Despite the growing demand for novel therapeutics to treat Alzheimer’s disease, just one innovator drug has been approved in the last decade by the UK’s Medicines and Healthcare Products Regulatory Agency (MRHA), according to GlobalData’s Drugs Database. The leading data and analytics company notes that the high costs of research combined with the post-Brexit regulatory environment could lead to lower interest in drug development.

Alzheimer’s disease and dementia are neurodegenerative disorders that cause progressive deterioration in memory, cognition, and locomotion. According to the Alzheimer’s Society, there were more than 1 million people living with dementia in the UK in 2021, and this is set to double to 2 million by 2051. Approximately 11% of deaths in England and Wales are caused by Alzheimer’s disease and dementia, and this percentage is expected to rise due to the aging UK population, according to the Office of National Statistics. This is expected to create huge demand for innovative therapeutics.

The EU has a significantly larger dementia pipeline, with 25 more drugs than the UK. Notably, the EU has a greater proportion of drugs in early-stage development, with 37.5% in Phase I and Preclinical stages compared to only 14.2% in the UK, according to GlobalData. The data suggests that early-stage drug developers find the UK market less attractive, which could have significant long-term consequences for drug development in Alzheimer’s disease and dementia.

Kevin Marcaida, Pharma Analyst at GlobalData, comments: “These numbers reflect the high failure rates common for drugs treating these diseases, which is then amplified by uncertainties caused by Brexit. This is because developers will often rely on government subsidies such as the EU’s Horizon Program to help support drug development in less profitable segments. However, since January 1, 2021, EU pharmaceutical law is no longer effective in the UK.”

Uncertainties surrounding access to EU funding led to a drop of nearly one-third in R&D investment and fewer scientist entering the UK which will likely hamper long-term innovation, according to the Royal Society. Furthermore, developers will now need to navigate the new rules implemented by the MHRA, which could lead to longer approval times, higher legal costs, and more expensive clinical trials.

Marcaida concludes: “In a field where high failures rates are common, and margins are tight, additional uncertainties surrounding funding and regulations have likely contributed to the UK’s weak pipeline. Currently, the UK is struggling to encourage sustainable drug development in the face of rising medical demand. The British government must now increase R&D investments to meet deficits left by Brexit, which should help cultivate a more competitive market.”