US Plasmid DNA Manufacturing Market Size, Share, Trends and Forecast by Grade, Development Phase, Application, Disease, and Region, 2025-2033

US Plasmid DNA Manufacturing Market Overview:

The US plasmid DNA manufacturing market size reached USD 526.11 Million in 2024. The market is projected to reach USD 4,122.70 Million by 2033, exhibiting a growth rate (CAGR) of 22.86% during 2025-2033. The market is driven by the accelerated pace of FDA approvals for cell and gene therapies, which has significantly increased demand for high-quality plasmid DNA as a critical starting material for viral vector production. Additionally, strategic expansions of manufacturing infrastructure are enhancing production capacity to meet the rapidly growing needs of gene therapy developers. Furthermore, increased government investment through public-private partnerships is expanding the US plasmid DNA manufacturing market share.

US Plasmid DNA Manufacturing Market Trends:

Accelerated FDA Approvals Driving Commercial-Scale Plasmid DNA Production

The rapid acceleration of FDA approvals for cell and gene therapies is fundamentally reshaping the plasmid DNA manufacturing landscape in the US. In 2024, the FDA approved eight novel cell and gene therapies, representing a notable increase from previous years and demonstrating the agency's progress toward its goal of approving 10 to 20 such therapies annually by 2025. This regulatory momentum is directly driving the demand for GMP-grade plasmid DNA, which serves as an indispensable starting material for viral vector production in gene therapies and as a direct therapeutic agent in DNA vaccine development. In 2025, the FDA approved multiple advanced therapies, including Libmeldy for metachromatic leukodystrophy and BEQVEZ™ for hemophilia B, expanding treatment options nationwide and reinforcing the critical role of plasmid DNA in enabling these breakthrough therapies. As more therapies advance through clinical development and receive approval, the demand for scalable, high-quality plasmid DNA manufacturing capabilities continues to intensify, driving investment and innovation throughout the supply chain. This trend is particularly pronounced in applications supporting chimeric antigen receptor T (CAR-T) cell therapies and engineered cell therapies targeting cancer and rare genetic disorders, where plasmid DNA quality and consistency are paramount to therapeutic efficacy and patient safety.

Strategic Infrastructure Expansion Meeting Unprecedented Manufacturing Demand

The explosive growth in cell and gene therapy development is catalyzing unprecedented expansion of plasmid DNA manufacturing infrastructure across the US. Leading contract development and manufacturing organizations are making substantial capital investments in state-of-the-art GMP facilities specifically designed for plasmid DNA production at clinical and commercial scales. In 2024, Bionova Scientific announced the establishment of a new dedicated plasmid DNA manufacturing facility in The Woodlands, Texas, with process development services beginning in the first quarter of 2025 and GMP manufacturing capabilities launching later in 2025. This expansion reflects the strategic response to growing global demand for plasmid DNA as a critical starting material for cell and gene therapies, mRNA vaccines, and antibody drugs. Similarly, ProBio opened its flagship 128,000 square foot Cell and Gene Therapy Center of Excellence in Hopewell, New Jersey, creating over 110 high-skilled jobs and establishing a comprehensive North American hub for plasmid DNA and viral vector manufacturing. These facility expansions are characterized by adoption of advanced single-use technologies, automated purification systems, and integrated quality control capabilities that significantly reduce production timelines while maintaining stringent regulatory compliance. The proliferation of specialized plasmid DNA CDMOs is enabling biotech and pharmaceutical companies to outsource complex manufacturing operations to capable service providers, allowing them to focus resources on research and development. This infrastructure buildout is also supporting the US plasmid DNA manufacturing market growth by reducing supply chain bottlenecks, improving turnaround times, and providing developers with reliable access to the critical starting materials.

