According to the latest research by Nova One Advisor, the global viral vector production (Research-use) market size is calculated at 1.95 billion in 2024 and is projected to Hit USD 7.62 billion by 2034 with a remarkable CAGR of 14.6% from 2024 to 2034.
Viral Vector Production (Research-use) Market Key Takeaways:
· The adeno-associated virus (AAV) segment accounted for a leading position with a market share of 23.6% in 2024.
· The lentivirus vectors are expected to grow faster at a CAGR of 16.2% in the forecast period.
· The gene and cell therapy development segment accounted for a leading position at the market share of 27.5% in 2024.
· The vaccine development segment is expected to witness a fast-growing CAGR of 14.1% in the forecast period.
· The downstream processing segment held a leading revenue share of 53.0% in 2024.
· The upstream processing is expected to register a fast-growing CAGR of 14.3% in the forecast period.
· The pharmaceutical and biopharmaceutical segment accounted for the largest revenue share of 17.4% in 2024.
· North America viral vector production (research-use) market accounted for 46.9% in 2024.
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Viral vectors production is an integral sector for the development of gene therapies and vaccines. Viral vectors are applied in wide array of healthcare settings such as developing therapeutic vaccines for cancer and chronic infectious diseases, in gene therapies for delivering genetic material to the cells, for research purposes and cell-based therapies which increases the demand of viral vectors development and manufacturing further driving the growth of viral vector production market.
Viral vectors are used as delivery vehicles in gene therapies and for vaccines as they are proficient in penetrating human cells. They are more efficient than non-viral vectors but can also trigger an immune response that can clear the vector or infected cells. The various types of viral vectors include Adeno-associated viral vectors (AAVs), adenovirus vectors, lentivirus vectors and herpes simplex virus (HSV) vectors.
The emerging strategic collaborations and acquisitions among biopharmaceutical industries, development of innovative treatments and the adoption of upstreaming and down streaming processes for reducing manufacturing costs and improving quality and output of viral vectors is expanding the market growth. Furthermore, the integration of artificial intelligence (AI) can be applied for designing, improving transfection efficiency, predicting truncation, simulating vector behavior, optimizing and analyzing proteins in viral vectors.
Additionally, the rising support from government initiatives, collaborations and funding is fueling market growth. For instance, in Oct 2024, Verica Biotech and Exmoor Pharma announced a new collaboration project which was funded by joint UK-Canada government initiative with the aim of enhancing the manufacturing of AAV vectors needed for gene therapies thereby improving accessibility of life-saving therapy and reducing production costs.
Viral Vector Production (Research-use) Market Trends
· Rising Collaborations and Acquisitions for Vector Manufacturing: The global increase in collaborations, mergers and acquisitions between biopharmaceutical companies, emerging start-ups and research institutes is paving the way for market development of viral vectors production.
· New Innovations and Platform Launches: The rise in innovative platform launches offering cost-effective, scalable production of viral vectors with improved quality as well as optimizing viral vector candidates for preclinical and clinical studies is supporting customers for developing effective therapies.
The viral vector manufacturing process
The manufacturing of viral vectors is a multi-stage process, indispensable for biotechnology in the production of vaccines and gene therapies.
- Host cell selection: The production process begins with the careful selection of host cells, which serve as the production platform for the viral vectors. They are typically derived from mammalian sources, with adherent HEK293 cell culture being a prominent approach.
- Genetic engineering: The selected host cells are genetically modified to enable them to produce the desired viral vectors. This step involves introducing the relevant genetic material, such as plasmids or viral DNA, into the host cells.
- Cell cultivation: The host cells transfected with a gene of interest are cultivated under controlled conditions in bioreactors. These bioreactors provide an environment conducive to cell growth and vector production, with factors like temperature, pH, and nutrient supply as well as the presence of additional reagents carefully regulated.
- Virus production: During cultivation, the host cells generate the viral vectors. This phase involves the replication of the viral genome and the assembly of vector particles. The choice of viral vector, such as adenovirus, adeno-associated virus (AAV), herpes simplex or lentivirus, determines specific production requirements, and is yet influenced by considerations such as their immunogenicity or whether they are planned for in vitro or in vivo applications.
- Harvesting: Once a sufficient quantity of viral vectors is produced, the culture is harvested, and the vectors are extracted. This step typically involves cell lysis and separation processes to recover the vectors.
- Purification: The harvested vectors undergo purification to remove impurities, including empty capsids, host cell proteins and nucleic acids. Multiple purification steps, often involving chromatography, are employed to achieve high vector purity.
- Quality control: Rigorous quality control tests are conducted to assess the safety and potency of the viral vectors. These tests include assessments of vector titer, purity, and functionality. Not only at this stage, adherence to Good Manufacturing Practices (GMP) is essential.
- Formulation: The purified vectors are then formulated into a suitable dosage form, ensuring stability and compatibility for storage and administration.
- Storage and distribution: The final vector product is stored under controlled conditions, with strict temperature and environmental controls to maintain vector integrity. Distribution to clinical trial sites or manufacturing facilities for downstream applications follows stringent logistics protocols.
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Viral Vector Production (Research-use) Market Report Scope
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Report Attribute |
Details |
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Market size value in 2025 |
USD 2.23 billion |
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Revenue forecast in 2034 |
USD 7.62 billion |
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Growth rate |
CAGR of 14.6% from 2024 to 2034 |
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Base year for estimation |
2024 |
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Historical data |
2019 - 2023 |
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Forecast period |
2024 - 2033 |
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Report updated |
December 2024 |
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Quantitative units |
Revenue in USD million and CAGR from 2024 to 2034 |
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Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
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Segment coverage |
Vector Type, Workflow, Application, End use, Region |
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Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
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Country scope |
U.S.; Canada; Mexico; Germany; UK; France; Italy; Spain; China; Japan; India; South Korea; Thailand; Australia; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
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Companies profiled |
Merck KGaA; Lonza; FUJIFILM Diosynth Biotechnologies.; Cobra Biologics Ltd; Thermo Fisher Scientific, Inc.; Waisman Biomanufacturing; Genezen; YPOSKESI, Inc; Advanced BioScience Laboratories, Inc. (ABL, Inc); Novasep Holdings SAS; Orgenesis Biotech Israel Ltd (formerly ATVIO Biotech ltd.); Vigene Biosciences, Inc. |
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Customization scope |
If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of the customization |
Innovations in viral vector production
To meet the challenges identified and increase optimization, novel techniques are transforming the manufacturing of viral vectors, resulting in improved safety, cost-effectiveness, scalability, and sustainability. Nevertheless, it was estimated that the viral vector manufacturing market 2023 is globally worth USD 5.5 billion, expected to more than double by 2028. This only illustrates the urgency of implementing efficient technologies and strategies in the attempt to make viral vector technology more accessible.
Challenges in viral vector production
Viral vector production brings challenges on different level – from the manufacturing techniques and processes to cost efficiency and safety down to regulatory demands. These challenges are even more crucial to overcome when the viral vector production is to be brought to a larger scale.
Scale-up hurdles in viral vector production
The process of scaling up viral vector production from laboratory-scale to large-scale, while upholding stringent Good Manufacturing Practices (GMP) and meeting regulatory criteria set by organizations like the FDA, presents substantial challenges in the field. These scale-up hurdles encompass critical steps of the manufacturing process.
Selecting the proper manufacturing platform is a crucial decision, as the move from small-scale research setups to large-scale commercial ones necessitates ensuring consistent quality and compliance with GMP standards.
The choice between a scale-out (parallel processing) or scale-up (increased volume in a single system) approach requires careful consideration, impacting efficiency, cost-effectiveness, and product quality.
Achieving the desired cell densities and vector titers at large scales necessitates the optimization of conditions to maximize vector yield while minimizing production costs.
Additionally, readiness for clinical trials, often contingent on successful scale-up, demands stringent adherence to safety, quality, and efficacy standards in production.
However, taking these scale-up hurdles is necessary for the successful transition of viral vector-based therapies from research or preclinical to large-scale commercial production, thereby extending the benefits of gene therapy to a broader public.
Restrictions of frequent culture systems
Mammalian cells grown in adherent suspension are widely used in the manufacturing of viral vectors. However, this culture system cannot be easily scaled up, considering the large number of different containers that need to be dealt with during the production, which leads to a bottleneck in downstream processing.
The specific type of viral vector to be produced does play a critical role in the selection of producer cell lines. However, new culture systems are to be considered that are more suitable for larger scale viral vector production.
