핵산 치료제 CDMO 시장 : 치료제 유형, 서비스 유형, 치료 용도, 최종사용자별 - 세계 예측(2025-2030년)

The Nucleic Acid Therapeutics CDMO Market was valued at USD 10.77 billion in 2024 and is projected to grow to USD 12.00 billion in 2025, with a CAGR of 11.42%, reaching USD 20.62 billion by 2030.

Nucleic acid therapeutics have emerged as transformative modalities redefining modern medicine. The landscape of contract development and manufacturing organizations (CDMOs) is rapidly evolving to meet the rigorous standards set by advanced gene therapies and revolutionary treatments. Recent scientific breakthroughs, combined with an expanding regulatory framework, have driven both innovation and an urgent need for specialized manufacturing services. The integration of robust analytical testing, precision quality control, and custom manufacturing solutions has enabled these organizations to support the complex demands of DNA- and RNA-based therapies.

Furthermore, the expansion of therapeutic applications across genetic disorders, infectious diseases, and oncology demonstrates a keen intersection between research breakthroughs and clinical needs. This market narrative not only highlights the importance of collaborative partnerships across academia, biotechnology, and pharmaceutical industries but also underscores the significance of adapting traditional manufacturing methodologies to handle novel biotherapeutic molecules. As market fundamentals shift, decision-makers are examining opportunities to leverage new technologies and optimize production efficiency.

The evolution of nucleic acid therapeutics presents both challenges and substantial opportunities. With increasing demands for precision, scalability, and rapid innovation, CDMOs are positioned uniquely at the confluence of scientific creativity and production expertise. This comprehensive exploration sets the stage for in-depth insights into market segmentation, regional dynamics, and the influence of key industry players, providing an authoritative overview structured to support strategic decision-making.

Transformative Shifts Reshaping the Nucleic Acid Therapeutics Landscape

The nucleic acid therapeutics market is experiencing dramatic shifts driven by scientific innovation, digital transformation, and evolving regulatory environments. Traditional drug development paradigms are being redefined by agile manufacturing processes and integrated technology solutions. The accelerating pace of RNA and DNA therapeutic discovery has necessitated new production methodologies that can deliver products with both high efficacy and reliability.

Stakeholders are witnessing a transition from conventional small molecule production to more nuanced biological manufacturing strategies. This transformation is characterized by the adoption of advanced analytical platforms and enhanced process control systems that ensure precise quality control. Moreover, the rapid expansion of therapeutic modalities, including gene editing and messenger RNA technologies, has driven demand for agile and robust manufacturing partnerships capable of scaling production swiftly while maintaining regulatory compliance.

Simultaneously, the marketplace is embracing the digital transformation of research and production methods. Cloud-based data analytics and real-time monitoring are being integrated into production workflows, enabling proactive adjustments and continuous improvement. These changes are propelling the sector to greater heights by significantly reducing time-to-market and overcoming some of the traditional bottlenecks inherent in biologics manufacturing.

Collectively, these factors are redefining competitive strategies across the landscape. The shift is not simply technological but cultural, demanding a renewed focus on collaboration, risk management, and strategic investment in state-of-the-art manufacturing infrastructure.

Key Segmentation Insights Driving Market Innovation

The segmented analysis of the nucleic acid therapeutics market reveals a multifaceted structure that caters to diverse needs and specialized capabilities. The market is dichotomized by therapeutics type, studying both DNA and RNA modalities. DNA therapeutics have traditionally provided stability and a proven track record, while RNA therapeutics continue to push boundaries, offering rapid development cycles and tunable gene expression. This dual pathway represents a strategic balance between established protocols and emerging innovations.

Service type segmentation further illuminates areas such as analytical testing and quality control, manufacturing, packaging and distribution, and process development and optimization. Each service category plays a pivotal role in ensuring therapies are not only effective but also reliably delivered. Analytical testing and quality control have become increasingly critical as regulatory bodies enforce stricter criteria, while manufacturing capabilities are being enhanced by the integration of precision engineering and automation. Packaging and distribution, coupled with process development, provide a seamless continuum from laboratory innovation to patient delivery.

When examining therapeutic applications, insights are drawn from various clinical sectors including genetic disorders, infectious diseases, neurological disorders, oncology, and rare disorders. Each application area carries unique challenges and opportunities that drive tailored research and development strategies. The evolution of treatment paradigms in oncology and neurological disorders, for instance, is prompting a re-examination of traditional drug delivery systems and inspiring the creation of novel, targeted interventions.

Moreover, the segment based on end users-spanning academic and research institutes, biotechnology firms, and pharmaceutical companies-exemplifies the extensive reach of nucleic acid therapies. The academic realm propels foundational research, while the biotechnology sector rapidly translates discoveries into clinical applications. Pharmaceutical companies, on the other hand, bring these innovations to a global market, ensuring accessibility and sustained growth in an increasingly competitive environment.

Based on Therapeutics Type, market is studied across DNA Therapeutics and RNA Therapeutics.

