Plasmid DNA Manufacturing Market – Increasing Number of Patients Opting for Gene Therapy
Plasmid (pDNA) DNA plays a major role in modern healthcare, as it is used directly as a therapeutic agent in gene therapy or generation of vaccine antigens. Furthermore, pDNA is used as a master-template product to support production of new and emerging biopharmaceutical products and processes including RNA, in-vitro protein production, and cell therapies.
The global plasmid DNA manufacturing market size was valued at US$ 65.1 million in 2017 and is expected to exhibit a CAGR of 23.7% over the forecast period (2018 – 2026).
Figure 1. Global Plasmid DNA Manufacturing Market Value (US$ Mn), by Region, 2017
Source: Coherent Market Insights Analysis (2019)
Increasing number of patients opting for gene therapy is expected to propel growth of plasmid DNA manufacturing market
Increasing number of patients opting for gene therapy is a major factor driving growth of the plasmid DNA manufacturing market. Gene therapy is a leading field in medical science, which promises new treatment development for patients suffering from various diseases.
For instance, Adeno-associated AAV2 vectors carrying therapeutic gene (RPE65) intra-retinal injection leads to improved vision of individuals suffering from Leber’s Congenital Amaurosis.
Several clinical trials are being conducted on viral vectors and plasmid DNA manufacturing that are focused on the potential of gene therapy. Increasing investments in drug development and commercialization of these therapies in order to meet significant medical needs are factors driving the market growth. These genetic markers are associated with complex diseases, therefore it is important to study about the genetic information and its clinical application in designing clinical trials and gene therapy product manufacturing.
According to a data published by the Journal of Gene Medicine: March 2018, till November 2017, an estimated 2,600 gene therapy clinical trials were ongoing, have been completed, or have been approved in 36 countries. Countries where the trials were conducted include the U.S., the U.K., Australia, Canada, China, France, Germany, Japan, Switzerland, the Netherlands, and others. Moreover, diseases targeted by gene therapies include cardiovascular diseases, cancer, inflammatory and infectious diseases, Hemophilia A and B, Severe Combined Immunodeficiency (SCID), ocular diseases, neurological diseases, and others.
Figure 2. Global Plasmid DNA Manufacturing Market Share (%), by Application, 2018 and 2026
Source: Coherent Market Insights Analysis (2019)
Collaboration by market players is expected to bolster the plasmid DNA manufacturing market growth in Europe
Europe region is expected to witness significant growth in the plasmid DNA manufacturing market due to adoption of strategies such as collaboration by the market players. For instance, in May 2018, PlasmidFactory GmbH & Co. KG collaborated with Sirion-Biotech GmbH, Vibalogics GmbH, and PROGEN for adeno-associated virus (AAV) vector manufacturing. This collaboration was done to accelerate timeline and to create easy workflow from plasmid manufacturing to GMP production, and analytics of recombinant AAV to fulfil the customers' requirement of AAV vector.
Major players operating in the global plasmid DNA manufacturing market include Cobra Biologics and Pharmaceutical Services, VGXI, Inc., Aldevron, Kaneka Corporation, Nature Technology Corporation, PlasmidFactory GmbH & Co. KG, Cell and Gene Therapy Catapult, and Waisman Biomanufacturing.
Plasmid DNA (pDNA) can be used directly as a therapeutic agent in gene therapy or generation of vaccine antigens, and indirectly in a range of research applications. These applications include its use as a critical starting material for transient transfection to produce both viral-vector constructs such as lentivirus or Adeno-associated virus (AAV) and transient proteins in development such as monoclonal antibody. pDNA is used as a master-template product to support production of new and emerging biopharmaceutical products and processes including RNA, in-vitro protein production, and cell therapies.
Plasmids used as therapeutic agents tend to be relatively small in size (4.5– 6.0 kb and even down to 2.5 kb), requiring relatively low quantities to support early phase clinical trials (1–5 g of purified pDNA). These advantages make plasmid DNA more suitable to carry out late phase clinical trials.
Increasing demand for plasmid DNA (pDNA) and increasing research and development activities are major factors driving the plasmid DNA manufacturing market growth. For instance, in April 2018, PlasmidFactory GmbH & Co. KG acquired new laboratory space to expand research and development activities and production of plasmid DNA.
Cobra Biologics, a U.K.-based contract development and manufacturing organization (CDMO) has been producing plasmid DNA for a number of clinical applications for over 15 years at an approved site in the U.K. under the European Union (EU) clinical trials directive.
The company developed its own manufacturing process for production and purification of pDNA with related proprietary technologies, which include an antibiotic-free plasmid maintenance system, operator repressor titration (ORT), and cell-lysis technologies (2–4). Moreover, company successfully executed over 240 DNA programs with process development, manufacturing, and stability studies for over 35 different customers, globally. Generated plasmids have been used in clinical trials for gene therapy and vaccines as well as in viral vector production.
Moreover, large scale companies are actively focusing on strategic partnerships for drug development activity, which is expected to drive the market growth over the forecast period.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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