Acute ischemic stroke Market

• In 2023, the Acute ischemic stroke market size was highest in the US among the 7MM, accounting for approximately USD 801 million which is further expected to increase by 2034 at a CAGR of 11%.
• In 2023, the diagnosed incidence of Acute Ischemic Stroke was highest in the US among the 7MM, accounting for nearly 754 thousand cases which is further expected to increase by 2034.
• In the United States, in 2023, ~376 thousand males and ~378 thousand females were affected with acute ischemic stroke.
• The Acute ischemic stroke treatment market is driven by advancements in thrombectomy, increasing incidence due to lifestyle factors, and funding for stroke care. Barriers include limited treatment windows, high costs, and a lack of awareness. Acute ischemic stroke unmet needs encompass improved diagnostics, extended treatment windows, neuroprotection, and better post-stroke rehabilitation.
• The current Acute ischemic stroke treatment market comprises antiplatelets, anticoagulants, tissue plasminogen activator (tPA), edaravone, and lipid-lowering agents. However, this market faces substantial challenges, such as a narrow treatment window, delayed diagnosis, limited access to specialized care, safety concerns, high costs, and regulatory obstacles. These issues highlight the critical need for improved early detection, public education, and more effective, accessible therapies.
• Glenzocimab’s ACTISAVE trial, a Phase II/III efficacy study, recruited participants from seven European countries, Israel, the UK, and the USA. The results from the 400-patient ACTISAVE study were presented at the European Stroke Organization Conference (ESOC) in May 2024.
• The Acute ischemic stroke market size in Japan was USD 122 million in 2023, which is expected to rise by 2034.

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Key Factors Driving Acute Ischemic Stroke Market

Acute Ischemic Stroke Patient Pool and Rising Prevalence

Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality, resulting from the obstruction of blood flow to the brain, often due to thromboembolic events. In 2023, the diagnosed incidence of AIS in the 7MM was highest in the United States, with approximately 754,000 cases, including around 376,000 males and 378,000 females. Japan accounted for about 122,000 cases in the same year. The prevalence and incidence are expected to rise steadily through 2034, driven by lifestyle-related risk factors, aging populations, and improved detection methods.

Acute Ischemic Stroke Market Growth and Treatment Landscape

The AIS treatment market in the 7MM was valued at approximately USD 801 million in the US in 2023 and is projected to grow at a CAGR of 11% by 2034. Current treatment options include antiplatelets, anticoagulants, tissue plasminogen activators (tPA), edaravone, and lipid-lowering agents, alongside procedural interventions such as thrombectomy. Market growth is fueled by advancements in neurovascular interventions, increased funding for stroke care, and the need for rapid and effective reperfusion therapies. 

Acute Ischemic Stroke Marketed and Emerging Therapies

Key emerging therapies under clinical investigation include Glenzocimab (ACT017) by Acticor Biotech and LT3001 by Lumosa Therapeutics, focusing on improved safety, extended treatment windows, and better functional outcomes. In addition, the FDA-approved TNKase (tenecteplase) offers an alternative thrombolytic option for adult AIS patients. Regulatory advances, such as Perfuze’s FDA 510(k) clearance for Zipline™ Access Catheters, support the adoption of innovative neurovascular devices, enhancing procedural efficiency and patient outcomes.

Acute Ischemic Stroke Clinical Trials and Competitive Landscape

The ACTISAVE trial for Glenzocimab, a Phase II/III study with 400 patients across seven European countries, Israel, the UK, and the USA, demonstrated the global scope of ongoing clinical research. Other companies actively developing therapies include Acticor Biotech, Lumosa Therapeutics, DiaMedica Therapeutics Inc., and additional emerging players, reflecting a robust and competitive market landscape focused on addressing unmet needs in AIS management.

DelveInsight’s “Acute Ischemic Stroke Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the acute ischemic stroke, historical and forecasted epidemiology as well as the Acute Ischemic Stroke market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain), the United Kingdom, and Japan.

The Acute Ischemic Stroke market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Acute Ischemic Stroke market size from 2020 to 2034. The Acute ischemic stroke treatment market report also covers current Acute Ischemic Stroke treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the Acute ischemic stroke market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020–2034

Acute Ischemic Stroke Treatment Market

Acute Ischemic Stroke Overview

Acute Ischemic Stroke (AIS) occurs when a blood vessel supplying the brain is blocked, leading to reduced blood flow and oxygen deprivation. This blockage is typically caused by a blood clot, often forming in narrowed arteries (atherosclerosis) or traveling from the heart or elsewhere in the body. The resulting lack of oxygen and nutrients causes brain cells to die, resulting in neurological deficits such as paralysis, speech difficulties, and cognitive impairments. Immediate medical intervention, such as intravenous thrombolysis or mechanical thrombectomy, is crucial to restore blood flow and minimize brain damage. Risk factors for Acute ischemic stroke include hypertension, diabetes, smoking, and obesity.

