Just reminding myself of one of the many reasons w

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...How Big Is LymPro Under CLIA / ROU...

A quick screen of ClinicalTrials.gov shows 335 active clinical programs with a primary indication tag of Alzheimer’s disease. Approximately 145 of these are classifies as Phase 2 in development stage. Amarantus believes the average Phase 2 AD study seeks to enroll around 100 patients. As such, there are currently an estimated 14,500 individuals current in Phase 2 clinical studies in the U.S. for Alzheimer’s disease.

Assuming the screen-to-enroll rate for these 14,500 patients was 2-to-1, approximately 29,000 individuals were screened using high-cost diagnostics such as PET for inclusion / exclusion from these clinical trials. At a price of $1,000 per patient, the initial target market for Amarantus looks to be between $25 and $30 million – assuming each individual only receives one test. If patients are screened at baseline and then again at the mid-point or end of the study, the revenue opportunity to Amarantus just for clinical trial enrollment in the U.S., looking at Phase 2 studies only, is between $50 and $100 million. Inclusion of Phase 3 studies doubles the market opportunity yet again.

Calculating the potential market opportunity for the “Research Use Only” market is a little more challenging. Sources (Visiongain, BCC Research) peg the Alzheimer’s diagnostic market at roughly $2.0 billion in size. Approximately 5.4 million American’s suffer from Alzheimer’s disease. The disease predominately affects individuals over the age of 65 years old. For example, 6.5% of adults over the age of 85 are diagnosed with Alzheimer's disease each year as compared with only .08% of those between the ages of 60 and 65 (source: BCC Research). Inclusion under Medicare / Medicaid as an annual screening test for all American’s starting at age 65 would be an enormous opportunity for Amarantus and LymPro. For example, according to U.S. Census data, approximately three million people will turn 65 in the U.S. during 2014. At $1,000 per test, that creates a potential $3.0 billion opportunity for LymPro once final commercial approval is granted. Under CLIA, the opportunity looks to be at least $100 million.

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