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