(MENAFN- GlobeNewsWire - Nasdaq) The U.S. mRNA therapeutics CDMO market is driven by biotech demand for mRNA in vaccines and cancer treatments, using CDMO services for cost-efficiency and faster market entry. Novel tech like automation and AI enhances production, while supportive regulations expedite development.

Dublin, Nov. 21, 2025 (GLOBE NEWSWIRE) -- The "U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Size, Share & Trends Analysis Report by Indication (Infectious Diseases, Metabolic & Genetic Diseases), by Application, by End Use, and Segment Forecasts, 2025-2033" report has been added to ResearchAndMarkets's offering.
The U.S. mRNA therapeutics contract development & manufacturing organization market size was estimated at USD 1.43 billion in 2024 and is projected to reach USD 4.85 billion by 2033, growing at a CAGR of 14.57% from 2025 to 2033. The market is driven by strong presence of biotech companies, research institutions, and a supportive regulatory environment.

Moreover, expanding usage of mRNA in vaccines, cancer treatments, and rare genetic diseases is expected to boost the market growth. As several biotech companies are involved in the development of mRNA-based therapeutics, these companies are increasingly turning to CDMOs for services such as plasmid DNA production, in vitro transcription (IVT), lipid nanoparticle (LNP) formulation, and aseptic fill/finish for cost-effectiveness and reduced time to market. In addition, integration of novel technologies such as automation, AI-based quality control, and advanced LNP systems boosts production capabilities, thereby driving the market growth potential in the near future.
The strong presence of leading pharmaceutical, biotechnology, and life sciences companies drives the demand in the market. The country remains a central drug discovery and innovation hub, supported by deep scientific expertise, advanced infrastructure, and robust funding ecosystems. The growing interest in clinical trials, particularly for mRNA-based therapeutics across oncology, infectious diseases, and rare genetic conditions, is propelling the demand for flexible and scalable CDMO services.

Besides, increasing innovation of live biotherapeutics and next-generation biologics is expected to drive the market growth. These advancements are especially relevant in targeting previously untreatable or rare diseases, creating substantial outsourcing opportunities for CDMOs equipped with mRNA synthesis, lipid nanoparticle (LNP) formulation, and aseptic fill/finish capabilities.

Furthermore, the well-established regulatory framework led by agencies such as the U.S. FDA facilitates accelerated development timelines, approvals through breakthrough therapy and fast-track designations, and a clear path for GMP compliance. Thus, supportive regulatory policies and government funding are anticipated to drive the market over the estimated time period.

Why should you buy this report?

• Comprehensive Market Analysis: Gain detailed insights into the industry across major regions and segments.
• Competitive Landscape: Explore the market presence of key players.
• Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
• Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

• Market intelligence to enable effective decision-making
• Market estimates and forecasts from 2018 to 2030
• Growth opportunities and trend analyses
• Segmental and regional revenue forecasts for market assessment
• Competition strategy and market share analysis
• Product innovation listings for you to stay ahead of the curve
• COVID-19's impact and how to sustain in these fast-evolving markets

Key Attributes:

Report Attribute	Details
No. of Pages	120
Forecast Period	2024 - 2033
Estimated Market Value (USD) in 2024	$1.43 Billion
Forecasted Market Value (USD) by 2033	$4.85 Billion
Compound Annual Growth Rate	14.5%
Regions Covered	United States

Key Topics Covered:
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. High growth in mRNA-based vaccine development
3.2.1.2. Growing clinical trial activities for development of novel mRNA therapeutics
3.2.1.3. Surge in government funding and strategic public-private partnerships
3.2.1.4. Rapid Adoption of Personalized and Decentralized Therapies
3.2.1.5. Growing preference for one-stop shop CDMOs
3.2.2. Market Restraint Analysis
3.2.2.1. Availability of low-cost substitute therapies
3.2.2.2. High Technical Barriers and Capital Intensity
3.3. Business Model Analysis
3.4. Pricing Model Analysis
3.5. Technology Landscape
3.6. Product Pipeline Analysis
3.7. Market Analysis Tools
3.7.1. Porter's Five Force Analysis
3.7.2. PESTEL by SWOT Analysis
3.7.3. COVID-19 Impact Analysis
Chapter 4. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Indication Estimates & Trend Analysis
4.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by Indication: Segment Dashboard
4.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by Indication: Movement Analysis
4.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, by Indication, 2021-2033 (USD Million)
4.4. Infectious Diseases
4.4.1. Infectious Diseases Market Estimates and Forecasts, 2021-2033 (USD Million)
4.5. Metabolic & Genetic Diseases
4.6. Cardiovascular & Cerebrovascular Diseases
Chapter 5. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Application Estimates & Trend Analysis
5.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by Application: Segment Dashboard
5.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by Application: Movement Analysis
5.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, by Application, 2021-2033 (USD Million)
5.4. Viral Vaccines
5.5. Protein Replacement Therapies
5.6. Cancer Immunotherapies
Chapter 6. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: End Use Estimates & Trend Analysis
6.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by End Use: Segment Dashboard
6.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, by End Use: Movement Analysis
6.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, by End Use, 2021-2033 (USD Million)
6.4. Biotech Companies
6.5. Pharmaceutical Companies
6.6. Government & Academic Research Institutes
Chapter 7. Competitive Landscape
7.1. Market Participant Categorization
7.1.1. Market Leaders
7.1.2. Emerging Players
7.2. Company Market Share/Assessment Analysis, 2024
7.3. Company Profiles

• Danaher (Aldevron)
• Biomay AG
• Bio-Synthesis, Inc.
• eTheRNA
• Kaneka Eurogentec S.A.
• TriLink BioTechnologies
• ApexBio Technology
• BioNTech SE
• Lonza
• Recipharm AB
• Catalent, Inc.
• Samsung Biologics

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