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市場調查報告書
商品編碼
1884056
前列腺癌疫苗市場規模、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 年)Prostate Cancer Vaccines Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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由於疾病盛行率上升、公眾意識增強以及個人化免疫療法的廣泛應用,全球前列腺癌疫苗市場正經歷快速增長。根據最近的一項研究,2024 年該市場規模為 4.904 億美元,預計到 2025 年將達到 5.339 億美元。預計到 2032 年將進一步成長至 11.836 億美元,預測期內複合年增長率 (CAGR) 為 12.0%。北美地區在2024年佔市場主導地位,市佔率高達79.79%,這主要得益於其完善的醫療保健基礎設施、免疫療法的廣泛應用以及人們對前列腺癌治療方案的高度認知。
攝護腺癌疫苗並非預防性疫苗,而是用於治療已確診的疾病。這些疫苗能夠活化攻擊前列腺癌細胞的免疫細胞,旨在根除復發性疾病或延緩疾病進展。目前,Dendreon Pharmaceuticals LLC. 的 PROVENGE(Sipuleucel-T)是唯一獲得FDA批准的疫苗,鞏固了其在北美市場的領先地位。對標靶性強、毒性小的療法的需求不斷增長,以及荷爾蒙療法和化療等傳統療法的局限性,正在推動市場進一步擴張。
根據世界癌症研究基金會預測,2022年全球將新增1,467,854例前列腺癌病例,凸顯了開發有效療法的迫切性。免疫療法因其副作用小、療效持久且可與傳統療法聯合應用,在治療前列腺癌方面正得到越來越廣泛的應用。
市場推動因素與機會
關鍵推動因素是晚期前列腺癌對荷爾蒙療法的抗藥性。雄性激素剝奪療法 (ADT) 可降低睪固酮水平,但由於雄性激素受體突變,腫瘤會隨著時間的推移產生抗藥性。加州大學洛杉磯分校 Jonsson 綜合癌症中心 2023 年 12 月的一項研究揭示了前列腺細胞的不同類型——基底細胞和腔細胞——這表明需要針對對激素療法反應較差的腫瘤開發替代療法。這推動了對疫苗的需求。
此外,個人化免疫療法的未滿足需求也帶來了巨大的市場機會。各公司正投資研發新型候選疫苗,包括病毒疫苗和 DNA 疫苗。 2024年12月,Candel Therapeutics公佈了其病毒免疫療法CAN-2409聯合放射療法的III期臨床試驗的積極結果,證實其對中高危險局限性前列腺癌患者有效。這些進展凸顯了市場的成長潛力以及持續研發投入的必要性。
市場阻礙因素與挑戰
疫苗複雜且耗時的給藥流程是主要阻礙因素。 Provenge需要進行白血球分離術、集中細胞處理和回輸,大約需要四天時間。這種勞動密集型流程可能會因物流挑戰、病患依從性問題和成本增加而限制其廣泛應用。
此外,市場還面臨監管挑戰和較高的臨床試驗失敗率。對細胞療法的嚴格監管往往會延遲其審批和商業化進程。例如,Ventac Partners 公司的抗原疫苗 RV001 因療效不足,於 2022 年 5 月的 II 期臨床試驗中失敗,凸顯了前列腺癌疫苗相關的財務和研發風險。
市場趨勢
一個值得關注的趨勢是開發旨在誘導強效抗腫瘤免疫反應的 DNA 疫苗。例如,Madison Vaccines 公司的 MVI-118 疫苗靶向轉移性去勢敏感性前列腺癌的雄性激素受體配體結合域。臨床前和早期臨床試驗已證實其安全性、耐受性和延長疾病進展間隔,這反映了核酸技術在免疫療法中日益重要的作用。與其他療法(包括免疫檢查點抑制劑,例如 ADT 和 Keytruda)合併使用的情況越來越普遍。
The global prostate cancer vaccines market is experiencing rapid growth due to rising disease prevalence, increasing awareness, and expanding adoption of personalized immunotherapies. According to recent insights, the market was valued at USD 490.4 million in 2024, is projected to reach USD 533.9 million in 2025, and is expected to grow to USD 1,183.6 million by 2032, reflecting a CAGR of 12.0% during the forecast period. North America dominated the market in 2024 with a 79.79% share, primarily due to well-established healthcare infrastructure, widespread access to immunotherapy, and higher awareness about prostate cancer treatment options.
