핵산 치료제 CDMO 시장 : 치료제 유형별, 서비스 유형별, 치료 용도별, 최종사용자별 - 세계 예측(2025-2032년)

The Nucleic Acid Therapeutics CDMO Market is projected to grow by USD 26.14 billion at a CAGR of 11.71% by 2032.

Framing the evolving strategic role of CDMOs in enabling complex nucleic acid therapeutic development amid accelerating scientific and regulatory demands

The nucleic acid therapeutics contract development and manufacturing landscape has entered a phase defined by rapid technological convergence and elevated strategic importance for both developers and contract partners. Recent advances in therapeutic modalities, manufacturing platforms, and regulatory expectations have elevated CDMOs from service vendors to strategic collaborators that materially influence program timelines and clinical viability. As developers pursue increasingly complex constructs, including modified oligonucleotides, viral vectors, and lipid nanoparticle formulations, demand for specialized process knowledge, stringent quality control, and adaptive manufacturing capacity has intensified.

Consequently, organizations that provide integrated capabilities spanning process development, analytical rigor, and scale-ready manufacturing are being evaluated not only on cost and capacity but also on agility, regulatory track record, and partnership models that de-risk development pathways. Stakeholders must therefore reassess their sourcing strategies, technology roadmaps, and compliance frameworks to reflect an environment where speed-to-clinic and supply continuity are as critical as technical excellence. Moving forward, the interplay between scientific innovation and pragmatic manufacturing constraints will determine which programs advance efficiently and which face protracted development timelines, making it imperative for executives to align commercial strategy with operational realities across the value chain.

Unpacking the multidimensional disruptive forces altering R&D, manufacturing modalities, regulatory expectations, and partnership models across nucleic acid therapeutics

Nucleic acid therapeutics are reshaping therapeutic paradigms, and with that transformation comes a cascade of shifts across R&D, manufacturing, and commercialization. Technological innovation is driving paradigm changes in how molecules are designed, produced, and tested; modular and continuous manufacturing approaches are replacing batch orthodoxy in many applications, while digital process controls and advanced analytics increasingly underpin quality systems and process understanding. These shifts have broadened the competency set required of contract development and manufacturing organizations, requiring investments in specialized equipment, real-time monitoring capabilities, and cross-disciplinary talent.

At the same time, regulatory expectations have matured, emphasizing lifecycle quality management, data integrity, and platform-based comparability. This maturation is influencing project planning and capitalization decisions and is prompting greater early-stage alignment between developers and manufacturers on quality by design principles. Moreover, commercial pressures are altering partnership structures: strategic alliances, risk-sharing arrangements, and capacity reservation models are becoming more common as sponsors seek to secure prioritized throughput and mitigate supply chain risk. Taken together, these transformative shifts mean that CDMOs must evolve beyond transactional relationships to become long-term strategic partners that co-design processes, anticipate regulatory challenges, and scale capabilities in lockstep with evolving modality requirements.

Assessing how tariff adjustments in 2025 have recalibrated sourcing, supplier qualification, and operational risk management across the nucleic acid therapeutics supply chain

The imposition and adjustment of tariffs by the United States in 2025 have introduced new variables into the supply and cost calculus for nucleic acid therapeutics manufacturing. Tariff measures that affect imported raw materials, specialized reagents, and certain manufacturing equipment have prompted manufacturers and sponsors to reassess sourcing strategies and to accelerate efforts to qualify alternative suppliers. As a result, procurement teams have increased scrutiny of supplier resilience and geographic diversification while manufacturing planners evaluate the trade-offs between nearshoring, onshoring, and maintaining offshore partnerships.

In practice, these tariff-driven dynamics have influenced capital allocation decisions and timetable assumptions. Sponsors that previously relied on a global sourcing model for key inputs have initiated dual-sourcing strategies and have elevated buffer management to preserve continuity for critical campaigns. Investments in supplier qualification and audits have increased, as firms seek to validate localized supply chains. Moreover, some organizations have advanced plans for regional capacity expansion to reduce exposure to cross-border cost volatility and mitigate potential lead-time disruptions. Regulatory dossiers and quality control frameworks have had to accommodate the introduction of new supplier-origin materials, requiring targeted comparability studies and additional documentation. While tariffs have not altered the scientific principles behind modality development, they have reshaped operational risk management and have heightened the strategic importance of supply chain transparency, supplier performance metrics, and contractual protections that address cross-border trade risk.

