Cracking the EMA Code

Expanding into Europe

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:

Potential Benefits

Increased Market Size

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.

Enhanced Brand Reputation

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.

Meet our experts

Industry’s rare disorders experts creating exceptional outcomes

Taking it forward

Accelerating Your Innovation’s Journey to Market with our bespoke Accelerator Program.