The acute ischemic stroke (AIS) therapeutics market generated $531m in 2012 across the six major markets (US, France, Germany, Italy, Spain, and UK). By the end of the forecast period in 2017, the market is expected to reach $1.2 billion in sales, growing at a compound annual growth rate (CAGR) of 17.3%. The US market will continue to generate the vast majority of sales due to having the highest prevalence and incidence of ischemic stroke, and comparatively high AIS therapy prices.
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Major drivers of growth for the AIS therapeutics market are:-
- The launch of desmoteplase, a novel next-generation thrombolytic, which has an extended therapeutic time window compared with the current standard of care, Activase/Actilyse.
- The increasing prominence of telemedicine, which will enhance accessibility to vital stroke care and treatment.
- The rapidly growing and aging population, which will result in a higher incidence of AIS as age is a major risk factor for stroke.
Major barriers to growth are:-
- Stringent eligibility criteria for thrombolysis treatment, as well as a narrow therapeutic time window, which means the majority of AIS patients are currently not treated with Activase/Actilyse.
- Impending patent expiry to Activase/Actilyse during the forecast period (2015 and 2016 in the US and 5EU, respectively).
- Clinical trials attrition in the late-stage pipeline, which continues to hamper R&D efforts to bring new novel therapies to market, meaning AIS patients are still restricted to few effective treatment options.
The Development of New Therapies for AIS Remains Challenging
There are many barriers associated with AIS clinical trials that need to be overcome in order to yield greater future trial success. 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 trials; for example, the inclusion of too many severe or mild patients makes it difficult to detect any treatment effect, or the inclusion of lacunar stroke patients when there is no preclinical evidence that the drug is effective for protection of white brain matter.
Desmoteplase Will Extend the Therapeutic Time Window, Addressing the Issue Regarding Low Treatment Rates
Given the high rate of trial failures, the late-stage pipeline for the AIS market has changed dramatically over the last five years; in fact, desmoteplase is the only remaining Phase III candidate that can potentially achieve FDA approval within the forecast period. As a next-generation thrombolytic, the higher selectivity and specificity for fibrin of desmoteplase, as well as a longer half-life, allows the potential for a superior efficacy and safety profile to Activase. GlobalData expects desmoteplase to launch in 2015 and 2016 in the US and 5EU, respectively. As desmoteplase will be fulfilling a key unmet need, this novel compound is likely to be priced at a premium to Activase.
Limited Availability of Treatment Options Remains the Greatest Unmet Need
Despite important advances in our knowledge of stroke pathophysiology, the high attrition rate in late-stage clinical trials has resulted in Activase/Actilyse being the only pharmacological therapy approved for AIS (in 1996). However, the narrow therapeutic time window and stringent eligibility criteria mean the vast majority of AIS patients do not have access to this vital therapy. This translates to reduced clinical outcomes for many patients, and marked escalation of healthcare costs due to increased hospitalizations.
Several Opportunities to Remain Unmet during the Five-Year Forecast Period
Given the significant unmet needs in this market, several opportunities remain for novel therapies:
- Thrombolytics that can be administered beyond nine hours. Although desmoteplase will have a potential extended therapeutic time window of nine hours, enabling a greater proportion of patients to be eligible for thrombolysis, there is ample opportunity for an effective and safe therapy that can be given after nine hours post-stroke onset.
- Effective neuroprotective therapies. AIS patients are still awaiting approval of the first effective neuroprotective therapies, and given the lack of Phase III neuroprotective agents, GlobalData does not expect any neuroprotective agents to launch within the five-year forecast period. With the absence of such a product in the AIS treatment paradigm, an approved first-in-class neuroprotective agent is likely to gain rapid patient uptake.
- Novel neurorestorative therapies. Although much progress has been made in the clinical management of stroke, for example in the form of next-generation thrombolytic agents such as desmoteplase, there are still limited treatment options to restore lost function once neuronal death has already occurred.
Spanning over 162 pages, 45 Tables and 21 Figures, “OpportunityAnalyzer: Acute Ischemic Stroke – Opportunity Analysis and Forecasts to 2017” report covering Introduction, Disease Overview, Epidemiology, Current Treatment Options, Unmet Needs Assessment and Opportunity Analysis, R&D Strategies, Pipeline Assessment, Pipeline Valuation Analysis, Appendix.
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