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20 Dec 2013

Acute Ischemic Stroke: Global Market Value to Grow Significantly by 2017, but Clinical Trial Challenges Remain

The acute ischemic stroke (AIS) therapeutics market in the six major countries — the US, France, Germany, Italy, Spain and UK — is forecast to jump from $531 million in 2012 to $1.2 billion by 2017, at a Compound Annual Growth Rate (CAGR) of 17.3%, says a new report from research and consulting firm GlobalData.


According to the company’s latest report*, the US market will continue to generate the majority of sales, more than doubling its revenue from $376.4 million in 2012 to $945.4 million by 2017, at a CAGR of 20.2%. This is due to the US having the highest prevalence and incidence of AIS and comparatively high AIS therapy prices.


Paul Sue, Analyst for GlobalData, says: “A major driver of the AIS market is the launch of desmoteplase, a novel next-generation thrombolytic, which has an extended therapeutic time window when compared with the current standard of care, Activase/Actilyse. In addition, the increasing prominence of telemedicine, whereby patients get medical information over the phone or on the internet, will enhance accessibility to vital stroke care and treatment.”


However, there are many barriers associated with AIS clinical trials that need to be overcome for new therapies to be developed successfully.


Sue says: “A fundamental challenge with both reperfusion and neuroprotective trials design is stroke heterogeneity. Most late-stage clinical trials conducted in the US and Europe to date, including all Phase III trials of neuroprotective agents for AIS, have been negative due to unrealistic study endpoints. In fact, there is currently limited agreement on what constitutes a minimally important treatment effect in AIS trials.


“Other common issues in such trials, which will require more robust consideration for future studies, include testing drugs too long after stroke onset, and poor patient selection for these trials,” the analyst concludes.


*OpportunityAnalyzer: Acute Ischemic Stroke — Opportunity Analysis and Forecasts to 2017

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