Deriving strategic implications from modality, service type, application, and end-user segmentation to target capability investments and partnership structures

A granular view of the landscape emerges when analyzing demand and capability along multiple segmentation axes. When viewed through the lens of therapeutic type, distinctions between DNA therapeutics and RNA therapeutics materially influence manufacturing workflows, analytical testing paradigms, and regulatory touchpoints; RNA modalities often demand specialized formulation expertise and cold-chain considerations, while DNA-based approaches entail distinct upstream and downstream purification challenges. From the perspective of service type, the interplay between analytical testing and quality control, manufacturing, packaging and distribution, and process development and optimization defines where value accrues; organizations that integrate end-to-end services can shorten timelines and reduce handoffs, while niche specialists retain relevance for highly technical tasks and method development.

Considering therapeutic application highlights divergent demand drivers: genetic disorders, infectious diseases, neurological disorders, oncology, and rare disorders each present unique payload requirements, dosing regimens, and clinical development risk profiles, which in turn shape manufacturing complexity and demand for tailored assays. Finally, end-user segmentation-academic and research institutes, biotechnology firms, and pharmaceutical companies-reveals differing expectations for flexibility, timelines, and regulatory support; academic partners often require adaptable, lower-volume services focused on method establishment, biotechnology firms prioritize speed and platform scalability for clinical progression, and pharmaceutical companies seek predictable quality systems and capacity for late-stage scale-up. Integrating these segmentation perspectives provides a multidimensional map to prioritize investments, align service offerings, and design partnership models that reflect client-specific needs and modality attributes.

Interpreting how regional ecosystems, regulatory frameworks, and capacity development across the Americas, EMEA, and Asia-Pacific shape CDMO strategic positioning

Regional dynamics continue to influence strategic decisions across the CDMO landscape, with distinct drivers shaping demand and capability in each geography. In the Americas, robust biotech ecosystems, venture capital activity, and a concentration of late-stage clinical programs drive demand for scalable manufacturing and stringent regulatory compliance. This environment fosters closer collaboration between sponsors and manufacturing partners on clinical-to-commercial transition planning and necessitates investments in GMP-capable facilities, regulatory affairs expertise, and supply chain resilience.

In Europe, the Middle East & Africa, evolving regulatory harmonization efforts, a strong translational research base, and growing local biomanufacturing initiatives create opportunities for regional partners to offer specialized capabilities and navigate complex cross-border regulatory landscapes. Sponsors operating in these jurisdictions often balance access to localized scientific talent with the need for interoperable quality systems and regulatory dossiers that align with multiple authorities. The Asia-Pacific region is characterized by rapid capacity expansion, a maturing supplier base for reagents and components, and significant investments by governments and private entities to build domestic manufacturing capabilities. This has encouraged the development of cost-effective manufacturing options as well as opportunities for technology transfer and joint ventures. Across all regions, supply chain transparency, compliance consistency, and the ability to execute complex analytics remain critical selection criteria for sponsors seeking to mitigate geopolitical and operational risks.

Understanding the competitive levers and partnership models that enable CDMOs to differentiate through technical depth, integrated services, and customer-aligned commercial structures

Competitive dynamics among companies serving the nucleic acid therapeutics ecosystem are increasingly defined by depth of modality expertise, integrated service offerings, and the ability to de-risk clinical translation through proven regulatory engagement. Leading providers distinguish themselves by investing in platform technologies that enable faster process development, higher product quality, and streamlined scale-up pathways. Capacity alone no longer differentiates; rather, organizations that combine robust quality systems with advanced analytics and a track record of successful transfers enjoy a competitive edge.

