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传讯RNA市场－全球及区域分析：按应用、按地区划分－分析与预测（2025-2035）
市场调查报告书
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1956052

传讯RNA市场－全球及区域分析：按应用、按地区划分－分析与预测（2025-2035）

Messenger RNA Market - A Global and Regional Analysis: Application and Regional Analysis - Analysis and Forecast, 2025-2035
出版日期: | 出版商: BIS Research | 英文 104 Pages | 商品交期: 1-5个工作天内

价格

传讯RNA(mRNA) 市场涵盖了基于 mRNA 的疫苗和疗法的开发和商业化，这些疫苗和疗法能够使细胞产生针对疾病的蛋白质，从而为治疗和预防提供了一种灵活快速的方法。

随着 mRNA COVID-19 疫苗在临床和商业性取得成功，市场迅速扩张，现在正扩展到感染疾病、肿瘤学、罕见遗传疾病和个人化医疗领域。

关键市场统计数据
预测期 2025-2035
截至2025年的评估 24.38亿美元
2035 年预测 209.901亿美元
复合年增长率 24.02%

关键成长要素包括已证实的显着临床疗效、更短的研发週期、不断增加的公共和私人投资，以及脂质奈米颗粒等递送技术的持续创新。然而，生产复杂性、低温运输要求、成本压力和不断变化的法规结构等挑战正在限制市场成长。儘管如此，持续的技术进步和多元化的产品线预计将在长期内支撑市场扩张。

市场概览

全球传讯RNA（mRNA）市场预计将迎来显着成长，到2035年市场规模预计将达到209.901亿美元。 mRNA市场的核心是一项创新生物技术，它利用合成的mRNA分子来指导人体细胞产生特定蛋白质，从而实现快速免疫反应和治疗效果。 Moderna和BioNTech/辉瑞等公司成功开发并在全球推广了基于mRNA的COVID-19疫苗，首次证明了该平台的临床和商业性可行性，也展示瞭如何快速高效地设计、生产和大规模部署mRNA构建体。

先前，mRNA技术受限于其不稳定性及递送难题，但如今，核苷修饰和脂质奈米颗粒（LNP）递送系统等创新技术正推动mRNA技术取得进展，显着提升了其稳定性、细胞摄取和免疫反应，同时最大限度地减少了不必要的发炎反应。这些突破对于拓展mRNA技术的应用范围至关重要，使其超越新冠肺炎的范畴，应用于下一代流感疫苗、癌症免疫疗法、蛋白质替代疗法以及罕见遗传疾病的治疗方法领域。目前，数百种候选药物正处于临床前和临床试验阶段。

然而，市场动态反映了机会与挑战并存的局面。一方面，mRNA平台快速的设计适应性、个人化医疗潜力以及扩充性正吸引着来自产业界、学术界和政府的大量研究投资和策略联盟。另一方面，mRNA体内稳定性、靶向特定组织递送以及优化剂量等挑战仍然是科学探索和技术开发的活跃领域。分子设计、替代递送技术和监管途径的持续创新正在塑造mRNA疫苗和疗法从研发阶段走向更广泛的临床应用，使mRNA市场成为推动精准医疗未来发展的关键基础。

对产业的影响

传讯RNA（mRNA）技术的兴起对生物製药产业产生了深远的影响，重塑了疫苗和治疗药物的研发和生产流程。与生物製药不同，mRNA平台能够实现快速模组化设计，使企业能够在数週而非数年内完成从标靶识别到临床候选药物开发的整个过程。这种变革在新冠疫情期间得到了充分体现，并在科学文献中得到了充分的证实。它导致了生物製药价值链的显着变化，包括脂质奈米颗粒专用生产的扩张、对高纯度核苷酸和酶的需求增加，以及专注于RNA产品的新型合约开发和生产机构（CDMO）的涌现。研究也强调了mRNA如何透过实现个人化和可扩展的治疗方法，加速肿瘤学、感染疾病和罕见疾病领域的创新，并促进生物技术公司、学术机构和技术提供者之间的跨产业合作。整体而言，mRNA 技术不仅催生了新的治疗方法，而且还在重新定义生命科学领域的产业时间表、供应链和创新模式。

市场区隔:

细分 1：按应用

  • 肿瘤学
  • 感染疾病
  • 罕见遗传疾病
  • 呼吸系统疾病

截至2024年，感染疾病领域在全球传讯RNA）市场中占最大份额，高达99.86%。近年来，mRNA技术在感染疾病预防领域的应用迅速扩展，这主要得益于新冠疫苗在临床和实际应用中的成功。 mRNA疫苗能够使人体自身细胞产生抗原，刺激标靶免疫反应，提供了快速、灵活且高效的预防方法。人们对预防流行病的必要性以及mRNA平台的多功能性日益重视，显着提升了其在更广泛感染疾病领域的应用前景。

新冠疫情标誌着一个关键的转捩点，辉瑞-BioNTech 和 Moderna 的疫苗成为首批实现全球大规模部署的 mRNA 疫苗。 mRNA 疫苗对重症新冠患者的高效性和快速的研发週期证明了其作为可行的疫苗策略，并加速了其应用。针对包括 Omicron 株在内的新出现的变异株，mRNA 疫苗的更新配方和加强配方的持续研发，进一步凸显了 mRNA 技术在应对不断演变的病毒威胁方面的适应性。

除了新冠肺炎之外，mRNA平台在流感疫苗研发领域也日益受到重视。儘管传统方法受限于病毒株不匹配和病毒变异，但新一代mRNA流感疫苗（例如Moderna公司的mRNA-1010）的临床试验表明，与传统疫苗相比，其在老年人群中的有效性有所提高。这些进展凸显了mRNA技术的巨大潜力，它可以透过更快的株更新、更高的有效性以及更具韧性的全球疫苗接种策略，彻底改变季节性和新兴感染疾病的防治方式。

