Oligonucleotide CDMO Market Size & Share 2026-2035

Oligonucleotide CDMO Market Size

The global oligonucleotide CDMO market was valued at USD 2.3 billion in 2025. The market is expected to grow from USD 2.8 billion in 2026 to USD 15.7 billion by 2035, growing at a CAGR of 21.1% during the forecast period, according to the latest report published by Global Market Insights Inc. The market growth is primarily driven by the expanding pipeline of oligonucleotide therapeutics, increasing outsourcing of development and manufacturing activities by pharmaceutical and biotechnology companies, advancements in oligonucleotide synthesis and delivery technologies, and rising investments in GMP manufacturing capacity.

In addition, the increasing prevalence of rare genetic disorders, cancers, and other chronic diseases is supporting market growth. According to the Rare Genomics Institute, about 300 million people worldwide are affected by rare diseases. About 80% of these rare disorders are genetic in origin, and 95% of them do not have even one treatment approved by the FDA. Oligonucleotide therapeutics have demonstrated significant potential in treating diseases with limited therapeutic options by selectively targeting disease-causing genes.

To date, the FDA has approved 24 oligonucleotide-based therapies, and there are more than 150 oligonucleotides in various stages of drug discovery & development, while around 20+ oligonucleotide candidates are at the late-stage clinical development phase. With the growing approvals of oligonucleotide drugs and their advancements in late-stage clinical developments, pharma & biotech firms have been increasingly using specialized CDMOs for process development, analytics, GMP manufacturing, and large-scale manufacturing processes. This trend is expected to strengthen long-term outsourcing demand across both clinical and commercial manufacturing.

Oligonucleotide CDMOs deliver end-to-end contract development and manufacturing services for the development and GMP manufacture of synthetic nucleic acid medicines, such as antisense oligonucleotides (ASOs), small interfering RNA (siRNA), gRNA (guide RNA), aptamers, and other oligonucleotide modalities.

Between 2022 and 2024, the market witnessed robust growth, growing from USD 1.4 billion in 2022 to USD 2 billion in 2024. This growth is driven by increased clinical development activities in RNA therapies, regulatory approval of oligonucleotide drugs, and investment in manufacturing capacity building.

Major oligonucleotide CDMO market participants include Agilent Technologies, WuXi AppTec, Bachem Holding, ST Pharm, Thermo Fisher Scientific, and Lonza. These companies are strengthening their market positions through capacity expansion, investments in advanced oligonucleotide synthesis technologies, strategic collaborations with pharmaceutical and biotechnology companies, and the establishment of commercial-scale GMP manufacturing facilities to support the growing global pipeline of oligonucleotide therapeutics.

Oligonucleotide CDMO Market Trends

• A key trend shaping the oligonucleotide CDMO industry is the rapid expansion of the oligonucleotide therapeutics pipeline and increasing regulatory approvals of RNA therapeutics. The growing number of approved antisense oligonucleotides (ASOs) and siRNA therapies has significantly increased demand for GMP manufacturing, analytical testing, and commercial-scale production.
• Further, the oligonucleotide drug development pipeline is rapidly expanding, featuring over 600 candidates from more than 200 companies, including Novartis, Amgen, and Alnylam. These therapies target genetic diseases, cancers, and rare disorders using advanced mechanisms like RNA interference and antisense oligonucleotides. These large numbers of clinical trials and pipeline products reflect sustained demand for specialized CDMO services.
• The market is also witnessing significant investments in commercial-scale manufacturing capacity. Leading CDMOs including Agilent Technologies, Bachem, ST Pharm, Lonza, Thermo Fisher Scientific, and WuXi AppTec have announced facility expansions and technology investments to address growing clinical and commercial demand.
• For instance, in January 2023, Agilent Technologies announced a USD 725 million investment to double its therapeutic nucleic acid manufacturing capacity, representing one of the largest investments in the oligonucleotide CDMO industry. Similarly, WuXi STA, a subsidiary of WuXi AppTec, inaugurated a new 30,570 sq. ft. oligonucleotide and peptide manufacturing facility at its Changzhou campus. The expansion increased the company's capacity to four large-scale production lines and more than 20 small- and mid-scale production lines, with single synthesis capacity increasing from 1.9 mol to 6.0 mol, enabling larger commercial-scale manufacturing.
• These investments focus on increasing solid-phase synthesis capacity, purification capabilities, automation, and GMP manufacturing infrastructure to support late-stage and commercial oligonucleotide programs.
• Outsourcing has become a strategic priority for pharmaceutical and biotechnology companies. As oligonucleotide manufacturing requires specialized equipment, complex purification processes, and stringent GMP compliance, many developers are partnering with CDMOs rather than building in-house capabilities. This trend is particularly evident among emerging biotechnology companies seeking to accelerate clinical development while minimizing capital expenditure.
• The expanding application of oligonucleotides beyond rare diseases is further driving market growth. Initially focused on rare genetic disorders, oligonucleotide therapeutics are increasingly being investigated for oncology, cardiovascular diseases, metabolic disorders, ophthalmology, and infectious diseases. This diversification is broadening the customer base for CDMOs and increasing demand for both clinical and commercial manufacturing services.
• According to industry pipeline assessments, neurological disorders and rare diseases remain the leading therapeutic areas, while cardiometabolic and oncology pipelines continue to expand rapidly.

