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市場調查報告書
商品編碼
2101672

寡核苷酸 CDMO 市場機會、成長促進因素、產業趨勢分析及 2026-2035 年預測。

Oligonucleotide CDMO Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2026 - 2035
出版日期: | 出版商: Global Market Insights Inc. | 英文 154 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球寡核苷酸 CDMO 市場預計到 2025 年將達到 23 億美元，年複合成長率為 21.1%，到 2035 年將達到 157 億美元。

寡核苷酸CDMO市場-IMG1

寡核苷酸療法研發管線的快速擴張、製藥和生物技術公司對外包的依賴性日益增強、寡核苷酸合成和遞送技術的不斷進步以及對GMP生產基礎設施投資的增加，共同推動了市場成長。隨著越來越多的寡核苷酸療法進入臨床開發階段並獲得監管部門批准，臨床和商業生產對專業合約研發生產力機構（CDMO）的需求持續成長。寡核苷酸CDMO市場在為合成核酸藥物提供一體化開發、製程最佳化、分析支援和GMP生產服務方面發揮著至關重要的作用。隨著RNA療法的商業化程度不斷提高，對大規模生產能力、先進分析能力和符合監管要求的生產設施的需求也進一步成長。預計在整個預測期內，寡核苷酸藥物開發項目的持續擴展以及製藥企業外包傾向的增強將進一步鞏固對專業CDMO服務的長期需求。

市場範圍
開始年份 2025
預測期 2026-2035
起始金額 23億美元
預測金額 157億美元
複合年成長率 21.1%

預計到2025年，契約製造業務的銷售額將達到12億美元。該業務的成長主要得益於後期臨床試驗計畫對大規模GMP生產的需求，以及已獲得商業已通過核准的寡核苷酸療法的增加。製藥和生物技術公司持續將生產營運外包給專業的CDMO（合約研發生產機構），以最大限度地減少擴大內部生產所需的巨額資本投資，同時利用先進的生產技術、符合規範的生產設施和可擴展的商業化生產能力。

預計到2025年，反義寡核苷酸（ASO）市佔率將達到38.7%。其主導地位得益於已通過核准療法的持續擴展以及針對多種疾病領域的大量臨床階段候選藥物的研發管線。反義寡核苷酸研發投入的增加，以及商業化生產需求的不斷成長，正推動著該領域對專業開發、分析和GMP生產服務的持續需求。

預計到2025年，北美寡核苷酸CDMO市場將佔據51.7%的市場佔有率，並繼續保持主導地位。這一區域成長得益於高度發展的製藥和生物技術產業、先進的生產能力、完善的法規環境以及眾多專業CDMO企業的集中佈局。美國憑藉其廣泛的生物技術生態系統、不斷擴大的臨床開發活動以及眾多製藥公司和專業寡核苷酸CDMO服務供應商的存在，持續推動區域銷售成長。

目錄

第1章：調查方法和範圍

第2章執行摘要

第3章 行業洞察

  • 產業生態系分析
  • 影響產業的因素
    • 成長促進因素
      • 擴大已通過核准和處於後期臨床階段的寡核苷酸療法的產品線。
      • 製藥和生物技術公司擴大將寡核苷酸的開發和生產外包。
      • GalNAc結合技術與脂質奈米顆粒（LNP）遞送技術的進展
      • 罕見遺傳疾病的盛行率和診斷數量增加
    • 產業潛在風險與挑戰
      • 需要大量的資本投資和專門的生產基礎設施。
      • 嚴格的監管要求和複雜的品管流程
    • 市場機遇
      • 商業規模寡核苷酸生產規模的擴大
      • 對下一代RNA和基因編輯療法的需求日益成長
  • 成長潛力分析
  • 監理情勢
    • 北美洲
      • 美國
      • 加拿大
    • 歐洲
    • 亞太地區
    • 拉丁美洲
    • 中東和非洲
  • 技術與創新展望
    • 最新科技趨勢
    • 新興技術
  • 價格趨勢分析
  • 波特的分析
  • PESTLE分析
  • 投資與資金籌措分析
    • 寡核苷酸CDMO領域的創業投資與私募股權趨勢
    • 主要公司對擴大生產能力進行策略性投資
    • 政府和機構為核酸生產提供資金
  • 未來市場趨勢
  • 人工智慧和生成式人工智慧對市場的影響

第4章 競爭情勢

  • 介紹
  • 企業市佔率分析
    • 北美洲
    • 歐洲
    • 亞太地區
  • 企業矩陣分析
  • 主要市場公司的競爭分析
  • 競爭定位矩陣
  • 主要進展
    • 併購
    • 夥伴關係和聯盟
    • 新產品發布
    • 業務拓展計劃

第5章 市場估計與預測：依服務業分類，2022-2035年

  • 契約製造
  • 合約開發
  • 分析和品管服務
  • 監管和合規支持
  • 其他服務

第6章 市場估計與預測：依分子類型分類，2022-2035年

  • 反義寡核苷酸（ASO）
  • 小干擾RNA
  • 引導RNA
  • 適體
  • 其他分子類型

第7章 市場估計與預測：依應用領域分類，2022-2035年

  • 治療
  • 診斷
  • 研究

第8章 市場估算與預測：依最終用途分類，2022-2035年

  • 製藥和生物技術公司
  • 診斷檢查室
  • 學術和研究機構

第9章 市場估計與預測：依地區分類，2022-2035年

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 西班牙
    • 義大利
    • 荷蘭
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳洲
    • 韓國
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
  • 中東和非洲
    • 南非
    • 沙烏地阿拉伯
    • UAE

第10章：公司簡介

  • 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
簡介目錄
Product Code: 16294

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.

Oligonucleotide CDMO Market - IMG1

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.

Market Scope
Start Year2025
Forecast Year2026-2035
Start Value$2.3 Billion
Forecast Value$15.7 Billion
CAGR21.1%

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