The Rising demand for gene therapy & cell therapy has driven the growth of the U.S. viral vectors & plasmid DNA manufacturing market. Gene therapy treatments for genetic disorders, cancer, and rare diseases require viral vectors and plasmid DNA. U.S. Food and Drug Administration and European Medicines Agency - European Union approvals for gene therapies like Zolgensma (spinal muscular atrophy) and Luxturna (inherited retinal disease) drive demand. The growth of CAR-T cell therapy & immunotherapy has driven the growth of the U.S. viral vectors & plasmid DNA manufacturing market in the future.
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U.S. Viral Vectors & Plasmid DNA Manufacturing Market Report Highlights
• Based on vector type, the adeno-associated virus (AAV) segment dominated the market with the largest revenue share of 25.8% in 2024.
• The lentivirus segment is projected to grow at the fastest CAGR of 20.3% during the forecast period.
• Based on workflow, the downstream processing segment dominated the market with the largest revenue share of 62.3% in 2024.
• The upstream processing segment is expected to grow at a CAGR of 19.3% over the forecast period.
• Based on the application, the vaccinology segment accounted for the largest revenue share of 28.0% in 2024.
• The cell therapy segment is expected to grow at the fastest CAGR over the forecast period.
• Based on end-use, the research institutes segment dominated the market with the largest revenue share of 65.9% in 2024.
• The pharmaceutical & biotechnology companies segment is expected to grow at a CAGR of 20.5% over the forecast period.
• Based on diseases, the cancer segment dominated the market with the largest revenue share of 44.7% in 2024.
• The genetic disorders are expected to grow rapidly during the forecast period.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Growth Factors
According to the World Health Organization (WHO) risk assessment, in April 2024, Avian Influenza A(H5N1)-virus, from 2003 to 1 April 2024, a total of 889 cases and 463 deaths (CFR 52%) caused by influenza A(H5N1) virus has been reported worldwide from 23 countries.
The Strong biotech & pharmaceutical investment has been observed to drive the growth of the U.S. vectors & plasmid DNA manufacturing market. Major funding from), venture capital, National Institutes of Health (NIH and Big Pharma (Novartis, Pfizer, Gilead) support gene therapy innovation. Startups and biotech firms increasingly partner with Contract Development & Manufacturing Organizations (CDMOs) to scale production.
· For instance, in June 2024, A global contract development and manufacturing organization (CDMO) specializing in biopharma's most complex therapies, PCI Pharma Services ("PCI"), invested over US$365 million in infrastructure to support the final assembly and packaging of drug-device combination products at the clinical and commercial scales using cutting-edge drug delivery systems, with a focus on injectable formats.
The initiative is a component of PCl's worldwide investment plan, is anchored and financed by recent new business, and consists of both new and enlarged facilities across North America and Europe. It is also intended to support and accommodate future development. The investments for PCI expand on the company's more than two decades of biologics experience, which is emphasized by its renowned Biotech Center of Excellence in Philadelphia. For prefilled syringes, syringe assembly and labeling, vial labeling and cartoning, and autoinjector assembly, that facility uses precision handling equipment. In order to improve capabilities and capacities at this facility and guarantee that it stays at the forefront of innovation, PCI recently made significant investments in sophisticated, automated, advanced medication delivery technology.
Furthermore, PCI is expanding its global reach and influence by acquiring a recently constructed pharmaceutical packaging and device assembly facility close to Dublin, Ireland, which has extensive temperature-controlled storage capacity. The plant will start operations in Q4 2024 and will offer injectables and oral solid dosage (OSD) medication items on a commercial scale for packaging and assembly.
Expanding mRNA & DNA vaccine development has been estimated to drive the growth of the U.S. viral vectors & plasmid DNA manufacturing market in the near future. Plasmid DNA is a key raw material for mRNA vaccines (e.g., Pfizer-BioNTech, Moderna COVID-19 vaccines). Ongoing R&D into cancer vaccines, personalized mRNA therapies, and infectious disease vaccines continues to drive demand.
