Viral Vectors And Plasmid DNA Manufacturing Market Size, Share & Trends Analysis Report By Vector Type (AAV, Lentivirus), By Workflow, By Application, By End-use, By Disease, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global viral vectors and plasmid DNA manufacturing market size was valued at USD 4.36 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 20.35% from 2023 to 2030. One of the primary factors driving the market is the advancement in gene therapy, as the development of new gene therapies is heavily reliant on high-quality viral vectors and plasmid DNA. Furthermore, improvements in manufacturing processes have made it possible to produce viral vectors and plasmid DNA more efficiently at larger scales, while also reducing costs and improving overall quality.

The viral vectors and plasmid DNA manufacturing market presented a lucrative opportunity due to the COVID-19 pandemic. Furthermore, the market players have shifted their business focus toward the development of viral vectors for the SARS-CoV-2 vaccine. Viral vectors are commonly employed tools used in the discovery and development of vaccines against SARS-CoV-2. The ongoing COVID-19 pandemic has encouraged investment in this space in search of a vaccine as viral vector-based vaccines can be manufactured and designed relatively quickly with the use of the same building blocks. For instance, Companies such as Johnson and Johnson/Janssen (J&J); AstraZeneca/University of Oxford; Gamaleya Research Institute; and CanSino Biologics have developed viral vector-based vaccines.

The market for viral vectors and plasmid DNA manufacturing is growing due to the increasing prevalence of target ailments and diseases and the efficacy of viral vectors in gene therapy delivery. This increase is aided by continued research into viral vector-based cell and gene therapies, as well as financing for gene therapy advancement. In addition, an increase in the number of gene therapy-based discovery programs initiated by biotechnology and pharmaceutical companies is expected to drive the demand for scalable production of gene therapy vectors.

A rising number of patients opting for gene therapy is driving the global market. Due to a surge in gene therapy development, demand for plasmid DNA is skyrocketing. Thus, Adeno-associated virus (AAV), lentivirus, and other viral vector systems require pDNA (Plasmid DNA) to be manufactured. In addition, several genetic illnesses and infectious diseases are on the rise in different areas of the globe. For instance, as per UNAIDS data, 38.4 million people across the globe were living with HIV in 2021, and 1.5 million people were newly infected with the virus.

Additionally, rising demand for synthetic genes and expanding market potential in untapped regions are projected to open up new chances for market players in the future. However, the risk of insertional mutagenesis and the high cost of gene treatments may thwart market expansion. Furthermore, technical innovations that address the constraints posed by traditional vector production processes create an attractive potential for industry manufacturers.

Vector Type Insights

The Adeno-associated virus (AAV) segment held the largest market share of 18.12% in 2022. The increase is due to the development of ocular and orthopedic gene therapy treatment exhibiting increased efficacy and efficiency. Recently, usage of AAV is rising considerably across several therapeutic areas, consequently witnessing a significant boost in adoption rate throughout the forecast period. Proven records of non-pathogenicity are one of the important key factors boosting their adoption and these factors are driving the segment market growth.

Adenoviral vectors are also deemed safe. Thus, they are rapidly being used in a variety of research contexts. ADV vectors are widely utilized as vaccines due to their ability to elicit significant humoral and T-cell responses. The use of an adenovirus vector as a CRISPR/Cas9 delivery method has resulted in successful gene disruption in the host genome of numerous human cells in studies.

Workflow Insights

The downstream manufacturing segment held the larger market share of 53.25% in 2022 owing to highly complex procedures carried out for polishing and purification of clinical grade final products. Moreover, the growing demand for viral vectors due to their increased adoption as therapeutics has led to an increase in the need for optimizing downstream manufacturing. Small-scale virus preparation methods regularly include procedures that are difficult to scale up and are considered complex. As a result, several scalable commercial processes are being investigated and optimized to ensure the quantity of viruses along with improved quality and these factors are driving the segment market growth.

Development of advanced products such as the ambr 15 microbioreactor system for high-throughput upstream process development is expected to drive the segment. ambr 15 microbioreactor system allows efficient cell culture processing with automated experimental setup & sampling, which requires less labor & laboratory space, and time taken for cleaning and sterilization is also very less. Companies such as GE Healthcare are involved in the development of upstream cell culture processes using modern tools and technologies to meet the rising demand for cost-effective and scalable manufacturing processes of viral vectors.

Application Insights

The vaccinology segment held the largest market share of 22.08% in 2022. This is due to the widespread use of viral vectors in vaccine development due to their efficiency-related benefits. The ability to trigger a broad immunological response, as well as the safety profiles and ease of manufacture, are all positives. In addition, EMA has approved the usage of AAV for clinical use as it can express episomal genes without integrating itself into the host genome. Furthermore, efforts undertaken to design and optimize vaccination regimens would drive the development of new vaccines.

