![]() |
市場調查報告書
商品編碼
1776751
2032 年 mRNA 治療市場預測:按類型、mRNA 類型、遞送系統、給藥途徑、應用、最終用戶和地區進行的全球分析mRNA Therapeutics Market Forecasts to 2032 - Global Analysis By Type, mRNA Type, Delivery System, Route of Administration, Application, End User and By Geography |
根據 Stratistics MRC 的數據,全球 mRNA 治療市場預計在 2025 年達到 166.5 億美元,到 2032 年將達到 564.4 億美元,預測期內的複合年成長率為 19.05%。
mRNA療法是一種利用傳訊RNA(mRNA) 指導細胞產生預防或治療疾病所需蛋白質的新型治療方法。透過將合成的mRNA遞送至體內,這些治療方法使細胞能夠直接產生治療性蛋白質,而無需外源性地施用蛋白質。 mRNA療法因其在COVID-19疫苗中的作用而備受關注,並正在被研究用於治療癌症、遺傳性疾病、感染疾病等。
根據世界衛生組織 (WHO) 估計,2022 年將有超過 1,000 萬人死於癌症,結核病和流感等感染疾病每年仍影響數百萬人。
慢性病和感染疾病的流行
包括流感、愛滋病毒和新興病毒威脅在內的感染疾病進一步凸顯了快速反應疫苗平台的必要性。 mRNA 疫苗在 COVID-19 疫情期間的成功證明了該平台的潛力,並加速了其應用。各國政府和醫療體係正在投資 mRNA 技術,以加強疫情防範並滿足尚未滿足的醫療需求。由此引發的疾病流行是 mRNA 治療市場擴張的主要催化劑。
製造和開發成本高
製造過程需要專用設備、嚴格的品管和低溫運輸物流,所有這些都導致營運成本高昂。此外,對脂質奈米顆粒等先進遞送系統的需求增加了製劑的複雜性和成本。這些經濟負擔對中小型生技公司尤其具有挑戰性,並限制了中低收入國家的生物技術應用。臨床試驗和法規合規的高成本進一步延緩了商業化。因此,mRNA 療法相關的經濟挑戰仍然是市場成長的主要限制因素。
增加研發投入和資金
世界各國政府正撥出大量資金,加強疫情防治,並支持RNA藥物的創新。大型製藥公司和生技新興企業正在拓展其產品線,包括基於mRNA的疫苗以及針對癌症、罕見疾病和自體免疫疾病的療法。策略合作夥伴關係、授權協議和創業投資資本的流入正在加速臨床開發和商業化。給藥系統和生產可擴展性的技術進步也正在贏得投資者的信心。資本和創新的湧入為市場擴張和多元化提供了重大機會。
低溫運輸物流及穩定性問題
許多基於mRNA的產品需要低至-70°C的溫度才能保持穩定,這構成了物流障礙,尤其是在偏遠和資源匱乏的地區。此類要求增加了分銷成本,並使全球取得變得複雜,尤其是在大規模疫苗宣傳活動期間。此外,運輸過程中的溫度波動可能會影響產品的功效和安全性。雖然目前正在努力開發耐熱配方,但其廣泛應用仍有限。在這些穩定性問題解決之前,對低溫運輸的依賴將繼續威脅mRNA療法的擴充性和公平性。
新冠疫情對mRNA療法產業而言至關重要,使其備受全球關注。 mRNA疫苗的緊急使用核准證明了該平台在感染疾病控制中的快速性、有效性和適應性。這一成功刺激了前所未有的投資、監管靈活性以及公眾對mRNA技術的信任。然而,疫情過後,我們看到需求發生了變化,疫苗銷量下降,研發重點也發生了轉變。儘管如此,這場疫情為mRNA在腫瘤學、罕見疾病和個人化醫療領域的廣泛應用奠定了基礎。
預防性疫苗預計將成為預測期內最大的市場
預防性疫苗領域預計將在預測期內佔據最大的市場佔有率,這得益於其在預防感染疾病取得的良好表現。 COVID-19 mRNA 疫苗的快速開發和部署證明了該平台應對全球衛生緊急情況的可行性。預防性 mRNA 疫苗具有高效、快速擴充性和對新變異株的適應性等優勢。監管支持和公共衛生措施正在進一步推動其在已開發地區和開發中地區的應用。
預計研究機構部門在預測期內將以最高複合年成長率成長
預計研究機構細分市場將在預測期內達到最高成長率。這得歸功於政府和學術機構資金的增加,這使得研究機構能夠探索感染疾病以外的新型mRNA應用。產學合作正在加速創新並促進技術轉移。個人化醫療和罕見疾病研究的日益重視也推動了學術界對基於mRNA的解決方案的需求。因此,研究機構正在成為mRNA治療生態系統中一個充滿活力的成長引擎。
預計亞太地區將在預測期內佔據最大的市場佔有率。中國、印度、日本和韓國等國家正大力投資生物技術基礎設施和疫苗生產能力。不斷成長的醫療支出、龐大的患者群體以及政府的支持性政策正在推動該地區的需求。本地公司正在與全球企業建立策略合作夥伴關係,以加速mRNA的開發和分銷。此外,該地區積極應對新冠疫情的舉措為未來基於mRNA的干涉措施奠定了堅實的基礎。
預計北美在預測期內的複合年成長率最高。該地區受益於強大的生物技術生態系統、先進的研發基礎設施和強大的監管支援。 Moderna 和輝瑞-BioNTech 等主要企業總部均設於該地區,推動創新和商業化進程。政府舉措和資助計畫持續支持各治療領域的 mRNA 研究。個人化醫療和腫瘤學日益受到關注,進一步推動了市場成長。
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.