The gene therapy market size is expected to grow from US$ 5.11 billion in 2023 to US$ 25.69 billion by 2031; it is projected to register a CAGR of 14.3% during 2023-2031.

Gene therapy is a pioneering treatment method that uses genes to treat diseases. Gene therapy offers a promising approach to treat and cure diseases by introducing genetic material into a patient's cells to replace or correct abnormal genes. Gene therapy can be classified into in-vivo and ex-vivo gene therapy. This innovative treatment method has gained significant attention and investment in recent years, leading to advancements in gene therapy techniques and technologies. The gene therapy market growth is attributed to the increasing burden of genetic diseases and the rising number of FDA approvals of gene therapies. However, the high cost of gene therapy products hinders the growth of the gene therapy market.

Researchers are working on making gene therapy available in clinics. A wide range of product portfolios are in the pipeline at various universities and institutes, and revenue generation is expected to increase during the forecast period. Following the FDA's approval of the first gene therapy, the number of clinical trials for gene therapy surged dramatically from 2017 to 2018. About 1,986 products, including CAR T-cell treatments and other genetically engineered cell therapies, are currently under development, according to the American Society of Gene & Cell Therapy. Over the projection period, the robust pipeline is anticipated to offer new opportunities for the growth of the gene therapy market.

Vectors-Based Insights

Based on vectors, the gene therapy market is categorized into non-viral vectors and viral vectors. The viral vectors segment held a significant gene therapy market share in 2023. It is anticipated to record a higher CAGR in the market during the forecast period. Viral vectors have the ability to competently deliver genetic material into target cells. They are derived from viruses that naturally can infect cells and transfer their genetic material. This makes them highly effective in delivering therapeutic genes into the cells of patients. In addition, viral vectors offer a high level of specificity and selectivity. They can be engineered to target particular types of cells or tissues, allowing for targeted delivery of therapeutic genes. This is particularly important in gene therapy, as it reduces the risk of off-target effects and enhances the effectiveness of the treatment. Moreover, viral vectors have been extensively studied and optimized over the years, leading to the development of safer and more efficient vector systems. Advances in vector design and manufacturing technologies have improved the safety profile and scalability of viral vectors, making them more suitable for clinical applications.

According to the analysis from clinicaltrials.gov, ~58% of gene therapies under development are using viral vectors. The most commonly employed viral vector for gene therapy is adeno-associated virus, owing to its ability to deliver genes to non-dividing cells where the gene has a long-term therapeutic impact. Different varieties of adeno-associated viruses target different cells, making them a suitable transporter of genetic material to desired locations inside the body, providing a customized treatment. In addition, viral vectors display low immunogenicity, safety, and long-term transient expression. Overall, the growing demand for safe and effective gene therapies, along with the advantages offered by viral vectors, has contributed to the segment's significant growth, positively influencing the gene therapy market growth.

The US Food and Drug Administration, the World Health Organization, and the Centers for Disease Control and Prevention are among the primary and secondary sources referred to while preparing the gene therapy market report.