Oligonucleotide CDMO Market Analysis

Based on the services, the oligonucleotide CDMO market is classified into contract manufacturing, contract development, analytical & quality control services, regulatory & compliance support, and other services. The contract manufacturing dominated the market with revenue of USD 1.2 billion in 2025.

• The dominance of this segment is driven by the increasing number of late-stage clinical and commercial oligonucleotide therapeutics requiring large-scale GMP production.
• Pharmaceutical and biotechnology companies increasingly outsource manufacturing to specialized CDMOs to leverage advanced synthesis technologies, GMP-compliant facilities, and commercial-scale production capabilities while avoiding substantial capital investments.
• The growing number of regulatory approvals for antisense oligonucleotides (ASOs) and siRNA therapeutics has further increased demand for reliable commercial manufacturing partners with proven GMP expertise.
• In addition, continuous investments by leading CDMOs in capacity expansion, automation, and advanced purification technologies are enabling efficient large-scale production, reinforcing the segment's market leadership.
• On the other hand, the contract development segment held the second-largest market share of 30.1% in 2025, supported by the expanding pipeline of oligonucleotide therapeutics entering preclinical and clinical development.
• CDMOs provide process development, scale-up, formulation optimization, and analytical method development, enabling sponsors to accelerate timelines and improve manufacturing efficiency.
• Further, the regulatory and compliance support segment is expected to witness rapid growth during the forecast period.
• Increasing regulatory scrutiny for oligonucleotide therapeutics and evolving global GMP requirements are driving demand for specialized regulatory consulting, documentation, validation, and quality assurance services throughout the product development lifecycle.

Based on molecule type, the oligonucleotide CDMO market is segmented into antisense oligonucleotides (ASO), small interfering RNA, guide RNA, aptamers, and other oligonucleotide types. The antisense oligonucleotides (ASO) segment held a dominant market share of 38.7% in 2025.

• The antisense oligonucleotides (ASO) segment accounted for the largest share of the oligonucleotide CDMO market in 2025 owing to the increasing number of approved ASO therapeutics and a robust late-stage clinical pipeline targeting rare genetic, neurological, and metabolic disorders.
• For instance, of the 24 FDA- and/or EMA-approved nucleic acid drugs, 14 are ASO drugs, highlighting the commercial maturity of this modality.
• The continued expansion of ASO therapies for indications such as spinal muscular atrophy, Duchenne muscular dystrophy, transthyretin amyloidosis, and other rare genetic disorders have significantly increased demand for GMP manufacturing and commercial-scale production.
• In addition, the complexity of ASO synthesis, purification, and analytical characterization has encouraged pharmaceutical and biotechnology companies to outsource manufacturing to specialized CDMOs with proven expertise in large-scale oligonucleotide production and regulatory compliance.
• The small interfering RNA (siRNA) segment held the second-largest market share in 2025 with a revenue of USD 836.5 million and is expected to witness strong growth throughout the forecast period.
• The increasing commercial success of siRNA therapeutics, expanding clinical pipeline, and widespread adoption of GalNAc conjugation technology for targeted liver delivery are driving demand for specialized development and manufacturing services.
• On the other hand, the guide RNA (gRNA) segment is projected to register the fastest CAGR of 24.7% during the forecast period.
• The rapid advancement of CRISPR-based gene editing therapies and increasing clinical research in genome editing are significantly boosting demand for high-quality guide RNA manufacturing.
• Growing investments in gene editing platforms and the expanding number of CRISPR clinical programs are expected to accelerate outsourcing opportunities for oligonucleotide CDMOs specializing in guide RNA production.

