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PUBLISHER: Bizwit Research & Consulting LLP | PRODUCT CODE: 1735707

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PUBLISHER: Bizwit Research & Consulting LLP | PRODUCT CODE: 1735707

Global mRNA Therapeutics Contract Development & Manufacturing Organization Market Size study, by Application, Indication, End-use, and Regional Forecasts 2022-2032

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The Global mRNA Therapeutics Contract Development & Manufacturing Organization (CDMO) Market is valued approximately at USD 4.14 billion in 2023 and is expected to expand with a compelling CAGR of 11.28% over the forecast period 2024-2032. As the race toward personalized, gene-based medicine intensifies, mRNA technology has surfaced as a transformative pillar in modern drug development-particularly in response to infectious diseases, cancer immunotherapy, and rare genetic disorders. At the heart of this scientific revolution lies the growing reliance on CDMOs, which offer end-to-end manufacturing, analytical, and regulatory support, accelerating the transition from discovery to commercial-scale production. This structural shift enables biotech innovators and pharmaceutical giants to de-risk development and focus resources on strategic innovation while leveraging CDMOs for operational excellence.

The mRNA therapeutics CDMO landscape is evolving rapidly as companies pivot toward building flexible, high-throughput, GMP-compliant facilities to accommodate increasing demands. Fueled by the success of COVID-19 mRNA vaccines, demand for scalable and modular platforms capable of producing lipid nanoparticles (LNPs), plasmid DNA, and encapsulated mRNA formulations has skyrocketed. Simultaneously, CDMOs are investing heavily in integrated service offerings-from vector design and cell banking to fill-finish solutions-to appeal to small and mid-sized biotechs seeking turnkey development paths. The market is also benefitting from regulatory tailwinds, with health authorities fast-tracking approvals for mRNA-based platforms due to their precision, speed, and adaptability in therapeutic design.

Despite robust momentum, the market faces several bottlenecks, most notably in the form of raw material shortages, high initial infrastructure investment, and limited expertise in complex lipid delivery systems. Furthermore, IP licensing restrictions and competition over proprietary manufacturing technologies pose risks to new entrants. However, these hurdles are simultaneously opening windows of opportunity for companies to differentiate through innovation in formulation, automated process design, and decentralized manufacturing models. Strategic collaborations and long-term capacity reservation agreements between CDMOs and biopharma companies are also driving financial stability and operational scalability across the sector.

From a segmentation perspective, oncology continues to lead the mRNA therapeutics space, accounting for a significant share of outsourced development due to the platform's ability to customize antigen targets rapidly. Infectious diseases remain a high-volume domain, especially for pandemic preparedness and seasonal vaccine pipelines. Among applications, personalized cancer vaccines and rare disease therapeutics are creating strong niche demand for CDMO partners who can handle small-batch, high-potency formulations under accelerated timelines. End-users such as pharmaceutical companies are increasingly co-investing with CDMOs to build bespoke production capabilities, while academic institutions and smaller biotechs are emerging as major contributors to early-phase outsourcing.

Geographically, North America held the largest market share in 2023, underpinned by robust R&D infrastructure, government funding, and the presence of established CDMO players specializing in biologics and nucleic acid manufacturing. Europe closely followed, driven by increased public-private consortia aimed at developing mRNA-based therapies beyond COVID-19. Meanwhile, Asia Pacific is expected to emerge as the fastest-growing region through 2032, with countries like China, India, and South Korea ramping up investments in biomanufacturing capabilities, regulatory harmonization, and academic-industry partnerships. This global proliferation of CDMO capacity is expected to drive a new era of decentralized, agile, and collaborative drug development.

Major market player included in this report are:

  • Catalent Inc.
  • Thermo Fisher Scientific Inc.
  • Samsung Biologics
  • Wuxi AppTec
  • Lonza Group AG
  • Eurofins Scientific
  • Rentschler Biopharma SE
  • AGC Biologics
  • Syngene International
  • BioNTech SE
  • Boehringer Ingelheim BioXcellence(TM)
  • Aldevron LLC
  • Exelead Biopharma
  • Precision NanoSystems Inc.
  • Polymun Scientific Immunbiologische Forschung GmbH

The detailed segments and sub-segment of the market are explained below:

