The DNA Plasmid Manufacturing Market size is projected to reach US$ 2.65 billion by 2031 from US$ 0.69 billion in 2024. The market is estimated to register a CAGR of 21.4% during 2024–2031. The integration of digital technologies in plasmid DNA manufacturing is likely to bring new trends to the market in the coming years.
The DNA plasmid manufacturing market is primarily driven by the rising demand for gene therapies, mRNA vaccines, and advanced biologics, which rely heavily on high-quality plasmid DNA as a critical raw material. Increasing investments in personalized medicine, coupled with advancements in recombinant DNA technology and growing adoption of plasmid-based gene editing tools like CRISPR, are creating substantial growth opportunities. Additionally, the expansion of contract manufacturing organizations (CMOs) offering scalable and cost-effective plasmid production solutions further propels market growth, while emerging applications in agriculture and synthetic biology present new avenues for innovation and revenue generation.
The rise in the prevalence of genetic diseases, orphan diseases, and other cancers has accelerated the advancement of gene therapy technologies, which are based largely on plasmid DNA as the fundamental element. Plasmid DNA helps introduce genetic material into patients' cells. It acts as a non-viral vector to deliver therapeutic genes that can fix or replace faulty genes. Unlike viral vectors, plasmids are safer, easier to produce, and cheaper, making them popular in gene therapy.
As gene therapies transition from preclinical development to clinical trials and commercial launch, the demand for substantial quantities of high-purity, GMP-grade plasmid DNA has escalated significantly. In March 2023, Charles River Laboratories International, Inc. announced the launch of its off-the-shelf pHelper (Helper Plasmid) offering, which is designed to secure supply and streamline adeno-associated virus (AAV)-based gene therapy programs from early discovery through commercial manufacturing.
Growing partnerships between companies to meet the quality and regulatory demands of gene therapy pipelines. In 2022, Myrtelle and Forge Biologics announced a viral vector and plasmid DNA cGMP manufacturing partnership. Forge will provide research-grade and GMP-Pathway plasmid manufacturing services as well as cGMP adeno-associated viral (AAV) process development and scale-up manufacturing services for Myrtelle’s program, Myr-201 (novel gene therapy for monogenic hearing loss).
Governments and regulatory agencies are also helping to drive this trend with expedited approvals for gene therapy products and national biotech infrastructure investment. VGXI, Inc. recently completed a successful FDA inspection at its GMP facility in Conroe, Texas. This inspection led to the approval of a client’s Biologics License Application (BLA). VGXI’s achievement reinforces its credibility as a plasmid DNA manufacturing leader as well as underscores its importance in enabling commercial-stage gene therapies, DNA vaccines, and RNA-based medicines.
The DNA plasmid market is transforming from a specialized research supply chain to an essential backbone of contemporary therapeutic development. Therefore, the increasing development of plasmids for gene therapy drives the DNA plasmid manufacturing market.
DNA vaccines are a winning alternative to conventional vaccine platforms, with faster design, more stability at different temperatures, and easier to produce at scale. Several research institutes are studying DNA plasmid vaccines owing to their high performance. For instance, in February 2025, Imunon reported immunogenicity and safety data from a DNA plasmid vaccine trial. Imunon reported new immunogenicity and safety data from ongoing analyses of its proof-of-concept Phase I trial for the IMNN-101 DNA plasmid vaccine. This investigational vaccine, developed using the company’s PlaCCine technology, targets the SARS-CoV-2 Omicron XBB1.5 spike antigen and is being evaluated as a seasonal COVID-19 vaccine. The trial enrolled 24 healthy volunteers who had previously been vaccinated against the Omicron XBB1.5 variant. The data indicate that the vaccine is safe and immunogenic, demonstrating the potential of the PlaCCine platform to develop vaccine candidates.
The study “Safety and Outcomes of a Plasmid DNA Vaccine Encoding the ERBB2 Intracellular Domain in Patients With Advanced-Stage ERBB2-Positive Breast Cancer” was published in November 2022. In this Phase 1 nonrandomized clinical trial, the plasmid DNA vaccine encoding the ERBB2 intracellular domain (ICD) demonstrated immune activation at all tested doses, with the 100-μg and 500-μg doses showing the strongest immunogenicity. Notably, the 100-μg dose induced significant and sustained levels of ERBB2-specific type 1 T cells in most patients. The vaccine is being evaluated in a randomized clinical trial as an adjuvant therapy for patients with ERBB2 low-expression, hormone receptor-negative breast cancer who have residual tumors following neoadjuvant treatment.
The nucleic acid-based vaccine technology has been one of the rapidly growing sectors across the globe post-pandemic. With numerous clinical trials underway, the DNA vaccines are showing promising results and expanding research and clinical successes of plasmid DNA vaccines.