Government Investment Accelerating Gene Therapy Innovation and Market Expansion

Government investment is spurring innovation and growth in the U.S. plasmid DNA production market. Federal and state programs are increasingly investing in advanced genetic research, biopharmaceutical production, and gene therapies of the future. These investments are fueling the construction of advanced plasmid DNA production facilities and spurring public-private partnerships between public research centers and private biotechnology companies. By supporting research programs and providing grants for capacity building, the government is enhancing in-country production capabilities and lowering dependence on foreign suppliers. This forward-thinking strategy is building a competitive environment that encourages quick commercialization of breakthrough therapies and facilitates rising demand for quality plasmid DNA. With favorable regulatory frameworks, the market is witnessing increased technological progress, scalability, and increased adoption of plasmid DNA in various applications, ranging from vaccines and gene therapies to cell-based therapeutics.

US Plasmid DNA Manufacturing Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country and regional levels for 2019-2033. Our report has categorized the market based on grade, development phase, application, and disease.

Grade Insights:

• R&D Grade
  • Viral Vector Development
    • AAV
    • Lentivirus
    • Adenovirus
    • Retrovirus
    • Others
• mRNA Development
• Antibody Development
• DNA Vaccine Development
• Others

The report has provided a detailed breakup and analysis of the market based on the grade. This includes R&D grade [viral vector development (AAV, lentivirus, adenovirus, retrovirus, and others)], mRNA development, antibody development, DNA vaccine development, and others.

Development Phase Insights:

• Pre-Clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

A detailed breakup and analysis of the market based on the development phase have also been provided in the report. This includes pre-clinical therapeutics, clinical therapeutics, and marketed therapeutics.

Application Insights:

• DNA Vaccine
• Cell and Gene Therapy
• Immunotherapy
• Others

The report has provided a detailed breakup and analysis of the market based on the application. This includes DNA vaccine, cell and gene therapy, immunotherapy, and others.

Disease Insights:

• Infectious Disease
• Cancer
• Genetic Disorder
• Others

A detailed breakup and analysis of the market based on the disease have also been provided in the report. This includes infectious disease, cancer, genetic disorder, and others.

Regional Insights:

• Northeast
• Midwest
• South
• West

The report has also provided a comprehensive analysis of all the major regional markets, which include Northeast, Midwest, South, and West.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

US Plasmid DNA Manufacturing Market News:

• July 2025: Charles River Laboratories International and Elly's Team, a parent-led organization focused on discovering a cure for the rare genetic condition NEDAMSS, revealed a contract development and manufacturing organization (CDMO) agreement for plasmid DNA. Through Charles River's Cell and Gene Therapy Accelerator Program, Elly's Team utilized existing gene therapy CDMO resources to produce essential starting materials for a Phase I clinical trial, leveraging Charles River's eXpDNA™ plasmid platform and ready-to-use AAV Rep/Cap plasmids to hasten clinic timelines.
• April 2024: Charles River Laboratories International and Ship of Theseus, a therapeutics firm focused on creating degradation-resistant homeobox family biologics, have declared a contract development and manufacturing organization agreement for Good Manufacturing Practice plasmid DNA. Ship of Theseus will utilize Charles River's top-tier expertise to produce GMP plasmid DNA, acting as the active drug substance for its primary candidate, aiding in therapeutic development for conditions such as diabetic and chronic wounds, neutropenia, psoriasis, androgenetic alopecia, women’s health and infertility, as well as epithelial cancers.

US Plasmid DNA Manufacturing Market Report Coverage:

Key Questions Answered in This Report:

• How has the US plasmid DNA manufacturing market performed so far and how will it perform in the coming years?
• What is the breakup of the US plasmid DNA manufacturing market on the basis of grade?
• What is the breakup of the US plasmid DNA manufacturing market on the basis of development phase?
• What is the breakup of the US plasmid DNA manufacturing market on the basis of application?
• What is the breakup of the US plasmid DNA manufacturing market on the basis of disease?
• What is the breakup of the US plasmid DNA manufacturing market on the basis of region?
• What are the various stages in the value chain of the US plasmid DNA manufacturing market?
• What are the key driving factors and challenges in the US plasmid DNA manufacturing market?
• What is the structure of the US plasmid DNA manufacturing market and who are the key players?
• What is the degree of competition in the US plasmid DNA manufacturing market?

Key Benefits for Stakeholders:

• IMARC's industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the US plasmid DNA manufacturing market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the US plasmid DNA manufacturing market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the US plasmid DNA manufacturing industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.