North America Oligonucleotide CDMO Market: by Type (Custom Oligonucleotides, Pre-designed Oligonucleotides, DNA Oligonucleotides, RNA Oligonucleotides, Modified Oligonucleotides, Others), Application (Diagnostics, Research, Therapeutics, Forensics, Others), Distribution Channels (Direct Tender, Online Sales, Distributors, Retail Sales, Others), Technology (Solid-Phase Synthesis, Liquid-Phase Synthesis, Enzymatic Synthesis, PCR-based Synthesis, Others), Organization Size (Small, Medium, Large) and By North America â Historical & Forecast Period (2020-2035) Comprehensive Study 2025
Last Updated: 31-07-2025 | Format: PDF | Report ID:20504
North America Oligonucleotide CDMO Market Analysis and Forecast (2025–2035)
The North America oligonucleotide CDMO market is focused on providing contract development and manufacturing services for synthetic oligonucleotides, critical for the production of therapeutics, diagnostics, research, and academic applications. Oligonucleotides are short DNA or RNA molecules, and their synthesis underlies advanced molecular diagnostics, gene editing, and RNA therapies. CDMOs enable pharmaceutical and biotech firms to access specialized manufacturing capacity, expertise, and regulatory support essential for clinical and commercial scale-ups. Rapid advances in gene and cell therapies, CRISPR-based research, and personalized medicine are major growth drivers. Heightened adoption of nucleic acid-based drugs, rising therapeutic approvals, and technology innovation in synthetic chemistry are fueling market expansion. Regulatory scrutiny and supply chain resilience remain significant considerations, while market leaders invest in automation and digitalization to drive quality and efficiency.
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Latest Market Dynamics
Key Drivers
Rising adoption of nucleic acid therapeutics, including antisense oligonucleotides and siRNA drugs, is propelling demand for CDMO capabilities—exemplified by Sarepta Therapeutics expanding supply contracts for Duchenne muscular dystrophy drug production in 2025.
Growth in precision medicine initiatives is boosting demand for customized and pre-designed oligonucleotides. Thermo Fisher Scientific’s scaling of custom manufacturing facilities across North America highlights this trend.
Key Trends
Continuous technology upgrades in solid-phase and enzymatic synthesis methods, led by IDT and Agilent Technologies, are shortening production times and reducing costs.
Increasing integration of digital platforms for order management and quality tracking, as seen with Twist Bioscience’s enhanced e-commerce solutions in 2025, is streamlining customer experience and accelerating market penetration.
Key Opportunities
Expansion of therapeutic oligonucleotide pipelines, with companies like Biogen Inc. collaborating on new RNA-based therapies, is increasing CDMO service opportunities.
A growing interest in rapid diagnostics, particularly post-pandemic, is fueling demand for oligonucleotides in molecular assay development, with LGC Biosearch Technologies launching new diagnostic partnerships in 2025.
Key Challenges
Maintaining compliance with evolving regulatory standards is challenging as the FDA mandates stricter GMP environments for oligonucleotide manufacturing; Merck KGaA invested in compliance upgrades to mitigate this risk.
Capacity constraints and raw material shortages are putting pressure on production timelines; Kaneka Eurogentec has started ramping up its supply chain partnerships to address these challenges.
Key Restraints
High initial investment and operational costs for advanced synthesis technologies can restrain entry; new entrants like GeneDesign Inc. face steep infrastructure spending.
Complexities in scaling up from laboratory to commercial production without compromising quality or yield continue to hinder market growth, as evidenced by recent challenges faced by BioSpring GmbH.
North America Oligonucleotide CDMO Market Share by Type, 2025
Custom oligonucleotides hold the largest share in North America’s oligonucleotide CDMO market, reflecting the increased demand for tailor-made sequences across research and therapeutics. Pre-designed oligonucleotides and modified forms are also significant, driven by growth in genetic testing and advanced drug development. DNA and RNA oligonucleotides collectively make up a substantial segment due to their critical role in molecular biology, diagnostics, and mRNA vaccine production. Market focus has shifted towards more specialized and modified offerings, given their application in areas like gene editing (CRISPR) and rare disease therapies, highlighting the importance of flexibility and technical expertise in CDMO partnerships.
