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市场调查报告书
商品编码
1856985
全球mRNA疫苗和疗法市场:预测至2032年-按产品、结构、递送系统、给药途径、应用、最终用户和地区进行分析mRNA Vaccines and Therapeutics Market Forecasts to 2032 - Global Analysis By Product (mRNA Vaccines, mRNA Therapeutics and mRNA-Based Diagnostics), Construct Type, Delivery System, Route of Administration, Application, End User and By Geography |
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根据 Stratistics MRC 的数据,全球 mRNA 疫苗和治疗市场预计到 2025 年将达到 266.4 亿美元,到 2032 年将达到 780.8 亿美元,年复合成长率为 16.6%。
mRNA疫苗和疗法是创新的生物医学干预手段,它利用传讯RNA(mRNA)分子来指导细胞产生特定的蛋白质(通常是抗原),从而触发免疫反应。与通常依赖灭活病原体或蛋白质次单元的传统疫苗不同,基于mRNA的方法利用人体自身的细胞机制来产生目标蛋白,安全有效地刺激免疫反应。这些平台具有设计快速、可扩展生产以及适应新出现的感染疾病优势。除了疫苗之外,mRNA疗法还具有治疗遗传性疾病、癌症和其他疾病的潜在应用价值,它能够实现患者细胞内精确的蛋白质表现和基因调控。
慢性病增多
mRNA平台能够快速开发标靶治疗,进而调节免疫反应和蛋白质表现。癌症、糖尿病和呼吸系统疾病的日益普遍,推动了对个人化和预防性疗法的投资。製药公司和生技新兴企业正在拓展其mRNA研发管线,以满足尚未满足的临床需求并缩短治疗週期。与基因组分析和生物标记发现相结合,可提高治疗的精准性和疗效。这些发展趋势正在推动该平台在慢性病管理和免疫疗法领域的应用。
稳定性和储存问题
mRNA分子本身不稳定,需要低温运输物流来维持其效力和安全性。超低温储存和运输基础设施增加了整个分销链的成本和复杂性。由于基础设施不足和对温度的敏感性,在农村和资源匮乏地区推广mRNA疫苗面临许多挑战。儘管改良的配方和冷冻干燥技术正在研发中,但其商业性应用仍受到限制。这些限制因素阻碍了mRNA疫苗在供应链中的公平取得和营运效率。
mRNA技术的进步
自扩增mRNA、环状RNA和耐热製剂正在提升临床应用中的疗效、持久性和递送效率。相关平台支援快速抗原设计、可扩展生产以及针对新兴病原体和个人化医疗的模组化客製化。对脂质奈米颗粒载体和肌肉注射系统的投入提高了生物有效性和免疫活化能力。监管机构正在简化基于mRNA的候选药物在应对疫情和肿瘤治疗领域的核准途径。这些趋势正在推动下一代mRNA平台和治疗管线的发展。
大众认知与疫苗犹豫
错误讯息、安全疑虑以及疫苗宣传活动的政治化降低了公众的信任度和接种率。长期数据和上市后监测缺乏透明度,使得风险沟通和相关人员参与变得更加复杂。不同文化和地区在医疗素养和信任度方面的差异,进一步限制了疫苗在全球市场的普及。製药公司和公共卫生机构必须加强对教育、透明度和社区宣传的投入,以减少抵制情绪。这些挑战持续限制着mRNA疫苗计画的市场渗透率和公共卫生影响。
新冠疫情加速了mRNA平台的检验和商业化进程,辉瑞-BioNTech和Moderna的疫苗展现了高效能和快速扩充性的能力。紧急使用核准和全球推广应用证明了mRNA技术在危机应变中的速度和适应性。为支持大规模免疫接种和变异株靶向,研发、生产和低温运输基础设施的投资激增。消费者和临床领域对mRNA科学及其潜在应用的认知度也随之提升。后疫情时代的策略已将mRNA视为疫苗创新、疫情防范和治疗药物研发的重要支柱。
预计在预测期内,脂质奈米颗粒(LNP)递送系统细分市场将达到最大。
预计在预测期内,脂质奈米颗粒(LNP)递送系统将占据最大的市场份额,因为它在稳定mRNA有效载荷并将其转运穿过细胞膜方面发挥关键作用。 LNP可保护mRNA免受降解,并促进抗原表达和免疫活化的细胞内递送。该平台利用可电离脂质、聚乙二醇化脂质和胆固醇载体来优化药物动力学和组织靶向性。疫苗和治疗药物研发管线对可扩展、生物相容且经过临床检验的递送系统的需求正在不断增长。
预计在预测期内,自扩增mRNA细分市场将达到最高的复合年增长率。
由于其能够在细胞内复製并以较低剂量产生更高蛋白产量,因此预计自扩增mRNA片段在预测期内将呈现最高的成长速度。 saRNA平台可降低生产成本,并提高预防和治疗应用中的免疫抗原性。与耐热製剂和无针给药系统的结合,拓展了其在应对疫情和全球疫苗接种方面的应用范围。学术界和商业性研发领域对癌症、呼吸系统疾病和热带疾病计画的投入正在增加。这些趋势正在加速自扩增mRNA创新和临床应用的发展。
由于北美拥有先进的生物技术生态系统、完善的监管机制和商业基础设施,预计在预测期内将占据最大的市场份额。美国和加拿大的公司在疫苗和治疗药物的mRNA研发、生产和临床试验方面占据主导地位。对低温运输物流、基因组医学和官民合作关係的投资支持了平台的扩充性和部署。大型製药公司、学术机构和监管机构的存在推动了创新和标准化进程。
预计亚太地区在预测期内将呈现最高的复合年增长率,这主要得益于医疗现代化、感染疾病负担以及生物技术投资在该地区各国经济中的融合。中国、印度、韩国和新加坡等国家正在扩大mRNA平台在公共卫生计画、肿瘤试验和出口导向製造领域的应用规模。政府支持的倡议正在帮助疫苗和治疗药物研发管线的基础建设、监管改革和新兴企业。本土企业正在推出适应当地气候和人口需求的配方和给药系统。这些趋势正在推动亚太地区mRNA创新和临床应用的成长。
