mRNA 치료제 위탁 개발 및 생산 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측 : 용도별, 적응증별, 최종사용자별, 지역별, 경쟁별(2021-2031년)

The Global mRNA Therapeutics Contract Development and Manufacturing (CDMO) Market is projected to increase from USD 9.99 billion in 2025 to USD 15.83 billion by 2031, expanding at a CAGR of 7.97%. This market consists of specialized organizations offering outsourcing services for the development, formulation, and commercial manufacturing of messenger RNA-based drugs and vaccines. Growth is primarily driven by the widening clinical pipeline for mRNA candidates targeting conditions beyond infectious diseases, such as oncology and rare genetic disorders, which creates a need for external manufacturing capabilities. Consequently, pharmaceutical developers are partnering with CDMOs to utilize existing infrastructure and reduce capital risks associated with building internal facilities, a trend supported by PhRMA data from 2025 indicating 265 DNA or RNA therapeutic projects in the pipeline.

However, the market faces a significant obstacle regarding the scarcity of specialized technical expertise and manufacturing capacity needed for complex mRNA synthesis and lipid nanoparticle encapsulation. The intricate nature of these production processes requires highly skilled personnel and strict quality controls, both of which are currently in short supply compared to rising demand. This talent gap, alongside high raw material costs and supply chain limitations, results in production bottlenecks that threaten to delay clinical timelines and limit the sector's overall scalability.

Market Driver

The primary catalyst propelling the CDMO sector is the rapid expansion of the global mRNA vaccines and therapeutics pipeline, as developers aggressively shift focus from infectious disease prophylaxis to oncology and rare genetic disorders. This diversification into complex therapeutic areas creates an urgent demand for specialized process development and clinical-scale manufacturing that few biopharmaceutical companies can handle internally. Consequently, CDMOs are required to support novel cargo and sophisticated lipid nanoparticle formulations, leading to a surge in service agreements for late-stage development. This trend is highlighted by BioNTech, which reported in May 2025 that its diversified oncology pipeline had advanced to include over 20 active Phase 2 and Phase 3 clinical trials, underscoring the volume of advanced candidates requiring robust external manufacturing infrastructure.

Simultaneously, high capital and technical barriers to in-house manufacturing are forcing a structural shift toward strategic outsourcing. Establishing cGMP-compliant mRNA production facilities demands massive financial investment for specialized equipment and encapsulation technologies, compounded by a scarcity of skilled technical personnel. This financial pressure drives pharmaceutical developers to partner with established CDMOs to mitigate risk and gain immediate scalability without the capital intensity of self-building. For instance, Thermo Fisher Scientific committed an additional $2 billion in April 2025 to enhance U.S. operations, with $1.5 billion allocated to manufacturing expansion, while Samsung Biologics secured approximately $2.4 billion in cumulative contract manufacturing orders by May 2025, reflecting the industry's critical reliance on outsourced capacity.

Market Challenge

The primary challenge hindering the growth of the Global mRNA Therapeutics CDMO Market is an acute shortage of specialized technical expertise and manufacturing capacity. Producing mRNA-based therapeutics involves highly intricate processes, such as lipid nanoparticle encapsulation, which demand a workforce possessing advanced scientific proficiency and precise operational skills. Currently, the supply of such specialized talent is insufficient to meet the surging demand from pharmaceutical developers. This workforce gap creates significant production bottlenecks, preventing CDMOs from effectively scaling operations to accommodate the influx of new projects.

These labor and capacity constraints directly impede market expansion by causing substantial delays in clinical timelines and commercial product releases. Without a fully staffed and skilled workforce, CDMOs cannot guarantee the throughput and quality control required for complex mRNA candidates. Data from the BioIndustry Association in 2024 projects a shortfall of 133,000 skilled workers in the life sciences sector by 2030, a deficit that threatens the industry's ability to maintain its growth trajectory. This scarcity of human capital limits the sector's ability to diversify beyond infectious diseases, thereby restricting the overall addressable market for CDMO services.

Market Trends

The emergence of self-amplifying and circular RNA technologies is compelling Contract Development and Manufacturing Organizations to re-engineer their production platforms for next-generation cargoes. Unlike conventional mRNA, these modalities offer sustained protein expression and enhanced stability, necessitating specialized purification protocols and longer plasmid constructs that challenge standard manufacturing footprints. CDMOs are aggressively expanding these capabilities to capture early-stage programs that promise lower dosage requirements and reduced cost of goods, positioning themselves as essential partners for biotech innovators lacking internal specialized infrastructure. This focus is evidenced by the Coalition for Epidemic Preparedness Innovations, which awarded up to $13.38 million to Gennova Biopharmaceuticals in March 2025 to advance a self-amplifying mRNA vaccine.

Simultaneously, the implementation of automated and continuous production workflows is becoming a critical differentiator for CDMOs seeking to improve batch consistency and reduce turnaround times. Manufacturers are moving away from static batch processing toward integrated digital systems that utilize real-time analytics to monitor encapsulation efficiency and purity, thereby minimizing human error and accelerating lot release. This operational shift is essential for meeting the stringent speed requirements of personalized therapeutics and rapid-response vaccine campaigns, where time-to-market is the primary competitive advantage. For example, in a June 2025 corporate update, Recipharm reported reducing RNA production timelines from 25 days to 5 days by deploying a new continuous manufacturing platform.

Key Market Players

• Danaher Corporation
• Recipharm AB
• Biomay AG
• Samsung Biologics
• Lonza Group AG
• Catalent , Inc
• Bio-Indication Inc
• Kaneka Eurogentec S.A
• TriLink BioTechnologies
• BioNTech SE

Report Scope

In this report, the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market, By Application

• Viral Vaccines
• Protein Replacement Therapies
• Cancer Immunotherapies

mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market, By Indication

• Infectious Diseases
• Metabolic & Genetic Diseases
• Cardiovascular & Cerebrovascular Diseases

mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market, By End user

• Biotechnology & Pharmaceutical Companies
• Academic & Research Institutions
• Others

mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market.

Available Customizations:

Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Application (Viral Vaccines, Protein Replacement Therapies, Cancer Immunotherapies)
  • 5.2.2. By Indication (Infectious Diseases, Metabolic & Genetic Diseases, Cardiovascular & Cerebrovascular Diseases)
  • 5.2.3. By End user (Biotechnology & Pharmaceutical Companies, Academic & Research Institutions, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Application
  • 6.2.2. By Indication
  • 6.2.3. By End user
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Application
      • 6.3.1.2.2. By Indication
      • 6.3.1.2.3. By End user
  • 6.3.2. Canada mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Application
      • 6.3.2.2.2. By Indication
      • 6.3.2.2.3. By End user
  • 6.3.3. Mexico mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Application
      • 6.3.3.2.2. By Indication
      • 6.3.3.2.3. By End user

7. Europe mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Application
  • 7.2.2. By Indication
  • 7.2.3. By End user
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Application
      • 7.3.1.2.2. By Indication
      • 7.3.1.2.3. By End user
  • 7.3.2. France mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Application
      • 7.3.2.2.2. By Indication
      • 7.3.2.2.3. By End user
  • 7.3.3. United Kingdom mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Application
      • 7.3.3.2.2. By Indication
      • 7.3.3.2.3. By End user
  • 7.3.4. Italy mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Application
      • 7.3.4.2.2. By Indication
      • 7.3.4.2.3. By End user
  • 7.3.5. Spain mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Application
      • 7.3.5.2.2. By Indication
      • 7.3.5.2.3. By End user

8. Asia Pacific mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Application
  • 8.2.2. By Indication
  • 8.2.3. By End user
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Application
      • 8.3.1.2.2. By Indication
      • 8.3.1.2.3. By End user
  • 8.3.2. India mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Application
      • 8.3.2.2.2. By Indication
      • 8.3.2.2.3. By End user
  • 8.3.3. Japan mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Application
      • 8.3.3.2.2. By Indication
      • 8.3.3.2.3. By End user
  • 8.3.4. South Korea mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Application
      • 8.3.4.2.2. By Indication
      • 8.3.4.2.3. By End user
  • 8.3.5. Australia mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Application
      • 8.3.5.2.2. By Indication
      • 8.3.5.2.3. By End user

9. Middle East & Africa mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Application
  • 9.2.2. By Indication
  • 9.2.3. By End user
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Application
      • 9.3.1.2.2. By Indication
      • 9.3.1.2.3. By End user
  • 9.3.2. UAE mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Application
      • 9.3.2.2.2. By Indication
      • 9.3.2.2.3. By End user
  • 9.3.3. South Africa mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Application
      • 9.3.3.2.2. By Indication
      • 9.3.3.2.3. By End user

10. South America mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Application
  • 10.2.2. By Indication
  • 10.2.3. By End user
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Application
      • 10.3.1.2.2. By Indication
      • 10.3.1.2.3. By End user
  • 10.3.2. Colombia mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Application
      • 10.3.2.2.2. By Indication
      • 10.3.2.2.3. By End user
  • 10.3.3. Argentina mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Application
      • 10.3.3.2.2. By Indication
      • 10.3.3.2.3. By End user

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Danaher Corporation
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Recipharm AB
• 15.3. Biomay AG
• 15.4. Samsung Biologics
• 15.5. Lonza Group AG
• 15.6. Catalent , Inc
• 15.7. Bio-Indication Inc
• 15.8. Kaneka Eurogentec S.A
• 15.9. TriLink BioTechnologies
• 15.10. BioNTech SE

16. Strategic Recommendations

17. About Us & Disclaimer