细分2：按区域

  • 北美洲
    • 我们
    • 加拿大
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 其他的
  • 亚太地区
    • 日本
    • 中国
    • 其他的
  • 其他地区

北美凭藉着在监管、科学创新和生产规模方面无可比拟的优势，在mRNA市场占据主导地位。美国食品药物管理局（FDA）早期采取的积极倡议——包括紧急使用授权、全面核准和突破性治疗方法认定——加速了mRNA技术在感染疾病和肿瘤领域的临床应用，尤其是在新冠疫情期间，辉瑞-BioNTech和Moderna疫苗取得了显着成功。这种清晰的法规环境显着降低了研发风险，并使该地区成为下一代mRNA产品（包括个人化癌症疫苗和母体免疫疫苗）的首选上市市场。

同时，北美受益于深厚的研发生态系统和持续的公共及私人投资，这支持了脂质奈米颗粒化学的快速改进、热稳定性的提升以及个人化治疗药物的自动化生产。该地区还在生产基础设施方面投入巨资，例如Moderna公司在美国和加拿大的大规模生产扩张（其位于魁北克省拉瓦尔的工厂既能满足正常供应需求，也能在疫情期间提升产能）。儘管仍存在一些挑战，例如低温运输物流、个人化癌症疫苗的规模化生产以及复杂的GMP要求，但先进的基础设施、沉重的疾病负担以及对创新治疗方法的早期应用，持续巩固北美在全球mRNA市场的主导地位。

传讯RNA市场的最新趋势

  • 2025年8月，Moderna公司宣布，加拿大卫生署已核准其更新版新冠病毒mRNA疫苗Spikevax，适用于6个月及以上人群，该疫苗针对SARS-CoV-2 LP.8.1变种。该公司计划在2025-2026年疫苗接种季之前供应这款更新版疫苗。
  • 2025 年 8 月，辉瑞-BioNTech 的 Comirnaty 获得美国 FDA核准，用于 65 岁及以上成年人和 5 至 64 岁有重病高风险的成年人。
  • 2025 年 4 月，专注于开发 RNA 疗法和疫苗的临床阶段生物技术公司 Ethris 与 Lonza 合作，开发了一种室温稳定的喷雾干燥製剂，该製剂是一种基于 mRNA 的候选疫苗，用于黏膜给药以对抗呼吸道疾病。
  • 2025年3月，Primrose Bio公司宣布推出一款旨在提高长模板mRNA疫苗生产效率的新产品。据称，Prima RNApols ExTend能够透过降低生产过程中双链RNA（dsRNA）的含量，帮助研发人员以更低的成本生产出更优的mRNA产品。

需求——驱动因素、挑战与机会

市场需求－感染疾病率不断上升

感染疾病率的上升是推动mRNA疫苗需求的主要因素，因为这些病原体持续构成复杂且不断变化的公共卫生挑战。虽然传统疫苗平台对许多疾病有效，但它们往往难以跟上流感、呼吸道融合细胞病毒（RSV）、HIV和其他新兴病原体等快速变异病毒的步伐。这些病毒具有分段RNA基因组，并频繁发生抗原突变，导致多种亚型的出现，使疫苗研发更加复杂。这种情况凸显了开发更具适应性、扩充性和快速性的疫苗技术（例如基于mRNA的平台）的必要性，以便能够快速应对不断变化的威胁。

流感病毒－流感仍然是全球一个重要的公共卫生议题。世界卫生组织（世卫组织）估计，季节性流感每年导致300万至500万例严重病例和29万至65万例死亡。流感病毒的分段RNA基因组会导致抗原不断漂移，因此需要频繁更新疫苗以维持其效能。传统的灭活疫苗难以适应这些变化，促使人们对mRNA疫苗越来越感兴趣。 Moderna公司的mRNA-1010疫苗针对四种不同的流感病毒株，是mRNA技术如何快速适应病毒变异的绝佳例证，展现了其相对于需要每年更新疫苗的传统疫苗的优势。

呼吸道融合细胞病毒(RSV) 是导致呼吸道疾病的主要病原体之一，特别易感于婴幼儿、老年人和免疫力缺乏。根据世界卫生组织统计，RSV 每年导致超过 360 万例五岁以下儿童住院治疗，约 10 万例死亡。数十年来，RSV 疫苗的匮乏使得人们对创新解决方案的需求日益增长。 Modern 公司研发的 mRNA-1345 是首个获得美国食品药物管理局 (FDA)核准的RSV mRNA 疫苗，标誌着在应对这一全球健康挑战方面迈出了重要一步。 mRNA 平台能够开发编码精确病毒蛋白结构的疫苗，有望提高疫苗效力并降低传播风险。 mRNA 疫苗的成功以及正在进行的 RSV 临床试验表明，基于 mRNA 的解决方案在应对高风险疾病方面正成为日益增长的趋势。

mRNA疫苗需求的不断增长源于其适应性强、研发速度快以及能够靶向多种病原体。 mRNA疫苗在新冠肺炎治疗中的成功开创了先河，并加速了将此技术应用于其他感染疾病的进程。随着新病原体的出现和现有病原体的变异，mRNA疫苗为应对这些挑战、加强全球公共卫生应变提供了一个广阔且灵活的解决方案。

