mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (Viral Vaccines, Protein Replacement Therapies, Cancer Immunotherapies), By Indication ( Infectious Diseases, Metabolic & Genetic Diseases, Cardiovascular & Cerebrovascular Diseases), By End user (Biotechnology & Pharmaceutical Companies, Academic & Research Institutions, Others), By Region and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 9.99 Billion
CAGR (2026-2031)	7.97%
Fastest Growing Segment	Infectious Diseases
Largest Market	North America
Market Size (2031)	USD 15.83 Billion

Market Overview

The Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market will grow from USD 9.99 Billion in 2025 to USD 15.83 Billion by 2031 at a 7.97% CAGR. The Global mRNA Therapeutics Contract Development and Manufacturing Organization (CDMO) market comprises specialized entities that provide outsourcing services for the process development, formulation, and commercial production of messenger RNA-based drugs and vaccines. The primary driver supporting market growth is the rapid expansion of the clinical pipeline for mRNA candidates targeting indications beyond infectious diseases, such as oncology and rare genetic disorders, which necessitates external manufacturing capabilities. Pharmaceutical developers are increasingly partnering with CDMOs to access established infrastructure and mitigate the capital risks associated with internal facility construction. According to PhRMA, in 2025, scientific advancements have led to 265 DNA or RNA therapeutic projects currently in the biopharmaceutical pipeline.

However, a significant challenge that could impede market expansion is the shortage of specialized technical expertise and manufacturing capacity required for complex mRNA synthesis and lipid nanoparticle encapsulation. The intricate nature of these production processes demands highly skilled personnel and precise quality controls that are currently in limited supply relative to the growing demand. This workforce gap, coupled with the high cost of raw materials and supply chain constraints, creates production bottlenecks that may delay clinical timelines and restrict the overall scalability of the sector.

Key Market Drivers

The Rapid Expansion of the Global mRNA Vaccines and Therapeutics Pipeline acts as the foremost catalyst propelling the CDMO sector, as developers aggressively pivot from infectious disease prophylaxis toward oncology and rare genetic disorders. This diversification into complex therapeutic areas has created an acute demand for specialized process development and clinical-scale manufacturing that few biopharmaceutical companies can manage internally. The shift requires CDMOs to support novel cargo and sophisticated lipid nanoparticle formulations, driving a surge in service agreements to support late-stage development. According to BioNTech, in May 2025, the company had progressed its diversified oncology pipeline to include more than 20 active Phase 2 and Phase 3 clinical trials, underscoring the significant volume of advanced candidates now necessitating robust external manufacturing infrastructure.

Concurrently, High Capital and Technical Barriers to In-House Manufacturing are necessitating a structural shift toward strategic outsourcing. Establishing cGMP-compliant mRNA production facilities requires immense financial outlay for specialized bioreactors and encapsulation technologies, alongside a scarcity of skilled technical personnel. This financial burden compels pharmaceutical developers to partner with established CDMOs to mitigate risk and access immediate scalability without the capital intensity of self-building. According to Thermo Fisher Scientific, in April 2025, the company committed an additional $2 billion investment to enhance U.S. operations, with $1.5 billion specifically allocated to manufacturing expansion, illustrating the massive capital requirements in this domain. This dynamic has accelerated deal activity; according to Samsung Biologics, in May 2025, the company secured cumulative contract manufacturing orders totaling approximately $2.4 billion for the year, reflecting the industry's critical reliance on outsourced capacity.

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Key Market Challenges

The primary challenge hampering the growth of the Global mRNA Therapeutics Contract Development and Manufacturing (CDMO) Market is the acute shortage of specialized technical expertise and manufacturing capacity. The production of mRNA-based therapeutics involves highly intricate processes, such as lipid nanoparticle encapsulation, which require a workforce with advanced scientific proficiency and precise operational skills. However, the current 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. According to the BioIndustry Association, in 2024, the life sciences sector faces a projected shortfall of 133,000 skilled workers 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.

Key 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. According to the Coalition for Epidemic Preparedness Innovations, March 2025, the organization awarded up to $13.38 million to Gennova Biopharmaceuticals to advance the development of a self-amplifying mRNA vaccine, highlighting the targeted investment flowing into this specialized technical segment.

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. According to Recipharm, June 2025, in a corporate update regarding its advanced biologics division, the company reported that it successfully reduced RNA production timelines from 25 days to 5 days by deploying a new continuous manufacturing platform.

Segmental Insights

The Infectious Diseases segment currently leads growth in the Global mRNA Therapeutics Contract Development and Manufacturing market following the clinical validation of mRNA technology during the recent pandemic. This success has motivated biopharmaceutical companies to prioritize development pipelines for targets such as influenza, respiratory syncytial virus, and HIV. Contract manufacturers are responding by expanding production capacities to accommodate increased demand for preventive vaccines. Furthermore, regulatory frameworks established by agencies like the U.S. FDA to facilitate rapid vaccine deployment continue to encourage outsourcing, ensuring that contract partners remain integral to the supply chain for infectious disease treatments.

Regional Insights

North America holds a leading position in the Global mRNA Therapeutics CDMO market, driven by the significant presence of major pharmaceutical developers and specialized manufacturing organizations. The region benefits from robust government support for biotechnology research, including initiatives funded by the Biomedical Advanced Research and Development Authority (BARDA). Furthermore, the United States Food and Drug Administration (FDA) maintains clear regulatory pathways that streamline the development and approval of mRNA-based treatments. This established infrastructure, combined with continuous investment in production capabilities for vaccines and therapeutics, secures the region's dominance in the global landscape.

Recent Developments

• In December 2025, ST Pharm partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and Seoul National University to develop a messenger RNA (mRNA) vaccine against the Severe Fever with Thrombocytopenia Syndrome (SFTS) virus. The South Korean contract development and manufacturing organization (CDMO) agreed to leverage its proprietary capping and lipid nanoparticle platforms to support the project from research and development through to commercialization. The collaboration aimed to produce the first vaccine for the tick-borne viral disease and validate the company's rapid response capabilities for future pandemic preparedness using its global manufacturing network.
• In October 2024, Vernal Biosciences launched its integrated analytical and quality control services for plasmid DNA, messenger RNA (mRNA), and lipid nanoparticles (LNPs) as part of its comprehensive manufacturing platform. The US-based contract development and manufacturing organization (CDMO) introduced these commercial services to assist drug developers in evaluating critical quality attributes and ensuring the safety and efficacy of their mRNA medicines. The offering included advanced testing technologies such as digital PCR, nanopore sequencing, and liquid chromatography, designed to streamline the development process and expedite clinical timelines for mRNA programs.
• In January 2024, AGC Biologics announced plans to construct a new biopharmaceutical manufacturing facility at its Yokohama Technical Center in Japan with an estimated investment of ¥50 billion. The contract development and manufacturing organization (CDMO) aimed to expand its presence in Asia by offering preclinical through commercial services for mammalian-based protein biologics, cell therapies, and messenger RNA (mRNA) pharmaceuticals. The site was designed to house single-use bioreactors and was expected to become operational in 2026, supported by a grant from the Japanese Ministry of Economy, Trade and Industry to strengthen domestic vaccine production capabilities.
• In January 2024, Lonza entered into a collaboration with Oxford Nanopore Technologies to develop and commercialize a novel analytical test for messenger RNA (mRNA) products. The partnership focused on adapting nanopore-based sequencing technology to accurately measure multiple critical quality attributes of mRNA simultaneously on the manufacturing site. The initiative aimed to simplify and streamline the regulatory testing requirements for mRNA therapeutics and vaccines, potentially accelerating their path to market. Lonza planned to pre-validate the test at its analytical development laboratory in Geleen, Netherlands, followed by technology transfer for current Good Manufacturing Practice (cGMP) validation.

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

By Application	By Indication	By End user	By Region
Viral Vaccines Protein Replacement Therapies Cancer Immunotherapies	Infectious Diseases Metabolic & Genetic Diseases Cardiovascular & Cerebrovascular Diseases	Biotechnology & Pharmaceutical Companies Academic & Research Institutions Others	North America Europe Asia Pacific South America Middle East & Africa

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