For instance, in February 2025, Researchers in Paris will develop new technology that could expedite the manufacturing of mRNA-based vaccines and increase the technology's accessibility worldwide. To improve their capacity to automate the production of synthetic DNA templates—the initial blueprint needed to produce mRNA—CEPI is giving DNA Script US$4.7 million. This investment could improve preparedness to make such vaccines, especially in Global South regions, and expedite the timelines for mRNA vaccine development. While making a DNA template can take up to a month, the production of mRNA itself only takes about seven days, which causes a manufacturing bottleneck. This is due to the fact that these templates are typically created via expensive and time-consuming biologically made techniques. CEO of DNA Script, Marc Montserrat, stated that in addition to immediately supporting the goal of accelerating vaccine development and delivery globally, DNA Script company’s partnership with CEPI to deploy DNA Script company’s exclusive enzymatic DNA synthesis technology is more generally consistent with DNA Script company’s objective to make biology programmable. DNA Script company is contributing to ensuring that cutting-edge vaccination technology can reach people most at risk during developing epidemics more quickly than ever before by significantly cutting down on the time required to generate DNA templates and facilitating the synthesis of longer and more complex DNA sequences.
Technological advancements in bioprocessing & manufacturing are estimated to drive the growth of the U.S. viral vectors & plasmid DNA manufacturing market in the near future. Innovations in scalable bioreactor systems, automation, and vector purification methods are improving production efficiency. Companies are adopting stable producer cell lines and suspension-based vector production for higher yields.
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U.S. Viral Vector And Plasmid DNA Manufacturing Market current Trends
• The adoption of artificial intelligence in biomanufacturing processes enhances efficiency, precision, and scalability, contributing to market growth. Implementing automated systems and digital tools streamlines production reduces errors, and accelerates time-to-market for genes.
• Advancements in Gene Therapy: The development of new gene therapies heavily relies on high-quality viral vectors and plasmid DNA, fueling demand in the market.
• Increased Funding: There is a notable rise in funding for gene therapy development, which supports the expansion of manufacturing capabilities.
• Companies like Touchlight are developing novel synthetic DNA platforms, such as the "doggybone" DNA (dbDNA) technology, which offers rapid and scalable production of high-purity DNA. This approach is gaining traction for its potential to accelerate the development of mRNA-based products.
• Advancements in gene editing technologies, including CRISPR-Cas9, are enabling the engineering of viral vectors and plasmid DNA with enhanced safety, efficacy, and targeting capabilities. This customization is becoming a prominent trend in the market.
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U.S. Viral Vector And Plasmid DNA Manufacturing Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 2,480 Million |
|
Revenue forecast in 2034 |
USD 10,660 Million |
|
Growth rate |
CAGR of 15.7% from 2025 to 2034 |
|
Base year |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Vector type, workflow, application, end-use, disease |
|
Country scope |
U.S. |
|
Key companies profiled |
Thermo Fisher Scientific, Inc.; Catalent Inc.; Waisman Biomanufacturing; Genezen; Revvity (SIRION Biotech); BioMarin; Virovek Incorporation; Charles River Laboratories (Cobra Biologics); RegenxBio, Inc. |
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Artificial intelligence impact Factor
Artificial Intelligence (AI) is transforming the viral vectors & plasmid DNA manufacturing industry by enhancing efficiency, reducing costs, and improving quality control. AI-powered bioprocess monitoring and automation improve fermentation, plasmid DNA synthesis, and viral vector production. Machine learning (ML) models analyze large datasets to optimize conditions for cell growth, viral vector yields, and purification efficiency. AI-assisted bioreactor control systems can adjust nutrient supply, pH, and temperature in real-time to maximize vector production.
AI-powered predictive maintenance reduces downtime and prevents costly equipment failures. Sensors collect real-time data on bioprocess equipment, and AI models predict maintenance needs before failures occur. Increases uptime, enhances efficiency and reduces production delays for viral vector and plasmid DNA manufacturing.
AI-driven image recognition and deep learning models detect contaminants, inconsistencies, and abnormalities in viral vector production. Automated real-time quality control (AI-assisted spectrometry, chromatography, and sequencing) ensures batch-to-batch consistency. Example: AI-powered real-time PCR (qPCR) and next-generation sequencing (NGS) tools enhance the accuracy of viral vector validation. AI speeds up plasmid DNA design for gene therapy and vaccine development, predicting gene expression, stability, and yield. AI-driven protein structure modeling (e.g., AlphaFold) helps optimize viral vector engineering for better gene delivery. For instance, AI identifies optimal plasmid DNA sequences for higher expression efficiency in mRNA vaccine production. Researchers have applied machine learning algorithms to predict viral assembly in adeno-associated virus (AAV) production. By analyzing data from AAV capsid libraries, these models can identify patterns that enhance the efficiency of viral vector assembly, leading to improved manufacturing processes.
