Acute ischemic stroke (AIS) - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• Acute ischemic stroke (AIS) incidence has been on the rise in young adults. However, the rates of ischemic stroke have declined in older adults.
• The American Heart Association/American Stroke Association added a new recommendation section, with the recommendations now grouped based on the etiological subtype.
• In 2022, there were over 1.5 million diagnosed incident cases of acute ischemic stroke in the 7MM. It is expected to reach around 2 million cases by 2032, owing to the rising prevalence of stroke risk factors.
• The total market size of acute ischemic stroke was nearly USD 1,300 million in the 7MM in 2022. The market is expected to grow at a CAGR of 10.67% to hit the USD 4,700 million mark by 2032, aided by the anticipated launch of several promising therapies in the forecast period.
• The US FDA approved BRILINTA, an oral, reversible, direct-acting P2Y12 receptor antagonist that inhibits platelet, in 2020 to reduce the risk of stroke in patients with an acute ischemic stroke or high-risk TIA.
• Genentech Patient Foundation offers a patient assistance program (PAP) for ACTIVASE (alteplase) injection, providing free medicine to patients not covered by insurance.
• Glenzocimab, a humanized monoclonal antibody (mAb) fragment that shows antithrombotic action, is being studied as an add-on therapy to thrombolysis. Its administration window is limited to 4.5 h. However, with the potential to overcome complications, glenzocimab can attain a reasonable market share. The mAb is expected to launch in 2025.
• The acute ischemic stroke (AIS) market will experience significant changes during the study period (2019-2032) owing to the expected launch of major late-stage products like glenzocimab, DM199, LT300, nerinetide, BMS-986177/milvexian, and invimestrocel.

This ‘Acute Ischemic Stroke (AIS) - Market Insights, Epidemiology, and Market Forecast - 2032' report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of acute ischemic stroke in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The report also provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted acute ischemic stroke market size from 2019 to 2032, segmented by the 7MM. Additionally, it covers the current acute ischemic stroke (AIS) treatment practice/algorithm, unmet medical needs, SWOT analysis, market outlook, and market access to curate the best of the opportunities and assess the underlying potential of the market.

Geographies Covered

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

Study Period: 2019-2032

Acute Ischemic Stroke (AIS): Disease Understanding and Treatment Algorithm

Acute Ischemic Stroke (AIS) Overview

Acute ischemic stroke (AIS) occurs due to a blockage in the artery resulting in reduced blood flow to the brain that damages and interrupts brain functions. Every year around 5.5 million people die from stroke, making it the world's second leading cause of death. Moreover, a high burden of morbidity is also seen in stroke patients leaving nearly 50% of stroke survivors disabled. Of total stroke cases, approximately 70-85% of cases are attributed to ischemic stroke.

Common signs and symptoms in patients with acute stroke include hemiparesis, sensory deficits, diplopia, dysarthria, and facial droop. Additionally, the symptoms commonly attributed to increased intracranial pressure, such as nausea, vomiting, headache, and blurred or double vision, may also provide evidence supporting a stroke. Based on the etiology, AIS is divided into four subtypes: cardioembolic, atherosclerosis (large artery disease), lacunar (small vessel disease), and other causes.

Acute Ischemic Stroke (AIS) Diagnosis

For the diagnosis of acute ischemic stroke (AIS), detection is emphasized by the term “time is brain” as the delay in diagnosis can impact the treatment choice. The diagnosis is based on clinical features and data collected by tests such as brain imaging (computed tomography/MRI), cardiac imaging (echocardiography, among others), duplex imaging of extracranial arteries, arteriography, and laboratory assessments for a prothrombotic state. Additionally, the National Institutes of Health Stroke Scale (NIHSS) is widely used to assess the neurological severity of acute ischemic stroke. However, early stroke detection is still critical in rural areas and small clinics due to the unavailability of costly diagnostic tools. Also, the delay in diagnosis can worsen stroke and hamper treatment.

Further, atypical presenting symptoms associated with brain stem and cerebellar-posterior circulation can cause over, under, and misdiagnosis of stroke. Additionally, misdiagnosis can be a risk in young patients with ischemic stroke, leading to delayed recognition, preventing thrombolytic therapy, and increasing morbidity and mortality. Hence, misdiagnosis limits the opportunities for a better treatment outcome.

