Ischemic stroke (IS) is one of the leading causes of death and neurological disability worldwide. In 2014, we estimate, nearly 1.5 million ischemic strokes occurred in the seven major pharmaceutical markets, and 1.1 million prevalent cases survived a stroke in the previous year. More than 15 years after its approval, recombinant tissue plasminogen activator (rt-PA; alteplase [Genentech’s Activase, Boehringer Ingelheim’s Actilyse, Kyowa Hakko Kirin’s Activacin, Mitsubishi Tanabe Pharma’s Grtpa]) remains the only pharmacological therapy approved for the acute treatment of IS in all markets under study. However, because of strict inclusion criteria and documented safety risks, we estimate the drug was administered to only 7% of diagnosed patients who experienced an IS event in 2014. Given the staggering societal costs of stroke and the historical propensity for pipeline therapeutics to fail in development, there remains a dire need and enormous opportunity for alternative treatments—be they thrombolytic, neuroprotective, or neurorestorative; drugs or devices; acute or recovery—that can safely and effectively prevent permanent neurological damage in a greater percentage of patients during an IS event and help restore lost function for the millions of post-stroke survivors who live with residual impairment.

Questions Answered:

  • Very few diagnosed IS patients are eligible for treatment with rt-PA, and only a fraction of those patients actually undergo thrombolysis. What percentage of patients arrives at the hospital in time for thrombolysis, and how will thrombolysis rates change over the forecast period?
  • Commercial opportunity for novel stroke therapeutics is significant, but pipeline attrition in stroke is extremely high. How many IS events, 12-month prevalent stroke survivors, and lifetime prevalent IS survivors are living in the major pharmaceutical markets we cover? How do interviewed stroke experts view novel mid- to late-stage agents for the acute and post-acute treatment of IS?
  • In addition to the critically important goal of elevating public awareness of stroke, interviewed experts cite continued infrastructure improvements as an important component to enhancing stroke care and maximizing patient outcomes. How has the state of stroke care evolved across the major markets under study? What impact might such efforts have on the use of thrombolysis and future stroke therapeutics?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 23 country-specific interviews with international stroke experts.

Epidemiology: Our epidemiological estimates include total, diagnosed, and drug-treated events of IS (first-ever and recurrent strokes), segmented by diagnosed events that present to a hospital within 3 hours, 3-4.5 hours, 4.5-6 hours, 6-9 hours, 9-12 hours, 12-24 hours, and later than 24 hours or for whom time of symptom onset is unknown; hourly presentation rates also presented for the first 9 hours. These estimates are based on primary data acquired from the U.S. Paul Coverdell National Acute Stroke Registry and other sources. Additional estimates of 12-month diagnosed prevalent cases of IS (i.e., stroke survivors at one year) and total lifetime prevalence of IS.

Emerging therapies: Phase II: 11 drugs; Phase III: 3 drugs; preregistration: 0 drugs; registered: 0 drugs. Coverage of 5 select preclinical and Phase I products.

