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市场调查报告书
商品编码
1776751
2032 年 mRNA 治疗市场预测:按类型、mRNA 类型、递送系统、给药途径、应用、最终用户和地区进行的全球分析mRNA Therapeutics Market Forecasts to 2032 - Global Analysis By Type, mRNA Type, Delivery System, Route of Administration, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球 mRNA 治疗市场预计在 2025 年达到 166.5 亿美元,到 2032 年将达到 564.4 亿美元,预测期内的复合年增长率为 19.05%。
mRNA疗法是一种利用传讯RNA(mRNA) 指导细胞产生预防或治疗疾病所需蛋白质的新型治疗方法。透过将合成的mRNA递送至体内,这些治疗方法使细胞能够直接产生治疗性蛋白质,而无需外源性地施用蛋白质。 mRNA疗法因其在COVID-19疫苗中的作用而备受关注,并正在被研究用于治疗癌症、遗传性疾病、感染疾病等。
根据世界卫生组织 (WHO) 估计,2022 年将有超过 1,000 万人死于癌症,结核病和流感等感染疾病每年仍影响数百万人。
慢性病和感染疾病的流行
包括流感、爱滋病毒和新兴病毒威胁在内的感染疾病进一步凸显了快速反应疫苗平台的必要性。 mRNA 疫苗在 COVID-19 疫情期间的成功证明了该平台的潜力,并加速了其应用。各国政府和医疗体係正在投资 mRNA 技术,以加强疫情防范并满足尚未满足的医疗需求。由此引发的疾病流行是 mRNA 治疗市场扩张的主要催化剂。
製造和开发成本高
製造过程需要专用设备、严格的品管和低温运输物流,所有这些都导致营运成本高昂。此外,对脂质奈米颗粒等先进递送系统的需求增加了製剂的复杂性和成本。这些经济负担对中小型生技公司尤其具有挑战性,并限制了中低收入国家的生物技术应用。临床试验和法规合规的高成本进一步延缓了商业化。因此,mRNA 疗法相关的经济挑战仍然是市场成长的主要限制因素。
增加研发投入和资金
世界各国政府正拨出大量资金,加强疫情防治,并支持RNA药物的创新。大型製药公司和生技新兴企业正在拓展其产品线,包括基于mRNA的疫苗以及针对癌症、罕见疾病和自体免疫疾病的疗法。策略合作伙伴关係、授权协议和创业投资资本的流入正在加速临床开发和商业化。给药系统和生产可扩展性的技术进步也正在赢得投资者的信心。资本和创新的涌入为市场扩张和多元化提供了重大机会。
低温运输物流及稳定性问题
许多基于mRNA的产品需要低至-70°C的温度才能保持稳定,这构成了物流障碍,尤其是在偏远和资源匮乏的地区。此类要求增加了分销成本,并使全球取得变得复杂,尤其是在大规模疫苗宣传活动期间。此外,运输过程中的温度波动可能会影响产品的功效和安全性。虽然目前正在努力开发耐热配方,但其广泛应用仍有限。在这些稳定性问题解决之前,对低温运输的依赖将继续威胁mRNA疗法的扩充性和公平性。
新冠疫情对mRNA疗法产业而言至关重要,使其备受全球关注。 mRNA疫苗的紧急使用核准证明了该平台在感染疾病控制中的快速性、有效性和适应性。这一成功刺激了前所未有的投资、监管灵活性以及公众对mRNA技术的信任。然而,疫情过后,我们看到需求发生了变化,疫苗销量下降,研发重点也发生了转变。儘管如此,这场疫情为mRNA在肿瘤学、罕见疾病和个人化医疗领域的广泛应用奠定了基础。
预防性疫苗预计将成为预测期内最大的市场
预防性疫苗领域预计将在预测期内占据最大的市场占有率,这得益于其在预防感染疾病取得的良好表现。 COVID-19 mRNA 疫苗的快速开发和部署证明了该平台应对全球卫生紧急情况的可行性。预防性 mRNA 疫苗具有高效、快速扩充性和对新变异株的适应性等优势。监管支持和公共卫生措施正在进一步推动其在已开发地区和开发中地区的应用。
预计研究机构部门在预测期内将以最高复合年增长率成长
预计研究机构细分市场将在预测期内达到最高成长率。这得归功于政府和学术机构资金的增加,这使得研究机构能够探索感染疾病以外的新型mRNA应用。产学合作正在加速创新并促进技术转移。个人化医疗和罕见疾病研究的日益重视也推动了学术界对基于mRNA的解决方案的需求。因此,研究机构正在成为mRNA治疗生态系统中一个充满活力的成长引擎。
预计亚太地区将在预测期内占据最大的市场占有率。中国、印度、日本和韩国等国家正大力投资生物技术基础设施和疫苗生产能力。不断增长的医疗支出、庞大的患者群体以及政府的支持性政策正在推动该地区的需求。本地公司正在与全球企业建立策略合作伙伴关係,以加速mRNA的开发和分销。此外,该地区积极应对新冠疫情的倡议为未来基于mRNA的干预措施奠定了坚实的基础。
预计北美在预测期内的复合年增长率最高。该地区受益于强大的生物技术生态系统、先进的研发基础设施和强大的监管支援。 Moderna 和辉瑞-BioNTech 等主要企业总部均设于该地区,推动创新和商业化进程。政府倡议和资助计画持续支持各治疗领域的 mRNA 研究。个人化医疗和肿瘤学日益受到关注,进一步推动了市场成长。
According to Stratistics MRC, the Global mRNA Therapeutics Market is accounted for $16.65 billion in 2025 and is expected to reach $56.44 billion by 2032 growing at a CAGR of 19.05% during the forecast period. mRNA therapeutics are a novel class of medical treatments that utilize messenger RNA (mRNA) to instruct cells to produce proteins necessary for preventing or treating diseases. By delivering synthetic mRNA into the body, these therapies enable cells to generate therapeutic proteins directly, rather than administering the proteins externally. This approach offers high specificity, flexibility, and rapid development potential. mRNA therapeutics have gained significant attention for their role in COVID-19 vaccines and are being explored for cancer, genetic disorders, and infectious diseases.