North America Oligonucleotide CDMO Market Share by Application, 2025
In 2025, diagnostics remain the leading application for oligonucleotide CDMOs in North America, making up over one-third of total demand. This is largely attributed to expanding molecular diagnostics for infectious disease and oncology. The therapeutics segment, closely following diagnostics, is fueled by ongoing innovation in RNA, antisense, and gene-editing drugs. Research applications (academic and commercial labs) also contribute substantially as high-throughput genetic analysis becomes standard across fields. The forensics sector, though smaller, is experiencing interest due to advanced DNA profiling techniques in legal and security domains. This distribution underscores the versatility of oligonucleotides and the sector’s responsiveness to medical and scientific advancements.
North America Oligonucleotide CDMO Market Revenue (2020–2035)
The market revenue for North America’s oligonucleotide CDMO sector continues its robust upward trajectory. In 2025, the revenue is projected to reach 2,450 Million USD, compared to 1,220 Million USD in 2020. The market is expected to surpass 7,200 Million USD by 2035, driven by a steady CAGR exceeding 11%. This acceleration is largely due to the expansion of gene and cell therapies, rising personalized medicine programs, and increasing collaborations between CDMOs and drug developers. Adoption of advanced synthesis technologies and an uptick in regulatory approvals for oligonucleotide drugs will continue to underpin growth across the forecast period.
North America Oligonucleotide CDMO Market YoY Growth Rate (2020–2035)
The year-on-year (YoY) growth rate of the North America oligonucleotide CDMO market illustrates strong momentum, peaking at approximately 12% between 2025 and 2027, then gradually stabilizing to around 8% by 2035. The growth rate is driven by surging investment in oligonucleotide-based therapeutics, continuous R&D funding, and expanding commercial applications. Periodic spikes align with breakthrough therapy approvals and expansion in clinical pipelines. The consistent double-digit growth in the latter part of the decade signifies persistent demand driven by new drug launches, academic research, and diagnostic test innovation.
North America Oligonucleotide CDMO Market Share by Region, 2025
The United States dominates the North American oligonucleotide CDMO market, accounting for 78% of market share in 2025, driven by a concentration of major biopharmaceutical companies, robust investment in R&D, and advanced healthcare infrastructure. Canada follows, making up 13% of the market, supported by expanding genomics research and government funding for biotech innovation. Mexico occupies 9%, with growing interest in contract manufacturing but lagging behind due to regulatory and infrastructure constraints. The disparate market shares highlight the importance of the US as a global hub for oligonucleotide development and innovation.
North America Oligonucleotide CDMO Market Player Share, 2025
Thermo Fisher Scientific and Integrated DNA Technologies (IDT) are the leading players—holding a combined 38% market share in 2025—through extensive portfolios and cutting-edge synthesis technologies. Agilent Technologies, Twist Bioscience, and Nitto Denko Avecia are notable challengers, leveraging expertise in automation, custom services, and regulatory compliance. Other participants such as LGC Biosearch Technologies, Bioneer Corporation, and BioSpring GmbH contribute to a fragmented competitive landscape, catering to niche and specialized segments such as modified oligonucleotides and high-throughput manufacturing. Market share concentration is expected to increase as large players pursue strategic acquisitions and capacity expansions.
North America Oligonucleotide CDMO Market Buyer Share, 2025
Pharmaceutical & biotech companies represent the largest buyer segment at 56%, reflecting the strong pipeline of oligonucleotide-based drugs. Academic & research institutions account for 28%, as universities and research hospitals accelerate genetic studies and clinical collaborations. Diagnostic laboratories contribute 12%, with increasing orders for molecular assays, while the remaining 4% is spread across forensics and contract research organizations. The dominance of pharma and biotech highlights the ongoing transformation in drug discovery and development driven by nucleic acid technologies.
June 2024: Thermo Fisher Scientific announced completion of a new oligonucleotide production facility in Carlsbad, CA, boosting capacity for gene therapy partners.
July 2024: Twist Bioscience launched a next-generation e-commerce platform enabling fully customized oligonucleotide orders with real-time QC updates.
August 2024: LGC Biosearch Technologies entered a strategic partnership with a major diagnostics company to co-develop molecular assay solutions for US labs.
September 2024: Agilent Technologies introduced an automated, high-capacity synthesizer system, improving scalability for research and commercial clients.
October 2024: Nitto Denko Avecia announced a $70 million investment to expand its Massachusetts facility, focusing on GMP-grade oligonucleotide manufacturing.
