Acute Ischemic Stroke (Event Driven)

Decision Resources, Inc, October 2011, Pages: 216

Acute ischemic stroke (AIS) is one of the leading causes of death and neurological disability worldwide: in 2010, we estimate, 1.8 million ischemic strokes occurred in the seven major pharmaceutical markets. Fifteen years after its approval, recombinant tissue plasminogen activator (rt-PA; alteplase [Genentech’s Activase, other brands]) remains the only pharmacological therapy approved for the acute treatment of ischemic stroke in all markets under study. However, because of strict inclusion criteria and safety concerns, the drug is administered to fewer than 5% of diagnosed patients. Given the staggering societal costs of stroke and the historical propensity for investigational drugs to fail in the pipeline, there remains a dire need and enormous opportunity for alternative treatments—be they thrombolytic, neuroprotective, or neurorestorative drugs or devices—that can safely and more effectively treat a greater proportion of AIS patients.

Executive Summary
What are the key parameters of the acute ischemic stroke market?
What factors are driving the market for acute ischemic stroke therapies?
What factors are constraining the market for acute ischemic stroke therapies?
What are the drug development activities of note in acute ischemic stroke?
What do the experts say?
What key challenges and opportunities remain?

1 . Etiology and Pathophysiology
Etiology
Thrombosis
Embolism
Small Penetrating Artery Disease
Pathophysiology
The Therapeutic Time Window
The Ischemic Penumbra
Therapeutic Options
The Ischemic Cascade
Initiation
Ion Imbalance
Excitotoxicity: Depolarization, Neurotransmitter Release, and Calcium Influx
Glutamate Overstimulation
Toxic Events Following Prolonged Ca++ Influx
Activation of Proteolytic Enzymes
Loss of Membrane Phospholipids and Generation of Free-Radical Species
Production of Nitric Oxide
Blood-Brain Barrier Dysfunction
Induction of Inflammation and Reperfusion Injury
PARP Activation
Apoptosis

2 . Epidemiology and Patient Populations
Overview
Disease Definition
Methods
United States
France
Germany
Italy
Spain
United Kingdom
Japan
Acute Ischemic Stroke Trends
Subpopulations
Percentage Diagnosed
Percentage Drug-Treated
Acute Ischemic Stroke

3 . Current Therapies and Medical Practice
Treatment Providers
Cognos
Goals of Treatment
Currently Marketed Products
Thrombolytics
Neuroprotectants
Edaravone
Citicoline
Mechanical Thrombectomy
Treatment Guidelines and Factors Influencing Drug Selection
Treatment Algorithm
Time of Arrival
Diagnosis
Thrombolytics
Nonthrombolytic Drug Therapy
Mechanical Thrombectomy
Country-Specific Prescribing Practices
Country-Specific Reimbursement Issues

4 . Unmet Needs
Overview
Neurorestorative Treatment
Neuroprotectants
Safer Thrombolytics
More-Effective Thrombolysis
Thrombolytics with a Wider Treatment Window
Proof that Mechanical Thrombectomy Improves Clinical Outcomes
Improved Patient Selection in Clinical Trials
Improved Preclinical Assessment

5 . Emerging Therapies
Overview
Future Positioning of Key Competitors
Drug Development and Regulatory Hurdles
Thrombolytics
Overview
Mechanism of Action
Desmoteplase
Metal Ion Chelators
Overview
Mechanism of Action
DP-b99
Neurotrophic Factors
Overview
Mechanism of Action
AX-200
NTx-265
Acute Ischemic Stroke
Cognos
Sigma-1 Receptor Agonists
Overview
Mechanism of Action
Cutamesine Dihydrochloride
Device Interventions
Overview
Ultrasound-Equipped Devices plus Thrombolysis
Microbubbles plus Ultrasound
NeuroFlo
NeuroThera Laser System
Ischemic Stroke System
Cell-Based Therapies

6 . Market Outlook
Overview
Drug-Class-Specific Trends
Thrombolytics
Anticoagulants
Free Radical Scavengers
Membrane-Stabilizing Agents
Region-Specific Trends
Alternative Market Scenarios
Appendix A . Bibliography—Acute Ischemic Stroke
Appendix B . Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy and Compliance
Generic Erosion
Appendix C . Experts Interviewed— Acute Ischemic Stroke
Appendix D . Supplemental Epidemiology Bibliography

