Nucleic Acid Therapeutics Contract Manufacturing Market (2025 - 2033) Size, Share & Trends Analysis Report By Type (Gene Therapy, RNA-based Therapies), By Service, By End Use, By Application, By Region, And Segment Forecasts

Nucleic Acid Therapeutics Contract Manufacturing Market Summary

Increasing regulatory support and government incentives are among the other factors driving market growth. In the global market, shifting trends towards outsourcing activities by biopharmaceutical companies to contract manufacturers are expected to drive market growth. This outsourcing activity reduces operational costs, accelerates time-to-market, and utilizes specialized expertise in nucleic acid production. According to an article published in July 2025, 82.6% of cell and gene therapy (CGT) companies outsource at least part of their biologics manufacturing, marking record-high levels of reliance on external contract manufacturing services.

In addition, outsourcing activities is also driven by the high complexity of mRNA, plasmid DNA, and oligonucleotide therapeutics, which require GMP-certified facilities, skilled personnel, and advanced technologies. Thus, contract manufacturers are witnessing an increasing requirement for integrated services, including process development, analytical testing, and commercial-scale manufacturing. In addition, outsourcing enables pharmaceutical firms to concentrate on research and development, ensuring that regulatory compliance and quality standards are met.

Moreover, the growing prevalence of chronic, rare, and infectious diseases drives the demand for advanced therapeutics, including mRNA vaccines, gene therapies, and oligonucleotide drugs. According to data on global genes, approximately 400 million people worldwide are affected by rare diseases, and 95% of these conditions currently lack FDA-approved treatments. The high prevalence of rare diseases and the lack of FDA-approved treatments are further driving market growth, with increased demand for innovative therapies. Furthermore, most pharmaceutical and biotech companies seeking to meet this demand are outsourcing production to specialized contract manufacturers. As a result, contract manufacturers experience higher utilization of GMP facilities, expanded manufacturing capacity, and increased investment in specialized technologies such as lipid nanoparticle (LNP) formulation and automated bioprocessing. Thus, such advancements accelerate development timelines, improve product quality, and enable faster initiation of clinical trials, contributing to global market growth.

Moreover, rapid innovations in biomanufacturing, such as automated single-use systems, AI-driven process optimization, continuous manufacturing, and lipid nanoparticle (LNP) delivery technologies, enhance efficiency, scalability, and product consistency. For instance, in March 2023, WACKER, CordenPharma, LMU, and HU Berlin launched a USD 1.51 million project to accelerate RNA drug development, using machine learning, to optimize lipid nanoparticle (LNP) formulations, reducing costs and development time for mRNA, saRNA, and circRNA therapeutics targeting vaccines, cancer, and hereditary diseases. This initiative highlights the growing role of advanced technologies, such as AI-driven formulation and LNP optimization, in streamlining nucleic acid drug development. Therefore, pharmaceutical companies increasingly outsource complex processes to contract manufacturers and CDMOs with advanced capabilities, driving demand for contract manufacturing services. The integration of advanced analytics, high-throughput screening, and digital monitoring further strengthens contract manufacturers’ ability to support global production needs, positioning them as essential partners in delivering high-quality, safe, and effective nucleic acid therapeutics to market rapidly.

Opportunity Analysis

The market presents significant opportunities driven by the expanding pipeline of mRNA, siRNA, and gene-editing therapies. The growing demand for personalized and precision medicines, combined with the limited in-house capabilities of biotech companies, is fueling outsourcing to specialized contract manufacturers. Advancements in lipid nanoparticle (LNP) delivery, AI-driven formulation, and automated synthesis are enhancing the efficiency and scalability of these technologies. In addition, growing government funding, strategic collaborations, and regulatory support for novel therapies are boosting market potential. Moreover, emerging markets in Asia-Pacific and the Middle East are also investing heavily in biomanufacturing infrastructure, creating lucrative opportunities for global contract manufacturers to expand capacity and service portfolios.

