Diamyd Medical Updates U.s. Market Potential For Diamyd

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Diamyd Medical has released an updated analysis of the commercial potential for its lead product candidate, the precision immunotherapy Diamyd rhGAD65/alum in the U.S. market. The addressable patient population for its launch indication is estimated at over 60,000 individual patients, with annual peak sales projections well exceeding block buster potential . Diamyd has Orphan Drug Designation status in the U.S. for its launch indication, and follow-on indications represent a market potential that is expected to equal or even exceed its primary indication.

Defined as annual sales of at least 1 billion .

Addressable market at launch

The addressable market for Diamyd at launch consists of two distinct populations, both comprising patients aged 12 years and older.

Newly diagnosed Stage 3 Type 1 Diabetes patients In 2024, approximately 47,000 patients in the U.S. are expected to be newly diagnosed with Stage 3 T1D. Of these, an estimated 19,000 individuals 40 are HLA DR3-DQ2 positive and eligible for Diamyd treatment.

Recently diagnosed Type 1 Diabetes patients with retained beta cell function An additional opportunity exists among recently diagnosed Type 1 Diabetes patients who retain beta cell function for up to two years following diagnosis. This population is estimated at 62,000 individuals in 2024, of whom approximately 25,000 are HLA positive. While this group is expected to shrink as Diamyd is adopted in newly diagnosed patients, it will remain a significant contributor to the addressable market.

These combined populations will annually total over 60,000 patients in the U.S. the coming years when accounting for incidence and population growth.

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