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市場調査レポート
商品コード
1676692
mRNA合成・製造市場:サービス別、サービスタイプ別、製造プロセス別、製造規模別、技術別、用途別、用途別、エンドユーザー別-2025-2030年世界予測mRNA Synthesis & Manufacturing Market by Services, Service Type, Manufacturing Process, Manufacturing Scale, Technology, Application, Usage, End-User - Global Forecast 2025-2030 |
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mRNA合成・製造市場:サービス別、サービスタイプ別、製造プロセス別、製造規模別、技術別、用途別、用途別、エンドユーザー別-2025-2030年世界予測 |
出版日: 2025年03月09日
発行: 360iResearch
ページ情報: 英文 185 Pages
納期: 即日から翌営業日
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mRNA合成・製造市場は、2023年に24億8,000万米ドルと評価され、2024年には27億1,000万米ドル、CAGR 9.35%で成長し、2030年には46億5,000万米ドルに達すると予測されています。
主な市場の統計 | |
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基準年 2023 | 24億8,000万米ドル |
推定年 2024 | 27億1,000万米ドル |
予測年 2030 | 46億5,000万米ドル |
CAGR(%) | 9.35% |
mRNAの合成と製造は、バイオテクノロジー分野における変革技術として登場し、技術革新を推進し、治療薬やワクチン開発を再定義しています。最近の世界の健康課題を受け、効率的でスケーラブルかつ高品質なmRNA生産への需要が加速しています。このようなダイナミックな環境では、中核となるプロセス、市場促進要因、将来を形作る戦略的イニシアチブについて、微妙な理解が求められます。
mRNA生産の情勢は、急速な技術進歩と進化する規制の枠組みによって特徴づけられています。mRNAのキャッピング、製剤化、試験管内転写、精製における新しい技術は、生産のスピードと質を向上させるだけでなく、新たな業界標準を設定しつつあります。市場が拡大するにつれ、利害関係者はプロセスの選択、技術の適応、リソースの配分に関する複雑な決定にますます直面するようになっています。
研究機関から大手製薬企業まで、業界関係者は競争優位性を維持するために次世代製造能力に投資しています。先進的な酵素キャッピングとキャップアナログ手法の統合は、保管と流通ロジスティクスの進化と相まって、顧客特異的なmRNA製品と標準化されたmRNA製品の両方のデリバリーを合理化しています。この入門編では、mRNA合成・製造市場に影響を与える様々な要素について掘り下げて解説し、さらなる分析と戦略立案のための枠組みを提供します。
mRNA合成・製造市場の変革
mRNA合成・製造業界は、従来のパラダイムを再定義し、革新的な成長への道を切り開く、変革的なシフトを目の当たりにしています。老舗企業も新興企業も、かつてない世界の需要に後押しされ、新たなチャンスをつかむために技術的強化や斬新なアプローチを取り入れています。
遺伝子工学とコドンの最適化における急速な進歩は、試験管内転写プロセスの大幅な改善につながりました。自動化されたワークフローが統合されたことで、生産期間が短縮されただけでなく、緊急のヘルスケアニーズに対応する上で重要な要素であるスケーラビリティと再現性も向上しました。さらに、公衆衛生上の危機の緊急性に後押しされた規制の進化が、新しい製造技術の採用を加速し、承認サイクルの迅速化と品質管理の透明性向上を可能にしています。
こうした変革的なシフトは、先進的な脂質ナノ粒子(LNP)製剤と酵素キャッピング技術への厳格な投資によって増幅されています。これらの手法の複合的な進化は、治療とワクチンの両方の用途に対応するための強固な枠組みを提供します。さらに、複雑な世界サプライチェーンの課題に直面しても、高品質のmRNA製品が効率的に目的の市場に到達するためには、保管・流通ロジスティクスの強化が極めて重要です。
今日の市場は、カスタム化と特定の顧客の要求へのシフトによって定義されています。顧客固有の注文や研究仕様に合わせたカスタムmRNA合成は、カタログや既製のmRNAセレクションに焦点を当てた従来のアプローチと肩を並べるようになりました。この進化は、実験的研究から大規模な臨床応用に至るまで、多様な要求に応えるという業界のコミットメントを反映しています。要するに、こうした市場のシフトは、従来の大量生産から、より機敏で適応性が高く、精度に焦点を当てた製造エコシステムへの移行を裏付けるものです。
