Viral Vector and Plasmid DNA Manufacturing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Market Overview

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.

Scope of the Report

As per the scope of this report, viral vectors and plasmid DNA are the products of gene therapy, which are used for the treatment of several diseases, such as Alzheimer's disease, Parkinson's disease, and rheumatoid arthritis. Gene therapies and other therapies that require genetic modification include the introduction of therapeutic DNA/gene into a patient's body or cell. This process is accomplished by the use of vectors. Over the past few decades, various viral and non-viral vectors have been developed and standardized for this purpose. Moreover, viral vectors and plasmid DNA are known to reduce the cost of treatment and help in decreasing repeated administration of medications.

The market is segmented by Product Type (Plasmid DNA, Viral Vector and Non-viral Vector), Application (Cancer, Genetic Disorder, Infectious Disease, and Other Applications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

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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.

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