Article
Alzheimer's Disease - A Burgeoning Market on the Horizon
IQVIA Pipeline Link/Trial Link
Aug 15, 2024
Alzheimer's disease is an irreversible progressive neurodegenerative disease characterized by the misfolding of the amyloid beta protein, which accumulates to form toxic amyloid plaques and protein tau in the brain that impairs cognitive function and leads to premature death.

Alzheimer's manifests mainly in individuals aged 65 years and older and is the most common form of dementia. The disease progresses in three stages: the preclinical stage without symptoms; the prodromal stage with mild cognitive impairment and the dementia stage with functional impairment.1 The World Health Organization has estimated that Alzheimer's and other dementias affect more than 55 million people worldwide and impose a global annual economic burden of USD 1.3 trillion in associated healthcare costs.

Treatment options for Alzheimer's disease

There are currently no drugs that cure, prevent or reverse the course of Alzheimer's disease and available treatments provide symptomatic relief of symptoms such as memory loss for a limited time. The two main classes of therapeutics include cholinesterase inhibitors, which prevent the breakdown of the neurotransmitter acetylcholine, and N-methylD-aspartate receptor antagonists that regulate the activity of glutamate excitotoxiity.

Biogen won the race to get the first of a new category of medication to market for Alzheimer's disease with the accelerated approval of aducanumab (ADUHELM), a humanized monoclonal antibody that targets amyloid beta, in the USA in June 2021. However, many healthcare providers and insurers have refused to cover aducanumab due to a lack of clear clinical benefit. In January 2024, Biogen announced it will discontinue the development and commercialization of aducanumab to reprioritize resources to advance new treatment modalities in this therapeutic area. Patients who are receiving aducanumab as part of a clinical trial and by prescription will have access to the drug until May 2024 and Nov 2024, respectively.

The accelerated approval of Eisai and Biogen's lecanemab (LEQEMBI) in the USA in January 2023 (later converted to a full approval in July 2023) marked the second anti-amyloid beta therapy approved for the disease. Lecanemab, a monoclonal antibody that targets the N3pG amyloid beta peptide which plays an important role in the formation of amyloid plaques in the brain, is indicated for treating early-stage Alzheimer's.

Despite the withdrawal from the market of aducanumab, the Alzheimer's disease market is entering a phase of growth with the US FDA approval in July 2024 of Lilly's donanemab (KISUNLA), an anti-N3pG amyloid beta peptide monoclonal antibody, for the treatment of adults with early symptomatic Alzheimer's disease. Donanemab provides a second treatment option for patients in the early stages of Alzheimer's disease and is expected to challenge lecanemab in a market square-off. Donanemab and may hold several advantages: it is administered as an intravenous infusion once monthly compared with lecanemab which is dosed biweekly offering a convenience edge but more significant is that donanemab can be stopped once patients amyloid levels have been successfully reduced, enabling fewer infusions and lower treatment costs.

Download the full article to learn more about the treatment options for Alzheimer's disease, R&D challenges of Alzheimer's therapeutic innovation, Next-generation therapies for Alzheimer's disease, future directions and more.  

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