ACUTE ISCHEMIC STROKE (AIS) MARKET ANALYSIS

Global acute ischemic stroke (AIS) market is estimated to be valued at US$ 9.21 Bn in 2023, and is expected to exhibit a CAGR of 4.0% during the forecast period (2023-2030).

Analysts’ Views on Global Acute Ischemic Stroke (AIS) Market:

Various research institutes are focusing on research initiatives and drug development activities for clinical research, and this is expected to drive the global acute ischemic stroke market growth over the forecast period. For instance, on December 5, 2022, General Dynamics Information Technology (GDIT), a business unit of General Dynamics, announced that it was awarded an US$ 84 Mn  contract by the Defense Health Agency (DHA), integrated Combat Support Agency, to support the Traumatic Brain Injury Center of Excellence (TBICoE). The contract has an eight-month base period with three option years. Under the contract, GDIT will continue to support the TBICoE in conducting clinical research, surveilling traumatic brain injuries (TBIs) across the Department of Defense (DOD), developing clinical recommendations, translating research findings into education tools, and disseminating these products to military healthcare providers, service members, veterans, and their families. GDIT will also partner with the TBICoE and DOD on the execution of current and future congressionally mandated projects . These includes the 15-year longitudinal study of TBIs incurred by the armed forces in Afghanistan and Iraq wars, as well as the Warfighter Brain Health program.

Figure 1. Global Acute Ischemic Stroke (AIS) Market Share (%), By Therapeutics, 2023

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Global Acute Ischemic Stroke (AIS) Market– Drivers

• Increasing investment & funding scenario: Increasing investment & funding by key market players is expected to accelerate the market growth over the forecast period. For instance, in May 2022, the National Institute of Neurological Disorders and Stroke (NINDS), a part of the U.S. National Institutes of Health (NIH), awarded a US$ 4 Mn  grant to the Keck School of Medicine to conduct a pivotal Phase 3 clinical trial of 3K3A-APC as a cerebroprotectant, a drug that hastens or augments recovery following tissue plasminogen activator (tPA) treatment for ischemic stroke.

•  Increasing research and development activities: Increasing research and development activities by key market players is expected to drive the market growth over the forecast period. For instance, In January 2023, Center Hospitalier Sud Francilien, a France-based hospital and medical company, compared early recanalization success rates in patients with acute distal vascular occlusion stroke and those treated with alteplase (ALT) to tenecteplase. (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed immediately after intravenous therapy (IVT). In the current study, researchers compared early sustained release rates in two lysis patients based on a retrospective review of magnetic resonance imaging (MRI) data obtained immediately after intravenous therapy (IVT).

Figure 2. Global Acute Ischemic Stroke (AIS) Market Share(%), By Region, 2023

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Global Acute Ischemic Stroke (AIS) Market- Regional Analysis

Among region, North America is estimated to hold a dominant position in the global acute ischemic stroke (AIS) market over the forecast period. North America is estimated to hold 33.5 % of the market share in 2023. The market is expected to witness significant growth in thenear future, owing to increasing product approval by regulatory authorities in North America region. For instance, on January 06, 2022, Otsuka America Pharmaceutical, Inc., (Otsuka), a healthcare company, and H. Lundbeck A/S (Lundbeck), a pharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) had approved the supplemental new drug application (sNDA) of REXULTI (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age.

Global Acute Ischemic Stroke (AIS) Market– Impact of Coronavirus (COVID-19) Pandemic

• Since the COVID-19 virus outbreak in December 2019, the disease spread to over 100 countries across the globe, and the World Health Organization (WHO), declared it a public health emergency on January 30, 2020.
• COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others faced problems regarding transportation of things from one place to another.
• However, the COVID-19 pandemic had positive impact on the global acute ischemic stroke (AIS) market, owing to increasing complication such as stroke caused by COVID-19. For instance, on September 06, 2022, according to the study published by Journal Brain, researchers reported that brain injury is common in the patients suffering from diseases like coronavirus disease 2019 (COVID-19) and influenza. COVID-19 is associated with neurologic complications such as stroke, autoimmune encephalitis, and Guillain-Barré syndrome. The physical brain injury were evident in COVID-19-related neurologic syndromes such as encephalitis and stroke. Various reports stated that COVID-19 is associated with brain injury that can occur even in the absence of a concomitant neurologic diagnosis.

Global Acute Ischemic Stroke (AIS) Market- Segmentation

Global acute ischemic stroke (AIS) market  is segmented into  therapeutics, distribution channel, and region.

• By therapeutics, the market is segmented into tissue plasminogen activator, anticoagulant, antiplatelet, and antihypertensive. Out of which, tissue plasminogen activator segment is expected to hold a dominant position in the global acute ischemic stroke (AIS) market during the forecast period due to increasing inorganic growth strategies such as partnership among the key market players.
• By distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Out of which, hospital pharmacies is expected to dominate the market over the forecast period due to increasing use of products in hospital pharmacies
• By region, the market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Out of which,  North America is expected to dominate the market over the forecast period due to increasing  organic growth strategies such as product launch and approvals.
• Among all the segmentation, the therapeutics segment is expected to dominate the market over the forecast period due to increasing research and development activities for tissue plasminogen activators in the treatment of ischemic stroke. For instance, in December 2021, The Melbourne Health Organization, a Australia-based research organization, carried out an evaluation study of Tenecteplase versus Alteplase for Stroke Thrombolysis. In December 2021, the study was in the phase II trial, and demonstrated tenecteplase to be significantly more effective at improving stroke survivor's recovery and opening blocked blood vessels than alteplase. The study has even shown that Tenecteplase, the experimental drug, outperforms alteplase as the current ideal of care in terms of cost, ease of administration (no time-consuming infusions needed), and suitability for an ambulance-delivered therapy.