Table of contents

  • Ischemic Stroke - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Introduction
        • Market Share of Ischemic Stroke Drug Classes in 2014
        • Market Share of Ischemic Stroke Drug Classes in 2024
        • Ischemic Stroke SWOT Analysis
      • Note About Our Epidemiology Estimates
      • Market Outlook
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Ischemic Stroke?
          • What Factors Are Constraining the Market for Ischemic Stroke?
          • Market Share of Ischemic Stroke Pharmacotherapy Sales by Country, 2014, 2019, 2024
          • Major-Market Patient Share of Ischemic Stroke Pharmacotherapies, 2014-2024
          • Major-Market Sales of Ischemic Stroke Pharmacotherapies, 2014-2024
          • Key Market Events for Ischemic Stroke
          • Major-Market Sales and Treated Patients in Ischemic Stroke, 2014-2024
        • Drug-Class-Specific Trends
          • Major-Market Patient Share of rt-PA in Ischemic Stroke by Country, 2014-2024
          • Sales and Patient Share of Ischemic Stroke Pharmacotherapies in Japan, 2014-2024
        • Alternative Market Scenarios
          • Alternative Scenarios for the Ischemic Stroke Market Through 2024
      • Forecast
        • Sales of Drugs to Treat Ischemic Stroke in the Major Pharmaceutical Markets, 2014-2024
      • Etiology and Pathophysiology
        • Etiology
          • Mechanisms of Occlusion in Ischemic Stroke
          • Etiologies of Ischemic Stroke
          • Platelets: Mechanisms of Action
        • Pathophysiology
          • Pathophysiology of Ischemic Stroke
          • Chronic Post-Stroke Neurological Deficits and Secondary Conditions
        • Key Pathways and Drug Targets
          • Mechanisms of Fibrinolysis
          • Current and Promising Future Drug Targets for Ischemic Stroke
      • Epidemiology Overview
        • Introduction
          • Key Findings
          • Expert Insight
          • Epidemiology Overview
        • Epidemiology Populations
          • Disease Definition
          • Studies Included in the Analysis of Ischemic Stroke
          • Studies Excluded from the Analysis of Ischemic Stroke
          • Ischemic Stroke Population and Forecast Parameters
          • Risk/Protective Factors for Ischemic Stroke
          • Key Sources for Ischemic Stroke Epidemiology and Model Parameters
          • United States
          • France
          • Germany
          • Italy
          • Spain
          • United Kingdom
          • Japan
          • Ischemic Stroke Trends
          • Number of Total Events of Ischemic Stroke in the Major Pharmaceutical Markets, 2018-2028
          • Ischemic Stroke Event Rate and Events (First-Ever and Recurrent) Across the Seven Major Markets, 2014
          • Trends in the Growth of Events of Ischemic Stroke over the Forecast Period
          • Number of Twelve-Month Diagnosed Prevalent Cases of Acute Ischemic Stroke in the Major Pharmaceutical Markets, 2018-2028
          • Time Between Stroke Onset and Presentation to a Hospital
          • Number of Diagnosed Cases of Ischemic Stroke by Time to Presentation in the Major Pharmaceutical Markets, 2018-2028
          • Time to Presentation Among Diagnosed Ischemic Stroke Events
          • Detailed Times to Presentation in the United States
          • Percentage Diagnosed
          • Percentage Drug-Treated
          • Number of Diagnosed/Drug-Treated Ischemic Stroke Events in the Major Pharmaceutical Markets, 2018-2028
          • Note About Our Epidemiology Estimates
      • Current Treatment Overview
        • Introduction
          • Key Findings
          • Expert Insight
          • Treatment Overview
        • Treatment Goals
          • Key End Points Used in Clinical Trials for Ischemic Stroke
          • Key Physician Insights on Clinical End Points
        • Key Current Therapies
          • Overview
          • Mechanism of Action of Key Current Drug Classes Used for Ischemic Stroke
          • Current Treatments Used for Ischemic Stroke
          • Market Events Impacting the Use of Key Current Therapies in Ischemic Stroke
          • Inclusion and Exclusion Criteria for Treatment with Intravenous Rt-PA in Acute Ischemic Stroke
          • Sales and Patient Share of rt-PA by Country, 2014
          • Advantages and Disadvantages of Thrombolytics
          • Expert Insight: Thrombolytics
          • Advantages and Disadvantages of Edaravone
          • Advantages and Disadvantages of Citicoline
          • Advantages and Disadvantages of Mechanical Thrombectomy
          • Expert Insight: Mechanical Thrombectomy
        • Medical Practice
          • Overview
          • Treatment Guidelines
          • Ischemic Stroke Treatment Guidelines, by Market
          • Factors Influencing Treatment Decisions in Ischemic Stroke
          • Challenges in Ischemic Stroke Care
          • Stroke Severity in U.S. Hospitals, Stratified by Time to Arrival
          • Treatment Decision Tree for Ischemic Stroke
      • Unmet Need Overview
        • Attainment of Unmet Need
          • Current Attainment of Unmet Needs
          • Top Unmet Needs in Ischemic Stroke: Current Attainment
          • Future Attainment of Unmet Needs
          • Top Unmet Needs in Ischemic Stroke—Future Attainment
      • Emerging Therapies Overview
        • Introduction
          • Key Findings
          • Expert Insight
          • Pipeline Trends for Ischemic Stroke
        • Late-Phase Pipeline Analysis
          • Notable Developments in the Late-Phase Pipeline for Ischemic Stroke
          • Therapies in Late-Phase Development for Ischemic Stroke
        • Drug Development and Regulatory Hurdles
          • Drug Development Hurdles in Ischemic Stroke
          • Summary of Key STAIR and STEPS Recommendations for the Development of Stroke Treatments
        • Key Emerging Therapies
          • Dalfampridine Profile
          • Dalfampridine Clinical Development
          • Expert Insight: Use of Dalfampridine in the Treatment of Ischemic Stroke
          • Expert Insight: Dalfampridine
          • Expectations for Launch and Sales Opportunity of Dalfampridine in Ischemic Stroke
          • Natalizumab Profile
          • Natalizumab Clinical Development
          • Expert Insight: Use of Natalizumab in the Treatment of Ischemic Stroke
          • Expert Insight: Natalizumab
          • Expectations for Launch and Sales Opportunity of Natalizumab in Ischemic Stroke
          • THR-18 Profile
          • THR-18 Clinical Development
          • Expert Insight: Use of THR-18 in the Treatment of Ischemic Stroke
          • Expert Insight: THR-18
          • Expectations for Launch and Sales Opportunity of THR-18 in Ischemic Stroke
          • Ischemic Stroke System Profile
          • Ischemic Stroke System Clinical Development
          • Expert Insight: Use of the Ischemic Stroke Treatment in the Treatment of Ischemic Stroke
          • Expert Insight: the Ischemic Stroke System
          • Expectations for Launch and Sales Opportunity of the Ischemic Stroke System in Ischemic Stroke
          • NA-1 Profile
          • NA-1 Clinical Development
          • Expert Insight: Use of NA-1 in the Treatment of Ischemic Stroke
          • Expert Insight: NA-1
          • Expectations for Launch and Sales Opportunity of NA-1 in Ischemic Stroke
        • Early-Phase Pipeline Analysis
          • Notable Developments in the Early-Phase Pipeline for Ischemic Stroke
          • Industry-Sponsored Treatments in Early-Phase Development for Ischemic Stroke
          • Academically Sponsored Treatments in Early-Phase Development for Ischemic Stroke
      • Access and Reimbursement Overview
        • Region-Specific Reimbursement Practices
          • Reimbursement Environment for Ischemic Stroke Therapies in the United States
          • Reimbursement Environment for Ischemic Stroke Therapies in Europe
          • Reimbursement Environment for Ischemic Stroke Therapies in Japan
      • Methodology
        • Appendix
          • Key Abbreviations Related to Ischemic Stroke
          • Brands, Marketers, and Generic Availability of Current Therapies Used for Ischemic Stroke, by Market
          • Ischemic Stroke Bibliography
          • Experts Interviewed

