The combination of government incentives to develop drugs for rare diseases and the promise of commercial opportunity will continue to fuel the industry’s interest in orphan drugs; and provide hope to patients with debilitating conditions and high unmet medical needs. In addition, the fast track approval system allows companies to enter the market faster and more cost-effectively with the potential to extend indications.

Significant unmet clinical need
While orphan diseases are rare, patients with rare diseases are numerous. There are up to 7,000 identifiable rare diseases, affecting an estimated 622 million people around the world. There is a ... read the full abstract




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