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Viral Vectors and Plasmid DNA Manufacturing Market

Viral Vectors and Plasmid DNA Manufacturing Market: Information by Vector Type (Adenovirus, Retrovirus), Application (Gene Therapy, Cell Therapy, Vaccinology), and Region — Forecast till 2030

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Market Snapshot

market snapshot
Base Year:
Study Period:
14.71 %
Fastest Growing Market:
Asia Pacific
Largest Market:
North America

The global viral vectors and plasmid DNA manufacturing market size was valued at USD 2.87 billion in 2021 and is expected to reach USD 9.87 billion in 2030 expanding at a compound annual growth rate (CAGR) of 14.71% from 2022 to 2030. Vectors are instruments that are used to carry genetic material into cells, and viral vectors are one such tool. Viruses have developed specific mechanisms that allow them to transfer their genomes into the cells that they infect. This represents a significant evolutionary step for viruses. There are many different forms of viral vectors that may be used to carry nucleic acids into the genetic composition of cells. These viral vectors include herpes simplex virus, retrovirus, adenovirus, and lentivirus. Adeno-associated virus is also a viral vector. Every virus comes with its own set of advantages and disadvantages, depending on the context in which it is used. Plasma DNA is a clump of DNA components that have been derived from a variety of cells and tissues.

It is a kind of microbial DNA that can reproduce on its own and is smaller, circular, and extrachromosomal. It is employed in the field of genetic engineering and recombinant DNA technology. There are several varieties of plasma DNA, including high-quality plasmid DNA, non-GMP grade plasmid DNA, and GMP grade plasmid DNA. Plasmid DNA is found in plasma. In order to produce recombinant viruses, antibodies, and RNA in accordance with Good Manufacturing Practices (GMP), high-quality plasmid DNA is required.

The market growth is driven by a number of factors, including the availability of effective viral vector gene treatments for rare illnesses and malignancies, continuous research efforts on viral vector gene therapies, and the recent approval of many different viral vector gene therapies. Because of the growing need for innovative clinical therapies and the increasing significance of developing fields in medical science, the viral vectors and plasmid DNA manufacturing market share have expanded dramatically in recent years. This growth may be attributed to both of these factors. In the fields of innovative drug discovery and vaccinology, viral vectors such as adenoviruses, baculoviruses, herpes simplex viruses, and others are finding increasing amounts of use.

Viral Vectors and Plasmid DNA Manufacturing Market Share

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Market Dynamics

Market Driving Factors

A Stable Pipeline for Viral Vectors and Gene Therapy

Nearly 400 embryonic cell and gene treatments are now being developed to treat a wide range of disorders. Cell and gene therapy are two branches of biomedical research that overlap one another and share therapeutic targets in the form of DNA or RNA that can be located either within or outside of the body. All of the treatments focus on modifying genetic material in some way, either to improve function or to combat the disease. To be more specific, gene therapy involves the modification of a patient's cells in an attempt to heal an inherited or acquired condition using genetic material, often known as DNA. Cell therapy can refer to either the injection of entire cells or the transplanting of whole cells into a recipient for the purpose of treating a hereditary or acquired condition.

As a result of rising demand, manufacturers are expanding their capacities

Because cell and gene treatments have the potential to move fast from clinical trials to commercialization, there is an increasing demand for practical manufacturing methods for viral vectors that can be easily standardized and scaled. Continuous efforts are being made by both Brammer Bio and Pall Biotech to build and implement cutting-edge solutions that will accelerate the process growth and scale-up required for the production of viral vectors. These solutions will speed up the growth of the process. Fermentation is typically used to produce biological drug substances that have a lower molecular weight. On the other hand, larger recombinant proteins and monoclonal antibodies (mAbs) are typically manufactured using well-established platform processes. Together, these two types of biologics make up the largest portion of the biologics that are currently available on the market. As a consequence of this, manufacturing equipment for the manufacture of mAbs has been created, and the room in which it is located is properly supplied by suppliers of equipment.

A surge in the production of gene therapies is driving an explosive increase in the market demand for plasmid DNA. The development of viral vector platforms like AAV (adeno-associated virus), lentivirus, and others requires the use of pDNA as a precursor. There has been an uptick in the number of people suffering from genetic illnesses and infectious diseases all over the world. For example, according to the numbers provided by UNAIDS, in 2019, there were 38.0 million people throughout the world who were living with HIV, and there were 1.7 million people who got newly infected with HIV.

Market Restraining Factors

Manufacturing viral vectors face difficulties

Viral vectors and plasmid DNA manufacturers whose products are now undergoing phase III of clinical trials or are engaged in the development of viral vectors for commercial use are up against a wide range of obstacles. Among these issues is the fact that many of the currently available methods for vector production are not suitable in terms of factors like as productivity, efficiency, stability, and so on. In addition, it is necessary for businesses in the market that manufacture goods in big or small volumes to engage in a variety of research activities. This need applies to both types of businesses.