市场挑战：製造复杂性和可扩展性

儘管mRNA的生产不需要活细胞，但它仍然是一个高度复杂且技术难度极高的过程，尤其是在从实验室规模放大到商业化生产时。体外转录看似简单，但其实是一个需要严格控制的多步骤过程，包括质体DNA的生产、无细胞转录、高级纯化、脂质奈米颗粒包覆以及最终的填充和表面处理工程。每个步骤都需要根据特定的mRNA构建体和治疗应用进行精确的客製化。 mRNA固有的不稳定性进一步加剧了这种复杂性，它对温度、剪切应力和RNase污染高度敏感。严格的製程控制和低温运输物流是必要的，这增加了成本并限制了其应用。此外，序列特异性的最佳化需求和规模依赖性的製程也为生产流程带来了挑战，因为规模化生产通常需要新的设备和单元操作，而不仅仅是增加生产量。此外，该行业还面临着诸多挑战，例如关键 GMP 级原材料的供应链限制、适用设备有限（尤其是脂质奈米颗粒製剂设备）以及 mRNA 表征和品管的分析和监管标准不断变化——所有这些都增加了营运风险并延缓了大规模部署。

市场机会－利用mRNA技术革新基因编辑领域

mRNA，尤其是与CRISPR技术结合使用时，正透过提高基因介入的精准性、安全性和通用性，成为基因编辑领域变革的核心力量。 mRNA能够高效地递送引导RNA并控制编辑组件的表达，从而增强标靶准确性并减少脱靶效应。这对于获得监管部门核准以及开发针对镰状细胞贫血症、囊肿纤维化和罕见遗传疾病等的精准治疗方法至关重要。除了编辑功能外，mRNA还可以在基因校正后瞬时表达治疗性蛋白质。这支持联合治疗和非永久性治疗策略，尤其适用于自体免疫神经退化性疾病。其合成性和可程式设计性使其能够快速原型製作并实现规模化生产，从而缩短个人化药物（例如癌症免疫疗法）的研发週期。脂质奈米颗粒递送技术的进步进一步强化了这一机会，实现了在单一系统中共递送mRNA和CRISPR组分，从而创造了具有竞争优势的平台。综上所述，这些特性使得基于 mRNA 的基因编辑技术能够在高度未满足需求的领域中获得早期应用，并在基因编辑法规结构不断完善的过程中提供先发优势。

市场趋势－拓展至感染疾病以外的治疗领域

虽然mRNA技术因新冠疫苗而获得全球认可，但影响远不止于感染疾病，尤其是在癌症免疫疗法方面。与预防性疫苗不同，mRNA癌症疫苗编码肿瘤相关或肿瘤特异性抗原，以训练免疫系统识别并摧毁癌细胞。与传统免疫疗法相比，mRNA平台具有更大的柔软性，能够编码多种抗原，诱导广泛且持久的免疫反应，同时也能应对免疫逃脱和疗效差异等挑战。它能够同时刺激抗体依赖性和T细胞依赖性免疫反应，从而增强多种免疫路径的抗肿瘤活性。利用患者特异性肿瘤新抗原的个人化mRNA癌症疫苗（例如Moderna和默克公司的V940）已取得显着进展，并展现出令人鼓舞的临床结果，例如与查核点抑制剂联合使用时，可提高高危险群黑色素瘤患者的无復发生存期。 mRNA疫苗也在前列腺癌领域进行探索，例如CureVac公司的CV9103和CV9104等候选疫苗，它们靶向多种前列腺特异性抗原以增强免疫识别。这不仅展现了mRNA疫苗的潜力，也显示仍需进一步优化。重要的是，mRNA技术透过改善抗原呈现和T细胞活化来克服癌细胞的免疫逃脱机制，使其成为下一代癌症治疗中一项变革性的策略支柱。

产品与创新策略：本报告深入分析了传讯RNA的最新技术趋势，使企业能够推动创新并开发符合市场需求的尖端产品。

透过全面的市场分析和对关键成长机会的识别，我们为企业提供製定有针对性的行销策略和有效扩大市场份额所需的知识。

该报告包含全面的竞争格局分析，以帮助企业了解竞争对手的优势和劣势，并制定有效的策略以获得市场竞争优势。

我们提供有关不断变化的法规结构、核准流程和行业指南的最新信息，以确保您的组织保持合规，并加速新型 mRNA 疗法的市场准入。

透过分析市场趋势、资金筹措模式和合作机会，我们帮助企业做出明智的投资决策，并识别潜在的併购机会以促进业务成长。

调查方法

市场设计与检验中的关键考虑因素与假设

  • 计算市场规模的基准年设定为2024年。对2021财年至2023财年期间进行了历史分析。 2024财年的市场规模进行了估算，并对2025财年至2035财年期间进行了预测。
  • 本报告的范围是根据与世界各地公司专家的对话精心製定的。报告提供了关于mRNA疗法及其在肿瘤学、感染疾病、罕见遗传疾病和呼吸系统疾病等各种应用领域的市场研究。
  • 各公司的收入均以 2023 财年及 2024 财年的年度报告为准。对于私人公司，其收入是根据一手调查资讯、资金筹措历史、市场合作和业务表现等因素估算得出的。
  • 本报告根据现有的传讯RNA疗法绘製了市场图，并介绍了在该领域提供重要产品和服务的所有主要企业。

主要市场参与企业及竞争格局概述

我们根据对目标产业、产品系列和市场渗透率的分析，并结合收集领先专家的意见，选择对其中进行介绍的公司。

该市场的一些主要企业包括：

  • Arcturus Therapeutics Inc
  • Moderna, Inc
  • SK Bioscience Co., Ltd.
  • Oncotelic Inc
  • Sanofi
  • Pfizer Inc.
  • AstraZeneca
  • CureVac SE
  • GSK plc
  • Abogen Biosciences
  • Beam Therapeutics Inc

