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, a
pprovals 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.
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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, a
pprovals 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.
U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. The analyst has segmented the U.S. mRNA therapeutics contract development & manufacturing organization market report based on indication, application, and end use.Indication Outlook (Revenue, USD Million, 2021-2033)
- Infectious Diseases
- Metabolic & Genetic Diseases
- Cardiovascular & Cerebrovascular Diseases
Application Outlook (Revenue, USD Million, 2021-2033)
- Viral Vaccines
- Protein Replacement Therapies
- Cancer Immunotherapies
End Use Outlook (Revenue, USD Million, 2021-2033)
- Biotech Companies
- Pharmaceutical Companies
- Government & Academic Research Institutes
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
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Table of Contents
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Variables, Trends & Scope
Chapter 4. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Indication Estimates & Trend Analysis
Chapter 5. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Application Estimates & Trend Analysis
Chapter 6. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: End Use Estimates & Trend Analysis
Chapter 7. Competitive Landscape
List of Tables
List of Tables
Companies Mentioned
The major companies profiled in this U.S. mRNA Therapeutics Contract Development & Manufacturing Organization market report include:- 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
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 120 |
| Published | August 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 1.43 Billion |
| Forecasted Market Value ( USD | $ 4.85 Billion |
| Compound Annual Growth Rate | 14.5% |
| Regions Covered | United States |
| No. of Companies Mentioned | 12 |