Based on Service Type, market is studied across Analytical Testing & Quality Control, Manufacturing, Packaging & Distribution, and Process Development & Optimization.

Based on Therapeutic Applications, market is studied across Genetic Disorders, Infectious Diseases, Neurological Disorders, Oncology, and Rare Disorders.

Based on End User, market is studied across Academic & Research Institutes, Biotechnology Firms, and Pharmaceutical Companies.

Key Regional Insights Across Global Markets

The global perspective of nucleic acid therapeutics uncovers significant regional variations that highlight both unique opportunities and sector-specific challenges. In the Americas, advanced research infrastructures and a robust funding environment have fostered an ecosystem where innovation thrives alongside regulatory excellence. This region continues to lead in terms of clinical trials and state-of-the-art manufacturing facilities, making it a hotspot for next-generation therapeutic discovery and production.

Across Europe, the Middle East, and Africa, there is a pronounced emphasis on harmonizing regulatory standards while fostering an environment conducive to public-private partnerships. European markets, in particular, are noted for stringent compliance and quality benchmarks, which drive industry standards upward. The Middle East and Africa are witnessing increasing investments in biotechnological research, motivated by a growing need to address regional health challenges and tap into emerging talent pools. This diverse region articulates a unique blend of legacy expertise and innovative agility.

In Asia-Pacific, rapid economic development and substantial investments in research and development are redefining the landscape. The region benefits from a mix of established industrial bases and nimble start-ups, which together contribute to a competitive production and innovation environment. The surge in regulatory reforms is further catalyzing innovation, ensuring that manufacturing processes keep pace with global benchmarks. This dynamic region not only supports large-scale clinical development but also serves as a critical hub for supply chain optimization and operational excellence across the nucleic acid therapeutics market.

These region-specific insights reinforce the view that a one-size-fits-all approach is untenable. Instead, tailored strategies that account for local market dynamics, resource availability, and regulatory environments are essential for tapping the diverse global potential of nucleic acid therapeutics.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key Companies Leading the Charge in Therapeutics Innovation

The competitive landscape is defined by a cadre of leading companies whose innovative approaches are setting new standards in the nucleic acid therapeutics market. Firms such as AGC Biologics Inc. and Agilent Technologies, Inc. are recognized for their commitment to integrating advanced analytics with meticulous quality control processes. Ajinomoto Bio-Pharma Services and Almac Group Ltd. have carved out reputations for excellence in manufacturing and process optimization, consistently delivering reliable solutions that meet rigorous industry standards.

Equally influential are organizations like Biomay AG and BioSpring GmbH, which have leveraged cutting-edge technologies to optimize both packaging and distribution channels. Catalent, Inc. and Charles River Laboratories International, Inc. have been instrumental in refining manufacturing protocols and streamlining analytical testing methodologies that enhance overall product reliability. Industry leaders such as CordenPharma International GmbH and Creative Biogene exemplify the ability to balance high-volume production with precision customization.

Danaher Corporation and Eurofins Scientific SE further underscore the critical role of innovative testing and quality assurance procedures, while companies including Evonik Industries AG and GenScript Biotech Corporation have accelerated process development and optimization. Lonza Group Ltd. and Polypeptide Group AG stand out for their scalable manufacturing solutions, ensuring seamless transitions from bench to market. Other key players, including Recipharm AB and Rentschler Biopharma SE, have continued to drive efficiency and innovation in both traditional and next-generation therapeutic production.

Samsung Biologics and The Scripps Research Institute illustrate the vital interconnectedness of research and manufacturing, a trait shared by Touchlight Group, Univercells Group, and WuXi AppTec Co., Ltd. Their combined efforts are not only redefining production paradigms but are also instrumental in pushing the boundaries of what is scientifically and commercially possible in the realm of nucleic acid therapeutics.

The report delves into recent significant developments in the Nucleic Acid Therapeutics CDMO Market, highlighting leading vendors and their innovative profiles. These include AGC Biologics Inc., Agilent Technologies, Inc., Ajinomoto Bio-Pharma Services, Almac Group Ltd., Biomay AG, BioSpring GmbH, Catalent, Inc., Charles River Laboratories International, Inc., CordenPharma International GmbH, Creative Biogene, Danaher Corporation, Eurofins Scientific SE, Evonik Industries AG, GenScript Biotech Corporation, Lonza Group Ltd., Polypeptide Group AG, Recipharm AB, Rentschler Biopharma SE, Samsung Biologics, The Scripps Research Institute, Touchlight Group, Univercells Group, and WuXi AppTec Co., Ltd.. Actionable Recommendations for Industry Leaders in Therapeutics

Industry leaders must adopt a multidimensional strategy to navigate the shifting landscape of nucleic acid therapeutics effectively. It is crucial to invest in state-of-the-art manufacturing infrastructure, ensuring seamless integration of digital analytics with process automation. Firms should proactively engage with regulatory bodies to remain ahead of compliance curves, thus securing a competitive edge in innovation and market penetration.

