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

Diamyd Medical Evaluates Market Potential for Diamyd®

Diamyd Medical has conducted an in-depth analysis to assess the commercial opportunities surrounding its leading product, the precision immunotherapy Diamyd® (rhGAD65/alum). The findings highlight an exciting landscape for its launch indication, catering to a significant patient population that exceeds 60,000 individuals in the U.S. This market holds the promise of substantial revenue, with peak sales projections anticipated to surpass the well-known threshold of $1 billion annually.

Understanding the Addressable Patient Market

The launch market for Diamyd® encompasses two key segments of patients aged 12 and older. The specifics of these groups are crucial for understanding the potential reach and efficacy of the therapy.

Newly Diagnosed Stage 3 Type 1 Diabetes Patients

In the near future, it's projected that around 47,000 individuals will be newly diagnosed with Stage 3 Type 1 Diabetes in the U.S. Notably, approximately 19,000 of these patients (about 40 percent) will qualify for Diamyd® treatment due to their HLA DR3-DQ2 positivity.

Recently Diagnosed Patients with Retained Beta Cell Function

Another promising patient segment includes those who have recently been diagnosed with Type 1 Diabetes but still retain some beta cell function for a limited time following diagnosis. This population is estimated to be around 62,000 individuals, with approximately 25,000 being eligible due to HLA positivity. Although this segment may decrease as new patients begin to receive Diamyd®, it remains a critical part of the overall market.

Key Market Considerations and Projections

Diamyd® has the potential for an annual patient population of over 60,000 in the United States, bolstered by continual incidence rates and expected population growth. Here, we delve into essential market assumptions that affect pricing and access.

Projected Pricing Strategies

The initial gross price for a complete course of Diamyd® is estimated around $157,000, informed by comprehensive market research involving both payers and healthcare providers. Discounts resulting from rebates and payer incentives will likely be minimal, given the therapy's unique position as a disease-modifying treatment.

Market Access and Coverage

A successful rollout of Diamyd® hinges on achieving significant market access. Projections indicate over 80% accessibility, attributed to broad insurance coverage for Type 1 Diabetes and high approval rates for prior authorizations, noting the therapy's FDA orphan drug designation.

Dynamics Driving Future Growth

Several factors are fueling optimism for Diamyd®'s growth trajectory:

Addressing Latent Autoimmune Diabetes in Adults (LADA)

This condition, impacting about 7% of the annual 1.2 million adults diagnosed with Type 2 Diabetes in the U.S., represents a market potential that rivals or even exceeds that of Stage 3 Type 1 Diabetes.

Expanding to Earlier Diabetes Stages

There is also substantial potential in offering Diamyd® to patients during the earlier stages of Type 1 Diabetes, paving the way for interventions that can slow disease progression. The market size will heavily depend on the presence of efficient screening measures.

Re-treatments and Global Opportunities

Boosting patient retention through re-treatment options further enhances market appeal. Additionally, international markets could contribute an estimated 40% more to total sales potential, drawing parallels to success seen in the Type 2 Diabetes sector.

Educating Health Care Practitioners

As critical drivers of patient eligibility, it's essential to enhance the education of health care practitioners regarding genetic and clinical indicators needed for patient selection. Awareness around measures such as HLA testing and C-peptide assessments is paramount.

About Diamyd Medical

Diamyd Medical specializes in developing precision medicine therapies aimed at preventing and managing Type 1 Diabetes and LADA. The company’s flagship product, Diamyd®, not only preserves endogenous insulin production but has also garnered multiple designations from the U.S. FDA, including Orphan Drug, Breakthrough, and Fast Track statuses.

Contact Information

For further inquiries, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41

Frequently Asked Questions

What is Diamyd Medical's primary product?

Diamyd Medical's leading product is Diamyd® (rhGAD65/alum), a precision immunotherapy for Type 1 Diabetes.

What is the estimated addressable market for Diamyd®?

The estimated addressable market for Diamyd® in the U.S. exceeds 60,000 patients annually.

What pricing strategies does Diamyd Medical anticipate for Diamyd®?

Diamyd Medical estimates the gross price for Diamyd® to start around $157,000 per treatment course, subject to market dynamics.

How is market access evaluated for Diamyd®?

The expected market access for Diamyd® is over 80% based on broad insurance coverage and high approval rates.

What growth opportunities exist for Diamyd Medical?

Diamyd Medical sees growth within LADA, earlier stages of Type 1 Diabetes, and global sales potential as significant opportunities ahead.

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