mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

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 Drivers

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 Challenges

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 Players Profiled in the mRNA Therapeutics Contract Development and Manufacturing (CDMO) Market

• 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:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

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

Available Customization

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