올리고뉴클레오티드 CDMO 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the oligonucleotide CDMO market size was valued at USD 3.02 billion in 2025 and is estimated to grow from USD 3.68 billion in 2026 to reach USD 9.87 billion by 2031, at a CAGR of 21.81% during the forecast period (2026-2031).

This report is Segmented by Service Type (Contract Manufacturing, Contract Development, Quality Control, Regulatory Support), Oligonucleotide Type (ASO, Sirna, GRNA, Aptamers, Others), Application (Therapeutic, Research, Diagnostic, Others), End User (Pharma, Biotech, Diagnostics, Academic, Gene Therapy, Others), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Forecasts in Value (USD).

Global Oligonucleotide CDMO Market Trends and Insights

Expanding Clinical Pipelines For RNA-Targeted Medicines

By mid-2026, over 200 organizations were contributing to the global oligonucleotide clinical pipeline, offering a broad customer base for the oligonucleotide CDMO market. Every IND-stage and late-stage program requires GMP material before approval and commercialization. The pipeline is shifting toward larger cardiometabolic opportunities, increasing batch sizes and adding pressure on commercial supply planning. Traditional synthesis setups are not designed for kilogram-to-tonne level demands for chronic conditions, leading sponsors to reserve capacity well in advance, tightening global GMP slot availability. Pipeline quality, timing, and volume are now critical factors shaping commercial contracts alongside scientific readiness.

Outsourcing Shift For Complex Oligonucleotide Synthesis And Fill-Finish

Challenges in managing complex oligonucleotide synthesis internally are driving an outsourcing trend. Manufacturing GalNAc-conjugated siRNA requires precise control across multiple stages, each adding technical complexity. By the first half of 2025, WuXi AppTec's TIDES platform supported 69 molecules for API and drug product services, more than doubling its count from two years earlier. The fill-finish step is becoming crucial as products transition to subcutaneous and prefilled formats, requiring sterile capacities beyond API synthesis. Asymchem's TJ4 facility, with an annual output of 45 million pre-filled syringe units in 2026, highlights the market's shift toward integrated API-to-drug-product solutions, raising entry barriers for smaller providers.

High Process Complexity And Yield Sensitivity In Long-Chain Oligonucleotides

The oligonucleotide CDMO market faces significant technical challenges due to the stepwise synthesis process, where one nucleotide is added at a time. For example, a 20-mer ASO undergoes at least 20 coupling cycles, and even minor efficiency losses at each step can lead to a noticeable drop in full-length yield. The complexity increases with modifications like phosphorothioate backbones, 2'-fluoro substitutions, or GalNAc ligands, which introduce side reactions and analytical difficulties. Providers transitioning from peptides or small molecules often underestimate transfer timelines, impurity management, and batch failure risks, resulting in slower capacity ramp-up despite strong demand. This explains why commercial supply remains concentrated among experienced companies with established operational histories.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Demand For Precision Medicine And Rare-Disease Programs
2. Scale-Up Pressure From Dual-Route Manufacturing, Clinical And GMP
3. Stringent Purity, Impurity, And Potency Control Requirements

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, Contract Manufacturing held 51.68% of the oligonucleotide CDMO market share, reflecting the industry's reliance on GMP production for approved products and late-stage clinical programs. As sponsors advance into Phase 2, Phase 3, and launch preparation, the market prioritizes assured scale over exploratory support. Bachem's Building K in Bubendorf began GMP commercial production ramp-up in 2026, adding kilogram-scale supply to the European network. ST Pharm's USD 126 million capacity expansion, targeting 14 moles annually, highlights the growing importance of commercial manufacturing as a core differentiator. Revenue remains anchored by companies capable of consistent GMP-quality production at scales sufficient for launch planning.

Contract Development is the fastest-growing segment in the oligonucleotide CDMO market, with a 22.90% CAGR projected through 2031. Sponsors increasingly seek seamless process design transitions from early development to commercial readiness, especially for programs with modified backbones or emerging chemistries. Impurity control, process transfer, and analytical expectations now require attention well before pivotal studies. Analytical and Quality Control Services, though smaller in revenue, are becoming integral to development as release strategies impact manufacturability and regulatory timelines. Regulatory and CMC Support Services are also gaining traction as sponsors prefer single partners to streamline process work and quality packages.

