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市場調查報告書
商品編碼
1880594
膀胱癌疫苗市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(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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由於膀胱癌負擔日益加重以及對有效治療性疫苗的需求不斷增長,全球膀胱癌疫苗市場正在快速擴張。根據2024年的產業分析,預計該市場在2024年的價值為2.97億美元,到2025年將達到3.505億美元。預計到2032年,該市場將進一步顯著成長至15.237億美元,在整個預測期內複合年增長率(CAGR)為23.36%。歐洲持續引領全球產業,截至2024年,其市佔率為37.20%,這得益於較高的疾病盛行率、完善的醫療保健基礎設施和積極的研究。
膀胱癌,尤其是非肌肉層浸潤性膀胱癌 (NMIBC),仍是全球最常見的癌症之一。卡介苗 (BCG) 傳統上用於治療結核病,是目前唯一獲準用於治療 NMIBC 的治療性疫苗,並被廣泛用於預防復發和進展。全球膀胱癌發生率的上升,以及免疫療法的日益普及,持續推動主要市場對膀胱癌疫苗的需求。
市場動態
市場推動因素
市場擴張的主要推動因素是膀胱癌盛行率的上升。吸菸、致癌物暴露、老化和職業風險等生活方式因素顯著加劇了發病率的上升。根據世界癌症研究基金會的報告,2022 年全球新增膀胱癌病例 614,289 例,凸顯了開發有效治療方法的緊迫感。卡介苗 (BCG) 仍然是非肌肉層浸潤性膀胱癌 (NMIBC) 治療的基石,持續推動疫苗療法的需求。
市場限制因子
主要阻礙因素之一是目前僅依賴卡介苗作為核准疫苗。缺乏其他疫苗療法限制了治療的靈活性,並增加了供應鏈短缺的風險。例如,2020 年,膀胱癌倡導網絡 (Bladder Cancer Advocacy Network) 對默克公司 TICE 卡介苗的供應短缺表示擔憂,導致疫苗配給和病患治療延誤。缺乏其他疫苗仍然是市場成長的障礙。
市場機會
不斷擴大的研發投入,旨在開發下一代膀胱癌疫苗,這帶來了巨大的市場機會。各公司正積極探索勝肽疫苗、基因疫苗和聯合免疫療法。例如,鹽野義製藥株式會社於2021年完成了其癌症勝肽疫苗S-588410的II期臨床試驗,為傳統的卡介苗療法提供了新的可能性。
市場趨勢
影響市場的顯著趨勢包括對聯合療法的日益重視,特別是將卡介苗與先進的免疫療法相結合。 2024年4月,美國食品藥物管理局(FDA)批准了諾加潘地金α/invaxcept-PMLN與卡介苗聯合用於治療對卡介苗無反應的非肌肉層浸潤性膀胱癌(NMIBC)。這顯示聯合療法有助於改善患者預後、降低復發率並拓寬治療選擇。
依產品分類
2024年,卡介苗(BCG)區隔市場佔主導地位,因為卡介苗仍是目前唯一可用於治療非肌肉浸潤性膀胱癌(NMIBC)的市售疫苗療法。策略供應夥伴關係,例如ImmunityBio在2024年與印度血清研究所(Serum Institute of India)的合作,將繼續鞏固這一區隔市場。
依給藥途徑分類
2024年,膀胱內給藥區隔市場佔最大佔有率。這是因為直接膀胱給藥可以最大限度地減少全身副作用並增強局部免疫反應。 2025年RUTIVAC-1試驗的良好結果證明了其持續的臨床價值。
依通路劃分
2024年,醫院仍是主要的通路,因為疫苗接種需要訓練有素的醫護人員和專門的臨床環境。經銷合作夥伴關係,包括ImmunityBio與美國泌尿科合作夥伴(US Urology Partners)在2025年的合作,進一步鞏固了這一領域。
2024年,歐洲以1.105億美元的市場規模引領全球市場。這主要得益於該地區較高的公眾意識、強大的篩檢率以及每年較高的確診病例數,預計2025年新增病例將超過22.4萬例。
預計北美市場將強勁成長,2024年市場規模將達到9,300萬美元,主要得益於診斷創新、研究的拓展以及免疫療法的進步。亞太地區則位居第三,主要得益於醫療保健投資的增加和癌症治療覆蓋範圍的擴大,從而加速了疫苗的普及。 隨著人們意識的提高和醫療保健服務的改善,預計拉丁美洲和中東及非洲地區將經歷穩步增長。
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