Market Snapshot

US mRNA therapeutics CDMO market was valued at US$ 1.78 billion in 2024 and is projected to hit the market valuation of US$ 6.27 billion by 2033 at a CAGR of 15.01% during the forecast period 2025–2033.

An analysis of recent data reveals a multi-faceted and rapidly escalating demand curve for the US mRNA therapeutics CDMO market. This demand is primarily fueled by an expansive clinical pipeline. As of early 2024, the existence of 1,503 mRNA programs underscores the sheer volume of work entering development. Industry leader Moderna entered 2024 with 45 therapeutic programs, nine of which are in late-stage development. This activity is not isolated to giants; emerging biotechs like ReCode Therapeutics, which initiated a Phase 1 study in February 2024, also contribute to the need for clinical trial materials. The complexity of this demand is highlighted by resource-intensive late-stage programs, such as the two separate Phase 3 trials for Moderna’s cancer therapy, mRNA-4157, creating a clear and present need for advanced manufacturing partnerships.

Regulatory actions and substantial government funding act as powerful, short-term demand catalysts in the mRNA therapeutics CDMO market. The FDA's approval of updated COVID-19 vaccines from both Moderna and Pfizer on August 22, 2024, triggered an immediate need for scaled production and commercial supply. Furthermore, direct government investment is de-risking development pipelines, allowing companies to confidently engage CDMOs. For instance, BARDA awarded Arcturus Therapeutics a contract worth up to $63 million in March 2025 for a bird flu vaccine trial. In a significantly larger commitment, the U.S. government awarded Moderna $590 million in January 2025 to accelerate its H5N1 vaccine work, which followed a prior $176 million allocation to the company in 2024 for influenza preparedness. These funded mandates translate directly into tangible manufacturing projects for CDMOs.

Looking forward, demand is being shaped by therapeutic diversification and clear corporate roadmaps in the mRNA therapeutics CDMO market. Moderna plans to expand its cancer therapy studies into additional tumor types in 2024, signaling a growing need for more specialized, smaller-batch manufacturing. The future pipeline is robust; Moderna anticipates up to three product approvals in 2025 and six registrational data readouts that same year. The company’s ambitious goal is to deliver up to 10 product approvals by 2027. Specific milestones, such as the planned BLA resubmission for its combined flu/COVID vaccine after May 2025, create predictable demand points for manufacturing slots. With Moderna expecting to break even financially in 2026, long-term R&D investment appears secure, solidifying a complex and evolving demand profile. 

Key Findings in US mRNA Therapeutics CDMO Market

• By indication, mRNA therapeutics CDMO is heavily used for the treatment of infectious diseases across the US.
• By application, mRNA therapeutics CDMO is mainly used for the production of viral vaccines.
• By end users, biotech companies are the key end users of the mRNA therapeutics CDMO
• US mRNA therapeutics CDMO market is projected to hit the market valuation of US$ 6.27 billion by 2033

To Get more Insights,  Request A Free Sample 

 Top 3 Trends Shaping the Future of US mRNA therapeutics CDMO Market 

1. A Strategic Shift from Pandemic Scale to Precision Oncology Manufacturing
   The market is pivoting from mass production of infectious disease vaccines to highly specialized, smaller-batch manufacturing. This trend is driven by a maturing pipeline focused on complex therapies like personalized cancer vaccines. As companies like Moderna expand clinical studies for their individualized neoantigen therapy (mRNA-4157) into new tumor types in 2024, the demand for agile CDMOs capable of handling flexible, GMP-grade production for targeted patient populations is intensifying. This requires a fundamental shift in manufacturing philosophy and capabilities away from the large-scale model.
2. Intensified Focus on Supply Chain Security and Advanced Manufacturing Technologies
   To de-risk development, therapeutic companies are aggressively securing their supply chains. This is evidenced by Moderna's acquisition of a U.S.-based enzyme supplier in December 2024 and raw material supplier Aldevron's new GMP plasmid DNA facility launch in December 2024. Simultaneously, the emergence of next-generation platforms like self-amplifying RNA (saRNA), which may require 100 times lower doses, is pushing mRNA therapeutics CDMO market to adopt new technologies and more sophisticated quality control measures, such as the advanced analytics being developed through the Lonza and Oxford Nanopore collaboration announced in January 2024.
3. Government Funding and Regulatory Agility Driving Targeted Production Surges
   Federal investment and directives are creating concentrated hotspots of manufacturing demand. Substantial government awards, such as the $590 million BARDA contract granted to Moderna in January 2025 for H5N1 vaccine development, create immediate and large-scale project opportunities for CDMOs. Furthermore, the FDA’s ability to pivot on guidance, like updating the required COVID-19 vaccine strain to KP.2 for the 2024-2025 season, necessitates that CDMOs maintain a high degree of operational agility to rapidly adapt production lines, making responsiveness a key competitive differentiator.

Expanding Clinical Pipelines Drive Diverse Manufacturing and Development Needs

The fundamental driver of demand for mRNA therapeutics CDMO market is the robust and rapidly diversifying clinical pipeline. As of early 2024, the scale of activity is immense, with 1,503 mRNA programs cataloged on clinicaltrials.gov. This broad base of research funnels a steady stream of projects to manufacturing partners. Industry leader Moderna entered 2024 with a formidable pipeline of 45 different therapeutic and vaccine programs. Critically for CDMOs, nine of these Moderna programs are in late-stage development, a phase requiring significant resources for GMP material production.

The demand is not just from established players. Emerging biotechs in the US mRNA therapeutics CDMO market are also advancing their candidates, as seen when ReCode Therapeutics dosed the first volunteer in its Phase 1 study for RCT2100 in February 2024. There is a strong, resource-intensive push into oncology. Moderna initiated a Phase 1 trial for its pan-tumor therapy, mRNA-4106, in May 2025. The company is also running two separate Phase 3 trials for its individualized cancer therapy, mRNA-4157. Furthermore, the pipeline is diversifying beyond oncology; Moderna announced positive Phase III efficacy results for its seasonal flu vaccine (mRNA-1010) in June 2024 and plans to expand its cancer studies to more tumor types in 2024. The technological frontier is also expanding, with at least three therapies utilizing novel RNA editing technology having entered clinical trials as of 2024. This activity creates a clear and sustained need for varied CDMO capabilities.

Government Funding and Regulatory Mandates Create Concentrated Demand Surges

Government actions and regulatory milestones create immediate, large-scale demand for mRNA therapeutics CDMO market, acting as powerful market accelerators. On a single day, August 22, 2024, the FDA approved the updated 2024-2025 COVID-19 vaccine formulas for both Moderna’s Spikevax and Pfizer’s Comirnaty, instantly triggering commercial production runs. This followed specific FDA guidance for manufacturers to target the KP.2 strain. Beyond approvals, direct federal funding is a primary catalyst for development and manufacturing contracts. In a major commitment to pandemic preparedness, the U.S. government awarded Moderna a substantial $590 million contract in January 2025 to accelerate its H5N1 vaccine development. This built upon a previous award of $176 million to the company in 2024.

This funding extends to smaller players as well in the US mRNA therapeutics CDMO market. In March 2025, Arcturus Therapeutics secured a BARDA contract valued at up to $63 million to support a Phase I trial for its bird flu vaccine. Tiba Biotech was also awarded $749,999 from BARDA in July 2024 for an influenza treatment. However, this influence is dynamic; in August 2025, the U.S. government also cancelled nearly $500 million in contracts for 22 different mRNA projects, forcing rapid strategic recalculations. Regulatory pathways create a forward-looking schedule of demand points. For example, Moderna received approval for its RSV vaccine in 2024 and plans to resubmit its BLA for the combined flu/COVID vaccine after May 2025, signaling future manufacturing needs.