According to the World Health Organization, over 10 million people died from cancer in 2022, and infectious diseases like tuberculosis and influenza continue to affect millions annually.
Growing prevalence of chronic and infectious diseases
Infectious diseases, including influenza, HIV, and emerging viral threats, have further underscored the need for rapid-response vaccine platforms. mRNA therapeutics offer a flexible and scalable solution, enabling faster development timelines compared to traditional biologics. The success of mRNA vaccines during the COVID-19 pandemic has validated the platform's potential and accelerated its adoption. Governments and healthcare systems are investing in mRNA technologies to strengthen pandemic preparedness and address unmet medical needs. As a result, the growing disease prevalence is a major catalyst for the expansion of the mRNA therapeutics market.
High production and development costs
The manufacturing process requires specialized equipment, stringent quality controls, and cold chain logistics, all of which contribute to high operational expenses. Additionally, the need for advanced delivery systems like lipid nano-particles adds complexity and cost to formulation. These financial burdens are particularly challenging for smaller biotech firms and limit accessibility in low- and middle-income countries. The high cost of clinical trials and regulatory compliance further slows down commercialization. Consequently, the economic challenges associated with mRNA therapeutics remain a key restraint to market growth.
Increased R&D investments and funding
Governments are allocating substantial funding to bolster pandemic preparedness and support innovation in RNA-based medicine. Pharmaceutical giants and biotech startups alike are expanding their pipelines to include mRNA-based vaccines and treatments for cancer, rare diseases, and autoimmune disorders. Strategic collaborations, licensing deals, and venture capital inflows are accelerating clinical development and commercialization. Technological advancements in delivery systems and manufacturing scalability are also attracting investor confidence. This influx of capital and innovation presents a significant opportunity for market expansion and diversification.
