DelveInsight’s “Acute Ischemic Stroke Market Insights, Epidemiology and Market Forecast – 2036” report delivers an in-depth understanding of acute ischemic stroke, historical and forecasted epidemiology, and the acute ischemic stroke therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Acute Ischemic Stroke Market Report

• In the United States, approximately 788,000 incident cases of acute ischemic stroke were recorded in 2025, with a nearly equal distribution between males and females.

• Across the EU4 and the UK, there were approximately 667,000 incident cases of acute ischemic stroke in 2025, with Germany contributing around 40% of the regional burden, followed by the United Kingdom.

• In Japan, the disease burden was highest among older adults, with around 80,000 cases occurring in individuals aged 75–84 years, followed by approximately 60,000 cases in those aged 85 years and above.

• By etiological subtype in the United States, undetermined causes accounted for the largest share of cases (~37%), followed by cardioembolism (~27%), small artery occlusions (~23%), and large artery atherosclerosis (~13%).

• The leading Acute Ischemic Stroke companies include Pharmazz, DiaMedica Therapeutics, Basking Biosciences, NC Medical Research, and Genentech, among others.

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Acute Ischemic Stroke Epidemiology Segmentation in the 7MM

• Total Incident Cases of Acute Ischemic Stroke

• Region-specific Incident Cases of Acute Ischemic Stroke

• Age-specific Incident Cases of Acute Ischemic Stroke

• Gender-specific Incident Cases of Acute Ischemic Stroke

• Type-specific Incident Cases of Acute Ischemic Stroke

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Marketed Acute Ischemic Stroke Therapies

• ACTIVASE (alteplase): Genentech ACTIVASE is a tissue-type plasminogen activator (tPA) indicated for the treatment of acute ischemic stroke. It became the first FDA-approved thrombolytic agent for this indication when it was cleared in 1996, and it has long served as the standard of care for eligible patients.

• TNKase (tenecteplase): Genentech TNKase is a clot-dissolving, fibrin-specific plasminogen activator delivered as a single five-second intravenous bolus that triggers breakdown of fibrin, a core structural component of blood clots. In March 2025, Genentech announced FDA approval of TNKase for acute ischemic stroke in adults, marking the company’s second stroke-related approval and the first new pharmacologic option in this indication in nearly three decades.

Emerging Acute Ischemic Stroke Therapies

• Sovateltide (PMZ-1620): Pharmazz Sovateltide is an endothelin-B receptor agonist shown in earlier research to increase cerebral blood flow, exert anti-apoptotic effects, and support neurovascular remodeling when given intravenously after an acute ischemic event. Building on encouraging Phase II findings, the candidate is now being assessed in the pivotal Phase III RESPECT-ETB trial, which enrolled its first patient in July 2025. In February 2026, Pharmazz shared positive interim findings from an ongoing Phase IV study of sovateltide (branded TYCAMZZI) at the International Stroke Conference 2026 in New Orleans.

• DM199 (rinvecalinase alfa): DiaMedica Therapeutics DM199 is a recombinant form of human tissue kallikrein-1 (rhKLK1) in development for acute ischemic stroke. The molecule is being studied in the ReMEDy2 program, a planned pivotal Phase II/III trial. DiaMedica has guided toward completion of an interim analysis covering the first 200 enrolled patients, with the company confirming that analysis was finished in the first half of 2026.

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Acute Ischemic Stroke Market Outlook Pharmacologic options for acute ischemic stroke have remained limited for decades, with ACTIVASE serving as the long-standing standard of care since its 1996 approval and TNKase only reaching the market in 2025 as the first new approved agent in nearly thirty years. Both thrombolytics carry meaningful constraints, including a narrow administration window and safety considerations in higher-risk patients. Against this backdrop, a wave of investigational candidates, such as sovateltide, DM199, BB-031, and NSC-01, is targeting new mechanisms aimed at improving acute recovery and longer-term neurological outcomes through neuroprotective, vascular-repair, and regenerative strategies. As stroke remains a major global cause of death and disability, this renewed pipeline activity reflects an industry push toward safer, more accessible, and more broadly applicable treatments.

Acute Ischemic Stroke Drugs and Companies

• Sovateltide (PMZ-1620): Pharmazz

• DM199 (rinvecalinase alfa): DiaMedica Therapeutics

• BB-031: Basking Biosciences

• NSC-01: NC Medical Research

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Scope of the Acute Ischemic Stroke Market Report

• Study Period: 2022–2036

• Coverage: 7MM

• Acute Ischemic Stroke Companies: Pharmazz, DiaMedica Therapeutics, Basking Biosciences, NC Medical Research, Genentech, among others

• Acute Ischemic Stroke Therapies: ACTIVASE (alteplase), TNKase (tenecteplase), Sovateltide (PMZ-1620), DM199 (rinvecalinase alfa), BB-031, and others

• Acute Ischemic Stroke Therapeutic Assessment: current marketed and emerging therapies

• Acute Ischemic Stroke Market Dynamics: market drivers and market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Acute Ischemic Stroke Unmet Needs, KOL’s views, Analyst’s views, Market Access and Reimbursement

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Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Acute Ischemic Stroke

4. Key Events

5. Epidemiology and Market Forecast Methodology of Acute Ischemic Stroke

6. Acute Ischemic Stroke Market Overview at a Glance

7. Disease Background and Overview of Acute Ischemic Stroke

8. Treatment and Management of Acute Ischemic Stroke

9. Guidelines

10. Epidemiology and Patient Population of Acute Ischemic Stroke

11. Patient Journey

12. Marketed Drugs

13. Emerging Drugs

14. Acute Ischemic Stroke: 7MM Analysis

15. Unmet Needs of Acute Ischemic Stroke

16. SWOT Analysis of Acute Ischemic Stroke

17. KOL Views of Acute Ischemic Stroke

18. Market Access and Reimbursement of Acute Ischemic Stroke

19. Appendix

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

About Us

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