mRNA製造における主要なセグメンテーションの洞察
mRNA合成・製造の市場セグメンテーションを詳細に調べると、特定の要件や応用領域に対応する複数の側面が明らかになります。サービスの観点から市場を分析すると、キャッピングとテーリング、製剤化、in silico設計、改変と最適化、精製と品質管理、保管と流通、鋳型DNA調製などの研究が、技術的な複雑さを理解するための基礎的な枠組みを提供します。さらに、サービスタイプの違いを考慮すると、市場はカスタムmRNA合成と標準mRNA製造の両方を評価することができます。前者は顧客固有のmRNA注文やオーダーメイドの研究仕様と密接に関連しており、後者はカタログ化されたmRNAバリアントや既製のmRNAセレクションを含み、多様な運営モデルを反映しています。
製造プロセスに基づくセグメンテーション分析では、高度なLNP製剤技術、キャップ類似体と組み合わせた酵素的キャッピング、コドンの最適化を伴う遺伝子工学、さらにはin vitro転写技術、プラスミドDNAテンプレートの使用、ポリアデニル化、RNA精製などの革新的技術に焦点を当てています。この視点は、製品を差別化し、市場のポジショニングに影響を与える重要な技術的・プロセス的要因を捉えています。同様に重要なのは、製造規模に基づくセグメンテーションであり、商業規模、ラボ規模、パイロット規模での操作の実際と課題に焦点を当て、それぞれに独自の操作フレームワークと経済的意味を提示しています。
技術に基づくセグメンテーションでは、in vitro合成とin vivo合成という二項対立が導入され、それぞれが独自の利点と限界を持つ特殊な技術的アプローチを示しています。アプリケーションに基づくセグメンテーションでは、さらに市場を治療薬とワクチンに区分します。ここでは、がん、感染症、希少疾患に焦点を当てた治療薬セグメントは、臨床要件と革新的ソリューションの複雑な相互作用を示します。一方、ワクチン分野は予防ワクチンと治療ワクチンに多様化し、予防と治療の戦略的バランスが強調されています。
用途やエンドユーザーのセグメンテーションといった付加的な側面は、市場力学に対する微妙な洞察を提供します。用途の観点では、ヒト用と動物用を区別し、目標とする製品設計と性能基準を反映します。一方、エンドユーザー・セグメンテーションは、学術研究機関、製造受託機関、製薬・バイオテクノロジー企業間の相互関係をマッピングすることで明確化し、学術研究機関内では政府研究機関や大学研究室に基づいてさらに区別します。この階層的なセグメンテーションは、市場の多面的な性質を浮き彫りにし、さまざまな顧客セグメントの正確なニーズを満たす、オーダーメイドの戦略と的を絞った製品イノベーションのためのロードマップを提供します。
The mRNA Synthesis & Manufacturing Market was valued at USD 2.48 billion in 2023 and is projected to grow to USD 2.71 billion in 2024, with a CAGR of 9.35%, reaching USD 4.65 billion by 2030.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 2.48 billion |
Estimated Year [2024] | USD 2.71 billion |
Forecast Year [2030] | USD 4.65 billion |
CAGR (%) | 9.35% |
mRNA synthesis and manufacturing have emerged as transformative technologies in the biotechnology sector, driving innovation and redefining therapeutic and vaccine development. In the wake of recent global health challenges, the demand for efficient, scalable, and high-quality mRNA production has accelerated. This dynamic environment calls for a nuanced understanding of the core processes, market drivers, and strategic initiatives that are shaping the future.
