Visiongain has published a new report entitled Viral Vectors & Plasmid DNA Manufacturing Market Report 2024-2034: Forecasts by Vector Type (Adenovirus, Retrovirus, Plasmid DNA, AAV, Lentivirus, Others), by Application (Antisense and RNAi, Gene Therapy, Cell Therapy, Vaccinology), by End-use (Pharma and Biopharma Companies, Research Institutes), by Disease (Oncology, Genetic Disorders, Infectious Diseases, Others), by Workflow (Upstream, Downstream) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.
The viral vectors and plasmid DNA manufacturing market is estimated at US$1,168.9 million in 2023 and is projected to grow at a CAGR of 17.5% during the forecast period 2024-2034.
The challenges in downstream processing (DSP) for viral vectors include a lack of standardization and low yields. Currently, expertise plays a crucial role, and quality-enhancing processes are often overlooked. Unlike monoclonal antibodies, there's no standardized method for large-scale viral-vector DSP. Viral vectors have varying physical features and behaviours inside cells, making it difficult to establish consistent platform techniques.
Various methods like ion-exchange, affinity, and size-exclusion chromatography, along with flow-through processes, are used for primary recovery, clarification, and purification of viral vectors. Different companies employ different combinations, requiring significant process optimization for each product. However, chromatography processes often result in low yields, typically less than 50%. In contrast, monoclonal antibody manufacturing achieves yields of over 90% with standardized platform techniques.
The larger size and higher sensitivity of viral vectors to elution buffers lead to higher losses in each purification step compared to proteins. Processes to enhance product quality, like enriching for complete capsids, are not widely adopted in the industry.
As industry experience grows and common viral vector platform approaches are established, downstream processes are expected to become more standardized over time. It remains uncertain whether this will involve a defined sequence of purification techniques or the adoption of newer methods like monolith chromatography or vector-specific affinity beads. However, industry collaboration is crucial to sharing best practices and guidelines, aiming to reduce variability in viral vector downstream processing.
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How has COVID-19 had a Significant Positive Impact on the Viral Vectors and Plasmid DNA Manufacturing Market?
The COVID-19 pandemic has had a significant impact on the field of viral vectors and plasmid DNA manufacturing, particularly in the context of vaccine development. With the urgent need for effective vaccines to combat the virus, there has been an increase in demand for viral vectors and plasmid DNA as critical components in the production of various COVID-19 vaccines. This unprecedented demand has not only accelerated development and manufacturing processes, but it has also highlighted the importance of robust and scalable production systems. Pharmaceutical and biotech companies have invested heavily in optimizing manufacturing platforms to meet the global demand for COVID-19 vaccines, resulting in improvements in the efficiency and scale of viral vector and plasmid DNA production.
Rapid development of adenovirus-based vaccines, such as those developed by AstraZeneca and Johnson & Johnson, is one recent example. These vaccines use viral vectors to deliver genetic material encoding the SARS-CoV-2 virus's spike protein, eliciting an immune response in the vaccinated individual. To ensure large-scale and high-quality vaccine production, the manufacturing processes for these viral vectors, as well as the plasmid DNA used in production, have been significantly refined. Furthermore, advances in mRNA vaccine technology, as demonstrated by the Pfizer-BioNTech and Moderna COVID-19 vaccines, have had an impact on the production of viral vectors and plasmid DNA. The success of these vaccines has increased interest and investment in mRNA technology, which uses synthetic mRNA rather than viral vectors to deliver vaccines. While not directly related to viral vectors and plasmid DNA, the success of mRNA vaccines has far-reaching implications for vaccine development and manufacturing processes in the future. As a result, not only has the pandemic accelerated the development of COVID-19 vaccines, but it has also pushed the limits of viral vector and plasmid DNA manufacturing capabilities, leaving a lasting impact on the field's future potential and applications beyond the current crisis.
How will this Report Benefit you?
Visiongain’s 408-page report provides 166 tables and 183 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 type, process, upstream, downstream, and company size 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?