According to Stratistics MRC, the Global MRNA Vaccines and Therapeutics Market is accounted for $26.64 billion in 2025 and is expected to reach $78.08 billion by 2032 growing at a CAGR of 16.6% during the forecast period. mRNA vaccines and therapeutics are innovative biomedical interventions that use messenger RNA (mRNA) molecules to instruct cells to produce specific proteins, typically antigens, that trigger an immune response. Unlike traditional vaccines, which often rely on inactivated pathogens or protein subunits, mRNA-based approaches harness the body's own cellular machinery to generate the target protein, stimulating immunity safely and efficiently. These platforms offer rapid design, scalable manufacturing, and adaptability against emerging infectious diseases. Beyond vaccines, mRNA therapeutics hold potential for treating genetic disorders, cancers, and other conditions by enabling precise protein expression or gene modulation within the patient's cells.
Increasing prevalence of chronic diseases
mRNA platforms enable rapid development of targeted treatments that modulate immune response and protein expression. Rising incidence of cancer, diabetes, and respiratory conditions is driving investment in personalized and preventive therapies. Pharmaceutical firms and biotech startups are scaling mRNA pipelines to address unmet clinical needs and reduce treatment latency. Integration with genomic profiling and biomarker discovery enhances therapeutic precision and efficacy. These dynamics are propelling platform expansion across chronic disease management and immunotherapy.
Stability and storage issues
mRNA molecules are inherently unstable and require cold-chain logistics to maintain potency and safety. Ultra-low temperature storage and transport infrastructure increases cost and complexity across distribution networks. Rural and resource-constrained regions face challenges in deploying mRNA vaccines due to infrastructure gaps and temperature sensitivity. Formulation improvements and lyophilization techniques are under development but remain commercially limited. These constraints continue to hinder equitable access and operational efficiency across mRNA supply chains.
Advancements in mRNA Technology
Self-amplifying mRNA, circular RNA, and thermostable formulations are improving efficacy, durability, and delivery across clinical applications. Platforms support rapid antigen design, scalable manufacturing, and modular customization for emerging pathogens and personalized medicine. Investment in lipid nanoparticle carriers and intramuscular delivery systems enhances bioavailability and immune activation. Regulatory bodies are streamlining approval pathways for mRNA-based candidates across pandemic preparedness and oncology. These trends are fostering growth across next-generation mRNA platforms and therapeutic pipelines.