Global Acute Ischemic Stroke (AIS) Market- Cross Sectional Analysis

• Among therapeutics tissue plasminogen activator is dominant in Europe region due to increasing number of research studies by key market players and non-profit organizations for ischemic stroke treatment with tissue plasminogen activator. For instance, in November 2022, AO GENERIUM, a Russia-based pharmaceutical company,  initiated a clinical trial study to evaluate the “safety and efficacy of GNR-060 vs. Metalyse in patients with ST-Elevation Myocardial Infarction (STEMI)”. The study is currently in phase 3 clinical trials and is estimated to be completed by December 2023.

Global Acute Ischemic Stroke (AIS) Market: Key Developments

• On April 27, 2023, Otsuka America Pharmaceutical, Inc. (Otsuka), a healthcare company,  and H. Lundbeck A/S (Lundbeck), a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved the New Drug Application (NDA) for ABILIFY ASIMTUFII (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.
• On January 13, 2023, TMS Co., Ltd., a Japan-based biopharmaceutical company, announced the positive results of TMS-007 Phase I Clinical trial, conducted at P1 Unit, Clinical Research Support Center of the University of Tokyo Hospital. The study supported the acceptability and safety of TMS-007 when administered intravenously in doses up to 360 mg per adult in male patients. The accomplishment provided the company the opportunity to begin and complete Phase IIa clinical trial with patients suffering from symptomatic ischemic stroke. On January 13, 2023, the results of the TMS-007 Phase I Clinical Trial was published in the British Journal of Clinical Pharmacology.
• On September 12, 2022,  Algernon Pharmaceuticals Inc., a clinical stage pharmaceutical development company, announced that it had received approval to conduct a Phase 1 clinical study of an intravenous formulation ("IVF") of AP-188 (“N,N-dimethyl tryptamine” or “DMT”) for the treatment of stroke in the Netherlands from the Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent Medical Research Ethics Committee (“MREC”). The trial will be conducted at the Centre for Human Drug Research (“CHDR”) in Leiden, Netherlands. DMT is a known psychedelic compound that is part of the tryptamine family.
• In June 2021, Pinteon Therapeutics, a biotechnology company, and Lonza Group AG, a biotechnology company, announced that both companies had expanded their manufacturing agreement to enable future clinical production of Pinteon's lead candidate named PNT001 that showed promising results in a Phase I clinical study. The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Global Acute Ischemic Stroke (AIS) Market: Trends

• Increasing inorganic growth strategies such as collaboration: Increasing inorganic growth strategies such as collaboration by research institutes is expected to drive the market growth over the forecast period. For instance, in October 2022, Assiut University, a university and research organization based in Asyut, Egypt, in collaboration with Aswan University Hospital, a university based in Egypt, initiated a clinical trial study to evaluate the efficiency of tissue plasminogen activator in acute stroke with COVID Virus in non-COVID-19 patients (rTPA). The clinical trial study is estimated to get completed by 2026.

Global Acute Ischemic Stroke (AIS) Market: Restraint

• High cost of tissue plasminogen activator drugs: Factors such as high cost of tissue plasminogen activator drugs and termination of clinical trials are expected to hamper growth of the global acute ischemic stroke (AIS) market over the forecast period. For instance, in January 2021, according to an article published by Stroke & Vascular Neurology Journal,  potential reasons for the low adherence rate of intravenous tissue plasminogen activator (IV-rt PA) in China was due to pre-hospital delay, lack of regional stroke care network, high cost of tPA, low insurance coverage, and concern about hemorrhagic risk. Also, according to the same source, hospitals achieving high adherence rate was seen in high-gross rating point (GRP) per capita areas.
• Counterbalance: Key players are focusing on  reducing drug cost

Global Acute Ischemic Stroke (AIS) Market- Key Players

Major players operating in the global acute ischemic stroke (AIS) market include F. Hoffmann-La Roche Ltd, Boehringer Ingelheim International GmbH, Bayer AG, Pfizer Inc., Biogen, DAIICHI SANKYO COMPANY, LIMITED, Bristol-Myers Squibb Company, Johnson & Johnson Services, Inc., AstraZeneca, SanBio Co,Ltd., Athersys, Inc., Abbott, Sanofi, ZZ Biotech, Teva Pharmaceutical Industries Ltd, Merck & Co., Inc., NoNO Inc., AliveCor, Inc., Amgen Inc., Genentech USA, Inc., DiaMedica Therapeutics, Inc.

*Definition: An ischemic stroke is caused by a blockage that cuts  off the blood supply to a region of the brain. A transient ischemic attack, is a temporary blockage of the blood supply to a region of the brain, resulting in symptoms, that lasts only  for a short amount of time. Stroke is a leading cause of disability and death worldwide. In the U.S.,  a stroke occurs every 40 seconds in individuals, and every four minutes, a person  dies of stroke. About one in four strokes are recurrent, with the risk particularly high within 30 days after the initial event and even higher at time periods closer to the initial event.