Based on application, the oligonucleotide CDMO market is classified into therapeutics, diagnostics, and research. The therapeutics segment is expected to reach USD 13.5 billion by the end of the forecast period.

• The dominance of the therapeutics segment is driven by the growing commercialization of oligonucleotide-based drugs, including antisense oligonucleotides (ASOs), small interfering RNA (siRNA), and guide RNA (gRNA) therapeutics for rare genetic disorders, oncology, and metabolic diseases.
• The increasing number of approved oligonucleotide therapeutics and a robust late-stage clinical pipeline are driving demand for GMP development and commercial manufacturing services offered by specialized CDMOs.
• Rising adoption of precision medicine and targeted therapies is encouraging pharmaceutical and biotechnology companies to invest in RNA-based drug development, further strengthening the therapeutics segment.
• The diagnostics segment held a market share of 14.5% in 2025. Growth of this segment is driven by the increasing use of oligonucleotides as primers, probes, and molecular detection reagents in PCR, qPCR, next-generation sequencing (NGS), and other molecular diagnostic assays.
• The rising adoption of precision diagnostics, companion diagnostics, and genetic testing is increasing demand for high-quality custom oligonucleotides.
• In addition, the growing prevalence of infectious diseases, cancer, and inherited genetic disorders has accelerated the development of molecular diagnostic assays, encouraging diagnostic companies to outsource oligonucleotide development and GMP manufacturing to specialized CDMOs.

Based on end use, the oligonucleotide CDMO market is classified into pharmaceutical & biotechnology companies, diagnostic laboratories, and academic & research institutions. The pharmaceutical & biotechnology companies segment dominated the market in 2025 and is anticipated to grow at a CAGR of 21.3% over the analysis timeframe.

• High segmental growth can be attributed to the increasing trend of outsourcing by pharmaceutical companies. These companies rely on CDMOs to access specialized expertise and infrastructure for the development and production of peptides and oligonucleotides.
• Secondly, outsourcing provides flexibility and scalability, allowing pharmaceutical companies to adjust their production capacity quickly in response to changing market demands without the need for significant investments in new facilities or equipment.
• Additionally, working with CDMOs helps pharmaceutical companies accelerate their development timelines and reduce costs. All these factors make pharmaceutical companies key end-users of CDMO services.

North America Oligonucleotide CDMO Market

The North America market dominated the global market in 2025 with a market share of 51.7%.

• The region's leadership is attributed to its well-established pharmaceutical and biotechnology industry, strong regulatory framework, advanced manufacturing infrastructure, and high concentration of leading oligonucleotide CDMOs.
• The U.S. continues to dominate the regional market owing to its robust biotechnology ecosystem, strong clinical pipeline, and the presence of leading pharmaceutical companies and specialized CDMOs.
• The U.S. oligonucleotide CDMO market was valued at USD 662.6 million and USD 782.7 million in 2022 and 2023, respectively. The market size reached USD 1.1 billion in 2025, growing from USD 929.4 million in 2024.
• The U.S. serves as the global hub for RNA therapeutics and oligonucleotide drug development, supported by leading biotechnology clusters, extensive venture capital funding, and strong NIH research investments.
• According to the National Institutes of Health (NIH), the agency operated with a nearly USD 48 billion budget in FY2024, investing the majority of its funding in biomedical research through extramural grants and intramural programs. This funding supports scientific advances across key areas including genomics, RNA therapeutics, rare diseases, cancer, neuroscience, and precision medicine.
• Similarly, large-scale investments by leading pharma manufacturers further support market demand.
• The region also benefits from a growing number of regulatory approvals for oligonucleotide therapeutics, driving demand for GMP development and commercial manufacturing.

