According to Vision Research Reports, the global viral vector and plasmid DNA manufacturing market size was estimated at around USD 5.37 billion
According to Vision Research Reports, the global viral vector and plasmid DNA manufacturing market size was estimated at around USD 5.37 billion in 2023 and it is projected to hit around USD 33.95 billion by 2033, growing at a CAGR of 20.25% from 2024 to 2033.
Understanding Viral Vector and Plasmid DNA Manufacturing
Before delving into the nuances of manufacturing, it’s essential to understand the fundamental components of viral vectors and plasmid DNA. Viral vectors are vehicles used to deliver genetic material into target cells, facilitating gene therapy, vaccine development, and gene editing applications. Plasmid DNA, on the other hand, serves as the blueprint for producing proteins or RNA molecules within cells, playing a crucial role in various biotechnological processes.
Key Pointers
- North America dominated the market in 2023, holding the largest share at 49%.
- Asia Pacific is anticipated to exhibit noteworthy growth with a significant compound annual growth rate (CAGR) during the forecast period.
- Among Vector Types, the adeno-associated virus (AAV) segment commanded the highest revenue share, accounting for 21% in 2023.
- The downstream processing segment emerged as the leader by Workflow, capturing 54% of the market share in 2023.
- In terms of Applications, vaccinology led the market with the highest share at 23% in 2023.
- Research institutes constituted the primary End-use segment, contributing the largest share of 59% to the market in 2023.
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Viral Vector and Plasmid DNA Manufacturing Application
- Vector Design and Optimization: Scientists design the viral vector or plasmid DNA sequence according to the specific application. This involves selecting appropriate promoters, enhancers, and other regulatory elements to control gene expression.
- Cell Culture: The vector or plasmid DNA is typically produced in mammalian, bacterial, or yeast cells. These cells are grown in large bioreactors under controlled conditions, such as temperature, pH, and nutrient supply, to promote optimal growth and gene expression.
- Vector Production: For viral vectors, the engineered DNA is introduced into host cells (such as HEK293 cells for adenoviral vectors or insect cells for baculoviral vectors) using transfection or transduction techniques. The host cells then replicate the viral vector, leading to the production of large quantities.
- Purification: After vector production, the cell culture undergoes purification to isolate the viral vectors or plasmid DNA from cellular debris, proteins, and other contaminants. This typically involves a series of filtration, chromatography, and precipitation steps to achieve high purity.
- Quality Control: Throughout the manufacturing process, rigorous quality control measures are implemented to ensure the safety, purity, and potency of the vectors or DNA. This includes testing for the presence of contaminants, assessing vector titers, and confirming the integrity of the genetic material.
Future Directions and Innovations
Enhancing Manufacturing Efficiency and Scalability: Continuous innovation in viral vector and plasmid DNA manufacturing is essential for meeting the growing demand for biopharmaceuticals and genetic therapies. Emerging technologies such as single-use bioreactors, automation, and synthetic biology hold promise for streamlining production processes and enhancing scalability.
Expanding Therapeutic Applications: The convergence of viral vector and plasmid DNA technologies opens new avenues for therapeutic interventions, ranging from cancer immunotherapy to regenerative medicine. Cross-disciplinary collaborations between academia, industry, and regulatory agencies are driving the translation of cutting-edge research into clinically viable treatments.
Addressing Regulatory and Ethical Considerations: As the field of viral vector and plasmid DNA manufacturing continues to evolve, robust regulatory frameworks and ethical guidelines are paramount to ensure patient safety and uphold ethical standards. Close collaboration between regulators, policymakers, and stakeholders is essential for navigating complex regulatory landscapes and fostering public trust in biotechnological innovations.
Some Related Reports
- Viral Vector Market: https://www.visionresearchreports.com/viral-vector-market/40225
- Viral Vector Production (Research-use) Market: https://www.visionresearchreports.com/viral-vector-production-research-use-market/38283
Vector Type Insights
The adeno-associated virus (AAV) segment led the market in terms of vector type, capturing a significant 21% revenue share in 2023. AAVs are in high demand, especially in clinical trials, due to their precision in delivering genes to specific areas. This increased adoption is evident in clinical trials focusing on orthopedic and ocular gene therapies, demonstrating improved efficiency and effectiveness. A notable development in August 2022 showcased the potential of AAV-mediated gene therapy in preventing acquired hearing loss. The application of AAVs is expanding across various therapeutic areas, leading to a significant rise in adoption rates.
Simultaneously, the lentivirus segment is expected to experience substantial growth with a noteworthy compound annual growth rate (CAGR) during the forecast period. The increased use of lentiviral vectors in ongoing research activities highlights the industry’s emphasis on advancing these vectors. Scientists are exploring non-integrating lentiviral vectors (NILVs) to reduce the risks of insertional mutagenesis, as NILVs can transduce both dividing and non-dividing cells. This versatility positions NILVs as valuable tools in CAR-T cell therapy research.
Workflow Insights
In 2023, the downstream processing segment emerged as the market leader in workflow, capturing the largest revenue share at 54%. This dominance is due to the complex procedures involved in refining and purifying clinical-grade final products. With an increasing demand for clinical-grade viral vectors, manufacturers are actively developing innovative and cost-effective downstream processes to overcome challenges associated with traditional lab-scale vector manufacturing. One notable example is integrating a fed-batch fermentation technique and genetically optimized cell systems with both traditional and novel purification technologies.
