fund 2022, there were 614,289 new bladder cancer cases globally, reflecting the urgent need for therapeutic interventions. Healthcare providers are increasingly adopting BCG vaccines for early-stage NMIBCs, boosting market demand.
Restraints: The market is currently constrained by the lack of alternative vaccine treatments. BCG remains the only approved vaccine for bladder cancer, and shortages or inefficiencies, such as those reported by the Bladder Cancer Advocacy Network in 2020, may limit patient access and restrict growth.
Opportunities: Emphasis on R&D for new vaccine candidates presents lucrative opportunities. Next-generation vaccines aim to improve safety, ease of administration, and efficacy. For example, Shionogi & Co., Ltd. completed a Phase II study of the S-588410 cancer peptide vaccine in 2021, showcasing innovation in therapeutic development.
Challenges: High clinical trial failures hamper growth. Tumor heterogeneity and variable immune responses make developing effective bladder cancer immunotherapies complex. Delays and supply chain challenges, such as those experienced by Ferring Pharmaceuticals in 2024, impact timely availability and adoption.
Market Trends
A key trend is the integration of vaccines with immunotherapies. Patients unresponsive to BCG are increasingly receiving combination treatments to enhance immune activation and reduce relapse rates. In April 2024, the FDA approved Nogapendekin alfa inbakicept-pmln with BCG for BCG-unresponsive NMIBC patients. This approach is reshaping treatment protocols and supporting market expansion.
Segmentation Analysis
By Product: The BCG segment dominates the market, being the only commercially approved therapeutic vaccine. Strategic partnerships, such as ImmunityBio's collaboration with the Serum Institute of India in May 2024, support next-generation recombinant BCG development for combination therapies like ANKTIVA.
By Route of Administration: The intravesical segment leads due to its targeted delivery, reducing systemic toxicity and lowering tumor recurrence. Clinical evidence from the RUTIVAC-1 Trial (EAU25, 2025) demonstrates enhanced immune response when BCG is administered intravesically.
By Distribution Channel: Hospitals dominate due to certified medical supervision required for intravesical administration. Collaborations, such as ImmunityBio's partnership with U.S. Urology Partners in 2025, address shortages and reinforce hospital-based distribution.
Regional Outlook
Europe: Led the market in 2025 with USD 127.26 billion, driven by high incidence and research initiatives. Over 224,000 new bladder cancer cases were reported in Europe in 2025, with 165,000 in the EU alone.
North America: Projected to grow at 31.3% CAGR, with advanced healthcare infrastructure supporting adoption. The region is expected to reach USD 93.0 million by 2034, driven by diagnostics and ongoing R&D.
Asia Pacific: Positioned as the third-largest market due to rising prevalence and healthcare expansion in China and India.
Latin America & Middle East & Africa: Moderate growth is anticipated due to increasing bladder cancer incidence and demand for effective vaccines.
Competitive Landscape
The market is concentrated, dominated by Merck & Co., Shionogi & Co., ImmunityBio, Altor BioScience, and others. These companies leverage R&D, collaborations, and global distribution to strengthen their positions. Notable developments include:
- August 2025: Hamlet BioPharma completed Phase II alpha1h study in NMIBC patients.
- January 2025: Pfizer's Phase III CREST trial evaluated sasanlimab with BCG for high-risk NMIBC.
- July 2025: ImmunityBio received UK MHRA approval for ANKTIVA combined with BCG.
Conclusion
The global bladder cancer vaccines market is set to grow from USD 350.46 billion in 2025 to USD 417.43 billion in 2026, reaching USD 2,423.37 billion by 2034 at a CAGR of 24.59%. Europe remains the dominant region, supported by rising prevalence and extensive research initiatives. Growth is fueled by the increasing burden of bladder cancer, strategic partnerships, combination therapies, and the development of next-generation vaccines. Despite challenges such as clinical trial failures and reliance on BCG, ongoing R&D and immunotherapy integrations are expected to drive substantial advancements, making the market highly promising for key players and new entrants alike.
