Target group analysis


A target group analysis for Advanced Therapy Medicinal Products (ATMPs) taking into account SGB 5 (Social Code Book 5) could look like the following:
 

  • How common is certain disease in a country and which therapy options are allowed, or mapped in SGB5?

  • Which regulatory authorities need to be addressed?

  • Which universities and research institutes are involved in this form of therapy so far?

  • Are doctors and hospital organisations involved in a comparable project?

  • Is there a lobby of patient organisations that have already addressed this issue?


Overall, it is important to consider both the medical and regulatory aspects early on in the target group analysis for ATMPs to ensure that the product is accessible to the patient group.