The Growing Market for Rare Drugs in the Healthcare Sector
- Published | 12 September 2018
Launch of a rare disease drug in a patient-centric world approved by US Food & Drug Administration
United States: The innovation in the healthcare industry is something that is not new due to emergence of several rare diseases across the globe. Amongst these rare diseases, Neurotropic Keratitis (NK) is a degenerative disease that effects the cornea resulting from the damage of the trigeminal nerve, that impairs the corneal sensation, poor corneal healing, spontaneous breakdown of corneal epithelium, growth of corneal thinning ulceration, perforation and melting. Presently, though the outbreak of this disease is low, the resultant impact of this disease is serious among the suffering patients. Hence, the launch of the rarehttps://en.wikipedia.org/wiki/Degenerative_disease disease drug will have a positive impact on the drug market and the healthcare industry will propel over a significant margin in the near future.
In Aug 2018, US Food & Drug Administration approved the first drug, Dompé farmaceutici’s Oxervate (cenegermin) that can heal cornea and it is first-ever tropical biologic medication approved in ophthalmology. Neurotropic keratitis can be hard to treat, disabling and many patients do not respond well to existing therapies. However, by directly marketing corneal healing, Oxervate has the ability to shift the way neurotropic keratitis is been cured and might eventually result in a new standard of treatment for patients with this rare condition. In the clinical trials, done for this medication, it has been observed that 70% of the patients got cured in eight weeks with the usage of this medicine, in comparison to 28% of other patients who did not receive this drug.
This medicine has also been assigned the Orphan Drug designation, which means that it has got the authority to support and encourage the emergence of drugs for rare diseases. Oxervate was authorized by the European Medicines Agency (EMA) in 2017 and represents Dompé's first approved therapy in United States, where Oxervate received Orphan Drug Designation, Fast Track Status, and Breakthrough Therapy Designation, which led to Priority Review.
There are a significant number of rare diseases affecting the overall population of America. The average drug approved under the Orphan Drug Act of 1983 (ODA), which governs rare disease approval is priced at USD 118.82 million per year. Considering the similar cost, if a single drug is been approved under the ODA for 10% of rare diseases, the total amount would exceed USD 350 billion per year which is above 10% of overall cost that America spends on health care.
According to BlueWeave Consulting, the breakout of rare diseases among people across the globe, due to numerous issues like environment-related factors, lifestyle changes that include drinking & smoking, nutritional deficiencies, consumption of adulterer food and disease carrying parasites, etc. has a significant impact on the healthcare market. In most part of the world, a rare disease requires treatment and medicines granted by the government regulations for their safety. Most of these rare diseases are genetic and hence they linger through a person's entire life, even when the symptoms do not immediately appear. Thus, the drug market for rare diseases is likely to propel the overall healthcare industry in the upcoming years.