Impact of U.S. Tariffs on the Global Market

The imposition of U.S. tariffs on imported biopharmaceutical materials and equipment is creating significant disruptions in the global market. Increased costs for raw materials, reagents, and advanced instruments are elevating production expenses for U.S.-based contract manufacturers, reducing profit margins and competitiveness. This has prompted companies to diversify supply chains, shift sourcing to tariff-exempt regions, or expand manufacturing in Asia and Europe to mitigate cost pressures. However, these shifts may delay production timelines and increase regulatory complexities. In the long term, the tariffs could accelerate regionalization of manufacturing and drive strategic partnerships to stabilize global supply networks.

Technological Advancements

Technological advancements are propelling the market toward efficiency and innovation. AI and machine learning accelerate formulation design and optimize manufacturing workflows. Automation and digital twin technologies enhance precision, reduce errors, and streamline GMP compliance. The market is witnessing advancements in lipid nanoparticle (LNP) delivery systems that improve stability and targeted delivery of RNA drugs.

Integration of single-use bioprocessing systems enables flexibility and rapid scale-up for personalized therapies. Furthermore, synthetic biology and enzymatic synthesis technologies offer sustainable, high-purity, and scalable production of nucleic acids. In conclusion, these innovations drive faster drug development, lower costs, and expand the therapeutic potential of nucleic acid-based medicines globally.

Pricing Model Analysis

In the market, pricing models are evolving to enhance flexibility and collaboration. Milestone-based pricing ties payments to project achievements, ensuring accountability. Value-based pricing focuses on the therapy’s clinical or market impact, rewarding innovation. Fixed-fee models offer cost predictability for standardized processes, while subscription or retainer models provide continuous access to contract manufacturers' expertise and infrastructure.

Thus, these models enable clients to optimize budgets, manage risks, and accelerate time-to-market. They reflect the industry’s shift toward outcome-driven, partnership-oriented frameworks that support the growing demand for scalable and efficient RNA, DNA, and gene therapy manufacturing solutions globally.

Market Concentration & Characteristics

The nucleic acid therapeutics contract manufacturing industry is in a moderate growth stage, with growth accelerating. The market is characterized by the degree of innovation, level of M&A activities, regulatory impact, service expansion, and regional expansion.

The market is witnessing continuous innovation in mRNA, saRNA, and LNP technologies. Contract manufacturers are integrating AI, automation, and advanced analytics to enhance process optimization, scalability, and quality. For instance, in October 2025, Recipharm received a major Gates Foundation grant to develop AI-enabled manufacturing for xRNA vaccines, enhancing efficiency and affordability. This innovation aims to reduce costs and expand access to life-saving therapies globally.

Mergers and acquisitions are accelerating as contract manufacturers seek to strengthen capabilities and global reach. Strategic consolidations allow companies to expand RNA and DNA manufacturing expertise, integrate advanced technologies, and streamline supply chains. For instance, in August 2023, the NIH and Exothera S.A. collaborated with Dartmouth experts to develop an intranasal COVID-19 vaccine, aiming to enhance mucosal immunity and simplify global vaccine delivery, thereby strengthening pandemic preparedness and equitable access.

Regulatory frameworks significantly influence market dynamics. Agencies such as the FDA and EMA are establishing clearer guidelines for the manufacturing of RNA, DNA, and gene therapies, ensuring product safety and consistency. Compliance with evolving GMP and quality standards drives investment in advanced manufacturing infrastructure, while harmonized global regulations facilitate faster approvals and cross-border collaborations among contract manufacturers and biotech innovators.

Contract manufacturers are broadening service portfolios to include process development, analytical testing, formulation, and fill-finish capabilities. Expansion into LNP formulation, plasmid DNA, and RNA synthesis enables end-to-end solutions for clients.

