#Sweden #Immunotherapy #Stockholm #Type 1 Diabetes #Diamyd Medical

Diamyd Medical's Insights on U.S. Market Potential for Diamyd®

Diamyd Medical, a pioneering company in the field of precision medicine, has announced an in-depth analysis of the market opportunities for its lead product, Diamyd® (rhGAD65/alum). This precision immunotherapy targets Type 1 Diabetes (T1D) and has shown considerable potential in the U.S. healthcare landscape. The company estimates that there is an addressable patient population exceeding 60,000 individuals for its primary indication, with projections indicating that annual sales could soar past the blockbuster threshold of $1 billion.

Addressable Market Overview

The market potential is categorized into two main patient groups aged twelve years and older. The first group consists of newly diagnosed Stage 3 Type 1 Diabetes patients, with approximately 47,000 expected diagnoses in 2024. Out of these, around 19,000 patients (or 40%) are identified as HLA DR3-DQ2 positive and are therefore eligible for treatment with Diamyd®.

The second opportunity lies among those recently diagnosed with Type 1 Diabetes who still retain beta cell function. This group, estimated at about 62,000 individuals in 2024, includes approximately 25,000 HLA positive patients. Even as this segment diminishes with the adoption of Diamyd® among newly diagnosed patients, it represents a substantial part of the overall addressable market.

By combining both segments, Diamyd® anticipates an annual total of over 60,000 potential patients in the U.S. as the incidence of T1D and the population grow.

Market Penetration and Pricing

Market assumptions suggest a forecasted gross price per treatment course for Diamyd® set at $157,000, although this may rise to $200,000 based on comprehensive Phase 3 trial results. It is expected that the product will enjoy more than 80% market access thanks to extensive insurance coverage for Type 1 Diabetes treatments and high rates of prior authorization approvals, highlighting Diamyd®'s unique profile as a disease-modifying therapy combined with its Orphan Drug Designation approved by the FDA.

Market penetration estimates suggest that at least 30% of Type 1 Diabetes patients could be reasonable targets for Diamyd®, reflecting a strong potential for the company's growth.

Growth Factors and Future Opportunities

Several clear growth drivers have emerged from market studies. For instance, Latent Autoimmune Diabetes in Adults (LADA) has been identified as a potentially lucrative segment, considering it affects about 7% of the 1.2 million adults diagnosed with Type 2 Diabetes in the U.S. Moreover, expanding the indications for Diamyd® to encompass Stage 1 and Stage 2 Type 1 Diabetes presents possibilities for intervention at earlier stages of the disease.

Booster courses for previous Diamyd® patients also represent another avenue for market expansion. Furthermore, considering a global perspective, opportunities outside of the U.S. could contribute an additional 40% to the total sales potential of Diamyd® based on observed market trends from Type 2 Diabetes products.

Importance of Education and Awareness

The conducted market research signals the critical need for enhanced education and engagement with healthcare practitioners (HCPs), as many are not yet familiar with the requisite genetic assessments required for identifying suitable patients. With Diamyd® being one of the first therapies approved to help preserve insulin production in Type 1 Diabetes, educating HCPs, patient advocacy groups, and insurance payers on the importance of maintaining endogenous insulin production is crucial for improving patient outcomes.

Diamyd Medical aims to harness this detailed analysis of market potential as it forges ahead with the development and potential commercialization of Diamyd®. The company's journey towards introducing this ground-breaking therapy to the market reflects its commitment to transforming the lives of T1D patients and advocating for advancements in diabetes treatment.

About Diamyd Medical

Diamyd Medical is at the forefront of developing innovative therapies for the treatment and prevention of Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). Their flagship product, Diamyd®, is a precision immunotherapy specifically designed to maintain endogenous insulin production. Diamyd has received multiple designations from the FDA, enhancing its profile in the competitive healthcare market. Being actively involved in several clinical trials across Europe and the U.S., Diamyd Medical continues to expand its clinical understanding and explore its products' market potential, hoping to significantly contribute to diabetes care on a global scale.

For more information about Diamyd Medical and their initiatives, please contact Ulf Hannelius, the President and CEO.

• - Phone: +46 736 35 42 41
• - Email: [email protected]