Viral vector is referred to as the tool for delivering the genetic material into cells. The modified viral vector is used as the viral vectors in gene therapy. Plasmid DNA is a bacterial smaller, circular and extrachromosomal DNA used in the different molecular genetic research such as gene therapy, gene transfer and recombinant DNA technology due to its self-replication property. A gene of interest is transferred into the target cell for studying the function or expression of a gene. The market is driven by the increasing demand for the viral vectors and plasmid DNA manufacturing for developing the DNA vaccines, gene therapy, immunotherapy, and others. There is growing usage of the viral vectors & plasmid DNA due to their advantages such as high transfection efficiency, effective gene delivery, and stable gene expression. There is an increase in the number of clinical studies for examining the efficacy and safety of the viral vectors and plasmid DNA.
There is an increase in the launch of the contract manufacturing business for viral vectors and plasmid DNA manufacturing. For instance, in December 2019, Helixmith Co., Ltd. and Genopis had launched the contract manufacturing business for plasmid DNA production. The company would establish additional smaller scale reactors (60-300 L, 6-30 L) with feasibility runs and start small volume production service. Genopis is equipped with the right technologies and quality systems.
Market Dynamics
Drivers
- Rising number of gene therapy patients is expected to drive the market growth
- Increasing approvals for novel gene therapies
- Increasing collaboration among companies and organizations for development of viral vectors and plasmid DNA
Restraints
- Complex and expensive manufacturing processes
- Regulatory challenges
Rising number of gene therapy patients is expected to drive the market growth
Increasing number of patients opting for gene therapy for treatment of diseases such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia, and AIDS is one of the major factors driving the growth of the market over the forecast period. For instance, According to the World Health Organization, an estimated 17.9 million people die due to cardiovascular diseases worldwide, each year. This represents 35% of global deaths. Viral vectors and plasmid DNA manufacturing use system biology and panomics to determine the cause of a patient's illness at the molecular level, followed by use of concentrated medications to address individual patient's illness. Moreover, viral vectors and plasmid DNA can reduce cost of treatment and help decrease repeated administration of medications. The demand for plasmid DNA is growing owing to increase in gene therapy development. Plasmid DNA is a prerequisite for the production of AAV (adeno-associated virus), lentivirus, and other viral vector platforms. Adeno-associated AAV2 vectors carrying therapeutic gene (RPE65) intra-retinal injection helps in improving the vision of individuals suffering from Leber’s Congenital Amaurosis.
Gene therapy with viral vectors provides a complete cure to patients affected with genetic disorders and other life threatening disorders, rather than ease symptoms with other therapeutic treatments.
There is an increased number of clinical studies conducted on viral vectors and plasmid DNA manufacturing, emphasizing the potential of gene therapy, to address important medical needs. For instance, As per a research article published in 2019, 'Cancer DNA vaccines: current preclinical and clinical developments and future perspectives', it was estimated that personalized DNA vaccines for the treatment of cancers are the future choice to provide the most appropriate combined therapy by analyzing single patient specificity and biomarkers that can predict the response to a specific agent.
Also, as per the data published by the Journal of Gene Medicine, in 2017, approximately 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.
Geographical Analysis
North America viral vector and plasmid DNA manufacturing and it is estimated to grow at a CAGR of 6.9% during the forecast period (2020-2027) to reach a market value of USD XX million by 2027.
North American viral vector and plasmid DNA manufacturing market is witnessing rapid growth in the market. Companies in the region are innovating new product approaches for viral vectors. For instance, in April 2018, United States-based GE Healthcare created a ‘factory-in-a-box’ facility for the production of viral vector-based drugs, including viral vector vaccines, oncolytic viruses, and gene and cell therapies. Many companies are increasing their production facilities in the region For instance, in January 2020, Genopis Inc. announced that it will build a contract manufacturing business for plasmid DNA production in the United States with its South Korea-based partner Helixmith. In January 2021, United States-headquartered Cobra Biologics, the gene therapy division of the Cognate BioServices’ group, announced that it had begun a multi-phase increase in its plasmid DNA services as a continuation of its gene therapy services’ expansion project for viral vectors and plasmid DNA.
Gene therapy in Canada is also rising rapidly which is used for the treatment of various diseases. For instance, Kymriah was the first gene therapy product approved in Canada for treating cancer in September 2018. Health Canada approved Novartis Kymriah for use in pediatric, young adult, and adult patients. In February 2019, Health Canada also approved another gene therapy product called Yescarta and manufactured by Kite Pharmaceuticals for an aggressive kind of non-Hodgkins lymphoma. Viral vector design and manufacturing control are critically important for the overall product quality, safety, and efficiency in patients through concerns, such as replication competence, vector integration, and vector shedding. Furthermore, there are significant advancements in developing novel viral vectors and several researchers are focusing on substituting pathogenic genes with therapeutic DNA. In addition, nowadays non-pathogenic, replication-defective, and human-friendly viral vectors are being widely used in gene therapy clinical trials and as more research is expected to be conducted on viral vectors and plasmid DNA, these developments are expected to have a positive effect on market growth. However, high cost associated with gene therapies and risk of mutagenesis & other impediments in gene therapy restrain the viral vectors and plasmid DNA manufacturing in the region.
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