To ascertain the development of the market to the highest degree of accuracy, vital market aspects, disease indication dynamics, and competitive hierarchy are scrutinized and their interrelationship is studied as well in this report.
The report finds out that familial amyloid polyneuropathy (FAP) is prevalent in very small numbers across the globe. It is a genetic disorder wherein mutation in the transthyretin amyloid neuropathy (TTR) gene leads to the condition. Transthyretin transports retinol and thyroid hormone in the body. The condition is characterized by symptoms such as limb weakness and loss of sensation, among others, and marked by a very slow development.
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In consideration of the prevalence of FAP, according to an article published in The Lancet Neurology, whilst FAP cases have been registered across the world, Europe accounts for strong genotypic heterogeneity, which is a precursor for genetic conditions such as FAP.
The line of treatment for FAP is also not well recognized. While liver transplant has proven to be the most successful remedy for the condition, long waiting periods for the availability of donors requires alternate effective treatment of FAP.
Worldwide, several clinical agencies and pharmaceutical companies have undertaken a significant number of clinical studies for the treatment of FAP. In Europe, only one drug has received governmental approval for the treatment of FAP: Vyndaqel. The drug is still under Phase III clinical trials to seek approval of the U.S. FDA.
Other than this, some other drugs have been found to be effective for the treatment of FAP. Nonsteroidal anti-inflammatory drugs (NSAID) are prescribed by physicians as an off-label medicine and have been found to restrict the progression of neurological impairment, although the FDA has not yet approved its utilization. To strengthen drug treatment for FAP, GlaxoSmithKline recently remunerated a sum of US$1 mn to Isis Pharmaceuticals, a U.S.-based company, for advancing the Phase III study of ISIS-TTRRx for the treatment of FAP.
The aforementioned factors indicate that the FAP market is still in its developmental stage and how much it will grow in the coming years is not exactly determinable, due to the presence of several variables in the mix.
Drug approval uncertainties for FAP, subject to cultural and jurisdictional inhibitions, are a major restraint for the market’s growth. High cost of treatment, which is affordable by only a small part of the population, is also restraining growth of the FPA market.
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