Industry Insights

Mapping Disease Burden and Trade Patterns to Spot Illicit Trade and Orphan-Drug Opportunities

Supply Chain Intelligence for Pharma

Orphan drugs are medicines for rare diseases with very small patient populations. Most orphan drugs have very few producers—often just one—at least for a number of years.

Why that happens:
Regulatory exclusivity: After approval, the sponsor gets market exclusivity for that indication (around 7 years in the U.S., 10 years in the EU). During that window, regulators won’t approve the same drug for the same use from another company unless it’s clinically superior.
Patents & know-how: IP plus complex manufacturing (especially for biologics, cell/gene therapies) deter fast followers.
Small markets: Tiny patient pools mean weak commercial incentives for multiple entrants—even after exclusivity expires.

Comparing disease burden data with trade intelligence reveals products moving through informal channels and unmet demand for legitimate brands, offering valuable insights for new commercial opportunities.

Identifying key rare conditions and estimating patient numbers helps define yearly treatment needs, which can be compared with import data to reveal supply gaps. For pharmaceutical companies, strengthening legitimate distribution is both risk management and a strategy for protecting patients and driving growth.

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