Plasmid DNA has been used extensively both directly and indirectly for numerous applications, most significantly in the field of genetic engineering and in nucleic acid therapy. Its role in nucleic acid therapy is best exemplified by its application in the transcription-mediated nucleic acid entry. The therapeutic effect is induced not by direct DNA replication but by transcription-mediated nucleic acid entry (TNA) directly affecting the transcription factor coding for the target locus. The nucleic acid used in this process is set into motion by transcription factor specific promoters which are embedded in the promoter region of the encoding DNA. The main advantage of using plasmid DNA for the purpose of genetic engineering and TNA is that it can be made up of any DNA material that can be replicated. This includes bacteria, viruses, synthetic DNA, etc.
Growing demand for viral vectors in the treatment of various diseases is driving the growth of plasmid DNA manufacturing market. An increase in the funding for R&D activities in the field of gene therapy coupled with the growing prevalence of cancer is again projected to propel the market growth. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. Also, increasing preferences for viral vectors for treating genetic disorder is further projected to foster market growth.
North America together is expected to gain significant growth over the forecast period and this is attributed to the high adoption of gene therapy in the region. Also, the surge in investment in the healthcare sector is further anticipated to propel the market growth. The first U.S. approvals of cell and gene therapies were in 2017 and the pace of research and development in cell and gene therapy is increasing. A 2018 PhRMA report reveal that the cell and gene therapy pipeline found 289 therapies in clinical development by biopharmaceutical companies in the United States. At present, that number is 362.
Key Developments:
In January 2020, Helixmith and Genopis announced the launch of a contract manufacturing business for plasmid DNA production.
In August 2020, Aldevron announced the plan to scale up the production capacity of plasmid DNA manufacturers due to the growing need for gene therapy. The company expects to open a new 189,000 sq. ft facility in spring 2021 to add to their existing 70,000 sq. ft of manufacturing space.
In December 2020, Thermo Fisher Scientific has announced plans to construct a new cGMP plasmid DNA manufacturing facility in Carlsbad, California.
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