The landscape of mRNA production is marked by rapid technological advancements and evolving regulatory frameworks. Novel techniques in mRNA capping, formulation, in vitro transcription, and purification are not only enhancing the speed and quality of production but are also setting new industry standards. As the market expands, stakeholders are increasingly confronted with complex decisions regarding process selection, technology adaptation, and resource allocation.
Industry participants-from research institutes to major pharmaceutical corporations-are investing in next-generation manufacturing capabilities to maintain competitive advantage. The integration of advanced enzymatic capping and cap analogue methodologies, combined with the evolution of storage and distribution logistics, is streamlining the delivery of both client-specific and standardized mRNA products. This introductory section sets the stage for an in-depth exploration of the various elements that influence the mRNA synthesis and manufacturing market, providing a framework for further analysis and strategic planning.
Transformative Shifts in the mRNA Synthesis & Manufacturing Landscape
The mRNA synthesis and manufacturing industry is witnessing transformative shifts that are redefining traditional paradigms and paving the way for innovative growth. Established companies and emerging players alike are embracing technological enhancements and novel approaches to seize new opportunities, driven by unprecedented global demand.
Rapid advancements in genetic engineering and codon optimization have led to significant improvements in in vitro transcription processes. The integration of automated workflows has not only reduced production timelines but has also increased scalability and reproducibility-critical factors in responding to urgent healthcare needs. Moreover, regulatory evolutions, driven by the urgency of public health crises, have accelerated the adoption of new manufacturing technologies, enabling faster approval cycles and enhanced transparency in quality control.
These transformative shifts are amplified by rigorous investments in advanced lipid nanoparticle (LNP) formulation and enzymatic capping technologies. The combined evolution of these methodologies offers a robust framework for addressing both therapeutic and vaccine applications. Additionally, enhancements in storage and distribution logistics have been pivotal in ensuring that high-quality mRNA products reach their intended markets efficiently, even in the face of complex global supply chain challenges.
The market today is defined by a shift towards customization and specific client requirements. Custom mRNA synthesis, driven by client-specific orders and tailored research specifications, now stands shoulder-to-shoulder with conventional approaches that focus on cataloged or off-the-shelf mRNA selections. This evolution reflects the industry's commitment to meeting diverse demands, ranging from experimental research to large-scale clinical applications. In essence, these market shifts underscore a transition from conventional mass production to a more agile, adaptable, and precision-focused manufacturing ecosystem.
Key Segmentation Insights in mRNA Manufacture
A detailed examination of market segmentation in mRNA synthesis and manufacturing reveals multiple dimensions that cater to specific requirements and application domains. Analyzing the market from the perspective of services, the study of capping and tailing, formulation, in silico design, modification and optimization, purification and quality control, storage and distribution, and template DNA preparation provide a foundational framework for understanding technological intricacies. Moreover, when considering service type distinctions, the market is evaluative of both custom mRNA synthesis and standard mRNA production. The former is intricately linked to client-specific mRNA orders and tailored research specifications, while the latter encompasses cataloged mRNA variants and off-the-shelf mRNA selections, reflecting diverse operational models.
The segmentation analysis based on the manufacturing process highlights innovations such as advanced LNP formulation technology, enzymatic capping combined with cap analogues, genetic engineering with codon optimization, as well as in vitro transcription techniques, plasmid DNA template use, polyadenylation, and RNA purification. This perspective captures the critical technological and process-driven factors that differentiate products and influence market positioning. Equally important is the segmentation based on manufacturing scale, which concentrates on the practicalities and challenges of commercial scale, lab scale, and pilot scale operations, each presenting unique operational frameworks and economic implications.
