Bladder Cancer Vaccines Market Size, Share & Industry Analysis, By Product (Bacillus Calmette-Guérin (BCG) and Others), By Route of Administration (Intravesical and Others), By Distribution Channel (Hospitals, Government & Organization Supply, and Others), and Regional Forecast, 2025-2032

The global bladder cancer vaccines market size was valued at USD 297.0 million in 2024. The market is projected to grow from USD 350.5 million in 2025 to USD 1,523.7 million by 2032, exhibiting a CAGR of 23.36% during the forecast period. Europe dominated the bladder cancer vaccines market with a market share of 37.20% in 2024.

Bladder cancer is one of the most prevalent types of cancer and a leading cause of death. It can be treated with BCG vaccines. The BCG vaccines that are primarily used for treatment of tuberculosis are therapeutic vaccines which are now administered for early stages of bladder cancer that have not invaded the bladder wall, called non-muscle invasive bladder cancers (NMIBCs) or in situ bladder cancers. The global bladder cancer vaccine market is projected to witness strong growth in the forecasted years. The rising prevalence of bladder cancer to augment the demand and drive growth of the therapeutic vaccines.

The market encompasses several key players with Merck & Co., Inc., Shionogi & Co., Ltd., and Altor BioScience, LLC at the forefront. Increasing investment in R&D, along with numerous pipeline candidates and strong geographic presence, are supporting the growth of these companies.

MARKET DYNAMICS

MARKET DRIVERS

Increasing Prevalence of Bladder Cancer to Boost Market Growth

The increasing prevalence of bladder cancer in the population is projected to drive the demand for cancer therapeutic vaccines. Lifestyle factors, such as prolonged exposure to carcinogens and smoking, are contributing to the rising prevalence of bladder cancer. These factors fuel the global bladder cancer vaccines market demand for therapeutic applications.

• For example, in 2022, the World Cancer Research Fund reported 614,289 new cases of bladder cancer globally.

MARKET RESTRAINTS

Lack of Alternative Vaccine Treatment to Limit Market Growth

Currently, only BCG Vaccines are approved for the treatment of bladder cancer. This overreliance on a single therapeutic option limits treatment flexibility. Shortages or reduced efficiency of these vaccines may adversely impact the market, limiting access to patients.  Hospitals may ration doses or delay treatments, restricting market growth.

• For instance, in September 2020, the Bladder Cancer Advocacy Network reported concern about shortages of Merck’s TICE BCG vaccine due to an increasing global demand and the resulting impact on the care of bladder cancer patients. Such factors may restrict the global bladder cancer vaccines market growth.

MARKET OPPORTUNITIES

Emphasis on Research and Development for New Product Development Offers Lucrative Growth Opportunities

Currently, the market solely relies on Bacillus Calmette-Guérin (BCG) vaccines, which are indicated for non-muscle invasive bladder cancer. However, it exhibits various side effects and is difficult to administer. This has led to an increase in the demand for safer, easy-to-administer, and effective vaccines. Research and development activities aimed at developing new vaccines candidates offer lucrative growth opportunities for the market.

• For instance, in July 2021, Shionogi & Co., Ltd. completed a Phase II clinical study of the cancer peptide vaccine S-588410 in patients with bladder cancer. The drug is licensed under an agreement with OncoTherapy Science, Inc.

BLADDER CANCER VACCINES MARKET TRENDS

Focus on the Combination of Vaccines with Immunotherapies is a Prominent Trend Observed

The shift toward next-generation immunotherapies is a major trend observed. BCG is the only vaccine approved for bladder cancer; however, a large number of patients remain unresponsive to BCG vaccines. These factors have created an urgent need for innovation. Various immunotherapies are now being used in combination with vaccines to overcome these challenges and enhance immune system activation.

• For instance, in April 2024, the Food and Drug Administration approved Nogapendekin alfa inbakicept-pmln with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). These therapies aim to expand treatment options for patients unresponsive to BCG, improve long-term survival, and reduce relapse rates. Such developments are likely to act as prominent global bladder cancer vaccines market trends.

MARKET CHALLENGES

High Clinical Trials Failures to Hamper Market Growth

Developing effective immunotherapies for bladder cancer is complex due to tumor heterogeneity, variable immune response among patients, and the difficulty of achieving durable efficacy beyond BCG. Many vaccine candidates in the pipeline have failed in Phase II or Phase III trials, leading to significant setbacks for both patients and manufacturers. Such failures delays the availability of alternatives and increase R&D costs and slow overall market growth.

• For instance, in January 2024, Ferring Pharmaceuticals observed supply chain delays for nadofaragene firadenovec (Adstiladrin). Although the therapy received approval in 2022, manufacturing and supply chain issues observed timely availability. To mitigate supply chain delays the company collaborated with FKD Therapies.

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Segmentation Analysis

By Product

Bacillus Calmette-Guérin (BCG) Segment Dominated due to Strategic Partnerships

On the basis of product, the market is classified into Bacillus Calmette-Guérin (BCG) and others.

The Bacillus Calmette-Guérin (BCG) dominated the global market in 2024. Currently, it is the only commercially available vaccine-based treatment for bladder cancer. The vaccine has shown effectiveness against NMBIC. Adjourning these benefits, the segment is anticipated to grow during the forecast period.