目录

执行摘要

第一章 全球传讯RNA市场：产业展望

  • 产业展望
    • 市场概览与生态系统
    • 临床试验
    • 监管状态
  • 专利分析
    • 专利申请（2023 年与 2024 年）
    • 排名前五的公司专利申请数量（2023 年与 2024 年比较）
  • 管道分析
  • 市场动态
    • 趋势、驱动因素、挑战和机会：评估当前和未来的影响
    • 趋势
    • 市场驱动因素
    • 市场限制
    • 市场机会
    • 市场挑战

第二章：应用类型

  • 概述
    • 肿瘤学
    • 感染疾病
    • 罕见遗传疾病
    • 呼吸系统疾病
    • 其他的

第三章 区域

  • 北美洲
  • 欧洲
  • 亚太地区
  • 其他地区

第四章 竞争标桿分析与公司概况

  • 推动传讯RNA市场发展的关键参与企业
  • 各公司的主要策略和发展
  • 关键发展分析
  • 公司简介
    • Arcturus Therapeutics Inc.
    • Moderna, Inc.
    • SK Bioscience Co., Ltd.
    • Oncotelic Inc.
    • Sanofi
    • Pfizer Inc.
    • AstraZeneca
    • CureVac SE
    • GSK plc.
    • Abogen Biosciences
    • Beam Therapeutics Inc.

第五章调查方法

Product Code: BHL2830SA

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Introduction of Messenger RNA

The messenger RNA (mRNA) market encompasses the development and commercialization of mRNA-based vaccines and therapeutics that enable cells to produce disease-targeting proteins, offering a flexible and rapid approach to treatment and prevention. The market has expanded rapidly following the clinical and commercial success of mRNA COVID-19 vaccines and is now advancing across infectious diseases, oncology, rare genetic disorders, and personalized medicine.

KEY MARKET STATISTICS
Forecast Period2025 - 2035
2025 Evaluation$2,438.0 Million
2035 Forecast$20,990.1 Million
CAGR24.02%

Key growth drivers include strong clinical validation, accelerated development timelines, increasing public and private investment, and ongoing innovations in delivery technologies such as lipid nanoparticles. However, the market growth is tempered by challenges including manufacturing complexity, cold-chain requirements, cost pressures, and evolving regulatory frameworks, though continued technological progress and pipeline diversification are expected to sustain long-term market expansion.

Market Introduction

The global messenger RNA market is expected to witness substantial growth, projected to reach $20,990.1 million by 2035. The messenger RNA (mRNA) market centers on a transformative class of biotechnologies that use synthetic mRNA molecules to instruct the body's cells to produce specific proteins, enabling rapid immune responses or therapeutic effects. This platform first proved its clinical and commercial viability with the successful development and global rollout of mRNA-based COVID-19 vaccines by companies such as Moderna and BioNTech/Pfizer, demonstrating how quickly and effectively mRNA constructs can be designed, manufactured, and deployed at scale.

Scientific research shows that mRNA technology, previously constrained by instability and delivery challenges, has advanced through innovations including nucleoside modifications and lipid nanoparticle (LNP) delivery systems, which improve stability, cellular uptake, and immune response while minimizing unwanted inflammation. These breakthroughs have been critical in expanding applications beyond COVID-19 to include next-generation influenza vaccines, cancer immunotherapies, protein replacement therapies, and treatments for rare genetic disorders, with hundreds of candidates under investigation in preclinical and clinical studies.

However, the market's dynamics reflect a balance of opportunity and challenge. On the one hand, the rapid design adaptability, potential for personalized medicine, and scalability of mRNA platforms attract heavy research investment and strategic partnerships across industry, academic, and government sectors. On the other hand, issues such as mRNA stability in vivo, targeted delivery to specific tissues, and optimized dosing remain active areas of scientific inquiry and engineering effort. Continued innovations in molecular design, alternative delivery technologies, and regulatory pathways are shaping how mRNA vaccines and therapeutics move from research pipelines into broader clinical use, positioning the mRNA market as a key enabler of future precision medicine.

Industrial Impact

The rise of messenger RNA (mRNA) technology has had a profound industrial impact, reshaping how vaccines and therapeutics are researched, developed, and manufactured. Unlike traditional biologics, mRNA platforms enable rapid, modular design, allowing companies to move from target identification to clinical candidates in weeks rather than years a shift demonstrated during the COVID-19 pandemic and well documented in scientific literature. This has driven major changes across the biopharmaceutical value chain, including the expansion of specialized manufacturing for lipid nanoparticles, increased demand for high-purity nucleotides and enzymes, and the emergence of new contract development and manufacturing organizations (CDMOs) focused on RNA-based products. Research studies also highlight how mRNA has accelerated innovation in oncology, infectious diseases, and rare disorders by supporting personalized and scalable therapies, encouraging cross-industry collaborations between biotech firms, academic institutions, and technology providers. Overall, mRNA technology is not only enabling new therapeutic modalities but also redefining industrial timelines, supply chains, and innovation models across the life sciences sector.

Market Segmentation:

Segmentation 1: By Application

  • Oncology
  • Infectious Disease
  • Rare Genetic Disease
  • Respiratory Disease

In the global messenger RNA market, as of 2024, the infectious disease segment holds the largest share at 99.86%. The application of mRNA technology in infectious disease prevention has expanded rapidly in recent years, driven primarily by the clinical and real-world success of COVID-19 vaccines. mRNA vaccines offer a fast, flexible, and highly effective approach by enabling the body's cells to produce antigens that stimulate a targeted immune response. Growing awareness of pandemic preparedness needs and the versatility of mRNA platforms has significantly increased interest in their use across a wider range of infectious diseases.

