Advanced therapy medicinal products (ATMP) drug development is a very dynamic and challenging field with many potential solutions for patients. ATMPs on the market in EU are growing, although less than expected despite many academic projects, start-ups, and small- and medium-sized enterprises involved in their development. The low level of commercialization of advanced medicines covering gene and cell therapies and tissue-engineered products has been attributed to a variety of factors such as complexity of technologies, high development costs, low investment returns, and difficulties with manufacturing processes. Regulatory issues and inconsistencies in clinical trials and manufacturing are also present. We want to give an update about the challenges, opportunities in ATMP drug development and promises for patients.