In biomanufacturing, digital twins—virtual replicas of physical processes—allow scientists and engineers to simulate and analyze biological systems under various conditions without physical experimentation. This approach enables real-time optimization and control of manufacturing processes, reducing costs and accelerating development timelines.
Form Bio has explored the integration of AI with AAV vector design and biological data to advance gene therapy development. By harmonizing these elements, AI facilitates the creation of safer and more effective treatments. Charles River Laboratories has implemented platform approaches for screening, manufacturing, and testing plasmids. Their case study highlights how these advancements overcome roadblocks and accelerate therapeutic programs, emphasizing the role of AI in optimizing manufacturing processes.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Report Segmentation Insights
Vector Type Insights
By vector type, the adeno-associated virus (AAV) segment registered its dominance over the U.S. viral vectors & plasmid DNA manufacturing market. Adeno-associated virus (AAV) dominates the viral vectors & plasmid DNA manufacturing market as it has a safety profile, long-term gene expression, broad tropism & tissue specificity, efficient gene delivery, strong industry investments, and favorable regulatory landscape. AAV does not cause disease in humans, making it a safer option for gene therapy. Compared to other viral vectors, AAV triggers a relatively mild immune response, reducing the risk of adverse reactions. AAV can establish stable gene expression in non-dividing cells, making it ideal for treating chronic diseases like hemophilia, muscular dystrophy, and neurological disorders. Various AAV serotypes allow targeting of specific tissues (e.g., AAV9 for the nervous system, AAV8 for the liver), enhancing therapeutic efficacy. AAV efficiently transduces both dividing and non-dividing cells, improving its effectiveness for in vivo gene therapy applications. Lonza Group AG is a leading entity in the sector. Lonza offers comprehensive services, including process development, manufacturing, and analytical testing for AAV vectors. Thermo Fisher Scientific Inc. is recognized as a prominent market player, and Thermo Fisher Scientific holds a significant position through product innovation and strategic collaborations. Merck KGaA holds a prominent market position, and it is involved in product innovation and strategic collaborations within the AAV vector manufacturing market.
The lentivirus segment is anticipated to grow with the highest CAGR in the market during the studied years. The lentivirus is in strong demand in CART–cell therapy development. Lentiviral vectors are the preferred choice for delivering genetic modifications in CAR-T cell therapies used to treat blood cancers (e.g., leukemia, lymphoma). FDA-approved therapies like Kymriah (Novartis), Yescarta (Gilead/Kite), and Breyanzi (BMS) use lentiviral vectors. Lentiviruses efficiently deliver CRISPR/Cas9 and other gene-editing tools into human cells, further increasing their demand. Lentiviruses integrate their genetic material into the host genome, leading to stable, long-term expression of therapeutic genes. This makes them ideal for treating genetic disorders and chronic diseases. Unlike AAV, which provides episomal (non-integrating) gene expression, lentiviral vectors are more suitable for therapies requiring permanent genetic modification. Lentiviral vectors efficiently transduce both dividing and non-dividing cells, making them highly versatile for various therapeutic applications. This advantage is particularly important in stem cell therapy, where stable gene delivery is crucial. The FDA has approved multiple lentivirus-based therapies, fueling investment in lentiviral vector manufacturing. More than 50% of gene therapy clinical trials in the U.S. involve lentiviral vectors, highlighting their growing market share. Leading CDMOs (Contract Development and Manufacturing Organizations) such as Thermo Fisher Scientific, Lonza, Catalent, and WuXi AppTec have expanded their lentiviral vector manufacturing capabilities. Biopharma giants like Gilead, Novartis, and BMS continue to drive demand through their investments in lentiviral-based therapies. The lentivirus segment is fastest growing in the U.S. market, driven by its critical role in CAR-T cell therapy, stable gene integration, high transduction efficiency, and increasing regulatory approvals. With continued advancements in manufacturing and commercialization, lentiviral vectors will remain a key player in the gene therapy revolution.
