The "mRNA Therapeutics Contract Development & Manufacturing Organization - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

The global market for mRNA Therapeutics Contract Development & Manufacturing Organization was estimated at US$5.0 Billion in 2024 and is projected to reach US$9.0 Billion by 2030, growing at a CAGR of 10.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

The rise of mRNA-based drugs and vaccines has dramatically increased the demand for contract development and manufacturing organizations (CDMOs) specializing in mRNA therapeutics. As biotechnology and pharmaceutical companies focus on research and development, many lack the infrastructure required for large-scale mRNA production, driving the need for specialized CDMOs. These organizations provide essential services, including raw material sourcing, in vitro transcription (IVT), purification, and lipid nanoparticle (LNP) formulation.

The rapid scalability of mRNA therapeutics, particularly demonstrated during the COVID-19 pandemic, has reinforced the importance of CDMOs in ensuring global vaccine and drug supply. Additionally, the expansion of mRNA applications beyond vaccines into personalized medicine, cancer immunotherapy, and rare disease treatments has increased the complexity of production, making outsourcing to expert CDMOs a strategic necessity. As the biotech industry continues to innovate, CDMOs have become crucial in bridging the gap between clinical development and commercial manufacturing, ensuring that mRNA therapeutics reach the market efficiently and cost-effectively.

What Are the Key Growth Drivers in the mRNA Therapeutics CDMO Market?

The growth in the mRNA therapeutics CDMO market is driven by several factors, including the increasing investment in mRNA drug development, expanding biopharmaceutical pipelines, and the rising need for scalable manufacturing solutions. The success of mRNA-based COVID-19 vaccines has accelerated funding for next-generation mRNA therapies, leading to a surge in clinical trials for infectious diseases, oncology, and metabolic disorders. Pharmaceutical companies are increasingly outsourcing mRNA production to CDMOs to reduce operational costs and accelerate time-to-market.

The emergence of next-generation RNA technologies, such as self-amplifying RNA and circular RNA, has further increased demand for specialized CDMO capabilities. Additionally, the growing adoption of modular and single-use bioprocessing systems has enabled CDMOs to offer flexible, cost-effective manufacturing solutions. As governments and biotech firms prioritize pandemic preparedness and personalized medicine, the role of mRNA therapeutics CDMOs is expected to expand, ensuring that innovative mRNA-based treatments reach global markets efficiently and at scale.

What Innovations Are Transforming the Manufacturing of mRNA Therapeutics?

Technological advancements have significantly improved the efficiency and scalability of mRNA therapeutics manufacturing, enhancing the role of CDMOs in drug production. One of the most critical innovations is the development of automated and closed-system IVT processes, which reduce contamination risks and improve batch consistency. The refinement of lipid nanoparticle (LNP) encapsulation technology has also improved mRNA stability and targeted delivery, ensuring optimal therapeutic effects.

AI-driven optimization of mRNA sequence design and predictive modeling have enabled CDMOs to refine production parameters, reducing waste and improving yield. Additionally, advancements in single-use bioprocessing systems have allowed CDMOs to enhance flexibility while minimizing costs and cross-contamination risks. Continuous manufacturing and real-time quality control systems have further streamlined production workflows, enabling faster turnaround times for clinical and commercial-scale manufacturing. As mRNA-based therapies evolve to include self-amplifying RNA (saRNA) and circular RNA (circRNA), CDMOs are investing in cutting-edge production techniques to meet the growing demand for innovative mRNA platforms.

How Are Regulatory and Supply Chain Factors Shaping the CDMO Market for mRNA Therapeutics?

The increasing complexity of regulatory requirements and global supply chain dynamics is shaping the operational strategies of mRNA-focused CDMOs. Regulatory agencies such as the FDA and EMA have established stringent guidelines for mRNA therapeutics, requiring CDMOs to maintain GMP-compliant facilities and implement rigorous quality control protocols. The evolving landscape of personalized medicine has further complicated regulatory approval pathways, particularly for mRNA-based cancer vaccines and gene therapies that require customized formulations.

The global supply chain for essential raw materials, including nucleotides, capping reagents, and lipids, has also faced disruptions, prompting CDMOs to invest in regional manufacturing hubs and vertical integration strategies to ensure uninterrupted production. Additionally, collaborations between CDMOs and biotech firms have strengthened supply chain resilience, enabling rapid response to emerging healthcare challenges. The adoption of digital manufacturing platforms and blockchain-based tracking systems has further improved traceability and compliance, ensuring transparency in the production and distribution of mRNA-based drugs.

