Viral Vector & Plasmid DNA Manufacturing Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global viral vector manufacturing market, valued at US$4.8 billion in 2022, is forecasted to grow at a robust CAGR of 18.2%, reaching US$5.5 billion in 2023 and an impressive US$12.8 billion by 2028. The growth of this market is majorly driven by g rising prevalence of target diseases and disorders, the availability of funding for gene therapy development, and effectiveness of viral vectors in gene therapy delivery. On the other hand, high operational cost associated with cell & gene therapy manufacturing is restraining the growth of this market.

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Viral Vector Manufacturing Market

Driver: Effectiveness of viral vectors

Viral vectors have been proven to be effective tools for delivering therapeutic genes to target cells in gene therapy. The effectiveness of viral vectors can depend on several factors, including the type of virus used, the target cell type, the dosage and mode of delivery, and the immune response of the patient. Currently, viral vectors are the most effective gene delivery methods, especially for in vivo gene transfers. Viruses have a natural tropism to some cell types and are hence utilized in therapeutic approaches. Viral vectors can be modified according to the required application and thus prove advantageous for targeting and entering cells.

Restraint: High operational costs associated with cell & gene therapy manufacturing

Currently, more than 1,000 cell & gene therapies are in trial worldwide. There are more than 700 investigational cell & gene therapies in clinical development in the US alone. However, manufacturing facilities have not kept up. It has been estimated that hundreds of facilities will be needed to manufacture the treatments that are now in clinical trials. One of the areas that need to be accelerated is viral capacity. Most viral vectors are produced using adherent manufacturing, which is expensive to operate—a vial of 20 million cells can cost USD 20,000 to USD 30,000 to make. The cost of manufacturing for a gene therapy can be between USD 500,000 and USD 1 million, excluding the costs for R&D, the costs to run crucial clinical trials, or the costs to build the commercial infrastructure necessary to provide access to patients.

The cost of manufacturing a cell & gene therapy is significantly more than conventional biologics such as monoclonal antibodies and recombinant proteins. Therefore, the significant operational costs associated with cell and gene therapy manufacturing are expected to negatively impact the viral vector and plasmid DNA manufacturing market during the forecast period.

Opportunity: Leveraging digital to facilitate operational excellence

To further address operational challenges in production, manufacturers could explore the use of digital tools. One such tool is advanced analytics-based models, which can help optimize yield by proactively identifying and correcting potential yield issues. By using an analytics-driven recommendation engine built on historic deviation and root-cause data, manufacturers can shorten timelines for resolving deviations.

Another potential solution to the industry-wide talent shortage is the use of augmented and virtual reality tools. These tools can be used to train operators without removing the lab or subject-matter expert from production. They can be particularly useful for initial onboarding or infrequent processes that require refresher training. By leveraging these digital tools, manufacturers can improve efficiency and address challenges in production, ultimately leading to more successful outcomes in manufacturing of viral vectors and plasmid DNA.

Thus, increasing usage of digital and automation tools in manufacturing of viral vector and plasmid DNA is expected to drive the market growth over the forecast period.

Challenge: Risk of mutagenesis and other unwanted outcomes

Several safety concerns have been highlighted in viral vectors that are used for cell and gene therapy manufacturing. These include inflammation, random insertion disrupting normal genes, the activation of proto-oncogenes, and insertional mutagenesis. As several factors are associated with the risk of viral vector-mediated insertional mutagenesis (viral and non-viral), a one-size-fits-all approach for reducing genotoxicity cannot be applied. Current genotoxicity testing strategies rely largely on detecting the effects on DNA (damage or mutation) following a short exposure and expression period for mutation. However, these are of limited use when considering vector-mediated insertional mutagenesis, as it takes weeks, months, or even years to manifest in patients.

The choice of test models to detect toxicity is also vital. However, the development of effective test systems to detect viral vector-induced genotoxicity, particularly considering the delayed onset, represents a major challenge. New in vitro and in vivo assays are being developed for the assessment of non-viral vector risk factors, such as age and disease state. These are expected to improve the pre-clinical safety assessment of viral vectors and improve patient-centric risk assessment.

