GMP Grade to Bolster DNA Plasmid Manufacturing Market Growth During 2024-2031

According to our new research study on "DNA Plasmid Manufacturing Market Forecast to 2031 - Global Analysis - by Product Type, Application, and End User" the market is expected to grow from US$ 2.65 Bn by 2031 from US$ 0.69 Bn in 2024; it is estimated to grow at a CAGR of 21.4% during 2024-2031. The report highlights trends prevailing in the market, and drivers and restraints pertaining to the market growth.

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 plasmid for gene therapy drives the DNA plasmid manufacturing market.

The DNA Plasmid Manufacturing Market is segmented on the basis of product type, application, and end user and geography. The DNA Plasmid Manufacturing Market, based on product type, is divided into GMP Grade and R&D grade. The GMP Grade segment held the largest share of the DNA Plasmid Manufacturing Market in 2024, and it is expected to register the highest CAGR during 2024-2031. By application, the market is segmented into Cell and Gene Therapy, DNA Vaccines, Immunotherapy, and Others. The Cell and Gene Therapy segment held the largest share of the DNA Plasmid Manufacturing Market in 2024. By End User, the market is segmented into Pharmaceutical and Biotechnology Companies, CROs and CDMOs and Others. The Pharmaceutical and Biotechnology Companies segment held the largest share of the DNA Plasmid Manufacturing Market in 2024.

In terms of geography, the DNA Plasmid Manufacturing Market is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (UAE, Saudi Arabia, Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & 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 contract development and manufacturing organizations (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.

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 among the key players in the market.

Companies operating in the DNA Plasmid Manufacturing Market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the DNA Plasmid Manufacturing Market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

A few of the developments made by the companies operating in DNA Plasmid Manufacturing Market are as follows:

- March 2025, WuXi Biologics Launched EffiX Microbial Expression Platform to Boost Recombinant Protein and Plasmid DNA Production. EffiX is designed to meet the industry's demand for a high-yield, stable, and non-lysogenic E. coli expression system. It serves as a comprehensive solution for developing and manufacturing non-monoclonal antibody (non-mAb) recombinant proteins and plasmid DNA for clients across the globe. EffiX delivers high-yield production across multiple modalities, achieving titers of over 15 g/L for non-mAb recombinant proteins and over 1 g/L for plasmid DNA.

- May 2025, SK Pharmteco, a global contract development and manufacturing organization (CDMO), announced the launch of Plasmid-IQ Design's innovative and proprietary plasmid engineering platform designed to optimize genetic constructs and significantly enhance their performance, stability, and production efficiency. Plasmids serve as critical raw materials in developing and manufacturing cell and gene therapies, vaccines, and biologics. Inefficiencies stemming from poorly designed plasmids can lead to reduced yields, increased costs, and significant delays. Plasmid-IQ Design directly addresses these challenges by applying scientifically validated design principles to create superior plasmid constructs.

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