Acute Ischemic Stroke Diagnosis

The diagnosis of acute Ischemic Stroke involves a combination of clinical evaluation and imaging techniques. Patients often present with sudden neurological symptoms such as weakness, speech difficulties, or visual disturbances. Rapid assessment using the NIH Stroke Scale (NIHSS) helps determine stroke severity. Computed Tomography (CT) scans or Magnetic Resonance Imaging (MRI) are crucial for differentiating Ischemic Stroke from hemorrhagic stroke, as well as identifying the affected brain region and the presence of ischemia. Additionally, vascular imaging techniques like CT angiography or MR angiography are used to assess blood vessel blockages, guiding appropriate treatment strategies.

Further details related to diagnosis are provided in the report...

Acute Ischemic Stroke Treatment

Treatment of acute Ischemic Stroke (AIS) focuses on rapidly restoring blood flow to the affected area of the brain. The primary treatments are thrombolytic therapy with tissue plasminogen activator (tPA), which dissolves blood clots and is most effective when administered within 4.5 hours of symptom onset. Mechanical thrombectomy, a procedure that physically removes clots using specialized devices, is another option for eligible patients, particularly when performed within 24 hours of stroke onset. Early diagnosis and prompt treatment are crucial in minimizing brain damage and improving recovery outcomes. Additional treatments may include antiplatelet agents, anticoagulants, and supportive care in a stroke unit.

Further details related to treatment are provided in the report...

Acute Ischemic Stroke Epidemiology

As the Acute ischemic stroke treatment market is derived using a patient-based model, the Acute Ischemic Stroke epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Diagnosed Incident Cases of Acute Ischemic Stroke, Gender-specific Cases of Acute Ischemic Stroke, Age-specific Cases of Acute Ischemic Stroke, and Type-specific Cases of Acute Ischemic Stroke in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In the assessment done by DelveInsight, the estimated total diagnosed incident cases of Acute Ischemic Stroke in the 7MM were nearly 1,640 thousand in 2023.
• The highest total diagnosed incident cases of Acute Ischemic Stroke were accounted by the US in 2023 (754 thousand), which are expected to show a rise in the future.
• Among the European countries, Germany had the highest diagnosed incident cases of Acute Ischemic Stroke with ~265 thousand cases in 2023. On the other hand, Spain had the lowest incident population (60 thousand cases).
• Japan had nearly 236 thousand total diagnosed incident cases of Acute Ischemic Stroke in 2023, accounting for approximately 14% in 7MM.
• The incident cases of acute ischemic stroke (AIS) in Japan in 2023 were categorized by type, including large-artery atherosclerosis, small artery occlusions, cardioembolism, and other/undetermined causes. Among these, cardioembolism had the highest incidence, with around 77 thousand cases reported.
• The cases were divided by age into four groups: 0-64 years, 65-74 years, 75-84 years, and 85+ years. In the EU4 and the UK, the highest number of cases in 2023 occurred in the 75-84 years age group, with approximately 200,000 cases reported.

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Recent Developments in Acute Ischemic Stroke Clinical Trials

• In March 2025, Perfuze, a leading medical device company dedicated to advancing stroke treatment, announced that it has received FDA 510(k) clearance for its Zipline™ Access Catheters. This regulatory milestone strengthens Perfuze’s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured €22 million in follow-on funding
• In March 2025, the U.S. Food and Drug Administration approved TNKase (tenecteplase), a thrombolytic agent, for the treatment of acute ischemic stroke in adults.
• In February 2025, Vena Medical announced that the FDA has granted Breakthrough Device designation for its MicroAngioscope, marking a "historic leap forward" in neurovascular care and stroke treatment.
• On October 30, 2024, Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has been granted Fast Track designation by the FDA for treating acute ischemic stroke (AIS). PP-007 is currently undergoing safety and efficacy evaluation in the ongoing U.S.-based clinical trial, HEMERA-1.
• On October 22, 2024, Remedy Pharmaceuticals, a leader in stroke drug development, announced that the FDA's Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation for CIRARA to treat large territory acute ischemic stroke, including large hemispheric infarctions (LHI).