Segmentation By Product
- Bacillus Calmette-Guerin (BCG)
- Others
By Route of Administration
- Intravesical
- Others
By Distribution Channel
- Hospitals
- Government & Organization Supply
- Others
By Geography
- North America (By Product, Route of Administration, Distribution Channel, and Country)
- U.S.
- Canada
- Europe (By Product, Route of Administration, Distribution Channel, and Country/Sub-region)
- Germany
- U.K.
- France
- Spain
- Italy
- Scandinavia
- Rest of Europe
- Asia Pacific (By Product, Route of Administration, Distribution Channel, and Country/Sub-region)
- China
- Japan
- India
- Australia
- Southeast Asia
- Rest of Asia Pacific
- Latin America (By Product, Route of Administration, Distribution Channel, and Country/Sub-region)
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa (By Product, Route of Administration, Distribution Channel, and Country/Sub-region)
- GCC
- South Africa
- Rest of the Middle East & Africa
Table of Content
1. Introduction
- 1.1. Research Scope
- 1.2. Market Segmentation
- 1.3. Research Methodology
- 1.4. Definitions and Assumptions
2. Executive Summary
3. Market Dynamics
- 3.1. Market Drivers
- 3.2. Market Restraints
- 3.3. Market Opportunities
- 3.4. Market Trends
4. Key Insights
- 4.1. Prevalence of Bladder Cancers, by Key Countries/ Region, 2025
- 4.2. Overview of Regulatory Scenario by Key Countries/Regions
- 4.3. Pipeline Analysis, Key Players
- 4.4. Key Industry Developments - Mergers, Acquisitions, Partnerships, Launches, Approvals, etc.
5. Global Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 5.1. Market Analysis, Insights and Forecast - By Product
- 5.1.1. Bacillus Calmette-Guerin (BCG)
- 5.1.2. Others
- 5.2. Market Analysis, Insights and Forecast - By Route of Administration
- 5.2.1. Intravesical
- 5.2.2. Others
- 5.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 5.3.1. Hospitals
- 5.3.2. Government & Organization Supply
- 5.3.3. Others
- 5.4. Market Analysis, Insights and Forecast - Region
- 5.4.1. North America
- 5.4.2. Europe
- 5.4.3. Asia Pacific
- 5.4.4. Latin America
- 5.4.5. Middle East & Africa
6. North America Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 6.1. Market Analysis, Insights and Forecast - By Product
- 6.1.1. Bacillus Calmette-Guerin (BCG)
- 6.1.2. Others
- 6.2. Market Analysis, Insights and Forecast - By Route of Administration
- 6.2.1. Intravesical
- 6.2.2. Others
- 6.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 6.3.1. Hospitals
- 6.3.2. Government & Organization Supply
- 6.3.3. Others
- 6.4. Market Analysis, Insights and Forecast - By Country
- 6.4.1. U.S.
- 6.4.2. Canada
7. Europe Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 7.1. Market Analysis, Insights and Forecast - By Product
- 7.1.1. Bacillus Calmette-Guerin (BCG)
- 7.1.2. Others
- 7.2. Market Analysis, Insights and Forecast - By Route of Administration
- 7.2.1. Intravesical
- 7.2.2. Others
- 7.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 7.3.1. Hospitals
- 7.3.2. Government & Organization Supply
- 7.3.3. Others
- 7.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 7.4.1. U.K.
