The current competitive market for Alzheimer’s disease focuses only on symptomatic treatments, providing an opening for urgent new disease-modifying drugs (DMDs), according to a report by GlobalData.

Titled ‘Alzheimer’s Disease: Competitive Landscape to 2026’, the report highlights the lack of approval of a new drug for the disease in the past 16 years. The scenario persists even after more than 400 clinical trials and billions of dollars being spent to address the unmet needs.

The drug development pipeline for Alzheimer’s is said to have experienced one of the highest failure rates, with only 3.2% of the total 657 candidates reaching the late-development stages.

Overall, the pipeline is ruled by small molecules and monoclonal antibodies, and amyloid precursor protein (Aβ peptide and protein) and microtubule associated protein tau (MAPT) are the major targets.

“The need for new DMDs is urgent as the current competitive landscape in AD offers medications that are aimed at treating only the symptoms of the disease. A few key drug makers have already stopped their research into AD, and given the significant amount of R&D failures, pharma companies may be disincentivised from producing new drugs,” states Alessio Brunello, pharma analyst at GlobalData.

Brunello adds that all Aβ-targeting drugs treating AD have failed, while recent studies demonstrated that tau could be responsible for the disease instead of beta amyloid.

“The need for new DMDs is urgent as the current competitive landscape in AD offers medications that are aimed at treating only the symptoms of the disease.”

It is expected that the future may hold tailored therapies with potentially anti-amyloid and anti-tau approaches being concurrently used.

Existing symptomatic treatments for the disease are three cholinesterase inhibitors (ChEIs) known as donepezil, rivastigmine and galantamine, an N-methyl-D-aspartate receptor (NMDA-R) antagonist called memantine, and one combination therapy of memantine/donepezil.

According to the report, these drugs fall short on desired efficacy, routes of administration and dosing frequencies.

However, upcoming launches of monoclonal antibodies gantenerumab and crenezumab by Roche, and aducanumab from Biogen are set to boost the Alzheimer’s market, with a potential to halt or prevent disease progression.

At present, the majority of tau-targeting approaches undergoing clinical trials are immunotherapies such as Axon neuroscience’s AADvac-1 and Eli Lilly’s LY3303560.

“Monoclonal antibodies have shown more promise than anything in the pipeline and in the next ten years, we’re going to have a good idea whether amyloid is really a meaningful player or not. The industry shifted a little to anti-tau therapies, showing that tau treatments represent a new direction with a possible combination approach if trials will provide positive results,” concludes Brunello.