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市场调查报告书
商品编码
1880594
膀胱癌疫苗市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察与预测(2024-2032)Bladder Cancer Vaccines Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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由于膀胱癌负担日益加重以及对有效治疗性疫苗的需求不断增长,全球膀胱癌疫苗市场正在快速扩张。根据2024年的产业分析,预计该市场在2024年的价值为2.97亿美元,到2025年将达到3.505亿美元。预计到2032年,该市场将进一步显着成长至15.237亿美元,在整个预测期内复合年增长率(CAGR)为23.36%。欧洲持续引领全球产业,截至2024年,其市占率为37.20%,这得益于较高的疾病盛行率、完善的医疗保健基础设施和积极的研究。
膀胱癌,尤其是非肌肉层浸润性膀胱癌 (NMIBC),仍是全球最常见的癌症之一。卡介苗 (BCG) 传统上用于治疗结核病,是目前唯一获准用于治疗 NMIBC 的治疗性疫苗,并被广泛用于预防復发和进展。全球膀胱癌发生率的上升,以及免疫疗法的日益普及,持续推动主要市场对膀胱癌疫苗的需求。
市场动态
市场推动因素
市场扩张的主要推动因素是膀胱癌盛行率的上升。吸烟、致癌物暴露、老化和职业风险等生活方式因素显着加剧了发病率的上升。根据世界癌症研究基金会的报告,2022 年全球新增膀胱癌病例 614,289 例,凸显了开发有效治疗方法的紧迫感。卡介苗 (BCG) 仍然是非肌肉层浸润性膀胱癌 (NMIBC) 治疗的基石,持续推动疫苗疗法的需求。
市场限制因子
主要阻碍因素之一是目前仅依赖卡介苗作为核准疫苗。缺乏其他疫苗疗法限制了治疗的灵活性,并增加了供应链短缺的风险。例如,2020 年,膀胱癌倡导网络 (Bladder Cancer Advocacy Network) 对默克公司 TICE 卡介苗的供应短缺表示担忧,导致疫苗配给和病患治疗延误。缺乏其他疫苗仍然是市场成长的障碍。
市场机会
不断扩大的研发投入,旨在开发下一代膀胱癌疫苗,这带来了巨大的市场机会。各公司正积极探索胜肽疫苗、基因疫苗和联合免疫疗法。例如,盐野义製药株式会社于2021年完成了其癌症胜肽疫苗S-588410的II期临床试验,为传统的卡介苗疗法提供了新的可能性。
市场趋势
影响市场的显着趋势包括对联合疗法的日益重视,特别是将卡介苗与先进的免疫疗法相结合。 2024年4月,美国食品药物管理局(FDA)批准了诺加潘地金α/invaxcept-PMLN与卡介苗联合用于治疗对卡介苗无反应的非肌肉层浸润性膀胱癌(NMIBC)。这显示联合疗法有助于改善患者预后、降低復发率并拓宽治疗选择。
依产品分类
2024年,卡介苗(BCG)区隔市场占主导地位,因为卡介苗仍是目前唯一可用于治疗非肌肉浸润性膀胱癌(NMIBC)的市售疫苗疗法。策略供应伙伴关係,例如ImmunityBio在2024年与印度血清研究所(Serum Institute of India)的合作,将继续巩固这一区隔市场。
依给药途径分类
2024年,膀胱内给药区隔市场占最大占有率。这是因为直接膀胱给药可以最大限度地减少全身副作用并增强局部免疫反应。 2025年RUTIVAC-1试验的良好结果证明了其持续的临床价值。
依通路划分
2024年,医院仍是主要的通路,因为疫苗接种需要训练有素的医护人员和专门的临床环境。经销合作伙伴关係,包括ImmunityBio与美国泌尿科合作伙伴(US Urology Partners)在2025年的合作,进一步巩固了这一领域。
2024年,欧洲以1.105亿美元的市场规模引领全球市场。这主要得益于该地区较高的公众意识、强大的筛检率以及每年较高的确诊病例数,预计2025年新增病例将超过22.4万例。
预计北美市场将强劲成长,2024年市场规模将达到9,300万美元,主要得益于诊断创新、研究的拓展以及免疫疗法的进步。亚太地区则位居第三,主要得益于医疗保健投资的增加和癌症治疗覆盖范围的扩大,从而加速了疫苗的普及。 随着人们意识的提高和医疗保健服务的改善,预计拉丁美洲和中东及非洲地区将经历稳步增长。
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.
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.
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
By Route of Administration
By Distribution Channel
By Geography