The origin of gene and cellular therapies has brought home opportunities in bulk for various segments in the medical health industry. It has inculcated a culture of site-specific modifications to correct mutated genes, thereby facilitating disease prevention without using drugs or surgery.

Genetically engineered viruses have shown great potential in the treatment of fatal diseases such as cancer, Parkinson's disease, rheumatoid arthritis, and Alzheimer's.

For gene therapy, vectors (viral and non-viral) manufacturing form the basic foundation. These vectors act as delivery vehicles for gene insertion and replacing mutated genes.

The global viral and non-viral vector manufacturing market was valued at $1.50 billion in 2020 and is expected to reach $27.03 billion by 2031, witnessing a CAGR of 18.54% during the forecast period 2021-2031. However, the high gene therapy cost and possible immune side-effects still stand as barriers to this market growth.

Gene therapy is a process in which new genetic material is introduced into the body cells. These genetic materials make up for the abnormal cells to synthesize usable protein.

When the natural protein disrupts due to a mutated gene, gene therapy is extended to restore the same via modification of cells either inside or outside the body. While performing in-body modifications, delivery trucks called ‘vectors’ carry the genetic material and transfer it to the target site.

What is viral and non-viral vector manufacturing?

Viral and non-viral vectors are critical components of gene therapy. Viral vectors are those vectors or carriers that use the blueprint of a virus to deliver the genetic material. Vectors are not only applied for gene therapy but also to create vaccines.

In order to eliminate the risk of viral infection, only the harmless parts of the virus are restored while the infectious segments are eliminated. Presently, only FDA-approved gene therapies allow viral vector manufacturing and usage. However, non-viral vectors refrain from virus blueprint usage. Instead, they rely on physical or chemical techniques to deliver the genetic material to the target site.

Although non-viral vectors are supposedly better than viral vectors, researchers are still looking for answers, and the process is relatively complex for non-viral vector applications.

Why are viral and non-viral vectors required?

Viral vectors and non-viral vectors are viruses with an incomplete genome to act as delivery trucks.

Viruses are used as carriers because they have a cellular design that enables them to penetrate the human cells and launch themselves into the desired body parts as per the requirement. After passing through the cell membrane, the virus reaches the nucleus and dissembles itself. Then, the genetic material comes out of the package and gets delivered safely.

In 1990, gene therapy had its first patient who was a 4-year-old ADA sufferer, and since then, it has been used for curing fatal diseases like:-

- Cancer
- Alzheimer’s disease
- Tumors (including cancer-linked tumors)
- Parkinson’s disease
- Genetic disorders like cystic fibrosis
- Heart diseases
- Hemophilia
- Acquired Immune Deficiency Syndrome (AIDS)

The worldwide demand for viral and non-viral vectors skyrocketed massively after the introduction of genetically-modified therapies. Since the discovery of viral vectors and prediction for their human application in the 1970s, the gene theory has spread widely across the globe.

The market can seize opportunities for further growth by increasing the funding in the research sector, application of vector-based vaccinology, better technologies, and increase in the number of clinical studies with the rise of occurrences of disorders.

Rising incidences of genetic disorders, cancers, and infectious diseases, coupled with the increasing number of clinical studies such as those using gene therapy, are further expected to fuel demand for viral and non-viral vectors.

The global market for manufacturing vectors or non-viral vectors has many manufacturers that are well established, but the market is also flooded with new companies that have begun to enter the space. Some of the well-established players have established tie-ups with other companies in order to overcome competition by collaborations and acquisitions.

Conclusion

Experiments have theoretically demonstrated the potency of gene therapy. Still, clinical trials and more profound research continue to happen in several countries like the U.S., the U.K., Japan, France, and Switzerland.

One of the main obstacles to market growth is the diverse perception of the masses. While some consider it an ethical application, another group supports selective usage.

However, the dynamics await the change with the rising oncology and hemophilia medication market changes.