The COVID-19 pandemic represented a major inflection point, with the Pfizer-BioNTech and Moderna vaccines becoming the first mRNA vaccines to achieve large-scale global deployment. Their strong effectiveness against severe COVID-19 and rapid development timelines validated mRNA as a viable vaccine modality and accelerated its adoption. Ongoing updates and booster formulations targeting emerging variants, including Omicron, further underscore the adaptability of mRNA technology in responding to evolving viral threats.

Beyond COVID-19, mRNA platforms are gaining traction in influenza vaccine development, where traditional approaches are limited by strain mismatch and viral mutation. Clinical studies of next-generation mRNA flu vaccines, such as Moderna's mRNA-1010, have shown improved efficacy in older adults compared with conventional vaccines. These advances highlight the potential of mRNA technology to transform seasonal and emerging infectious disease management through faster strain updates, improved effectiveness, and more resilient global vaccination strategies.

Segmentation 2: By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe
  • Asia-Pacific
    • Japan
    • China
    • Rest-of-Asia-Pacific
  • Rest of the World

North America dominates the mRNA market due to its unmatched combination of regulatory leadership, scientific innovation, and manufacturing scale. Early and proactive engagement by the U.S. FDA through Emergency Use Authorizations, full approvals, and breakthrough designations accelerated the clinical validation of mRNA technologies across infectious diseases and oncology, most notably during the COVID-19 pandemic with Pfizer-BioNTech and Moderna vaccines. This regulatory clarity significantly reduced development risk and positioned the region as the preferred launch market for next-generation mRNA products, including personalized cancer vaccines and maternal immunizations.

In parallel, North America benefits from deep R&D ecosystems and sustained public-private investment that support rapid iteration in lipid nanoparticle chemistry, thermostability improvements, and automated manufacturing for personalized therapies. The region has also made substantial investments in production infrastructure, exemplified by Moderna's large-scale manufacturing expansion in the U.S. and Canada, including the Laval, Quebec facility designed for both routine supply and pandemic surge capacity. While challenges remain such as cold-chain logistics, scalability of individualized oncology vaccines, and complex GMP requirements the region's advanced infrastructure, high disease burden, and early adoption of innovative therapies continue to reinforce North America's leadership in the global mRNA market.

Recent Developments in the Messenger RNA Market

  • In August 2025, Moderna announced that Health Canada has approved its updated COVID-19 mRNA vaccine, Spikevax, formulated to target the SARS-CoV-2 LP.8.1 variant, for use in individuals aged six months and older. The company is set to supply the updated vaccine ahead of the 2025-2026 vaccination season.
  • In August 2025, Pfizer and BioNTech's COMIRNATY has received U.S. FDA approval for adults aged 65 and older, as well as individuals aged 5 to 64 who are at an increased risk of severe COVID-19.
  • In April 2025, Ethris, a clinical-stage biotechnology company focused on RNA therapeutics and vaccines, has partnered with Lonza to develop room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates, designed for mucosal delivery to address respiratory diseases.
  • In March 2025, Primrose Bio introduced a new product designed to enhance the manufacturing of long-template mRNA vaccines. The Prima RNApols ExTend is said to help developers produce mRNA products with improved performance at a lower cost by reducing the levels of dsRNA in the production process.

Demand - Drivers, Challenges, and Opportunities

Market Demand Drivers: Growing Incidence of Infectious Diseases

The rising incidence of infectious diseases is significantly driving the demand for mRNA vaccines, as these pathogens continue to pose evolving and complex public health challenges. Traditional vaccine platforms, while effective for many diseases, often struggle to keep pace with rapidly mutating viruses such as influenza, respiratory syncytial virus (RSV), HIV, and other emerging pathogens. These viruses, with their segmented RNA genomes, undergo frequent antigenic shifts, leading to the emergence of multiple subtypes that complicate vaccine development. This scenario underscores the necessity for more adaptable, scalable, and rapid vaccine technologies, such as mRNA-based platforms, which can quickly respond to these evolving threats.

Influenza Virus: Influenza remains a significant public health concern worldwide. The World Health Organization (WHO) estimates that seasonal influenza causes three to five million cases of severe illness and 290,000 to 650,000 deaths annually. Influenza's segmented RNA genome allows for constant antigenic drift, requiring frequent updates to vaccines to maintain their effectiveness. Traditional inactivated vaccines face challenges in adapting to these changes, which has spurred increased interest in mRNA vaccines. Moderna's mRNA-1010 vaccine, targeting four different influenza strains, exemplifies how mRNA technology can rapidly adapt to viral mutations, offering an advantage over conventional vaccines that need annual reformulation.

Respiratory Syncytial Virus (RSV): RSV is a leading cause of respiratory illness, especially among infants, older adults, and immunocompromised individuals. According to the WHO, RSV results in over 3.6 million hospitalizations and about 100,000 deaths annually in children under the age of five years. The absence of effective vaccines for RSV for decades has heightened the demand for innovative solutions. Moderna's mRNA-1345, the first FDA-approved mRNA vaccine for RSV, marks a significant step forward in addressing this global health challenge. The mRNA platform allows the development of vaccines that encode precise viral protein structures, enhancing efficacy and potentially reducing transmission. The success of mRNA vaccines in RSV and the ongoing clinical trials reflect a growing trend toward mRNA-based solutions for high-risk diseases.

The increasing demand for mRNA vaccines is driven by their adaptability, rapid development timelines, and ability to target a wide array of pathogens. The success of mRNA-based vaccines for COVID-19 has set a precedent, accelerating efforts to use this technology for other infectious diseases. As new pathogens emerge and existing ones evolve, mRNA vaccines offer a promising, flexible solution to meet these challenges and enhance global public health response efforts.