Need for many individualized processes
In the manufacturing of gene therapies, customized processes in viral vector manufacturing are ubiquitous. Gene therapy offers hope to individuals with specific genetic conditions, but its efficacy hinges on adapting production to individual patient needs.
Patient genetics are diverse, making it essential to tailor processes for each case. Unlike standard pharmaceuticals, gene therapy must be customized to suit the unique genetic variations within the patient population.
Customization starts with adapting manufacturing steps, from transgene insertion into plasmids to final vector production, ensuring alignment with each patient's genetic makeup. All of these adaptations demand high variability. This requirement, though, is no excuse for underscoring regulatory standards (as will be discussed in the following chapter), but forces manufacturers to adapt complex procedures regularly and efficiently.
Quality control and regulatory demands
Quality control and regulatory demands are essential aspects of viral vector manufacturing, ensuring the safety and efficacy of gene therapy products. Stringent quality control measures are necessary to meet regulatory standards set forth by organizations like the FDA. These demands encompass a comprehensive evaluation of every stage of the manufacturing process, from initial cell line development to final vector product release.
Adhering to Good Manufacturing Practices (GMP) is a fundamental requirement, emphasizing the need for consistency, traceability, and documentation throughout production. Quality control protocols encompass critical assessments of vector titer, purity, and potency, safeguarding the integrity of gene therapy products.
Furthermore, regulatory approval for clinical trials and eventual commercialization necessitates meticulous documentation, adherence to established protocols, and transparency in reporting. Achieving compliance with regulatory requirements is not only a significant challenge, but also a crucial milestone on the path to bringing viral vector-based therapies to patients.
Long-term storage of viral vectors
Efficient long-term storage of viral vectors is a cornerstone of their utility in gene therapy, vaccine development, and biopharmaceutical research. It ensures that these vectors remain viable and fully functional over extended periods, ready for use in critical applications.
One of the primary challenges in long-term storage lies in formulation. Developing the right formulations is intricate work, as they must preserve the integrity and functionality of viral vectors during storage, ensuring their suitability for clinical and research purposes. The selection of excipients, stabilizers, and optimal storage conditions becomes paramount in this context.
Selecting appropriate freezing methods is equally crucial in the preservation of biopharmaceutical products based on viral vector. Nevertheless, factors like the low stability of rAAVs (recombinant AAVs) and the different serotypes of AAVs make it necessary to store them in a frozen state. This raises the question on how to achieve ultra-low temperatures while preserving the integrity of the frozen substances and avoiding damaging effects like aggregation. Considerations on the ideal freezing rates are equally important as logistic planning, since viral vectors should not be subjected to multiple freeze/thaw cycles.2
Segment Insights
Vector Type Insights
The adeno-associated virus (AAV) segment accounted for a leading position with a market share of 23.6% in 2024. The AAV vectors are a popular opinion applied in gene delivery studies such as vaccine development and gene-based antibody delivery, in animal research and gene editing owing to its several advantages such as broad tropism, long-term transgene expression, lack of immunogenicity in vivo and transduction demonstrating its safety and efficacy for treatments. The growing focus on gene therapy based vaccine development, promising results of clinical trials, rising research collaborations among industries and the advancements in methods for preventing immune responses to AAV are paving way for improved delivery of AAV gene therapies to patients thereby fuelling the market growth of this segment.
· For instance, in Oct 2023, Regeneron Pharmaceuticals announced expanded research collaboration with Intellia Therapeutics which will combine Intellia’s proprietary Nme2 CRISPR/Cas9 (Nme2Cas9) systems adapted for viral vector delivery and designed to precisely modify a target gene with Regeneron’s proprietary antibody-targeted AAV vector delivery systems together for treatment of neurological and muscular diseases.
The lentivirus vectors are expected to grow faster at a CAGR of 16.2% in the forecast period. Lentiviral vectors are widely applied in clinical research, T cell engineering, gene therapies owing to their safety in integrating into the host genome stably and transduction. The rising innovations in LV production such as development of new protocols, packaging cell lines, culture devices, improved processes and cost-effective manufacturing are promoting market expansion of this segment. Moreover, the increased strategic collaborations for LV manufacturing and breakthroughs in vector technology are expected to boost the market of this segment over the forecast period.