Partnership models are evolving: strategic alliances, co-development agreements, and capacity reservation arrangements are common among organizations seeking to secure long-term pipeline throughput. Investment in talent-particularly in process scientists, analytical chemists, and regulatory specialists-is a critical differentiator, as is the ability to demonstrate successful comparability and validation work across multiple modalities. Mergers and acquisitions continue to be a lever for accessing niche capabilities quickly, but the integration of disparate quality systems and cultures requires deliberate planning. Finally, forward-looking companies prioritize customer-centric commercial models that offer transparency around capacity, pricing mechanisms that reflect value and risk, and collaborative governance structures to resolve program-level challenges efficiently.

Actionable strategic imperatives for executive leaders to strengthen partnerships, supply resilience, digital quality, and talent for reliable nucleic acid therapeutic development

Industry leaders and program sponsors must adopt a set of pragmatic actions to align operations, partnerships, and investment plans with the evolving realities of nucleic acid therapeutic development. First, prioritize co-development frameworks that formalize early-stage collaboration between sponsors and manufacturers to accelerate process transfer and minimize downstream surprises. Establishing joint milestones and decision gates clarifies expectations and reduces rework during scale-up. Second, invest in supply chain visibility and dual-sourcing strategies for critical raw materials and specialized reagents to manage exposure to trade policy shifts and single-source dependencies. Engaging in supplier qualification early will shorten timelines when alternate sources are needed.

Third, accelerate adoption of digital quality management and process analytical technologies to enable real-time monitoring and to support regulatory dossiers that emphasize lifecycle control. These investments reduce batch failure risk and enhance comparability assessments across manufacturing sites. Fourth, align commercial agreements with operational realities by incorporating capacity reservation clauses, risk-sharing provisions, and transparent escalation mechanisms for schedule adjustments. Fifth, build internal capabilities through targeted hiring and training programs that focus on analytics, aseptic processing, and regulatory strategy, while also evaluating strategic acquisitions or partnerships to fill capability gaps rapidly. By implementing these measures, organizations can reduce program risk, preserve development momentum, and create clearer pathways from discovery to commercial supply.

Explaining the mixed-methods research design combining primary expert interviews, technical validation, and triangulated secondary sources to ensure actionable and defensible insights

The underlying research methodology synthesizes multiple evidence streams to ensure robust, actionable insights. Secondary research involved systematic review of scientific literature, regulatory guidance documents, industry white papers, and technical standards to establish baseline technical and regulatory contexts. Primary research consisted of structured interviews with manufacturing leaders, process scientists, regulatory experts, procurement leads, and program managers to capture first-hand perspectives on operational challenges, supplier performance, and partnership dynamics. These qualitative inputs were complemented by technical validation exercises, including case study analyses of recent technology transfers, comparability efforts, and process scale-up examples.

Data triangulation was applied to corroborate themes across sources, ensuring that observed patterns in capacity expansion, quality system investments, and supply chain strategies were not isolated anecdotes. The methodology also incorporated scenario analysis to evaluate the operational implications of shifts such as tariff changes, regional capacity additions, and modality-specific manufacturing complexities. Where appropriate, the research team validated assumptions through follow-up interviews and document reviews to minimize bias. Together, these methods yield a defensible synthesis that balances technical specificity with strategic relevance for decision-makers in development, manufacturing, and commercial organizations.

Synthesizing how strategic alignment of capabilities, partnerships, and supply chain resilience determines successful translation of nucleic acid therapeutics from discovery to supply

The landscape for nucleic acid therapeutics manufacturing is in flux, driven by scientific innovation, evolving regulatory expectations, and shifting operational imperatives. Organizations that recognize the strategic nature of CDMO partnerships and that invest in integrated capabilities-spanning analytical excellence, adaptive manufacturing, and resilient supply chains-will be better positioned to convert scientific advances into reliable clinical and commercial supply. Transitional pains such as tariff-driven supply adjustments, regional capacity realignment, and the need for advanced analytics present operational challenges, but they also create opportunities for providers that can offer clear, validated pathways to de-risked scale-up.

