Commercialization of cell and gene therapy in Canada: Current landscape, challenges and opportunities

Abstract

Cell and gene therapies (CGTs) offer transformative treatments for certain genetic diseases and cancers, with a growing number of global approvals. Yet Canadian commercialization lags behind the USA and Europe. This review identifies key barriers and proposes policy solutions informed by international examples. A policy-oriented environmental scan was conducted using regulatory documents, peer-reviewed literature, government reports, and industry publications. Barriers and solutions are organized into four domains: regulation, manufacturing, pricing and reimbursement, and access and equity. Despite recent investment downturns in this therapeutic area, Canada’s approval of its first clustered regularly interspaced short palindromic repeats (CRISPR)-based therapy and chimeric antigen receptor (CAR) T-cell expansion suggest future growth. Strategic reforms could improve domestic CGT innovation, affordability, and equitable access.