· For instance, in March 2023, ProteoNic Biosciences, a leading provider of premium vector technology and services for biologics production launched its awaited LV-2G UNic Early Access Program offering its state-of-the vector technology for lentivirus manufacturing optimization.
Application Insights
In 2023, The gene and cell therapy development segment accounted for a leading position at the market share of 27.5% in 2024. The CGT sector has surged as an evolutionary force in disease treatment with colossal growth potential guaranteed by the recent technological advancements, rising medical needs, extensive research in clinical trials and expanding manufacturing platforms which is strengthening its dominance in the market. The increase in rare genetic disorders, accelerated FDA approvals, strategic collaborations between companies, notable growth in cell therapy, viral vector technologies and gene editing methods are fuelling the market growth of this segment.
· For instance, in March 2024, ProteoNic Biosciences announced a strategic alliance with Gingko Bioworks which will enable Gingko’s customers access to ProteoNic’s cutting edge vector technology in the field of protein production alongwith novel viral vector technology for applications in cell and gene therapy thereby promoting innovations in customer R&D programs.
The vaccine development segment is expected to witness a fast-growing CAGR of 14.1% in the forecast period. Viral vectors vaccines utilize a genetically modified, harmless virus such as AAV or LV for inducing antibody production against viruses causing infections and diseases. Viral vectors are extensively used in vaccine development owing to the rise in viral infections and emerging pandemics across the globe as well as in CGT for providing safe, effective treatments thereby improving patient life outcomes. Moreover, the rising applications of viral vectors as vaccines in both pre-clinical and clinical is expected to promote the growth of this market.
· For instance, in Dec 2024, Genetic Immunity (GI), a leader in plasmid DNA-based immunotherapies announced a strategic partnership with VectorBuilder, a global specialist in gene delivery solutions. The alliance plans to advance GI’s innovative plasmid DNA HIV vaccine into Phase 3 trial following the promising clinical success in previous trials.
Workflow Insights
The downstream processing segment held a leading revenue share of 53.0% in 2024. The technological advancements in viral vector downstream processing has created opportunities for increasing product quality and output. Various approaches can be leveraged for optimizing viral vector downstream processing such as ultrafiltration or diafiltration operations and use of modified chromatography processes which can reduce the number and size of unit operations. These developed downstream technologies are useful in reducing viral vector purification times from hours to minutes with improved recovery rate as well as assisting scale-up, decreasing the process footprint and allows utilizing facility more efficiently.
· For instance, in May 2024, Donaldson Company, a leading worldwide provider of innovative filtration products and solutions announced that its subsidiaries Isolere Bio and Univercells Technologies are developing an integrated upstream and downstream platform for viral vector manufacturing. The first phase will prioritize lentivirus (LV) manufacturing with focus on improved recoveries with a scalable process while minimizing the manufacturing footprint.
The upstream processing is expected to register a fast-growing CAGR of 14.3% in the forecast period. Optimizing the viral vector upstream processing segment facilitates successful manufacturing by maximizing the viral vector titers. Additionally, it is crucial for product development teams for assessing all aspects of viral vector production such as raw materials, cell culture media, conditions for cell and virus growth, clarification and nucleic acid digestion. For reducing risks and flexibility across these process inputs, manufacturing companies can utilize collaboration and acquisition strategies with an expert and knowledgeable technological enterprise skilful in all aspects of viral vector production along with related products and services.
· For example, in May 2024, Merck, a leading science and technology company acquired life science company Mirus Bio for US $ 600 million. This acquisition will advance Merck’s unified offering for viral vector manufacturing.
End use Insights
The pharmaceutical and biopharmaceutical segment accounted for the largest revenue share of 17.4% in 2024. These companies play a major role in manufacturing, development, research and distribution of viral vectors worldwide. The growing competitions among key market players, rising funding’s’ and investments of private sectors to establish capital and large demands for developing advanced therapies and treatments is fuelling the market growth of this segment. Moreover, the active involvement of research institutions in developing innovative viral vector-based cures is expanding the market.
