Viral Vectors and Plasmid DNA Manufacturing: Current Landscape and Opportunity Areas

Over the last few decades, various Viral Vectors and non-viral vectors have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. Currently, the most popular viral vectors, on the basis of their use in active clinical trials, are those based on AAV, adenovirus, lentivirus and retrovirus. On the other hand, among non-viral gene delivery tools, plasmid DNA has emerged as the preferred option. Overall, eleven genetically modified therapies have been approved so far. In addition, over 430 gene therapy candidates are presently in different stages of clinical development, for which over 500 clinical studies are currently underway in various regions across the globe.  The growing number of gene therapy candidates, coupled with their rapid progression through various phases of clinical development, is expected to continue to create an increasing demand for vectors.

Rising Optimism Amongst Stakeholders is Driven by Increasing Outsourcing Trend

Opinions expressed by industry stakeholders highlight the increasing outsourcing trend of vector manufacturing for the development of genetically modified therapies

Over 160 Organizations are Involved in the Manufacturing of Viral / Plasmid DNA Vectors

The landscape is well distributed across vector types; a number of facilities are operating at the lab / clinical scale with significant support from academic / non-industry players

CMOs are Acting as Key Enablers to Cater to the Growing Demand

Advances in genetically modified therapies have led to an increase in the demand of vectors; CMOs enable an accelerated transition towards commercial development

The Manufacturing Activity is Heavily Concentrated in the US and the EU

To cater to the growing global demand, companies have established presence across different regions; the US and EU have emerged as key hubs

Overall Installed Manufacturing Capacity will Likely Witness Significant Growth

The installed vector manufacturing capacity is estimated to be over 50 thousand litres; in order to maintain a competitive advantage, stakeholders are looking to expand further

As Companies Actively Collaborate, Novel Vectors are Being Investigated

Increasing instances of partnerships showcase the rising interest in this domain; companies are actively collaborating to develop novel manufacturing technology platforms

Driven by Adoption of Advanced Technologies …

Our outlook is highly promising; overall, we expect the market to grow at an annualized rate of over 20% during the next decade

… We Expect the Market to Grow at an Accelerated Pace

In the short-term, clinical products are expected to dominate the market; commercial scale will gradually become mainstream in about five years

Overall, the Long Term Opportunity is Likely to be Well-Distributed

As expected, oncology will account for a significant share of the market; the future opportunity is expected to be well-distributed amongst vector types in the long-term

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