올리고뉴클레오티드 CDMO 시장 기회, 성장 촉진요인, 업계 동향 분석 및 예측(2026-2035년)

The Global Oligonucleotide CDMO Market was valued at USD 2.3 billion in 2025 and is estimated to grow at a CAGR of 21.1% to reach USD 15.7 billion by 2035.

Market growth is being fueled by the rapid expansion of oligonucleotide-based therapeutic pipelines, increasing reliance on outsourcing by pharmaceutical and biotechnology companies, continuous advancements in oligonucleotide synthesis and delivery technologies, and growing investments in GMP manufacturing infrastructure. As more oligonucleotide therapies advance through clinical development and receive regulatory approvals, demand for specialized contract development and manufacturing organizations continues to rise across both clinical and commercial production. The oligonucleotide CDMO market plays a critical role by providing integrated development, process optimization, analytical support, and GMP manufacturing services for synthetic nucleic acid medicines. Increasing commercialization of RNA-based therapeutics is further accelerating the need for large-scale manufacturing capacity, advanced analytical capabilities, and regulatory-compliant production facilities. The continued expansion of oligonucleotide drug development programs and growing outsourcing preferences among pharmaceutical manufacturers are expected to reinforce long-term demand for specialized CDMO services throughout the forecast period.

The contract manufacturing segment generated USD 1.2 billion in 2025. Segment growth is supported by the increasing number of late-stage clinical programs and commercially approved oligonucleotide therapies requiring large-scale GMP production. Pharmaceutical and biotechnology companies continue to outsource manufacturing activities to specialized CDMOs to gain access to advanced production technologies, regulatory-compliant manufacturing facilities, and scalable commercial capabilities while minimizing significant capital expenditures associated with in-house manufacturing expansion.

The antisense oligonucleotides (ASO) segment held 38.7% share in 2025. Its leading position is supported by the continued expansion of approved therapies and a strong pipeline of clinical-stage drug candidates targeting multiple disease areas. Growing investment in antisense oligonucleotide research, combined with increasing commercial manufacturing requirements, continues to strengthen demand for specialized development, analytical, and GMP manufacturing services across this segment.

North America Oligonucleotide CDMO Market accounted for 51.7% share in 2025, maintaining its position as the leading regional market. Regional growth is supported by a highly developed pharmaceutical and biotechnology industry, advanced manufacturing capabilities, a well-established regulatory environment, and a strong concentration of specialized contract development and manufacturing organizations. The United States continues to dominate regional revenue due to its extensive biotechnology ecosystem, expanding clinical development activities, and the presence of numerous pharmaceutical companies and dedicated oligonucleotide CDMO service providers.

Major companies operating in the global oligonucleotide CDMO market include Lonza Group, Thermo Fisher Scientific, WuXi AppTec, ST Pharm, Agilent Technologies, Kaneka Eurogentec, PolyPeptide Group, Eurofins Scientific, GenScript Biotech, CordenPharma, Ajinomoto Bio-Pharma Services, Axolabs, Hongene Biotech, BioSpring, CPC Scientific, Bachem Holding, Aurigene Pharmaceutical Services, Asymchem Laboratories (Tianjin), and TriLink BioTechnologies. Companies operating in the oligonucleotide CDMO market are strengthening their market position by expanding GMP manufacturing capacity, investing in advanced synthesis technologies, and enhancing end-to-end development capabilities to support growing customer requirements. Many organizations are increasing investments in research and process optimization to improve manufacturing efficiency, product quality, and scalability for clinical and commercial production. Strategic collaborations with pharmaceutical and biotechnology companies continue to play an important role in securing long-term manufacturing agreements and expanding project pipelines. Companies are also pursuing geographic expansion through new production facilities, capacity additions, and acquisitions to improve global service capabilities.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Research approach
• 1.2 Quality commitments
  • 1.2.1 GMI AI policy & data integrity commitment
    • 1.2.1.1 Source consistency protocol
• 1.3 Research trail & confidence scoring
  • 1.3.1 Research trail components
  • 1.3.2 Scoring components
• 1.4 Data collection
  • 1.4.1 Partial list of primary sources
• 1.5 Data mining sources
  • 1.5.1 Paid sources
    • 1.5.1.1 Sources, by region
• 1.6 Base estimates and calculations
  • 1.6.1 Base year calculation for any one approach
• 1.7 Market estimates & forecasts parameters
• 1.8 Forecast model
  • 1.8.1 Quantified market impact analysis
    • 1.8.1.1 Mathematical impact of growth parameters on forecast
• 1.9 Research transparency addendum
  • 1.9.1 Source attribution framework
  • 1.9.2 Quality assurance metrics
  • 1.9.3 Our commitment to trust