By Region
North America viral vector production (research-use) market accounted for 46.9% in 2024. With the rising demand of viral vectors for developing viral vector-based vaccines to treat various life-threatening diseases and in rare genetic disorders for advancing novel CGT are the factors promoting the dominance of this region in the market. Furthermore, the rise of contract development and manufacturing organizations (CDMOs) and strategic collaboration between biopharmaceutical companies as well as technological advancements in viral vector-based techniques and increased government support are fuelling the market growth. For instance, in June 2024, ProBio Inc., a New Jersey based CDMO announced the expansion of its plasmid DNA and viral vector manufacturing facility which will strengthen ProBio’s capability for supporting the manufacturing of transformative cell and gene therapies in North America.
The Asia Pacific is anticipated to flourish during the forecast period owing to the increasing healthcare research for adopting viral vector manufacturing techniques, growing incidence of chronic diseases and viral infections, technological advancements, focus on viral vector based CGTs and the rising trend of outsourcing drug discovery services are the prevailing factors contributing to the market growth of this region. Moreover, the extensive clinical trials, improvement in research and manufacturing facilities adopting advanced techniques as well as the rising government support is anticipated to boost the demand for viral vectors in this region.
Europe Viral Vector Production (Research-use) Market Trends
Europe viral vector production (research-use) market is poised to grow at a rapid CAGR of 13.7% in the forecast period. The growing emphasis on gene therapy and vaccines is expected to remain vital for the clinical industry in Europe. Viral vectors have shown significant results in preclinical studies for treating diseases such as HIV/AIDS and Hepatitis C. These studies have demonstrated successful feasibility studies against Ebola and Influenza as these vaccines deliver viral DNA into cells, that trigger an immune response.
Asia Pacific Viral Vector Production (Research-use) Market Trends
Asia Pacific viral vector production (research-use) market is expected to witness substantial growth in the forecast period. This is attributed to the rising incidences of target conditions, diseases, and the effectiveness of viral vectors in gene therapy. The availability of private funding for research projects for the advancement of gene therapy is expected to boost the regional market growth. The ongoing research and development on genes and cell therapies dependent on viral vectors fuels the market growth. Moreover, high levels of engagement in public-private partnerships directed at research and manufacturing is expected to boost the need for viral vectors in the region.
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Some of the prominent players in the viral vector production (research-use) market include:
· Lonza
· FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
· Waisman Biomanufacturing
· Genezen
· Yposkesi,Inc.
· Advanced BioScience Laboratories, Inc. (ABL, Inc.)
Viral Vector Production (Research-use) Market Recent Developments
· In Nov 2024, VectorBuilder, a global leader in end-to-end gene delivery services announced a strategic collaboration with Sartorius, a leading international partner in life science research and biopharmaceutical industry. The collaboration focuses on providing gene vector and mRNA bioprocess solutions and services which will facilitate the development and clinical translation of innovative biopharmaceutical projects.
· In Nov 2024, NewBiologix, a technology innovation company pioneering tools for efficient, cost-effective and scalable production of viral vectors for CGT launched its Xcell rAAVProduction and Analytics Platform (Xcell rAAV Platform) which will allow gene therapy companies for identifying and producing optimal rAAV candidates for preclinical and clinical studies with improved quality.
· In Oct 2024, Ginkgo Bioworks, Inc. which is building the leading platform for cell programming and biosecurity and Virica Biotech Inc., a leading developer of enhancers for scaling of viral vectors as well as cell and gene therapies announced a strategic partnership for amplifying their AAV gene therapy manufacturing platforms.
· In July 2024, Genezen, a leading gene therapy organization strategically acquired uniQure’s commercial gene therapy manufacturing facility in Lexington which is a commercially-licensed viral vector facility, enabling Genezen for supporting customers from preclinical development programs through late-phase, commercial manufacturing and also serve as Genezen's global AAV center of excellence.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the viral vector production (research-use) market
By Vector Type
· Adeno-associated Virus (AAV)
· Lentivirus
· Adenovirus
· Retrovirus
· Others
By Application
· Cell & Gene Therapy Development
· Vaccine Development
· Biopharmaceutical & Pharmaceutical Discovery
· Biomedical Research
By Workflow
· Upstream Processing
o Vector Amplification & Expansion
o Vector Recovery & Harvesting
· Downstream Processing
o Purification
o Fill-finish
By End Use
· Pharmaceutical and Biopharmaceutical Companies
· Research Institutes
By Regional
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East and Africa (MEA)
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