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市場調查報告書
商品編碼
1934225
mRNA治療藥物合約開發和生產市場-全球產業規模、佔有率、趨勢、機會及預測(按應用、適應症、最終用戶、地區和競爭格局分類,2021-2031年)mRNA Therapeutics Contract Development & Manufacturing, Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application, By Indication, By End user, By Region & Competition, 2021-2031F |
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全球 mRNA 療法合約開發和生產 (CDMO) 市場預計將從 2025 年的 99.9 億美元成長到 2031 年的 158.3 億美元,複合年成長率為 7.97%。
該市場由專門從事信使傳訊RNA(mRNA)藥物和疫苗的開發、配方和商業化生產外包服務的專業機構組成。推動市場成長的主要因素是針對感染疾病以外疾病(例如腫瘤和罕見遺傳疾病)的mRNA候選藥物臨床研發管線不斷擴大,這催生了對外部生產能力的需求。因此,製藥開發商正與合約研發生產機構(CDMO)合作,以利用現有基礎設施並降低自建設施相關的資本風險。美國藥品研究與製造商協會(PhRMA)2025年的數據也支持了這一趨勢(265個DNA或RNA治療計劃正在研發中)。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 99.9億美元 |
| 市場規模:2031年 | 158.3億美元 |
| 複合年成長率:2026-2031年 | 7.97% |
| 成長最快的細分市場 | 感染疾病 |
| 最大的市場 | 北美洲 |
然而,市場面臨許多挑戰,例如缺乏複雜mRNA合成和脂質奈米顆粒包覆所需的專業技術知識和生產能力。這些生產過程的複雜性要求高技能人員和嚴格的品管,而這兩方面目前都遠遠無法滿足日益成長的需求。人才短缺,加上原料成本上漲和供應鏈受限,導致生產瓶頸,有可能延緩臨床開發進程,並限制整個產業的擴充性。
CDMO產業的關鍵驅動力之一是全球mRNA疫苗和治療藥物研發管線的快速擴張,因為研發人員正積極將重心從感染疾病預防轉向腫瘤和罕見遺傳疾病。這種向複雜治療領域的多元化發展,對專業製程開發和臨床規模生產的需求日益迫切,而鮮有生物製藥公司能夠獨立完成這些工作。因此,CDMO被要求為新型藥物載體和先進脂質奈米顆粒製劑提供支持,導致後期研發服務合約激增。 BioNTech在2025年5月宣布其多元化的癌症治療管線已進入20多項II期和III期臨床試驗,這一趨勢尤為明顯,凸顯了先進候選藥物的規模之大,以及對強大的外部生產基礎設施的需求。
同時,內部生產面臨的高昂資本和技術壁壘正推動著向策略外包的結構性轉變。建造符合cGMP標準的mRNA生產設施需要對專用設備和封裝技術進行大量投資,且熟練勞動力短缺。這種財務壓力促使製藥開發商與成熟的合約研發生產機構(CDMO)合作,以降低風險並實現即時規模化生產,同時避免內部建設所需的大量資本投入。例如,賽默飛世爾科技公司於2025年4月宣布,將追加20億美元投資以加強在美國的業務,其中15億美元將用於擴大生產能力。此外,截至2025年5月,三星生物製劑公司已累計獲得總額約24億美元的契約製造訂單,凸顯了該產業對外包能力的依賴。
全球mRNA療法CDMO市場成長面臨的主要挑戰之一是專業技術人才和生產能力的嚴重短缺。 mRNA療法的生產涉及高度複雜的工藝,例如脂質奈米顆粒包封,這需要具備先進科學知識和精準操作技能的人員。目前,此類專業人員的供應不足以滿足藥物研發人員日益成長的需求。人才短缺造成了嚴重的生產瓶頸,並阻礙了CDMO有效擴大營運規模以應對新計畫的湧入。
勞動力和產能的限制直接阻礙了市場擴張,導致臨床開發週期和產品商業化進程顯著延遲。如果沒有足夠的人員和高技能人才,CDMO(合約研發生產機構)就無法保證複雜mRNA候選藥物所需的產量和品管。根據生物產業協會2024年的數據,預計到2030年,生命科學領域將出現13.3萬名技術純熟勞工的缺口,這將威脅到該產業維持成長動能的能力。這種人力資本短缺限制了CDMO服務向感染疾病以外的領域多元化發展,最終縮小了其整體潛在市場規模。
自擴增和環狀RNA技術的出現正迫使合約研發生產機構(CDMO)改造其生產平台,以適應新一代藥物遞送系統。與傳統mRNA不同,這些技術能夠實現持續的蛋白質表現和更高的穩定性,但這需要特殊的純化通訊協定和複雜的質體構建,超出了標準生產設備的承載能力。 CDMO正積極拓展這些能力,以收購那些有望降低劑量和生產成本的早期專案。這使得CDMO成為缺乏內部專業基礎設施的生物技術創新者的重要合作夥伴。感染疾病防範創新聯盟(CEPI)的案例便反映了這種關注。該聯盟於2025年3月向Genova Biopharmaceuticals公司撥款高達1,338萬美元,用於推進自擴增mRNA疫苗的研發。
同時,採用自動化連續生產流程正成為CDMO(合約研發產量機構)提升批次間一致性、縮短週轉時間的關鍵差異化優勢。製造商正從靜態批次處理轉向整合式數位化系統,利用即時分析監測包封效率和純度,從而最大限度地減少人為錯誤,加快批次放行。這種營運轉型對於滿足個人化醫療和快速疫苗宣傳活動等對速度的嚴格要求至關重要,因為上市時間是關鍵的競爭優勢。例如,Recipharm在2025年6月發布的企業資料更新報告中指出,新連續生產平台的實施已將其RNA生產週期從25天縮短至5天。
The Global mRNA Therapeutics Contract Development and Manufacturing (CDMO) Market is projected to increase from USD 9.99 billion in 2025 to USD 15.83 billion by 2031, expanding at a CAGR of 7.97%. This market consists of specialized organizations offering outsourcing services for the development, formulation, and commercial manufacturing of messenger RNA-based drugs and vaccines. Growth is primarily driven by the widening clinical pipeline for mRNA candidates targeting conditions beyond infectious diseases, such as oncology and rare genetic disorders, which creates a need for external manufacturing capabilities. Consequently, pharmaceutical developers are partnering with CDMOs to utilize existing infrastructure and reduce capital risks associated with building internal facilities, a trend supported by PhRMA data from 2025 indicating 265 DNA or RNA therapeutic projects in the pipeline.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 9.99 Billion |
| Market Size 2031 | USD 15.83 Billion |
| CAGR 2026-2031 | 7.97% |
| Fastest Growing Segment | Infectious Diseases |
| Largest Market | North America |
However, the market faces a significant obstacle regarding the scarcity of specialized technical expertise and manufacturing capacity needed for complex mRNA synthesis and lipid nanoparticle encapsulation. The intricate nature of these production processes requires highly skilled personnel and strict quality controls, both of which are currently in short supply compared to rising demand. This talent gap, alongside high raw material costs and supply chain limitations, results in production bottlenecks that threaten to delay clinical timelines and limit the sector's overall scalability.