• For instance, in May 2024, ImmunityBio, Inc. partnered with the Serum Institute of India to supply ImmunityBio with Bacillus Calmette-Guérin (BCG) vaccines. As part of this agreement, a next-generation recombinant BCG (iBCG) is undergoing testing for use in combination with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications.

By Route of Administration

Intravesical Segmental Led the Market due to its Ability Lower Tumor Recurrence

In terms of route of administration, the market is categorized into intravesical and others.

The intravesical segment captured the largest global bladder cancer vaccines market share in 2024. The only approved vaccine for bladder cancer is administered intravesically . This route of administration reduces the risk of systemic toxicity and offers site-targeted treatment. These benefits reinforce the strong dominance of the segment.

• For instance, in March 2025, Annual Congress of the European Association of Urology (EAU25), data from the RUTIVAC-1 Trial showcased promising advancements in bladder cancer treatment. The study showcased that administering the vaccine intravesically alongside standard therapy significantly boosted the immune response, enhancing the body's ability to prevent tumor recurrence.

By Distribution Channel

Hospitals Segment Led the Market due to Industry Collaboration

Based on distribution channel, the market is segmented into hospitals, government & organization supply, and others.

The hospitals segment held the dominating position in the forecasted years. Hospitals are the first line of contact for patients and play a crucial role in the distribution channel. As bladder cancer vaccines are administered intravescially, they require the presence of certified medical practitioners. These factors contribute significantly to the growth of the segment. Additionally, collaboration between various operational entities are reinforcing the segment’s dominance.

• For instance, in March 2025, ImmunityBio, Inc. partnered with U.S. Urology Partners, an independent provider of urology and related specialty services. The collaboration aimed to address the current shortage of TICE BCG in the U.S.

Bladder Cancer Vaccines Market Regional Outlook

By geography, the market is categorized into Europe, North America, Asia Pacific, Latin America, and Middle East & Africa.

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The Europe held the leading market share in 2023 valued at USD 91.7 million, and also took the leading share in 2024 with USD 110.5 million. The region’s strong market position is driven by high prevalence and rising demand for bladder cancer medications. To provide effective treatments, the region is actively boosting research initiatives for innovative product development.

For instance, in March 2025, World Bladder Cancer Coalition reported that over 224,000 new cases are diagnosed in Europe with 165,000 people diagnosed in the EU alone.  

Other regions such as North America and the Asia Pacific are estimated to witness a notable growth in the coming years. During the forecast period, the North America region is projected to record a growth rate of 31.3% for the forecast period of 2025-2032, reaching the valuation of USD 93.0 million by 2024. The growth in the region is driven by advancements in diagnostics, robust healthcare infrastructure and increasing research and development. In 2024, after North America, the market in the Asia Pacific is to secure the position of the third-largest region in the market.

Latin America and the Middle East & Africa regions would witness a moderate growth during the study period. The rising incidence of bladder cancer and the rising need for safer and effective vaccines are likely to drive market growth in these regions.

COMPETITIVE LANDSCAPE

Key Industry Players

Market Players Focus on Research and Development Activities to Reinforce their Market Position

The global cancer vaccine market shows a concentrated structure, with a few companies actively operating across the globe. Leading players are actively involved in product innovation, strategic partnerships, and geographic expansion, while mid-size companies are entering space with targeted developments.

Merck & Co., Inc., R, Shionogi & Co., Ltd., and ImmunityBio, Inc., are some of the dominating players in the market. Their strong portfolios of bladder cancer vaccines, extensive global distribution network, and collaborations with research and academic institutions reinforce their leadership in the market.

In addition, other prominent players include Hamlet BioPharma, Asieris Pharmaceuticals, Pfizer Inc., and others. These companies are undertaking various strategic initiatives, such as investments in R&D and partnerships with pharmaceutical companies, to enhance their market presence.

LIST OF KEY BLADDER CANCER VACCINES COMPANIES PROFILED

• Merck & Co., Inc., (U.S.)
• Shionogi & Co., Ltd. (Japan)
• ImmunityBio, Inc. (U.S.)
• Altor BioScience, LLC (U.S.)
• Hamlet BioPharma. (Sweden)
• Asieris Pharmaceuticals. (China)
• Pfizer Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS

• August 2025: Hamlet BioPharma completed the alpha1h phase II study in non-muscle invasive bladder cancer patients. The clinical study highlighted promising treatment effects in urinary bladder cancer.
• January 2025: Pfizer Inc. reported positive results from its Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy, with or without maintenance, in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
• May 2021: Asieris Pharmaceuticals collaborated with BeiGene, Ltd. to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC).
• July 2019: Taris Bio initiated a Phase Ib clinical trial to assess its drug candidate TAR-200 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in bladder cancer patients.
• July 2025: ImmunityBio, Inc. received marketing authorization from UK Medicines and Healthcare Products Regulatory Agency (MHRA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients.

REPORT COVERAGE

The global bladder cancer vaccines market analysis provides an in-depth study of the market size & forecast by all the market segments included in the report. It includes details on the market dynamics and market trends expected to drive the market in the forecast period. It offers information on current available treatments, pipeline candidates, key industry developments, and details on partnerships, mergers & acquisitions. The market report also encompasses a detailed competitive landscape with information on the market share and profiles of key operating players.

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Report Scope & Segmentation