U.S. Plasmid DNA Contract Manufacturing Market Summary

The U.S. plasmid DNA contract manufacturing market size was estimated at USD 146.0 million in 2023 and is projected to grow at a CAGR of 19.2% from 2024 to 2030. This strong growth is largely driven by the rising adoption of cell and gene therapies for the treatment of a wide range of diseases. The increasing use of gene therapy, especially chimeric antigen receptor T-cell (CAR-T) therapies, has significantly boosted the demand for plasmid DNA, thereby accelerating the requirement for contract manufacturing services. As cell and gene therapies move toward commercialization and broader clinical adoption, contract manufacturers are playing a critical role in meeting the complex production needs of this field.

Technological advancements aimed at overcoming the limitations of conventional vector production methods are also expected to support the expansion of the plasmid DNA contract manufacturing market. Innovations in large-scale manufacturing, purification techniques, and quality control have made it possible to deliver high-quality plasmid DNA efficiently. Furthermore, the application of gene therapy has expanded to cover a wide range of diseases, including viral infections, malignancies, hereditary disorders, and immunotherapy-related treatments. In particular, the increasing use of gene therapy for cancer has emerged as a major driver of market growth in the U.S., given the rising number of patients and new therapy approvals.

Key Market Trends & Insights

• Based on application, the cell and gene therapy segment dominated the market with a 60.4% share in 2023 and is expected to maintain this leadership throughout the forecast period. The dominance of this segment can be attributed to the rising number of clinical trials, which has led to a surge in approved therapies. With increasing reliability, improved safety, and growing efficiency of gene treatments, the demand for plasmid DNA is expected to remain consistently high, supporting the need for contract manufacturing.
• In terms of therapeutic insights, the cancer segment accounted for the largest share of 39.1% in 2023. This dominance is primarily driven by the increasing prevalence of cancer in the U.S. population and the heightened focus of biopharmaceutical companies on developing innovative cancer therapeutics. The rapid adoption of cell and gene therapies for cancer treatment has significantly fueled the demand for plasmid DNA, further boosting the growth of contract manufacturing services.
• Based on end-use, pharmaceutical and biotechnology companies held the largest market share at 59.3% in 2023. This leadership is attributed to the increasing demand for plasmid DNA-based therapeutics and vaccines across the U.S. Additionally, key companies are actively investing in strategic initiatives, partnerships, and technological advancements to enhance production capacity and ensure a reliable supply of pDNA. These efforts are expected to further support segment growth over the coming years.
• The research institutes segment is anticipated to register the fastest growth from 2024 to 2030. This growth is driven by rising funding and grants dedicated to cell and gene therapy research, which has led to an expansion of plasmid DNA-related projects in academic and institutional settings. Research institutes are becoming increasingly important players in advancing cell and gene therapy pipelines, thereby fueling the demand for reliable contract manufacturing services.

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Market Size & Forecast

• 2023 Market Size: USD 146.0 million
• 2030 Projected Market Size: USD 497.8 million
• CAGR (2024 - 2030): 19.2%

Key Companies & Market Share Insights

The market landscape is consolidated, with the presence of a small number of companies holding majority stake. Key players operating in the market are Aldevron; Charles River Laboratories; Akron Biotech; VGXI, Inc., and Catalent, Inc.

The market growth is further enhanced by new expansion activities, product approvals, partnerships, mergers & acquisitions. Furthermore, there has been a significant increase in the demand for U.S. plasmid DNA contract manufacturing due to the growing research and development activities that are fueling the market growth.

Key Players

• Aldevron
• Charles River Laboratories
• Akron Biotech
• VGXI, Inc.
• Catalent, Inc
• DH Life Sciences, LLC
• Recipharm AB
• TriLink BioTechnologies
• AGC Biologics
• Thermo Fisher Scientific Inc.

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Conclusion

The U.S. plasmid DNA contract manufacturing market is experiencing robust growth, fueled by the rising adoption of cell and gene therapies, particularly for cancer treatment. Increasing clinical trials, advancements in vector production technologies, and supportive funding for research are accelerating demand across pharmaceutical companies, biotech firms, and research institutes. With cancer and other chronic diseases driving therapeutic innovation, the market is witnessing strong demand from both commercial and academic sectors. As plasmid DNA remains a cornerstone in the development of advanced therapies, contract manufacturing will continue to play a critical role in shaping the future of gene-based medicine in the U.S.