Workflow Insights
By workflow insights, the downstream processing segment held a dominant presence in the market in 2024. Downstream processing is critical for plasmid DNA manufacturing because it ensures high purity, efficiency, and compliance with regulatory standards. With the rising demand for gene therapies, cell therapies, and mRNA vaccines, companies are investing in advanced DSP technologies to improve scalability and cost-effectiveness. Automated purification systems, membrane-based chromatography, and improved filtration technologies are making downstream processing more efficient and scalable. These innovations allow for faster and more cost-effective pDNA production while reducing process variability.
By workflow, the upstream manufacturing segment is expected to be the fastest-growing market. Upstream processing, the first stage of processing, is exposing cells to the virus, allowing them to proliferate, and then removing the virus from them. This specific field is expected to benefit from the rise in creative product development, such as the number 15 microbioreactor system for high throughput upstream process development.
Application Insights
By application insights, the vaccinology segment accounted for the largest revenue share in 2024. Viral vectors and plasmid DNA play a crucial role in modern vaccinology due to their ability to deliver antigens efficiently, induce strong immune responses, and offer rapid scalability. Viral vectors mimic natural infections, triggering both humoral (antibody) and cellular (T-cell) immunity, making them ideal for vaccines. Plasmid DNA vaccines stimulate a strong cytotoxic T-cell response, which is crucial for fighting viral infections and cancers. For instance, Adenovirus-based COVID-19 vaccines (AstraZeneca, J&J) generate robust immunity by delivering the SARS-CoV-2 spike protein gene. Plasmid DNA vaccines can be synthesized quickly without requiring live viruses, making them ideal for pandemic response. Viral vector platforms can be repurposed for different diseases, reducing development time. The mRNA COVID-19 vaccines (Pfizer & Moderna) use plasmid DNA as a template to produce mRNA encoding the spike protein. Viral vectors and plasmid DNA have revolutionized vaccine development by offering safety, rapid production, scalability, and strong immune responses. Their success in COVID-19, Ebola, and cancer vaccines has solidified their place as next-generation vaccine platforms.
The cell therapy segment is anticipated to grow with the highest CAGR in the market during the studied years. As next-generation transfer vectors have been developed, cell therapy-based medications are becoming more and more popular. These vectors have been shown to be both secure and effective. Vectors for gene therapy are typically used to enlarge, extract, and further transduce patient samples. For therapeutic purposes, patients are subsequently given these altered transduced cells.
End-use Insights
Based on end-use, the research institutes segment dominated the U.S. viral vectors & plasmid DNA manufacturing market with the largest revenue share. Research institutes dominate the viral vector and plasmid DNA manufacturing market because they drive innovation, receive strong funding, lead clinical trials, and collaborate with biotech firms. Their role in early-stage gene therapy, vaccine R&D, and vector optimization makes them essential to this growing market. Over 1,500 gene therapy clinical trials are in progress, many initiated by research institutions. Research centers focus on novel viral vector designs, improved plasmid DNA delivery, and safer genome editing techniques. For instance, the National Institutes of Health (NIH) Clinical Center leads multiple AAV and lentivirus-based gene therapy trials. Academic institutions partner with biotech firms for clinical translation of gene therapies. Universities often license innovations in viral vector engineering to pharmaceutical companies. The University of Pennsylvania collaborated with Novartis to develop Kymriah, the first FDA-approved CAR-T therapy. University of Pennsylvania is a pioneer in gene therapy research, particularly in the development of adeno-associated virus (AAV) vectors. The University of Pennsylvania Collaborated with industry partners to bring gene therapies like Luxturna to market.
The pharmaceutical & biotechnology companies segment is projected to expand rapidly in the market over the forecast period. Many biopharmaceutical companies are turning their attention to these cutting-edge remedies as a result of growing investments in the field of gene and cell therapy. As a result, businesses are now conducting more research to assess the potential of gene and cell therapies. Pharmaceutical and biotechnology firms are aggressively working to produce cutting-edge treatments for a number of serious illnesses. Abeona Therapeutics is now evaluating AAV9-based gene treatments for CLN1 and CLN3 illnesses. In a similar vein, StrideBio, a U.S.-based business, provides AAV-mediated gene therapy options based on their research.
