Expanding a Rare Disease drug’s marketing authorization into Europe can potentially increase a company’s net worth, but it’s not a guaranteed outcome.
Here’s a breakdown of the factors involved:
Europe represents a significant market with a large population. Expanding authorization allows the company to access a wider patient base, potentially leading to increased patients, data, reputation, and revenue.
While FDA approval is a crucial step, established healthcare payor systems in Europe offer a more comprehensive approach for Rare Disease drugs. They provide a clearer path to patient access and reimbursement, leading to greater stability for pharmaceutical companies developing these life-saving treatments. This stability allows companies to further invest in research and development, ultimately benefiting patients with Rare Diseases.
Successfully navigating the European regulatory process and entering a new market can enhance the company’s reputation as a leader in Rare Disease treatment. This can attract investors and potentially increase share prices.
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