Opportunities in Viral Vectors and Plasmid DNA Manufacturing Market

Increased Allogeneic and Autologous Cell Therapy Development

While the clinical evidence in favor of patient-specific therapy is strong, the development of allogeneic cell therapy now outpaces that of autologous cell therapy due to its greater commercial appeal. There is potential for the development of both autologous and allogeneic cell treatments, which have very different production needs, patient administration methods, and price structures.

The patient's own stem cells are transplanted in an autologous transplant to cure a variety of disorders, including cancer. Blood or bone marrow stem cells are harvested, frozen, and then used for harvesting. Different bodily cells are harmed by high dosages of chemotherapy or radiation therapy. Therefore, the frozen stem cells are reintroduced into the patient's body to repair the damaged cells following these treatments for cancer therapy. There is no chance of transplant rejection since autologous stem cell transplantation uses the patient's own cells. Leukemia, lymphomas, and multiple myeloma are the principal diseases treated with this kind of transplant. It is occasionally used to treat follicular lymphoma and pediatric malignancies.

Segmental Overview

The viral vectors and plasmid DNA manufacturing market is segmented into the following categories: Vector Type, Workflow, Application, End Use, Disease, and Region.

By Vector Type Analysis

Based on vector type the market is divided into Adenovirus, Retrovirus, Adeno-Associated Virus (AAV), Lentivirus, Plasmids and Others. In 2021, the Adeno-Associated Virus (AAV) market segment had the biggest market share (18.86%). The rise is attributable to the development of gene therapy treatments for orthopedic and ophthalmic conditions that are more effective and efficient. AAV utilization has recently increased significantly across various therapeutic domains, leading to a large increase in adoption rate over the course of the projection period. One of the major elements promoting their use and these variables fueling the category market expansion is their shown non-pathogenicity.

Additionally declared safe are adenoviral vectors. As a result, they are increasingly utilized in a range of research scenarios. ADV vectors are frequently used as vaccines because of their capacity to significantly stimulate humoral and T-cell immune responses. Numerous human cells' host genomes have successfully had genes disrupted in experiments using an adenovirus vector as a CRISPR/Cas9 delivery mechanism.

By Workflow Analysis

Based on Workflow the market is divided into Upstream Manufacturing (Vector Amplification & Expansion and Vector Recovery/Harvesting) and Downstream Manufacturing (Purification and Fill Finish). Due to the extremely intricate processes used to polish and purify clinical grade end goods, the downstream processing sector had the biggest market share, accounting for 53.31% in 2021. Additionally, there is a greater need for improving downstream processing as a result of the rising demand for viral vectors as a result of their expanded use as treatments. Small-scale viral preparation techniques sometimes involve steps that are sophisticated and challenging to scale up. In order to assure the number of viruses combined with enhanced quality, numerous scalable commercial procedures are being researched and refined, and these elements are fueling the sector's market expansion.

The category is anticipated to be driven by the creation of cutting-edge products like the ambr 15 microbioreactor system for high-throughput upstream process development. The ambr 15 microbioreactor system enables effective cell culture processing with automated experimental setup and sampling, requiring less personnel and laboratory space. Cleaning and sterilizing time is also significantly reduced. To fulfill the growing need for affordable and scalable production procedures for viral vectors, businesses like GE Healthcare are engaged in the development of upstream cell culture techniques.

By Application Analysis

Based on Application the market is divided into Antisense & RNAi Therapy, Gene Therapy, Cell Therapy, Vaccinology and Research Applications. In 2021, the sector for vaccinations had the biggest market share at 24.76%. This is a result of viral vectors' extensive usage in vaccine development due to the advantages associated with efficiency. Positives include the capacity to elicit a wide immunological response, as well as the safety profiles and simplicity of production. Additionally, because AAV may express episomal genes without integrating into the host genome, EMA has approved its use in clinical settings. The planning and optimization of vaccination schedules would also encourage the creation of novel vaccines.

The use of viral vectors in vaccine development has been spurred by the current COVID-19 virus epidemic. Prior to the emergence of COVID-19, viral vectors were often used for vaccine manufacturing; however, because a vaccine against this virus was required, the scientific community was forced to repurpose existing techniques. Non-replicating viral vectors are utilized in COVID-19 viral vector vaccines, and these elements are fueling the segment's market expansion.

In 2021, the research institutes' market share was 56.60%, which was the highest. Due to the high need for viral vectors for conducting research, it is anticipated that the growing engagement of scientific communities in gene and cell therapy research would boost the demand for viral vectors. In addition, the market for viral vectors and plasmid DNA synthesis is seeing the emergence of research institutions, pharmaceutical, and biopharmaceutical firms as major end-users, which is helping to drive the development of sophisticated drugs and an increasing number of gene therapy-based R&D initiatives. One of these companies, Abeona Therapeutics, for instance, is exploring AAV9-based gene therapies for CLN1 and CLN3 illnesses. It will thus encourage market expansion.