- 7.4.2. Germany
- 7.4.3. France
- 7.4.4. Italy
- 7.4.5. Spain
- 7.4.6. Scandinavia
- 7.4.7. Rest of Europe
8. Asia Pacific Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 8.1. Market Analysis, Insights and Forecast - By Product
- 8.1.1. Bacillus Calmette-Guerin (BCG)
- 8.1.2. Others
- 8.2. Market Analysis, Insights and Forecast - By Route of Administration
- 8.2.1. Intravesical
- 8.2.2. Others
- 8.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 8.3.1. Hospitals
- 8.3.2. Government & Organization Supply
- 8.3.3. Others
- 8.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 8.4.1. China
- 8.4.2. Japan
- 8.4.3. India
- 8.4.4. Southeast Asia
- 8.4.5. Australia
- 8.4.6. Rest of Asia Pacific
9. Latin America Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 9.1. Market Analysis, Insights and Forecast - By Product
- 9.1.1. Bacillus Calmette-Guerin (BCG)
- 9.1.2. Others
- 9.2. Market Analysis, Insights and Forecast - By Route of Administration
- 9.2.1. Intravesical
- 9.2.2. Others
- 9.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 9.3.1. Hospitals
- 9.3.2. Government & Organization Supply
- 9.3.3. Others
- 9.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 9.4.1. Brazil
- 9.4.2. Mexico
- 9.4.3. Rest of Latin America
10. Middle East & Africa Bladder Cancer Vaccines Market Analysis, Insights and Forecast, 2021-2034
- 10.1. Market Analysis, Insights and Forecast - By Product
- 10.1.1. Bacillus Calmette-Guerin (BCG)
- 10.1.2. Others
- 10.2. Market Analysis, Insights and Forecast - By Route of Administration
- 10.2.1. Intravesical
- 10.2.2. Others
- 10.3. Market Analysis, Insights and Forecast - By Distribution Channel
- 10.3.1. Hospitals
- 10.3.2. Government & Organization Supply
- 10.3.3. Others
- 10.4. Market Analysis, Insights and Forecast - By Country/ Sub-Region
- 10.4.1. GCC
- 10.4.2. South Africa
- 10.4.3. Rest of Middle East & Africa
11. Competitive Analysis
- 11.1. Global Market Share Analysis (2025)
- 11.2. Company Profiles (Overview, Product, SWOT analysis, Recent developments, strategies, financials (based on availability))
- 11.2.1. Merck & Co., Inc.,
- 11.2.2. Shionogi & Co., Ltd.
- 11.2.3. ImmunityBio, Inc.
- 11.2.4. Altor BioScience, LLC
- 11.2.5. Hamlet BioPharma.
- 11.2.6. Asieris Pharmaceuticals.
- 11.2.7. Pfizer Inc.
List of Tables
- Table 1: Global Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 2: Global Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 3: Global Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 4: Global Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Region, 2021-2034
- Table 5: North America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 6: North America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 7: North America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 8: North America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Country, 2021-2034
- Table 9: Europe Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 10: Europe Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 11: Europe Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 12: Europe Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Country/ Sub-region, 2021-2034
- Table 13: Asia Pacific Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 14: Asia Pacific Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 15: Asia Pacific Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 16: Asia Pacific Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Country/ Sub-region, 2021-2034
- Table 17: Latin America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 18: Latin America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 19: Latin America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 20: Latin America Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Country/ Sub-region, 2021-2034
- Table 21: Middle East & Africa Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Product, 2021-2034
- Table 22: Middle East & Africa Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Route of Administration, 2021-2034
- Table 23: Middle East & Africa Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Distribution Channel, 2021-2034
- Table 24: Middle East & Africa Bladder Cancer Vaccines Market Revenue (USD million) Forecast, by Country/ Sub-region, 2021-2034
List of Figures
- Figure 1: Global Bladder Cancer Vaccines Market Revenue Breakdown (USD million, %) by Region, 2025 & 2034