Market Challenges: Manufacturing Complexity and Scalability

Although mRNA manufacturing eliminates the need for living cells, it remains highly complex and technically demanding, particularly when scaling from laboratory to commercial production. The apparent simplicity of in vitro transcription conceals a tightly controlled, multi-step process involving plasmid DNA production, cell-free transcription, extensive purification, lipid nanoparticle encapsulation, and final fill-finish operations, each requiring precise customization based on the specific mRNA construct and therapeutic use. This complexity is compounded by the inherent instability of mRNA, which is highly sensitive to temperature, shear stress, and RNase contamination, necessitating strict process controls and cold-chain logistics that increase costs and limit accessibility. Manufacturing workflows are further challenged by sequence-specific optimization needs and scale-dependent processing, as scaling up often requires new equipment and unit operations rather than simple volume increases. In addition, the industry faces supply chain constraints for critical GMP-grade inputs, limitations in fit-for-purpose equipment particularly for lipid nanoparticle formulation and evolving analytical and regulatory standards for mRNA characterization and quality control, all of which contribute to operational risk and slow large-scale deployment.

Market Opportunities: Revolutionizing Gene Editing with mRNA Technology

mRNA is increasingly central to transforming the gene-editing landscape, particularly when combined with CRISPR technologies, by improving the precision, safety, and versatility of genetic interventions. By enabling efficient delivery of guide RNAs and controlled expression of editing components, mRNA enhances target accuracy and reduces off-target effects, an essential factor for regulatory acceptance and the development of precision therapies for conditions such as sickle cell disease, cystic fibrosis, and rare genetic disorders. Beyond editing, mRNA can transiently express therapeutic proteins after gene correction, supporting combination or non-permanent treatment strategies that are especially valuable in autoimmune and neurodegenerative diseases. Its synthetic, programmable nature allows rapid prototyping and scalable manufacturing, accelerating development timelines for personalized applications such as cancer immunotherapy. Advances in lipid nanoparticle delivery further strengthen this opportunity by enabling co-delivery of mRNA and CRISPR components in a single system, creating competitive platform advantages. Together, these attributes position mRNA-enabled gene editing to gain early traction in high-unmet-need areas, offering first-mover advantages as regulatory frameworks for gene editing continue to mature.

Market Trends: Expansion into Therapeutic Areas beyond Infectious Diseases

While mRNA technology gained global prominence through COVID-19 vaccines, its impact now extends well beyond infectious diseases, particularly into cancer immunotherapy. Unlike preventive vaccines, mRNA cancer vaccines are designed to train the immune system to recognize and destroy tumor cells by encoding tumor-associated or tumor-specific antigens. Compared with traditional immunotherapies, mRNA platforms offer greater flexibility, enabling the encoding of multiple antigens to generate broader and more durable immune responses while addressing challenges such as immune evasion and variable treatment efficacy. Their ability to stimulate both antibody-mediated and T-cell-driven immunity strengthens anti-tumor activity across multiple immune pathways. A major advancement is the emergence of personalized mRNA cancer vaccines, such as Moderna and Merck's V940, which leverage patient-specific tumor neoantigens and have demonstrated promising clinical outcomes, including improved recurrence-free survival in high-risk melanoma when combined with checkpoint inhibitors. mRNA vaccines are also being explored in prostate cancer, with candidates like CureVac's CV9103 and CV9104 targeting multiple prostate-specific antigens to enhance immune recognition, highlighting both the potential and ongoing need for optimization. Importantly, mRNA technology helps overcome cancer's immune escape mechanisms by improving antigen presentation and T-cell activation, positioning mRNA-based cancer vaccines as a transformative and increasingly strategic pillar of next-generation oncology therapies.

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in messenger RNA, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors' strengths and weaknesses and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines, ensuring organizations stay compliant and accelerate market entry for new mRNA therapies

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

  • The base year considered for the calculation of the market size is 2024. A historical year analysis has been done for the period FY2021-FY2023 The market size has been estimated for FY2024 and projected for the period FY2025-FY2035.
  • The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of mRNA therapies and its use for various application such as oncology, infectious disease, rare genetic disorder, respiratory disease, etc.
  • Revenues of the companies have been referenced from their annual reports for FY2023 and FY2024. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
  • The market has been mapped based on the available messenger RNA therapies. All the key companies with significant offerings in this field have been considered and profiled in this report.

Primary Research:

The primary sources involve industry experts in messenger RNA market including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

  • Validation and triangulation of all the numbers and graphs
  • Validation of the report's segmentation and key qualitative findings
  • Understanding the competitive landscape and business model
  • Current and proposed production values of a product by market players
  • Validation of the numbers of the different segments of the market in focus
  • Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

  • Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
  • Annual reports, SEC filings, and investor presentations of the leading market players
  • Company websites and detailed study of their product portfolio
  • Gold standard magazines, journals, white papers, press releases, and news articles
  • Paid databases

The key data points taken from the secondary sources include:

  • Segmentations and percentage shares
  • Data for market value
  • Key industry trends of the top players of the market
  • Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • Quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

Profiled companies have been selected based on inputs gathered from primary experts, as well as analyzing company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

  • Arcturus Therapeutics Inc
  • Moderna, Inc
  • SK Bioscience Co., Ltd.
  • Oncotelic Inc
  • Sanofi
  • Pfizer Inc.
  • AstraZeneca
  • CureVac SE
  • GSK plc
  • Abogen Biosciences
  • Beam Therapeutics Inc

