The global viral vector and plasmid DNA manufacturing market was valued at USD 591.29 million in 2020, and it is expected to reach USD 2,244.29 million by 2026, registering a CAGR of 23.38 %, during the period of 2021-2026.
COVID-19 is expected to have a positive effect on the Viral Vector and Plasmid DNA Manufacturing Market. Several COVID-19 vaccine candidates that are entering clinical trials include viral vector vaccines. These vaccines are likely to be among the COVID-19 vaccines authorized for use across the world. Many of them have also received or are in the final stages of receiving approval. In January 2021, Johnson & Johnson announced favorable efficacy and safety data from its Phase 3 ENSEMBLE clinical trial using its AdVac vaccine platform for COVID-19. Its single-dose COVID-19 vaccine, currently under development, at its Janssen Pharmaceutical Companies, was found to have met all preconditions and targets. The AdVac viral vector technology could provide a potent and long-lasting humoral and cellular immune response to the body. Another viral vector-based vaccine, which has received several approvals is the Oxford-AstraZeneca COVID-19 vaccine. The vaccine was first discovered in November 2020 and has since then been mass-produced to vaccinate people. The COVID-19 viral vector vaccines under development across the world using non-replicating viral vectors. The immune response of these vaccines follow a similar pattern: it includes antibody-producing B cells, as well as T cells, which seek out and destroy infected cells in the body providing long-lasting immunity. Further research and increased investment in this field are expected to have a positive effect on vaccine development.
Demand for plasmid DNA is rising steeply because of a boom in gene therapy development. pDNA is a prerequisite for the production of AAV (adeno-associated virus), lentivirus, and other viral vector platforms. There is also an increase in several genetic disorders and numerous life-threatening disorders, especially heart diseases, AIDS, cystic fibrosis, and age-related disorders. 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. Gene therapy with viral vectors thus provides a complete cure to patients affected with genetic disorders and other life threateningdisorders, rather than ease symptoms with other therapeutic treatments. A number of clinical studies are being conducted on viral vectors and plasmid DNA manufacturing, emphasizing the potential of gene therapy, to address important medical needs. According to 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.
Several players, including pharmaceutical companies, contract manufacturing organizations, research institutes, and non-profit organizations, are playing a critical role in the development and production of these vectors. In 2018, UniQure Biopharma BV sponsored for the trial of AMT-061 in severe or moderately severe Hemophilia B patients, and AMT-061 is a recombinant adeno-associated viral vector.
Moreover, factors, such as technological advancements to mitigate challenges posed by conventional methods of vector production, increase in the number of clinical studies, and a growing number of gene therapy candidates, coupled with their rapid progression through various phases of clinical development, are primarily driving the demand for viral vector and plasmid DNA manufacturing. However, high cost of gene therapies and challenges in viral vector manufacturing capacity are expected to obstruct the market growth.
Key Market Trends Plasmid DNA Segment is Expected to Register Robust Growth.
Plasmid DNA plays a key role in healthcare, as it is used directly as a therapeutic agent in gene therapy or generation of vaccine antigens. Furthermore, plasmid DNA is used as a master-template product to support production of new and emerging biopharmaceutical products and processes including in-vitro protein production, RNA and cell therapies. The recent advances have led to the emergence of several other innovative viral/ non-viral gene delivery approaches that are being utilized for the development of various therapies that require gene modification
The demand and therapeutic applications for plasmid DNA have grown rapidly and have expanded. Plasmid DNA and viral vector-based cancer vaccines have several inherent features that make them promising cancer vaccine candidates. The plasmid DNA is also being used to deliver tumor-specific antigens to induce a tumor-specific immune response. Their applications in cancer have, in turn, helped in the growth of the market.
The increase in interest in this field can be understood by the rising number of mergers and acquisitions. For example, in July 2019, EQT VIII Fund announced that it had acquired a majority interest in Aldevron. Aldevron is one of the largest suppliers of GMP, GMP-SourceTM and Research Grade plasmid DNA. Its products are used in clinical, commercial, and research stage gene therapies, as well as in the manufacture of proteins, antibodies and mRNA.
Moreover, growing R&D on cancer research owing to the rising burden of the disease and the increasing demand for DNA therapeutics are expected to fuel the segment growth over the forecast period.
North America Dominates the Market in Terms of Revenue Generated
Currently, the North American viral vector and plasmid DNA manufacturing market is witnessing rapid growth in the market studied. Companies in the region are innovating new product approaches for viral vectors. For example, 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 too. For example, 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 is 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.
Competitive Landscape The market studied is still in its infant stage. Hence, the increasing focus is mainly on the development of innovative products. Key market players include Cobra Biologics, Fujifilm Diosynth Biotechnologies, SIRION Biotech, Merck KGaA Inc, and Thermo Fisher Scientific among others.
Various strategies, such as research and development, mergers and acquisition, and product launch, are being adopted by domestic companies to strengthen their market position. In December 2020, CHA Biotech signed a lease agreement with Matica Bio, to construct a viral vector production facility in College Station, Texas. The construction of the 25,000 sq. ft facility started in Q4 2020, and it is expected to be dedicated to the production of viral vectors used in cell and gene therapies, vaccines, and oncolytic products. It is scheduled to open in Q3 2021.
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Gross Domestic Expenditure On R&D
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