Nevertheless, the advances in diagnostic tools and equipment, continuous efforts in discovering blood-based biomarkers, and improving diagnosis would drive the growth of the acute ischemic stroke market. Heart and stroke screenings in developed countries will also contribute to market growth.

Further details related to country-based variations are provided in the report.

Acute Ischemic Stroke (AIS) Treatment

Time plays an important role in treating indications like acute ischemic strokes, where it is a medical emergency and treatment options have a restricted administration window. Hence, reaching the hospital within the time window is paramount to receiving treatment. The treatment landscape focuses on breaking down the clot via thrombolysis or mechanical removal to facilitate re-vascularization and prevent secondary stroke. Additionally, it requires a multidisciplinary approach that demands correct diagnosis for selecting appropriate drugs for treatment, symptomatic management, secondary prevention, and rehabilitation. Intravenous tissue-type plasminogen activator (IV tPA) is the only approved treatment for patients with acute ischemic stroke (AIS) and has a restricted time window of 3-4.5 h. Besides, it is associated with complications and contraindications, making around 70-80% of patients ineligible for the therapy.

Tenecteplase is another thrombolytic agent with high fibrinogen specificity often used as off-label practice in acute ischemic stroke. Clinical trials have demonstrated higher reperfusion and a better outcome for tenecteplase than alteplase (tPA). A few other drugs have been approved for the prevention and risk reduction of stroke. In Japan, edaravone (RADICUT), a free radical scavenger, is widely used for AIS treatment as it has shown a greater improvement in neurological symptoms in any subtype, although the difference is small and of limited clinical significance. It was approved in Japan in May 2001. Additionally, in November 2020, the US FDA approved BRILINTA (ticagrelor) to reduce the risk of stroke in patients with AIS or high-risk TIA.

Other approved drugs recommended in secondary management of ischemic stroke prevention are one of the four DOACs, apixaban, dabigatran, edoxaban, and rivaroxaban. Additionally, studies have suggested that administering antithrombotic agents, including aspirin, glycoprotein IIb/IIIa inhibitors, or thrombin inhibitors, during or immediately after alteplase infusion might reduce the risks of re-occlusion and therefore improve functional outcomes. Additionally, with the emergence of endovascular therapy, the treatment landscape was dramatically changed as the window expanded to up to 16 and 24 h for eligible patients; however, it is limited to large vessel occlusion patients.

However, even after two decades of alteplase, no drug that addresses tPA-ineligible patients has been approved, leaving around 80% of acute ischemic patients with no treatment.

Acute Ischemic Stroke (AIS) Epidemiology

As the market is derived using a patient-based model, the acute ischemic stroke (AIS) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed incident cases of acute ischemic stroke, gender-specific cases of acute ischemic stroke, age-specific cases of acute ischemic stroke, type-specific cases of acute ischemic stroke in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032.

• Among the 7MM, the US accounted for the highest number of cases of acute ischemic stroke, with more than 700,000 cases in 2022, owing to the long-term psychological, physical, and social consequences among the population.
• Among the EU4 and the UK, Germany accounted for the highest number of acute ischemic stroke cases (around 250,000). On the contrary, Spain accounted for the least cases in 2022.
• Assessments showed that the US had a nearly equal number of male and female acute ischemic stroke cases in 2022. On the other hand, in Japan, more males were affected by acute ischemic stroke (nearly 100,000 cases) than females (around 90,000 cases) in 2022.
• In Japan, there were around 60,000 cases of large artery, 58,000 cases of small artery occlusions, 77,000 cases of cardioembolism, and 35,000 cases of other/undetermined types in 2022.

Acute Ischemic Stroke Drug Chapters

The drug chapter segment of the acute ischemic stroke report encloses a detailed analysis of acute ischemic stroke marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps 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.

Marketed Drugs

The paucity of licensed drugs affects the treatment landscape of acute ischemic stroke. To date, only alteplase has been approved in the 7MM with limited usage. However, edaravone is approved to administer within 24 h of stroke onset in Japan. Additionally, in 2020, the US FDA approved BRILINTA for the secondary prevention and management of stroke with a priority review. Other drugs approved for secondary prevention include apixaban, dabigatran, edoxaban, and rivaroxaban.