Ultimately, success will favor those who approach manufacturing as a strategic asset rather than a transactional function, establishing collaborative governance, transparent commercial terms, and continuous improvement processes that accelerate program timelines and reduce technical and regulatory risk. By aligning investment priorities with modality-specific demands and by cultivating flexible, high-integrity supply chains, sponsors and providers can create more predictable development trajectories and realize the full potential of nucleic acid therapeutics across diverse therapeutic areas.

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

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Rising demand for scalable mRNA production platforms with optimized lipid nanoparticle formulation capabilities
• 5.2. Integration of automated high-throughput screening in oligonucleotide manufacturing workflows to accelerate process development
• 5.3. Adoption of continuous manufacturing for plasmid DNA to enhance yield consistency and reduce contamination risk
• 5.4. Strategic partnerships between CDMOs and biotech firms for co-development of gene editing therapies using CRISPR-Cas systems
• 5.5. Investment in modular single-use bioreactor systems tailored for viral vector production to support gene therapy pipelines

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Nucleic Acid Therapeutics CDMO Market, by Therapeutics Type

• 8.1. DNA Therapeutics
• 8.2. RNA Therapeutics

9. Nucleic Acid Therapeutics CDMO Market, by Service Type

• 9.1. Analytical Testing & Quality Control
• 9.2. Manufacturing
• 9.3. Packaging & Distribution
• 9.4. Process Development & Optimization

10. Nucleic Acid Therapeutics CDMO Market, by Therapeutic Applications

• 10.1. Genetic Disorders
• 10.2. Infectious Diseases
• 10.3. Neurological Disorders
• 10.4. Oncology
• 10.5. Rare Disorders

11. Nucleic Acid Therapeutics CDMO Market, by End User

• 11.1. Academic & Research Institutes
• 11.2. Biotechnology Firms
• 11.3. Pharmaceutical Companies

12. Nucleic Acid Therapeutics CDMO Market, by Region

• 12.1. Americas
  • 12.1.1. North America
  • 12.1.2. Latin America
• 12.2. Europe, Middle East & Africa
  • 12.2.1. Europe
  • 12.2.2. Middle East
  • 12.2.3. Africa
• 12.3. Asia-Pacific

13. Nucleic Acid Therapeutics CDMO Market, by Group

• 13.1. ASEAN
• 13.2. GCC
• 13.3. European Union
• 13.4. BRICS
• 13.5. G7
• 13.6. NATO

14. Nucleic Acid Therapeutics CDMO Market, by Country

• 14.1. United States
• 14.2. Canada
• 14.3. Mexico
• 14.4. Brazil
• 14.5. United Kingdom
• 14.6. Germany
• 14.7. France
• 14.8. Russia
• 14.9. Italy
• 14.10. Spain
• 14.11. China
• 14.12. India
• 14.13. Japan
• 14.14. Australia
• 14.15. South Korea

15. Competitive Landscape

• 15.1. Market Share Analysis, 2024
• 15.2. FPNV Positioning Matrix, 2024
• 15.3. Competitive Analysis
  • 15.3.1. AGC Biologics Inc.
  • 15.3.2. Agilent Technologies, Inc.
  • 15.3.3. Ajinomoto Bio-Pharma Services
  • 15.3.4. Almac Group Ltd.
  • 15.3.5. Biomay AG
  • 15.3.6. BioSpring GmbH
  • 15.3.7. Catalent, Inc.
  • 15.3.8. Charles River Laboratories International, Inc.
  • 15.3.9. CordenPharma International GmbH
  • 15.3.10. Creative Biogene
  • 15.3.11. Danaher Corporation
  • 15.3.12. Eurofins Scientific SE
  • 15.3.13. Evonik Industries AG
  • 15.3.14. GenScript Biotech Corporation
  • 15.3.15. Lonza Group Ltd.
  • 15.3.16. Polypeptide Group AG
  • 15.3.17. Recipharm AB
  • 15.3.18. Rentschler Biopharma SE
  • 15.3.19. Samsung Biologics
  • 15.3.20. The Scripps Research Institute
  • 15.3.21. Touchlight Group
  • 15.3.22. Univercells Group
  • 15.3.23. WuXi AppTec Co., Ltd.