Oncolytic Virus Therapy Market Trends

Growth Drivers

• Rising burden of cancer: As per the National Cancer Institute, globally, there were 9.7 million cancer-related deaths and about 20 million new cases in 2022. As a result, there is an ongoing need for more targeted and efficacious treatments. Its unique promise can be valuable in patients who have not adequately responded to standard therapies. There is an increase in researchers' ERD in solid tumours and in previously hopeless instances. As a result of compound cancer implications being better genetically understood, precision virotherapies will shift toward gleaning applicable insights from clinical experience. Additionally, governmental and world health organizations are spending more on immuno-oncology R&D through clinical investigations.

• Advancements in genetic engineering of viruses: Sustainable molecular engineering technologies can facilitate next-generation oncolytic viruses (OVs) that deliver different immune-stimulatory genes. This capacity to engineer viruses for specific impact on host immunity and/or to specifically target the cancer cells has improved the precision and effectiveness of virotherapy. Vector platform companies adapt viruses into proprietary viral backbones with engineered safety, persistence, and therapeutic payloads. This has led to a rise in IND filings and Phase I/II trials around the world.

• Supportive regulatory environment: Regulatory bodies like the FDA, EMA, and PMDA (Japan) are becoming far more supportive of oncolytic virotherapy. In fact, Japan approved G47Δ (Teserpaturev) under a conditional approval for glioma, a significant milestone. The U.S. FDA approved Fast Track designation for ImmVira's MVR-T3011 and future pipeline candidates. These types of accelerated pathways provide shorter development timelines and stimulate early innovation. Additionally, new updated regulatory guidance for Genetically Modified Organisms (GMOs) is becoming easier to navigate for virotherapies. In fact, regulatory bodies are showing more awareness and willingness to accommodate combination products and personalized virotherapies aligned with the goals of precision oncology.

Challenges

• Complex manufacturing and scalability issues: Producing oncolytic viruses requires very specialized facilities that must work under strict biosafety protocols. Further, there are more logistics needed to maintain a cold chain on top of the work being done with either a mucosal or parenteral route of administration. Furthermore, there is still a technical and regulatory hurdle when considering the processes surrounding scaling up viral vector manufacturing while still maintaining purity, potency, and safety. The timelines for developing viable GMP-compliant viral production processes are also longer. Therefore, this, in turn, limits the ability for more rapid commercialization as well as incurs additional costs to manufacture.

• Limited tumor selectivity and penetration: Achieving exact tumour selectivity while sparing normal tissues represents a significant obstacle. Some oncolytic viruses may not replicate well across all types of tumors, or may not sufficiently penetrate the hypoxic cores of tumors. In addition, the dense tumour microenvironments and extracellular matrices will often block or limit the diffusion of the virus, leading in tumours to a limited efficacy upon access to the tumour. New engineering approaches are necessary to deliver virotherapy more effectively, improving tropism and spread in tissue.