The products segment dominated viral vector and plasmid DNA manufacturing market by products & services

The products segment held the largest share of the global market in 2022. The process of viral vector and plasmid DNA manufacturing involves several key products and reagents that are essential for the successful production, purification, and characterization of viral vectors and plasmid DNA. Products considered under this segment are cell lines, specialized media, purification kits and reagent, assay kits, vector amplification kits and expansion products. The large share of this segment can be attributed to factors such as the increasing demand for viral vector and plasmid DNA based therapies, rising research and development activities are expected to rise the demand for products used in viral vector and plasmid DNA manufacturing and anticipated to drive the segment growth over the forecast period.

Asia Pacific region of viral vector and plasmid DNA manufacturing market is estimated to register the highest CAGR during the forecast period.

Asia Pacific offers lucrative growth potential for the market. This can be attributed to the increasing pharmaceutical R&D spending, the growing trend of outsourcing drug discovery services, growing life sciences research, and increasing government initiatives for healthcare research.

One significant growth driver for the viral vector and plasmid DNA manufacturing market in the Asia Pacific region is the increasing investment in healthcare infrastructure and research & development (R&D) activities. Governments and private entities are allocating substantial funds and launching various research programs to enhance healthcare facilities and promote scientific advancements, including viral vector and plasmid DNA manufacturing technologies. These investments are driving the adoption of viral vector and plasmid DNA manufacturing techniques across various applications and research fields.

The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) and its Regulatory Harmonization Steering Committee (RHSC) adopted a strategic plan (Vision 2020: A Strategic Framework: Regulatory Convergence for Medical Products by 2020). This strategic plan provided the basic proposal and rationale for achieving regional regulatory convergence of medical product approval procedure. The forum’s vision is to accelerate regulatory convergence for medical products in the APEC region as much as possible by 2030 in order to protect people’s safety, make life-saving products available, save public resources, attract investments, mitigate corruption, and improve global standing in every APEC economy. Thus, favourable regulatory guidelines for product approval is expected to drive the market growth.

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Key players in the viral vector and plasmid DNA manufacturing market include Lonza Group AG (Switzerland), Merck KGaA (Germany), Thermo Fisher Scientific Inc. (US), Charles River Laboratories International, Inc. (US), Catalent Inc. (US), WuXi AppTec (China), FUJIFILM Corporation (Japan), GenScript Biotech Corporation (US), Takara Bio Inc. (Japan), Oxford Biomedica (UK), Novartis AG (Switzerland), Precision Biosciences (US), Bluebird Bio, Inc. (US), Sartorius AG (Germany), Danaher Corporation (US), SIRON Biotech (Germany), VGXI, Inc. (US), Waisman Biomanufacturing (US), Kaneka Eurogentec S.A. (Belgium), PlasmidFactory GmbH (Germany), ATUM (US), Addgene (US), Cell and Gene Therapy Catapult (UK), Batavia biosciences (Netherlands), and Altogen Biosystems (US).

Viral Vector & Plasmid DNA Manufacturing Market Report Scope

This report categorizes the viral vector and plasmid DNA manufacturing market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Viral Vectors
  • Retroviruses
  • Adenoviruses
  • Adeno-associated viruses (AAVs)
  • Lentiviruses
  • Others
• Plasmid DNA

By Product & Services

• Product
• Services

By Workflow

• Upstream Manufacturing
  • Vector Amplification, Editing and Expansion
  • Vector Recovery/Harvesting
• Downstream Manufacturing
  • Purification
  • Fill Finish

By Application

• Cell and Gene Therapy
• Vaccine Development
• Research

By Disease Indication

• Cancer
• Generic Disorders
• Infectious Diseases
• Others

By End User

• Pharmaceutical and Biopharmaceutical Companies
• Academics and Research Institutes
• Others

By Region

• North America
  • US
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • RoLATAM
• Middle East and Africa (MEA)

Recent Developments

• In August 2022, MERCK KGaA the VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform, which offers a full viral vector manufacturing offering including AAV, Lentiviral vectors.
• In May 2022, Catalent Inc., launched UpTempo Virtuoso platform process for the development and manufacturing of adeno-associated viral (AAV) vectors.

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