Disease Landscape & Forecast
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
- Disease Landscape u0026 Forecast
- Executive Summary
- Introduction
- 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?
- Drug-Class-Specific Trends
- Thrombolytics
- Free-Radical Scavengers
- Anticoagulants
- Alternative Market Scenarios
- Market Drivers and Constraints
- Forecast
- Etiology and Pathophysiology
- Etiology
- Pathophysiology
- Key Pathways and Drug Targets
- Epidemiology Overview
- Introduction
- Key Findings
- Expert Insight
- Epidemiology Overview
- Epidemiology Populations
- Disease Definition
- Literature Review
- Population and Forecast Parameters
- Key Sources by Geography
- Population Methods
- Note About Our Epidemiology Estimates
- Introduction
- Current Treatment Overview
- Introduction
- Key Findings
- Expert Insight
- Treatment Overview
- Treatment Goals
- Key Physician Insights on Clinical End Points
- Key Current Therapies
- Overview
- Thrombolytics
- Neuroprotectants
- Mechanical Thrombectomy
- Medical Practice
- Overview
- Treatment Guidelines
- Forces Influencing Stroke Care
- Region-Specific Treatment Practices
- Introduction
- Unmet Need Overview
- Attainment of Unmet Need
- Current Attainment of Unmet Needs
- Future Attainment of Unmet Needs
- Attainment of Unmet Need
- Emerging Therapies Overview
- Introduction
- Key Findings
- Expert Insight
- Pipeline Overview
- Late-Phase Pipeline Analysis
- Notable Developments in the Late-Phase Pipeline for Ischemic Stroke
- Drug Development and Regulatory Hurdles
- Key Emerging Therapies
- Chronic Symptomatic Therapies
- Anti-Inflammatory Agents
- Thrombolytic Modulators
- Devices
- Neuroprotectants
- Early-Phase Pipeline Analysis
- Notable Developments in the Early-Phase Pipeline for Ischemic Stroke
- Introduction
- Access and Reimbursement Overview
- Region-Specific Reimbursement Practices
- United States
- EU5
- Japan
- Region-Specific Reimbursement Practices
- Methodology
- Market Forecast Methodology
- Bottom-Up Forecasting Overview
- Patient Populations
- Drug-Specific Assumptions
- Bottom-Up Forecast Assumption
- General Sources of Data
- General Statements About Pricing
- Dosing, Days of Therapy, and Compliance
- Generic Erosion
- Appendix
- Ischemic Stroke Bibliography
- Experts Interviewed
- Executive Summary
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 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 in neuroscience from Drew University.
Bethany Christmann, 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 in neuroscience from Brandeis University, where she studied the cellular interactions involved in memory consolidation and their link to sleep behavior.