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Orphan drugs are pharmaceutical agents developed specifically to treat rare diseases, often referred to as orphan or rare diseases, which affect a small percentage of the population. These conditions are typically life-threatening or chronically debilitating, such as Huntington’s disease, cystic fibrosis, or certain types of cancer. Because the potential market for such drugs is limited, pharmaceutical companies may be hesitant to invest in their development without special incentives. To address this, governments—most notably through legislation like the U.S. Orphan Drug Act of 1983 and the European Union’s Orphan Medicinal Products Regulation—offer benefits such as tax credits, market exclusivity, and reduced regulatory fees to encourage the development of these treatments.
The importance of orphan drugs has grown significantly in recent years, as advances in biotechnology and genetic research have enabled more targeted and effective treatments for rare conditions. Despite the challenges of limited patient populations and high research costs, orphan drugs represent a vital area of innovation in modern medicine. They not only offer hope to patients with few or no treatment options but also often pave the way for breakthroughs in more common diseases. However, due to their limited market, orphan drugs are frequently expensive, raising concerns about accessibility and healthcare affordability.
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