Market Research Report
Disease Analysis: Alzheimer's disease
|Published by||Datamonitor Healthcare||Product code||920044|
|Published||Content info||87 Pages
Delivery time: 1-2 business days
|Disease Analysis: Alzheimer's disease|
|Published: May 7, 2020||Content info: 87 Pages||
Datamonitor Healthcare estimates that in 2018, there were 74.5 million prevalent cases of Alzheimer's disease in adults aged 65 years and older worldwide, and forecasts that number to increase to 102.5 million prevalent cases by 2027. The US Alzheimer's disease market only includes four marketed products that are well established. The anticipation of growth has faded with the failure of immunotherapies to produce efficacious results on cognitive outcomes. The acetylcholinesterase class of drugs will continue to dominate the treatment of mild Alzheimer's disease, while NMDA receptor antagonist memantine is used primarily as an add-on or second-line therapy in more severe disease stages.
In the first half of 2020, an FDA approval decision is expected for Adlarity, a once-weekly transdermal formulation of gold-standard Alzheimer's disease treatment donepezil. In late 2019, China granted a conditional approval for GV-971, an oligosaccharide derived from brown algae, representing the first novel drug approved for Alzheimer's disease in nearly two decades.
Biogen's unexpected decision to pursue FDA approval for its previously discontinued amyloid-targeting biologic aducanumab in Alzheimer's disease was met with skepticism given the surprising nature of the turnaround. It is by no means clear the drug will skate through the FDA approval process. Even if the drug is approved, it is uncertain how patients, physicians, and payers might weigh the potential cost of the drug against what could be viewed as incremental efficacy.
Trial data from the Phase III clinical trials for remaining beta amyloid-targeting antibodies BAN2401 and gantenerumab are expected in 2022. Other Phase III products targeting additional pathways have not produced sufficient clinical evidence to suggest a high likelihood of approval.
Generic erosion in Japan will contract the overall Alzheimer's disease market. This may be slightly offset by the increased prevalence owing to an aging population and advances in screening for the earliest phases of Alzheimer's disease that may lead to improved diagnosis rates.
The likelihood of approval of a Phase III Alzheimer's disease asset is 15%, compared to 51% in the overall neurology space.