The North America Oligonucleotide CDMO (Contract Development and Manufacturing Organization) Market is experiencing robust growth, driven by increased investments in genomic medicine and biopharmaceuticals. The market size was valued at USD 1,350 Million in 2025 and is projected to reach USD 5,600 Million by 2035, expanding at a CAGR of 13.7% from 2024 to 2035.
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Market Growth Drivers
Expansion of Therapeutic Applications: The growing adoption of oligonucleotide-based therapies for rare genetic disorders, cancer, and infectious diseases significantly propels market growth. Pharmaceutical companies such as Ionis Pharmaceuticals have paved the way with successful FDA-approved drugs, like Spinraza, underlining the clinical potential of oligonucleotides. This has encouraged other biotechs and CDMOs to invest in R&D and manufacturing capacities, fostering a fertile ecosystem for innovation and commercial production.
Strategic Collaborations and CDMO Capacity Expansion: Leading CDMOs such as Thermo Fisher Scientific and Catalent have announced significant expansions in their oligonucleotide manufacturing capacities in North America. These expansions, driven by collaborative agreements and an increased focus on supporting clinical trials and commercialization, are improving speed-to-market for gene and RNA-based therapeutics. By establishing advanced synthesis and scale-up capabilities, these organizations are responding to the surging demand from the pharmaceutical sector.
Market Trends
Adoption of Automated Synthesis Platforms: Advanced automation technologies are being rapidly integrated into oligonucleotide manufacturing, reducing lead times and improving quality. Companies like Agilent Technologies have introduced scalable, automated synthesis platforms tailored for custom and high-throughput needs, enabling faster turnaround and enhanced process efficiency. This trend is steering the market toward higher production scales and supporting the growing requirements of clinical and commercial supply.
Focus on High-Purity and Modified Oligonucleotides: There is a rising demand for high-purity, chemically modified oligonucleotides used in gene editing, RNAi, and antisense oligonucleotide therapeutics. Players such as TriLink BioTechnologies have invested in proprietary technologies for the synthesis of NTPs and modified oligos, supporting the growing complexity of pharmaceutical pipelines. As more drug candidates incorporate modified structures, specialized CDMOs with cutting-edge capabilities are set to benefit most.
Market Opportunities
Expansion into Personalized Medicine: With the shift towards precision medicine, CDMOs catering to custom oligonucleotide synthesis for personalized therapies are expected to see accelerated demand. For example, LGC Biosearch Technologies is investing heavily to address growing orders for tailor-made oligonucleotide therapeutics targeted at individual patient needs.
Growing Demand from Clinical Trials: The increase in clinical trials involving RNA-based drugs and gene therapies is fueling demand for reliable, scalable, and GMP-compliant oligonucleotide manufacturing, creating opportunities for North American CDMOs to partner with global biopharma innovators.
North America Oligonucleotide CDMO Market Revenue (USD Million), 2020-2035
The chart depicts a consistent, high-growth trajectory for the North America Oligonucleotide CDMO market from 2020 to 2035. Starting at an estimated USD 340 Million in 2020, the market shows steady annual increases, reaching approximately USD 1,350 Million by 2025. The subsequent years reflect accelerating growth, propelled by increased biologics R&D and new drug approvals, culminating in an estimated USD 5,600 Million by 2035. This rapid rise demonstrates the market’s responsiveness to technological advancements, regulatory support, and surging clinical pipeline demand, making it an attractive sector for stakeholders and new entrants alike.
North America Oligonucleotide CDMO Market Share by Region (%) in 2025
The pie chart illustrates the regional market share distribution in North America for the Oligonucleotide CDMO sector in 2025. The United States dominates with a commanding 78% share, attributed to a vibrant biopharmaceutical industry and leading CDMO presence. Canada holds a 13% share, benefitting from strong governmental support and growing biotech clusters. Mexico accounts for 5%, with its emerging pharmaceutical manufacturing base. The remaining 4% is shared between 'Rest of North America,' including smaller countries and offshore operations. This regional concentration highlights the critical role the U.S. plays in shaping the North American oligonucleotide CDMO landscape.
Recent Developments
In April 2024, Thermo Fisher Scientific announced the opening of its expanded cGMP oligonucleotide manufacturing facility in Greenville, North Carolina. The upgraded site has tripled its previous capacity, integrating automated synthesis and purification technologies aimed at serving the rising demand for late-stage clinical and commercial-scale productions.
In February 2024, Catalent invested $50 million to enhance its oligonucleotide development and manufacturing capabilities at its Maryland facility. The expansion includes new high-throughput synthesizers, advanced analytical labs, and a dedicated team for custom and complex oligo synthesis, targeting next-generation mRNA and RNAi drugs.
In January 2024, Agilent Technologies formed a strategic partnership with a major North American biopharmaceutical company to provide end-to-end oligonucleotide synthesis and quality control solutions. This collaboration aims to accelerate development timelines for new oligonucleotide-based therapeutics through integrated AI-driven process optimization and rapid scale-up.
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