Viral Vector and Plasmid DNA Manufacturing Market-Market Insights
Viral vectors are used as carriers to transfer the genetic material into other living organisms. The viral vector production can be done in two types of culture system such as suspension cell cultures and adherent-cell systems. For large-scale manufacturing of viral vectors, the conventional lab processes of adherent-cell systems such as multilayer flasks, hollow-fiber technologies, T-flasks, and roller bottles experience challenges in scaling up such as larger space requirement and increased manual workload.
Plasmid DNA is extrachromosomal DNA found in bacteria, which is generally circular in shape. The genetic engineers use plasmid DNA to create recombinant DNA, in order to transfer genetic material in other organisms. Plasmid DNAs are limited by some biological barriers such as endosomal attack, renal clearance, and degradation by serum endonucleases. Moreover, for direct gene transfer into humans, good manufacturing practice (GMP)-grade plasmid DNA is mandatory. Therefore, around 70% of gene therapy clinical trials, to date, have involved viral vector systems.
The global viral vector and plasmid DNA manufacturing market is expected to be valued at US$ 427.2 million in 2019, and is expected to exhibit a CAGR of 22.8% over the forecast period (2019-2027).
Figure 1. Global Viral Vector and Plasmid DNA Manufacturing Market Value (US$ Mn), by Region, 2019
Source: Coherent Market Insights Analysis (2020)
Increasing number of gene therapy patients is expected to propel the market growth over the forecast period
The increasing number of patients opting for gene therapy for treating diseases such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia, and AIDS is expected to drive growth of the viral vector and plasmid DNA manufacturing market over the forecast period. For instance, Adeno-associated AAV2 vectors carrying therapeutic gene (RPE65) intra-retinal injection lead to improve vision of individuals suffering from Leber’s Congenital Amaurosis.
Moreover, several clinical trials are being conducted on viral vectors and plasmid DNA manufacturing that are focused on the potential of gene therapy. According to a data published by the Journal of Gene Medicine, in 2017, around 2,600 gene therapy clinical trials are ongoing, have been completed or approved in 36 countries. Moreover, countries, where the trials were conducted include the U.S., U.K., Australia, Canada, China, France, Germany, Japan Switzerland, the Netherlands, and others.
Figure 2. Global Viral Vector and Plasmid DNA Manufacturing Market Share (%), by Therapeutic Application, 2027
Source: Coherent Market Insights Analysis (2020)
Increasing technological advancements in the manufacturing of viral vector and plasmid DNA is expected to drive the market growth over the forecast period
The rising demand for viral vector and plasmid DNA for gene therapies has led major players in the market to launch new and technologically advanced programs and devices to scale up the production of viral vectors and plasmid DNA. For instance, in April 2018, GE Healthcare Life Sciences launched a prefabricated, modular bioprocessing facility KUBio BSL 2 for production of viral vector-based vaccines, oncolytic virus, and cell and gene therapies.
Moreover, government funding is increasing for development of new technologies and production facilities of viral vector. For instance, in 2018, Innovate UK, Department for Business, Energy & Industrial awarded the Industrial Strategy Challenge Fund of US$ 3.4 million capital to Cobra Biologics for infrastructure investment to expand manufacturing capabilities and commercialization of DNA and viral vectors products. Thus, rising research and development funding from government organization is expected to drive growth of the market over the forecast period.
However, the manufacturing processes of viral vectors is expensive and time consuming. Large scale production of recombinant viral vector is a complex process and is considered as a major challenge and large barrier for commercialization. Therefore, increasing difficulties in viral vector manufacturing capacity is expected to hinder growth of the global viral vectors and plasmid DNA manufacturing market.
Major players operating in the global viral vector and plasmid DNA manufacturing market include Lonza Group AG, FinVector Vision Therapies, Cobra Biologics and Pharmaceutical Services, Sigma-Aldrich Co. LLC, VGXI, Inc., VIROVEK, SIRION Biotech GmbH, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., Sanofi, Cell and Gene Therapy Catapult, Brammer Bio, and MassBiologics.
Viral vectors aids in transferring genetic material into target cells and therefore, used in various therapeutic areas. Viral vectors can be significantly used in vaccines development against pathogens such as Mycobacterium tuberculosis, Plasmodium falciparum, HIV, and various bio-threat targets such as filoviruses. Plasmid DNA (pDNA) is gaining traction for clinical research applications in genetic vaccination and gene therapy. It is becoming increasingly useful as novel biotechnology product for DNA vaccines and gene medicines. It can be directly used as a therapeutic agent and indirectly used for various applications such as a starting material for transient transfection to produce transient proteins and viral vector constructs. Furthermore, pDNA is used as a master-template product to support production of new and developing biopharmaceutical products and processes such as cell therapies.
Increasing approvals by regulatory authorities for novel gene therapies is expected to drive growth of the gene therapy segment. For instance, in September 2017, GeneOne Life Science, Inc., received approval from the South Korean Ministry of Food and Drug Safety (KMFDS) for an Investigational New Drug application for a Phase I/IIa study of its investigational vaccine, GLS-5300, against the Middle East Respiratory Syndrome coronavirus (MERSCoV). Moreover, in May 2019, AveXis Inc. received the U.S. Food and Drug Administration approval for its Zolgensma (onasemnogene abeparvovec-xioi), an adeno-associated virus vector-based gene therapy for the treatment of pinal muscular atrophy (SMA) in children less than two years old.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.