The global viral vector manufacturing market was valued at USD 1,469.6 million in 2024 and is expected to reach USD 8,512.2 million by 2033, exhibiting a CAGR of 21.6% during 2025-2033. This growth is driven by rising genetic disorders, increased gene therapy adoption, and advancements in viral vector production technologies. North America dominates with a market share exceeding 49.3%.
Study Assumption Years
- Base Year: 2024
- Historical Years: 2019-2024
- Forecast Period: 2025-2033
Viral Vector Manufacturing Market Key Takeaways
- Current Market Size: USD 1,469.6 million in 2024
- CAGR: 21.6% (2025-2033)
- Forecast Period: 2025-2033
- North America holds over 49.3% market share in 2024, led by advanced biotech infrastructure and increased gene therapy adoption.
- The U.S. dominates viral vector manufacturing with 91.90% of the total market share.
- FDA approval of gene therapies reached 36 by March 2024, with over 500 in development and expected 10-20 annual approvals by 2025.
- Technological advances, such as HEK293 cell line adoption by Samsung Biologics, increased viral vector yield by 25% in 2022.
- Challenges include lengthy approval times (3-5 years) and scaling manufacturing while ensuring quality control.
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Market Growth Factors
The viral vector manufacturing market is rapidly expanding due to the increasing prevalence of genetic disorders and infectious diseases globally. Advancements in gene and cell therapy fuel this growth, as a growing number of viral vectors are used in developing innovative therapies to treat rare diseases, cancer, and neurological conditions. Expanding clinical trials and rising government funding, especially in the United States and North America, support this robust market expansion. Furthermore, collaborations among pharmaceutical companies and research institutions accelerate new therapy development, strengthening this sector.
Investments in scalable manufacturing technologies significantly boost the viral vector market. For example, Samsung Biologics’ implementation of HEK293 stable packaging cell line technology increased viral vector yield by 25% in 2022. Automation and artificial intelligence inclusion are simplifying scaling and lowering costs, facilitating the production of clinical-grade viral vectors essential for gene therapies. The pharmaceutical industry’s sustained investment in viral vector manufacturing infrastructure ensures reliable supply chains crucial for successful therapy commercialization.
Regulatory support from bodies like the FDA plays a vital role in market growth. As of March 2024, the FDA has approved 36 gene therapies and anticipates 10 to 20 new gene therapy approvals annually by 2025, reflecting increasing trust in the safety and efficacy of these treatments. However, the market faces challenges such as lengthy approval times often extending 3-5 years and complex scaling up processes that maintain quality and minimize contamination risks. Regulatory agencies collaborate with industry stakeholders to clarify guidelines, aiming to balance safety with accelerated access to therapies.
Market Segmentation
By Type:
- Adeno-associated Viral Vectors: The largest segment in 2024, valued for versatility and minimal immune response, extensively used in gene therapy for genetic disorders such as spinal muscular atrophy and inherited retinal diseases. Ongoing engineering advancements improve efficiency and clinical trial prevalence reinforces their dominance.
By Disease:
- Cancer: Leading disease segment with about 37.6% market share in 2024, driven by adoption of viral vectors in gene therapy and oncolytic virotherapy. Innovations such as CAR-T cell therapies using viral vectors amplify this segment’s growth.
By Application:
- Gene Therapy: Dominates with approximately 56.9% market share in 2024, propelled by adoption to treat genetic disorders, cancers, and rare diseases. Increasing regulatory approval and scalable manufacturing technologies support this lead.
By End User:
- Pharmaceutical and Biopharmaceutical Companies: Primary end users with extensive use in gene and cell therapy development, clinical trials, and commercial manufacture.
- Research Institutes: Key contributors fostering innovation through preclinical research and collaborations, boosted by government biotechnology funding.
Regional Insights
North America is the dominant region, holding over 49.3% market share in 2024. The market is driven by a strong biotech infrastructure, advanced clinical trial activities, government funding, and the presence of key industry players. The U.S., accounting for 91.90% of the total market share, leads with innovations in scalable production processes and federal incentives strengthening its global leadership in viral vector manufacturing.
Recent Developments & News
- November 2024: FUJIFILM Diosynth Biotechnologies expanded cell therapy manufacturing at Thousand Oaks, California, investing around USD 200 million to enhance viral vector and cell therapy production capacity.
- October 2024: Lonza finalized acquisition of a large-scale biologics site in Vacaville, US, from Roche, boosting its commercial manufacturing footprint.
- October 2024: FinVector opened Finport, a global gene therapy manufacturing facility in Kuopio, to produce viral vector-based drugs for Ferring Pharmaceuticals.
- May 2024: Merck & Co agreed to acquire Mirus Bio for USD 600 million, enhancing viral vector manufacturing through transfection reagent technologies.
- March 2024: Oxford Biomedica reported strong demand for CDMO services in lentiviral and AAV viral vectors including late-stage therapeutic programs.
Key Players
- Aldevron LLC
- Catalent, Inc
- Charles River Laboratories International Inc.
- Cytiva (Danaher Corporation)
- F. Hoffmann-La Roche Ltd
- FUJIFILM Diosynth Biotechnologies
- Genezen
- Kaneka Corporation
- Lonza
- Merck KGaA
- Oxford Biomedica PLC
- Thermo Fisher Scientific Inc.
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