Plasmid DNA Manufacturing

Plasmid DNA Manufacturing

Plasmid DNA is described as small, circular, and double helix structures compact molecules of DNA present in bacteria and other microorganisms including yeast. In contrast to chromosomal DNA, plasmids are capable of replication within the cell, and they contain genes that may provide the cell with certain advantages, for instance, genes that give resistance to antibiotics. Such plasmids may be as small as a few thousand base pairs or as large as ten thousand base pairs. They are employed mostly in molecular biology and genetic engineering where researchers manipulate certain genes and place them in plasmids to form recombinant DNA for cloning, gene expression, or protein synthesis.

The Plasmid DNA Manufacturing Market is expected to grow with a significant CAGR of 20.11% during the forecast period (2024-2032). This is mainly due to the continuous research and development by pharmaceutical companies, along with increased mergers and acquisitions activities to boost their capacities and to increase their knowledge of new advancements and technologies, which can enhance the development of Plasmid DNA-based therapeutics for cancer, HIV and other rare genetic disorders. Moreover, the growing support from the regulatory bodies is further assisting in the significant growth of the plasmid DNA manufacturing market.

• On the basis of plasmid grade, the global plasmid DNA manufacturing market is categorized as research-grade, high-quality, and good manufacturing practice (GMP) plasmid DNA. Of these, the GMP-grade segment is likely to be the largest due to its application in clinical applications such as gene therapy and vaccines. Due to the heightened quality requirements of GMP products, it can make them crucial for meeting regulatory requirements in clinical research and commercial distribution. In addition, owing to the growing need for highly efficient therapies, GMP-grade plasmids can be expected to grow significantly in the future. However, high-quality plasmid DNA is still expected to grow considerably, especially in Phase I and II clinical trials as well as in preclinical studies. This segment is most suitable for applications that demand much higher purity than those offered by research-grade products but that do not yet require full GMP compliance. The shift towards creating viral vectors and mRNA therapies will increase the requirement for premium plasmids in the future.
• By the application, the global plasmid DNA manufacturing market is divided into gene therapy, DNA vaccines, immunotherapy, and others. Out of these, the gene therapy segment will be the most prominent one because of the significant application of this technology in dealing with genetic diseases and cancers. The persistence in clinical trials and approval of gene therapy especially plasmid vector-based therapies underlines this trend in this technology. Another type of vaccine is the DNA vaccine, which is expected to grow greatly, especially after the practice of DNA-based techniques during the COVID-19 pandemic. This success has promoted the desire to create DNA vaccines for different infectious illnesses and cancer vaccinations. One of the major advantages of DNA vaccines has been shown to be their capacity to mobilize intense immune responses. Even though immunotherapy is on the rise, especially in the area of cancer, it will have a slower pace of growth than gene therapy and DNA vaccines.
• Depending on the application of the plasmid DNA by diseases there are three segments which include cancer, infectious diseases, and others. Among these, the cancer segment is leading the market primarily because of growing concerns regarding the development of new therapies effective in treating different types of cancers. Personalized medicine and specifically immunotherapy, which utilizes plasmid DNA to raise an immune response against tumor-associate antigens are among the most promising innovations generating strong interest and investment. But on the same note, the infectious diseases segment is also expected to move up a notch especially with advancements in DNA vaccines currently being worked upon. The use of DNA vaccine platforms in the recent COVID-19 pandemic has therefore revived the interest in using DNA vaccines and control or prevention of newly emerging epidemic diseases besides application for the management of chronic viral diseases including HIV and hepatitis. The other segment, which has applications in genetic diseases and veterinary use, is forecasted to grow albeit at a slower pace than cancer and infection diseases.
• For a better understanding of the market penetration of plasmid DNA manufacturing, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, France, U.K., Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. Asia-Pacific is expected to grow with a significant CAGR in the forecast period (2024-2032) owing to the growing incidence of cancer and infectious diseases. The emphasis is made on the growing collaboration activities to improve product development in the Plasmid DNA Manufacturing market for bringing new therapeutics.

For instance, in June 2024, Genexine announced that its subsidiary VGXI, a leading contract development and manufacturing organization (CDMO) in the field of nucleic acid biopharmaceuticals, including gene therapy, DNA vaccines, and RNA drugs, has formed a strategic partnership with NASDAQ-listed Sutro Biopharma, Inc. to produce plasmid DNA used in the clinical trials of luveltamab tazevibulin (abbreviation: luvelta), an antibody-drug conjugate (ADC) anticancer drug currently under development by Sutro Biopharma.

• Some of the major players operating in the market include Charles River Laboratories International, Inc., VGXI, Inc. (GeneOne Life Science), Catalent Inc. (Novo Holdings), Akron Biotech., PlasmidFactory GmbH, DH Life Sciences, LLC, Thermo Fisher Scientific Inc., Lonza, Merck KGaA, GenScript Biotech Corporation.