Europe Oligonucleotide CDMO Market

The Europe oligonucleotide CDMO industry accounted for a significant share of the global market in 2025.

• Europe benefits from a mature pharmaceutical manufacturing industry, strong regulatory oversight, and extensive research collaborations between academia and industry.
• The region is home to several leading oligonucleotide CDMOs, including Bachem, Lonza, BioSpring, Kaneka Eurogentec, and CordenPharma, supporting both clinical and commercial manufacturing.
• Increasing investments in RNA therapeutics, precision medicine, and rare disease research continue to strengthen regional demand for specialized CDMO services.
• For instance, Bachem is investing in a new large-scale production site in Sisseln, Switzerland, dedicated to expanding peptide and oligonucleotide manufacturing capacity to meet growing commercial demand.
• Germany represents one of the largest markets in Europe owing to its advanced life sciences industry, strong biotechnology sector, and significant investments in nucleic acid therapeutics manufacturing.
• Switzerland also plays a critical role through the presence of globally recognized CDMOs such as Bachem and Lonza, which continue to expand GMP manufacturing capacity for oligonucleotide therapeutics.

Asia Pacific Oligonucleotide CDMO Market

The Asia Pacific oligonucleotide CDMO industry is anticipated to register the fastest CAGR during the forecast period.

• Rapid expansion of the pharmaceutical and biotechnology industries, lower manufacturing costs, increasing clinical research, and supportive government initiatives are driving regional growth.
• Countries across the region are investing heavily in advanced biologics and nucleic acid manufacturing infrastructure while strengthening regulatory capabilities.
• China dominates the Asia Pacific market owing to its rapidly expanding CRDMO industry, large-scale manufacturing capabilities, and strong government support for biotechnology innovation.
• According to China's National Medical Products Administration, regulatory reforms and accelerated review pathways have significantly improved approval timelines for innovative therapeutics, encouraging investment in RNA-based medicines.
• Leading companies such as WuXi AppTec, Asymchem, and Hongene Biotech continue to expand commercial oligonucleotide manufacturing capacity to support growing global outsourcing demand.

Latin America Oligonucleotide CDMO Market

The Latin America oligonucleotide CDMO industry is expected to witness steady growth during the forecast period.

• Growth is supported by expanding pharmaceutical manufacturing capabilities, improving healthcare infrastructure, and increasing adoption of precision medicine.
• Rising participation in international clinical trials and increasing government investment in biotechnology research are expected to support future demand for oligonucleotide development and manufacturing services.
• Brazil remains the largest market in the region owing to its well-established pharmaceutical industry and growing biotechnology ecosystem.

Middle East & Africa Oligonucleotide CDMO Market

The Middle East & Africa oligonucleotide CDMO industry is projected to experience gradual growth over the forecast period.

• Increasing investment in healthcare infrastructure, biotechnology research, and genomic medicine are supporting regional market expansion.
• Governments across the region are implementing national genomics and precision medicine initiatives, creating opportunities for RNA-based therapeutics and specialized manufacturing services.
• Growing collaborations with international pharmaceutical companies and increasing adoption of advanced therapeutics are expected to support long-term demand for oligonucleotide CDMO services across the region.

Oligonucleotide CDMO Market Share

The competitive landscape of the oligonucleotide CDMO industry is characterized by strong competition among specialized oligonucleotide manufacturers, global CDMOs, and integrated contract research, development, and manufacturing organizations (CRDMOs). Leading companies such as Agilent Technologies, WuXi AppTec, Bachem Holding, ST Pharm, Thermo Fisher Scientific, and Lonza collectively account for approximately 45–50% of the global market. These companies continue to strengthen their market positions through investments in GMP manufacturing capacity, advanced oligonucleotide synthesis technologies, automation, and analytical capabilities to support the growing clinical and commercial demand for RNA therapeutics.

