Sept. 22, 2011 -
PRLog -- The global market for amyotrophic lateral sclerosis (ALS) therapeutics was valued at approximately $168m in 2010. Rilutek (riluzole) is the only approved drug prescribed for the treatment of ALS.It is a disease modifying drug which helps to increase the patient survival rate by a few months. Nevertheless,its low efficacy and moderate safety as well as its high annual cost of therapy limits the use of Rilutek among the medical practitioners.However, its high cost of therapy also serves to give Rilutek a significant share of the market in terms of value. During the forecast period 2010-2018, the ALS therapeutics market is expected to witness the patent expiry of Rilutek and the approval of dexpramipexole, olesoxime and Radicut (edaravone). The launch of these new products will serve to negate the impact of the patent expiry of Rilutek and drive the growth of the market to reach approximately $234.8m by 2018 at a Compound Annual Growth Rate (CAGR) of 4.3%. The promising pipeline candidate, dexpramipexole received fast track approval from the US Food and Drug Administration (FDA) and orphan drug status by both the US FDA and the European Medicines Agency (EMEA) in 2009,Olesoxime was granted orphan drug status by the US FDA and Orphan Medicinal Product designation by the European Commission in the EU in 2005.Radicut was assigned orphan drug status in Japan in 2005.Therefore these three new drugs which are expected to enter the market by 2014 will help to drive the market growth. The challenging clinical development environment, due to a lack of understanding of the pathophysiology of ALS, poses a significant barrier for the approval of new drugs in the ALS therapeutics market. This is borne out by the fact that there have been no major drug approvals for the treatment of ALS in the last decade following the approval of Rilutek in Japan in 2001. Moreover, in 2002, the development of Xaliproden by erstwhile Sanofi-Synthelabo Inc. (currently Sanofi), had been terminated in its Phase III development stage, due to fewer survival benefits observed in the trial when compared with the expected outcome.
The current competition in the ALS therapeutics market is weak,which is largely due to the presence of
only one approved drug, Rilutek. This drug was developed by Sanofi and exhibits disease modifying characteristics.However, its low efficacy, side-effect profile and high cost of therapy makes its risk versus
benefit ratio unattractive which serves to limit the preference for Rilutek among clinicians. The current
market has a high dependence on off-label treatment options such as muscle relaxants, antidepressants,
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and opiods. It is anticipated that this trend is likely to
continue for the next three to four years after which the promising pipeline candidates are expected to
enter the market.
For Sample Pages, please click or add the below link to your browser:
http://www.globaldata.com/reportstore/RequestSamplePages....The current ALS therapeutics market is served by one approved drug, Rilutek and several off-label drugs.
The unmet need exists in terms of the absence of approved therapies offering disease modifying properties as well as improved safety and efficacy. The current assessment of the market suggests that
the unmet need is high (49%). The market needs therapies that not only target disease progression and
improve survival rates but also exhibit high safety and efficacy. Although Rilutek reduces the damage to
the motor neurons by decreasing the release of glutamate it has an unsatisfactory safety and efficacy profile.
GlobalData, the industry analysis specialist, has released its new report, “Amyotrophic Lateral Sclerosis (ALS) Therapeutics - Pipeline Assessment and Market Forecasts to 2018”. The report is an essential source of information and analysis on the global Amyotrophic Lateral Sclerosis(ALS)
therapeutics market. The report identifies the key trends shaping and driving the 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 ALS 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.
For further details, please click or add the below link to your browser:
http://www.globaldata.com/reportstore/Report.aspx?ID=Amyo...Visit our report store:
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