In 2025, Antisense Oligonucleotides (ASOs) accounted for 58.23% of the oligonucleotide CDMO market, driven by demand in central nervous system, hepatic, and cardiometabolic indications. Ionis maintained a 12-candidate neurology pipeline in 2026, underscoring the strong outsourcing demand tied to ASOs. Established chemistry simplifies processes but still requires experienced CDMOs for transfer, scale-up, and validation, keeping ASOs as the largest revenue contributor despite growing interest in newer modalities.

Small Interfering RNA (siRNA) is the fastest-growing oligonucleotide type, with a 23.25% CAGR projected through 2031. This growth is fueled by expanding commercial portfolios and advancing late-stage pipelines. Alnylam's commercial footprint and Arrowhead's Phase 3 progress in cardiometabolic diseases are driving siRNA-oriented manufacturing needs. Guide RNA and aptamers, though smaller categories, are gaining relevance as gene editing programs advance. Other oligonucleotide types, such as PMOs and splice-switching formats, remain niche but commercially viable for specialized providers. The market is diversifying, even as ASOs continue to dominate revenue.

Complete Report Scope:

• By Service Type
  • Contract Manufacturing
  • Clinical Stage
  • Commercial Stage
  • Contract Development
  • Analytical and Quality Control Services
  • Regulatory and CMC Support Services
• By Oligonucleotide Type
  • Antisense Oligonucleotides
  • Small Interfering RNA
  • Guide RNA
  • Aptamers
  • Other Oligonucleotide Types
• By Application
  • Therapeutic Applications
  • Rare Diseases
  • Oncology
  • Neurology
  • Cardiometabolic Diseases
  • Infectious Diseases
  • Research Applications
  • Diagnostic Applications
  • Others
• By End User
  • Pharmaceutical and Biotechnology Companies
  • Diagnostic Companies
  • Academic and Research Institutes
  • Gene Therapy and Cell Therapy Developers
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

In 2025, North America held a 39.55% share of the oligonucleotide CDMO market, driven by a concentration of RNA-targeted drug developers and established GMP sites in the U.S. and Canada. Companies like Alnylam, Ionis, Arrowhead, and Wave Life Sciences, along with manufacturing leaders such as Agilent and Thermo Fisher Scientific, anchor the region's market. Agilent's 2026 launch of Agilent Advanced Therapeutics, integrating BIOVECTRA in Canada and Nucleic Acid Solutions in Colorado, strengthened North America's CDMO offerings. Familiarity with FDA regulations and long GMP track records make the region a preferred partner for NDA-enabling and launch-related supplies. However, its lead may narrow as global capacities expand and delivery time advantages diminish.

Europe remains a key technical hub in the oligonucleotide CDMO market, led by Germany and Switzerland with high-purity API manufacturing and sustained capital investments. BioSpring's EUR 100 million investment in a new nucleic acid API facility in Offenbach, spanning 15,200 m2, is set for completion by late 2027. Bachem invested CHF 332.6 million in 2025, advancing Building K to commercial production in 2026, with over CHF 400 million in additional 2026 CapEx planned. Lonza, projecting 11-12% sales growth for 2026, continues to enhance advanced synthesis and antibody-oligonucleotide conjugate capabilities at its Oss site in the Netherlands. Europe's strength lies in its technical expertise, regulatory rigor, and ability to meet stringent quality demands.

Asia-Pacific is the fastest-growing region in the oligonucleotide CDMO market, with a 24.56% CAGR projected through 2031, driven by capacity expansions in China, South Korea, and Japan. Asymchem's TJ4 facility in Tianjin, launched in 2026, offers 180 mol per year of oligonucleotide capacity with advanced processing tools and an integrated drug product facility. WuXi AppTec's API sites in Changzhou and Taixing passed FDA inspections in 2025, ensuring continued U.S. supply. Japan's Nippon Shokubai is expanding GMP-compliant nucleic acid API capacity tenfold. South America and the Middle East & Africa remain emerging markets, primarily relying on imports from North America, Europe, and Asia-Pacific hubs.

