Segments - Viral Vectors and Plasmid DNA Manufacturing Market by Application (Antisense & RNAi Therapy, Vaccinology, Gene Therapy, Cell Therapy, and Research Applications), Disease Type (Cancer, Infectious Diseases, Genetic Disorders, and Others), Vector Type (Adeno-associated Virus (AAV), Lentivirus, Adenovirus, Retrovirus, Lentivirus, Plasmids, and Others), Workflow (Upstream Manufacturing [Vector Recovery/Harvesting and Vector Amplification & Expansion] and Downstream Manufacturing [Fill Finish and Purification]), End-user (Research Institutes and Pharmaceutical & Biopharmaceutical Companies), and Region (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2023 – 2031
The global viral vector & plasmid DNA manufacturing market size was USD 5.7 Bn in 2022 and is likely to reach USD 12.9 Bn by 2031, expanding at a CAGR of 18.4% during 2023–2031. The growth of the market is attributed to increasing prevalence of cancer, genetic disorders, and infectious diseases.
Several infectious diseases and genetic disorders such as Duchenne Muscular Dystrophy (DMD), granulomatous disease, and Rett syndrome are on the rise across the globe. For instance,
Viruses have a natural affinity for certain cell types, and are, therefore, used in therapeutic approaches. These vectors are modified according to the required application, which makes them advantageous for targeting and entering cells. Moreover, these vectors are effective tools used in gene therapy to deliver therapeutic genes to target cells.
The effectiveness of viral vectors is determined by various factors such as the target cell type, the type of virus used, the dosage, mode of delivery, and the immune response of the patient. These vectors are the most efficient method for in vivo gene transfers. The effectiveness of viral vectors supports the market growth in the coming years.
The research report finds that the COVID-19 pandemic positively impacted viral vector & plasmid DNA manufacturing market. The pandemic fuelled the use of viral vectors in the vaccine research, as viral vectors had application in the vaccine production before the introduction of COVID-19. Scientific community repurposed existing methodologies of vaccine production to combat the virus outbreak.
Increasing number of clinical studies emphasizes the potential of gene therapy and is anticipated to boost the market during the forecast period. Clinical research or trial helps to find new ways to detect, prevent, or treat disease. Moreover, it is employed to determine if the novel technique or medication works and is safe. For instance,
In May 2022, Catalent Inc. has recently introduced its new UpTempo Virtuos platform process for the CGMP manufacturing and development of adeno-associated viral (AAV) vectors. This platform aims to streamline and standardize the various time-consuming steps involved in AAV manufacturing, which is expected to help to reduce the timeline from gene to clinic and enable rapid first-in-human clinical evaluation.
High cost of gene therapies is projected to hinder the market expansion in the coming years. Furthermore, the cost of manufacturing a cell and gene therapy is considerably more than conventional biologics, including recombinant proteins and monoclonal antibodies. Thus, market players face challenges regarding the viral vector production capacity.
Viral vectors used in cell and gene therapy manufacturing have raised safety concerns. These vectors cause inflammation, disrupt normal genes, activate proto-oncogenes, and cause insertional mutagenesis. However, there is no one solution to reduce genotoxicity, as the risk factors associated with viral vector-mediated insertional mutagenesis are varied.
Genotoxicity test is likely to hamper the market growth in the coming years, as it mainly relies on detecting damage or mutation in DNA. This test is not sufficient to detect vector-mediated insertional mutagenesis, which mostly takes weeks, months, or even years to show up in patients. It is important to choose the correct method of testing to detect toxicity.
New in vitro and in vivo assays are being developed to assess non-viral vector risk factors such as age and disease state. These tests are expected to improve pre-clinical safety assessment of viral vectors and risk assessment for patients. This is projected to create lucrative opportunities for market players in the coming years.
The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes |
Details |
Report Title |
Viral Vector & Plasmid DNA Manufacturing Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
Base Year |
2022 |
Historic Data |
2016–2021 |
Forecast Period |
2023–2031 |
Segmentation |
Application (Antisense & RNAi Therapy, Vaccinology, Gene Therapy, Cell Therapy, and Research Applications), Disease Type (Cancer, Infectious Diseases, Genetic Disorders, and Others), Vector Type (Adeno-associated Virus (AAV), Lentivirus, Adenovirus, Retrovirus, Lentivirus, Plasmids, and Others), Workflow (Upstream Manufacturing [Vector Recovery/Harvesting and Vector Amplification & Expansion] and Downstream Manufacturing [Fill Finish and Purification]), and End-user (Research Institutes and Pharmaceutical & Biopharmaceutical Companies) |
Regional Scope |
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
Report Coverage |
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast |
Key Players Covered in the Report |
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.; Merck KGaA; Lonza; and FUJIFILM Diosynth Biotechnologies |
On the basis of application, the market is segmented into antisense & RNAI therapy, vaccinology, gene therapy, cell therapy, and research applications. The vaccinology segment is projected to expand at a considerable CAGR during the forecast period, due to the rising widespread use of viral vectors in vaccine development. It possesses efficiency related benefits and triggers a broad immunological response.
