Advanced therapy medicinal products (ATMPs) are a group of innovative biological medicines that have been gaining increasing attention in recent years. Most of them use a unique approach to treating diseases by either removing or repairing diseased cells. They are primarily used when standard therapy is ineffective or non-existent, but their use is expanding to first-line treatment as well. Their uniqueness and high efficacy come with significant challenges and limitations. The first limitation is the cost of each treatment, which can reach millions; the second is accessibility, and the third includes strict manufacturing and distribution requirements. Despite these limitations, the number of ATMPs is growing. In our study, we focused on ATMPs authorized for marketing in the European Union. The aim of the research was to review existing medicines and, using the method of identifying emerging health technologies, create a database of potential upcoming therapies in the next two years. After forming the database, we analyzed, classified, and evaluated it. Our review was conducted in October 2024. At that time, 20 ATMPs had marketing authorization in the European Union, while 7 had lost their authorization. Most of these medicines belong to the field of gene therapy and are primarily intended for rare diseases. Using the method of identifying emerging health technologies, we created a database of 63 medicines from various sources. We defined the characteristics of these new therapies and found that they differ significantly from those that have already obtained marketing authorization. Our research suggests that the dominance of gene therapy will become more balanced among different therapy types, including gene therapy, somatic cell therapy, and tissue engineering therapy. Additionally, medicines combining different types of therapies will start to emerge. The therapeutic areas identified in our research have expanded to include cardiovascular and musculoskeletal diseases, in addition to rare diseases. However, the majority of ATMPs still target cancer treatment. The high costs associated with development, production, and distribution are funded by the pharmaceutical industry. The number of ATMPs and their areas of application are increasing, accessibility is improving through governmental and organizational efforts, and the future presents new opportunities and possibilities for advanced therapy medicinal products.
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