Tables and Figures

Acute Ischemic Stroke
Table 2-1 . Number of Total, Diagnosed, and Drug-Treated Events of Acute Ischemic Stroke in the Major Pharmaceutical Markets, 2010-2020
Table 2-2 . Detailed Times to Presentation in the United States
Table 2-3. Number of Diagnosed Events of Acute Ischemic Stroke in the Major Pharmaceutical Markets, by Time to Presentation, 2010-2020
Table 2-4 . Key Sources for Acute Ischemic Stroke Epidemiology and Model Parameters
Table 3-1 . Acute Ischemic Stroke Treatment Providers and Referral Patterns, by Market
Table 3-2 . End Points Used in Clinical Trials for Acute Ischemic Stroke
Table 3-3 . Current Classes Used for Acute Ischemic Stroke—Mechanism of Action
Table 3-4 . Current Pharmacological Therapies Used for the Treatment of Acute Ischemic Stroke
Table 3-5 . Current Endovascular Devices Used for the Treatment of Acute Ischemic Stroke
Table 3-6. Summary of Efficacy Findings from Key Clinical Trials for Acute Ischemic Stroke
Table 3-7 . Comparison of Current Therapies for Acute Ischemic Stroke
Table 3-8 . Inclusion and Exclusion Criteria for Treatment with Intravenous rt-PA in Acute Ischemic Stroke
Table 3-9 . Acute Ischemic Stroke Treatment Guidelines, by Market
Table 3-10. Factors Influencing Treatment Selection in Acute Ischemic Stroke
Table 3-11 . Factors That Prevent or Delay Acute Treatment
Table 3-12 . Acute Ischemic Stroke Care Resources and Treatment Practices, by Market
Table 3-13 . Expert Insight on Treatment Practices, by Market
Table 3-14 . Reimbursement Environment for Acute Ischemic Stroke, by Market
Table 4-1 . Expert Insight: Unmet Needs in Acute Ischemic Stroke
Table 4-2 . Summary of Key STAIR and STEPS Recommendations for the Development of Acute Stroke Treatments
Table 5-1 . Therapies in Development for Acute Ischemic Stroke
Table 5-2 . Industry-Sponsored Drug and Device Treatments in Early-Stage Development for Acute Ischemic Stroke
Table 5-3 . Therapies and Therapeutic Strategies in Development for Acute Ischemic Stroke That Lack Commercial Relevance
Table 5-4 . Expert Insight: Leading Emerging Therapies for the Treatment of Acute Ischemic Stroke
Table 5-5 . Key Research Studies on Stem Cells in Stroke
Table 5-6 . Stem Cell Transplantation Therapies in Development for Acute Ischemic Stroke
Table 6-1 . Sales of Drugs to Treat Acute Ischemic Stroke (all populations) in the Major Acute Ischemic Stroke Pharmaceutical Markets, 2010-2020
Table 6-2 . Timeline of Key Market Events in Acute Ischemic Stroke
Table 6-3 . Alternative Scenarios for the Acute Ischemic Stroke Market Through 2020
Table B-1 . Sources for Drug Prices
Figure 1-1 . Etiologies of Ischemic Stroke .
Figure 1-2 . Platelets: Mechanisms of Action .
Figure 1-3 . Mechanisms of Fibrinolysis .
Figure 1-4 . The Ischemic Cascade .
Figure 2-1 . Acute Ischemic Stroke Event Rate and Events (First-Ever and Recurrent) Across the Seven Major Markets, 2010.
Figure 2-2 . Drivers of Growth in the Number of Events of Acute Ischemic Stroke, 2010-2020 .
Figure 3-1 . Treatment Algorithm for Acute Ischemic Stroke .
Figure 3-2 . Stroke Severity and Time to Arrival in U .S . Hospitals .
Figure 3-3 . Time-to-Scan in U .S . Hospitals
Figure 3-4 . Diffusion-Weighted Imaging and Perfusion Imaging MRI: Approximating the Penumbra to Guide Treatment Decisions .
Figure 3-5 . Cascade of Eligibility for rt-PA in Select Hospital Studies .
Figure 3-6 . Door-to-Needle Time in U .S . Hospitals .
Figure 3-7 . Administration of Thrombolysis for Acute Ischemic Stroke in U .S . Hospitals .
Figure 3-8 . Thrombolysis in U .S . Hospitals: Route of Administration .
Figure 4-1 . Unmet Needs: Attainment and Remaining Opportunity in Acute Ischemic Stroke .
Figure 6-1 . Acute Ischemic Stroke Pharmacotherapies, 2010-2020: Market Share .
Figure 6-2 . Patient Share and Market Share of Leading Acute Ischemic Stroke Therapies in the Major Pharmaceutical Markets, 2020.
Figure 6-3 . Timeline of Near-Term Events in Acute Ischemic Stroke .

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