The recent COVID-19 virus outbreak has prompted the use of viral vectors in vaccine research. Though viral vectors are widely employed for vaccine production before the introduction of COVID-19, the scientific community had to repurpose existing methodologies due to the necessity of developing a vaccine against this virus. In the COVID-19 viral vector vaccines, non-replicating viral vectors are used. Such factors are driving the segment market growth.

End-use Insights

The research institutes segment held the larger market share of 58% in 2022. Owing to the high demand for vectors for conducting research and the increasing involvement of scientific communities in gene and cell therapy research is expected to increase the demand for viral vectors. In addition, research organizations, pharmaceutical, and biopharmaceutical companies are the key end-users in the viral vectors and plasmid DNA manufacturing market, contributing to an increase in the introduction of sophisticated medicines and a growing number of gene therapy-based R&D initiatives. Abeona Therapeutics, for instance, is one of these firms that is testing AAV9-based gene treatments for CLN1 and CLN3 disorders. Thus, it will fuel the market growth.

Pharmaceutical and biotechnological companies are leading in terms of the use of vectors. These vectors are used for the development of advanced therapies to treat chronic conditions like cancer and genetic disorders. This, in turn, has led to the major share of pharmaceutical and biopharmaceutical companies in the market. The growing interest of pharma companies in new areas of medicine including gene therapies is expected to drive the segment. On the other hand, research institutes are expected to grow significantly throughout the forecast period owing to the high demand for vectors for conducting research.

Disease Insights

The cancer segment held the largest market share of 38.04% in 2022. An increase in the adoption of vectors for the development of cancer therapies, a large number of research programs, and recent approvals of gene therapy products have led to the growth of the market. Companies have a robust pipeline of cancer gene therapy products, which in turn is expected to boost market growth throughout the forecast period.

A number of research studies are being carried out to study the efficiency of viral vector-based therapies used in the treatment of genetic disorders. Some genetic disorders for which gene therapy applications are being investigated include X-linked chronic granulomatous disease, Duchenne Muscular Dystrophy (DMD), and Rett syndrome.

Regional Insights

North America dominated the global market with a share of 48.98% in 2022. Some of the major factors that have contributed to the large share of this regional market are the presence of a substantial number of centers and institutes that are engaged in the R&D of advanced therapies. Investments made by the federal bodies for the expansion of cell therapy research base in the region are anticipated to enhance the growth of North America market.

Key Companies & Market Share Insights

The market for viral vectors and plasmid DNA manufacturing is highly competitive with the presence of well-established as well as small and mid-sized emerging players. A prominent number of players are rapidly opting for geographical expansion, strategic collaborations, and partnerships through mergers and acquisitions in emerging and economically favorable regions. For instance, in November 2022, Thermo Fischer Scientific, Inc. launched the Gibco CTS AAV-MAX Helper-Free AAV Production System, a brand-new all-in-one tool developed to meet clinical and commercial needs for the economical and scalable development of adeno-associated virus (AAV)-based gene treatments.

Moreover, in May 2022, Catalent Inc. launched its new, UpTempo Virtuos platform process for the CGMP manufacturing and development of adeno-associated viral (AAV) vectors. This platform would streamline & standardize various time consuming steps in AAV manufacturing to reduce the timeline from gene to clinic and enable rapid first-in-human clinical evaluation. Some of the key players in the global viral vectors and plasmid DNA manufacturing market include:

• Merck KGaA

• Lonza

• FUJIFILM Diosynth Biotechnologies

• Thermo Fisher Scientific

• Cobra Biologics

• Catalent Inc.

• Wuxi Biologics

• Takara Bio Inc.

• Waisman Biomanufacturing

• Genezen laboratories

• Batavia Biosciences

• Miltenyi Biotec GmbH

• SIRION Biotech GmbH

• Virovek Incorporation

• BioNTech IMFS GmbH

• Audentes Therapeutics

• BioMarin Pharmaceutical

• RegenxBio, Inc.

Viral Vectors And Plasmid DNA Manufacturing Market Report Scope

Global Viral Vectors And Plasmid DNA Manufacturing Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the viral vectors and plasmid DNA manufacturing market based on vector type, workflow, application, end-use, disease and region:

• Vector Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Adenovirus

  • Retrovirus

  • Adeno-Associated Virus (AAV)

  • Lentivirus

  • Plasmids

  • Others

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)

  • Upstream Manufacturing

    • Vector Amplification & Expansion

    • Vector Recovery/Harvesting

  • Downstream Manufacturing

    • Purification

    • Fill Finish

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Antisense & RNAi Therapy

  • Gene Therapy

  • Cell Therapy

  • Vaccinology

  • Research Applications

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical and Biopharmaceutical Companies

  • Research Institutes

• Disease Outlook (Revenue, USD Million, 2018 - 2030)

  • Cancer

  • Genetic Disorders

  • Infectious Diseases

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

    • France

    • Spain

    • Italy

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait