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Biotech and Orphan Drugs Create New Revenues for Drug Firms, Business and Industry Trends Analysis

Many biotech companies have focused on developing drugs for relatively small patient populations. For example, biotech pioneers Genentech and Biogen Idec developed Rituxan for the treatment of non-Hodgkin’s lymphoma, an important but relatively small market.

Drugs such as Rituxan are commonly referred to as “orphan drugs,” which means that they treat illnesses that no other drug on the market addresses, which are needed by relatively small patient populations. Technically, a drug designated by the FDA with orphan status provides therapeutic benefit for a disease or condition that affects less than 200,000 people in the U.S. These drugs enjoy a unique status due to the Orphan Drug Act of 1983, which gives pharmaceutical companies a seven-year monopoly on the drug without having to file for patent protection, plus a tax credit for research and development costs.

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