Viral vectors and plasmids play a key role in enabling precision and breakthroughs in biotechnology
Viral vectors and plasmids are instrumental in the field of biotechnology, especially in the context of advancements like CRISPR-Cas9 gene editing. They serve as indispensable vehicles for delivering genetic material with precision, enabling scientists to manipulate and modify genes for various purposes, from basic research to therapeutic interventions. Viral vectors, such as adeno-associated viruses (AAVs) and lentiviruses, have become central players in gene therapy, allowing for the targeted insertion of genetic material into host cells. Plasmids, on the other hand, are versatile circular pieces of DNA commonly used in molecular biology research to introduce foreign genes into cells or organisms. Their importance extends beyond gene editing to encompass a wide array of biotechnological applications, including vaccine development and protein production.
Recent developments in the biotechnology landscape further underscore the critical role of viral vectors and plasmids. In January 2023, Catalent, a prominent player in the biopharmaceutical industry, inaugurated a state-of-the-art plasmid DNA (pDNA) manufacturing facility in Gosselies, Belgium. This facility not only signifies the growing demand for plasmids but also the need for their efficient production at a commercial scale. Catalent's commitment to producing off-the-shelf plasmids to support cell and gene companies reflects the broader trend in the industry, where these genetic tools are in high demand. The integration of pDNA expertise in Gosselies with the clinical and commercial production of viral vectors for gene therapy, cell therapy, and mRNA across their network is a strategic move that ensures the continuity of the supply chain. It's a testament to the interdependence of these elements in the biotechnology ecosystem and their collective role in driving therapeutic innovations.
Investing in Progress Entails Reaping the Benefits of the Viral Vector Revolution
The surge in funding for viral vector and plasmid DNA manufacturing companies, driven by a growing interest from investors and pharmaceutical firms, underscores the pivotal role these components play in the realm of biotechnology. This increased financial support reflects a recognition of their significance in advancing therapeutic innovations and biotechnological breakthroughs. Notably, collaborations like the one between Novartis and Harvard to develop a scalable lentiviral vector platform highlight the industry's commitment to optimizing the production of viral vectors, ensuring they are both efficient and scalable to meet the burgeoning demand.
An exemplary instance of the intensified focus on viral vectors is exemplified by the partnership established in June 2023 between Charles River Laboratories (CRL) and Curigin, a Korean biotechnology company specializing in oncolytic ribonucleic acid interference (RNAi) gene therapies. This collaboration underscores the industry's commitment to unlocking the potential of viral vectors. Through harnessing the expertise of Charles River in Contract Development and Manufacturing Organization (CDMO) solutions, Curigin is positioned to elevate its capabilities for both preclinical and clinical trials. This cooperative venture highlights the growing trend in the biotechnology sector, where companies are increasingly collaborating with established CDMOs to optimize operational efficiency and ensure high-quality production of viral vectors. This strategic alliance is poised to contribute significantly to advancements in healthcare and therapeutic applications.
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Where are the Market Opportunities?
Growing Need for Synthetic DNA Templates in RNA Medicine
The effective use of mRNA vaccinations during the COVID-19 pandemic has thrust RNA medicine into the spotlight, with tremendous possibilities in infectious diseases, cancer therapies, and protein-encoding replacement treatments. Because of its ease of design, rapid scaling, and manufacturing capabilities, RNA-based therapies, particularly mRNA, have gained significance. This paradigm shift benefits not just research and development but also provides a safer option to DNA-based medicines, which may face concerns connected with insertional mutagenesis. Despite these benefits, intracellular mRNA distribution to target cells while preserving stability remains a substantial hurdle.
The necessity for effective DNA templates for RNA production, particularly synthetic DNA, has surfaced as a potential possibility. Synthetic DNA has various advantages over conventional plasmid DNA, including a smaller manufacturing footprint, easier downstream processes, and decreased error rates. Its scalability and versatility match the needs of RNA-based treatments, allowing for the creation of DNA templates at diverse scales to meet the changing healthcare landscape. Furthermore, the improved safety features of synthetic DNA, such as the absence of enzymatic linearization, provide dependable and stable mRNA production. This increasing demand for synthetic DNA templates in the context of RNA therapeutics provides a tremendous potential for the viral vector and plasmid DNA manufacturing business, which is poised for rapid expansion and innovation.
Advancements in Genome Sequencing Driving Market Expansion
The expansion of gene therapy, combined with strides in genome sequencing and an enhanced comprehension of DNA sequences, has ushered in a compelling avenue of research. In recent decades, the application of viral vectors in gene therapy has evolved into a highly promising and swiftly emerging methodology. Despite earlier difficulties, there has been a substantial surge in gene therapy research as a result of the widespread acceptance of viral vector medicines, several of which are in late-stage clinical studies. Key vectors that are currently being studied and employed in clinical trials include retroviral, adenoviral, adeno-associated viral, and lentiviral ones. The expense of manufacture, the immune reaction, and the capacity to precisely control the transgene's expression are only a few of the obstacles that the use of viral vectors still faces. However, the use of viral vectors in gene therapy in the future is looking more and more viable as more clinical trials demonstrate its effectiveness, safety, and rising financial investment. For instance, in November 2023, Genezen, a leading entity within the Contract Development and Manufacturing Organization (CDMO) market specialized in cell and gene therapy, has effectively concluded a subsequent expansion equity investment, securing a total of 18.5 million USD. The forefront of this funding initiative is held by Ampersand Capital Partners, strategically aimed at expediting Genezen's endeavours to enhance its manufacturing capabilities, particularly in the production of retroviral, lentiviral, and adeno-associated viral (AAV) vectors. Furthermore, this substantial investment is poised to play a pivotal role in facilitating entrepreneurs involved in cutting-edge cell and gene therapies, enabling the seamless execution of a robust pipeline of client projects in the dynamic healthcare landscape.
Adenovirus, adeno-associated virus, retrovirus, and lentivirus are commonly utilized as vectors in gene therapy. While there have been challenges associated with their use, ongoing research and enhancements in their design are expected to pave the way for their application in therapeutic contexts. Currently, viral vectors are actively employed in numerous global clinical trials addressing various medical conditions. The successful utilization of these vectors in advanced clinical trials and laboratory settings has attracted increased venture capital investment and led to pharmaceutical companies acquiring gene therapy start-ups. This heightened interest and financial backing in the field of gene therapy underscore the positive trend and recognition of the significance of viral vectors in advancing healthcare solutions.
Competitive Landscape
The major players operating in the AI in oncology market are Amicus Therapeutics, Lonza, Merck KGaA, uniQure N.V., Catalent Inc., Thermo Fisher Scientific Inc., Charles River Laboratories, FUJIFILM Diosynth Biotechnologies, bluebird bio Inc., Aldevron, Addgene, Creative Biogene, VIVEbiotech, Recipharm AB, Waisman Biomanufacturing, VGXI Inc., Batavia Biosciences B.V., WuXi AppTec, ATUM, Altogen Biosystems, GENEZEN, Yposkesi, Inc, CEVEC Pharmaceuticals GmbH, Virovek, Advanced BioScience Laboratories, Inc. (ABL), Biovian Oy, BioNTech IMFS. 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 launch.
Recent Developments
- In November 2023, Yposkesi launched AAVelocity a plug-and-play Adeno-Associated Virus (AAV) platform. AAVelocity is designed to bring cost and time-efficiencies to drug developers in the production of AAV gene delivery systems used to transport a gene therapy into tissue to prevent, treat or cure inherited disorders and rare diseases.
- In October 2023, Batavia Biosciences announced its new Alliance for Regenerative Medicine (ARM) membership. ARM is a premier international advocacy organization that brings regenerative medicines and advanced therapies to patients worldwide. By joining ARM, Batavia Biosciences is committed to advancing the cell and gene therapy field.
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- Biological Drug API Manufacturing Services Market Report 2023-2033
- Bioprocess Validation Market Report 2023-2033
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