Viral Vector Manufacturing: Current Landscape and Opportunities

Over the last few decades, various viral vector manufacturing 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 gene 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 viral vector manufacturing.

---

Rising Optimism Amongst Stakeholders is Driven by Increasing Outsourcing Trend

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

---

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

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. Viral vector and non viral vector manufacturing companies are Advanced BioScience Laboratories, AGC Biologics, Aldevron, Altruist Biotechnology, BioNTech Innovative Manufacturing Service (a subsidiary of BioNTech), BioReliance (a subsidiary of Merck KGaA), Biovian, Catalent Biologics, Celonic, Centre for Process Innovation

---

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 viral vector manufacturing market; the future opportunity is expected to be well-distributed amongst vector types in the long-term.

For more details, you can also download the SAMPLE REPORT on viral vector manufacturing by Roots Analysis.