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Services trends
  • 2.2.3 Molecule type trends
  • 2.2.4 Application trends
  • 2.2.5 End use trends
• 2.3 CXO perspectives: Strategic imperatives

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Expanding pipeline of approved and late-stage oligonucleotide therapeutics
    • 3.2.1.2 Increasing outsourcing of oligonucleotide development and manufacturing by pharmaceutical and biotechnology companies
    • 3.2.1.3 Advancements in GalNAc conjugation and lipid nanoparticle (LNP) delivery technologies
    • 3.2.1.4 Rising prevalence and diagnosis of rare genetic disorders
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High capital investment and specialized manufacturing infrastructure requirements
    • 3.2.2.2 Stringent regulatory requirements and complex quality control processes
  • 3.2.3 Market opportunities
    • 3.2.3.1 Expansion of commercial-scale oligonucleotide manufacturing
    • 3.2.3.2 Growing demand for next-generation RNA and gene editing therapeutics
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
    • 3.4.1.1 U.S.
    • 3.4.1.2 Canada
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technology and innovation landscape
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 3.6 Pricing trend analysis (Driven by Primary Research)
• 3.7 Porter's analysis
• 3.8 PESTEL analysis
• 3.9 Investment & funding analysis
  • 3.9.1 Venture capital & private equity trends in oligonucleotide CDMOs
  • 3.9.2 Strategic capacity expansion investments by key players
  • 3.9.3 Government & institutional funding for nucleic acid manufacturing
• 3.10 Future market trends
• 3.11 Impact of AI & Generative AI on the market

Chapter 4 Competitive Landscape, 2025

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 North America
  • 4.2.2 Europe
  • 4.2.3 Asia Pacific
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Merger and acquisition
  • 4.6.2 Partnership and collaboration
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Services, 2022 - 2035 ($ Mn)

• 5.1 Key trends
• 5.2 Contract manufacturing
• 5.3 Contract development
• 5.4 Analytical & quality control services
• 5.5 Regulatory & compliance support
• 5.6 Other services

Chapter 6 Market Estimates and Forecast, By Molecule Type, 2022 - 2035 ($ Mn)

• 6.1 Key trends
• 6.2 Antisense oligonucleotides (ASO)
• 6.3 Small interfering RNA
• 6.4 Guide RNA
• 6.5 Aptamers
• 6.6 Other molecule types

Chapter 7 Market Estimates and Forecast, By Application, 2022 - 2035 ($ Mn)

• 7.1 Key trends
• 7.2 Therapeutics
• 7.3 Diagnostics
• 7.4 Research

Chapter 8 Market Estimates and Forecast, By End Use, 2022 - 2035 ($ Mn)

• 8.1 Key trends
• 8.2 Pharmaceutical & biotechnology companies
• 8.3 Diagnostic laboratories
• 8.4 Academic & research institutions

Chapter 9 Market Estimates and Forecast, By Region, 2022 - 2035 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 India
  • 9.4.3 Japan
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Agilent Technologies
• 10.2 Ajinomoto Bio-Pharma Services
• 10.3 Asymchem Laboratories (Tianjin)
• 10.4 Aurigene Pharmaceutical Services
• 10.5 Axolabs
• 10.6 Bachem Holding
• 10.7 BioSpring
• 10.8 CordenPharma
• 10.9 CPC Scientific
• 10.10 Eurofins Scientific
• 10.11 GenScript Biotech
• 10.12 Hongene Biotech
• 10.13 Kaneka Eurogentec
• 10.14 Lonza Group
• 10.15 PolyPeptide Group
• 10.16 ST Pharm
• 10.17 Thermo Fisher Scientific
• 10.18 TriLink BioTechnologies
• 10.19 WuXi AppTec