Acute Ischemic Stroke Emerging Drugs

Drug developers are gradually shifting their attention toward acute ischemic stroke (AIS) to meet the patient pool's current demands and counter the unmet needs of the therapeutic market.

Several companies are working actively on new therapies expected to bring significant change in the acute ischemic stroke market. Some of the treatments that are in the late stage of development include glenzocimab (Acticor Biotech), DM199 (DiaMedica Therapeutics), LT3001 (Lumosa Therapeutics), nerinetide (NoNO Inc.), BMS-986177/milvexian (Bristol Myers Squibb Company/Janssen Pharmaceuticals), and invimestrocel (Healios/Athersys).

Glenzocimab, developed by Acticor Biotech, is a humanized monoclonal antibody directed against the human platelet glycoprotein GPVI. The drug is an add-on to the standard of care of AIS and is to be administrated within 6 h IV to cover the duration of the acute phase. The Phase II/III results demonstrated a favorable safety profile, reduced patient hemorrhage and mortality, and received PRIME designation from the EMA.

DiaMedica's DM199 is a synthetic form of human tissue kallikrein-1. The therapy is a safer alternative for patients excluded from other treatment options because of clot location, delayed arrival at the emergency department, or other safety considerations. It can be administered within 24 h post onset of stroke and is currently being evaluated in the Phase II/III trial. Additionally, the US FDA granted FTD to DM199 for treating acute ischemic stroke.

LT3001 is a peptide moiety with antioxidant properties that limit oxidative stress and protect tissues from ischemia/reperfusion injuries. It restores the occluded blood flow without causing hemorrhage, which holds promise as a superior and safer therapy to expand the treatable population and can improve the outcome after stroke. It is investigated in a Phase II trial by Lumosa Therapeutics and designated as a fast track by the US FDA.

Note: Detailed emerging therapies assessment will be provided in the final report.

Acute ischemic stroke (AIS) Market Outlook

The acute ischemic stroke (AIS) market outlook of the report builds a detailed comprehension of the historical, current, and forecasted acute ischemic stroke (AIS) market trends by analyzing the impact of current therapies on the market, unmet needs, and demand for better technology.

This segment gives a thorough detail of the acute ischemic stroke (AIS) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market, and KOL view. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The shortcomings associated with the current treatment regime in the acute ischemic stroke (AIS) landscape warrant the development of new therapies. As per our analysis, the emerging treatment landscape is robust. Therapies that will impact the future market are glenzocimab, DM199, LT3001, nerinetide, BMS-986177/milvexian, and invimestrocel, among others.

The market presents a significant opportunity for the key-mentioned players to capitalize on the untapped market. The emerging treatment consists of different classes, such as antithrombotics, TRPM4 protein inhibitors, recombinant human tissue kallikrein-1, and plasminogen activators. Additionally, multistem cell therapy is also set to pave its way shortly. Launching novel therapies would revolutionize the treatment landscape by expanding the treatment window to up to 36 h and reducing the major complication of intracranial bleeding. Although the space is quite active and trials are underway to treat patients with acute ischemic stroke (AIS), continuous efforts are further needed to develop drugs that would be more effective and less toxic. As the entire landscape has only one approved pharmaceutical treatment addressing only a subset of patients, a significant development in this direction is expected to impact the existing market scenario during the forecast period (2023-2032).

• In the 7MM, the market size of acute ischemic stroke stood at approx. USD 1,300 million in 2022. The market is expected to grow by 2032, driven by rising incidence, better diagnosis, improved stroke care, and the launch of novel therapies.
• The market size in the 7MM will increase at a CAGR of 10.6% due to increasing awareness and continuous research and development.
• The United States accounted for the largest market share (>USD 700 million) of acute ischemic stroke in 2022 because the most advanced healthcare system is providing better patient access to therapies.
• The total EU4 (Germany, France, Italy, and Spain) and the UK market size of acute ischemic stroke were more than USD 300 million in 2022.
• Invimestrocel (Athersys/Healios) is expected to be the most successful therapy amongst the pipeline candidates and shall account for the highest market revenue in the coming years.