Prostate cancer vaccines are therapeutic, targeting existing disease rather than prevention. The vaccines aim to activate immune cells capable of attacking prostate cancer cells, either to eradicate recurrent disease or delay disease progression. Currently, PROVENGE (Sipuleucel-T) by Dendreon Pharmaceuticals LLC. remains the only FDA-approved vaccine, reinforcing North America's leadership in the market. Rising demand for targeted, low-toxicity therapies and the limitations of traditional treatments such as hormone therapy and chemotherapy further propel market expansion.
According to the World Cancer Research Fund, 1,467,854 new prostate cancer cases were reported globally in 2022, emphasizing the urgent need for effective therapies. Immunotherapy offers durable responses with fewer side effects and can be combined with conventional treatments, enhancing its adoption in prostate cancer care.
Market Drivers and Opportunities
A key driver is the resistance to hormone therapy observed in advanced prostate cancer. Androgen deprivation therapy (ADT) reduces testosterone levels, yet tumors may develop resistance over time due to mutations in androgen receptors. Research from UCLA Jonsson Comprehensive Cancer Center in December 2023 revealed distinct basal and luminal prostate cells, highlighting that tumors less responsive to hormone therapy require alternative treatments, thereby increasing demand for vaccines.
Furthermore, the unmet need for personalized immunotherapies provides significant market opportunities. Companies are investing in novel vaccine candidates, including viral and DNA-based vaccines. In December 2024, Candel Therapeutics, Inc. reported positive Phase 3 results for CAN-2409 viral immunotherapy, combined with radiation therapy, demonstrating efficacy in intermediate-to-high-risk localized prostate cancer patients. Such developments highlight the market's growth potential and ongoing R&D investment.
Market Restraints and Challenges
The complex and lengthy administration of vaccines is a major restraint. Provenge requires leukapheresis, cell processing at a centralized facility, and reinfusion, spanning approximately four days. This labor-intensive process may limit adoption due to logistical challenges, patient compliance, and increased costs.
Additionally, the market faces regulatory challenges and high clinical trial failure rates. Strict regulations for cellular therapies often delay approvals and commercialization. For example, Ventac Partners' RV001 antigen-based vaccine failed its Phase 2 trial in May 2022 due to insufficient efficacy, illustrating the financial and developmental risks associated with prostate cancer vaccines.
Market Trends
A prominent trend is the development of DNA-based vaccines, designed to trigger potent anti-tumor immune responses. Vaccines such as MVI-118 by Madison Vaccines, Inc. target the androgen receptor ligand-binding domain for metastatic castration-sensitive prostate cancer. Preclinical and early clinical trials demonstrated safety, tolerability, and prolonged disease progression intervals, reflecting the growing role of nucleic acid technologies in immunotherapy. Integration with other therapies, including ADT and checkpoint inhibitors like Keytruda, is becoming increasingly common.
Competitive Landscape
The market is highly consolidated, with Dendreon Pharmaceuticals LLC. leading due to PROVENGE. Other key players, including Barinthus Biotherapeutics, Candel Therapeutics, Inc., BioNTech, and Madison Vaccines, Inc., are advancing R&D pipelines and clinical trials to expand market presence and introduce novel vaccine candidates.
Conclusion
With a market size of USD 490.4 million in 2024, expected to reach USD 533.9 million in 2025, and projected to hit USD 1,183.6 million by 2032, the prostate cancer vaccines market is poised for substantial growth. Drivers include rising prevalence, resistance to hormonal therapies, and innovation in immunotherapy platforms, while regulatory complexity and administration challenges remain key hurdles. Continuous R&D, DNA-based vaccines, and expansion of treatment centers will shape market dynamics through 2032.
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