Further segmentation based on technology introduces the dichotomy between in vitro synthesis and in vivo synthesis, each representing specialized technological approaches with their own advantages and limitations. Application-based segmentation further dissects the market into therapeutics and vaccines. Here, the therapeutic segment, with its focus on cancer, infectious diseases, and rare diseases, demonstrates a complex interplay of clinical requirements and innovative solutions. Meanwhile, the vaccine segment diversifies into prophylactic vaccines and therapeutic vaccines, highlighting a strategic balance between prevention and treatment.
Additional dimensions such as usage and end-user segmentation offer nuanced insights into market dynamics. The usage perspective distinguishes between human and veterinary use, reflecting targeted product design and performance criteria. Meanwhile, end-user segmentation provides clarity by mapping the interrelationships between academic and research institutes, contract manufacturing organizations, and pharmaceutical and biotechnology companies, with further differentiation within academic and research institutes based on government research bodies and university laboratories. This layered segmentation highlights the multifaceted nature of the market, offering a roadmap for tailored strategies and targeted product innovations that meet the precise needs of different customer segments.
Based on Services, market is studied across Capping & Tailing, Formulation, In Silico Design, Modification & Optimization, Purification & Quality Control, Storage & Distribution, and Template DNA Preparation.
Based on Service Type, market is studied across Custom mRNA Synthesis and Standard mRNA Production. The Custom mRNA Synthesis is further studied across Client-Specific mRNA Orders and Tailored Research Specifications. The Standard mRNA Production is further studied across Cataloged mRNA Variants and Off-the-Shelf mRNA Selections.
Based on Manufacturing Process, market is studied across Advanced LNP Formulation Technology, Enzymatic Capping & Cap Analogues, Genetic Engineering & Codon Optimization, In Vitro Transcription, Plasmid DNA Template, Polyadenylation, and RNA Purification Techniques.
Based on Manufacturing Scale, market is studied across Commercial Scale, Lab Scale, and Pilot Scale.
Based on Technology, market is studied across In Vitro Synthesis and In Vivo Synthesis.
Based on Application, market is studied across Therapeutics and Vaccines. The Therapeutics is further studied across Cancer, Infectious Diseases, and Rare Diseases. The Vaccines is further studied across Prophylactic Vaccines and Therapeutic Vaccines.
Based on Usage, market is studied across Human Use and Veterinary Use.
Based on End-User, market is studied across Academic & Research Institutes, Contract Manufacturing Organizations, and Pharmaceutical & Biotechnology Companies. The Academic & Research Institutes is further studied across Government Research Bodies and University Laboratories.
Key Regional Insights Influencing Market Dynamics
The geographic dimension of mRNA synthesis and manufacturing is characterized by varied regional trends and strategic imperatives. Analysis across the Americas has revealed robust investment in state-of-the-art research and development facilities, driven by both private and public funding that positions the region at the forefront of technological innovation. This dynamic is propelled by strong collaborations between academic institutions and the pharmaceutical industry, fostering an ecosystem conducive to rapid product iteration and market responsiveness.
Turning to the Europe, Middle East & Africa region, the focus is on regulatory harmonization and quality control standards that are essential for both local markets and broader international trade. Increased governmental support paired with strategic partnerships in biotech research has enabled significant inroads in mRNA technology. This region's evolved regulatory framework not only supports innovative research but also accelerates the path from laboratory discovery to clinical application, thereby enhancing overall market competitiveness.
In the Asia-Pacific region, the market is buoyed by rapid industrial growth, extensive investments in manufacturing infrastructure, and a burgeoning talent pool of scientific professionals. Innovations here are underscored by a commitment to scale commercial production while maintaining rigorous standards in laboratory research. The integration of advanced manufacturing processes with local expertise supports both customized and standardized production models, driving efficiency and ensuring that emerging products meet global quality benchmarks. Together, these regional insights play a pivotal role in shaping market strategies and investment decisions for companies operating across diverse geographies.
Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Key Companies Shaping Industry Innovation
The competitive landscape is defined by the presence of several key companies that continuously drive innovation and market growth in mRNA synthesis and manufacturing. Leading firms such as Aurigene Pharmaceutical Services Ltd. by Dr. Reddy's Laboratories Limited and Bio-Synthesis Inc. have been instrumental in advancing client-specific service offerings, leveraging their robust research capabilities to meet specialized demands. Creative Biogene and Creative Biolabs contribute significantly by combining tailored research with comprehensive standard production platforms, thereby bridging the gap between novelty and consistency.
Another critical group includes Croyez Bioscience Co., Ltd. and Danaher Corporation, both of which invest heavily in state-of-the-art production technologies that improve process automation and yield. FUJIFILM Wako Pure Chemical Corporation and Genewiz by Azenta Life Sciences focus on providing high-quality enzymes and reagents that are essential to enhancing the precision and robustness of mRNA manufacturing. GenScript Biotech Corporation and Jena Bioscience GmbH by Enzo Biochem Inc. continue to influence the market through their dedicated advancements in process optimization and genetic engineering techniques.
The manufacturing scale is further impacted by major industry leaders such as Lonza Group Ltd. and Merck KGaA, which have set benchmarks in large-scale production workflows as well as quality control mechanisms. New England Biolabs, Inc., alongside PackGene Biotech, Inc. and Promega Corporation, are well-regarded for their contributions to developing efficient pilot and lab scale production systems while maintaining consistency across commercial scale outputs. Companies like Samsung Biologics Co., Ltd. and Sartorius AG have also brought precision and operational excellence to the forefront, expanding production capacities and streamlining logistics.
Additional market influencers include ST Pharm and System Biosciences, LLC, who invest in cutting-edge research and process innovation. Takara Bio Inc. and Telesis Bio Inc. further add to the competitive momentum by focusing on integrated manufacturing solutions that blend in vitro synthesis with advanced analytic capabilities. Thermo Fisher Scientific Inc. and TriLink BioTechnologies LLC by Maravai Intermediate Holdings, LLC, with their diverse service portfolios, have also positioned themselves as leaders in both custom and standard mRNA production methodologies. Finally, WuXi Biologics (Cayman) Inc. rounds out an impressive list of companies dedicated to advancing production capabilities, reinforcing the industry's commitment to quality and innovation at every stage of mRNA synthesis and manufacturing.
The report delves into recent significant developments in the mRNA Synthesis & Manufacturing Market, highlighting leading vendors and their innovative profiles. These include Aurigene Pharmaceutical Services Ltd. by Dr. Reddy's Laboratories Limited, Bio-Synthesis Inc., Creative Biogene, Creative Biolabs, Croyez Bioscience Co., Ltd., Danaher Corporation, FUJIFILM Wako Pure Chemical Corporation, Genewiz by Azenta Life Sciences, GenScript Biotech Corporation, Jena Bioscience GmbH by Enzo Biochem Inc., Lonza Group Ltd., Merck KGaA, New England Biolabs, Inc., PackGene Biotech, Inc., Promega Corporation, Samsung Biologics Co., Ltd., Sartorius AG, ST Pharm, System Biosciences, LLC, Takara Bio Inc., Telesis Bio Inc., Thermo Fisher Scientific Inc., TriLink BioTechnologies LLC by Maravai Intermediate Holdings, LLC, and WuXi Biologics (Cayman) Inc. Actionable Recommendations for Industry Leaders in mRNA Manufacturing
Invest in Continuous Process Optimization: The rapid pace of technological advancements demands ongoing investments in process innovation. Establish dedicated research and development units to continuously refine production techniques, focusing on areas such as advanced LNP formulation technology, enzymatic capping innovations, and state-of-the-art genetic engineering practices. Regular audits of in vitro transcription, plasmid template preparation, and RNA purification technologies will not only drive operational efficiencies but also ensure compliance with emerging regulatory standards.
Embrace Flexible Production Models: With the market segmented by manufacturing scale-from lab and pilot scale to full commercial production-it is crucial to build adaptive production units that can scale based on demand fluctuations. Flexible manufacturing setups allow firms to optimize resource allocation and manage risks associated with overproduction or underutilization of facilities. Adopting modular manufacturing strategies can help streamline transitions between different production scales, ensuring a seamless response to shifting market dynamics.