Acute Ischemic Stroke Drug Chapters

The drug chapter segment of the Acute Ischemic Stroke drugs market report encloses a detailed analysis of Acute Ischemic Stroke off-label drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the Acute Ischemic Stroke clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Acute Ischemic Stroke Drugs

Glenzocimab (ACT017): Acticor Biotech

Glenzocimab (ACT017) is a humanized monoclonal antibody (mAb) fragment directed against a novel target of major interest, platelet glycoprotein VI (GPVI). It inhibits platelet binding to the thrombus without affecting physiological hemostasis, thereby limiting the bleeding risk, particularly in the brain. GPVI is expressed exclusively by platelets and their precursors, megakaryocytes. It is a key receptor on platelets for polymerized fibrin, fibrinogen, and collagen. GPVI interaction with its ligands triggers platelet activation, leading to aggregation, the recruitment of additional platelets, and promoting coagulation. GPVI blockade has demonstrated efficient antithrombotic potential in experimental thrombosis models without increasing bleeding.

Glenzocimab is in advanced clinical development for Acute Ischemic Stroke and myocardial infarction, with mixed results from ongoing trials.

LT3001: Lumosa Therapeutics

LT3001 is a novel small molecule for the treatment of acute ischemic stroke. It is a novel molecule composed of a synthetic peptide and a free radical scavenger and has demonstrated recanalization capabilities without the increased risk of hemorrhagic transformation. The peptide moiety is modified from the degradation products of fibrinogen, and it blocks the binding between platelet and fibrinogen, the two major components of thrombus. The small molecule portion is an antioxidant designed to limit oxidative stress and protect tissues from ischemia/reperfusion injury. Additionally, at the thrombosis site, it safely restores blood vessel patency by promoting the local endogenous fibrinolysis activity, enhancing plasminogen binding to the fibrin clot and facilitating the activation of plasminogen to plasmin while simultaneously protecting the tissues from free radicals and inflammation-mediated injury.

LT3001 has shown promising results in its Phase IIa trial, meeting its primary safety endpoint and demonstrating neurological improvement in Acute Ischemic Stroke patients.

Note: Detailed emerging therapies assessment will be provided in the final report of Acute ischemic stroke...

Acute Ischemic Stroke Market Outlook

Acute Ischemic Stroke (AIS) is a critical medical condition caused by a sudden blockage in a blood vessel supplying the brain, leading to a loss of blood flow and oxygen to the affected brain region. Rapid treatment is essential to minimize brain damage and improve outcomes.

The primary treatment for Acute ischemic stroke involves restoring blood flow to the brain as quickly as possible. The mainstay of pharmacological treatment is intravenous thrombolysis with tissue plasminogen activator (tPA), such as alteplase. tPA works by dissolving the blood clot blocking the artery and must be administered within 4.5 hours of stroke onset to be most effective. Beyond this time frame, the risks of bleeding complications increase significantly.

For patients with large artery occlusions, mechanical thrombectomy has emerged as a highly effective treatment option. This minimally invasive procedure involves inserting a catheter through the blood vessels to the site of the blockage, where a device like a stent retriever or aspiration catheter removes or breaks up the clot. Mechanical thrombectomy can be performed within 24 hours of symptom onset and is often used in conjunction with tPA.

Additional treatments for Acute ischemic stroke may include antiplatelet agents, anticoagulants, and supportive care to manage blood pressure, blood sugar, and other vital parameters. Post-stroke rehabilitation, involving physical, occupational, and speech therapies, is crucial for maximizing recovery and improving the quality of life for stroke survivors.

• The Acute ischemic stroke market size in the 7MM was ~USD 1,296 million in 2023, which is further anticipated to increase during the forecast period.
• The United States accounted for the highest Acute ischemic stroke market size approximately 62% of the total Acute ischemic stroke market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Among the EU countries, Germany had the highest Acute ischemic stroke market size with nearly USD 150 million  in 2023, while Spain had the lowest Acute ischemic stroke market size with USD ~34 million in 2023.
• The Acute ischemic stroke market size in Japan was estimated to be about USD 122 million in 2023.
• With the expected launch of upcoming Acute ischemic stroke therapies, such as Glenzocimab (ACT017), LT3001, and DM199, among others, the total Acute ischemic stroke market size is expected to show change in the upcoming years.

Acute Ischemic Stroke Drugs Uptake

This section focuses on the uptake rate of potential Acute ischemic stroke drugs expected to launch in the market during 2020–2034. For example, DM199 in the US is expected to be launched by 2025 with a peak share of 2.88%. DM199 is anticipated to take 7 years to peak with a medium uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Acute Ischemic Stroke Pipeline Development Activities

The Acute ischemic stroke treatment market report provides insights into different Acute Ischemic Stroke clinical trials within Phase III, Phase II, and Phase I stage. It also analyzes key Acute ischemic stroke companies involved in developing targeted therapeutics.

