In 2023, the United States dominated the Acute Ischemic Stroke market across the seven major markets (7MM), generating revenues of nearly USD 801 million. The U.S. market is projected to expand at a CAGR of about 11% through 2034. The country also reported the highest number of diagnosed cases, totaling around 754,000, with an almost equal split between men (~376,000) and women (~378,000). Market expansion is being supported by an increasing incidence of stroke, advancements in thrombectomy procedures, and higher investments in stroke care infrastructure. Nevertheless, the market continues to face hurdles such as narrow therapeutic windows, high treatment costs, delayed diagnosis, limited access to specialized stroke centers, and low disease awareness. Current therapeutic approaches include antiplatelet agents, anticoagulants, tissue plasminogen activator (tPA), edaravone, and lipid-lowering therapies. Despite these options, unmet needs persist in early diagnosis, neuroprotection, extended treatment windows, and post-stroke rehabilitation. Notably, Glenzocimab’s ACTISAVE Phase II/III trial, conducted across several countries, reported important outcomes at ESOC 2024. Meanwhile, Japan’s Acute Ischemic Stroke market reached USD 122 million in 2023 and is anticipated to witness steady growth by 2034.
DelveInsight has announced the publication of its latest research report titled “Acute Ischemic Stroke Market Insights, Epidemiology, and Market Forecast 2034.” The report delivers a comprehensive evaluation of the evolving AIS treatment ecosystem, including current therapies, pipeline candidates, ongoing clinical trials, and regulatory developments across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. It provides a detailed assessment of disease epidemiology, market dynamics, treatment trends, and company pipelines, making it an essential reference for stakeholders seeking data-driven insights into the AIS market. Backed by extensive coverage of FDA, EMA, and PDMA approvals, emerging drugs, and competitive intelligence, the report serves as an authoritative outlook on the future of AIS therapeutics.
To explore the detailed market outlook, drug uptake, treatment scenario, and epidemiology trends, access the full report here: Acute Ischemic Stroke Market Forecast
Acute Ischemic Stroke Market Outlook: Increasing Disease Burden Fueling Growth
The Acute Ischemic Stroke treatment market is expected to witness notable growth during the forecast period from 2020 to 2034. This expansion is driven by rising disease prevalence, improving awareness, and an influx of innovative therapies progressing into late-stage clinical trials.
The AIS market size was estimated at approximately USD 1,296 million in 2023 and is projected to grow at a strong CAGR through 2034. In the same year, the United States accounted for the largest share of the 7MM market, valued at USD 801 million, and is forecasted to maintain an 11% CAGR over the forecast period. Within Europe, Germany represented the largest market with revenues of around USD 150 million, while Spain recorded the smallest market size at nearly USD 34 million.
Japan’s Acute Ischemic Stroke market was valued at USD 122 million in 2023, contributing roughly 14% of total cases across the 7MM. The launch of novel drugs and the broadening of therapeutic options are expected to significantly improve patient outcomes and accelerate market penetration over the next decade.
Recent Regulatory Developments and Approvals in Acute Ischemic Stroke
- Several important regulatory and clinical advancements have influenced the AIS treatment landscape in recent years:
- In October 2025, Silver Creek Pharmaceuticals, a clinical-stage biotechnology company focused on growth factor-based therapies, announced encouraging Phase II trial results for its investigational candidate scp776 in Acute Ischemic Stroke. The findings were presented at the 2025 World Stroke Congress in Barcelona, Spain. Results from the ARPEGGIO study demonstrated clinically meaningful improvements in patients treated during a late intervention window, an area currently lacking approved therapies, indicating a potential breakthrough in stroke management.
- In July 2025, Revalesio disclosed that the U.S. FDA granted Fast Track designation to RNS60, its lead investigational therapy for Acute Ischemic Stroke. The designation aims to expedite the development and regulatory review of RNS60, which has the potential to protect brain tissue even after reperfusion through standard interventions.
- In March 2025, Genentech, part of the Roche Group, received FDA approval for TNKase® (tenecteplase) as a thrombolytic treatment for AIS. This approval followed the earlier success of Activase® (alteplase), reinforcing Genentech’s strong position in the stroke therapeutics space.
- In September 2024, Simcere Pharmaceuticals announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol) became the first stroke therapy to receive FDA Breakthrough Therapy designation for AIS, highlighting a significant shift in treatment innovation.
- Also in September 2024, Basking Biosciences initiated dosing of the first patient in the RAISE Phase II clinical trial evaluating BB-031 for safety, tolerability, and efficacy in Acute Ischemic Stroke.
- Collectively, these milestones underscore the accelerating pace of AIS research and development, with multiple candidates advancing through regulatory pathways including the FDA, EMA, and PDMA.
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Acute Ischemic Stroke Epidemiology Insights: Evaluating the Patient Population
- DelveInsight’s epidemiological assessment offers a detailed analysis of AIS incidence and prevalence across key markets:
- The total number of diagnosed incident cases across the 7MM reached approximately 1.64 million in 2023.
- The United States accounted for the highest number of cases at around 754,000. Germany reported nearly 265,000 cases, while Spain recorded the lowest incidence at about 60,000 cases.
- Japan documented approximately 236,000 cases, with cardioembolic stroke emerging as the most prevalent subtype, accounting for nearly 77,000 cases.
- Gender-based analysis shows a slightly higher incidence among women, although men remain at a higher overall risk for AIS.
These insights highlight the growing clinical and economic burden of Acute Ischemic Stroke and emphasize the urgent need for improved therapeutic solutions.
Discover epidemiology trends, country-wise patient data, and key pipeline insights with a complimentary sample of the Acute Ischemic Stroke Market Report. Request Free Sample – Acute Ischemic Stroke Prevalence
Acute Ischemic Stroke: Disease Overview
Acute ischemic stroke occurs when blood flow to a part of the brain is obstructed, most commonly by a thrombus or embolus, resulting in rapid neurological impairment. It represents the majority of stroke cases worldwide and is a leading contributor to mortality and long-term disability. Major risk factors include hypertension, diabetes, atrial fibrillation, smoking, obesity, and advanced age. Prompt diagnosis using CT or MRI imaging is critical, as treatment success is highly time-dependent. Standard management strategies focus on restoring cerebral blood flow through intravenous thrombolysis with tPA and mechanical thrombectomy in eligible patients. Supportive therapies include antiplatelets, anticoagulants, and neuroprotective agents such as edaravone. Despite technological and therapeutic advances, challenges remain due to limited treatment windows, delayed hospital presentation, restricted access to specialized stroke centers, and the absence of highly effective neuroprotective agents. Ongoing research efforts aim to extend therapeutic windows, enhance diagnostic accuracy, and improve post-stroke recovery and functional outcomes.
Gain exclusive access to in-depth insights, forecasts, and competitive analysis of the Acute Ischemic Stroke Treatment Market through 2034 – Acute Ischemic Stroke Market Forecast
Key Acute Ischemic Stroke Companies and Emerging Therapies
Innovation from leading pharmaceutical and biotechnology companies continues to shape the Acute Ischemic Stroke market. Prominent players and pipeline assets include:
- Acticor Biotech – Glenzocimab (ACT017)
- NoNO Inc. – Nerinetide
- Athersys / Healios K.K. – Invimestrocel (HLCM051), MultiStem
- Bristol Myers Squibb – BMS986177
- Lumosa Therapeutics – LT-3001
- AbbVie – Elezanumab
The anticipated launch of these therapies is expected to reshape treatment paradigms and address key unmet needs within the AIS landscape.
Acute Ischemic Stroke Market Drivers and Challenges
Market Drivers
- Increasing awareness of stroke symptoms and the importance of rapid intervention.
- Expansion of national and regional stroke registries supporting clinical research.
- Technological advancements in acute stroke care.
- A robust late-stage pipeline with multiple therapies approaching commercialization.
Market Challenges
- Absence of approved neuroprotective treatments to limit long-term brain damage.
- Delays in diagnosis and limited access to timely treatment, particularly in rural areas.
- High costs associated with innovative biologics and regenerative therapies.
- Despite these limitations, the rising incidence of AIS and sustained investment in research and development continue to create strong growth opportunities for market participants.
Scope of the Acute Ischemic Stroke Market Report
- Study duration: 2020–2034
- Geographic coverage: United States, EU5, and Japan (7MM)
- In-depth competitive intelligence including SWOT, PESTLE, Porter’s Five Forces, and BCG Matrix analyses
- Detailed evaluation of approved and pipeline therapies
- Comprehensive assessment of market drivers, restraints, and future growth opportunities
- Patient population analysis by prevalence, disease severity, and gender
Stay ahead with detailed updates on breakthrough therapies, FDA approvals, and ongoing AIS clinical trials shaping the future of stroke treatment – Acute Ischemic Stroke treatment market
Analyst Commentary
The Acute Ischemic Stroke treatment market is entering a period of significant evolution, supported by progress in clinical research, regulatory momentum, and the emergence of novel therapies aimed at improving survival rates and long-term functional recovery. DelveInsight’s 2034 market forecast delivers actionable intelligence on emerging trends, competitive positioning, and unmet needs that will define the next phase of AIS management.
About DelveInsight
DelveInsight is a prominent life sciences market research and business consulting firm known for its syndicated reports and tailored research solutions. With deep expertise in drug development, epidemiology, market forecasting, and competitive intelligence, DelveInsight supports healthcare organizations in making well-informed strategic decisions.
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