Public perception and vaccine hesitancy
Misinformation, safety concerns, and politicization of vaccine campaigns degrade public confidence and compliance. Lack of long-term data and post-market surveillance transparency complicates risk communication and stakeholder engagement. Cultural and regional differences in healthcare literacy and trust further constrain adoption across global markets. Pharmaceutical firms and public health agencies must invest in education, transparency, and community outreach to mitigate resistance. These challenges continue to limit market penetration and public health impact across mRNA programs.
The pandemic accelerated mRNA platform validation and commercialization as Pfizer-BioNTech and Moderna vaccines demonstrated high efficacy and rapid scalability. Emergency use authorizations and global deployment showcased the speed and adaptability of mRNA technologies in crisis response. Investment surged across R&D, manufacturing, and cold-chain infrastructure to support mass immunization and variant targeting. Public awareness of mRNA science and its potential applications increased across consumer and clinical segments. Post-pandemic strategies now include mRNA as a core pillar of vaccine innovation, pandemic preparedness, and therapeutic development.
The lipid nanoparticle (LNP) delivery systems segment is expected to be the largest during the forecast period
The lipid nanoparticle (LNP) delivery systems segment is expected to account for the largest market share during the forecast period due to their critical role in stabilizing and transporting mRNA payloads across cellular membranes. LNPs protect mRNA from degradation and facilitate intracellular delivery for antigen expression and immune activation. Platforms use ionizable lipids, PEGylated lipids, and cholesterol-based carriers to optimize pharmacokinetics and tissue targeting. Demand for scalable, biocompatible, and clinically validated delivery systems is rising across vaccine and therapeutic pipelines.
The self-amplifying mRNA segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the self-amplifying mRNA segment is predicted to witness the highest growth rate due to its ability to replicate intracellularly and produce higher protein yields with lower doses. saRNA platforms reduce manufacturing cost and improve immunogenicity across prophylactic and therapeutic applications. Integration with thermostable formulations and needle-free delivery systems expands use cases across pandemic response and global immunization. Investment in oncology, respiratory, and tropical disease programs is rising across academic and commercial R&D. These dynamics are accelerating growth across self-amplifying mRNA innovation and clinical translation.
During the forecast period, the North America region is expected to hold the largest market share due to its advanced biotech ecosystem, regulatory engagement, and commercial infrastructure. U.S. and Canadian firms dominate mRNA R&D, manufacturing, and clinical trials across vaccines and therapeutics. Investment in cold-chain logistics, genomic medicine, and public-private partnerships supports platform scalability and deployment. Presence of leading pharmaceutical companies, academic institutions, and regulatory bodies drives innovation and standardization.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR as healthcare modernization, infectious disease burden, and biotech investment converge across regional economies. Countries like China, India, South Korea, and Singapore scale mRNA platforms across public health programs, oncology trials, and export-oriented manufacturing. Government-backed initiatives support infrastructure development, regulatory reform, and startup incubation across vaccine and therapeutic pipelines. Local firms launch regionally adapted formulations and delivery systems tailored to climate and population needs. These trends are accelerating regional growth across mRNA innovation and clinical deployment.
Key players in the market
Some of the key players in MRNA Vaccines and Therapeutics Market include Moderna, Inc., BioNTech SE, CureVac N.V., Arcturus Therapeutics, Pfizer Inc., Sanofi S.A., GlaxoSmithKline plc (GSK), AstraZeneca plc, Daiichi Sankyo Company, Limited, Gennova Biopharmaceuticals Ltd., Translate Bio, eTheRNA Immunotherapies, Strand Therapeutics, Omega Therapeutics and Chimeron Bio.
In March 2025, Moderna expanded its partnership with CARsgen Therapeutics to co-develop mRNA-based CAR-T therapies targeting solid tumors. The collaboration integrates Moderna's mRNA delivery expertise with CARsgen's tumor-specific antigen platforms, aiming to overcome immunosuppressive microenvironments in cancers like glioblastoma and pancreatic adenocarcinoma.
In January 2025, BioNTech announced the advancement of BNT327/PM8002, a next-generation mRNA-based immuno-oncology backbone. The candidate supports pan-tumor treatment approaches and is being positioned for combination with antibody-drug conjugates (ADCs). The launch includes global clinical trials targeting small cell and non-small cell lung cancer, with registrational potential.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.