Next-generation gene therapies have played a pivotal role in the treatment of chronic disorders such as cancer and rheumatoid arthritis. The development of advanced gene-based therapies has become possible with plasmid vectors. Plasmid DNA serves as a vector, transmits genetic information, and develops recombinant vaccines for the treatment of diseases. It is an extrachromosomal circular DNA that allows the replication of recombinant genes and the selection of non-recombinant genes— facilitating the development of modified genes and proteins for treatment purposes.
The increasing adoption of personalized medicines and gene therapies for target specific disease treatment such as cancer has heightened the use of plasmid DNA. The tool becomes the backbone for the development of therapeutic genes that help to treat genetic disorders and rare conditions. As the development of DNA based therapeutic drug increases, the plasmid DNA manufacturing market is growing rapidly. The focus of plasmid DNA manufacturing companies is on developing plasmid DNA vaccines because they can deliver significant amounts of DNA with minimum risk of immunogenicity. All these factors further contribute to the growth of the plasmid DNA manufacturing market.
What is plasmid DNA?
Plasmid is an extrachromosomal DNA molecule that has posse’s capability of independent replication. Typically, plasmid has fewer genes that help bacteria to survive under stressful conditions. Notably, this plasmid DNA has been isolated from bacterial cells to use as a vector for delivering gene therapies.
Some of the notable features of the plasmid DNA include:
▪ They possess unique restriction sites or enzymes, probably known as restriction endonucleases, to cleave DNA at specific sites.
▪ They consist of an antibiotic-resistance gene that works as a selectable marker. It helps to select recombinant proteins and non-recombinant proteins.
▪ Plasmid can be used as a vector to transfer desired genes or DNA fragments into cells.
▪ Plasmid DNA can easily be isolated from bacteria and altered to deliver enormous amounts of genetic material into another cell, making them a feasible option to deliver gene therapies.
Therapeutic Applications of Plasmid DNA
Plasmid DNA offers diverse functions, including the transfer of foreign genes into the cell and enabling gene expression and regulation. The presence of restriction enzymes, antibiotic resistance genes, and selectable markers allows the production of recombinant proteins, therapeutic genes, and other molecules to modulate gene function.
Being a self-autonomously replicating DNA and gene regulator, it helps in gene editing and empowers the therapeutic application usage. The most common therapeutic applications of plasmid DNA includes:
§ Recombinant Protein
Plasmid DNA manufacturing companies use it as a tool to produce recombinant proteins, antibodies, hormones, and enzymes that have been extensively used in therapies and biotechnological research. For instance, monoclonal antibodies that are available today for the treatment of chronic diseases such as cancer are engineered using plasmid DNA.
§ Gene Therapy
Plasmid design makes it an essential tool for genetic engineering. By using recombinant DNA technology, plasmid manufacturers can introduce the desired genes into the cells, allowing the treatment of genetic disorders. For instance, genetic therapies have been used to treat inherited disorders like cystic fibrosis.
§ Vaccine Development
The Plasmid DNA manufacturing market also uses this tool to produce vaccines. These recombinant vaccines help to treat rare diseases and infectious diseases such as Hepatitis B and more.
Plasmid DNA Manufacturing Market Landscape
Plasmid-DNA-based vaccines give a new direction to the healthcare sector because it is safe, cost-effective, and stable. Furthermore, the increasing awareness regarding gene therapies and their potential to treat non-curable diseases further cater to the growth of the plasmid manufacturing market.
Plasmid DNA sets the base for the DNA vaccines that help to treat genetic diseases, influenza, and acquired diseases. The rapid demand for such vaccines accelerated the growth of the Plasmid-DNA manufacturing market, accelerating the efforts of research & development pharmaceuticals players such as Thermo Fisher Scientific, OriGene Technologies, Merck, Waisman Biomanufacturing, Laboratories, ProteoGenix, and Eurofins Scientific to develop advanced therapies using plasmid DNA.
In ongoing clinical trials based on plasmid-based DNA vaccines, the treatment of diseases such as cancer and cardiovascular disease and immunization against the same has been investigated. Moreover, plasmid DNA engineering is gaining popularity for various clinical research applications such as gene therapy and genetic vaccination.
Plasmid DNA Manufacturing Market: Recent News and Developments
The increase in technological advancements in the healthcare industry and the increasing use of plasmid DNA will further increase the plasmid DNA manufacturing market. Some of the recent news on plasmid DNA manufacturing that predict promising growth in the future includes:
▪ In November 2021, Enzychem signed an agreement (Manufacturing License and Technology Transfer) with Zydus Cadila for the development of the COVID-19 plasmid-DNA vaccine in South Korea.
▪ In June 2021, Biotage launched an advanced automated solution (Biotage® PhyPrep) for plasmid DNA purification, utilizing (dual flow chromatography technology) to produce endotoxin-free, supercoiled, and transfection-grade pDNA.
▪ In October 2021, the FDA, the National Institutes of Health, pharmaceutical companies, and non-profit organizations collaborated to escalate gene therapy production for more than 30 million Americans suffering from rare diseases. Furthermore, the pandemic crisis of 2020 further led to the increase of DNA-based vaccines using plasmid engineering to cure patients suffering from COVID-19.
Plasmid DNA Manufacturing Market Future
The skyrocketing demand for immunotherapy, gene therapy, and immunotherapy further pushes plasmid DNA manufacturing companies to experience high tides. Various plasmid DNA manufacturers have also shown their keen interest, which further paves the plasmid DNA growth in the future. Plasmid DNA is the future of gene medicines and DNA vaccines.
The growing demand has facilitated plasmid-DNA manufacturing under clinical trial phases. The demand for plasmid DNA manufacturing will be accelerated as soon as it enters the biopharmaceutical world. Furthermore, plasmid DNA manufacturing will receive an impressive outlook within the next few years.
The growth of vaccines based on plasmid DNA is taking charge over vaccines produced by using recombinant viruses because the plasmid DNA has the potential to deliver huge amounts of DNA with minimal risk of oncogenesis. This further laid a strong background for plasmid DNA applications. Driven by the above factors, the plasmid DNA manufacturing market is expected to grow at a CAGR of ~15%, according to Roots Analysis.
Plasmid-DNA Manufacturing Market: Key Players
The top pharmaceutical players have shown keen interest in plasmid-DNA. Some of the leading players who are stepping into the plasmid-DNA manufacturing market are:
▪ Thermo Fisher Scientific
▪ OriGene Technologies
▪ Merck
▪ Waisman Biomanufacturing, Laboratories
▪ ProteoGenix
▪ Eurofins Scientific
▪ Integrated DNA Technologies
▪ Cobra Biologics.
▪ Sangamo Biosciences
▪ Spark Therapeutics
About Roots Analysis
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