THE UNMET NEED
Americans living with Alzheimer’s in 2019
Americans estimated to have Alzheimer’s by 2050
People living with Alzheimer’s worldwide in 2019
In 2019, 5.8 million Americans are living with Alzheimer’s Disease, and 35 million worldwide. This figure is estimated to reach 14 million Americans by 2050. The 2018 report from Alzheimer’s Association reported between 2000 and 2015, deaths from AD have more than doubled, rising 123% which is in starch contrast to a decline of 11% mortality from heart disease, the leading cause of death in US.
The US healthcare cost of caring for Alzheimer’s Disease, and other dementias is $206 billion in 2020. By the time we reach 2050, it is projected to cost $777 billion.
Most of these patients’ amyloid-β protein level are unknown to their attending physicians since PET-scan costs $3000 to $4000 (without imbursement from CMS) and invasive spinal tap for CSF has low patients’ acceptance. Knowledge of amyloid-β protein level is clinically actionable. JAMA (April 2019) published a CMS-sponsored clinical trial where 11,409 patients with dementia completed PET-scan for amyloid-β. Results showed attending physicians changed management of 61% (6,959) of patients with known amyloid-β information.
In addition to sales to diagnostic companies or hospitals, another opportunity is companion diagnostics for pharmas in characterizing amyloid-β level of subjects prior to enrollment for Alzheimer’s Disease-related clinical trials. Recent interaction with IQVIA, the largest CRO worldwide, confirmed that this is an extremely urgent need for pharmas.