The gene therapy segment is anticipated to account for a major market share during the forecast period, owing to rising incidence and prevalence of cancer. Gene therapy based on viral vectors is gaining prominence in the area of cancers. Major players are developing novel products. Researchers engineer viral vectors for both therapeutic and preventive applications. For instance,
Based on disease type, the viral vectors and plasmid DNA manufacturing market is divided into cancer, infectious diseases, genetic disorders, and others. The cancer segment is expected to hold a significant share of the market in the coming years, due to rising adoption of vectors for the research and development of cancer therapies. Key players have robust pipeline for several research programs and gene therapy products, which in turn boosts the segment.
The genetic disorders segment accounts for a significant market share, owing to the rising research and development activities. Several pharmaceutical companies conduct research to study the efficiency of viral vectors-based therapies to find out the effective treatment for genetic disorders.
On the basis of vector type, the market is segregated into Adeno-associated virus (AAV), lentivirus, adenovirus, retrovirus, lentivirus, plasmids, and others. The Adeno-associated virus (AAV) segment is anticipated to expand at a substantial CAGR during the forecast period, owing to rising development of orthopedic and ocular gene therapy. Moreover, AAV is considered effective in several therapeutic areas and proven record of non-pathogenicity is anticipated to fuel the segment during the forecast period.
The adenovirus segment is expected to hold a significant share of the market, as it is widely utilized as vaccines and in variety of research contexts. These viral vectors are able to elicit important humoral and T-cell responses. Furthermore, these vectors as a CRISPR/Cas9 offer successful gene disruptions in the host genome of several human cells in studies.
Based on workflow, the viral vectors and plasmid DNA manufacturing market is segmented into upstream manufacturing and downstream manufacturing. The upstream manufacturing segment is further classified as vector recovery/harvesting and vector amplification & expansion. The downstream manufacturing segment is categorized as fill finish and purification.
The downstream manufacturing segment is projected to register considerable share of the market in the coming years, owing to vastly complex procedures directed for purification and polishing of clinical grade final products. Additionally, the rising demand for viral vectors in therapeutics upsurges the need for downstream manufacturing.
The upstream manufacturing segment is expected to hold substantial CAGR in the coming years. Upstream manufacturing process has importance in the development of advanced products, including Ambr 15 microbioreactor system. Ambr 15 microbioreactor system offers effective cell culture processing with automated experimental sampling and setup. Furthermore, it requires less laboratory space & workers, and take less time for sterilization and cleaning.
Based on end-user, the market is divided into research institutes and pharmaceutical & biopharmaceutical companies. The research institutes segment is expected to hold a significant share of the market in the coming years, due to rising involvement of researchers and scientific communities in gene and cell therapy as well as high demand for vectors for conducting research.
The pharmaceutical & biopharmaceutical companies segment accounts for a significant market share, owing to the growing demand for viral vectors in the manufacturing of sophisticated medicines. Key players widely use these vectors for the development of advanced treatments for chronic conditions, including genetic disorders and cancer.
In terms of region, the global viral vectors and plasmid DNA manufacturing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period, due to the presence of a significant number of research institutes that are involved in the R&D of advanced therapies.
The market in Asia Pacific is anticipated to expand at a rapid pace during the forecast period, due to rising trend of outsourcing drug discovery services, growing investment in pharmaceutical research & development spending, and increasing government initiatives & funding in healthcare research.
The global viral vectors and plasmid DNA manufacturing market has been segmented on the basis of
Key players competing in the global viral vectors and plasmid DNA manufacturing market are 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.; Merck KGaA; Lonza; FUJIFILM Diosynth Biotechnologies; and Thermo Fisher Scientific.
Some of the key players aim at the expansion of manufacturing units to develop their consumer base and increase their product portfolio. Major players in the market are rapidly opting for strategic collaborations and partnerships as well as acquisitions and mergers. For instance,
In February 2021, Wacker announced the acquisition of the US-based Genopis Inc., a major manufacturer of plasmid DNA.
In December 2020, CHA Biotech signed a lease agreement with Matica Bio to construct a viral vector production facility in College Station, Texas, US. The construction of the 25,000 sq. ft facility began in Q4 of 2020, and it is expected to be dedicated to producing viral vectors used in cell and gene therapies, vaccines, and oncolytic products. The facility was scheduled to open in Q3 of 2021.