At the same time, the upstream processing segment is expected to experience significant compound annual growth rate (CAGR) throughout the forecast period. Upstream processing involves infecting cells with the virus, cultivating cells, and harvesting the virus from these cells. Advancements in product development, such as the ambr 15 microbioreactor system designed for high-throughput upstream process development, are anticipated to drive this segment. The ambr 15 microbioreactor system streamlines cell culture processing through automated experimental setup and sampling, reducing the need for labor, laboratory space, and minimizing the time required for cleaning and sterilization.
Application Insights
In 2023, the vaccinology segment emerged as the leading application in the market, capturing the largest revenue share at 23%. This dominance is driven by the rising demand for vaccines targeting various diseases, including cancer and infectious diseases like COVID-19. The extensive use of viral vectors and plasmid DNA in vaccine development, along with a growing focus on research and development for new vaccines, is expected to sustain growth in this market segment.
Simultaneously, the cell therapy segment is set to experience the fastest compound annual growth rate (CAGR) over the forecast period. This growth is attributed to the increasing adoption of personalized cancer treatments. The success of Chimeric Antigen Receptor (CAR)-based cell therapies for cancer treatment is expected to further fuel market growth in this segment.
End-use Insights
In 2023, the research institutes segment emerged as the dominant player in the market, securing the largest revenue share at 59%. This leadership is driven by research endeavors aimed at enhancing vector production conducted by various research institutions. An illustrative example is the collaboration between Bluebird Bio and the Institute for NanoBiotechnology in July 2021. This partnership aims to develop innovative technologies that improve the production of viral vectors for the advancement of novel gene therapies.
Concurrently, the pharmaceutical and biotechnology companies segment is expected to witness substantial compound annual growth rate (CAGR) over the forecast period. This growth is attributed to the continuous introduction of advanced therapies, along with a subsequent increase in the number of gene therapy-based research programs initiated by pharmaceutical firms. The expanding utilization of vectors for therapeutic production by a growing number of biotech companies is significantly contributing to the anticipated growth in this segment.
Disease Insights
In 2023, the cancer segment emerged as the top player in the market, holding the largest revenue share at 38%. This dominance stems from the concerning rise in new cancer cases, projected to reach 28.4 million within the next two decades according to Globocan. The anticipated 47% increase from 2020 is attributed to the adoption of a western lifestyle, high alcohol consumption, smoking, poor dietary choices, and physical inactivity. The escalating prevalence of cancer cases is expected to fuel the demand for gene therapies aimed at treating cancer patients, consequently increasing the need for viral vectors and plasmid DNA for the development of these therapies.
Simultaneously, genetic disorders are forecasted to exhibit significant compound annual growth rate (CAGR) during the forecast period. Gene therapy applications in genetic disorders represent a highly focused area, with more than 10% of ongoing clinical trials targeting this category. This positioning makes gene therapy for genetic disorders one of the most pivotal markets in the forecast years, expected to strongly support the growth of the viral vectors and plasmid DNA manufacturing market.
Regional Insights
In 2023, North America solidified its dominance in the market, capturing a significant 49% share. This leadership is driven by the active involvement of companies in gene and cell therapy research and product development, along with the substantial presence of contract development organizations in the region. Additionally, domestic companies are expanding their manufacturing facilities, further bolstering North America’s leading position. Within North America, the U.S. held the highest revenue share in the viral vectors and plasmid DNA manufacturing market, propelled by the presence of key market players, including Contract Development and Manufacturing Organizations (CDMOs) offering Good Manufacturing Practice (GMP) services. The adoption of highly innovative manufacturing technologies for production has also played a pivotal role in the U.S. market’s prominence.
Concurrently, Asia Pacific is positioned to be the fastest-growing region, exhibiting a notable compound annual growth rate (CAGR) during the forecast period. China, in particular, stands out as one of the leading countries, driven by advancements in the regulatory framework for cell-based research activities. These regulatory advancements significantly contribute to the overall growth of the Asia Pacific market. Moreover, the increasing development and commercialization of novel vaccines in China are anticipated to further propel market expansion.
Viral Vector and Plasmid DNA Manufacturing Market Key Companies
- Merck KGaA
- Lonza
- FUJIFILM Diosynth Biotechnologies
- 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.
Viral Vector and Plasmid DNA Manufacturing Market Segmentations:
By Vector Type
- Adenovirus
- Retrovirus
- Adeno-Associated Virus (AAV)
- Lentivirus
- Plasmids
- Others
By Workflow
- Upstream Manufacturing
- Vector Amplification & Expansion
- Vector Recovery/Harvesting
- Downstream Manufacturing
- Purification
- Fill Finish
By Application
- Antisense & RNAi Therapy
- Gene Therapy
- Cell Therapy
- Vaccinology
- Research Applications
By End-use
- Pharmaceutical and Biopharmaceutical Companies
- Research Institutes
By Disease
- Cancer
- Genetic Disorders
- Infectious Diseases
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
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