Global players are expanding their geographic footprint to meet rising regional demand. North America and Europe lead innovation, while Asia-Pacific emerges as a key manufacturing hub due to cost advantages and supportive policies. Expansion into Latin America and the Middle East further diversifies production networks, ensuring resilience, local access, and scalability for global biotherapeutics supply.

Type Insights

Based on type, in 2024, the RNA-based therapies segment held the largest market share, accounting for a revenue share of 65.27%. This growth is driven by their transformative potential in treating a wide range of diseases, including cancer, genetic disorders, and infectious diseases, as well as by increasing government-based initiatives and funding. For instance, in September 2025, the UK government invested USD 38.31 million in the RNA Biofoundry at CPI’s Centre of Excellence that will accelerate RNA therapy development, fostering innovation and faster patient access. The success of mRNA vaccines has accelerated global investment and innovation, leading to rapid advancements in RNA synthesis, modification, and delivery technologies. Contract manufacturers are expanding their capabilities in mRNA, siRNA, and saRNA production by utilizing advanced lipid nanoparticle (LNP) formulations and AI-enabled process optimization.

The gene therapy segment is the fastest-growing area within the market. The market is driven by the rising prevalence of genetic disorders and the growing demand for targeting rare genetic disorders. According to a WHO report, genetic disorders and congenital abnormalities affect approximately 2%-5% of all live births, contributing to up to 30% of pediatric hospital admissions and nearly 50% of childhood deaths in industrialized nations. In addition, growing advancements in viral and non-viral delivery systems, such as adeno-associated viruses (AAVs) and lipid nanoparticles (LNPs), have significantly enhanced therapeutic precision and safety. Increasing regulatory approvals and government funding are accelerating the progress of clinical trials and commercial production. Furthermore, expanding contract manufacturers' capabilities in process development, GMP manufacturing, and analytical testing are supporting the large-scale production of gene therapies.

Service Insights

GMP manufacturing led the market in 2024, with the largest revenue share, and is expected to be the fastest-growing segment over the forecast period. The market is growing due to its essential role in ensuring high-quality, safe, and regulatory-compliant production of nucleic acid-based therapies. The contract manufacturers provide end-to-end GMP services, including the production of plasmid DNA, mRNA, siRNA, and oligonucleotides, supporting both clinical and commercial-scale needs. In addition, process consistency and minimum batch variability are achieved through advanced facilities, automation, and stringent quality control systems.

The process development and optimization segment is the second fastest-growing market, owing to its critical role in ensuring product quality, scalability, and regulatory compliance. These services enable efficient transition from laboratory-scale synthesis to large-scale GMP manufacturing, reducing production costs and time-to-market. In addition, contract manufacturers increasingly employ advanced analytics, automation, and AI-driven process modeling to enhance reproducibility and yield. Moreover, continuous manufacturing techniques and real-time monitoring are also being adopted to meet growing demand for nucleic acid-based therapies such as mRNA, siRNA, and oligonucleotides.

Application Insights

Genetic disorders represented the largest segment in the market in 2024, driven by the rising global prevalence of genetic disorders, increasing demand for targeted therapies, and precision medicine for treatments. These therapies aim to replace faulty genes responsible for inherited diseases such as cystic fibrosis, Duchenne muscular dystrophy, hemophilia, and spinal muscular atrophy. CDMOs support development through large-scale plasmid DNA and viral vector production under GMP conditions. Moreover, advancements in gene editing and delivery technologies, including AAV and lentiviral vectors, are expanding the pipeline of curative treatments. Such factors are expected to drive the market growth.

The infectious diseases segment is projected to witness the fastest growth during the forecast period due to the urgent global need for vaccines and antiviral therapies. Outbreaks of diseases such as COVID-19, influenza, and emerging viral infections have accelerated the development of mRNA, siRNA, and DNA-based therapeutics. In addition, contract manufacturing organizations play a crucial role by offering specialized capabilities in process optimization, GMP manufacturing, and quality control to meet rapid production demands. Furthermore, advancements in technology, such as oral nucleic acid delivery systems, lipid nanoparticle delivery systems, and RNA stabilization, further enhance therapeutic efficacy.

