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
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.
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. For this study, Grand View Research 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
Table of Contents
Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Indication
1.2.2. Application
1.2.3. End Use
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. GVR's Internal Database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Information Or Data Analysis
1.5.1. Data Analysis Models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity Flow Analysis
1.7.2. Value-Chain-Based Sizing & Forecasting
1.7.3. Multivariate Model Analysis
1.8. List Of Secondary Sources
1.9. List Of Abbreviations
1.10. Objectives
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)