Disease Insights
Based on disease, the cancer segment led the U.S. viral vectors & plasmid DNA manufacturing market. Viral vectors and plasmid DNA play a critical role in cancer treatment by enabling gene therapy, immunotherapy, and personalized medicine. They are used to deliver therapeutic genes, modify immune cells, and develop cancer vaccines, making them essential tools in modern oncology. Viral vectors (AAV, Lentivirus, Retrovirus) deliver genes that correct genetic mutations, suppress tumor growth, or enhance immune responses. Plasmid DNA-based therapies are used to introduce tumor-suppressing genes or enhance immune activation. For instance, an oncolytic adenovirus therapy that selectively destroys tumor cells. Viral vectors and plasmid DNA are transforming cancer treatment by enabling gene therapy, CAR-T therapy, cancer vaccines, oncolytic virus therapy, and precision medicine. Their ability to deliver genes, modify immune cells, and selectively target tumors makes them essential tools in oncology.
By disease, the genetic disorders segment is set to grow the fastest in the U.S. viral vectors & plasmid DNA manufacturing market. The majority of genetic illnesses are congenital, although others can be contracted by chance mutations. Hemophilia and sickle cell anemia, two of the most prevalent genetic disorders, are typified by hemoglobin synthesis and blood clot formation, which impair the blood's ability to carry oxygen.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Top Key Companies:
• Thermo Fisher Scientific, Inc.
• Catalent Inc.
• Waisman Biomanufacturing
• Genezen
• Revvity (SIRION Biotech)
• Virovek Incorporation
• Charles River Laboratories (Cobra Biologics)
• RegenxBio, Inc.
Recent Developments:
• On January 09, 2025, INOVIO, a biotechnology company, revealed that the company will, by mid-2025, submit your BLA to the FDA in the United States and ask for a priority review. The first DNA medication to be licensed for any use in the US would be INO-3107, which may be the recommended non-surgical treatment option for recurrent respiratory papillomatosis (RRP). The previously reported single-use array manufacturing issue should be resolved by February 2025. In order to update the active Investigational New Drug (IND) Application for the confirmatory trial and the BLA submission, the next steps after resolution include finishing the retesting procedure for the CELLECTRA device and finalizing the device sections of the Chemistry, Manufacturing, and Controls (CMC) module. About 100 patients will be randomized to either INO-3107 or a placebo on a 2:1 ratio as part of the trial, which will be carried out at about 20 prestigious academic institutions in the United States. This experiment aims to assess a cohort that is highly typical of the wide range of RRP disease, with eligible patients having a history of two or more operations annually to treat their RRP. Based on input from European and UK regulators thus far, INOVIO thinks the confirmatory trial's design may also facilitate growth into other markets.
• In March 2024, Polyplus company Enhances Its Position in Cell & Gene Therapy and Biologic Solutions with the Release of an Innovative Plasmid for AV Vector Production. PLUS® AAV-RC2, a revolutionary ReCap plasmid designed for the production of adeno-associated virus vector 2 (AAV2), has been introduced by Polyplus, a division of Sartorius, a renowned upstream solutions provider for biologic, cell, and gene therapy production and a member of the Sartorius group. Polyplus's portfolio has grown significantly with this introduction, which supports the company's strategic goal of becoming a major supplier of essential raw materials for the manufacture of AVs. The pPLUS AAV-RC2 plasmid, which is already commercially available, is intended to simplify the production of AAV vectors by providing a ready-to-use solution that improves vector production's dependability and efficiency. This program is a component of a larger plan to support PLUS AAV-Helper, which was only launched in September 2023.
U.S. Viral Vector And Plasmid DNA Manufacturing Market Report Segmentation
This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this report, Statifacts has segmented the U.S. viral vector and plasmid DNA manufacturing market report based on vector type, workflow, application, end use, and disease:
By Vector Type
• Adenovirus
• Retrovirus
• Adeno-Associated Virus (AAV)
• Lentivirus
• Plasmids
• Others
By Workflow
• Upstream Manufacturing
o Vector Amplification & Expansion
o Vector Recovery/Harvesting
• Downstream Manufacturing
o Purification
o Fill Finish
By Application
• Antisense & RNAi Therapy
• Gene Therapy
• Cell Therapy
• Vaccinology
• Research Applications
By End-use
• Pharmaceutical and Biopharmaceutical Companies
• Research Institutes
By Disease
• Cancer
• Genetic Disorders
• Infectious Diseases
• Others
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