When it comes to the usage of vectors, pharmaceutical and biotechnology firms are at the forefront. Advanced therapeutics for the treatment of long-term illnesses including cancer and genetic abnormalities are being developed using these vectors. Consequently, pharmaceutical and biopharmaceutical businesses now hold a significant market share. The category is anticipated to be driven by pharma companies' rising interest in cutting-edge medical fields including gene treatments. On the other hand, because there is such a high need for research vectors, research institutes are anticipated to expand greatly over the course of the projection year.

By Disease Type Analysis

Based on Disease type the market is segmented into Cancer, Genetic Disorders, Infectious Diseases and Others. In 2021, the cancer sector had the biggest market share (37.28%). The market expanded as a result of several research initiatives, an increase in the use of vectors for the creation of cancer medicines, and recent approvals of gene therapy products. Companies currently have a strong pipeline of cancer gene therapy products, which is anticipated to spur market expansion over the course of the projected period.

The effectiveness of viral vector-based therapeutics used to cure genetic abnormalities is the subject of several research papers. The use of gene therapy in treating conditions like X-linked chronic granulomatous disease, Duchenne muscular dystrophy (DMD), and Rett syndrome is one such genetic ailment.

Regional Overview

Based on region the viral vectors and plasmid DNA manufacturing market are segmented into North America, Europe, Asia Pacific, Latin America, and Middle East.

Viral Vectors and Plasmid DNA Manufacturing Market Regional Analysis

Regional Growth Insights Request Sample Pages

In 2021, North America held a 48.99% share of the worldwide market, dominating it. The existence of a sizable number of centers and institutions involved in the R&D of advanced medicines is one of the key reasons that has led to the huge share of this regional market. The federal agencies' investments in the region's cell therapy research base are expected to boost the market's expansion in North America.

According to estimates, the Asia Pacific region would have the quickest growth due to factors including the growing patient population, increased R&D spending in this area, and others. Additionally, because the legal environment is less severe in this location, patients from western nations are flying there for stem cell therapy. Global businesses have also changed their business strategies in this region as a consequence of the enormous regional population and untapped potential. Additionally, this area provides reasonably priced operational & manufacturing facilities for performing research. These elements are anticipated to significantly contribute to the development of the stem cell sector in this area and accelerate the market's expansion.

Competitors in Global Market

List of key viral vectors and plasmid DNA manufacturing market companies profiled

  • Merck KGaA
  • Lonza
  • FUJIFILM Diosynth Biotechnologies U.S.A. Inc.
  • Cobra Biologics Ltd.
  • Brammer Bio
  • Waisman Biomanufacturing
  • Genezen
  • Advanced BioScience
  • Laboratories Inc. (ABL Inc.)
  • Novasep Holding S.A.S
  • ATVIO Biotech Ltd

Recent Developments by Key Players

To fulfill the rising demand for plasmid DNA-based medicines and mRNA-based vaccinations, Thermo Fisher Scientific Inc. announced the establishment of a new cGMP plasmid DNA production facility in Carlsbad, California, in July 2021.

Lonza unveiled the Next Generation 4D-Nucleofector Cell Transfection Platform in May 2021. This platform has increased usability and performance that has been shown. Modular architecture offers unparalleled size and throughput flexibility while offering performance that has been tested.

Aldevron and Ziopharm Oncology partnered strategically in June 2020 to help produce plasmid DNA for T cell treatment of solid malignancies.

For its BioReliance virus and gene therapy service offering, Merck announced the launch of the second facility in Carlsbad, California, in the United States, in April 2020. The new facilities, which cost €100 million, will more than quadruple the manufacturing capacity now available and allow for the large-scale commercial manufacture of medicines used in gene and virus therapies.

Global Viral Vectors and Plasmid DNA Manufacturing Market: Segmentation

By Vector Type

  • Adenovirus
  • Retrovirus
  • Adeno-Associated Virus (AAV)
  • Lentivirus
  • Plasmids
  • Others

By Workflow

  • Upstream Manufacturing (Vector Amplification & Expansion and Vector Recovery/Harvesting)
  • Downstream Manufacturing (Purification and Fill Finish)

By Application

  • Antisense & RNAi Therapy
  • Gene Therapy
  • Cell Therapy
  • Vaccinology
  • Research Applications

By End Use

  • Pharmaceutical and Biopharmaceutical Companies
  • Research Institutes

By Disease Type

  • Cancer
  • Genetic Disorders
  • Infectious Diseases
  • Others

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
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