The surge is fueled by a rapidly expanding gene and cell therapy pipeline, with over 4,000 therapies in development and more than 2,000 active clinical trials worldwide. North America leads the market, bolstered by substantial investment, regulatory support, and clinical activity.
Chicago, Jan. 27, 2026 (GLOBE NEWSWIRE) — The global viral vectors & plasmid DNA manufacturing market was valued at 4.21 billion in 2024 and is expected to reach US$ 20.30 billion by 2033, growing at a CAGR of 19.1% from 2025 to 2033.
A burgeoning clinical pipeline is intensifying the demand for the viral vectors & plasmid DNA manufacturing market. An astounding 4,000 cell and gene therapies are now in development, with gene therapies comprising half of this pipeline. Projections show that the FDA will approve 10 to 20 cell and gene therapies annually by 2025. A surge is highlighted by more than 2,000 active clinical trials globally in 2024 for these treatments. A strong 500 gene therapies are currently in the pipeline, signaling a massive future demand for manufacturing capacity.
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Gene Therapy Market Sees Explosive Growth, Driving Surge in Talent and Capital Requirements
A growth trajectory of such magnitude creates a substantial requirement for specialized talent and capital. Venture funding for gene therapy ventures reached US$ 773 million across 20 rounds in 2024. Bioprocess engineers are in high demand to optimize production. Overall investment in the cell and gene therapy sector hit US$ 15.2 billion in 2024. There are now about 3,000 developers in the space, running around 2,000 clinical trials. As of early 2024, there are 36 FDA-approved gene therapies. The FDA anticipates between 10 and 20 approvals per year by 2025, solidifying a period of intense and sustained demand for the foreseeable future.
Allogeneic “Off-the-Shelf” Cell Therapies Reshape Viral Vectors Market with Large-Scale Demand
The rise of allogeneic, or “off-the-shelf,” cell therapies is fundamentally reshaping the viral vectors & plasmid DNA manufacturing market. Unlike autologous treatments, these therapies utilize donor cells to create large batches of a standardized product. A model requires a massive, consistent supply of high-quality viral vectors for genetic modification. As of early 2024, there are more than 150 allogeneic cell therapies in the global clinical pipeline. This number is estimated to rise, with an anticipated 25 new allogeneic therapy IND applications to be filed with the FDA by 2025.
Investment in the space is strong in the viral vectors & plasmid DNA manufacturing market, with allogeneic therapy developers securing more than US$ 2 billion in dedicated financing during 2024. To support these programs, CDMOs are adapting their strategies. An estimated 12 new manufacturing suites are being specifically created for the large-scale vector production required for allogeneic platforms by 2025. One leading allogeneic company plans to treat more than 1,000 patients from a single manufacturing campaign in 2025, a feat demanding hundreds of liters of viral vectors. The number of collaborations between allogeneic developers and specialist vector CDMOs is anticipated to rise by 40 new agreements in 2024.
Furthermore, developers are working to streamline processes, aiming to reduce the vector cost per patient dose by an additional US$ 5,000 by 2025 through manufacturing efficiencies. The global workforce skilled in allogeneic manufacturing is also set to expand by an estimated 2,000 specialists by the end of 2024, highlighting the sector’s rapid growth.
FDA Approvals and 250+ Clinical Trials Reinforce AAV’s Dominance in Gene Therapy
Adeno-Associated Virus (AAV) vectors have firmly established their leadership, holding more than 22% of the vector-type segment in the viral vectors & plasmid DNA manufacturing market. This supremacy is rooted in AAV’s superior safety profile and its efficient, long-term gene expression in a broad range of human cells. In 2024, the FDA’s approval of Pfizer’s Hemophilia B therapy, Beqvez, and PTC Therapeutics’ Kebilidi for AADC deficiency, highlights the regulatory confidence in this vector.
With more than 250 AAV-based clinical trials active as of early 2025 and seven new therapy approvals in 2024, the clinical pipeline is strong. This momentum has attracted more than US$ 5 billion in venture capital in Q1 2024 for manufacturing expansion, signaling strong market confidence and future growth.
The commercial appeal of AAV is further amplified by continuous innovation. By 2025, more than 50 AAV serotypes will be in active development, with novel capsids demonstrating an impressive 60% growth in neuronal transduction efficiency. This progress is met with expanding infrastructure, evidenced by at least 10 pharmaceutical giants growing their in-house abilities in 2024 and Viralgen’s 2024 launch of the world’s largest AAV-dedicated facility. The formation of 8 new strategic collaborations in 2025 to scale production further cements AAV’s role as the premier vector, making it a cornerstone of the modern viral vectors & plasmid DNA manufacturing market.
North America Strengthens Global Leadership in Viral Vector Manufacturing Through FDA Reviews and NIH Support
North America commands the global viral vectors & plasmid DNA manufacturing market, boosted by substantial investment and a dense concentration of clinical activity. In 2024, U.S. biopharmaceutical companies reported expansions totaling more than 500,000 square feet committed to viral vector production. To staff these rising operations, an estimated 3,500 new bioprocessing and manufacturing jobs are estimated in the U.S. and Canada by 2025. This growth is propelled by a strong pipeline, with U.S.-based companies anticipated to initiate at least 150 new Phase I/II clinical trials for gene therapies in 2024.
Regulatory support further solidifies the region’s dominance. The FDA is anticipated to review more than 40 Investigational New Drug (IND) applications for cell and gene therapies in 2024. Venture capital continues to pour in, with North American gene therapy startups raising more than US$ 3 billion in early-stage funding in the first half of 2024 alone. Government backing is also strong; the National Institutes of Health has allocated approximately US$ 500 million for gene therapy manufacturing research in 2024. Major CDMOs in the region plan to add a collective 25 new large-scale bioreactors online by 2025 to fulfill the surging demand from the viral vectors & plasmid DNA manufacturing market.
Viral Vectors & Plasmid DNA Manufacturing Market Major Players:
- ABNOVA
- BGI Genomics
- Boehringer Ingelheim
- Catalent Inc.
- Cobra Biologics
- FinVector
- Fujifilm Diosynth Biotechnologies
- GenScript
- Lonza
- Medigen Biotechnology Corp
- Oxford Biomedica
- Sarepta Therapeutics
- Synthra
- Takara Bio
- Thermo Fisher Scientific
- UniQure NV
- Univercells
- Viralgen
- Wuxi AppTec
- Other Prominent Players
Key Market Segmentation:
By Vector Type
- AAV
- Plasmid DNA
- Lentivirus
- Adenovirus
- Retrovirus
- Others
By Application
- Vaccinology
- Gene Therapy
- Antisense &RNAi
- Cell Therapy
By Disease
- Cancer
- Genetic Disorders
- Infectious Diseases
- Others
By Workflow
- Upstream Processing
-
- Vector Amplification & Expansion
- Vector Recovery/Harvesting
- Downstream Processing
-
- Fill-finish
- Purification
By End-User
- Research Institutes
- Biopharmaceutical and Pharmaceutical Companies
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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