Market Driver
The primary catalyst propelling the CDMO sector is the rapid expansion of the global mRNA vaccines and therapeutics pipeline, as developers aggressively shift focus from infectious disease prophylaxis to oncology and rare genetic disorders. This diversification into complex therapeutic areas creates an urgent demand for specialized process development and clinical-scale manufacturing that few biopharmaceutical companies can handle internally. Consequently, CDMOs are required to support novel cargo and sophisticated lipid nanoparticle formulations, leading to a surge in service agreements for late-stage development. This trend is highlighted by BioNTech, which reported in May 2025 that its diversified oncology pipeline had advanced to include over 20 active Phase 2 and Phase 3 clinical trials, underscoring the volume of advanced candidates requiring robust external manufacturing infrastructure.
Simultaneously, high capital and technical barriers to in-house manufacturing are forcing a structural shift toward strategic outsourcing. Establishing cGMP-compliant mRNA production facilities demands massive financial investment for specialized equipment and encapsulation technologies, compounded by a scarcity of skilled technical personnel. This financial pressure drives pharmaceutical developers to partner with established CDMOs to mitigate risk and gain immediate scalability without the capital intensity of self-building. For instance, Thermo Fisher Scientific committed an additional $2 billion in April 2025 to enhance U.S. operations, with $1.5 billion allocated to manufacturing expansion, while Samsung Biologics secured approximately $2.4 billion in cumulative contract manufacturing orders by May 2025, reflecting the industry's critical reliance on outsourced capacity.
Market Challenge
The primary challenge hindering the growth of the Global mRNA Therapeutics CDMO Market is an acute shortage of specialized technical expertise and manufacturing capacity. Producing mRNA-based therapeutics involves highly intricate processes, such as lipid nanoparticle encapsulation, which demand a workforce possessing advanced scientific proficiency and precise operational skills. Currently, the supply of such specialized talent is insufficient to meet the surging demand from pharmaceutical developers. This workforce gap creates significant production bottlenecks, preventing CDMOs from effectively scaling operations to accommodate the influx of new projects.
These labor and capacity constraints directly impede market expansion by causing substantial delays in clinical timelines and commercial product releases. Without a fully staffed and skilled workforce, CDMOs cannot guarantee the throughput and quality control required for complex mRNA candidates. Data from the BioIndustry Association in 2024 projects a shortfall of 133,000 skilled workers in the life sciences sector by 2030, a deficit that threatens the industry's ability to maintain its growth trajectory. This scarcity of human capital limits the sector's ability to diversify beyond infectious diseases, thereby restricting the overall addressable market for CDMO services.
Market Trends
The emergence of self-amplifying and circular RNA technologies is compelling Contract Development and Manufacturing Organizations to re-engineer their production platforms for next-generation cargoes. Unlike conventional mRNA, these modalities offer sustained protein expression and enhanced stability, necessitating specialized purification protocols and longer plasmid constructs that challenge standard manufacturing footprints. CDMOs are aggressively expanding these capabilities to capture early-stage programs that promise lower dosage requirements and reduced cost of goods, positioning themselves as essential partners for biotech innovators lacking internal specialized infrastructure. This focus is evidenced by the Coalition for Epidemic Preparedness Innovations, which awarded up to $13.38 million to Gennova Biopharmaceuticals in March 2025 to advance a self-amplifying mRNA vaccine.
Simultaneously, the implementation of automated and continuous production workflows is becoming a critical differentiator for CDMOs seeking to improve batch consistency and reduce turnaround times. Manufacturers are moving away from static batch processing toward integrated digital systems that utilize real-time analytics to monitor encapsulation efficiency and purity, thereby minimizing human error and accelerating lot release. This operational shift is essential for meeting the stringent speed requirements of personalized therapeutics and rapid-response vaccine campaigns, where time-to-market is the primary competitive advantage. For example, in a June 2025 corporate update, Recipharm reported reducing RNA production timelines from 25 days to 5 days by deploying a new continuous manufacturing platform.
Report Scope
In this report, the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market.
Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: