U.S. mRNA Therapeutics CDMO Market to Hit Valuation of US$ 6.27 Billion by 2033
Chicago, Aug. 14, 2025 (GLOBE NEWSWIRE) -- The US mRNA therapeutics CDMO market was valued at US$ 1.78 billion in 2024 and is expected to reach US$ 6.27 billion by 2033, growing at a CAGR of 15.01% during the forecast period 2025–2033.
The outlook for the US mRNA therapeutics CDMO market is exceptionally bright, anchored by a vast clinical pipeline poised for commercialization. As of early 2024, an incredible 1,503 mRNA programs were in development, creating a deep reservoir of future manufacturing demand. This is exemplified by Moderna, which entered 2024 with 45 programs, including nine in late-stage development. The transition from R&D to market is accelerating, with Moderna anticipating up to three potential product approvals in 2025 alone. Looking further, the company is targeting the delivery of up to 10 product approvals by 2027, creating a clear, multi-year roadmap for sustained CDMO engagement from clinical scale-up to commercial supply.
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This promising pipeline is backed by extraordinary financial commitments and strategic infrastructure expansion. In 2024, Lonza acquired a major U.S. biologics site for $1.2 billion and plans to invest another $560 million in upgrades. Venture capital is also pouring in, with Strand Therapeutics raising $153 million in August 2025 and Centivax securing $45 million in July 2025. Government confidence remains high, highlighted by BARDA's $590 million award to Moderna in January 2025 for influenza preparedness. This massive influx of capital ensures that the manufacturing capacity and technological capabilities will be in place to meet the escalating demands of this innovative therapeutic frontier.
Key Findings US mRNA Therapeutics CDMO Market
Market Forecast (2033)
US$ 6.27 billion
CAGR
15.01%
Top Drivers
Sustained government funding for pandemic preparedness and biodefense initiatives.
Rapid clinical development timelines attracting investment for diverse therapeutic areas.
Expansion of mRNA applications into oncology and rare diseases.
Top Trends
Integration of AI for optimizing mRNA sequence and LNP design.
Development of next-generation delivery systems beyond traditional lipid nanoparticles.
A shift toward personalized mRNA cancer vaccines and therapeutics.
Top Challenges
Securing the supply chain for critical raw materials (plasmids, enzymes).
Navigating evolving and complex regulatory pathways for novel therapeutics.
Managing the high cost of goods for personalized therapies.
An Expanding Clinical Pipeline Fuels Intense Manufacturing and Development Demand
The depth and breadth of the clinical pipeline serve as the primary engine for the US mRNA therapeutics CDMO market. As of early 2024, an impressive 1,503 mRNA programs were listed on clinicaltrials.gov, a testament to the technology's burgeoning potential. Industry leader Moderna entered 2024 with 45 therapeutic and vaccine programs in its pipeline, nine of which are in late-stage development. This activity is not confined to established players; in February 2024, ReCode Therapeutics initiated a Phase 1 clinical study for its mRNA therapeutic candidate, RCT2100, by dosing its first volunteer.
The focus on oncology is particularly intense. In May 2025, Moderna initiated a Phase 1 trial for its novel pan-tumor antigen therapy, mRNA-4106. Furthermore, its partnership with Merck is advancing a Phase 3 trial for the individualized neoantigen therapy (INT), mRNA-4157, for high-risk melanoma, with a second Phase 3 trial enrolling patients for non-small cell lung cancer. Beyond cancer, Moderna also announced positive Phase III efficacy results for its seasonal flu vaccine (mRNA-1010) in June 2024, while at least three therapies using novel RNA editing technology entered clinical trials in 2024.
Strategic Regulatory Actions and Government Funding Shape Market Contours
Federal oversight and funding are pivotal forces sculpting the competitive landscape and demand cycles of the US mRNA therapeutics CDMO market. On August 22, 2024, the U.S. FDA took decisive action by approving the updated 2024–2025 formula of Moderna's Spikevax and Pfizer-BioNTech's Comirnaty. Concurrently, Emergency Use Authorizations (EUAs) were granted for both vaccines for younger age groups. This followed FDA guidance from June 2024 advising manufacturers to target a monovalent JN.1-lineage, which was later updated to the KP.2 strain. Government funding continues to be a powerful catalyst. In March 2025, Arcturus Therapeutics secured a BARDA contract valued at up to $63 million for a bird flu vaccine trial.
Similarly, the U.S. government awarded Moderna $590 million in January 2025 to accelerate its mRNA-based H5N1 vaccine development, building on a previous $176 million award in 2024. Tiba Biotech also received $749,999 from BARDA in July 2024 for an influenza treatment. However, in a significant policy shift, the Department of Health and Human Services cancelled nearly $500 million in contracts for 22 different mRNA projects in August 2025, highlighting the dynamic nature of government priorities.
Fueling Innovation Through Strategic Corporate and Venture Capital Investments
The immense promise of mRNA technology is attracting substantial financial backing, which directly fuels R&D and manufacturing activities within the US mRNA therapeutics CDMO market. This influx of capital is enabling emerging biotechs to advance their novel platforms and pipelines. In a significant vote of confidence, Strand Therapeutics, a developer of programmable mRNA therapeutics, raised an impressive $153 million in a Series B financing round in August 2025. This recent funding builds upon the $97 million the company had previously raised to support its research efforts.
The investment momentum is also visible in specialized niches, with Centivax, a Silicon Valley startup developing a universal flu mRNA vaccine, securing a $45 million Series A round in July 2025. Furthermore, major pharmaceutical collaborations provide crucial non-dilutive funding and validation; Merck underscored its commitment to the space by paying Moderna an option exercise fee of $250 million back in October 2022 to jointly develop personalized mRNA cancer vaccines.
Performance Metrics of Key Players Shaping the Competitive Landscape
The financial performance and strategic planning of market leaders in the US mRNA therapeutics CDMO market offer a clear quantitative measure of the industry's health and future CDMO demand. Moderna reported substantial product sales of approximately $6.7 billion for the full year 2023. The company initially forecasted sales of around $4 billion for 2024, which was later revised in January 2025 to a range of $3.0 to $3.1 billion. Of these 2024 sales, a significant $1.7 billion were generated within the United States.
Looking ahead, Moderna anticipates having an ending cash balance of approximately $6.0 billion in 2025 and is implementing cost-saving measures, including an additional $500 million in savings planned for 2026. Its cash operating costs were already reduced by over 25 percent in 2024 compared to 2023, with a goal to reduce 2025 cash costs by a further $1 billion. Meanwhile, competitor Pfizer posted strong sales of $5.35 billion for its mRNA vaccine, Comirnaty, in 2024, reinforcing the continued commercial relevance of established mRNA products.
Fortifying the Foundational Supply Chain for Advanced mRNA Manufacturing
A resilient and technologically advanced supply chain for critical raw materials is the bedrock of the entire US mRNA therapeutics CDMO market. Recognizing this, key suppliers are making substantial investments to boost capacity and innovation. In December 2024, Aldevron, a Danaher subsidiary, began operations at its new GMP plasmid DNA facility in Fargo, North Dakota, specifically to supply mRNA vaccine developers. In a similar move, Cytiva, also part of Danaher, completed an expansion of its Marlborough, MA site in February 2025, adding crucial new capacity for high-purity enzymes and nucleotides. Innovation is also accelerating, with TriLink BioTechnologies introducing a new class of modified nucleotides in February 2025 optimized for the long-read mRNA sequences used in oncology.
TriLink also partnered with Johns Hopkins University in May 2024 to accelerate RNA discovery research. Therapeutic developers are also securing their supply lines, as seen in Moderna's December 2024 acquisition of a U.S.-based enzyme supplier and its November 2024 strategic agreement with Thermo Fisher Scientific for custom raw materials.
CDMO Capacity Expansion Meeting Surging Next-Generation Therapeutic Production Demand
Leading CDMOs in the US mRNA therapeutics CDMO market are aggressively expanding their infrastructure and service offerings to capture the explosive growth in the sector. These strategic expansions are critical to supporting the increasingly complex and diverse needs of mRNA therapeutic developers. In a key move in 2024, Catalent broadened its integrated OneBio platform to specifically include development and manufacturing services for mRNA, signaling a strong commitment to the modality. Global giant Lonza is also bolstering its presence through the acquisition of a U.S. manufacturing site from Roche, a move that will significantly increase its biologics capacity. The competitive pressure is also being felt from overseas. In the fourth quarter of 2024, European CDMO BSP revised its strategic plan for 2025-2030, which includes a total planned investment of approximately 600 million Euro. These investments will, in part, support RNA-based onco-vaccines, potentially influencing the global supply chain and increasing competitive options for U.S.-based developers, further energizing the US mRNA therapeutics CDMO market.
Pioneering Technological Breakthroughs Redefining mRNA Therapeutic Efficacy and Production
Continuous innovation in both therapeutic platforms and manufacturing processes is setting the stage for the next wave of growth. The industry is rapidly moving beyond first-generation mRNA, with development now focused on self-amplifying RNA (saRNA) and circular RNA (circRNA) technologies, which promise longer-lasting immune responses from single, low doses. The potential is immense; preclinical data suggests saRNA vaccines could achieve the desired immune response with a dose that is 100 times lower than current mRNA vaccines. This technological leap could dramatically alter manufacturing requirements and cost structures.
To support these advanced products, manufacturing analytics must also evolve. In January 2024, Oxford Nanopore Technologies and Lonza announced a collaboration to validate and market a new, advanced quality control test for mRNA products, addressing a critical need for more precise and efficient production oversight. This focus on next-generation technology will be a key differentiator in the US mRNA therapeutics CDMO market.
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Diversifying Therapeutic Applications Beyond Infectious Diseases into New Frontiers
While infectious diseases provided the initial commercial proof-of-concept, the future of mRNA lies in its application across a much wider spectrum of conditions. As of July 2024, infectious disease applications still accounted for 70% of ongoing mRNA vaccine trials, but the momentum is shifting. Moderna and Merck plan to expand their clinical studies of individualized neoantigen therapy to additional tumor types in 2024. Underscoring this diversification, Moderna's extensive pipeline now includes therapeutics and vaccines for immuno-oncology, rare diseases, and autoimmune diseases. This shift has profound implications for manufacturing.
The rise of personalized cancer vaccines, in particular, is driving the need for more tailored, flexible, and smaller-scale GMP-grade RNA production processes in the US mRNA therapeutics CDMO market. The industry is facing the challenge of transitioning from large-scale pandemic production to this new paradigm in 2025, a transition that experts predict will fuel a surge in contract services funding in 2025, for which agile US CDMOs must prepare.
U.S. 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
Key Market Segmentation:
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
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About Astute Analytica
Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.
With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.
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