The ATMP field encompasses products of different types that, despite their differences, fall within the definition of an advanced therapy medicinal product. It is key to understand these differences and being able to properly classify them.
The market value of the ATMP sector is growing rapidly. In the US, the annual growth rate for the T-cell and tissue engineering markets between 2020 and 2027 is approximately 15% for the T-cell and 14% for tissue engineering, while the global cancer gene therapy market is expected to grow at an annual rate of 32.5%.
An additional challenge is the differing regulatory requirements of different health authorities. For example, a product that is an ATMP for the EMA is not an ATMP for the US and vice versa. Within the EU, there are several levels of legislation that can affect each EU country, and this will also be briefly discussed in the course.
Finally, there are several challenges that will be faced in the development and marketing of an ATMP and it is necessary to have a good view of these to see the point of improvement and to be able to anticipate them.