Viral Vector Production (Research-use) Market Size to Hit USD 7.62 Bn by 2034

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.

1. 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. 
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Formulation: The purified vectors are then formulated into a suitable
   dosage form, ensuring stability and compatibility for storage and
   administration.
9. 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

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:

·        
Merck
KGaA

·        
Lonza

·        
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

·        
Charles
River Laboratories.

·        
Thermo Fisher Scientific

·        
Waisman Biomanufacturing

·        
Genezen

·        
Yposkesi,Inc.

·        
Advanced
BioScience Laboratories, Inc. (ABL, Inc.)

·        
Orgenesis
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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