mRNA Therapeutics Contract Development & Manufacturing Organization

Global mRNA Therapeutics Contract Development & Manufacturing Organization Market to Reach US$9.0 Billion by 2030

The global market for mRNA Therapeutics Contract Development & Manufacturing Organization estimated at US$5.0 Billion in the year 2024, is expected to reach US$9.0 Billion by 2030, growing at a CAGR of 10.3% over the analysis period 2024-2030. Infectious Diseases Indication, one of the segments analyzed in the report, is expected to record a 8.8% CAGR and reach US$5.0 Billion by the end of the analysis period. Growth in the Metabolic & Genetic Diseases Indication segment is estimated at 12.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$1.3 Billion While China is Forecast to Grow at 9.5% CAGR

The mRNA Therapeutics Contract Development & Manufacturing Organization market in the U.S. is estimated at US$1.3 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$1.4 Billion by the year 2030 trailing a CAGR of 9.5% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 8.9% and 8.5% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 8.3% CAGR.

Global mRNA Therapeutics Contract Development & Manufacturing Organization Market – Key Trends & Drivers Summarized

Why Is the Demand for mRNA Therapeutics CDMOs Increasing?

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 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.

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.

SCOPE OF STUDY:

The report analyzes the mRNA Therapeutics Contract Development & Manufacturing Organization market in terms of units by the following Segments, and Geographic Regions/Countries:

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.

Select Competitors (Total 34 Featured) -

• AGC Biologics
• Aldevron
• ARCALIS, Inc.
• BioNTech SE
• Catalent, Inc.
• CordenPharma International
• Curia Global, Inc.
• FUJIFILM Diosynth Biotechnologies
• Laboratorios Farmacéuticos 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

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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