Viral Vector and Plasmid DNA Manufacturing Market (By Vector Type: AAV, Lentivirus; By Workflow, By Application; By End-use; By Disease) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

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.

Key Pointers

• North America dominated the market with the largest market share of 49% in 2023.
• Asia Pacific is expected to grow at the notable CAGR during the forecast period.
• By Vector Type, the adeno-associated virus (AAV) segment held the largest revenue share of 21% in 2023.
• By Workflow, the downstream processing segment had the largest market share of 54% in 2023.
• By Application, the vaccinology segment registered the maximum market share of 23% in 2023.
• By End-use, the research institutes segment generated the maximum market share of 59% in 2023.

Viral Vector and Plasmid DNA Manufacturing Market Overview

In recent years, the viral vector and plasmid DNA manufacturing market has witnessed significant growth and garnered attention within the biopharmaceutical industry. This surge can be attributed to the increasing demand for advanced gene therapies and vaccines, as well as the expanding field of gene editing technologies. This overview aims to provide insights into the key facets of this market, shedding light on its current landscape and future prospects.

Viral Vector and Plasmid DNA Manufacturing Market Growth

The growth of the viral vector and plasmid DNA manufacturing market can be attributed to several key factors. Firstly, the escalating demand for advanced gene therapies and vaccines has fueled increased production of viral vectors and plasmid DNA, reflecting the market's responsiveness to emerging healthcare needs. Additionally, the expanding field of gene editing technologies, such as CRISPR-Cas9, has driven the need for efficient manufacturing processes, stimulating growth within the industry. Furthermore, advancements in molecular biology and genetic engineering have played a pivotal role in enhancing the capabilities and applications of viral vectors and plasmid DNA, propelling the market forward.

Viral Vector and Plasmid DNA Manufacturing Market Trends:

• Increasing Demand for Gene Therapies: The viral vector and plasmid DNA manufacturing market is witnessing a surge in demand driven by the growing prevalence of genetic disorders. The rise of personalized medicine and the pursuit of targeted therapies have elevated the need for gene therapies, consequently boosting the production of viral vectors and plasmid DNA.
  
  
• Advancements in Gene Editing Technologies: The market is experiencing a notable trend towards advancements in gene editing technologies, particularly with the widespread adoption of CRISPR-Cas9. This trend is influencing manufacturing processes, with companies focusing on innovative approaches to efficiently produce viral vectors and plasmid DNA required for these cutting-edge gene editing techniques.
  
  
• Focus on Regulatory Compliance: Given the critical nature of gene therapies and the regulatory scrutiny they face, there is a growing trend toward ensuring stringent compliance with regulatory requirements. Companies are investing in quality control measures, robust documentation, and adherence to Good Manufacturing Practices (GMP) to meet regulatory standards and ensure the safety and efficacy of their products.
  
  
• Expansion of Applications beyond Healthcare: The applications of viral vectors and plasmid DNA are expanding beyond traditional healthcare. Industries such as agriculture and environmental science are exploring the potential of gene editing technologies for various purposes. This diversification in applications is influencing the manufacturing market and opening up new avenues for growth.
  
  
• Investments in Research and Development: Continuous research and development efforts are driving innovation in the Viral Vector and Plasmid DNA Manufacturing Market. Companies are investing in R&D to explore novel production techniques, improve the purity and yield of products, and stay ahead in the competitive landscape.

Vector Type Insights

The adeno-associated virus (AAV) segment took the lead in the market based on vector type, commanding a significant 21% revenue share in 2023. AAVs are witnessing high demand, particularly in clinical trials, owing to their precision in delivering genes to specific regions. The surge in adoption is evident in clinical trials focused on orthopedic and ocular gene therapies, showcasing enhanced efficiency and efficacy. A noteworthy development in August 2022 highlighted AAV-mediated gene therapy's potential to prevent acquired hearing loss. The application of AAVs is expanding across various therapeutic areas, leading to a considerable increase in adoption rates.

Concurrently, the lentivirus segment is anticipated to exhibit substantial growth at a noteworthy Compound Annual Growth Rate (CAGR) during the forecast period. The heightened use of lentiviral vectors in ongoing research activities underscores the industry's focus on advancing these vectors. Scientists are exploring non-integrating lentiviral vectors (NILVs) to mitigate insertional mutagenesis risks, 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 terms of workflow, capturing the largest revenue share at 54%. This dominance is attributed to the intricate procedures involved in refining and purifying clinical-grade final products. With an escalating demand for clinical-grade viral vectors, manufacturers are actively engaged in developing innovative and cost-effective downstream processes to overcome challenges associated with conventional lab-scale vector manufacturing. One notable example is the integration of a fed-batch fermentation technique and genetically optimized cell systems with both traditional and novel purification technologies.

Concurrently, the upstream processing segment is poised to exhibit a substantial Compound Annual Growth Rate (CAGR) throughout the forecast period. Upstream processing encompasses infecting cells with the virus, cultivating cells, and harvesting the virus from these cells. Advancements in product development, exemplified by the ambr 15 microbioreactor system designed for high-throughput upstream process development, are anticipated to propel 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 market leader in terms of application, securing the largest revenue share at 23%. This dominance is propelled by the escalating demand for vaccines targeting a range of diseases, including cancer and infectious diseases like COVID-19. The widespread utilization of viral vectors and plasmid DNA in vaccine development, coupled with a growing emphasis on research and development for novel vaccines, is anticipated to drive sustained growth in this market segment.

Concurrently, the cell therapy segment is poised to exhibit the fastest Compound Annual Growth Rate (CAGR) over the forecast period. This growth is attributed to the increasing adoption of personalized cancer treatments. Notably, the success of Chimeric Antigen Receptor (CAR)-based cell therapies for cancer treatment is anticipated to act as a catalyst, further propelling market growth in this segment.

End-use Insights

In 2023, the research institutes segment emerged as the dominant force in the market, securing the largest revenue share at 59%. This leadership is propelled by research activities focused on enhancing vector production conducted by various research entities. 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 enhance the production of viral vectors for the advancement of novel gene therapies.

Concurrently, the pharmaceutical and biotechnology companies segment is projected to exhibit a substantial Compound Annual Growth Rate (CAGR) over the forecast period. This growth can be attributed to the continuous introduction of advanced therapies, coupled 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 contributing significantly to the anticipated growth in this segment.

Disease Insights

In 2023, the cancer segment emerged as the market leader, commanding the largest revenue share at 38%. This dominance is fueled by the alarming increase in new cancer cases, projected to reach 28.4 million within the next two decades according to Globocan. The anticipated 47% rise from 2020 is attributed to the adoption of a western lifestyle, high alcohol consumption, smoking, poor dietary choices, and physical inactivity. The growing prevalence of cancer cases is expected to drive demand for gene therapies aimed at treating cancer patients, consequently elevating the need for viral vectors and plasmid DNA for the development of these gene therapies.

Concurrently, genetic disorders are forecasted to register a significant CAGR during the forecast period. Gene therapy applications in genetic disorders constitute a highly focused area, with more than 10% of ongoing clinical trials directed toward 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 asserted its dominance in the market, accounting for a substantial 49% share. This stronghold can be attributed to the heightened engagement of companies in gene and cell therapy research and product development, coupled with a significant presence of contract development organizations in the region. Additionally, indigenous companies are expanding their manufacturing facilities, further contributing to 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, driven 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 crucial role in the U.S. market's prominence.

Concurrently, Asia Pacific is poised 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, propelled by advancements in the regulatory framework for cell-based research activities. These regulatory developments 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 fuel 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)