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市场调查报告书
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1738505

全球mRNA癌症疫苗的临床试验趋势:各适应症市场趋势，开发优先顺序，市场机会(2025年)

Global mRNA Cancer Vaccines Clinical Trials, Market Trends By Indication, Development Priority Status & Market Opportunity Insight 2025
出版日期: | 出版商: KuicK Research | 英文 150 Pages | 商品交期: 最快1-2个工作天内

价格

全球mRNA癌症疫苗临床试验趋势报告重点：按适应症、开发重点和市场机会划分的市场趋势（2025年）

  • mRNA癌症疫苗临床试验洞察：60多种mRNA癌症疫苗
  • mRNA癌症疫苗临床试验洞察：按公司、国家、适应症和分期划分
  • 主要疫苗临床试验开始和完成年份洞察
  • 持续的市场合作、交易与投资情景
  • mRNA癌症疫苗开发的专有技术和研究方法
  • 按地区和适应症划分的市场发展趋势
  • 竞争格局

mRNA癌症疫苗领域已成为现代製药业发展最快的领域之一。受mRNA技术在新冠疫情期间取得成功的推动，製药业和研发机构正利用这项平台开发高度个人化的抗癌疗法。与不精准且易产生全身毒性的传统疗法不同，mRNA癌症疫苗提供针对每个肿瘤中特定基因突变的标靶免疫疗法。这种特异性有可能重新定义肿瘤学的治疗标准。

在临床方面，目前有60多种mRNA癌症疫苗候选药物处于不同的研发阶段。其中大多数处于初步研究或临床前开发阶段，但也有一些已进入中后期临床试验阶段。与传统疫苗不同，mRNA癌症疫苗可以根据个别患者的肿瘤模式进行客製化。

目前正在研发的最先进的mRNA癌症疫苗之一是Moderna和Merck联合研发的Intismeran Autogene (mRNA-4157/V940)，该疫苗目前正处于治疗黑色素瘤和非小细胞肺癌(NSCLC)的III期临床试验阶段。该疫苗与免疫检查点抑制剂帕博利珠单抗合併使用，以最大限度地提高免疫识别和杀死癌细胞的能力。这种联合疗法旨在优化免疫活化并破坏抗药性机制。如果成功，两家公司计划在2027年第二季将Intismeran Autogene商业化。

BioNTech与纪念斯隆凯特琳癌症中心合作研发的Autogene sevumeran (BNT122)最近也在胰臟癌的I期临床试验中显示出良好的疗效。 2025年初的数据显示，疫苗诱发的免疫细胞在某些患者体内持续存在了近四年。对疫苗有反应的患者有较长的无復发期，这表明可以产生持久的肿瘤特异性T细胞反应。

商业界对mRNA癌症疫苗的兴趣也日益增长。大型生物科技公司和大型製药公司正在投入数十亿美元用于研发。此外，新一代生物科技新创公司正在启动临床试验，探索新的抗原标靶方法、递送策略和疫苗生产方法。 CK Life Sciences开发的针对TROP2（一种与三阴性乳癌等恶性肿瘤相关的蛋白质）的环状mRNA疫苗是一项前景光明的研发成果。动物模型的临床前试验表明，该疫苗几乎完全抑制了肿瘤。

儘管前景一片光明，但必须指出的是，目前尚无任何mRNA癌症疫苗获得监管部门的批准。儘管如此，疫苗研发进程很快，监管机构也相应地进行调整。美国食品药物管理局（FDA）、欧洲药品管理局（EMA）和英国药品和保健产品监管局（MHRA）等机构正在积极制定指南，以适应个人化免疫疗法。 NHS 癌症疫苗启动平台就是此类发展的一个例子，它在英格兰各地招募患者进行个人化疫苗试验。

全球有超过 60 种 mRNA 癌症疫苗候选药物正在开发中，其中一些已进入后期临床试验阶段，这些疗法具有巨大的潜力，有望彻底改变肿瘤学。特别是那些面临监管审批和量产挑战的疗法，生物技术、基因组学和免疫疗法的协同作用，或许很快就会让癌症疫苗个性化，惠及最受益的个体。

