Eli Lilly and Biogen & Eisai are hoping to retain their dominance in the Alzheimer’s market after their respective therapies, Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) have continued to show benefit years into dosing.
Data presented at the 2025 Alzheimer’s Association International Conference (AAIC) have found that Lilly’s amyloid plaque-targeting monoclonal antibody (mAb) reduces a patient’s risk of disease progression by 27% when administered early.
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This was measured by the clinical dementia rating global score (CDR-G) in the Phase III TRAILBLAZER ALZ 2 long-term extension study (NCT04437511).
Kisunla’s impact on cognitive decline also grew with time, with patients experiencing a cognitive decline of 1.2 points after three years compared with a 0.6 point decrease at 18 months, as measured by the average clinical dementia rating sum of boxes (CDR-SB) score.
In the 18-month timeframe, more than 75% of patients treated with Kisunla reached amyloid clearance.
Meanwhile, long-term results from the Phase III Clarity AD trial (NCT03887455) reveal that Biogen and Eisai’s anti-amyloid beta (Aβ) protofibril antibody, Leqembi, reduced CDR-SB by up to 1.75 points over four years compared to patients in the Alzheimer’s disease neuroimaging initiative (ADNI) cohort (NCT00106899). This was a marked improvement on the three-year CDR-SB score of 1.01 points.
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By GlobalDataThis effect was only amplified when compared to the BioFINDER (NCT01208675) cohort, with early administration of Leqembi showing a difference in CDR-SB reduction of 2.17 points at the four-year treatment point.
Long-term administration of Leqembi also diminished cognitive symptoms in 56% of patients with low levels of tau accumulation in the brain — a key early indicator of early onset Alzheimer’s.
Alzheimer’s market to explode
Though the Alzheimer’s disease market stood at $2.4bn in 2023, Clinical Trials Arena‘s parent company GlobalData predicts that the sector will soar to a value of $19.3bn across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan and China) by 2033.
GlobalData predicts this will primarily be driven predominantly through the US market, with forecasts suggesting that the nation will spend $12.6bn on Alzheimer’s drugs in 2033.
The European market has been more challenging for Lilly and Biogen. It was only in July 2025 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Kisunla, but this was in a limited patient population.
Both Lilly and Biogen and Eisai’s drugs have also faced difficulties in the UK, having both been rejected for use by the National Institute for Health and Care Excellence (NICE), meaning they are unavailable for access through the National Health Service (NHS) in England. Both companies told Pharmaceutical Technology, a sister title to Clinical Trials Arena, that they would be appealing the decision.
The market’s dramatic upward trend will primarily be driven by recent approvals of disease-modifying therapies (DMTs) such as Kisunla and Leqembi, which offer a new lease of life to a previously stagnant market relying on symptom-targeting therapies.
GlobalData neurology analyst Philippa Salter said: “The launch of novel DMTs will revolutionise the field of Alzheimer’s disease therapeutics, and their high annual costs of therapy, compared with current symptomatic drugs for Alzheimer’s disease, will significantly drive market growth.
“As more DMTs reach the market — particularly oral drugs that can be easily accessed and added into current therapeutic regimens — treatment rates will likely increase as more options for patients become available.”
Salter also notes that the validation and integration of cheaper, easy-to-use diagnostics for Alzheimer’s disease into clinical practice will make it easier for patients to be diagnosed and treated earlier.
She concludes: “By validating predictive biomarkers, physicians could diagnose Alzheimer’s disease at a pre-symptomatic stage, presenting the potential for preventive therapies.”
