Nucleic Acid Therapeutics CDMO Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Gene Therapy, RNA-based Therapies), By Service (Process Development & Optimization, Manufacturing Services, Analytical and Quality Control Services, others), by Application (Oncology, Genetic Disorders, Infectious Diseases, others), by region, and Competition, 2020-2030F

Market Overview

The Global Nucleic Acid Therapeutics CDMO Market, valued at USD 11.52 Billion in 2024, is projected to experience a CAGR of 8.29% to reach USD 18.58 Billion by 2030. Nucleic acid therapeutics represent a distinct class of pharmaceutical products utilizing genetic material, such as DNA or RNA, to modulate gene expression for therapeutic purposes, encompassing modalities like antisense oligonucleotides, small interfering RNAs, and messenger RNAs. The global Contract Development and Manufacturing Organization (CDMO) market for these therapeutics is primarily driven by expanding biopharmaceutical research and development investments, the increasing pipeline of novel nucleic acid drug candidates, and the critical need for specialized manufacturing capabilities. Furthermore, the rising prevalence of genetic disorders and the advancement of personalized medicine initiatives contribute significantly to market growth.

According to the Pharmaceutical Research and Manufacturers of America (PhRMA) 2024 Special 301 Submission, PhRMA member companies invested nearly $101 billion in research and development in 2022, signifying substantial underlying innovation in the broader biopharmaceutical sector that fuels demand for CDMO services. However, a significant challenge that could impede market expansion is the inherent complexity and scalability issues associated with manufacturing these advanced therapeutic modalities, particularly in consistently achieving required quality and purity standards at commercial production volumes.

Key Market Drivers

The expanding therapeutic pipeline for nucleic acid modalities significantly underpins the growth of the Contract Development and Manufacturing Organization market. The increasing number of novel drug candidates, including antisense oligonucleotides, messenger RNAs, and small interfering RNAs, necessitates specialized expertise and infrastructure for their development and large-scale production. These modalities offer targeted approaches for previously intractable diseases, creating a robust demand for outsourced services. For example, according to the article "Advancements in clinical RNA therapeutics: Present developments and prospective outlooks" published in PMC in April 2024, the exploration of antisense oligonucleotide-based therapies alone has progressed through 100 Phase I trials, with 25% of these advancing to Phase II or III trials, indicating a substantial volume of candidates requiring further development and manufacturing support. This progression through clinical stages directly translates into a requirement for advanced process development, analytical testing, and Good Manufacturing Practice compliant production.

Parallel to pipeline expansion, advancements in nucleic acid manufacturing and delivery technologies are a critical accelerant for the CDMO market. Innovations in synthesis, purification, and encapsulation, particularly with lipid nanoparticles, enhance drug stability, efficacy, and targeted delivery, making commercialization more viable. For instance, according to Business Wire, in January 2023, Agilent Technologies Inc. announced a significant investment of approximately $725 million to triple its therapeutic nucleic acid production capacity, demonstrating the industry's commitment to scaling these technologies. Such technological progress enables CDMOs to offer more efficient and cost-effective services, attracting biopharmaceutical companies that may lack the in-house capabilities for these complex molecules. Furthermore, sustained investment fuels the broader sector; according to a Fierce Biotech release in October 2025, venture capital firm Ascenta, which includes RNA-focused ADARx Pharmaceuticals in its portfolio, has delivered over $100 million in collective capital to biotechs in early-stage clinical trials, signifying ongoing financial commitment to this innovative therapeutic area.

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Key Market Challenges

The inherent complexity and scalability issues associated with manufacturing advanced nucleic acid therapeutics, particularly in consistently achieving required quality and purity standards at commercial production volumes, represent a significant impedance to the growth of the global Contract Development and Manufacturing Organization (CDMO) market. These modalities often require specialized equipment, highly controlled environments, and intricate purification processes, leading to elevated operational costs and extended development timelines for CDMOs. Such manufacturing intricacies limit the capacity of CDMOs to efficiently process the increasing pipeline of novel drug candidates, creating bottlenecks within the supply chain.

This manufacturing challenge directly restricts the expansion of the CDMO market by hindering its ability to meet escalating demand. According to the American Society for Gene and Cell Therapy (ASGCT), as of April 2023, there were 897 RNA therapeutics in the clinical pipeline. The substantial volume of these innovative therapies underscores the critical need for robust and scalable manufacturing solutions. However, the complexities involved in scaling production while maintaining stringent quality control make it difficult for CDMOs to onboard new projects and achieve commercial production volumes promptly, thereby delaying market entry for new therapies and constraining revenue growth for manufacturing service providers.

Key Market Trends

Strategic Capacity Expansion Initiatives represent a significant trend as Contract Development and Manufacturing Organizations invest heavily to meet the escalating demand for nucleic acid therapeutics. This involves constructing new facilities, expanding existing operational footprints, and integrating advanced equipment to enhance overall manufacturing throughput and capabilities. Such proactive investments are crucial for ensuring the reliable and timely supply of critical drug substances and products, thereby supporting the clinical and commercial progression of novel therapies. For instance, according to a BioSpace report in January 2024, Lonza projected flat sales for the year but confirmed mid-term guidance and reported full-year 2023 sales of $7.75 billion, driven by strong performance in its Biologics and Small Molecules divisions, highlighting sustained investment in its manufacturing network. In October 2024, Lonza also completed the acquisition of a large-scale biologics facility in Vacaville, US, from Roche, further expanding its capabilities and dedicating CHF 1.4 billion of CapEx in 2024 towards its organic investment program for future growth across technologies.

