Transparency Market Research
The gene therapy arena has gained significant momentum from the last decade in research areas such as cancer treatment, vaccination, rare genetic diseases, etc. The most common vector being used in these gene modification studies include viruses and plasmid DNAs. Gene modification therapies very rarely receive regulatory approval; however, the viral vectors and plasmid DNAs are extensively used for preclinical and clinical trials. These vectors which are used for commercial trials are manufactured using cGMP guidelines, and are highly documented with master cell banks. The shift of focus for treatment approaches beyond regenerative medicine has resulted in significant advancements in the techniques used for viral vectors and plasmid DNA manufacturing. Viral vectors are usually constructed by using structural plasmid, helper plasmid, and therapeutic transgene. Advantages of using viral vectors include, but are not limited to, low risk of chromosomal integration, limited infection to broad spectrum of cells, robustness due to process validations, and easy culture production. They are also easy to mutate or manipulate.
The global market is characterized by continuous technological advancements in areas in which these vectors and plasmid DNA are manufactured. Growth of the market is attributed to factors such as rising focus on gene therapy research, collaborations between key players and research institutes to co-develop innovative treatment methods, and increasing research for flexibilities in the scale up approaches for plasmid DNA and viral vector production processes. The market is driven by continuous increase in commercial grade products which can be used for delivering high doses of biopharmaceutical drugs like viral vaccines. However, factors such as challenges involved in the sterility maintenance of these cultures and stringent guidelines related to purification achieved in downstream processes are anticipated to hamper the growth of the global viral vectors and plasmid DNA manufacturing market.
The global viral vectors and plasmid DNA manufacturing market has been segmented on the basis of product type, application, end-user, and region. In terms of product type, the market has been segmented into Adenovirus, Lentivirus, Adeno-Associated Virus (AAV), plasmid DNA, and others. In terms of application, the market has been categorized into gene and cancer therapies, viral vaccines, protein expression studies, and others. Based on end-user, the market has been divided into hospitals, biopharmaceutical companies, research institutes, and others.
In terms of regions, the market is categorized into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Asia Pacific is expected to witness continual growth owing to increasing market penetration of contract manufacturing organizations and continuous advancements in healthcare infrastructure. North America is expected to dominate the global viral vectors and plasmid DNA manufacturing market during the forecast period due to significant investments in research and development of gene therapies across a wide range of disease indications. Cutting edge technological innovations in manufacturing procedures, gene encodings, and protein expressional assays are projected to fuel the growth of the market in the near future. The manufacturing of viral vectors and plasmid DNA is governed by various authorities like the Food and Drug Administration (FDA), the Japanese Pharmaceuticals & Medical Devices Agency (PMDA), European Medicines Agency (EMA), and others.
Continuous innovations in biopharmaceutical industry serve as a major opportunity for the global viral vectors and plasmid DNA manufacturing market. High demand for academic as well as commercial use is anticipated to fuel the growth of the global viral vectors and plasmid DNA manufacturing market. The global viral vectors and plasmid DNA manufacturing market is characterized by the trend of increasing number of active gene therapy trials for different applications that include trials for inherited diseases, cancer, viral infections, etc. by major biopharmaceutical companies as well as academic universities.
Major market players operating in the global viral vectors and plasmid DNA manufacturing market are General Electric Company (GE Healthcare), Lonza, FinVector Vision Therapies, Sigma-Aldrich Co. LLC, Kaneka Corporation (Eurogentec), VGXI, Inc., VIROVEK, SIRION Biotech GmbH, Cobra Biologics, Novasep, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., and others.
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