How to Identify New Orphan Drug Market Opportunities

1. How to Identify New Orphan Drug Market Opportunities

2. Introduction The orphan drug space is growing. Many companies are looking at rare diseases because they see both scientific value and market potential. But breaking into this space isn’t simple. You need to spot the right opportunities early — and act fast.

3. What Is an Orphan Drug? • An orphan drug treats a rare disease. In the U.S., a rare disease affects fewer than 200,000 people. In the EU, it’s fewer than 5 in 10,000. These drugs often serve patient populations that would otherwise be overlooked. Governments support this work by offering: • Market exclusivity • Tax credits • Fee waivers • Fast-track approvals

4. Steps Identify New Orphan Drug Market Opportunities • Step 1: Use an Orphan Drug Database • Step 2: Look at Rare Disease Prevalence • Step 3: Analyze Clinical Trial Activity • Step 4: Map the Clinical Drug Development Phases • Step 5: Study Regulatory Designations • Step 6: Monitor CRO Clinical Trials • Step 7: Watch for Licensing and M&A Activity • Step 8: Scan Scientific Literature • Step 9: Talk to Patient Advocacy Groups • Step 10: Build a Shortlist

5. Final Thought Identifying new orphan drug market opportunities takes more than interest in rare diseases. It takes a clear process, access to reliable data, and a solid understanding of how orphan drug development works. When you combine that with clinical trial insights, regulatory designations, and patient input, you get a full picture of what’s possible — and what’s worth pursuing.

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