United States Bladder Cancer Vaccines Market 2025 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The Global Bladder Cancer Vaccines market reached US$254 million in 2024, up from US$209 million in 2023, and is projected to reach US$1,446 million by 2033, growing at a robust CAGR of 21.32% from 2025 to 2033.

Key Development & Recent Mergers and acquisitions:

United States: Recent Industry Developments

✅ In September 2025, the U.S. FDA approved the Gemcitabine intravesical system (InlexzoTM), previously TAR-200, for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. This marks a breakthrough in sustained intravesical drug delivery for bladder cancer treatment.

✅ In April 2025, the Mount Sinai Health System reported progress on its personalized neoantigen vaccine (PGV001) for bladder cancer, designed to target each patient's unique tumor mutations to generate a robust immune response and improve long-term remission.

✅ In March 2025, Sun Pharmaceutical Industries (India-based but acquiring a US company) announced acquisition of Checkpoint Therapeutics (USA) for US$355 million, adding immunotherapy/oncology assets (though not explicitly bladder-cancer vaccine) to expand its portfolio.

Japan: Recent Industry Developments

✅ In August 2025, the Japan Agency for Medical Research and Development (AMED) launched a double-match grant initiative supporting Japanese biopharma startups developing immuno-oncology solutions, including bladder-cancer vaccine programs, strengthening national R&D investments in next-gen therapies.

✅ In April 2025, results from a Japanese Phase III trial of Nadofaragene firadenovec-vncg (Adstiladrin) in high-risk BCG-unresponsive NMIBC demonstrated a 75% complete response rate at 3 months, paving the way for potential approval in Japan.

✅ In early 2025, a Phase I trial of oral cancer vaccine B440 targeting PD-1/PD-L1 inhibitor-resistant advanced urothelial carcinoma commenced across multiple Japanese centers, expanding vaccine-based immunotherapy research beyond traditional intravesical approaches.

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Bladder cancer vaccines are immunotherapies designed to stimulate the body's immune system to recognize and destroy bladder cancer cells. They aim to prevent recurrence, improve survival rates, and enhance treatment outcomes by inducing targeted immune responses.

Key Players:

=> Merck & Co., Inc., Shionogi & Co., Ltd., ImmunityBio, Inc., Altor BioScience, LLC, Hamlet BioPharma, Asieris Pharmaceuticals, Pfizer Inc., among others.

Growth Forecast Projected:

The Global Bladder Cancer Vaccines Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Bladder Cancer Vaccines Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Product: Bacillus Calmette-Guerin (BCG), Others

➥ By Route of Administration: Intravesical, Others

➥ By Distribution Channel: Hospitals, Government Organizations, Others

Regional Analysis for Bladder Cancer Vaccines Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Bladder Cancer Vaccines producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Bladder Cancer Vaccines revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Bladder Cancer Vaccines Market?

A: In 2024, the Bladder Cancer Vaccines Market was valued at US$254 million, reflecting its strong industry presence.

Q2: How large is the Bladder Cancer Vaccines Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Bladder Cancer Vaccines Market will grow to around US$1,446 million, demonstrating significant expansion.

Q3: What is the growth rate of the Bladder Cancer Vaccines Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 21.32% during the forecast period from 2025 to 2033.

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