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市場調查報告書
商品編碼
1856985
全球mRNA疫苗和療法市場:預測至2032年-按產品、結構、遞送系統、給藥途徑、應用、最終用戶和地區進行分析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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根據 Stratistics MRC 的數據,全球 mRNA 疫苗和治療市場預計到 2025 年將達到 266.4 億美元,到 2032 年將達到 780.8 億美元,年複合成長率為 16.6%。
mRNA疫苗和療法是創新的生物醫學干預手段,它利用傳訊RNA(mRNA)分子來指導細胞產生特定的蛋白質(通常是抗原),從而觸發免疫反應。與通常依賴去活化病原體或蛋白質次單元的傳統疫苗不同,基於mRNA的方法利用人體自身的細胞機制來產生目標蛋白,安全有效地刺激免疫反應。這些平台具有設計快速、可擴展生產以及適應新出現的感染疾病優勢。除了疫苗之外,mRNA療法還具有治療遺傳性疾病、癌症和其他疾病的潛在應用價值,它能夠實現患者細胞內精確的蛋白質表現和基因調控。
慢性病增多
mRNA平台能夠快速開發標靶治療,進而調節免疫反應和蛋白質表現。癌症、糖尿病和呼吸系統疾病的日益普遍,推動了對個人化和預防性療法的投資。製藥公司和生技新興企業正在拓展其mRNA研發管線,以滿足尚未滿足的臨床需求並縮短治療週期。與基因組分析和生物標記發現相結合,可提高治療的精準性和療效。這些發展趨勢正在推動該平台在慢性病管理和免疫療法領域的應用。
穩定性和儲存問題
mRNA分子本身不穩定,需要低溫運輸物流來維持其效力和安全性。超低溫儲存和運輸基礎設施增加了整個分銷鏈的成本和複雜性。由於基礎設施不足和對溫度的敏感性,在農村和資源匱乏地區推廣mRNA疫苗面臨許多挑戰。儘管改良的配方和冷凍乾燥技術正在研發中,但其商業性應用仍受到限制。這些限制因素阻礙了mRNA疫苗在供應鏈中的公平取得和營運效率。
mRNA技術的進步
自擴增mRNA、環狀RNA和耐熱製劑正在提升臨床應用中的療效、持久性和遞送效率。相關平台支援快速抗原設計、可擴展生產以及針對新興病原體和個人化醫療的模組化客製化。對脂質奈米顆粒載體和肌肉注射系統的投入提高了生物有效性和免疫活化能力。監管機構正在簡化基於mRNA的候選藥物在應對疫情和腫瘤治療領域的核准途徑。這些趨勢正在推動下一代mRNA平台和治療管線的發展。
大眾認知與疫苗猶豫
錯誤訊息、安全疑慮以及疫苗宣傳活動的政治化降低了公眾的信任度和接種率。長期數據和上市後監測缺乏透明度,使得風險溝通和相關人員參與變得更加複雜。不同文化和地區在醫療素養和信任度方面的差異,進一步限制了疫苗在全球市場的普及。製藥公司和公共衛生機構必須加強對教育、透明度和社區宣傳的投入,以減少抵制情緒。這些挑戰持續限制著mRNA疫苗計畫的市場滲透率和公共衛生影響。
新冠疫情加速了mRNA平台的檢驗和商業化進程,輝瑞-BioNTech和Moderna的疫苗展現了高效能和快速擴充性的能力。緊急使用核准和全球推廣應用證明了mRNA技術在危機應變中的速度和適應性。為支持大規模免疫接種和變異株靶向,研發、生產和低溫運輸基礎設施的投資激增。消費者和臨床領域對mRNA科學及其潛在應用的認知度也隨之提升。後疫情時代的策略已將mRNA視為疫苗創新、疫情防範和治療藥物研發的重要支柱。
預計在預測期內,脂質奈米顆粒(LNP)遞送系統細分市場將達到最大。
預計在預測期內,脂質奈米顆粒(LNP)遞送系統將佔據最大的市場佔有率,因為它在穩定mRNA有效載荷並將其轉運穿過細胞膜方面發揮關鍵作用。 LNP可保護mRNA免受分解,並促進抗原表達和免疫活化的細胞內遞送。該平台利用可電離脂質、聚乙二醇化脂質和膽固醇載體來最佳化藥物動力學和組織靶向性。疫苗和治療藥物研發管線對可擴展、生物相容且經過臨床檢驗的遞送系統的需求正在不斷成長。
預計在預測期內,自擴增mRNA細分市場將達到最高的複合年成長率。
由於其能夠在細胞內複製並以較低劑量產生更高蛋白產量,因此預計自擴增mRNA片段在預測期內將呈現最高的成長速度。 saRNA平台可降低生產成本,並提高預防和治療應用中的免疫抗原性。與耐熱製劑和無針給藥系統的結合,拓展了其在應對疫情和全球疫苗接種方面的應用範圍。學術界和商業性研發領域對癌症、呼吸系統疾病和熱帶疾病計畫的投入正在增加。這些趨勢正在加速自擴增mRNA創新和臨床應用的發展。
由於北美擁有先進的生物技術生態系統、完善的監管機制和商業基礎設施,預計在預測期內將佔據最大的市場佔有率。美國和加拿大的公司在疫苗和治療藥物的mRNA研發、生產和臨床試驗方面佔據主導地位。對低溫運輸物流、基因組醫學和官民合作關係的投資支持了平台的擴充性和部署。大型製藥公司、學術機構和監管機構的存在推動了創新和標準化進程。
預計亞太地區在預測期內將呈現最高的複合年成長率,這主要得益於醫療現代化、感染疾病負擔以及生物技術投資在該地區各國經濟中的融合。中國、印度、韓國和新加坡等國家正在擴大mRNA平台在公共衛生計畫、腫瘤試驗和出口導向製造領域的應用規模。政府支持的舉措正在幫助疫苗和治療藥物研發管線的基礎建設、監管改革和新興企業。本土企業正在推出適應當地氣候和人口需求的配方和給藥系統。這些趨勢正在推動亞太地區mRNA創新和臨床應用的成長。
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.