In 2024, the global market for mRNA therapeutics CDMO (Contract Development and Manufacturing Organizations) was valued at USD 4.62 billion. Just a year later, it climbed to USD 5.15 billion, and forecasts suggest a remarkable leap to USD 13.63 billion by 2034, expanding at a CAGR of 11.37% (2025–2034).

But this growth isn’t just about numbers—it’s about a shift in how medicine is made, delivered, and commercialized. This case study delves into the factors propelling this shift and how CDMOs are playing a crucial behind-the-scenes role in shaping the future of mRNA-based therapeutics.

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Background: What is an mRNA Therapeutics CDMO?

mRNA therapeutics CDMOs are third-party partners that help biopharma companies design, manufacture, and deliver mRNA-based treatments and vaccines. These CDMOs provide a suite of services—such as plasmid DNA production, in vitro transcription (IVT), lipid nanoparticle (LNP) formulation, fill-finish operations, analytical testing, and regulatory support.

The massive success of mRNA COVID-19 vaccines opened the floodgates, bringing mRNA therapies into the spotlight for treating not just infectious diseases but also cancer, rare genetic disorders, and even in the realm of personalized medicine.

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Market Drivers: What’s Fueling the Momentum?

1. Chronic and Infectious Diseases Are Driving R&D

The global health burden of chronic and infectious diseases is escalating. In response, pharmaceutical companies are accelerating R&D, exploring mRNA therapies to provide faster, more targeted solutions. The versatility of mRNA—acting as a template to produce therapeutic proteins—makes it a standout candidate for next-gen treatments.

2. Clinical Trials Are Increasing in Volume and Scope

As of March 2025, two mRNA therapeutics—Comirnaty and Spikevax—have been fully approved by the FDA, validating the mRNA platform’s credibility. This has opened the door to more clinical trials, both for new indications and for enhancing efficacy of existing therapies.

3. Government Support and Public Funding

The U.S. government alone invested nearly $31.9 billion from 1985 to 2022 into developing and producing mRNA COVID-19 vaccines. Other countries, such as Canada and those across Europe, are making substantial investments to build sovereign mRNA capabilities.

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Opportunities: What’s Ahead for CDMOs?

End-to-End Partnerships Are the Future

Biotech and pharma companies are increasingly outsourcing the entire lifecycle—from R&D to commercial packaging—to specialized CDMOs. These partners offer advanced facilities, scalability, and compliance expertise, freeing up innovators to focus on product development and go-to-market strategies.

This trend is especially evident in the end-to-end CDMO services segment, which is projected to experience the fastest growth rate in the coming years.

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Segmental Highlights: Where is Growth Concentrated?

By Service Type:

• mRNA Drug Substance Manufacturing led in 2024, accounting for ~34% of market share. Advances in synthetic RNA production and increased demand post-pandemic have solidified its dominance.

• End-to-End CDMO Services are expected to see rapid adoption, offering integrated solutions from discovery through distribution.

By Application:

• Infectious Diseases led the charge in 2024, buoyed by continued COVID-19 case reports and vaccine rollouts. WHO reported 346,000 COVID-19 cases globally between May 15 and June 15, 2025, with Thailand leading in incidence.

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Geographical Insights: Regional Trends and Strategies

North America: The Powerhouse

Holding a 44% revenue share in 2024, North America leads the mRNA therapeutics CDMO market, thanks to:

• High concentration of global CDMO leaders like Catalent, Aldevron, and Thermo Fisher Scientific.

• Robust R&D infrastructure.

• Favorable regulatory frameworks and public-private partnerships.

Canada: Research-Driven Growth

Canada’s government recently announced $11 million in funding to back two major mRNA vaccine research projects, reinforcing the nation’s growing role in biotech innovation.

Europe: Fastest-Growing Contender

Europe is projected to grow at the fastest CAGR during the forecast period. Its success is attributed to:

• Strategic investments in oncology pipelines.

• Personalized medicine initiatives.

• Strong public healthcare infrastructure and supportive regulation.

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AI’s Transformational Role

AI is redefining what’s possible in mRNA therapeutics:

• Molecular Design: Algorithms predict mRNA structures for higher stability and efficacy.

• LNP Optimization: Machine learning accelerates the creation of effective delivery systems.

• Manufacturing Efficiency: AI-driven process automation enhances throughput and minimizes errors.

Recent examples include:

• TriLink Biotechnologies’ February 2025 agreement with Aldevron to boost access to CleanCap capping technology.

• Inventage Lab’s $17M acquisition of Quratis to expand CDMO operations and gain management control—reflecting an aggressive growth strategy in Asia.

Source : https://www.towardshealthcare.com/insights/mrna-therapeutics-cdmo-market-sizing