Digital Transformation and Automation of Operations is another pivotal trend, focusing on integrating advanced technologies such as robotics, artificial intelligence, and process analytical technology into manufacturing workflows. This trend aims to optimize efficiency, minimize human error, and ensure stringent quality control across complex production processes for nucleic acid modalities. The implementation of automated systems facilitates real-time monitoring, data integrity, and streamlined regulatory compliance, which are essential for the high-value and sensitive nature of these therapeutics. For example, in October 2025, Technology Networks reported that Multiply Labs and Thermo Fisher Scientific expanded their collaboration to integrate Thermo Fisher’s automated Gibco™ CTS™ DynaCellect™ Magnetic Separation System with Multiply Labs’ robotic platforms, aiming for end-to-end automation in cell therapy production to reduce manual intervention and improve process consistency. This strategic adoption of automation is vital for scaling production effectively and cost-efficiently.

Segmental Insights

The RNA-based Therapies segment is experiencing rapid growth within the Global Nucleic Acid Therapeutics CDMO Market, driven by several interconnected factors. The proven success of messenger RNA (mRNA) vaccines has significantly broadened interest and investment in these modalities, extending applications beyond infectious diseases to oncology and rare genetic disorders. This expansion is supported by continuous technological advancements in manufacturing processes and delivery systems, such as lipid nanoparticles, enhancing therapeutic stability and efficacy. Furthermore, an expanding pipeline of RNA therapies in clinical development and evolving regulatory guidance from bodies like the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are streamlining development pathways, fostering innovation and accelerating market entry.

Regional Insights

North America leads the Global Nucleic Acid Therapeutics CDMO Market, primarily due to its robust biopharmaceutical industry and extensive research and development landscape. The region benefits from substantial investment and funding support, coupled with a proactive regulatory environment facilitated by institutions such as the U. S. Food and Drug Administration, which fosters a significant number of product approvals and ongoing clinical trials. Furthermore, the strong presence of established pharmaceutical companies and leading academic and research institutions contributes to continuous innovation and demand for specialized contract development and manufacturing services in nucleic acid therapies. This established infrastructure and commitment to advancing novel treatments solidify North America's dominant position.

Recent Developments

• In April 2025, Wacker Biotech, a contract development and manufacturing organization and wholly owned subsidiary of Wacker Chemie AG, announced a strategic collaboration with RNAV8 Bio. This partnership aims to advance the development and production of mRNA-based advanced therapies for the biopharmaceutical industry. The collaboration leverages Wacker Biotech's expertise in plasmid DNA and mRNA manufacturing, alongside lipid nanoparticle formulation, combined with RNAV8 Bio's innovative mRNA engineering platform. This joint effort is designed to enhance mRNA drug efficacy and offer comprehensive, integrated services in the evolving mRNA therapeutics CDMO landscape.

• In January 2025, Evonik announced a strategic partnership with ST Pharm, a contract development and manufacturing organization specializing in active ingredients for gene therapy. This collaboration is set to expand Evonik's range of RNA and nucleic acid therapeutic services. The alliance combines ST Pharm's expertise in customized nucleic acids with Evonik's capabilities in lipid and lipid nanoparticle drug product development, aiming to streamline development processes. This initiative is designed to reduce complexity for pharmaceutical companies and accelerate the market entry of nucleic acid therapeutics, thereby enhancing global offerings in this specialized CDMO sector.

• In June 2024, ProBio Inc., a New Jersey-based contract development and manufacturing organization, expanded its plasmid DNA and viral vector production capabilities. The company inaugurated a new state-of-the-art facility in Hopewell, New Jersey, which will serve as its North American operational hub. This expansion significantly increases ProBio's capacity to support the manufacturing of cell and gene therapies, which rely heavily on plasmid DNA and viral vectors. The facility is equipped for both process development and current good manufacturing practice production, directly addressing the growing demand within the Global Nucleic Acid Therapeutics CDMO Market.

• In April 2024, ST Pharm, a CDMO specializing in small-molecule oligonucleotides and mRNA, announced a significant investment of $110 million to expand its oligonucleotide active pharmaceutical ingredient production capacity. This expansion at its Banwol campus in South Korea is planned to increase production capacity from 6.4 mole to 8.7 mole by 2025. The new "Oligo Plant 2" is designed to diversify the company's capabilities for manufacturing antisense oligonucleotides, siRNA, and CRISPR sgRNA. This strategic investment positions ST Pharm to meet the increasing global demand for oligonucleotide therapeutics within the nucleic acid therapeutics CDMO market.

Key Market Players

• Catalent Inc.
• Thermo Fisher Scientific Inc.
• Lonza Group Ltd.
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Charles River Laboratories International, Inc.
• Eurofins Genomics
• Sirion Biotech GmbH
• Oxford Biomedica Plc.
• Danaher Corp.

Report Scope:

In this report, the Global Nucleic Acid Therapeutics CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Nucleic Acid Therapeutics CDMO Market, By Type:

o   Gene Therapy

o   RNA-based Therapies

• Nucleic Acid Therapeutics CDMO Market, By Service:

o   Process Development & Optimization

o   Manufacturing Services

o   Analytical and Quality Control Services

o   Others

• Nucleic Acid Therapeutics CDMO Market, By Application:

o   Oncology

o   Genetic Disorders

o   Infectious Diseases

o   Others

• Nucleic Acid Therapeutics CDMO Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Nucleic Acid Therapeutics CDMO Market.

Available Customizations:

Global Nucleic Acid Therapeutics CDMO Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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