Welcome to Phacilitate’s 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.

Joining Phacilitate to shed some light on market access struggles are Director at NJ Redfern Limited and ex-bluebird bio UK GM Nicola Redfern, former SVP & CBO at Novartis Gene Therapies and current AviadoBio CEO Lisa Deschamps, and, Vice President and Global Head of Value and Access, at Novartis, Tay Salimullah.

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.

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