Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing costs, incremental benefit claims that extend over an extended time frame, restriction to centres of excellence and disruption of existing service delivery processes, often requiring significant reallocation of healthcare resources. Development, manufacturing and commercialisation are highly co-dependent processes and do not exist in the sequential, standalone systems in which small molecules and biologics function. In order for commercialisation to be successful, a constant feedback loop should be in place early on in development that drives quality, efficiency, scalability and patient-centred treatment management.
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