The growing complexity of gene therapies and increasing regulatory demands have led to a significant rise in outsourcing plasmid DNA production to specialized Contract Development and Manufacturing Organizations (CDMOs). These CDMOs offer scalable, GMP-compliant manufacturing capabilities, enabling biopharmaceutical companies to accelerate time-to-market and avoid the high capital costs of building in-house facilities. Two leading CDMOs in this field are Aldevron, a Danaher company known for its high-quality plasmid DNA used in gene and cell therapies and mRNA vaccines, and VGXI, a subsidiary of GeneOne Life Science, recognized for its proprietary Helixfermentation technology and end-to-end-plasmid-DNA-service. Both have made significant investments to expand production capacity and meet the growing global demand for plasmid-based therapeutics.
In April 2025, ProBio—a global CDMO—announced the launch of its GMP plasmid DNA manufacturing service at its Hopewell facility. This new service enables the production of clinical-grade plasmid DNA from cell bank to batch release in three months, significantly faster than standard industry timelines. The offering provides reliable and accelerated access to high-quality plasmid DNA aimed at supporting gene and cell therapy developers. ProBio ensures that every batch—ranging from small-scale (50–200 mg) to gram-level quantities—meets client specifications with complete transparency and no hidden fees.
In June 2024, Bionova Scientific, a full-service biologics CDMO and part of the Asahi Kasei Group, announced a US$ 100 million investment to expand into plasmid DNA (pDNA) manufacturing. This investment aims to build a 100,000-square-foot development and production facility in The Woodlands, Texas, near Houston. Set to become operational in the first quarter of 2025, the facility will initially offer pDNA development services along with the production of research-grade and high-quality pDNA, with GMP manufacturing capabilities expected to come online in early 2026. Therefore, the expansion of CDMOs is expected to offer lucrative opportunities to the DNA plasmid manufacturing market in the coming years.
Key segments that contributed to the derivation of the DNA plasmid manufacturing market analysis are product type, application, end user, and geography.
The geographic scope of the DNA plasmid manufacturing market report is mainly divided into five major regions: North America, Europe, Asia Pacific, the Middle East and Africa, and South and Central America. The DNA plasmid manufacturing market in North America is segmented into the US, Canada, and Mexico. North America is leading the DNA plasmid manufacturing market in terms of market share owing to its advanced biotechnology infrastructure, strong pharmaceutical industry presence, and significant investments in gene therapy and vaccine development. Additionally, the continuous R&D investments and expanding applications in personalized medicine, oncology, and infectious disease vaccines are expected to propel the market growth during the forecast period. The US holds the major market share as the country houses many leading biotech companies and research institutions focused on innovative genetic therapies. This region benefits from a robust regulatory framework and government initiatives that support cutting-edge research and development in plasmid DNA technologies. Additionally, the surging demand for gene therapies and DNA vaccines has further propelled the growth of DNA plasmid manufacturing in the region. For instance, companies such as PlasmidFactory and Aldevron have established large-scale plasmid DNA manufacturing facilities in the US allowing efficient production for clinical and commercial use. These organizations play a critical role in supplying high-quality plasmid DNA for various applications, including mRNA vaccine production, which gained global prominence during the COVID-19 pandemic.
The presence of CDMOs in the region enables scalable plasmid DNA production, catering to both small biotech startups and large pharmaceutical firms. Technological advancements such as improved bacterial fermentation processes and purification techniques have enhanced production efficiency and product quality. Additionally, collaborations between academic institutions and industry players, such as the partnership between the National Institutes of Health (NIH) and private companies, have accelerated innovation in gene editing and plasmid manufacturing technologies.
The regional trends and factors influencing the DNA Plasmid Manufacturing Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses DNA Plasmid Manufacturing Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.
| Report Attribute | Details |
|---|---|
| Market size in 2024 | US$ 0.69 Billion |
| Market Size by 2031 | US$ 2.65 Billion |
| Global CAGR (2024 - 2031) | 21.4% |
| Historical Data | 2021-2023 |
| Forecast period | 2024-2031 |
| Segments Covered |
By Product Type
|
| Regions and Countries Covered | North America
|
| Market leaders and key company profiles |
The DNA Plasmid Manufacturing Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.
Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.
Major Companies operating in the DNA Plasmid Manufacturing Market are:
Disclaimer: The companies listed above are not ranked in any particular order.
The DNA plasmid manufacturing market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the key developments in the market are listed below:
The "DNA Plasmid Manufacturing Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:
The market is expected to reach US$ 2.65 billion by 2031.
The market is expected to register a CAGR of 21.4% during 2024–2031.
WuXi Biologics Inc, Charles River Laboratories International Inc, Catalent Inc, Thermo Fisher Scientific Inc., AGC Biologics AS, Takara Bio Inc, SK pharmteco Inc, Sartorius, Creative Biogene, GenScript Biotech Corporation are key players in the market.
Increasing plasmid developments for gene therapy and growing research on DNA plasmid vaccine development fuel the market growth.
North America dominated the market in 2024.
Integration of digital technologies in plasmid DNA manufacturing is expected to be a future market trend in the coming years.