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. The market is projected to grow at a CAGR of 21.6% during the forecast period from 2025 to 2033. Growth is driven by the rising prevalence of genetic disorders, adoption of gene therapies, advanced biotechnology infrastructure, and expanding clinical trials. North America dominates the market, holding over 49.3% share in 2024.

Study Assumption Years

• Base Year: 2024
• Historical Year/Period: 2019-2024
• Forecast Year/Period: 2025-2033

Viral Vector Manufacturing Market Key Takeaways

• Current Market Size (2024): USD 1,469.6 Million
• CAGR (2025-2033): 21.6%
• Forecast Period: 2025-2033
• North America holds over 49.3% market share in 2024, driven by biotech infrastructure and government funding.
• The United States accounts for 91.90% of the total market share, led by gene therapy clinical trials and government investments.
• Technological advancements like HEK293 cell line technology increased viral vector yield by 25% in 2022.
• FDA has approved 36 gene therapies as of March 2024, with more than 500 in development.
• Challenges include lengthy approval times (3-5 years) and scaling-up manufacturing with quality control.

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Market Growth Factors

The global viral vector manufacturing market is propelled by a rising prevalence of genetic disorders and infectious diseases, alongside advancements in gene and cell therapy. The adoption of viral vectors in therapies for rare diseases, cancer, and neurological disorders fuels demand. Expanding clinical trials and increasing government investments in biotechnology and pharmaceutical research provide further support. Scalable manufacturing technologies improve production efficiency and cost-effectiveness. Collaborations between pharmaceutical companies and research institutions accelerate novel therapy development, underpinning market growth.

Pharmaceutical firms are investing heavily in viral vector manufacturing to meet the growing demands for gene therapy. The FDA had approved 36 gene therapies by March 2024, with around 10 to 20 expected annually by 2025. This increase, supported by regulatory fast-tracking and investment, reflects growing confidence in gene therapies' safety and efficacy. Sustaining good quality viral vectors is critical for successful therapies, prompting infrastructure investments to address manufacturing scale-up challenges and broaden patient access.

Technological advancements greatly influence market growth. Stable packaging cell lines enhance production efficiency, exemplified by Samsung Biologics' adoption of HEK293 cell line technology, which raised viral vector yield by 25% in 2022. Automation and AI integration in manufacturing lower costs and simplify scaling processes. These innovations meet rising demands for clinical-grade viral vectors and improve production reliability. Regulatory bodies like the FDA and EMA engage with stakeholders to establish clearer manufacturing guidelines, balancing safety requirements with efficient time-to-market strategies despite approval delays of 3 to 5 years.

Market Segmentation

Analysis by Type:

• Adenoviral Vectors
• Adeno-associated Viral Vectors
• Lentiviral Vectors
• Retroviral Vectors
• Others

*Adeno-associated viral (AAV) vectors are the largest segment in 2024, valued for versatility, low immune response, and effectiveness in treating genetic disorders like spinal muscular atrophy and inherited retinal diseases. Ongoing advancements and FDA approvals bolster their prominence.*

Analysis by Disease:

• Cancer
• Genetic Disorders
• Infectious Diseases
• Others

Cancer is the leading disease segment in 2024, holding approximately 37.6% share, due to viral vectors' use in gene therapies and oncolytic virotherapy. Advances in immunotherapy, including CAR-T cell therapies, drive this growth.

Analysis by Application:

• Gene Therapy
• Vaccinology

Gene therapy dominates in 2024 with about 56.9% share, propelled by its use in treating genetic disorders, cancers, and rare diseases. Regulatory approvals and technological advancements fuel expansion.

Analysis by End User:

• Pharmaceutical and Biopharmaceutical Companies
• Research Institutes

Pharmaceutical and biopharmaceutical companies are the primary end-users, driven by gene and cell therapy development and commercial manufacturing demands. Research institutes contribute through innovation and government-funded biotechnology research.

Regional Insights

North America dominates the viral vector manufacturing market with over 49.3% share in 2024. Factors include advanced aerospace and energy industries, a robust company base fostering innovation, and a strong R&D infrastructure with universities leading material science and engineering research. The United States, driven by clinical trials and federal incentives, is a key hub with expanding manufacturing capacity by major players.

Recent Developments & News

• November 2024: Fujifilm Diosynth Biotechnologies expanded cell therapy manufacturing in Thousand Oaks, California, with a USD 200 million project adding production suites and cleanroom capacity.
• October 2024: Lonza finalized acquisition of a large-scale biologics manufacturing site from Roche in Vacaville, US.
• October 2024: FinVector opened Finport, a gene therapy manufacturing facility in Kuopio for Ferring Pharmaceuticals' FDA-approved gene therapy, Adstiladrin.
• May 2024: Merck & Co Inc agreed to purchase Mirus Bio in a USD 600 million deal to enhance viral vector manufacturing capabilities.
• March 2024: Oxford Biomedica reported high demand for CDMO services including lentiviral and AAV-based gene therapy 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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