To date, the global drug market is valued at approximately $150 billion, and by 2024, orphan drugs are expected to have a market size of $242 billion and capture about 20% of all worldwide prescription drug sales.

There are many advantages that come with U.S. orphan drug status including tax credits, a provision for 7-year exclusive marketing rights post approval and assistance from the FDA with clinical research study design. But there’s a caveat to the accelerated pace of orphan drug development – limited time means that there is a pressure to get it right the first time.

In this report, we highlight the trends shaping the orphan drug market with a focus on expedited drug development. The report explores:

• Rare disease statistics
• Orphan designation, key incentives and accelerated development pathways
• Challenges related to the development and manufacturing of orphan drugs
• How drug sponsors are working with CDMOs to achieve their goals

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