Global Viral Vector and Plasmid DNA Manufacturing Market - 2020-2027
発行: DataM Intelligence
Viral vector is referred 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 global viral vector and plasmid DNA manufacturing market valued USD XX million in 2018 and it is expected to grow at a CAGR of XX% to reach USD XX million by 2026.
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 increase in the number of the clinical studies for examining the efficacy and safety of the viral vectors and plasmid DNA.
There is 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.
Several companies are entering into the collaboration with the several organizations for the manufacturing of the viral vectors and plasmid DNA. For instance, in June 2020, Oxford Biomedica plc had entered into the collaboration agreement with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization established to provide the UK's first strategic vaccine development and advanced manufacturing capability. This five-year agreement would involve the organizations working collaboratively to enable the manufacture of viral vector-based vaccines, contributing towards a rapid increase in the United Kingdom domestic capacity for this specialized field of vaccine manufacturing. Under the terms of the agreement, VMIC would provide manufacturing equipment for Oxford Biomedica to equip two new GMP manufacturing suites within Oxford Biomedica's new 7,800 m2 commercial manufacturing center, Oxbox, located in Oxford, United Kingdom.
The global viral vector and plasmid DNA manufacturing market is segmented based on the product type as the plasmid DNA, viral vector, and non-viral vector. The viral vector segment accounts for the highest market growth due to the increasing penetration of the viral vectors for targeted delivery, efficient transduction, and controlled gene expression. There is increased in the usage of the viral vectors due to their efficiency in delivery gene into the target cells and protecting the new genes from degradation. Different types of the viral vectors such as retrovirus, lentivirus, adenovirus, adeno-associated virus and herpes simplex virus are used for transferring the nucleic acids into the genetic makeup of cells. Out of these viral vectors, adenovirus and retrovirus are widely used across the globe as these viral vectors have the integration ability with large transgenes and easy production at high titers.
Several companies are focusing on the expansion of the manufacturing facilities for the viral vectors to meet the increasing demand. For instance, in May 2019, Thermo Fisher Scientific Inc. had opened its new $90 million viral vector contract development and manufacturing organization (CDMO) site in Lexington, MA. The 50,000-square-foot facility would support the development, testing and manufacture of viral vectors essential for advancing gene and cell therapies globally.
Further, the market is also classified based on the application as the cancer, genetic disorder, infectious disease, and other diseases. The cancer segment accounts for the highest market share of XX% in 2019 due to the higher usage of the viral vector, and plasmid DNA for delivering the anticancer genes. Several biotechnology and pharmaceutical companies are examining the viral vectors or plasmid DNA encoding a therapeutic gene, often an immunomodulatory or suicide gene in the various cancer gene therapy trials. Clinical studies have demonstrated that the injection of a plasmid DNA encoding a cytokine gene have a significant antitumor effect. There is increasing research and development activities for the gene therapies and other advanced cell therapies for the treatment of the various cancers. The increase in the approval of the viral vector, and plasmid DNA based therapies shall stimulate the market growth. For instance, the approval of the lentiviral vector-based CAR-T cell therapies for the treatment of Acute Lymphoblastic Leukemia (ALL) and large B cell lymphoma.
By region, the global viral vector and plasmid DNA manufacturing market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global viral vector and plasmid DNA manufacturing market and expected to grow at the highest CAGR during the forecasted period due to the increasing number of the clinical studies for evaluating the use of the viral vector and plasmid DNA for the treatment of the genetic disorders, cancer, and infectious diseases. The increase in the approval of the advanced cell therapies shall stimulate the market growth. There is growing research and development activities of the gene therapies. Several companies, institutes, associations, and foundations are raising the investment and funding for the development of the gene therapies. The growing initiatives by the Food and Drug Administration (FDA) for improving the regulatory support for the cell and gene therapy shall boost the demand for the viral vector and plasmid DNA manufacturing.
Asia Pacific is expected to witness the positive market growth due to the growing clinical transformation and industrialization of advanced therapies medicinal products including the gene therapy manufacturing. There is presence of the several companies manufacturing the viral vector and plasmid DNA. Contract manufacturers are providing the several services for viral vector and plasmid DNA manufacturing. There is growing adoption of the advanced technologies for manufacturing the viral vector and plasmid DNA.
The global viral vector and plasmid DNA manufacturing market is highly competitive with the presence of several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition. Brammer Bio, Cobra Biologics, Cell and Gene Therapy Catapult, FinVector Vision Therapies, Fujifilm Diosynth Biotechnologies, SIRION Biotech, Merck KGaA Inc., Thermo Fisher Scientific, and Uniqure NV are the leading market players with significant market share.
The major players are entering into the collaborations, acquisitions, mergers, and licensing activities for increasing their market presence. For instance, in August 2019, FUJIFILM Corporation had acquired the Biogen (Denmark) Manufacturing ApS, a large-scale biologic manufacturing site located in Hillerød near Copenhagen, Denmark from Biogen. The Hillerød Manufacturing site would be the fourth biopharmaceutical manufacturing site of FUJIFILM Diosynth Biotechnologies, a subsidiary of Fujifilm and a leading Contract Development and Manufacturing Organization (CDMO) with expertise in the development and manufacture of biologics and advanced therapies.
In March 2019, Merck had entered into the non-binding Memorandum of Understanding with Chinese biotech company GenScript for a strategic alliance focusing on plasmid and viral vector manufacturing. The manufacturing of high-quality plasmid and viral vectors would help in the commercialization of cell and gene therapy. This collaboration would help the company to accelerate the industrialization and commercialization of cell and gene therapy in China. Merck would provide GenScript with comprehensive products, training and consulting services covering process design, facility concept design and quality management system set-up from lab development to large-scale GMP manufacturing.
In December 2017, MilliporeSigma had entered into the commercial supply agreement to manufacture viral vectors for bluebird bio, Inc., of Cambridge, Massachusetts, for its use in potentially transformative gene therapies. Under the terms of agreement, MilliporeSigma would manufacture lentiviral vectors for bluebird bio's drug products developed to treat a variety of rare genetic diseases. This contract builds upon MilliporeSigma's deep experience in producing viral vectors for gene therapy from clinical to commercial scale.
In June 2014, Applied Genetic Technologies Corporation had entered into the collaboration with the Sigma-Aldrich Corporation to provide the gene therapy manufacturing services to companies developing gene-based therapies. Under the terms of the agreement, the two companies will co-market AGTC's proprietary HAVE manufacturing method with SAFC's cGMP manufacturing capabilities. AGTC will assist clients in engineering AAV-based vectors and the associated helper viruses for HAVE-based manufacturing activities. SAFC will manufacture AAV vectors with the HAVE system to either support initial research or in accordance with cGMP requirements to support clinical trial development and eventual commercial production.