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AAV/lentiviral vector capacity

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Overview: AAV/lentiviral vector capacity — context, definitions, and current market posture.

What is AAV/lentiviral vector capacity?

AAV/lentiviral vector capacity refers to the global manufacturing infrastructure and throughput for adeno-associated virus (AAV) and lentiviral gene delivery systems. As of 2025, there are 28 cGMP-certified production sites across the US and EU dedicated to viral vector manufacturing, supported by $950 million in automation investments. These facilities collectively produce billions of vector genomes per batch, enabling large-scale clinical and commercial supply. Patent filings for viral vector manufacturing reached 430 in 2025, and non-viral delivery pipelines doubled, reflecting a 13% year-over-year capacity expansion driven by process innovation and automation.

Market snapshot

Current projections indicate the global gene therapy market is expected to reach an estimated $68 billion by 2033, reflecting a base-case Compound Annual Growth Rate (CAGR) of 21.2% from 2025. Within this, the CAR-T therapy market segment alone is forecast to achieve $21.5 billion by 2033. This growth is underpinned by a burgeoning clinical pipeline, with 1,420 active gene therapy clinical trials in 2025, projected to surpass 2,100 by 2033. Oncology represents the dominant therapeutic area, accounting for 64% of global gene therapy trials.

Regulatory notes

The regulatory landscape for gene therapy is dynamic, marked by significant innovation in harmonization, expedited trial launches, and commercial approvals. Key agencies such as the FDA, EMA, and NMPA are actively evolving risk/benefit frameworks and fostering international collaboration.
In 2025, the FDA launched four gene therapy fast-tracks for oncology and rare diseases in the US, while the EMA broadened its harmonized approval framework with five pathway types in the EU. China’s NMPA expedited three new pathways for CRISPR/CAR-T approvals. These expedited pathways, utilized by 41% of gene therapy candidates in 2025, are critical for accelerating market entry. Post-marketing compliance demands are also intensifying, with the FDA increasing vigilance for commercialization risk and the EMA expanding compliance fast-tracks to rare and pediatric indications. International harmonization workshops, coordinated by EMA and NMPA, underscore efforts to streamline global regulatory processes for gene therapy clinical trial pipeline regulatory approval trends.

Next: See the Biopharma & Life Sciences guide or the full 2025–2033 report for forecasts and detailed methodology.

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