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Orphan drugs require a shorter timeline for their complete development and launch into the market due to the fast-track regulatory approval process. The clinical trials involving orphan diseases require less number of patients than those involving non-orphan diseases. In addition to this, clinical trials involving orphan drugs are significantly shorter. On an average, the time taken to carry out the clinical trials and regulatory review of orphan drugs is five years, whereas non-orphan drugs take an approximate time of more than seven years for clinical trials and regulatory review. Therefore, shorter development time can be translated to a lower cost for the overall development of orphan drugs.

According to our report, "Global Orphan Drugs Market Outlook 2020", Orphan Drug Exclusivity is another factor that is aiding the growth of the market. This exclusivity is provided by The Orphan Drug Act. This act provides procedures to facilitate the development of drugs for rare diseases or conditions. These rare conditions are those that affect fewer than 200,000 persons in the US or for which there is no reasonable expectation that drug developers will recoup the considerable costs associated with developing a new drug. 

Unlike other pharmaceuticals, which possess an exclusivity of five years, orphan drugs have exclusivity for seven years in the US. Once the FDA has designated a drug as an orphan drug and approved it for marketing to the public, the orphan exclusivity prohibits approval of generic copies of the drug for the same rare disease or condition. This helps the orphan drug developing pharmaceutical companies to earn profit for seven years without the possibility of competition from generic versions of the same drug. 

This exclusivity also delays approval of another company's version of the orphan drug for seven years, even if that company submits a full new drug application containing a new set of safety and effectiveness investigations. Therefore, orphan drug exclusivity is attracting various new players to enter the orphan drug market, thereby propelling the growth of the market.

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