A Comprehensive Review on the Prospects and Impediments for the Innovation of Orphan Drug Development in India, Australia and the USA

Abstract

This article highlights the comprehensive review of the prospects and impediments to the innovation of orphan drug development. Orphan medications are used to treat rare diseases. Orphan medication products have been one of the fastest-increasing sectors of drug research. Orphan diseases represent an issue for the world's health sector and a chance to concentrate on innovation. Many nations around the world continue to struggle with rare diseases. Several parties must come up with fresh and innovative solutions to assist the millions of people worldwide who suffer from uncommon diseases. To strategically develop their treatments, pharmaceutical industries concentrate on rare diseases and hinge on novel alliances. To accelerate the research and approval of new drugs, regulatory agencies like US FDA and TGA have developed a wide variety of strategies like financial aid. The process of developing an orphan medicine is the same as for common diseases but requires substantial resources and infrastructure. Several nations including the USA and Australia have implemented orphan drug legislation, which successfully advocated research and development for the creation of novel medication used in the treatment of rare disorders. The purpose of orphan drug regulations was to encourage research and development by providing incentives for the creation of drugs that have the potential to cure millions of individuals suffering from rare illnesses. Prospects related to innovation of orphan drug developments like fee waivers, reimbursements, tax credits and market exclusivity and the majority of the impediments are related to orphan drug pricing patterns, the lack of treatment and diagnosis for rare diseases, regulatory constraints, and the approval process. The individual patient is the major focus of the orphan medication market. For example, the majority of the impediments are related to orphan drug pricing patterns, the lack of treatment and diagnosis for rare diseases, regulatory constraints, and the approval process.