The field of regenerative medicine (RM) is rapidly expanding as there are currently 53 marketed RM products and 175 RM pipeline agents in development in the eight major markets (8MM*), according to GlobalData.

The company’s report, ‘Regenerative Medicine in Pharma – Thematic Research’, states that gene therapy is the most valuable regenerative medicine segment, but is also expected to be slowed down by high cost which may limit its accessibility. The gene therapy market was valued at $734 million in 2019 in the 8MM and is forecast to reach $13.3 billion by 2026 with Novartis’ Zolgensma leading the market.

Alessio Brunello, Managing Pharma Analyst at GlobalData, comments, “As indications continue to expand, potential markets will also grow as a greater number of patients benefit from these products. This is expected to increase adoption and further push payers into finding ways to pay for these treatments. The COVID-19 pandemic could be an opportunity for the companies pursuing the development of gene therapies, as few products are in development to fight the viral illness. However, challenges are still present for gene therapies, as these type of therapies need to produce enough evidence of proven safety and also a better efficacy comparing with already marketed products, such as antiviral drugs.”

The cell therapy field is also expanding, but lack of data and manufacturing are barriers for this sector. The cell therapy market was valued at $121 million in 2019 in the 8MM and is forecast to reach $3.1 billion by 2026.

Brunello adds, “The cell therapy space is expanding rapidly, especially in the oncology arena. CAR-T therapies, such as Novartis’ Kymriah, in particular are a large focus of the field due to the incredible promise they hold to shrink and eliminate cancers altogether. A major challenge in the cell therapy space is how these products are manufactured. Many approaches use a patient’s own cells as a basis for modifications. These must then be manipulated and expanded into a usable product. Establishing this manufacturing process across regions is a significant hurdle. Off-the-shelf solutions are an immediate boon with regards to regional consistency, but these come with their own pitfalls with respect to host rejection.

“Special designations and programs exist across the 8MM, which expedite the development and approval of regenerative medicines. However, the high cost of certain products, such as gene therapies, could hinder their adoption and accessibility for patients.”

*8MM: US, France, Germany, Italy, Spain, UK, Japan and South Korea