 Segmental Analysis 

Infectious Disease Urgency Fuels US mRNA Therapeutics CDMO Market Expansion

The intense focus on infectious diseases serves as the primary engine for the US market. Catalyzed by the pandemic, the demand is sustained by a strategic shift towards national health security and pandemic preparedness. Government initiatives like Project NextGen, with its 5 billion allocation, ensure a steady flow of capital into novel countermeasure development. This environment is highly favorable for CDMOs, who are essential partners in translating research into reality. The proven ability of mRNA technology to move from viral sequencing to a Phase 1 candidate in under 65 days has made it the platform of choice. This speed is a critical advantage that biotech and pharmaceutical companies leverage by partnering with CDMOs, pushing the pipeline to over 150 active programs targeting a wide array of pathogens.

This momentum is not just theoretical, it is materializing in significant infrastructure and research expansion in the mRNA therapeutics CDMO market. The focus now extends far beyond COVID-19, with active research targeting over 30 different pathogens and at least 15 ongoing clinical trials for an mRNA-based flu vaccine alone. The recent FDA approval of 2 new mRNA RSV vaccines further solidifies the platform's viability and regulatory pathway. In response, CDMOs are aggressively scaling up, with one major player investing 500 million in a facility expansion and the industry collectively aiming to produce over 1 billion annual doses. These developments underscore a robust, long-term demand cycle where CDMOs are indispensable for meeting the nation’s public health goals.

• Over 25 major strategic partnerships for infectious diseases were formed between biotechs and CDMOs since 2022.
• Initial pandemic-era funding exceeded 12 billion, creating the foundational infrastructure that CDMOs now operate and expand upon.
• The pipeline is diversifying rapidly, with research now targeting over 30 different viral and bacterial pathogens using advanced mRNA platforms.

Viral Vaccines Spearhead Dominance in the Market

Viral vaccines are the undisputed powerhouse, commanding over 68% of the US mRNA therapeutics CDMO market. This dominance is a direct legacy of the COVID-19 pandemic, which not only proved the platform's efficacy but also led to the build-out of a massive manufacturing ecosystem. With over 1.5 billion mRNA vaccine doses administered in the US, the technology, supply chains, and regulatory pathways are now firmly established. This foundation has spurred immense confidence, attracting over 9 billion in private investment for viral vaccine platforms and leading to a pipeline where over 100 of the 150 infectious disease programs are for viral targets. Government support remains strong, with the Department of Defense committing over 1 billion to ensure domestic CDMOs are prepared for future viral outbreaks.

The infrastructure supporting this segment is robust and expanding. At least 12 major US CDMOs now have dedicated mRNA vaccine production lines, with new facilities like one in North Carolina designed to produce 200 million doses annually. This specialization enables rapid response and efficient scale-up, a capability proven when CDMOs increased production by a factor of 1000 in less than a year. The clinical development pipeline further solidifies this lead, with the top 5 biotechs holding over 40 viral vaccine candidates and innovative projects like the 5 COVID-flu combination vaccines advancing. The sheer scale, evidenced by over 500,000 clinical trial participants, ensures that viral vaccines will continue to be the primary revenue driver for the US mRNA therapeutics CDMO market for the foreseeable future.

• The top 5 mRNA biotechs have a combined pipeline of over 40 viral vaccine candidates, ensuring a steady stream of work for CDMOs.
• The demonstrated ability to scale production by a factor of 1000 in under 12 months provides unparalleled value for pandemic preparedness.
• Development is advancing toward next-generation products, with at least 5 different COVID-flu combination vaccine candidates currently underway.

Innovative Biotech Companies Emerge as the Primary Clients for mRNA CDMOs

Biotechnology firms represent the core clientele driving the US mRNA therapeutics CDMO market, creating a powerful symbiotic relationship. The primary driver for this is economic and logistical necessity; most biotechs, particularly the over 200 firms without in-house manufacturing, cannot afford the 250 million-plus price tag and 24-36 month timeline required to build their own cGMP-compliant facilities. Instead, they leverage their capital—bolstered by over 20 billion in recent VC funding—to focus on R&D and outsource production. This asset-light model enables them to advance their pipelines rapidly, making CDMOs non-negotiable partners. The result is a landscape where top clinical-stage biotechs maintain an average of 3 separate CDMO contracts to ensure capacity and mitigate risk, cementing their role as the industry's key end-users.

This reliance deepens as therapies progress from concept to clinic. More than 90 small and mid-sized biotechs depend entirely on the US mRNA therapeutics CDMO market for producing the critical materials needed for their first-in-human trials. CDMOs, in turn, have become innovation hubs, employing over 5,000 specialized scientists and investing over 1 billion in proprietary technologies for essential components like plasmids and lipid nanoparticles. This expertise is something few biotechs can replicate internally. The establishment of over 50 new mRNA startups since 2021, nearly all adopting an outsourcing model, and the signing of at least 15 long-term strategic manufacturing agreements confirm that for the foreseeable future, the growth of the entire US market is intrinsically tied to the success and outsourcing strategies of its biotech clients.

• Over 50 new mRNA-focused startups have launched since 2021, almost exclusively relying on CDMOs for manufacturing needs.
• CDMOs have strategically invested over 1 billion in proprietary technologies for plasmid DNA and LNP formulation to attract biotech partners.
• At least 15 long-term (5+ year) manufacturing agreements were signed recently, indicating a shift toward stable, strategic partnerships.

Billions in Capital Injections Signal Intense Confidence in US mRNA Therapeutics CDMO Market

• Lonza completed its acquisition of the large-scale biologics manufacturing site in Vacaville, California, from Roche in October 2024 for US$1.2 billion. This site is one of the largest biologics facilities globally with about 330,000 liters of bioreactor capacity. Lonza also committed to investing approximately 500 million Swiss francs (around US$560 million) to upgrade the Vacaville facility to support next-generation mammalian biologics therapies.
• Strand Therapeutics, a Boston-based developer of programmable mRNA therapies for cancer, raised US$153 million in a Series B funding round in August 2025, with participation from major investors including Regeneron Ventures, Amgen Ventures, and Eli Lilly.
• Moderna was awarded US$590 million from BARDA in January 2025 to accelerate development of mRNA-based pandemic influenza vaccines, specifically targeting strains like H5N1.
• Centivax, focused on developing a universal mRNA flu vaccine, closed a US$45 million Series A funding round in July 2025 to advance clinical trials of its candidate.
• National Resilience’s subsidiary received nearly US$17.5 million in October 2024 in funding from the U.S. government’s ASPR to support domestic production of starting materials and active pharmaceutical ingredients for critical medicines in the mRNA therapeutics CDMO market.
• Aldevron, a Danaher company and key plasmid DNA supplier for mRNA production, opened a new Innovation Center in Waltham, Massachusetts, in July 2025 to accelerate R&D in DNA, RNA, and proteins.
• Tiba Biotech was awarded a BARDA contract of US$749,999 in July 2024 to develop RNAi-based therapeutics against influenza.
• Although many mRNA vaccine contracts were cancelled in 2025, the U.S. government allowed completion of certain late-stage projects, including a contract with Arcturus Therapeutics for an mRNA bird flu vaccine.
• Novo Holdings acquired Catalent in late 2024 for US$16.5 billion, with plans for Novo Nordisk to buy three fill-finish sites for US$11 billion, marking one of the largest CDMO transactions of the year.

 Top Companies in the US mRNA Therapeutics CDMO Market

• ApexBio Technology
• Biomay AG
• BioNTech SE
• Bio-Synthesis, Inc.
• Catalent, Inc.
• Danaher (Aldevron)
• eTheRNA
• Kaneka Eurogentec S.A.
• Lonza
• Recipharm AB
• Samsung Biologics
• TriLink BioTechnologies
• Other Prominent Players

Market Segmentation Overview

By Application

• Protein Replacement Therapies
• Cancer Immunotherapies
• Viral Vaccines

By Indication

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

By End Use 

• Pharmaceutical Companies
• Government & Academic Research Institutes
• Biotech Companies