The approval of the first disease-modifying Alzheimer's treatments has triggered an unprecedented investment boom in the neurodegenerative disease space, with total M&A deal value surging 780% from $2 billion in 2022 to $18 billion in 2024, according to a new GlobalData analysis.
The dramatic increase follows the January 2023 approval of Biogen and Eisai's Leqembi (lecanemab), followed by Eli Lilly's Kisunla (donanemab) in July 2024. These monoclonal antibodies represent the first treatments to actually modify Alzheimer's disease progression, moving beyond symptom management offered by the previously available Aricept.
Safety Profile Emerges as Key Differentiator
Clinical trial data reveals significant safety differences between the two approved therapies, particularly regarding Amyloid-Related Imaging Abnormalities (ARIA). Leqembi demonstrated a 12.6% incidence of ARIA-E (edema) and 17.3% ARIA-H (hemorrhage) in Phase 3 trials, with most cases characterized as mild-to-moderate and self-resolving.
In contrast, Kisunla showed substantially higher rates with 24% ARIA-E and 31.4% ARIA-H incidence—nearly double Leqembi's rates. This safety differential has important implications for market adoption, as higher ARIA risk poses barriers including increased monitoring costs and potential insurer pushback on coverage.
Diagnostic Innovation Supports Market Access
The FDA's recent clearance of the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test has created a significant advantage for Leqembi. This blood-based diagnostic, developed by Fujirebio, costs approximately $200-$300 compared to PET scans at $3,000-$5,000, with Medicare reimbursement already established.
The test demonstrates 91.7% sensitivity and 97.3% specificity, streamlining patient selection for Leqembi treatment while eliminating geographic and logistical barriers associated with invasive lumbar punctures or costly imaging. Analysts project the Lumipulse test could diagnose over 500,000 U.S. patients annually, directly supporting Leqembi's patient pipeline.
Market Performance and Projections
Despite the therapeutic breakthrough, both drugs have faced modest initial sales. Leqembi reported $22.8 million in sales in May, showing an upward trend, while Kisunla collected $11 million in the same period. Both Eisai/Biogen and Lilly have had to lower future sales expectations significantly.
RBC Capital Markets analysts project Leqembi will capture approximately 60% of the U.S. market share by 2030, compared to Kisunla's projected 25%, citing Leqembi's safety advantages and diagnostic synergies as key drivers.
Investment Landscape Transformation
"Large pharmaceutical companies, such as AbbVie and Sanofi, are placing their bets on Alzheimer's disease through high value acquisitions," noted Alison Labya, business fundamentals pharma analyst at GlobalData.
Major deals driving the investment surge include AbbVie's $1.4 billion acquisition of Aliada Therapeutics in December 2024, bringing the Phase I anti-pyroglutamate amyloid beta therapy ALIA-1758 with novel blood-brain barrier crossing technology. Johnson & Johnson's $14.6 billion buyout of Intra-Cellular Therapies, while primarily focused on the schizophrenia drug Caplyta, also included the Phase II oral small molecule ITI-1284 for Alzheimer's-associated agitation and psychosis.
Sanofi contributed with its $470 million acquisition of Vigil Neuroscience in May, reinvigorating the TREM2 pipeline after previous clinical setbacks. Additionally, GSK signed a licensing deal with Muna Therapeutics, paying $25 million upfront with up to $147.6 million per target to access the MiND-MAP platform for new Alzheimer's drug discovery.
Future Treatment Paradigm
Investment priorities have shifted toward improving efficacy and safety while exploring targets beyond amyloid-beta. "The future Alzheimer's disease treatment paradigm is anticipated to be combinatorial, where novel drugs targeting alternative disease mechanisms, other than amyloid-beta plaques, must demonstrate additive efficacy alongside Leqembi and Kisunla, as well as improved safety, to achieve market success," Labya explained.
The renewed pharmaceutical interest reflects confidence that the approval stalemate has been broken, opening pathways for innovative approaches that could eventually complement the current monoclonal antibody treatments in combination therapy regimens.
