The DNA plasmid Manufacturing Market is expected to reach US$ 2.65 Bn by 2031 from US$ 0.69 Bn in 2024; the market is estimated to grow at a CAGR of 21.4% during 2024-2031. Major factors driving the market growth include increasing plasmid developments for gene therapy and growing research on DNA plasmid vaccine development. However, high manufacturing costs among the market deterrents.

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 comparative company analysis evaluates and categorizes the DNA plasmid Manufacturing Market based on product portfolio (product satisfaction, product features, and availability), recent market developments (merger & acquisition, new product launch & enhancement, investment & funding, award, agreement, collaboration, & partnership, recognition, and expansion), and geographic presence that aids better decision-making and understanding of the competitive landscape. The report profoundly explores the recent significant developments and innovations by the leading vendors in the global DNA plasmid Manufacturing Market. The key market players are 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

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. Based on Application, the DNA plasmid Manufacturing Market is segmented into Cell and Gene Therapy, DNA Vaccines, Immunotherapy, and Others. In 2024, the cell and gene therapy segment held the largest share of the market. Based on end user, the DNA plasmid Manufacturing Market is segmented into Pharmaceutical and Biotechnology Companies, CROs and CDMOs and Others. In 2024, the Pharmaceutical and Biotechnology Companies segment held the largest share of the market.

Various organic and inorganic strategies are adopted by companies operating in the DNA plasmid Manufacturing Market. The organic strategies mainly include product launches and product approvals. Inorganic growth strategies witnessed in the market are acquisitions, collaboration, and partnerships. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, along with contributing to the overall market growth. Furthermore, strategies such as acquisitions and partnerships helped strengthen their customer base and extend their product portfolios. A few of the significant developments by key players in the DNA plasmid Manufacturing Market are listed below.

In 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.