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傳訊RNA市場－全球及區域分析：按應用、按地區分類－分析與預測（2025-2035）
市場調查報告書
商品編碼
1956052

傳訊RNA市場－全球及區域分析：按應用、按地區分類－分析與預測（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個工作天內

價格

傳訊RNA(mRNA) 市場涵蓋了基於 mRNA 的疫苗和療法的開發和商業化，這些疫苗和療法能夠使細胞產生針對疾病的蛋白質，從而為治療和預防提供了一種靈活快速的方法。

隨著 mRNA COVID-19 疫苗在臨床和商業性取得成功，市場迅速擴張，現在正擴展到感染疾病、腫瘤學、罕見遺傳疾病和個人化醫療領域。

關鍵市場統計數據
預測期 2025-2035
截至2025年的評估 24.38億美元
2035 年預測 209.901億美元
複合年成長率 24.02%

關鍵成長要素包括已證實的顯著臨床療效、更短的研發週期、不斷增加的公共和私人投資，以及脂質奈米顆粒等遞送技術的持續創新。然而，生產複雜性、低溫運輸要求、成本壓力和不斷變化的法規結構等挑戰正在限制市場成長。儘管如此，持續的技術進步和多元化的產品線預計將在長期內支撐市場擴張。

市場概覽

全球傳訊RNA（mRNA）市場預計將迎來顯著成長，到2035年市場規模預計將達到209.901億美元。 mRNA市場的核心是一項創新生物技術，它利用合成的mRNA分子來指導人體細胞產生特定蛋白質，從而實現快速免疫反應和治療效果。 Moderna和BioNTech/輝瑞等公司成功開發並在全球推廣了基於mRNA的COVID-19疫苗，首次證明了該平台的臨床和商業性可行性，也展示瞭如何快速高效地設計、生產和大規模部署mRNA構建體。

先前，mRNA技術受限於其不穩定性及遞送難題，但如今，核苷修飾和脂質奈米顆粒（LNP）遞送系統等創新技術正推動mRNA技術取得進展，顯著提升了其穩定性、細胞攝取和免疫反應，同時最大限度地減少了不必要的發炎反應。這些突破對於拓展mRNA技術的應用範圍至關重要，使其超越新冠肺炎的範疇，應用於下一代流感疫苗、癌症免疫療法、蛋白質替代療法以及罕見遺傳疾病的治療方法領域。目前，數百種候選藥物正處於臨床前和臨床試驗階段。

然而，市場動態反映了機會與挑戰並存的局面。一方面，mRNA平台快速的設計適應性、個人化醫療潛力以及擴充性正吸引著來自產業界、學術界和政府的大量研究投資和策略聯盟。另一方面，mRNA體內穩定性、靶向特定組織遞送以及最佳化劑量等挑戰仍然是科學探索和技術開發的活躍領域。分子設計、替代遞送技術和監管途徑的持續創新正在塑造mRNA疫苗和療法從研發階段走向更廣泛的臨床應用，使mRNA市場成為推動精準醫療未來發展的關鍵基礎。

對產業的影響

傳訊RNA（mRNA）技術的興起對生物製藥產業產生了深遠的影響，重塑了疫苗和治療藥物的研發和生產流程。與生物製藥不同，mRNA平台能夠實現快速模組化設計，使企業能夠在數週而非數年內完成從標靶識別到臨床候選藥物開發的整個過程。這種變革在新冠疫情期間得到了充分體現，並在科學文獻中得到了充分的證實。它導致了生物製藥價值鏈的顯著變化，包括脂質奈米顆粒專用生產的擴張、對高純度核苷酸和酶的需求增加，以及專注於RNA產品的新型合約開發和生產機構（CDMO）的湧現。研究也強調了mRNA如何透過實現個人化和可擴展的治療方法，加速腫瘤學、感染疾病和罕見疾病領域的創新，並促進生物技術公司、學術機構和技術提供者之間的跨產業合作。整體而言，mRNA 技術不僅催生了新的治療方法，而且還在重新定義生命科學領域的產業時間表、供應鏈和創新模式。

市場區隔:

細分 1：按應用

  • 腫瘤學
  • 感染疾病
  • 罕見遺傳疾病
  • 呼吸系統疾病

截至2024年，感染疾病領域在全球傳訊RNA）市場中佔最大佔有率，高達99.86%。近年來，mRNA技術在感染疾病預防領域的應用迅速擴展，這主要得益於新冠疫苗在臨床和實際應用中的成功。 mRNA疫苗能夠使人體自身細胞產生抗原，刺激標靶免疫反應，提供了快速、靈活且高效的預防方法。人們對預防流行病的必要性以及mRNA平台的多功能性日益重視，顯著提升了其在更廣泛感染疾病領域的應用前景。

