Over 55 million people worldwide were suffering of dementia in 2020. This number is expected to almost double every 20 years, reaching 78 million in 2030 and rising to 139 million in 2050 according to the Alzheimer’s Association. The worldwide cost of dementia is estimated at US$1.3 trillion and is expected to rise to US$ 2.8 trillion by 2030.
Alzheimer’s disease (AD) remains an area of severe unmet need and decades of research, but significant progress was recently made with innovative treatments. Following the FDA approval aducanumab (Leqembi™) from Eisai and donanenab-azbt (Kisunla™) from Eli Lilly aiming at addressing underlying disease biology are now marketed. Similarly, impactful progress was achieved in the discovery and validation of laboratory tests to support disease diagnostics and monitor disease progression, highlighted by a major advance in 2025 with the regulatory approval of blood-based assays: Fujirebio Lumipulse® pTau217/Aβ42 (FDA) and Roche Elecsys® pTau181 (FDA and CE-Marked IVDR).
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Authors:
PATRICE HUGO, Ph. D., Chief Scientific Advisor, IQVIA Laboratories and R&DS Design and Delivery Innovation
MAREK BIENIEK, MD, MS, Sr. Director Medical Strategy, CNS Center of Excellence, R&DS Design and Delivery Innovation
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