Strengthen Collaborative Networks: In today's competitive landscape, forging strategic partnerships is key to unlocking synergies and driving innovation. Collaborations with academic research institutions, government research bodies, and private sector leaders can facilitate the exchange of expertise and best practices. Such networks not only enhance technological capabilities but also provide opportunities for joint research initiatives, faster adoption of breakthrough technologies, and improved market outreach.
Prioritize Technology Integration: With segmentation based on service type and technological approaches-whether in vitro or in vivo synthesis-integrating advanced analytics and process automation is critical. Utilize digital twin technology and real-time data monitoring systems to optimize manufacturing workflows, improve quality control, and reduce production bottlenecks. Embracing Industry 4.0 principles will enable organizations to unlock efficiencies and make data-driven decisions that enhance overall operational performance.
Diversify Product Portfolios: Expanding product offerings to include both custom mRNA synthesis and standardized production allows companies to serve a broader segment of the market. By tailoring solutions to meet specific client needs-whether for client-specific orders or cataloged mRNA variants-businesses can capture a wider audience while mitigating risks associated with relying on a single product line. Diversification also opens up new revenue streams, enhances market resilience, and fosters a customer-centric approach to product development.
Focus on Regulatory Compliance and Quality Assurance: Given the critical impact of quality control in mRNA manufacturing, robust systems to ensure regulatory compliance are indispensable. Regular training, process audits, and investments in advanced quality control technologies will minimize risks and build consumer trust. Establishing transparent and rigorous documentation practices is essential for navigating regulatory landscapes and sustaining long-term market viability.
Invest in Workforce Development: As technological complexity increases, so does the need for skilled personnel. Industry leaders should prioritize training and development programs to equip their workforce with the latest techniques in mRNA synthesis and manufacturing. Enhancing technical expertise not only improves operational efficiency but also drives innovation, ensuring that companies remain agile in the face of emerging industry trends.
Pursue Market Expansion Strategically: Finally, a thorough understanding of regional market dynamics-across the Americas, Europe, Middle East & Africa, and Asia-Pacific-should inform expansion strategies. Tailoring market entry plans and product offerings to the unique demands and regulatory environments of each region can unlock new opportunities and bolster international growth. Overall, strategic investments in process innovation, talent development, and robust quality assurance practices will position industry leaders for sustainable success in a competitive and rapidly evolving market.
Conclusion: Embracing Innovation for Future Growth
The mRNA synthesis and manufacturing landscape is characterized by rapid innovation, complex segmentation, and expansive market opportunities. As industry leaders continue to leverage advanced manufacturing processes, integrate cutting-edge technology solutions, and foster strategic collaborations, the stage is set for a new era of precision medicine and breakthrough therapeutic solutions.
This comprehensive analysis underscores the importance of continuous process optimization, flexible production models, and the integration of state-of-the-art technologies. The segmentation insights reveal a market that is as diverse in its applications as it is in its methodologies. Whether it is the intricate processes involved in enzymatic capping, the precision of genetic engineering, or the adaptability required for various manufacturing scales, each facet contributes to a vibrant and competitive ecosystem.
Moreover, regional insights highlight that global collaboration and tailored strategies are pivotal to navigating the unique challenges and opportunities present in different geographies. With major players driving innovation and setting high benchmarks for quality and efficiency, the future of mRNA synthesis and manufacturing looks not only promising but fundamentally transformative.
In conclusion, by embracing a culture of innovation, proactive market expansion, and continuous improvement, stakeholders can unlock unprecedented growth and revolutionize the manner in which life-saving therapies and vaccines are developed. The journey ahead calls for a steadfast commitment to quality, agility, and visionary leadership, ensuring that the full potential of mRNA technology is realized in both current and future applications.