7.2 million Americans have Alzheimer's dementia, but anti-amyloid therapy reaches only the amyloid-confirmed MCI and mild-dementia window, not the whole population.

Alzheimer's disease is the most common cause of dementia. An estimated 7.2 million Americans aged 65 and older were living with Alzheimer's dementia in 2025, a figure projected to reach nearly 13 million by 2050. A further 22% of adults 65 and older have mild cognitive impairment, the earlier clinical stage from which Alzheimer's dementia typically progresses. The disease is now staged along a continuum, from preclinical and asymptomatic through mild cognitive impairment to mild, moderate and severe dementia, and it is that staging, not the raw prevalence figure, that defines the commercially addressable population.

The two approved disease-modifying therapies are indicated only for the mild cognitive impairment and mild-dementia window, and only in patients with confirmed amyloid pathology. One pivotal trial showed a 27% slowing of cognitive decline at 18 months; another showed 35% slowing in a lower-tau population. Amyloid confirmation is therefore the true gate to therapy, historically through a PET scan or spinal fluid test, and now through the first FDA-cleared blood test, cleared in May 2025, with roughly 92% positive and 97% negative concordance against PET or spinal fluid testing. Scalable blood-based confirmation is the single biggest lever on how many eligible patients actually reach diagnosis.

A blood test, not a new drug, may be Alzheimer's biggest market lever.

Five questions this report answers:

Q1 - How large is the amyloid-confirmed, therapy-eligible US Alzheimer's population?

Q2 - Where are the biomarker-confirmation bottlenecks in the US Alzheimer's diagnostic pathway?

Q3 - How do lecanemab and donanemab differ on efficacy and safety?

Q4 - How many Alzheimer's patients are actually eligible for anti-amyloid therapy?

Q5 - What is the new blood test for Alzheimer's amyloid confirmation?

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Mike || Global Pharma Commercial Marketing Head

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