End Use Insights

Based on end use, the large biopharmaceutical companies segment accounted for the largest share in 2024. The growth of this segment is driven by its extensive R&D budgets, established manufacturing infrastructure, and global distribution networks. These companies actively collaborate with contract manufacturers to accelerate the development and commercialization of RNA, DNA, and oligonucleotide therapeutics. Their robust pipelines for gene therapies, mRNA vaccines, and rare disease treatments require scalable, high-quality contract manufacturing solutions to meet regulatory standards and market demand. Strategic partnerships, technology licensing, and investment in next-generation manufacturing platforms further strengthen their market.

The medium biopharmaceutical companies segment is the fastest-growing in the market, with a notable CAGR, fueled by the rising number of innovative biotech firms developing niche RNA, DNA, and oligonucleotide therapeutics. These companies often lack in-house large-scale manufacturing capabilities, driving demand for specialized contract manufacturing services to accelerate process development, GMP production, and clinical trial supply. Strategic collaborations with contract manufacturers allow medium-sized firms to access advanced technologies, reduce time-to-market, and manage costs effectively.

Regional Insights

North America held the largest market revenue share of 47.42% in 2024, primarily attributed to the rising demand for mRNA vaccines, gene and oligonucleotide therapies, and the increasing presence of leading pharmaceutical companies. Besides, a strong clinical research infrastructure and growing regulatory support are further contributing to market growth. In addition, the region is witnessing advancements in scalable enzymatic and in vitro transcription platforms, single-use bioprocessing, automation, and continuous manufacturing. Furthermore, the growing development and commercialization of innovative biologic treatments are anticipated to drive the market growth. Some of the key players, such as Agilent, Curia, Ajinomoto, Danaher (Aldevron), KNC Laboratories, LGC, Merck KGaA, WuXi AppTec, BIOSPRING, Univercells, and Exothera, compete on capacity, speed, and quality.

U.S. Nucleic Acid Therapeutics Contract Manufacturing Market Trends

The nucleic acid therapeutics contract manufacturing market in the U.S. accounted for the largest market share in the North American market, driven by rising demand for mRNA, growing demand for biosimilars, and increasing strategic collaborations between contract manufacturers. In the market, most CDMOs are expanding their biologics capabilities. For instance, in September 2024, ReciBioPharm partnered with Hongene Biotech to enhance the manufacturing of gene-editing drugs. Hongene’s novel sgRNA synthesis reduces impurities, improving quality, whereas ReciBioPharm’s Boston-based GMP facilities advance continuous mRNA-LNP manufacturing in collaboration with MIT and the FDA’s CBER.

Canada nucleic acid therapeutics contract manufacturing market is expected to grow at a significant CAGR during the forecast period, driven by strong government incentives, a strong biopharmaceutical ecosystem, and favorable government initiatives. For instance, in October 2024, OmniaBio Inc. opened Canada’s largest CGT CDMO facility in Ontario, an AI-driven, automated center of excellence enhancing cell and gene therapy manufacturing efficiency. Canada is also a well-established competitive capital for advanced nucleic acid therapeutics, enabling scalable, high-quality production and accelerating access to innovative biotherapies worldwide.

Europe Nucleic Acid Therapeutics Contract Manufacturing Market Trends

The nucleic acid therapeutics contract manufacturing market in Europe is projected to experience growth at a specific CAGR during the forecast period, driven by rising biotech investment, expanding biologics pipelines, and facility expansions across the region. Some key trends driving this market include the use of digital technologies, such as AI and blockchain, which are improving efficiency and patient engagement. In addition, in January 2025, Exothera partnered with Vaxthera to develop a universal COVID-19/Mpox bivalent vaccine, providing process development, scale-up, and GMP manufacturing for Phase 1 EU trials, advancing global vaccine innovation and healthcare resilience.