新冠疫情標誌著一個關鍵的轉捩點，輝瑞-BioNTech 和 Moderna 的疫苗成為首批實現全球大規模部署的 mRNA 疫苗。 mRNA 疫苗對重症新冠患者的高效性和快速的研發週期證明了其作為可行的疫苗策略，並加速了其應用。針對包括 Omicron 株在內的新出現的變異株，mRNA 疫苗的更新配方和加強配方的持續研發，進一步凸顯了 mRNA 技術在應對不斷演變的病毒威脅方面的適應性。

除了新冠肺炎之外，mRNA平台在流感疫苗研發領域也日益受到重視。儘管傳統方法受限於病毒株不匹配和病毒變異，但新一代mRNA流感疫苗（例如Moderna公司的mRNA-1010）的臨床試驗表明，與傳統疫苗相比，其在老年人群中的有效性有所提高。這些進展凸顯了mRNA技術的巨大潛力，它可以透過更快的株更新、更高的有效性以及更具韌性的全球疫苗接種策略，徹底改變季節性和新興感染疾病的防治方式。

細分2：按區域

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 其他
  • 亞太地區
    • 日本
    • 中國
    • 其他
  • 其他地區

北美憑藉著在監管、科學創新和生產規模方面無可比擬的優勢，在mRNA市場佔據主導地位。美國食品藥物管理局（FDA）早期採取的積極舉措——包括緊急使用授權、全面核准和突破性治療方法認定——加速了mRNA技術在感染疾病和腫瘤領域的臨床應用，尤其是在新冠疫情期間，輝瑞-BioNTech和Moderna疫苗取得了顯著成功。這種清晰的法規環境顯著降低了研發風險，並使該地區成為下一代mRNA產品（包括個人化癌症疫苗和母體免疫疫苗）的首選上市市場。

同時，北美受益於深厚的研發生態系統和持續的公共及私人投資，這支持了脂質奈米顆粒化學的快速改進、熱穩定性的提升以及個人化治療藥物的自動化生產。該地區還在生產基礎設施方面投入巨資，例如Moderna公司在美國和加拿大的大規模生產擴張（其位於魁北克省拉瓦爾的工廠既能滿足正常供應需求，也能在疫情期間提升產能）。儘管仍存在一些挑戰，例如低溫運輸物流、個人化癌症疫苗的規模化生產以及複雜的GMP要求，但先進的基礎設施、沉重的疾病負擔以及對創新治療方法的早期應用，持續鞏固北美在全球mRNA市場的主導地位。

傳訊RNA市場的最新趨勢

  • 2025年8月，Moderna公司宣布，加拿大衛生署已核准其更新版新冠病毒mRNA疫苗Spikevax，適用於6個月及以上人群，該疫苗針對SARS-CoV-2 LP.8.1變種。該公司計劃在2025-2026年疫苗接種季之前供應這款更新版疫苗。
  • 2025 年 8 月，輝瑞-BioNTech 的 Comirnaty 獲得美國 FDA核准，用於 65 歲及以上成年人和 5 至 64 歲有重病高風險的成年人。
  • 2025 年 4 月，專注於開發 RNA 療法和疫苗的臨床階段生物技術公司 Ethris 與 Lonza 合作，開發了一種室溫穩定的噴霧乾燥製劑，該製劑是一種基於 mRNA 的候選疫苗，用於黏膜給藥以對抗呼吸道疾病。
  • 2025年3月，Primrose Bio公司宣布推出一款旨在提高長模板mRNA疫苗生產效率的新產品。據稱，Prima RNApols ExTend能夠透過降低生產過程中雙鏈RNA（dsRNA）的含量，幫助研發人員以更低的成本生產出更優的mRNA產品。

需求——促進因素、挑戰與機遇

市場需求－感染疾病率不斷上升

感染疾病率的上升是推動mRNA疫苗需求的主要因素，因為這些病原體持續構成複雜且不斷變化的公共衛生挑戰。雖然傳統疫苗平台對許多疾病有效，但它們往往難以跟上流感、呼吸道融合細胞病毒（RSV）、HIV和其他新興病原體等快速變異病毒的步伐。這些病毒具有分段RNA基因組，並頻繁發生抗原突變，導致多種亞型的出現，使疫苗研發更加複雜。這種情況凸顯了開發更具適應性、擴充性和快速性的疫苗技術（例如基於mRNA的平台）的必要性，以便能夠快速應對不斷變化的威脅。