Table of Contents

Executive Summary

Scope and Definition

1 Global Messenger RNA Market: Industry Outlook

  • 1.1 Industry Outlook
    • 1.1.1 Market Overview and Ecosystem
    • 1.1.2 Clinical Trials
    • 1.1.3 Regulatory Landscape
      • 1.1.3.1 Regulatory Framework for mRNA-Based Therapeutics
        • 1.1.3.1.1 Overview
        • 1.1.3.1.2 U.S. Regulatory Pathway
        • 1.1.3.1.3 European Union Regulatory Pathway
  • 1.2 Patent Analysis
    • 1.2.1 Patent Filing (2023 vs. 2024)
    • 1.2.2 Patent Filings by Top 5 Players (2023 Vs 2024)
  • 1.3 Pipeline Analysis
  • 1.4 Market Dynamics
    • 1.4.1 Trends, Drivers, Challenges, and Opportunities: Current and Future Impact Assessment
    • 1.4.2 Trends
      • 1.4.2.1 Expansion into Therapeutic Areas beyond Infectious Diseases
    • 1.4.3 Market Drivers
      • 1.4.3.1 Growing Incidence of Infectious Diseases
      • 1.4.3.2 Advancements in mRNA Technology
      • 1.4.3.3 Rising Demand for Personalized mRNA
      • 1.4.3.4 Increasing Investment and Funding
    • 1.4.4 Market Restraints
      • 1.4.4.1 Manufacturing Complexity and Scalability
      • 1.4.4.2 High Production Cost
    • 1.4.5 Market Opportunities
      • 1.4.5.1 Revolutionizing Gene Editing with mRNA Technology
    • 1.4.6 Market Challenges
      • 1.4.6.1 Fragmented and Evolving Regulatory Landscape for mRNA-Based Products

2 Application Type

  • 2.1 Overview
    • 2.1.1 Oncology
    • 2.1.2 Infectious Disease
    • 2.1.3 Rare Genetic Disease
    • 2.1.4 Respiratory Disease
    • 2.1.5 Others

3 Region

  • 3.1 North America
    • 3.1.1 Regional Overview
    • 3.1.2 Driving Factors for Market Growth
    • 3.1.3 Factors Challenging the Market
    • 3.1.4 Market Sizing and Forecast
      • 3.1.4.1 North America Messenger RNA Market, by Application
      • 3.1.4.2 North America Messenger RNA Market, by Country
    • 3.1.5 U.S.
      • 3.1.5.1 Country Overview
        • 3.1.5.1.1 Market Sizing and Forecast
    • 3.1.6 Canada
      • 3.1.6.1 Country Overview
        • 3.1.6.1.1 Market Sizing and Forecast
  • 3.2 Europe
    • 3.2.1 Regional Overview
    • 3.2.2 Driving Factors for Market Growth
    • 3.2.3 Factors Challenging the Market
    • 3.2.4 Market Sizing and Forecast
      • 3.2.4.1 Europe Messenger RNA Market, by Application
      • 3.2.4.2 Europe Messenger RNA Market, by Country
    • 3.2.5 U.K.
      • 3.2.5.1 Country Overview
        • 3.2.5.1.1 Market Sizing and Forecast
    • 3.2.6 Germany
      • 3.2.6.1 Country Overview
        • 3.2.6.1.1 Market Sizing and Forecast
    • 3.2.7 France
      • 3.2.7.1 Country Overview
        • 3.2.7.1.1 Market Sizing and Forecast
    • 3.2.8 Italy
      • 3.2.8.1 Country Overview
        • 3.2.8.1.1 Market Sizing and Forecast
    • 3.2.9 Spain
      • 3.2.9.1 Country Overview
        • 3.2.9.1.1 Market Sizing and Forecast
    • 3.2.10 Rest-of-the- Europe
      • 3.2.10.1 Country Overview
        • 3.2.10.1.1 Market Sizing and Forecast
  • 3.3 Asia-Pacific
    • 3.3.1 Regional Overview
    • 3.3.2 Driving Factors for Market Growth
    • 3.3.3 Factors Challenging the Market
    • 3.3.4 Market Sizing and Forecast
      • 3.3.4.1 Asia-Pacific Messenger RNA Market, by Application
      • 3.3.4.2 Asia-Pacific Messenger RNA Market, by Country
    • 3.3.5 China
      • 3.3.5.1 Country Overview
        • 3.3.5.1.1 Market Sizing and Forecast
    • 3.3.6 Japan
      • 3.3.6.1 Country Overview
        • 3.3.6.1.1 Market Sizing and Forecast
    • 3.3.7 Rest-of-the- Asia-Pacific
      • 3.3.7.1 Country Overview
        • 3.3.7.1.1 Market Sizing and Forecast
  • 3.4 Rest of the World
    • 3.4.1 Regional Overview
    • 3.4.2 Driving Factors for Market Growth
    • 3.4.3 Factors Challenging the Market
    • 3.4.4 Market Sizing and Forecast
      • 3.4.4.1 Rest of the World Messenger RNA Market, by Application

4 Competitive Benchmarking and Company Profiles

  • 4.1 Key Players Driving Messenger RNA Market Developments
  • 4.2 Key Strategies and Developments by Company
  • 4.3 Key Developments Analysis
  • 4.4 Company Profiles
    • 4.4.1 Arcturus Therapeutics Inc.
      • 4.4.1.1 Overview
    • 4.4.2 Moderna, Inc.
      • 4.4.2.1 Overview
    • 4.4.3 SK Bioscience Co., Ltd.
      • 4.4.3.1 Overview
    • 4.4.4 Oncotelic Inc.
      • 4.4.4.1 Overview
    • 4.4.5 Sanofi
      • 4.4.5.1 Overview
    • 4.4.6 Pfizer Inc.
      • 4.4.6.1 Overview
    • 4.4.7 AstraZeneca
      • 4.4.7.1 Overview
    • 4.4.8 CureVac SE
      • 4.4.8.1 Overview
    • 4.4.9 GSK plc.
      • 4.4.9.1 Overview
    • 4.4.10 Abogen Biosciences
      • 4.4.10.1 Overview
    • 4.4.11 Beam Therapeutics Inc.
      • 4.4.11.1 Overview

