Eli Lilly's Donanemab Approval Boosts Alzheimer's Treatment Market

The FDA has approved Eli Lilly's donanemab, an anti-amyloid antibody, positioning it as the third drug aimed at modifying Alzheimer’s disease progression. This development sets the stage for heightened competition between Eli Lilly's donanemab and Biogen and Eisai's ADUHELM (aducanumab) and LEQEMBI (lecanemab).

Alzheimer's disease, the most prevalent form of dementia, is a progressive neurodegenerative disorder characterized by a decline in cognitive and functional abilities. This deterioration eventually leads to an inability to perform daily tasks independently. According to DelveInsight, in 2023, there were 15.4 million diagnosed prevalent cases of Alzheimer's disease across seven major markets (7MM). This number is anticipated to rise further from 2024 to 2034. In 2023, the United States accounted for the highest proportion of these cases at approximately 41%, while the United Kingdom had the lowest share at about 4%.

The increase in the US population aged 65 and older is expected to drive the number of Americans with Alzheimer’s or other dementias upwards. Although no cure currently exists, early and sustained treatment is essential for alleviating clinical symptoms. Early diagnosis allows for the application of symptomatic therapies, addressing behavioral issues, and implementing lifestyle changes that may reduce dementia risk and slow disease progression.

Current dementia treatments typically aim to adjust neurotransmitter levels in the brain. Medications such as acetylcholinesterase inhibitors (AChEIs) and N-methyl-D-aspartate (NMDA) receptor antagonist memantine have been used for symptomatic relief in the US for over a decade. However, due to potential side effects, treatment must be tailored to individual patients, considering their other health conditions and therapies.

The approval of novel anti-amyloid biologics has marked a significant shift from traditional symptomatic treatments. These biologics, targeting specific mechanisms underlying Alzheimer’s, have shown promise. In recent years, notable approvals include Biogen and Eisai’s ADUHELM in June 2021 and LEQEMBI in July 2023. ADUHELM was the first treatment approved to target amyloid β plaques, although it has faced availability challenges due to its regulatory status. LEQEMBI received full FDA approval in July 2023 after demonstrating a significant slowing in cognitive decline during a confirmatory trial.

Following the FDA's previous rejection of accelerated approval for Eli Lilly’s donanemab, the agency has now granted full approval for the anti-amyloid therapy. Marketed as KISUNLA, it is prescribed for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment and early-stage dementia. KISUNLA, administered monthly, specifically targets amyloid plaques and allows for discontinuation upon plaque removal, potentially reducing treatment costs and infusion frequency.

The Alzheimer's treatment market is highly competitive, with multiple companies conducting clinical trials in hopes of advancing the therapeutic landscape. Promising drugs in development include BioVie’s NE3107, AB Science’s masitinib, and Cassava Sciences’ simufilam, among others. These emerging therapies are expected to transform the market and offer new standards of care, driving significant growth and innovation.

DelveInsight forecasts substantial growth in the Alzheimer's disease market, with an expected increase from USD 2.6 billion in 2023 to a significantly higher figure by 2034, driven by the introduction of new therapies and rising disease prevalence. This expansion is likely to attract new entrants, fostering increased competition and innovation in the field.