Collaboration remains a powerful tool in this sector. Establishing strategic partnerships with research institutions, biotechnology innovators, and global pharmaceutical companies can help accelerate product development and broaden market reach. Emphasis on robust risk management strategies, coupled with the adoption of advanced manufacturing platforms, will serve as catalysts for operational excellence. Leaders in the field are encouraged to leverage emerging technologies that promise enhanced scalability and faster time-to-market, aligning production capabilities with the rapidly evolving clinical demands.

Lastly, maintaining an agile mindset is critical as market dynamics continue to evolve. Organizations that invest in continual improvement and foster an environment of cross-disciplinary innovation will be best positioned to capitalize on the emerging opportunities within this space.

Conclusion: Embracing Change in Nucleic Acid Therapeutics

In conclusion, the advancement of nucleic acid therapeutics represents a significant leap forward in modern medicine. The market is witnessing an era of transformative change, driven by innovative scientific breakthroughs, strategic segmentation insights, and a competitive ecosystem dominated by leading industry players. The evolving landscape requires a nuanced understanding of the interplay between technology, regulation, and market dynamics.

This comprehensive analysis underscores the importance of adopting forward-thinking strategies and leveraging global insights to build resilient and efficient production pipelines. The future of nucleic acid therapeutics lies in the hands of those who not only embrace change but also proactively drive its evolution through innovation, collaboration, and strategic investment.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Growing prevalence of genetic disorders globally
    • 5.1.1.2. Rising demand for personalized medicine and targeted gene therapies
    • 5.1.1.3. Expansion of research and development activities in pharmaceutical and biotechnology sectors
  • 5.1.2. Restraints
    • 5.1.2.1. Stringent regulatory compliance in production of nucleic acid therapeutics
  • 5.1.3. Opportunities
    • 5.1.3.1. Leveraging advanced nucleic acid stabilization techniques and analytical testing platforms for advanced therapeutic applications in CDMO settings
    • 5.1.3.2. Ongoing development of mRNA-based vaccines and therapeutics
  • 5.1.4. Challenges
    • 5.1.4.1. Lack of skilled professionals specialized in nucleic acid therapeutics development
• 5.2. Market Segmentation Analysis
  • 5.2.1. Service Type: Increasing preference for analytical testing & quality control services for their purity, and potency
  • 5.2.2. End User: Expanding utilization of nucleic acid therapeutics CDMO in academic & research institutes
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Nucleic Acid Therapeutics CDMO Market, by Therapeutics Type

• 6.1. Introduction
• 6.2. DNA Therapeutics
• 6.3. RNA Therapeutics

7. Nucleic Acid Therapeutics CDMO Market, by Service Type

• 7.1. Introduction
• 7.2. Analytical Testing & Quality Control
• 7.3. Manufacturing
• 7.4. Packaging & Distribution
• 7.5. Process Development & Optimization

8. Nucleic Acid Therapeutics CDMO Market, by Therapeutic Applications

• 8.1. Introduction
• 8.2. Genetic Disorders
• 8.3. Infectious Diseases
• 8.4. Neurological Disorders
• 8.5. Oncology
• 8.6. Rare Disorders

9. Nucleic Acid Therapeutics CDMO Market, by End User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Biotechnology Firms
• 9.4. Pharmaceutical Companies

10. Americas Nucleic Acid Therapeutics CDMO Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Nucleic Acid Therapeutics CDMO Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Nucleic Acid Therapeutics CDMO Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2024
• 13.2. FPNV Positioning Matrix, 2024
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Maravai LifeSciences broadens its nucleic acid therapeutics pipeline by acquiring Officinae Bio's DNA and RNA business
  • 13.3.2. GSK forges strategic licensing deal with Touchlight to access advanced doggybone DNA technology
  • 13.3.3. FUJIFILM Toyama Chemical and Synplogen Forge Alliance to Enhance mRNA Therapeutics Production
  • 13.3.4. Exothera Launches Advanced RNA Therapeutics Platform 'Ntensify' in North America, Streamlining Nucleic Acid Drug Development
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. AGC Biologics Inc.
• 2. Agilent Technologies, Inc.
• 3. Ajinomoto Bio-Pharma Services
• 4. Almac Group Ltd.
• 5. Biomay AG
• 6. BioSpring GmbH
• 7. Catalent, Inc.
• 8. Charles River Laboratories International, Inc.
• 9. CordenPharma International GmbH
• 10. Creative Biogene
• 11. Danaher Corporation
• 12. Eurofins Scientific SE
• 13. Evonik Industries AG
• 14. GenScript Biotech Corporation
• 15. Lonza Group Ltd.
• 16. Polypeptide Group AG
• 17. Recipharm AB
• 18. Rentschler Biopharma SE
• 19. Samsung Biologics
• 20. The Scripps Research Institute
• 21. Touchlight Group
• 22. Univercells Group
• 23. WuXi AppTec Co., Ltd.