Getting ready for primetime in cell & gene therapy

Cell and gene therapies (CGTs) have a lot going for them from an industry perspective – with a market predicted to reach US$50 billion annually by 2027,   an opportunity to expand the frontier of medical science and the potential to save or improve countless lives. But with logistical, supply chain and manufacturing complexities interwoven into development, bringing CGTs to large patient populations may prove uniquely challenging.With over 3,633 therapies in development as of mid-2022,  CGTs are two of the fastest-growing areas of healthcare. To date, less than two dozen therapies have made it to market, but this number is expected to grow exponentially.  So far, therapies have been niche, serving relatively small patient populations and costing hundreds of thousands of dollars. But new treatment possibilities are emerging across a broad range of diseases - including leukaemia, haemophilia and sickle cell disease - that could extend CGTs for use as frontline treatments for hundreds of thousands, even millions, of people.  Genetic and cell engineering advances are driving this rapid evolution. Regulatory bodies are also becoming increasingly accommodating of CGTs. In the US, several FDA-led CGT initiatives and two new guidance documents for CGTs were released this year, sparking optimism surrounding market growth in 2023 and beyond.  The UK has also released new guidance on the development of advanced therapy medicinal products (ATMPs, a term for cell, gene and tissue t...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news