Acute Ischemic Stroke Drugs Uptake

This section focuses on the uptake rate of potential drugs launched or expected to be launched in the market during the study period 2019-2032. For example, Invimestrocel, with the regenerative medicine advanced therapy (RMAT) designation from FDA and fast-track review from PMDA, we expect the drug uptake to be medium with a probability-adjusted peak share of 3.28%, and the ‘years to peak' is expected to be 6 years from the year of launch.

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

Acute Ischemic Stroke (AIS) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II. It also analyses acute ischemic stroke (AIS)'s key players in developing targeted therapeutics.

Major players in acute ischemic stroke include DiaMedica Therapeutics, Lumosa Therapeutics, NoNO Inc., Bristol Myers Squibb Company, Acticor Biotech, Athersys/Healios, and others, whose key products are expected to get launched in the US, EU4, and the UK, and Japan market by 20XX.

Pipeline Development Activities

The report covers collaborations, acquisitions, mergers, licensing, and patent details for emerging acute ischemic stroke (AIS) therapies.

KOL Views

To keep up with current market trends, The publisher interviewsed KOLs and obtained SMEs' opinions through primary research to fill the data gaps and validate our secondary research. Their opinion helped understand and validate current and emerging treatment patterns or acute ischemic stroke (AIS) market trends. This supported the identification of potential novel treatments by identifying the overall scenario of the market and the unmet needs.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Hotchkiss Brain Institute Europe, MD American Psychiatric Association, Director of Immunology England, MD University of Colorado Anschutz Medical Campus, etc., were contacted. Their opinion helps understand and validate current and emerging therapies, treatment patterns, and market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs 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 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 therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in acute ischemic stroke trials, a few of the important primary outcome measures are the reduction in stroke recurrence, stroke recovery based ordinal mRS, and neurological outcome defined by NIHSS.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. 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 therapies are decided.

Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years.

The 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. For instance, in the US, the Centers for Medicare and Medicaid Services (CMS) covers thrombolytic agents for acute ischemic stroke. Individuals submitting valid claims according to Medicare rules receive payment from rules for thrombolytic agents.

Scope of the Report

• The report covers a segment of key events, an executive summary, a descriptive overview of acute ischemic (stroke), explaining its causes, signs and symptoms, pathogenesis, 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, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the acute ischemic stroke market, historic and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The 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 in shaping and driving the 7MM acute ischemic stroke (AIS) market.

Acute Ischemic Stroke (AIS) Report Insights

• Patient Population
• Therapeutic Approaches
• Acute Ischemic Stroke (AIS) Pipeline Analysis
• Acute Ischemic Stroke (AIS) Market Size and Trends
• Existing and Future Market Opportunity

Acute Ischemic Stroke (AIS) Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Acute Ischemic Stroke (AIS) Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Acute Ischemic Stroke (AIS) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market insights

• What was the acute ischemic stroke (AIS) total market size, market size by therapies, market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• How will the emerging therapies, with an expanded therapeutic window, affect the treatment paradigm in acute ischemic stroke?
• What kind of uptake will TRPM4 protein inhibitors and recombinant human tissue kallikrein-1 witness in the next decade?
• Among the oral factor XIa inhibitors, will it be milvexian or asundexian that captures the major share?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology insights

• What are the disease risk, burden, and unmet acute ischemic stroke (AIS) needs? What will be the growth opportunities across the 7MM concerning the patient population of acute ischemic stroke (AIS)?
• What is the historical and forecasted acute ischemic stroke (AIS) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• How is the limited presence of stroke units or facilities affecting patient treatment?
• Which population age group is most affected by acute ischemic stroke (AIS)?
• What are the reasons for patients' ineligibility toward alteplase (tPA) therapy?
• What factors are affecting the increase in the diagnosis of ischemic stroke cases?

Current treatment scenario, marketed drugs, and emerging therapies

• What are the current options for the treatment of acute ischemic stroke (AIS)? What are the current treatment guidelines for the treatment of acute ischemic stroke (AIS) in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of acute ischemic stroke (AIS)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of acute ischemic stroke (AIS)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What key designations have been granted for the emerging therapies for acute ischemic stroke (AIS)?
• What will be the impact of newer therapies with an expanded treatment window expected patent expiry?
• What drugs are being developed as an add-on, combination, adjunctive, or monotherapy?
• What is the cost burden of approved therapies on the patient?
• What are the country-specific accessibility issues of approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of acute ischemic stroke (AIS)?