本报告提供全球mRNA癌症疫苗的临床试验市场相关调查，市场概要，以及药物趋势，临床试验趋势，各地区趋势，及的加入此市场的主要企业的竞争情形等。

目录

第1章 下一代癌症免疫疗法的mRNA疫苗

  • mRNA疫苗概要
  • mRNA疫苗和其他的癌症治疗方法的比较
  • mRNA疫苗和其他的疫苗的比较

第2章 全球mRNA癌症疫苗市场概要

  • 目前市场趋势
  • 未来市场商业化和临床机会

第3章 全球mRNA癌症疫苗临床试验的洞察，企业，国家，适应症，各相

  • 调查
  • 前临床
  • 第一阶段
  • 第一/二阶段
  • 第二阶段
  • 第二/三阶段
  • 第三阶段

第4章 全球癌症mRNA疫苗的临床实验平台概要

  • 各企业
  • 各国
  • 各适应症
  • 患者各市场区隔
  • 各相
  • 优先各状态

第5章 mRNA癌症疫苗临床形势，各适应症

  • 乳癌
  • 脑瘤
  • 黑色素瘤
  • 头颈椎癌症
  • 肺癌症
  • 子宫颈癌症
  • 消化器官癌症

第6章 mRNA癌症疫苗市场趋势，各国

  • 美国
  • 中国
  • 澳洲
  • 欧洲
  • 加拿大
  • 英国

第7章 全球mRNA癌症疫苗市场上联盟，交易，投资

第8章 mRNA癌症疫苗开发的独家技术和方法论

第9章 竞争情形

  • BioNTech
  • Combined Therapeutics
  • CureVac
  • EpiVax
  • HDT Bio
  • Immorna
  • Immune Design
  • MDimune
  • Moderna Therapeutics
  • NeoCura
  • pHion Therapeutics
  • Providence Therapeutics
  • RinuaGene
  • RNAimmune
  • TransCode Therapeutics

Global mRNA Cancer Vaccines Clinical Trials, Market Trends By Indication, Development Priority Status & Market Opportunity Insight 2025 Report Highlights:

  • Insight On mRNA Cancer Vaccines In Clinical Trials: > 60 mRNA Cancer Vaccines
  • mRNA Cancer Vaccine Clinical Trials Insight By Company, Country, Indication & Phase
  • Key Vaccines Initiation & Completion Year Insight
  • Ongoing Market Collaborations, Deals & Investments Scenario
  • Proprietary Technologies & Methodologies For mRNA Cancer Vaccine Development
  • Market Development Trends By Region & Indications
  • Competitive Landscape

mRNA cancer vaccine space has become one of the most rapidly evolving domains in modern pharmaceutical sciences. Encouraged by the success with mRNA technology during the COVID-19 pandemic, the pharmaceutical industry and research institutions are currently leveraging this platform to develop highly individualized anticancer therapies. Unlike conventional therapies, which tend to be imprecise and cause systemic toxicity, mRNA cancer vaccines provide targeted immunotherapy depending on the specific genetic mutations present in an individual tumor. Such specificity has the potential to redefine oncology standards of care.

On the clinical front, over 60 mRNA cancer vaccine candidates are under development at different stages. Though most of them are in preliminary research and preclinical development, a few are already in mid- and late stage clinical trials. These vaccines function by teaching the body to generate tumor-specific antigens, eliciting an immune response against cancer cells. mRNA cancer vaccines differ from conventional vaccines in that they can be customized to each individual patient's tumor pattern, a tactic which has already yielded encouraging results in enhancing long-term immune surveillance.

One of the most advanced mRNA cancer vaccine in the pipeline is Moderna and Merck's Intismeran Autogene (mRNA-4157/V940), currently in Phase 3 for melanoma and non-small cell lung cancer (NSCLC). The vaccine is given in combination with Pembrolizumab, an immune checkpoint inhibitor, to maximize immune recognition and killing of cancer cells. This combination approach is meant to optimize immune activation with breakage of resistance mechanisms. Upon a successful outcome, the firms seek to commercialize Intismeran Autogene by the second quarter of 2027.

