The Addressable Alzheimer’s Market
Prior to the recent development of having approved AD therapies available, there has not been any urgent clinical need to provide widespread genetic screening to patients or to conduct the now available blood tests that correlate with the presence of plaque in the brain. When the U.S. FDA first approved Leqembi, Eisai and Biogen’s drug for AD, in a post-earnings call, GE HealthCare CEO Peter Arduini called it a “profound growth opportunity” for all providers offering PET scans and molecular imaging.
In a 2024 article published by Scientific American, the global economic burden of AD was estimated to be US$1 trillion in 2019 with a projected increase of up to US$10 trillion projected in 2050.1 The recent U.S. FDA approval of two new AD antibody therapies that require a brain specific PET scan (or alternatively a spinal tap) before AD treatments can be started, have created a billion-dollar market opportunity for the brain specific PET scan and AD treatment space.
The current number of full body PET/CT scanners in the U.S. (which need a special adapter for brain-specific imaging) is vastly insufficient to serve the massive newly opening AD treatment market. The majority of PET/CT scanners, 45% which are located in hospitals, and are primarily prioritized as cancer diagnostic and theranostic tools, and for cardiac imaging, make it challenging to schedule brain specific scans on a timely basis.
Algernon’s AD diagnostic and treatment clinics will offer a comprehensive package of medical services, including AD screening, FDA-cleared brain specific PET scan imaging (the Positrigo NeuroLF), and multiple treatment options, including the new FDA approved monoclonal antibody treatment therapies developed by Eli Lilly and Eisai/Biogen that can clear amyloid plaque from the brain. The AD PET brain scan and the new drug therapies are covered by U.S. Medicare and Medicaid.
Alzheimer’s by the Numbers
In the U.S. alone there are an estimated 7 million people living with AD along with 750,000 in Canada, numbers that are expected to double by the year 2030. With 45% of AD patients estimated to have early-stage disease, (and therefore eligible to receive treatment), the related market to provide PET scans at an approximate cost of US $5,000 (CAD$ 7,100) per scan, is expected to exceed US$18 billion.
In addition, the recent decision by the U.S. Centers for Medicare and Medicaid Services to lift their coverage limit of only one beta-amyloid PET scan per lifetime for AD patients, allows physicians to order several scans for the purpose of disease staging and as a theranostic, further dramatically increasing the size the potential PET imaging market.
With the recent advancement of a genetic test that can help predict a person’s lifetime risk of developing AD, and multiple blood tests that confirm the presence of phosphorylated tau proteins (an established biomarker for AD, correlated to amyloid plaque) and a prerequisite for a brain specific PET scan, new screening tools have now arrived to help identify patients with pre-clinical and early-stage disease. According to the University of Michigan National Poll on Ageing, less than 1% of the population has ever received the brain plaque blood test.
In a 2020 study, published in JAMA Neurology, about 30 percent of 4,486 patients, between the ages of 60 to 80 yrs. old, who were clinically normal and cognitively unimpaired at baseline after an extensive battery of neurocognitive assessments, tested positive for amyloid-beta protein after a PET scan.2 Since the approved AD drug data suggests that treatment in early stage AD patients has better outcomes, early and comprehensive genetic and blood screening along with a confirmatory PET scans could accelerate and facilitate treatment more quickly for patients, in order to help delay the onset of cognitive disability.
Some data also suggests that AD can even be prevented with much earlier treatment. In a March 2025 study led by Dr. Randall J. Bateman, the Charles F. and Joanne Knight Distinguished Professor of Neurology at WashU Medicine showed that early intervention in patients in their 30s, 40s and 50s with anti-amyloid drugs may reduce the risk in people destined to develop AD. “We’ve entered into a new era of Alzheimer’s research where we can not only modify the course of the disease, but where prevention is possible with therapeutic intervention,” said Dr. Howard Fillit, MD, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation.3
Algernon’s new healthcare initiative is focussed on delivering near term cash flow and profitability by capitalizing on the major gap between the expansive need for brain specific PET scan imaging for the diagnosis of AD, and the immediate need for comprehensive medical services specializing in the screening, diagnosis, and treatment of AD. One of the Company’s goals will be the recruitment of neurologists as collaborators and potential franchisees to help accelerate the Company’s plans for growth,
While this initiative represents a new business channel for Algernon, the Company will continue to maintain and advance its current drug development research programs, including its active work on restoring brain function following stroke and traumatic brain injury through its subsidiary Algernon Neuroscience.
2 https://jamanetwork.com/journals/jamaneurology/fullarticle/2763540
Clinical Trials and Other Brain Diseases
The shortage of PET scanners for brain specific scanning has an impact beyond patient care. With 162 AD drugs under development, there is also a significant opportunity to provide PET scan imaging services to drug development companies engaged in clinical trials, as another source of revenue for Algernon.
In addition, the Positrigo NeuroLF Brain PET Scanner is also cleared by the U.S. FDA for dementia, epilepsy, neuro-oncology, and movement disorders providing potential additional patient-based revenue for the Company.
A New Era in AD Detection, Treatment, and Prevention
Through its recent acquisition and decision to establish the world’s first AD diagnostic and treatment clinics, Algernon is uniquely positioned to address the gap between the urgent and growing demand for brain-specific diagnostics for AD and the limited PET scan imaging equipment currently available.
The recent U.S. FDA approval of Kisunla and the 2023 approval of Leqembi, both monoclonal antibody therapies which clear the amyloid plaque clusters out of the brain, and the same agency’s clearance of the new ultra compact Positrigo NeuroLF Brain PET Scanner, has ushered in a new pathway to advanced AD care - one that emphasizes early screening and early intervention for a disease that doctors have sometimes referred to as a death sentence.
Additionally, and as previously referenced, a study from JAMA Neurology showed PET scans were able to identify amyloid plaque burden in adults who had subtle cognitive deficits but were asymptomatic for Alzheimer's disease. Since early detection and treatment of AD is key to reduce the amount of brain damage a patient can suffer, there may be benefits for people who have not yet displayed any cognitive deficits and who have not yet entered into any form of patient care, to use brain specific PET scans to identify amyloid plaques in the brain and begin treatment.
These two developments together have opened billion-dollar market opportunities for AD brain specific imaging (PET Scan) and AD treatments in the U.S., (and anticipated in Canada as well), which are also expected to be repeated globally as the treatments and Positrigo NeuroLF Brain PET Scanners are approved in various international jurisdictions.
Algernon’s company-owned AD clinics and franchised clinics model will be instrumental in rapidly scaling access to these services across North America and, in the future, globally.