5 Research Methodology

  • 5.1 Data Sources
    • 5.1.1 Primary Data Sources
    • 5.1.2 Secondary Data Sources
    • 5.1.3 Inclusion and Exclusion
    • 5.1.4 Data Triangulation
  • 5.2 Market Estimation and Forecast

List of Figures

  • Figure 1: Messenger RNA Market (by Scenario), $Million, 2024, 2028, and 2035
  • Figure 2: Global Messenger RNA Market, 2024 and 2035
  • Figure 3: Top Countries, Global Messenger RNA Market, $Million, 2024
  • Figure 4: Global Messenger RNA Market Snapshot
  • Figure 5: Global Messenger RNA Market, $Million, 2024 and 2035
  • Figure 6: Messenger RNA Market (by Application Type), $Million, 2024, 2028, and 2035
  • Figure 7: Messenger RNA Market Segmentation
  • Figure 8: Transformational Benefits of mRNA over the Next 5-10 Years
  • Figure 9: mRNA Trials Initiated, 2016-2025
  • Figure 10: mRNA Trials Initiation across Different Disease Sectors, 2016-2025
  • Figure 11: Ongoing Clinical Trails Involving mRNA Therapies for Infectious Disease
  • Figure 12: Patent Filing (2023 vs. 2024)
  • Figure 13: Patent Filings by Top 5 Players
  • Figure 14: Milestones and Development Timeline in mRNA Technologies and LNP Delivery Systems
  • Figure 15: Global Messenger RNA Market (by Application Type), $Million, 2024, 2028, and 2035
  • Figure 16: Advantages of mRNA Vaccines in the Context of Cancer Therapy
  • Figure 17: Messenger RNA Market, Oncology, $Million, 2024-2035
  • Figure 18: Messenger RNA Market, Infectious Disease, $Million, 2024-2035
  • Figure 19: Messenger RNA Market, Rare Genetic Disease, $Million, 2024-2035
  • Figure 20: Messenger RNA Market, Respiratory Disease, $Million, 2024-2035
  • Figure 21: Messenger RNA Market, Others, $Million, 2024-2035
  • Figure 22: North America Messenger RNA Market, $Million, 2024-2035
  • Figure 23: U.S. Messenger RNA Market, $Million, 2024-2035
  • Figure 24: Canada Messenger RNA Market, $Million, 2024-2035
  • Figure 25: Europe Messenger RNA Market, $Million, 2024-2035
  • Figure 26: U.K. Messenger RNA Market, $Million, 2024-2035
  • Figure 27: Germany Messenger RNA Market, $Million, 2024-2035
  • Figure 28: France Messenger RNA Market, $Million, 2024-2035
  • Figure 29: Italy Messenger RNA Market, $Million, 2024-2035
  • Figure 30: Spain Messenger RNA Market, $Million, 2024-2035
  • Figure 31: Rest-of-the Europe Messenger RNA Market, $Million, 2024-2035
  • Figure 32: Asia Pacific Messenger RNA Market, $Million, 2024-2035
  • Figure 33: China Messenger RNA Market, $Million, 2024-2035
  • Figure 34: Japan Messenger RNA Market, $Million, 2024-2035
  • Figure 35: Rest-of-the Asia-Pacific Messenger RNA Market, $Million, 2024-2035
  • Figure 36: Rest of the World Messenger RNA Market, $Million, 2024-2035
  • Figure 37: Key Strategies and Developments, 2023-2025
  • Figure 38: Inclusion and Exclusion Criteria for the Global Messenger RNA Market
  • Figure 39: Data Triangulation
  • Figure 40: Top-Down and Bottom-Up Approach
  • Figure 41: Assumptions and Limitations

List of Tables

  • Table 1: Market Snapshot
  • Table 2: List of Ongoing Clinical Trials Involving mRNA Therapies for Cancers
  • Table 3: U.S. Public Investment in Development of mRNA COVID-19 Vaccines
  • Table 4: Estimated Total Annual Cost Needed for Starting Up mRNA Vaccine Manufacturing in Injectable Medicine Facilities and Producing 100 Million Doses of mRNA Vaccines
  • Table 5: Examples of Ongoing Clinical Trials Involving mRNA Therapies for Oncology
  • Table 6: Examples of Ongoing Clinical Trials on Infectious Diseases
  • Table 7: Examples of mRNA based Biotherapeutic Candidates in Clinical Trials for Rare Genetic Disorders
  • Table 8: Examples of mRNA based Biotherapeutic Candidates in Clinical Trials for Respiratory Diseases
  • Table 9: Examples of mRNA Vaccines in Clinical Trials for Other Disease
  • Table 10: Global Messenger RNA Market (by Region), $Million, 2024-2035
  • Table 11: North America Messenger RNA Market (by Application), $Million, 2024-2035
  • Table 12: North America Messenger RNA Market (by Country), $Million, 2024-2035
  • Table 13: Europe Messenger RNA Market (by Application), $Million, 2024-2035
  • Table 14: Europe Messenger RNA Market (by Country), $Million, 2024-2035
  • Table 15: Asia-Pacific Messenger RNA Market (by Application), $Million, 2024-2035
  • Table 16: Asia-Pacific Messenger RNA Market (by Country), $Million, 2024-2035
  • Table 17: Rest of the World Messenger RNA Market (by Application), $Million, 2024-2035