Summary

U.S. mRNA Therapeutics CDMO Market Summary

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

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Table of Contents

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)
4.4. Infectious Diseases
4.4.1. Infectious Diseases Market Estimates and Forecasts, 2021 – 2033 (USD Million)
4.5. Metabolic & Genetic Diseases
4.5.1. Metabolic & Genetic Diseases Market Estimates and Forecasts, 2021 – 2033 (USD Million)
4.6. Cardiovascular & Cerebrovascular Diseases
4.6.1. Cardiovascular & Cerebrovascular Diseases Market Estimates and Forecasts, 2021 – 2033 (USD Million)
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
5.4.1. Viral Vaccines Market Estimates and Forecasts, 2021 – 2033 (USD Million)
5.5. Protein Replacement Therapies
5.5.1. Protein Replacement Therapies Market Estimates and Forecasts, 2021 – 2033 (USD Million)
5.6. Cancer Immunotherapies
5.6.1. Cancer Immunotherapies Market Estimates and Forecasts, 2021 – 2033 (USD Million)
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
6.4.1. Biotech Companies Market Estimates and Forecasts, 2021 – 2033 (USD Million)
6.5. Pharmaceutical Companies
6.5.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 – 2033 (USD Million)
6.6. Government & Academic Research Institutes
6.6.1. Government & Academic Research Institutes Market Estimates and Forecasts, 2021 – 2033 (USD Million)
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
7.3.1. Danaher (Aldevron)
7.3.1.1. Company Overview
7.3.1.2. Financial Performance
7.3.1.3. Service Benchmarking
7.3.1.4. Strategic Initiatives
7.3.2. Biomay AG
7.3.2.1. Company Overview
7.3.2.2. Financial Performance
7.3.2.3. Service Benchmarking
7.3.2.4. Strategic Initiatives
7.3.3. Bio-Synthesis, Inc.
7.3.3.1. Company Overview
7.3.3.2. Financial Performance
7.3.3.3. Service Benchmarking
7.3.3.4. Strategic Initiatives
7.3.4. eTheRNA
7.3.4.1. Company Overview
7.3.4.2. Financial Performance
7.3.4.3. Service Benchmarking
7.3.4.4. Strategic Initiatives
7.3.5. Kaneka Eurogentec S.A.
7.3.5.1. Company Overview
7.3.5.2. Financial Performance
7.3.5.3. Service Benchmarking
7.3.5.4. Strategic Initiatives
7.3.6. TriLink BioTechnologies
7.3.6.1. Company Overview
7.3.6.2. Financial Performance
7.3.6.3. Service Benchmarking
7.3.6.4. Strategic Initiatives
7.3.7. ApexBio Technology
7.3.7.1. Company Overview
7.3.7.2. Financial Performance
7.3.7.3. Service Benchmarking
7.3.7.4. Strategic Initiatives
7.3.8. BioNTech SE
7.3.8.1. Company Overview
7.3.8.2. Financial Performance
7.3.8.3. Service Benchmarking
7.3.8.4. Strategic Initiatives
7.3.9. Lonza
7.3.9.1. Company Overview
7.3.9.2. Financial Performance
7.3.9.3. Service Benchmarking
7.3.9.4. Strategic Initiatives
7.3.10. Recipharm AB
7.3.10.1. Company Overview
7.3.10.2. Financial Performance
7.3.10.3. Service Benchmarking
7.3.10.4. Strategic Initiatives
7.3.11. Catalent, Inc.
7.3.11.1. Company Overview
7.3.11.2. Financial Performance
7.3.11.3. Service Benchmarking
7.3.11.4. Strategic Initiatives
7.3.12. Samsung Biologics
7.3.12.1. Company Overview
7.3.12.2. Financial Performance
7.3.12.3. Service Benchmarking
7.3.12.4. Strategic Initiatives