Another top contender, Autogene cevumeran (BNT122), from BioNTech in partnership with Memorial Sloan Kettering Cancer Center, is also showed promising Phase 1 trial results in pancreatic cancer recently. Early 2025 data showed the vaccine-induced immune cells lasted in some patients for almost four years. Patients who responded to the vaccine had longer relapse-free periods, which suggested the development of long-lasting, tumor-specific T-cell responses.

Commercial interest in mRNA cancer vaccines is also heating up. Billions are being invested in R&D by large biotech companies and big pharma alike. On top of this, a new generation of biotech startups is going into clinical trials with new antigen targeting modalities, delivery strategies, and vaccine production methods. CK Life Sciences' circular mRNA-based vaccine for TROP2, a protein associated with aggressive tumors such as triple-negative breast cancer, is a promising development. Preclinical outcomes in animal models produced almost complete tumor suppression.

Although the enthusiasm is evident, it must be mentioned that none of the mRNA cancer vaccines have been approved by regulatory authorities yet. That said, the journey is rapid, and regulatory agencies are also adapting themselves in tune. Organizations like the FDA, EMA, and the MHRA of the UK are keenly defining guidelines to accommodate individualized immunotherapies. The NHS's Cancer Vaccine Launch Pad is a real-life example of such development, recruiting patients for individualized vaccine trials throughout England.

With more than 60 mRNA cancer vaccine candidates in development worldwide and some at late stages of clinical trials, the possibility of these treatments revolutionizing oncology is vast. Despite challenges, especially in approval by regulators and mass production, bioengineering, genomics, and immunotherapy synergy could soon bring cancer vaccines personalized to individuals who would benefit the most from them.

Table of Contents

1. mRNA Vaccines As Next Generation Cancer Immunotherapy

  • 1.1 mRNA Vaccines Overview
  • 1.2 mRNA Vaccines v/s Other Cancer Therapeutic Approaches
  • 1.3 mRNA Vaccines v/s Other Vaccines

2. Global mRNA Cancer Vaccines Market Overview

  • 2.1 Current Market Trends
  • 2.2 Future Market Commercialization & Clinical Opportunities

3. Global mRNA Cancer Vaccine Clinical Trials Insight By Company, Country, Indication & Phase

  • 3.1 Research
  • 3.2 Preclinical
  • 3.3 Phase I
  • 3.4 Phase I/II
  • 3.5 Phase II
  • 3.6 Phase II/III
  • 3.7 Phase III

4. Global Cancer mRNA Vaccines Clinical Pipeline Overview

  • 4.1 By Company
  • 4.2 By Country
  • 4.3 By Indication
  • 4.4 By Patient Segment
  • 4.5 By Phase
  • 4.6 By Priority Status

5. Global mRNA Cancer Vaccines Clinical Landscape By Indication

  • 5.1 Breast Cancer
  • 5.2 Brain Cancer
  • 5.3 Melanoma
  • 5.4 Head & Neck Cancers
  • 5.5 Lung Cancer
  • 5.6 Cervical Cancer
  • 5.7 Gastrointestinal Cancers

6. Global mRNA Cancer Vaccines Market Trends By Country

  • 6.1 US
  • 6.2 China
  • 6.3 Australia
  • 6.4 Europe
  • 6.5 Canada
  • 6.6 UK

7. Global mRNA Cancer Vaccines Market Collaborations, Deals & Investments

8. Proprietary Technologies & Methodologies For mRNA Cancer Vaccine Development

9. Competitive Landscape

  • 9.1 BioNTech
  • 9.2 Combined Therapeutics
  • 9.3 CureVac
  • 9.4 EpiVax
  • 9.5 HDT Bio
  • 9.6 Immorna
  • 9.7 Immune Design
  • 9.8 MDimune
  • 9.9 Moderna Therapeutics
  • 9.10 NeoCura
  • 9.11 pHion Therapeutics
  • 9.12 Providence Therapeutics
  • 9.13 RinuaGene
  • 9.14 RNAimmune
  • 9.15 TransCode Therapeutics