      Author(s): Tamara Blutstein, PhD; Bethany Christmann, PhD; Tamara Blutstein, PhD

      Tamara Blutstein is a Senior Business Insights Analyst on the Central Nervous System, Pain, and Ophthalmology team. She is responsible for analyzing and forecasting pharmaceutical markets, primarily in Neurology indications, with specific expertise in Alzheimer’s disease, Parkinson’s disease, and ischemic stroke.

      Prior to joining the company, Tamara was a postdoctoral fellow at Tufts University School of Medicine, where she studied the role of gliotransmission in the regulation of sleep and sleep homeostasis. She earned a Ph.D. in neuroscience from the University of Maryland School of Medicine where she conducted research on the role of gonadal hormones in modulating neuronal-glial communication. She holds a B.A. in neuroscience from Drew University.

      Bethany Christmann, Ph.D., has been with DRG since 2015, and is a Senior Business Insights Analyst with the Central Nervous System/Ophthalmology team. In this role, she covers the neurology space, specializing in Parkinson’s disease and epilepsy; she provides expert insight and authors primary market research and forecasting content focused on these and other neurology indications. Prior to joining DRG, Bethany earned her Ph.D. in neuroscience from Brandeis University, where she studied the cellular interactions involved in memory consolidation and their link to sleep behavior.

      Tamara Blutstein is a Senior Business Insights Analyst on the Central Nervous System, Pain, and Ophthalmology team. She is responsible for analyzing and forecasting pharmaceutical markets, primarily in Neurology indications, with specific expertise in Alzheimer’s disease, Parkinson’s disease, and ischemic stroke.

      Prior to joining the company, Tamara was a postdoctoral fellow at Tufts University School of Medicine, where she studied the role of gliotransmission in the regulation of sleep and sleep homeostasis. She earned a Ph.D. in neuroscience from the University of Maryland School of Medicine where she conducted research on the role of gonadal hormones in modulating neuronal-glial communication. She holds a B.A. in neuroscience from Drew University.