- Figure 2: Global Bladder Cancer Vaccines Market Value Share (%), by Product, 2025 & 2034
- Figure 3: Global Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025 & 2034
- Figure 4: Global Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025 & 2034
- Figure 5: Global Bladder Cancer Vaccines Market Value Share (%), by Region, 2025 & 2034
- Figure 6: North America Bladder Cancer Vaccines Market Value (USD million), by Product, 2025 & 2034
- Figure 7: North America Bladder Cancer Vaccines Market Value Share (%), by Product, 2025
- Figure 8: North America Bladder Cancer Vaccines Market Value (USD million), by Route of Administration, 2025 & 2034
- Figure 9: North America Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025
- Figure 10: North America Bladder Cancer Vaccines Market Value (USD million), by Distribution Channel, 2025 & 2034
- Figure 11: North America Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025
- Figure 12: North America Bladder Cancer Vaccines Market Value (USD million), by Country, 2025 & 2034
- Figure 13: North America Bladder Cancer Vaccines Market Value Share (%), by Country, 2025
- Figure 14: Europe Bladder Cancer Vaccines Market Value (USD million), by Product, 2025 & 2034
- Figure 15: Europe Bladder Cancer Vaccines Market Value Share (%), by Product, 2025
- Figure 16: Europe Bladder Cancer Vaccines Market Value (USD million), by Route of Administration, 2025 & 2034
- Figure 17: Europe Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025
- Figure 18: Europe Bladder Cancer Vaccines Market Value (USD million), by Distribution Channel, 2025 & 2034
- Figure 19: Europe Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025
- Figure 20: Europe Bladder Cancer Vaccines Market Value (USD million), by Country/ Sub-region, 2025 & 2034
- Figure 21: Europe Bladder Cancer Vaccines Market Value Share (%), by Country/ Sub-region, 2025
- Figure 22: Asia Pacific Bladder Cancer Vaccines Market Value (USD million), by Product, 2025 & 2034
- Figure 23: Asia Pacific Bladder Cancer Vaccines Market Value Share (%), by Product, 2025
- Figure 24: Asia Pacific Bladder Cancer Vaccines Market Value (USD million), by Route of Administration, 2025 & 2034
- Figure 25: Asia Pacific Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025
- Figure 26: Asia Pacific Bladder Cancer Vaccines Market Value (USD million), by Distribution Channel, 2025 & 2034
- Figure 27: Asia Pacific Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025
- Figure 28: Asia Pacific Bladder Cancer Vaccines Market Value (USD million), by Country/ Sub-region, 2025 & 2034
- Figure 29: Asia Pacific Bladder Cancer Vaccines Market Value Share (%), by Country/ Sub-region, 2025
- Figure 30: Latin America Bladder Cancer Vaccines Market Value (USD million), by Product, 2025 & 2034
- Figure 31: Latin America Bladder Cancer Vaccines Market Value Share (%), by Product, 2025
- Figure 32: Latin America Bladder Cancer Vaccines Market Value (USD million), by Route of Administration, 2025 & 2034
- Figure 33: Latin America Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025
- Figure 34: Latin America Bladder Cancer Vaccines Market Value (USD million), by Distribution Channel, 2025 & 2034
- Figure 35: Latin America Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025
- Figure 36: Latin America Bladder Cancer Vaccines Market Value (USD million), by Country/ Sub-region, 2025 & 2034
- Figure 37: Latin America Bladder Cancer Vaccines Market Value Share (%), by Country/ Sub-region, 2025
- Figure 38: Middle East & Africa Bladder Cancer Vaccines Market Value (USD million), by Product, 2025 & 2034
- Figure 39: Middle East & Africa Bladder Cancer Vaccines Market Value Share (%), by Product, 2025
- Figure 40: Middle East & Africa Bladder Cancer Vaccines Market Value (USD million), by Route of Administration, 2025 & 2034
- Figure 41: Middle East & Africa Bladder Cancer Vaccines Market Value Share (%), by Route of Administration, 2025
- Figure 42: Middle East & Africa Bladder Cancer Vaccines Market Value (USD million), by Distribution Channel, 2025 & 2034
- Figure 43: Middle East & Africa Bladder Cancer Vaccines Market Value Share (%), by Distribution Channel, 2025
- Figure 44: Middle East & Africa Bladder Cancer Vaccines Market Value (USD million), by Country/ Sub-region, 2025 & 2034
- Figure 45: Middle East & Africa Bladder Cancer Vaccines Market Value Share (%), by Country/ Sub-region, 2025
- Figure 46: Global Bladder Cancer Vaccines Market Share (%), by Company, 2025