List of Figures

  • Figure 4-1: Global - mRNA Cancer Vaccines Clinical Pipeline by Company (Numbers), 2025
  • Figure 4-2: Global - Number Of mRNA Cancer Vaccines Trials by Country (Numbers), 2025
  • Figure 4-3: Global - mRNA Cancer Vaccines Clinical Trials by Indication (Numbers), 2025
  • Figure 4-4: Global - mRNA Cancer Vaccines Clinical Pipeline by Patient Segment (Numbers), 2025
  • Figure 4-5: Global - mRNA Cancer Vaccines Clinical Pipeline by Phase (Numbers), 2025
  • Figure 4-6: Global - mRNA Cancer Vaccines Clinical Pipeline by Priority Status (Numbers), 2025
  • Figure 5-1: KEYNOTE-603 Phase I (NCT03313778) Study - Initiation & Completion Year
  • Figure 5-2: Autogene Cevumeran Phase I (NCT03289962) Study - Initiation & Completion Year
  • Figure 5-3: CVGBM Phase I (NCT05938387) Study - Initiation & Completion Year
  • Figure 5-4: Autogene Cevumeran Phase I (NCT03289962) Study - Initiation & Completion Year
  • Figure 5-5: BNT111 Phase I (NCT04526899) Study - Initiation & Completion Year
  • Figure 5-6: mRNA-4157 Phase II (NCT03897881) Study - Initiation & Completion Year
  • Figure 5-7: mRNA-4157 Phase III (NCT05933577) Study - Initiation & Completion Year
  • Figure 5-8: BNT113 Phase II (NCT04534205) Study - Initiation & Completion Year
  • Figure 5-9: mRNA-4157 Phase I (NCT03313778) Study - Initiation & Completion Year
  • Figure 5-10: V940 Phase III (NCT06077760) Study - Initiation & Completion Year
  • Figure 5-11: LuCa-MERIT-1 Phase I (NCT05142189) Study - Initiation & Completion Year
  • Figure 5-12: EMPOWERVAX Lung 1 Phase I (NCT05557591) Study - Initiation & Completion Year
  • Figure 5-13: Autogene Cevumeran Phase I (NCT04161755) Study - Initiation & Completion Year
  • Figure 5-14: Autogene cevumeran Phase II (NCT05968326) Study - Initiation & Completion Year
  • Figure 5-15: BNT122 Phase II (NCT04486378) Study - Initiation & Completion Year
  • Figure 8-1: BioNTech - uRNA products
  • Figure 8-2: BioNTech - iNeST technology
  • Figure 8-3: CureVac - CureVac Method for Generation of mRNA Therapeutics
  • Figure 8-4: Moderna - mRNA Technology
  • Figure 8-5: NeoCura - NeoCura Ag Platform
  • Figure 8-6: Providence Therapeutic - mRNA Medicines Platform Benefits

List of Tables

  • Table 1-1: mRNA Vaccines v/s Other Cancer Therapeutic Approaches
  • Table 1-2: mRNA-Based Cancer Vaccines vs. Other Cancer Vaccines
  • Table 2-1: Regulatory Designations Granted to Investigational mRNA Cancer Vaccines
  • Table 5-1: Breast Cancer - Some mRNA Vaccines in Clinical Trials
  • Table 5-2: Brain Cancer - Some mRNA Vaccines in Clinical Trials
  • Table 5-3: Melanoma - Some mRNA Vaccines in Clinical Trials
  • Table 5-4: Head & Neck Cancer - mRNA Vaccines in Clinical Trials
  • Table 5-5: Lung Cancer - Some mRNA Vaccines in Clinical Trials
  • Table 5-6: Cervical Cancer - Some mRNA Vaccines in Clinical Trials
  • Table 5-7: Gastrointestinal Cancers - Some mRNA Vaccines in Clinical Trials