세계의 방광암 백신 시장 : 시장 규모, 점유율, 성장 및 산업 분석 - 유형별, 용도별, 지역별 인사이트 및 예측(2024-2032년)

Growth Factors of bladder cancer vaccines Market

The global bladder cancer vaccines market is experiencing rapid expansion as the burden of bladder cancer rises and the need for effective therapeutic vaccines intensifies. According to the 2024 industry analysis, the market was valued at USD 297.0 million in 2024, is expected to reach USD 350.5 million in 2025, and is projected to grow significantly to USD 1,523.7 million by 2032, reflecting a strong CAGR of 23.36% throughout the forecast period. Europe continued to lead the global industry with a 37.20% market share in 2024, supported by high disease prevalence, robust healthcare infrastructure, and strong research involvement.

Bladder cancer remains one of the most frequently diagnosed cancers worldwide, particularly non-muscle invasive bladder cancer (NMIBC). Bacillus Calmette-Guerin (BCG), traditionally used for tuberculosis, remains the only approved therapeutic vaccine for NMIBC and is widely used to prevent recurrence and progression. The rising global incidence of bladder cancer, combined with increasing adoption of immunotherapies, continues to drive demand for bladder cancer vaccines across major markets.

Market Dynamics

Market Drivers

A major factor fueling market expansion is the increasing prevalence of bladder cancer. Lifestyle factors such as smoking, exposure to carcinogens, aging populations, and occupational risk contribute significantly to growing incidence. As reported by the World Cancer Research Fund, 614,289 new bladder cancer cases were recorded globally in 2022, highlighting the urgent need for effective therapeutic options. BCG remains the cornerstone of NMIBC treatment, creating sustained demand for vaccine-based therapies.

Market Restraints

One of the key restraints is the dependence on only one approved vaccine type-BCG. This lack of alternative vaccine treatments limits therapeutic flexibility and increases vulnerability to supply chain shortages. For instance, in 2020, the Bladder Cancer Advocacy Network raised concerns regarding shortages of Merck's TICE BCG vaccine, which resulted in rationing and delayed patient care. The absence of alternative vaccines continues to pose a barrier to market growth.

Market Opportunities

Growing R&D efforts aimed at developing next-generation bladder cancer vaccines present substantial market opportunities. Companies are actively exploring peptide vaccines, genetic vaccines, and combination immunotherapies. Shionogi & Co., Ltd., for example, completed a Phase II study in 2021 for its cancer peptide vaccine S-588410, offering new possibilities beyond traditional BCG.

Market Trends

A prominent trend shaping the market is the increasing focus on combination therapies, particularly combining BCG with advanced immunotherapies. In April 2024, the FDA approved Nogapendekin alfa inbakicept-pmln combined with BCG for BCG-unresponsive NMIBC, demonstrating how combination regimens can enhance patient outcomes, reduce recurrence, and expand treatment options.

Segmentation Insights

By Product

The BCG segment dominated the market in 2024, as BCG remains the only commercially available vaccine-based therapy for NMIBC. Strategic supply partnerships, such as ImmunityBio's 2024 collaboration with Serum Institute of India, continue to strengthen this segment.

By Route of Administration

The intravesical segment held the largest share in 2024 due to its direct delivery into the bladder, which minimizes systemic side effects and improves local immune response. Promising trial results from the RUTIVAC-1 study in 2025 highlight its continued clinical relevance.

By Distribution Channel

Hospitals maintained dominance in 2024 as vaccines require trained medical professionals and specialized clinical environments for administration. Distribution partnerships, including ImmunityBio's collaboration with U.S. Urology Partners in 2025, further reinforce this segment.

Regional Outlook

Europe led the global market with a value of USD 110.5 million in 2024, supported by high awareness, strong screening rates, and the region's significant number of annual diagnoses-over 224,000 new cases in 2025.

North America is positioned for strong future growth, projected to reach USD 93.0 million in 2024, driven by innovation in diagnostics, research expansion, and advancements in immunotherapy. The Asia Pacific region ranks third, with rising healthcare investments and expanding access to cancer care accelerating vaccine adoption. Latin America and the Middle East & Africa are expected to grow steadily as awareness and healthcare access improve.

Conclusion

With the market expected to surge from USD 297.0 million in 2024 to USD 1,523.7 million by 2032, the global bladder cancer vaccines industry is entering a period of transformative growth. Strong demand for improved therapeutic vaccines, rising cancer prevalence, advancement in combination immunotherapies, and active clinical pipelines will drive the market's evolution over the next decade.

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, 2024
• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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 (2024)
• 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.