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as AGC Biologics, Aldevron, ARCALIS, Inc., BioNTech SE, Catalent, Inc. and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the Infectious Diseases Indication segment, which is expected to reach US$5.0 Billion by 2030 with a CAGR of a 8.8%. The Metabolic & Genetic Diseases Indication segment is also set to grow at 12.8% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, estimated at $1.3 Billion in 2024, and China, forecasted to grow at an impressive 9.5% CAGR to reach $1.4 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Scope of Study:

• Segments: Indication (Infectious Diseases Indication, Metabolic & Genetic Diseases Indication, Cardiovascular & Cerebrovascular Diseases Indication); Application (Viral Vaccines Application, Protein Replacement Therapies Application, Cancer Immunotherapies Application); End-Use (Biotech Companies End-Use, Government & Academic Research Institutes End-Use, Pharmaceutical Companies End-Use)
• Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Key Attributes:

Key Topics Covered:

MARKET OVERVIEW

• Influencer Market Insights
• Tariff Impact on Global Supply Chain Patterns
• mRNA Therapeutics Contract Development & Manufacturing Organization - Global Key Competitors Percentage Market Share in 2025 (E)
• Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

MARKET TRENDS & DRIVERS

• Surge in mRNA-based Therapeutics Drives Significant Demand for Specialized CDMO Services
• Increasing Investment in mRNA Vaccine and Therapeutic Development Expands the Addressable Market for CDMOs
• Growth in Pharmaceutical Outsourcing for mRNA Production Strengthens the Business Case for CDMO Partnerships
• Technological Advancements in mRNA Manufacturing Processes Propel Growth in CDMO Offerings
• Rising Need for Scalable and Flexible Manufacturing Solutions Drives the Adoption of CDMO Services in mRNA Production
• Regulatory Support for mRNA Therapeutics and Vaccines Expands Opportunities for CDMOs in the Market
• The Emergence of mRNA-based Cancer Therapies Generates Long-term Growth for CDMO Services in Oncology
• Increasing Complexity of mRNA Synthesis Drives Demand for Advanced Expertise and Technology in CDMO Partnerships
• Expansion of Global Clinical Trials for mRNA-based Drugs Strengthens Market Opportunities for CDMO Providers
• The Growing Role of CDMOs in the Production of mRNA Vaccines for Emerging Infectious Diseases Expands Market Reach
• Increasing Focus on Speed and Efficiency in mRNA Drug Development Accelerates Demand for Specialized CDMO Services
• The Rise of Personalized Medicine and Targeted Therapies Boosts Demand for Custom CDMO Solutions in mRNA Production
• Increasing Collaboration Between Biopharma Companies and CDMOs Expands Market Growth Potential for mRNA Therapeutics
• The Growth of Public and Private Investments in mRNA Technology Strengthens the Financial Case for CDMO Expansion
• The Need for High-Quality and GMP-compliant Manufacturing Drives Adoption of Leading CDMO Providers for mRNA Production
• Regulatory Challenges in mRNA Therapeutic Manufacturing Drive Innovation in CDMO Capabilities and Standards
• The Continued Success of COVID-19 Vaccines Strengthens Long-term Demand for mRNA Therapeutics and CDMO Services
• The Shift Towards Modular and Automated Manufacturing Solutions Promotes Growth and Efficiency in mRNA CDMOs
• The Increasing Demand for Global Supply Chain Optimization in mRNA Production Expands CDMO Opportunities
• Growing Competitive Landscape in mRNA Therapeutics Drives Demand for Specialized and Reliable CDMO Partnerships

FOCUS ON SELECT PLAYERS | Some of the 34 companies featured in this report

• AGC Biologics
• Aldevron
• ARCALIS, Inc.
• BioNTech SE
• Catalent, Inc.
• CordenPharma International
• Curia Global, Inc.
• FUJIFILM Diosynth Biotechnologies
• Laboratorios Farmaceuticos Rovi, S.A.
• Lonza Group
• Merck KGaA
• Moderna, Inc.
• Rentschler Biopharma SE
• Samsung Biologics
• ST Pharm
• Thermo Fisher Scientific
• TriLink BioTechnologies
• Vernal Biosciences
• WuXi AppTec

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