Fabry’s Disease Therapeutics - Pipeline Assessment and Market Forecasts to 2018

Dec. 15, 2011 - PRLog -- GlobalData estimates that the global Fabry’s disease therapeutics market grew at a compound annual growth rate (CAGR) of 9.9% during 2005-2010 and was worth $412.8m in 2010. The market is expected to record a CAGR of 12.8% from 2010-2018, to reach a value $1,078.8m by 2018. Currently, enzyme replacement therapy (ERT) is the major available therapy for Fabry patients. The ERT class includes Fabrazyme (agalsidase beta) of Genzyme (a Sanofi company) and Replagal (agalsidase alfa) of Shire as approved products. Fabrazyme has been marketed in the European region since 2001, in the US since 2003, and in Japan since 2004. Fabrazyme has also received marketing approval in 44 countries, commercial sales in 31 countries, and in addition several post-marketing commitments are also ongoing. Replagal has been approved in the European region since 2001 and in Japan since February 2007. Replagal has yet to be approved in the US. Fabrazyme was the leading product the Fabry’s disease therapeutics market until a shortage occurred in 2009 due to viral contamination by Vesivirus 2117 at an Allston manufacturing unit. This provided Replagal with a chance to capture market share and Shire filed a Biologocal Licencing Application (BLA) for the use of Replagal in the.

GlobalData‘s analysis indicates that the growth of the Fabry’s disease therapeutics market in the historic period was due to an increase in patient awareness and patient identification worldwide, the introduction of Fabrazyme and Replagal into many markets, and the increased cost of these products. In addition, various foundations, organizations and support groups were active in educating and supporting Fabry patients. GlobalData also predicts that the Fabry’s disease therapeutics market will be a significant growing market in the forecast period due to the expected launch of Amigal (migalastat hydrochloride), a pharmacological chaperone, which has shown its efficacy in treating the misfolding of enzyme in Fabry patients. In addition, the expected recommencement of Fabrazyme production and the expected approval of Replagal for US Fabry’s Disease patients will help to drive the Fabry’s disease therapeutics market.

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According to GlobalData analysis, the current competition in the Fabry’s disease therapeutics market is weak. This weakness is mainly attributed to limited options of treatment offering only symptomatic relief. The approved products do not treat the progression of disease. Currently, Fabrazyme and Replagal are the only approved products to treat Fabry’s Disease patients. Fabrazyme is the product of Genzyme (a Sanofi company) and Replagal is product of Shire Human Genetic Therapies Inc. Fabrazyme has the major market share for Fabry therapeutics area. However, there was a shortage of Fabrazyme in 2009 due to viral contamination (calicivirus of the type Vesivirus 2117) in the Allston Landing manufacturing facility. As a result of this, Fabry patients started shifting to Repalgal therapy. Overall, these findings suggest that the current competition in the Fabry’s disease therapeutics market is weak due to the availability of limited options and the shortage of drugs for treatment.

GlobalData, the industry analysis specialist, has released its new report, “Fabry's Disease Therapeutics
- Pipeline Assessment and Market Forecasts to 2018”. The report is an essential source of information and analysis on the global Fabry's Disease Therapeutics market. The report identifies the key trends shaping and driving the global Fabry's Disease Therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Fabry's Disease Therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

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