1. Agilent Technologies
2. Ajinomoto Co., Inc.
3. Almac Group Limited
4. Asymchem Laboratories (Tianjin) Co., Ltd.
5. Bachem Holding
6. BioSpring GmbH
7. Corden Pharma International
8. Curia Global, Inc.
9. Danaher
10. EUROAPI S.A.
11. Eurofins
12. Genscript
13. Kaneka
14. Lonza Group
15. Maravai LifeSciences Holdings, Inc.
16. Merck
17. PolyPeptide Group AG
18. ST Pharm Co., Ltd.
19. Syngene International
20. Thermo Fisher Scientific
21. WuXi AppTec Co., Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expanding Clinical Pipelines for RNA-Targeted Medicines
  • 4.2.2 Outsourcing Shift for Complex Oligonucleotide Synthesis and Fill-Finish
  • 4.2.3 Rising Demand for Precision Medicine and Rare-Disease Programs
  • 4.2.4 Scale-Up Pressure From Dual-Route Manufacturing, Clinical and Commercial
  • 4.2.5 Analytical Release Burden for Modified and Conjugated Oligomers
  • 4.2.6 Supply Localization for Nucleoside, Phosphoramidite, and Specialty Raw Materials
• 4.3 Market Restraints
  • 4.3.1 High Process Complexity and Yield Sensitivity in Long-Chain Oligo Synthesis
  • 4.3.2 Stringent Purity, Impurity, and Potency Control Requirements
  • 4.3.3 Limited Availability of Specialized Talent and Qualified GMP Capacity
  • 4.3.4 Raw-Material Dependency and Batch-Level Supply Volatility
• 4.4 Supply/Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value, USD)

• 5.1 By Service Type
  • 5.1.1 Contract Manufacturing
  • 5.1.2 Clinical Stage
  • 5.1.3 Commercial Stage
  • 5.1.4 Contract Development
  • 5.1.5 Analytical and Quality Control Services
  • 5.1.6 Regulatory and CMC Support Services
• 5.2 By Oligonucleotide Type
  • 5.2.1 Antisense Oligonucleotides
  • 5.2.2 Small Interfering RNA
  • 5.2.3 Guide RNA
  • 5.2.4 Aptamers
  • 5.2.5 Other Oligonucleotide Types
• 5.3 By Application
  • 5.3.1 Therapeutic Applications
  • 5.3.2 Rare Diseases
  • 5.3.3 Oncology
  • 5.3.4 Neurology
  • 5.3.5 Cardiometabolic Diseases
  • 5.3.6 Infectious Diseases
  • 5.3.7 Research Applications
  • 5.3.8 Diagnostic Applications
  • 5.3.9 Others
• 5.4 By End User
  • 5.4.1 Pharmaceutical and Biotechnology Companies
  • 5.4.2 Diagnostic Companies
  • 5.4.3 Academic and Research Institutes
  • 5.4.4 Gene Therapy and Cell Therapy Developers
  • 5.4.5 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Agilent Technologies, Inc.
  • 6.3.2 Ajinomoto Co., Inc.
  • 6.3.3 Almac Group Limited
  • 6.3.4 Asymchem Laboratories (Tianjin) Co., Ltd.
  • 6.3.5 Bachem Holding AG
  • 6.3.6 BioSpring GmbH
  • 6.3.7 CordenPharma International
  • 6.3.8 Curia Global, Inc.
  • 6.3.9 Danaher Corporation
  • 6.3.10 EUROAPI S.A.
  • 6.3.11 Eurofins Scientific SE
  • 6.3.12 GenScript Biotech Corporation
  • 6.3.13 Kaneka Corporation
  • 6.3.14 Lonza Group Ltd
  • 6.3.15 Maravai LifeSciences Holdings, Inc.
  • 6.3.16 Merck KGaA
  • 6.3.17 PolyPeptide Group AG
  • 6.3.18 ST Pharm Co., Ltd.
  • 6.3.19 Syngene International Limited
  • 6.3.20 Thermo Fisher Scientific Inc.
  • 6.3.21 WuXi AppTec Co., Ltd.

7 Market Opportunities and Future Outlook

• 7.1 White-space and Unmet-Need Assessment