By Application

  • Infectious Diseases
  • Oncology
  • Rare Genetic Disorders
  • Others

By Indication

  • COVID-19
  • Cancer
  • Cytomegalovirus (CMV)
  • Others

By End-use

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

By Region:

  • North America
  • U.S.
  • Canada
  • Europe
  • UK
  • Germany
  • France
  • Spain
  • Italy
  • ROE
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • RoAPAC
  • Latin America
  • Brazil
  • Mexico
  • Middle East & Africa
  • Saudi Arabia
  • South Africa
  • RoMEA

Years considered for the study are as follows:

  • Historical year - 2022
  • Base year - 2023
  • Forecast period - 2024 to 2032

Key Takeaways:

  • Market Estimates & Forecast for 10 years from 2022 to 2032.
  • Annualized revenues and regional level analysis for each market segment.
  • Detailed analysis of geographical landscape with Country level analysis of major regions.
  • Competitive landscape with information on major players in the market.
  • Analysis of key business strategies and recommendations on future market approach.
  • Analysis of competitive structure of the market.
  • Demand side and supply side analysis of the market.

Table of Contents

Chapter 1. Global mRNA Therapeutics CDMO Market Executive Summary

  • 1.1. Global mRNA Therapeutics CDMO Market Size & Forecast (2022-2032)
  • 1.2. Regional Summary
  • 1.3. Segmental Summary
    • 1.3.1. By Application
    • 1.3.2. By Indication
    • 1.3.3. By End-use
  • 1.4. Key Trends
  • 1.5. Recession Impact
  • 1.6. Analyst Recommendation & Conclusion

Chapter 2. Global mRNA Therapeutics CDMO Market Definition and Research Assumptions

  • 2.1. Research Objective
  • 2.2. Market Definition
  • 2.3. Research Assumptions
    • 2.3.1. Inclusion & Exclusion
    • 2.3.2. Limitations
    • 2.3.3. Supply Side Analysis
      • 2.3.3.1. Availability
      • 2.3.3.2. Infrastructure
      • 2.3.3.3. Regulatory Environment
      • 2.3.3.4. Market Competition
      • 2.3.3.5. Economic Viability (Client Perspective)
    • 2.3.4. Demand Side Analysis
      • 2.3.4.1. Regulatory Frameworks
      • 2.3.4.2. Technological Advancements
      • 2.3.4.3. Clinical Adoption Patterns
      • 2.3.4.4. Biotech & Pharma Outsourcing Trends
  • 2.4. Estimation Methodology
  • 2.5. Years Considered for the Study
  • 2.6. Currency Conversion Rates

Chapter 3. Global mRNA Therapeutics CDMO Market Dynamics

  • 3.1. Market Drivers
    • 3.1.1. Surge in mRNA Vaccine and Therapeutic Development
    • 3.1.2. Biopharma Outsourcing to Accelerate Time-to-Market
    • 3.1.3. Regulatory Fast-tracking of mRNA Platforms
  • 3.2. Market Challenges
    • 3.2.1. Raw Material Shortages and Supply-Chain Bottlenecks
    • 3.2.2. High Capital Expenditure for GMP-Compliant Facilities
    • 3.2.3. IP Licensing Complexities over Proprietary Technologies
  • 3.3. Market Opportunities
    • 3.3.1. Decentralized and Modular Manufacturing Models
    • 3.3.2. Integrated End-to-End Service Offerings
    • 3.3.3. Expansion in Emerging Biomanufacturing Hubs

Chapter 4. Global mRNA Therapeutics CDMO Market Industry Analysis

  • 4.1. Porter's Five Forces Model
    • 4.1.1. Bargaining Power of Suppliers
    • 4.1.2. Bargaining Power of Buyers
    • 4.1.3. Threat of New Entrants
    • 4.1.4. Threat of Substitutes
    • 4.1.5. Competitive Rivalry
    • 4.1.6. Futuristic Approach to Porter's Model
    • 4.1.7. Impact Analysis of Five Forces
  • 4.2. PESTEL Analysis
    • 4.2.1. Political
    • 4.2.2. Economic
    • 4.2.3. Social
    • 4.2.4. Technological
    • 4.2.5. Environmental
    • 4.2.6. Legal
  • 4.3. Top Investment Opportunities
  • 4.4. Top Winning Strategies
  • 4.5. Disruptive Trends
  • 4.6. Industry Expert Perspective
  • 4.7. Analyst Recommendation & Conclusion

Chapter 5. Global mRNA Therapeutics CDMO Market Size & Forecasts by Application 2022-2032

  • 5.1. Segment Dashboard
  • 5.2. Global Market: Application Revenue Trend Analysis, 2022 & 2032 (USD Million)
    • 5.2.1. Infectious Diseases
    • 5.2.2. Oncology
    • 5.2.3. Rare Genetic Disorders
    • 5.2.4. Others

Chapter 6. Global mRNA Therapeutics CDMO Market Size & Forecasts by Indication 2022-2032

  • 6.1. Segment Dashboard
  • 6.2. Global Market: Indication Revenue Trend Analysis, 2022 & 2032 (USD Million)
    • 6.2.1. COVID-19
    • 6.2.2. Cancer
    • 6.2.3. Cytomegalovirus (CMV)
    • 6.2.4. Others

Chapter 7. Global mRNA Therapeutics CDMO Market Size & Forecasts by End-use 2022-2032

  • 7.1. Segment Dashboard
  • 7.2. Global Market: End-use Revenue Trend Analysis, 2022 & 2032 (USD Million)
    • 7.2.1. Pharmaceutical & Biotechnology Companies
    • 7.2.2. Academic & Research Institutions
    • 7.2.3. Others

Chapter 8. Global mRNA Therapeutics CDMO Market Size & Forecasts by Region 2022-2032

  • 8.1. North America Market
    • 8.1.1. U.S. Market
      • 8.1.1.1. Application breakdown size & forecasts, 2022-2032
      • 8.1.1.2. Indication breakdown size & forecasts, 2022-2032
    • 8.1.2. Canada Market
  • 8.2. Europe Market
    • 8.2.1. UK Market
    • 8.2.2. Germany Market
    • 8.2.3. France Market
    • 8.2.4. Spain Market
    • 8.2.5. Italy Market
    • 8.2.6. Rest of Europe Market
  • 8.3. Asia Pacific Market
    • 8.3.1. China Market
    • 8.3.2. India Market
    • 8.3.3. Japan Market
    • 8.3.4. Australia Market
    • 8.3.5. South Korea Market
    • 8.3.6. Rest of Asia Pacific Market
  • 8.4. Latin America Market
    • 8.4.1. Brazil Market
    • 8.4.2. Mexico Market
    • 8.4.3. Rest of Latin America Market
  • 8.5. Middle East & Africa Market
    • 8.5.1. Saudi Arabia Market
    • 8.5.2. South Africa Market
    • 8.5.3. Rest of Middle East & Africa Market

Chapter 9. Competitive Intelligence

  • 9.1. Key Company SWOT Analysis
    • 9.1.1. Catalent Inc.
    • 9.1.2. Thermo Fisher Scientific Inc.
    • 9.1.3. Samsung Biologics
  • 9.2. Top Market Strategies
  • 9.3. Company Profiles
    • 9.3.1. Catalent Inc.
      • 9.3.1.1. Key Information
      • 9.3.1.2. Overview
      • 9.3.1.3. Financial (Subject to Data Availability)
      • 9.3.1.4. Product Summary
      • 9.3.1.5. Market Strategies
    • 9.3.2. Thermo Fisher Scientific Inc.
    • 9.3.3. Samsung Biologics
    • 9.3.4. Wuxi AppTec
    • 9.3.5. Lonza Group AG
    • 9.3.6. Eurofins Scientific
    • 9.3.7. Rentschler Biopharma SE
    • 9.3.8. AGC Biologics
    • 9.3.9. Syngene International
    • 9.3.10. BioNTech SE
    • 9.3.11. Boehringer Ingelheim BioXcellence(TM)
    • 9.3.12. Aldevron LLC
    • 9.3.13. Exelead Biopharma
    • 9.3.14. Precision NanoSystems Inc.
    • 9.3.15. Polymun Scientific Immunbiologische Forschung GmbH

Chapter 10. Research Process

  • 10.1. Research Process
    • 10.1.1. Data Mining
    • 10.1.2. Analysis
    • 10.1.3. Market Estimation
    • 10.1.4. Validation
    • 10.1.5. Publishing
  • 10.2. Research Attributes
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Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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