The U.S. viral vector and plasmid DNA manufacturing market size is expected to reach USD 11,315.21 million by 2032, exhibiting a compound annual growth rate (CAGR) of 19.9% during the forecast period (2024 – 2032).
The U.S. Viral Vector and Plasmid DNA Manufacturing Market is a cornerstone in the biotechnology and pharmaceutical industries. As gene therapy and genetic engineering gain traction in treating complex diseases, the demand for efficient manufacturing processes for viral vectors and plasmid DNA has surged. These components play a critical role in advancing cell and gene therapies, making this market a focal point for innovation and investment.
Download Free Sample PDF Copy of the Report:
Market Overview
Definition and Importance
Viral vectors and plasmid DNA are pivotal in delivering genetic material to target cells. Viral vectors, such as lentivirus, adenovirus, and adeno-associated virus (AAV), are extensively used in gene therapies. Plasmid DNA serves as the foundation for producing these vectors and is also employed directly in DNA-based vaccines.
Market Size and Growth
The U.S. market for viral vector and plasmid DNA manufacturing has experienced exponential growth, driven by the rising adoption of gene therapies and the expansion of clinical trials. In recent years, this market has been valued in billions, with projections showing continued robust growth due to the increasing pipeline of gene therapy candidates.
Key companies in the U.S. viral vector and plasmid DNA manufacturing market include
- Bio-Rad Laboratories, Inc.
- Catalent Inc.
- Charles River Laboratories (Cobra Biologics)
- Genezen
- Promega Corporation
- RegenxBio, Inc.
- Revvity (SIRION Biotech)
- Thermo Fisher Scientific, Inc.
- Virovek Incorporation
- Waisman Biomanufacturing
U.S. Viral Vector and Plasmid DNA Manufacturing Market Segmentation
The U.S. Viral Vector and Plasmid DNA Manufacturing Market segmentation divides the market into several segments. The industry segmentation is primarily based on vector type, Disease Outlook, Workflow Outlook, application, end-use. Besides, the research study covers several sub-segments of the market.
U.S. Viral Vector and Plasmid DNA Manufacturing Market, Vector Type Outlook (Revenue, USD Million, 2019-2032)
- Adeno-Associated Virus (AAV)
- Adenovirus
- Lentivirus
- Others
- Plasmids
- Retrovirus
U.S. Viral Vector and Plasmid DNA Manufacturing Market, Disease Outlook (Revenue, USD Million, 2019-2032)
- Cancer
- Genetic Disorders
- Infectious Diseases
- Others
U.S. Viral Vector and Plasmid DNA Manufacturing Market, Workflow Outlook (Revenue, USD Million, 2019-2032)
- Upstream Manufacturing
- Vector Amplification & Expansion
- Vector Recovery/Harvesting
- Downstream Manufacturing
- Fill Finish
- Purification
U.S. Viral Vector and Plasmid DNA Manufacturing Market, Application Outlook (Revenue, USD Million, 2019-2032)
- Antisense & RNAi Therapy
- Cell Therapy
- Gene Therapy
- Research Applications
- Vaccinology
U.S. Viral Vector and Plasmid DNA Manufacturing Market, End-Use Outlook (Revenue, USD Million, 2019-2032)
- Pharmaceutical and Biopharmaceutical Companies
- Research Institutes
Market Growth Drivers
Advancements in Gene Therapy
The growing prevalence of genetic disorders and cancers has propelled the development of gene therapies. FDA approvals of gene therapy products have further bolstered the demand for scalable and efficient manufacturing solutions.
COVID-19 and Beyond
The pandemic highlighted the critical role of plasmid DNA in vaccine production, especially for mRNA vaccines. This has accelerated investments in manufacturing capabilities and infrastructure, ensuring readiness for future healthcare challenges.
Rising Investments
Major pharmaceutical companies and biotech firms are making significant investments in viral vector and plasmid DNA manufacturing to meet growing clinical and commercial needs.
Key Trends
Automation and Technological Innovations
The adoption of automation, single-use technologies, and advanced bioreactor systems is streamlining manufacturing processes, reducing costs, and enhancing product consistency.
Expansion of Manufacturing Capacity
To cater to the rising demand, manufacturers are expanding their facilities and collaborating with contract development and manufacturing organizations (CDMOs).
Regulatory Advancements
Efforts to harmonize regulatory guidelines and ensure compliance have positively impacted market growth, enabling faster development and approval of therapies.
Research Scope
Clinical Development
The growing number of clinical trials in oncology, rare diseases, and infectious diseases underscores the need for robust research into scalable production methods.
Emerging Therapeutic Areas
Innovative therapies for neurological and cardiovascular conditions are creating new opportunities for viral vector and plasmid DNA manufacturing.
Bioprocess Optimization
Research into optimizing bioprocesses, reducing contamination risks, and enhancing yield efficiency remains a critical focus area.
Future Outlook
The U.S. Viral Vector and Plasmid DNA Manufacturing Market is poised for sustained growth. Innovations in biomanufacturing, coupled with increasing collaborations between academic institutions and biotech companies, are expected to drive the market forward. As gene therapy adoption widens and new therapeutic applications emerge, the need for cutting-edge manufacturing solutions will continue to grow. Additionally, the focus on affordability and accessibility will shape future market dynamics, ensuring broader patient reach and improved healthcare outcomes.
Recent Developments in the U.S. Viral Vector and Plasmid DNA Manufacturing Industry
January 2024: Charles River Laboratories International, Inc. introduced an off-the-shelf Rep/Cap plasmid product designed to streamline adeno-associated virus (AAV)-based gene therapy programs. This ready-to-use plasmid aims to reduce manufacturing efforts by up to 66%, thereby simplifying supply chains and accelerating the delivery of therapies to patients.
August 2022: Thermo Fisher Scientific expanded its cell and gene therapy capabilities by opening a new 300,000-square-foot viral vector manufacturing facility in Plainville, Massachusetts. The state-of-the-art site is expected to add approximately 300 jobs and enhance the company’s capacity for the development, testing, and large-scale manufacturing of viral vectors, which are essential for gene therapy applications.
May 2021: Bio-Rad Laboratories, Inc. launched two products for its Droplet Digital PCR (ddPCR) platforms: the Vericheck ddPCR Mycoplasma Detection Kit and ddPCR Assays for AAV Viral Titer. These tools are designed to support the development and production of safe and effective cell and gene therapies by enabling precise detection and quantification of mycoplasma contamination and AAV viral titers.
These developments reflect the industry’s commitment to advancing gene therapy manufacturing processes, aiming to improve efficiency, scalability, and safety in bringing innovative treatments to patients.