Market Access Report 2022
Advanced therapies market access is a hot topic. Conversations surrounding this issue are pivotal for maintaining attention on the need for a movement towards adopting more flexible reimbursement and regulatory guidelines.
The last decade has hosted impressive progress in both the development and launch of advanced therapeutic products.
According to Global Data [1], to date, 40 cell and gene therapies have been authorized for marketing, including 7 in dermatology, cardiovascular and ophthalmology, and 6 in both musculoskeletal disorders and oncology.
Currently, 11 products are in the pre-registration stages and 103 in Phase III trials, with more than 1000 therapies undergoing Phase 0–II trials and a further 1500 under preclinical investigation. The majority of all the cell and gene therapies yet to reach the market – 1439 – are targeting oncological indications, followed by 750 for central nervous system disorders and 415 focusing on ophthalmology.
This data all points to one thing – we are likely to see an influx of cell and gene therapies attempting to gain market access in the upcoming years. But, is the market ready to support innovative drug products with needs outside of traditional reimbursement models? We will need to see authoritative bodies adapt current ways of working and support the unique challenges cell and gene therapies present, for these transformative products to change the life’s of the patients who need them.
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