流感病毒－流感仍然是全球一個重要的公共衛生議題。世界衛生組織（世衛組織）估計，季節性流感每年導致300萬至500萬例嚴重病例和29萬至65萬例死亡。流感病毒的分段RNA基因組會導致抗原不斷漂移，因此需要頻繁更新疫苗以維持其效能。傳統的去活化疫苗難以適應這些變化，促使人們對mRNA疫苗越來越感興趣。 Moderna公司的mRNA-1010疫苗針對四種不同的流感病毒株，是mRNA技術如何快速適應病毒變異的絕佳例證，展現了其相對於需要每年更新疫苗的傳統疫苗的優勢。

呼吸道融合細胞病毒(RSV) 是導致呼吸道疾病的主要病原體之一，特別易感於嬰幼兒、老年人和免疫力缺乏。根據世界衛生組織統計，RSV 每年導致超過 360 萬例五歲以下兒童住院治療，約 10 萬例死亡。數十年來，RSV 疫苗的匱乏使得人們對創新解決方案的需求日益成長。 Modern 公司研發的 mRNA-1345 是首個獲得美國食品藥物管理局 (FDA)核准的RSV mRNA 疫苗，標誌著在應對這一全球健康挑戰方面邁出了重要一步。 mRNA 平台能夠開發編碼精確病毒蛋白結構的疫苗，有望提高疫苗效力並降低傳播風險。 mRNA 疫苗的成功以及正在進行的 RSV 臨床試驗表明，基於 mRNA 的解決方案在應對高風險疾病方面正成為日益成長的趨勢。

mRNA疫苗需求的不斷成長源於其適應性強、研發速度快以及能夠靶向多種病原體。 mRNA疫苗在新冠肺炎治療中的成功開創了先河，並加速了將此技術應用於其他感染疾病的進程。隨著新病原體的出現和現有病原體的變異，mRNA疫苗為應對這些挑戰、加強全球公共衛生應變提供了一個廣闊且靈活的解決方案。

市場挑戰：製造複雜性和可擴展性

儘管mRNA的生產不需要活細胞，但它仍然是一個高度複雜且技術難度極高的過程，尤其是在從實驗室規模放大到商業化生產時。體外轉錄看似簡單，但其實是一個需要嚴格控制的多步驟過程，包括質體DNA的生產、無細胞轉錄、高級純化、脂質奈米顆粒包覆以及最終的填充和表面處理工程。每個步驟都需要根據特定的mRNA構建體和治療應用進行精確的客製化。 mRNA固有的不穩定性進一步加劇了這種複雜性，它對溫度、剪切應力和RNase污染高度敏感。嚴格的製程控制和低溫運輸物流是必要的，這增加了成本並限制了其應用。此外，序列特異性的最佳化需求和規模依賴性的製程也為生產流程帶來了挑戰，因為規模化生產通常需要新的設備和單元操作，而不僅僅是增加生產量。此外，該行業還面臨著諸多挑戰，例如關鍵 GMP 級原料的供應鏈限制、適用設備有限（尤其是脂質奈米顆粒製劑設備）以及 mRNA 表徵和品管的分析和監管標準不斷變化——所有這些都增加了營運風險並延緩了大規模部署。

市場機會－利用mRNA技術革新基因編輯領域

mRNA，尤其是與CRISPR技術結合使用時，正透過提高基因介入的精準性、安全性和通用性，成為基因編輯領域變革的核心力量。 mRNA能夠高效地遞送引導RNA並控制編輯組件的表達，從而增強標靶準確性並減少脫靶效應。這對於獲得監管部門核准以及開發針對鐮狀細胞貧血症、囊腫纖維化和罕見遺傳疾病等的精準治療方法至關重要。除了編輯功能外，mRNA還可以在基因校正後瞬時表達治療性蛋白質。這支持聯合治療和非永久性治療策略，尤其適用於自體免疫神經退化性疾病。其合成性和可程式設計性使其能夠快速原型製作並實現規模化生產，從而縮短個人化藥物（例如癌症免疫療法）的研發週期。脂質奈米顆粒遞送技術的進步進一步強化了這一機遇，實現了在單一系統中共遞送mRNA和CRISPR組分，從而創造了具有競爭優勢的平台。綜上所述，這些特性使得基於 mRNA 的基因編輯技術能夠在高度未滿足需求的領域中獲得早期應用，並在基因編輯法規結構不斷完善的過程中提供先發優勢。

