Global Viral Vector and Plasmid DNA Manufacturing Market - 2022-2029

Market Overview

Viral Vector and Plasmid DNA Manufacturing Market size was valued US$ 2.85 billion in 2021 and is estimated to reach US$ XX billion by 2029, growing at a CAGR of 14.2% during the forecast period (2022-2029).

The viral vector is referred to as the tool for delivering genetic material into cells. The modified viral vector is used as a viral vector in gene therapy. Plasmid DNA is a bacterial smaller, circular, and extrachromosomal DNA used in 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.

Market Dynamics

The global viral vector and plasmid DNA manufacturing market growth is driven by several factors such as increasing demand for viral vectors and plasmid DNA manufacturing for developing DNA vaccines, gene therapy, immunotherapy, and others.

Increasing demand for gene therapy and immunotherapy is expected to drive the global viral vector and plasmid DNA manufacturing market during the forecast period.

The market is driven by the increasing demand for viral vectors and plasmid DNA manufacturing for developing DNA vaccines, gene therapy, immunotherapy, and others. There are growing 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 examining the viral vectors' efficacy and safety and plasmid DNA.

There is an increase in the contract manufacturing business launch for viral vectors and plasmid DNA manufacturing. For instance, in December 2019, Helixmith Co., Ltd. and Genopis 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 a small-volume production service. Genopis is equipped with the right technologies and quality systems.

Several companies are entering into a collaboration with several organizations to manufacture viral vectors and plasmid DNA. For instance, in June 2020, Oxford Biomedica plc entered into a 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 to a rapid increase in the United Kingdom domestic capacity for this specialized vaccine manufacturing field. 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.

Risk of mutagenesis associated with vector or plasmid treatments are likely to hinder the market growth

As genetic engineered viral vector and plasmid DNA are being used in various gene therapy and immunotherapy procedures. There is a risk of insertional mutagenesis associated with these genetic modified vectors and plasmids that can restrain the market growth and the high cost of gene treatments can also limit the growth of market.

Industry Analysis

The global viral vector and plasmid DNA manufacturing market provides in-depth analysis of the market based on various industry factors such as porter's five forces, regulatory analysis, supply chain analysis, pricing analysis.

Segment Analysis

The viral vector segment is expected to hold the largest market share in global viral vector and plasmid DNA manufacturing market

The global viral vector and plasmid DNA manufacturing market is segmented on the product type 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 an increase in the viral vectors' usage due to their efficiency in delivering genes into the target cells and protecting the new genes from degradation. Different types of 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 worldwide as these viral vectors have the integration ability with large transgenes and easy production at high titers.

Several companies are focusing on expanding 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 cancer, genetic disorder, infectious disease, and other diseases. The cancer segment accounts for the highest market share due to the higher usage of the viral vector and plasmid DNA for delivering the anti-cancer 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 plasmid DNA encoding a cytokine gene has a significant antitumor effect. There are increasing research and development activities for gene therapies and other advanced cell therapies to treat various cancers. The increase in the approval of the viral vector and plasmid DNA-based therapies shall stimulate market growth. For instance, the lentiviral vector-based CAR-T cell therapies are approved for treating Acute Lymphoblastic Leukemia (ALL) and large B cell lymphoma.

Geographical Analysis

North America region holds the largest market share in the global viral vector and plasmid DNA manufacturing market

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 is expected to grow at the highest CAGR during the forecasted period due to the increasing number of 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 advanced cell therapies shall stimulate market growth. There is growing research and development activities of gene therapies. Several companies, institutes, associations, and foundations raise the investment and funding to develop gene therapies. The growing initiatives by the Food and Drug Administration (FDA) for improving the regulatory support for cell and gene therapy shall boost the demand for viral vector and plasmid DNA manufacturing.

The Asia Pacific is expected to witness positive market growth due to the growing clinical transformation and industrialization of advanced therapies medicinal products, including gene therapy manufacturing. There is a presence of several companies manufacturing the viral vector and plasmid DNA. Contract manufacturers are providing several services for viral vector and plasmid DNA manufacturing. There is growing adoption of advanced technologies for manufacturing viral vectors and plasmid DNA.

Competitive Landscape

The global viral vector and plasmid DNA manufacturing market is highly competitive with 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 enter into collaborations, acquisitions, mergers, and licensing activities to increase their market presence. For instance, in Apr 2022, FUJIFILM Diosynth Biotechnology, a Contract Development Manufacturing Organisation that develops recombinant biopharmaceuticals and viral gene therapy announced its manufacturing agreement with Chimeron Bio, RNA company that develops self-amplifying RNA vaccines and therapies that are developed by their own proprietary ChaESAR RNA delivery platform.

In March 2019, Merck 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 plasmids and viral vectors would help in the commercialization of cell and gene therapy. This collaboration would help the company 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.

Key Companies to Watch

Brammer Bio:

Overview: Brammer Bio is a contract development and manufacturing organization (CDMO) that develops and manufactures viral vector and helps biopharmaceutical companies to deliver breakthrough medicines in form of gene modified cell therapies to patients. Founded in 2013 and headquartered in Florida.

Product Portfolio:

Lipofectamine CRISPRMAX Cas9 Transfection Reagent: It is a 1st lipid nanoparticle optimized reagent for transfection use for CRISPR-Cas9 protein delivery. It is a cost effective, high throughput friendly alternate for electroporation.

Key Developments: In May 2019, Thermo Fisher Scientific Inc., company serving science announced acquisition of Brammer Bio, viral vector manufacturing company for gene therapies for around $1.7 billion.

The global viral vector and plasmid DNA manufacturing market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.