Acute ischemic stroke Clinical Trials Activities

The Acute ischemic stroke drugs market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging Acute Ischemic Stroke therapies. 

Acute ischemic stroke KOL Views

To keep up with current Acute ischemic stroke market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Acute Ischemic Stroke evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Medical University of South Carolina, US; Sapienza University of Rome, Italy; University of Duisburg-Essen, Germany; Hôpital Lariboisière, France; Vall d'Hebron University Hospital, Spain; University College London Hospitals, UK and Kyoto University Hospital, Japan; and others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Acute Ischemic Stroke market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Acute ischemic stroke market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging Acute ischemic stroke therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of Acute ischemic stroke therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging Acute ischemic stroke therapies are decided.

Acute ischemic stroke Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global Acute ischemic stroke drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The Acute ischemic stroke treatment market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc. 

Scope of the Acute Ischemic Stroke Market Report

• The Acute ischemic stroke treatment market report covers a segment of key events, an executive summary, descriptive overview of acute ischemic stroke, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Acute Ischemic Stroke drugs market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The Acute ischemic stroke market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Acute Ischemic Stroke treatment market.

Acute Ischemic Stroke Market Report Insights

• Acute Ischemic Stroke Patient Population
• Acute Ischemic Stroke Therapeutic Approaches
• Acute Ischemic Stroke Pipeline Analysis
• Acute Ischemic Stroke Market Size
• Acute ischemic stroke Market Trends
• Existing and Future Acute ischemic stroke Market Opportunity

Acute Ischemic Stroke Market Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Acute Ischemic Stroke Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Acute Ischemic Stroke Drugs Uptake
• Key Acute Ischemic Stroke Market Forecast Assumptions

Acute Ischemic Stroke Market Report Assessment

• Current Acute Ischemic Stroke Treatment Practices
• Acute Ischemic Stroke Unmet Needs
• Acute Ischemic Stroke Pipeline Product Profiles
• Acute Ischemic Stroke Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Acute Ischemic Stroke Market Drivers
• Acute Ischemic Stroke Market Barriers

Key Questions Answered In The Acute ischemic stroke Market Report

Acute Ischemic Stroke Market Insights

• What was the Acute Ischemic Stroke market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Acute Ischemic Stroke treatment market size as well as market size by therapies across the 7MM during the forecast period (2024–2034)?
• What are the key findings pertaining to the Acute ischemic stroke treatment market across the 7MM and which country will have the largest Acute Ischemic Stroke market size during the forecast period (2024–2034)?
• At what CAGR, the Acute Ischemic Stroke market is expected to grow at the 7MM level during the forecast period (2024–2034)?
• What would be the Acute Ischemic Stroke market outlook across the 7MM during the forecast period (2024–2034)?
• What would be the Acute Ischemic Stroke market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the Acute ischemic stroke market dynamics and subsequent analysis of the associated trends?

Acute Ischemic Stroke Epidemiology Insights

• What is the disease risk, burden, and unmet needs of acute ischemic stroke?
• What is the historical Acute Ischemic Stroke patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Acute Ischemic Stroke at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to acute ischemic stroke?
• Out of the above-mentioned countries, which country would have the highest incident population of Acute Ischemic Stroke during the forecast period (2024–2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024–2034)?

Current Acute Ischemic Stroke Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Acute Ischemic Stroke along with the approved therapy?
• What are the current treatment guidelines for the treatment of Acute Ischemic Stroke in the US, Europe, And Japan?
• What are the Acute Ischemic Stroke marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many Acute ischemic stroke companies are developing therapies for the treatment of acute ischemic stroke?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of acute ischemic stroke?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acute Ischemic Stroke therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Acute Ischemic Stroke and their status?
• What are the key designations that have been granted for the emerging therapies for acute ischemic stroke?
• What are the 7MM historical and forecasted Acute ischemic stroke market?

Reasons to Buy Acute Ischemic Stroke Market Report

• The Acute ischemic stroke market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Acute Ischemic Stroke Treatment Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing Acute ischemic stroke market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved Acute ischemic stroke products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming Acute ischemic stroke companies in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging Acute ischemic stroke therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing Acute ischemic stroke market so that the upcoming Acute ischemic stroke companies can strengthen their development and launch strategy.

Related Insights:

• Acute Ischemic Stroke Market Infographic
  
• Wider Administration Window – Need of the Moment for Acute Ischemic Stroke Patients