市場趨勢－拓展至感染疾病以外的治療領域

雖然mRNA技術因新冠疫苗而獲得全球認可，但影響遠不止於感染疾病，尤其是在癌症免疫療法方面。與預防性疫苗不同，mRNA癌症疫苗編碼腫瘤相關或腫瘤特異性抗原，以訓練免疫系統識別並摧毀癌細胞。與傳統免疫療法相比，mRNA平台具有更大的柔軟性，能夠編碼多種抗原，誘導廣泛且持久的免疫反應，同時也能應對免疫逃脫和療效差異等挑戰。它能夠同時刺激抗體依賴性和T細胞依賴性免疫反應，從而增強多種免疫路徑的抗腫瘤活性。利用患者特異性腫瘤新抗原的個人化mRNA癌症疫苗（例如Moderna和默克公司的V940）已取得顯著進展，並展現出令人鼓舞的臨床結果，例如與查核點抑制劑聯合使用時，可提高高危險群黑色素瘤患者的無復發生存期。 mRNA疫苗也在前列腺癌領域進行探索，例如CureVac公司的CV9103和CV9104等候選疫苗，它們靶向多種前列腺特異性抗原以增強免疫識別。這不僅展現了mRNA疫苗的潛力，也顯示仍需進一步最佳化。重要的是，mRNA技術透過改善抗原呈現和T細胞活化來克服癌細胞的免疫逃脫機制，使其成為下一代癌症治療中一項變革性的策略支柱。

產品與創新策略：本報告深入分析了傳訊RNA的最新技術趨勢，使企業能夠推動創新並開發符合市場需求的尖端產品。

透過全面的市場分析和對關鍵成長機會的識別，我們為企業提供製定有針對性的行銷策略和有效擴大市場佔有率所需的知識。

該報告包含全面的競爭格局分析，以幫助企業了解競爭對手的優勢和劣勢，並制定有效的策略以獲得市場競爭優勢。

我們提供有關不斷變化的法規結構、核准流程和行業指南的最新資訊，以確保您的組織保持合規，並加速新型 mRNA 療法的市場准入。

透過分析市場趨勢、資金籌措模式和合作機會，我們幫助企業做出明智的投資決策，並識別潛在的併購機會以促進業務成長。

調查方法

市場設計與檢驗中的關鍵考慮因素與假設

  • 計算市場規模的基準年設定為2024年。對2021會計年度至2023會計年度期間進行了歷史分析。 2024會計年度的市場規模進行了估算，並對2025會計年度至2035會計年度期間進行了預測。
  • 本報告的範圍是根據與世界各地公司專家的對話精心製定的。報告提供了關於mRNA療法及其在腫瘤學、感染疾病、罕見遺傳疾病和呼吸系統疾病等各種應用領域的市場研究。
  • 各公司的收入均以 2023 會計年度及 2024 會計年度的年度報告為準。對於私人公司，其收入是根據一手調查資訊、資金籌措歷史、市場合作和業務表現等因素估算得出的。
  • 本報告根據現有的傳訊RNA療法繪製了市場圖，並介紹了在該領域提供重要產品和服務的所有主要企業。

主要市場參與企業及競爭格局概述

我們根據對目標產業、產品系列和市場滲透率的分析，並結合收集領先專家的意見，選擇對其中進行介紹的公司。

該市場的一些主要企業包括：

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

目錄

執行摘要

第1章 全球傳訊RNA市場：產業展望

  • 產業展望
    • 市場概覽與生態系統
    • 臨床試驗
    • 監管狀態
  • 專利分析
    • 專利申請（2023 年與 2024 年）
    • 排名前五的公司專利申請數量（2023 年與 2024 年比較）
  • 管道分析
  • 市場動態
    • 趨勢、促進因素、挑戰和機會：評估當前和未來的影響
    • 趨勢
    • 市場促進因素
    • 市場限制
    • 市場機遇
    • 市場挑戰

第2章：應用類型

  • 概述
    • 腫瘤學
    • 感染疾病
    • 罕見遺傳疾病
    • 呼吸系統疾病
    • 其他

第3章 區域

  • 北美洲
  • 歐洲
  • 亞太地區
  • 其他地區

第4章 競爭標桿分析與公司概況

  • 推動傳訊RNA市場發展的關鍵參與企業
  • 各公司的主要策略和發展
  • 關鍵發展分析
  • 公司簡介
    • 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5章調查方法

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