Germany nucleic acid therapeutics contract manufacturing market held the highest share in 2024. fueled by rising R&D investment, increasing healthcare awareness, and technological innovations. Furthermore, the increasing focus on precision medicine and advanced therapies is further strengthening innovation in clinical trial approaches. In addition, the country has seen an increase in innovation in monoclonal antibodies, biosimilars, and cell and gene therapies, which is expected to drive segment growth over the estimated period. Such factors are expected to drive the market growth.

The nucleic acid therapeutics contract manufacturing market in the UK accounted for the largest share in 2024. Growth of this region is driven by strong government support, advanced infrastructure, and a thriving biotech ecosystem. For instance, in August 2025, the UK advanced its RNA therapeutics capabilities with the USD 37.8 million launch of the UK RNA Biofoundry at CPI’s RNA Centre of Excellence, designed to accelerate drug development, lower production costs, and improve scalability for early-stage clinical trials.

Asia Pacific Nucleic Acid Therapeutics Contract Manufacturing Market Trends

The nucleic acid therapeutics contract manufacturing market in the Asia Pacific is projected to experience growth at a specific CAGR during the forecast period. The region is driven by government-backed R&D initiatives, increasing demand for mRNA vaccines, gene therapies, cost-effective research capabilities, and oligonucleotide-based drugs. In addition, countries such as China, India, and Japan are establishing GMP facilities, implementing automation systems, and forming strategic collaborations to accelerate the production of nucleic acid drugs in a scalable and cost-efficient manner. Major players are leading advancements through automation, AI-driven quality control, and GMP-certified facilities.

Japan nucleic acid therapeutics contract manufacturing market accounted for the largest share in 2024. Market growth is driven by strong government initiatives, advanced healthcare infrastructure, and rising investments in biopharmaceutical R&D across the country. Besides, the country's expertise in monoclonal antibodies, regenerative medicine, and cell and gene therapies drives the requirement for outsourcing among CROs for preclinical and clinical research.

The nucleic acid therapeutics contract manufacturing market in India is expected to grow at the fastest CAGR during the forecast period, supported by expanding biologics and GMP-certified manufacturing capabilities. For example, in June 2025, Aragen announced plans to start GMP manufacturing at its new Bangalore biologics facility. The country is developing a skilled scientific workforce, with advanced clinical trial infrastructure and a favorable regulatory environment, which further attracts global outsourcing partnerships.

China nucleic acid therapeutics contract manufacturing market is expected to register substantial growth during the forecast period. The expansion of biopharma clusters and advanced CDMO infrastructure drives growth. For instance, in September 2025, Porton Advanced partnered with RongCan Biotech to co-develop ionizable lipids for mRNA delivery, combining innovation and GMP manufacturing expertise. This collaboration strengthens the region’s global competitiveness, accelerating the commercialization of next-generation gene and cell therapies.

Latin America Nucleic Acid Therapeutics Contract Manufacturing Market Trends

The nucleic acid therapeutics contract manufacturing market in Latin America is projected to register a significant CAGR during the forecast period, driven by growing biopharmaceutical demand and cost-competitive manufacturing. Some of the advancements include expansion of GMP facilities, lipid nanoparticle technology, and regional regulatory harmonization, which propel the market growth. In addition, companies, including local firms and international partnerships, focus on technology transfer, process scale-up, and regulatory compliance.

Brazil nucleic acid therapeutics contract manufacturing market is experiencing robust growth driven by rising demand for mRNA vaccines, gene therapies, and oligonucleotide-based drugs. Government support, tax incentives, and biotech clusters in São Paulo and Rio de Janeiro foster innovation and infrastructure growth. In addition, key players, including local contract manufacturing and international partnerships, focus on GMP-compliant facilities, advanced LNP technologies, and process scale-up capabilities.

