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 trade intelligence can identify products that move through informal or unregulated channels, but also an unmet supply by legitimate pharmaceutical brand owners. Understanding the unmet supply, the countries, volumes is valuable business intelligence that can trigger commercial opportunities.

Identifying the main semi-rare conditions in the region and estimating the number of patients affected is the first step. Those figures are translated into the yearly requirement for doses and treatment units, then compared against import records for relevant active ingredients and brands.

For a pharmaceutical company, reinforcing legitimate distribution in such cases is not just risk management, it can be a sound strategy for protecting patients and securing market growth.

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