The market is also witnessing strategic capacity expansions, technology collaborations, and long-term manufacturing agreements between CDMOs and pharmaceutical and biotechnology companies to support the rapidly expanding pipeline of antisense oligonucleotides (ASOs), siRNA, guide RNA, and other nucleic acid therapeutics. In addition, regional players are expanding their manufacturing capabilities and global footprint to capitalize on increasing outsourcing demand. This highly competitive landscape, supported by continuous investments in commercial-scale production, advanced purification technologies, and regulatory expertise, is expected to drive innovation and sustained growth in the market.

Oligonucleotide CDMO Market Companies

Prominent players operating in the oligonucleotide CDMO industry are as mentioned below:

• Agilent Technologies
• Ajinomoto Bio-Pharma Services
• Asymchem Laboratories (Tianjin)
• Aurigene Pharmaceutical Services
• Axolabs
• Bachem Holding
• BioSpring
• CordenPharma
• CPC Scientific
• Eurofins Scientific
• GenScript Biotech
• Hongene Biotech
• Kaneka Eurogentec
• Lonza Group
• PolyPeptide Group
• ST Pharm
• Thermo Fisher Scientific
• TriLink BioTechnologies
• WuXi AppTec

• Agilent Technologies

Agilent Technologies is a leading player in the oligonucleotide CDMO market, with an estimated market share of ~10–12%. Through its Nucleic Acid Solutions business, the company offers end-to-end contract development and GMP manufacturing services for therapeutic oligonucleotides, including antisense oligonucleotides (ASOs), siRNA, and guide RNA. Agilent strengthened its competitive position by announcing a USD 725 million investment to expand its nucleic acid therapeutics manufacturing capacity, enabling it to support the growing global demand for clinical and commercial RNA-based therapeutics.

• Bachem Holding

Bachem Holding is one of the leading global CDMOs specializing in peptide and oligonucleotide manufacturing. The company has established a strong competitive position through its extensive expertise in large-scale GMP oligonucleotide synthesis, advanced purification technologies, and regulatory compliance. Bachem continues to strengthen its market presence through significant capacity expansion projects, including its new manufacturing site in Sisseln, Switzerland, allowing the company to meet the growing commercial demand for oligonucleotide therapeutics and support pharmaceutical and biotechnology companies throughout the product lifecycle.

Oligonucleotide CDMO Industry News:

• In July 2024, CordenPharma announced an investment of EUR 900 million (approximately USD 1.06 billion) to expand its peptide platform across its Colorado, U.S., facility and European operations, further strengthening its capabilities for complex modalities, including oligonucleotides.
• In April 2024, ST Pharm announced an investment of approximately USD 110 million to expand its Oligo Plant 2 in South Korea. The expansion aims to increase GMP manufacturing capacity for antisense oligonucleotides (ASOs), siRNA, and CRISPR guide RNA (sgRNA) while incorporating advanced automation and process analytical technologies.
• In February 2023, Ajinomoto Bio-Pharma Services announced the successful development of a proprietary ancestral RNA ligase enzyme designed to significantly improve the productivity and efficiency of double-stranded oligonucleotide manufacturing, strengthening its oligonucleotide CDMO capabilities.
• In January 2023, Agilent Technologies announced an investment of approximately USD 725 million to double its therapeutic nucleic acid manufacturing capacity at its Frederick, Colorado facility. The expansion includes two new GMP manufacturing lines to support the growing demand for antisense oligonucleotides (ASOs), siRNA, and CRISPR guide RNA therapeutics.

The oligonucleotide CDMO market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2022 - 2035 for the following segments:

Click here to Buy Section of this Report

Market, By Services

• Contract manufacturing
• Contract development
• Analytical & quality control services
• Regulatory & compliance support
• Other services

Market, By Molecule Type

• Antisense oligonucleotides (ASO)
• Small interfering RNA
• Guide RNA
• Aptamers
• Other oligonucleotide types

Market, By Application

• Therapeutics
• Diagnostics
• Research

Market, By End Use

• Pharmaceutical & biotechnology companies
• Diagnostic laboratories
• Academic & research institutions

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Africa
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE