Visiongain has published a new report entitled Viral Vectors and Plasmid DNA Manufacturing 2022-2032. It includes profiles of Viral Vectors and Plasmid DNA Manufacturing and Forecasts Market Segment by Vector Type (Adenovirus, Retrovirus, Plasmid DNA, AAV, Lentivirus, Others), Market Segment by Application (Antisense & RNAi, Gene Therapy, Cell Therapy, Vaccinology), Market Segment by End-use (Pharma and Biopharma Companies, Research Institutes), Market Segment by Disease (Oncology, Genetic Disorders, Infectious Diseases, Others), Market Segment by Workflow (Upstream, Downstream), plus COVID-19 Impact Analysis and Recovery Pattern Analysis (“V”-shaped, “W”-shaped, “U”-shaped, “L”-shaped), Profiles of Leading Companies, Region and Country.
The viral vectors and plasmid DNA manufacturing market was valued at US$482.3 million in 2021 and is projected to grow at a CAGR of 18.09% during the forecast period 2022-2032.
Challenges Associated with Shortage of Viral Vector Manufacturing Capacities
Due to the rise in clinical-stage start-ups, contract manufacturers, on which new gene & cell therapy enterprises rely for early-stage development activities, are undergoing a shortage of viral vector manufacturing capacities. To avoid the challenges of outsourcing, when these businesses achieve commercial scale, they usually opt to maintain complete control over their manufacturing. As a result, biotech companies started to prepare for growth, organise internal teams, and/or seek advice from site consultants. These experts aid in the hunt for suitable R&D facilities or, increasingly, new construction sites in the markets.
These internal capabilities enable gene & cell therapy enterprises to swiftly scale up manufacturing from clinical quantities to commercial scale, even when therapies are still in the R&D stage. This also enables co-location with R&D operations, enabling a smooth technology transfer with minimal disruption. Existing buildings, which are becoming more difficult to locate in developed biotech centres due to market demand, are the focus because of the pressing requirement for "time-to-market." Cost sensitivity is a requirement for all ventures, but businesses that have received venture investment are especially concerned with expenses and the need to reduce both initial and recurring cash outlays.
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How has COVID-19 had a Significant Impact on the Viral Vectors and Plasmid DNA Manufacturing Market?
COVID-19 has pushed innovation to scale viral-vector manufacturing while also increasing knowledge and infrastructure. To manufacture higher-quality and more versatile viral vectors at a lower cost, high-yield producer cell lines are currently the focus of viral-vector research and financing. Although hybrid systems, like packaging cell lines, might combine some of the benefits of several systems, the use of many common capsids may be constrained by patents to original firms or partnerships. However, they have not yet been tested in clinical development. Novel methods that are now being developed are attempting to address all three criteria and may become attractive in the future.
Whether to expand manufacturing capacity internally or outsource production to specialised CDMOs is a crucial production decision. Utilizing external manufacturing platforms can facilitate a more rapid ramp-up of production while also providing access to trustworthy GMP-certified facilities, resources, and technical and regulatory experience.
Although start-up timelines for contract manufacturing can take longer than 18 months due to high demand. This time should be cut down and the standardisation of tech transfer procedures should continue to be supported by increases in CDMO capacity brought on by the manufacture of the COVID-19 vaccine. Smaller businesses or early-stage research activities are particularly well-suited for the usage of CDMOs, and there are numerous examples of tactical alliances with contract manufacturers. By avoiding significant expenditures in the manufacturing capabilities of a modality that may still raise concerns about its application to a larger patient population, offers access to expertise that can be beneficial in a competitive market. Nevertheless, a few bigger businesses have invested in their manufacturing capabilities to create their production methods and scale lower cost of goods (COGs).
How will this Report Benefit you?
Visiongain’s 400-page report provides 152 tables and 177 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the viral vectors and plasmid DNA manufacturing market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Viral Vectors and Plasmid DNA Manufacturing. Get financial analysis of the overall market and different segments including vector type, application, end-use, disease, workflow, and capture higher market share. We believe that there are strong opportunities in this fast-growing viral vectors and plasmid DNA manufacturing market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.
What are the Current Market Drivers?
Increasing Number of Clinical Studies
The future does certainly appear bright for gene treatments, given the growing number of clinical trials that are being conducted as well as the significant mergers, acquisitions, and venture capital investments made in the cell and gene therapy industry as a whole. GMP-produced plasmids are the foundation for increasing the availability of viral vectors, and considerable advancements in viral-vector production are needed to both increase batch size and lower manufacturing costs. Increasing vector potency and lowering therapeutic dose needs could be another way to overcome supply issues and high costs.
Investments by Large CDMOs Anticipated to Fuel Market Growth
Due to the rising demand, viral-vector production has had to quickly advance. Higher yields and reduced cost of products are necessary for the wider use of viral-vector-based gene treatments (for instance, for more prevalent diseases). Large CDMOs have made significant investments in this field and have made several sizable acquisitions recently. Although exciting, this sudden infusion of cash and cutting-edge technology hasn't yet resolved the manufacturing bottlenecks and difficulties associated with viral vectors.
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Where are the Market Opportunities?
Continuous Collaboration is Projected to Offer Lucrative Growth Opportunities
Numerous gene therapies that have been approved and hundreds of products in development are accelerating the growth of industry expertise. The regulatory framework is also quickly evolving, which boosts industry and regulatory maturity and gives people more faith in their ability to comprehend rules. The continuous collaboration between academic research, business investment, and regulatory commitment have enormous potential for streamlining AAV manufacturing and enabling the development of novel, high-quality AAV therapies.
Competitive Landscape
The major players operating in the viral vectors and plasmid DNA manufacturing market are Advanced BioScience Laboratories, Inc. (ABL, Inc.), Batavia Biosciences, BioMarin, BioNTech IMFS, Biovian Oy, bluebird bio, Inc., Creative Biogene, CEVEC Pharmaceuticals GmbH, Charles River Laboratories, Cytiva, FUJIFILM Diosynth Biotechnologies, Genezen, Lonza, Merck KGaA, Novasep (Thermofisher Scientific Inc.), Patheon Pharma Services (Thermo Fisher Scientific Inc.), Paragon Bioservices, Inc. (Catalent), Sirion-Biotech GmbH, VGXI, Inc., Vibalogics, Virovek, Vivebiotech, Waisman Biomanufacturing, Wuxi AppTec, and Yposkesi, Inc. among other prominent players. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.
Recent Developments
- In August 2022, Thermo Fisher Scientific expanded its cell and gene therapy capabilities with the opening of its new viral vector manufacturing facility in Plainville, Mass. The manufacturing facility will support the development, testing, and manufacture of viral vectors, which are critical components in the development and commercialization of gene therapies.
- In August 2022, WuXi Advanced Therapies announced a licensing agreement with Janssen Biotech, Inc. Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral (AAV) vectors than traditional AAV manufacturing systems. Janssen will also have access to work on WuXi ATU's proprietary clonal suspension HEK293 cell line.
- In February 2022, IDT Biologika and Exothera S.A. collaborated to develop a large-scale manufacturing process for viral vector-based vaccines.
To find more Visiongain research reports on the Pharma sector, click on the following links:
- Gene Therapy R&D Market Report 2022-2032
- mRNA Vaccines & Therapeutics Market Report 2022-2032
- Contract Research Organisations (CROs) Market Report 2022-2032
Do you have any custom requirements we can help you with? Any need for a specific country, geo region, market segment or specific company information? Contact us today, we can discuss your needs and see how we can help: oliver.davison@visiongain.com
About Visiongain
Visiongain is one of the fastest-growing and most innovative independent market intelligence providers around, the company publishes hundreds of market research reports which it adds to its extensive portfolio each year. These reports offer in-depth analysis across 18 industries worldwide. The reports, which cover 10-year forecasts, are hundreds of pages long, with in-depth market analysis and valuable competitive intelligence data. Visiongain works across a range of vertical markets with a lot of synergies. These markets include automotive, aviation, chemicals, cyber, defence, energy, food & drink, materials, packaging, pharmaceutical and utilities sectors. Our customised and syndicated market research reports offer a bespoke piece of market intelligence customised to your very own business needs.
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