Middle East & Africa Nucleic Acid Therapeutics Contract Manufacturing Market Trends

The nucleic acid therapeutics contract manufacturing market in the MEA is growing steadily, driven by increasing healthcare investments and government-backed biotech initiatives. Strategic collaborations with global biopharma firms and the adoption of advanced technologies are enhancing manufacturing efficiency. Key players focus on establishing GMP-certified contract manufacturing facilities, advanced process development, and technology transfer partnerships.

South Africa nucleic acid therapeutics contract manufacturing market is expected to be the fastest CAGR during the forecast period, due to the growing biotech ecosystem, increasing prevalence of infectious diseases, and rising pharmaceutical demand. The government’s investment in biotech infrastructure, coupled with supportive regulations and funding initiatives, is fostering growth. Some of the key companies and emerging local CDMOs focus on establishing GMP-compliant facilities, process scale-up, and technology transfer partnerships.

The nucleic acid therapeutics contract manufacturing market in the UAE is gaining momentum, supported by strategic healthcare initiatives and growing demand for advanced healthcare solutions. Some key players, such as PureHealth and emerging local contract manufacturers, are expanding their GMP-certified facilities and integrating advanced technologies, including AI-driven bioprocessing and automation. For instance, in April 2025, Abu Dhabi’s DoH and Abu Dhabi Investment Office (ADIO) partnered with GSK to establish a multi-omics research institute, advancing oncology-focused genomic science, precision medicine, and early-stage discovery within the UAE.

Key Nucleic Acid Therapeutics Contract Manufacturing Company Insights

Key players in the market include Agilent Technologies, WuXi AppTec, Curia, Danaher (Aldevron), Merck KGaA, LGC, KNC Laboratories, BIOSPRING, Univercells, Exothera, and Aragen. These companies compete through technological innovation, GMP-certified facilities, strategic partnerships, and capacity expansions, shaping global market dynamics and capturing significant shares. For example, in October 2025, Ajinomoto Bio-Pharma partnered with Gene Tools to streamline oligonucleotide production, combining early-stage synthesis with purification and GMP capabilities, accelerating research, GLP studies, and clinical development of genetic therapies.

Recent Developments

• In January 2025, Evonik partnered with ST Pharm to expand RNA and nucleic acid therapeutic services, integrating LNP development and system solutions to streamline production, reduce complexity, and accelerate speed-to-market for drug developers. This collaboration enhances Evonik’s CDMO offerings, supporting the rapid growth and commercialization of nucleic acid therapeutics globally.

• In April 2025, Wacker Biotech and RNAV8 Bio combined expertise in pDNA/mRNA manufacturing and LNP formulation with mRNA engineering, optimizing UTR sequences to improve drug stability, efficacy, and production efficiency. The partnership positions both companies as leading premium providers of mRNA-based therapeutic solutions.

• In June 2024, Nippon Shokubai announced a tenfold expansion of GMP-compliant nucleic acid API manufacturing to meet growing global demand, supporting large-scale production for the treatment of rare diseases, neurological disorders, and cancer therapies by 2027.

Nucleic Acid Therapeutics Contract Manufacturing Market Report Scope

Global Nucleic Acid Therapeutics Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global nucleic acid therapeutics contract manufacturing market report based on type, service, application, end use, and region:

• Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Gene Therapy

    • Plasmid DNA (pDNA)

    • Viral Vectors

    • Non-viral Gene Delivery Systems

    • Others

  • RNA-based Therapies

    • Messenger RNA (mRNA)

    • Small Interfering RNA (siRNA)

    • Antisense Oligonucleotides (ASO)

    • Other

• Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Process Development and Optimization

  • GMP Manufacturing

  • Analytical and Quality Control Service

  • Fill-Finish Contract Manufacturing

  • Regulatory Support

  • Others

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Oncology

  • Rare Diseases

  • Genetic Disorders

  • Infectious Diseases

  • Others

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Large Biopharmaceutical Companies

  • Medium Biopharmaceutical Companies

  • Small Biopharmaceutical Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia

    • Kuwait

    • Qatar

    • Oman