Cold chain logistics and stability issues
Many mRNA-based products require temperatures as low as -70°C to maintain stability, posing logistical hurdles, especially in remote or resource-limited regions. These requirements increase distribution costs and complicate global access, particularly during large-scale immunization campaigns. Additionally, temperature excursions during transit can compromise product efficacy and safety. Efforts are underway to develop thermostable formulations, but widespread implementation remains limited. Until these stability issues are resolved, cold chain dependency will continue to threaten the scalability and equity of mRNA therapeutics.
The COVID-19 pandemic served as a pivotal moment for the mRNA therapeutics industry, propelling it into the global spotlight. Emergency use authorizations for mRNA vaccines demonstrated the platform's speed, efficacy, and adaptability in combating infectious diseases. This success catalyzed unprecedented investment, regulatory flexibility, and public trust in mRNA technologies. However, the post-pandemic period has seen a recalibration of demand, with declining vaccine sales and shifting R&D priorities. Despite this, the pandemic laid the groundwork for broader applications of mRNA in oncology, rare diseases, and personalized medicine.
The prophylactic vaccines segment is expected to be the largest during the forecast period
The prophylactic vaccines segment is expected to account for the largest market share during the forecast period, due to its proven success in preventing infectious diseases. The rapid development and deployment of COVID-19 mRNA vaccines showcased the platform's ability to respond to global health emergencies. Prophylactic mRNA vaccines offer advantages such as high efficacy, rapid scalability, and adaptability to emerging variants. Regulatory support and public health initiatives are further driving adoption across both developed and developing regions.
The research institutes segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the research institutes segment is predicted to witness the highest growth rate, attributed to increased government and academic funding is enabling institutes to explore novel mRNA applications beyond infectious diseases. Collaborations between academia and industry are accelerating innovation and facilitating technology transfer. The growing emphasis on personalized medicine and rare disease research is also fueling demand for mRNA-based solutions in academic settings. As a result, research institutes are emerging as dynamic growth engines within the mRNA therapeutics ecosystem.
During the forecast period, the Asia Pacific region is expected to hold the largest market share. Countries like China, India, Japan, and South Korea are investing heavily in biotechnology infrastructure and vaccine manufacturing capabilities. Rising healthcare expenditure, a large patient population, and supportive government policies are driving regional demand. Local companies are forming strategic alliances with global players to accelerate mRNA development and distribution. Additionally, the region's proactive response to COVID-19 has laid a strong foundation for future mRNA-based interventions.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR. The region benefits from a robust biotech ecosystem, advanced R&D infrastructure, and strong regulatory support. Leading companies such as Moderna and Pfizer-BioNTech are headquartered here, driving innovation and commercialization. Government initiatives and funding programs continue to support mRNA research across therapeutic areas. The growing focus on personalized medicine and oncology is further accelerating market growth.
Key players in the market
Some of the key players in mRNA Therapeutics Market include ModernaTX, Inc., Shape Therapeutics, BioNTech SE, Orbital Therapeutics, Pfizer Inc., Beam Therapeutics Inc., AstraZeneca plc, Sangamo Therapeutics, Sanofi, Ethris GmbH, GlaxoSmithKline plc (GSK), Gennova Biopharmaceuticals Limited, CureVac N.V., Daiichi Sankyo Company, Limited, Arcturus Therapeutics Holdings Inc., and Vertex Pharmaceuticals Incorporated.
In June 2025, BioNTech SE and CureVac N.V. announced that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on messenger ribonucleic acid ("mRNA"). The all-stock transaction will bring together two highly complementary companies based in Germany.
In November 2023, ShapeTX announced the expansion of its partnership with Roche, with Roche adding a new target to their ongoing collaboration, which was initially established in August 2021. This expansion marks the beginning of a new program where ShapeTX will use its proprietary AI-powered RNA editing platform to develop a potential one-time therapy for patients with high unmet needs for an undisclosed disease affecting millions of people worldwide.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.