Unmet Needs in Stroke Treatment
Each year, approximately 15 million people worldwide suffer from a stroke, with about 5 million of these cases resulting in death and another 5 million leading to permanent disability. Stroke remains one of the leading causes of long-term disability, with significant impacts on patient's quality of life and a heavy burden on healthcare systems [1].
The economic impact of ischemic stroke, primarily attributed to productivity loss, is estimated to be over €60 billion annually in Europe [2]. Therefore, there is an urgent need for innovative treatments to address this issue. Ischemic stroke can be divided into three chronological phases: acute (<24 h), subacute (<6 months), and chronic . Currently, the only approved treatments for ischemic stroke in the acute phase are intravenous recombinant tissue plasminogen activator (rt-PA) and mechanical thrombectomy. However, they are often limited by narrow therapeutic windows, high risks of complications, and varying effectiveness depending on the time of intervention and the specific characteristics of the stroke. Additionally, existing therapies often fail to address the underlying neuroinflammation and secondary damage that occurs after the initial event, which can lead to further neuronal loss and exacerbate functional impairments.
During the subacute phase of the disease, rehabilitation is employed to facilitate functional recovery. However, the effects of rehabilitation diminish over time, and patients typically reach a plateau in their recovery within several weeks to months after the stroke. In fact, approximately 80% of patients reach their maximum functional capacity within 6 weeks from the onset of the stroke, primarily due to the limited endogenous recovery capacity of the brain [3].
Therefore, there is an urgent need for innovative, targeted, and more effective treatments that not only address the ischaemic event but also promote tissue repair to significantly improve long-term outcomes. This critical need was further underscored through our discussions with leading medical professionals during our human practices .
Cell therapy presents a promising approach to enhance functional recovery in patients with ischemic stroke [4]. Preclinical and clinical studies have demonstrated its diverse effects on recovery, including cell differentiation, immunomodulation, anti-inflammation, and stimulation of endogenous repair processes such as angiogenesis and neurogenesis.
Among various stem cell sources, neural progenitor cells (NPCs) are among the most attractive for stem cell therapy because they can differentiate into various different neural lineages that are needed for the replacement of cells in the stroke‐damaged brain.
Previous studies indicate that transplanted NPCs can survive and differentiate into various neuronal phenotypes, integrating into the host's neural network. This innovative approach positions our therapy as a transformative solution for improving functional recovery in ischemic stroke patients.
Key Stakeholder Pain Points in Stroke Recovery
The following outlines critical challenges faced by patients, healthcare providers, healthcare systems, and companies in addressing stroke recovery.
Patients
Stroke survivors face substantial challenges, with nearly half living with permanent disabilities that severely impact their quality of life. Current treatments often fail to restore neurological function, leading to emotional issues such as depression and social isolation. The narrow therapeutic window for interventions like tPA, effective only within 4.5 to 6 hours post-stroke, increases the risk of long-term disability.
Healthcare providers
CMedical professionals struggle to manage chronic disabilities in stroke patients, as existing treatments primarily focus on acute care and lack options for promoting neural recovery. Long-term rehabilitation services are resource-intensive and often yield limited functional improvements, underscoring the need for innovative regenerative therapies.
Healthcare systems & payers
The economic burden of stroke care is significant, with costs in Europe projected to rise from €60 billion in 2017 to €86 billion by 2040. In Spain, annual stroke-related expenses reach €1.98 billion, alongside informal care costs of €6.53 billion. Inefficiencies in acute care delivery, particularly in underserved areas, contribute to poorer outcomes and increased long-term expenses.
Companies and industries
Pharmaceutical and medical device companies face challenges in developing effective stroke therapeutics. Current solutions mainly address acute care and prevention, leaving a critical gap in treatments that repair existing damage. The complexity of developing brain regeneration therapies slows innovation and leaves a substantial unmet need. Additionally, navigating regulatory hurdles adds time and cost to the development process, delaying the market entry of novel therapies.
Current limitations of existing solutions
Limited acute interventions: Treatments like thrombolysis and thrombectomy are effective only for a 15% of patients who arrive at the hospital quickly enough. Even when successful, these therapies do not address long-term neurological damage [5] [6].
No therapies for brain regeneration: Except for vagal nerve stimulation (VNS) with intensive rehabilitation, approved by the FDA in 2021 [7], there are no treatments aimed at restoring lost function in patients with chronic ischaemic stroke. No FDA-approved therapy exists to regenerate brain tissue or significantly reverse stroke-induced deficits.
Inconsistent outcomes with experimental therapies: Emerging treatments such as cellular therapies face challenges in ensuring cell survival, integration, and differentiation within the brain, resulting in inconsistent clinical outcomes and limited adoption.
The unmet needs in stroke recovery present a significant opportunity for innovation, particularly in developing therapies that can promote neuronal survival, enhance synaptic plasticity, and ultimately restore lost brain function. By addressing these gaps, we could transform stroke recovery, offering new hope for millions of patients worldwide.
Economic and Market Opportunity
The Total Addressable Market (TAM) quantifies the total potential revenue for stroke-related therapies under the assumption of complete market penetration. In 2022, the global stroke management market was valued at €36.1 billion and is projected to nearly double to €74 billion by 2032, reflecting a robust Compound Annual Growth Rate (CAGR) of 7.4% [8]. This growth is driven by several factors, including an ageing global population, advancements in diagnostic technologies, and increased awareness surrounding stroke prevention and early intervention.
In Europe, stroke presents a significant public health challenge, with more than 1.2 million new cases diagnosed each year [9]. The economic impact is substantial, with treatment costs exceeding €30,000 per patient, contributing to a total expenditure of over €60 billion annually. Given that ischaemic strokes comprise approximately 85% of all stroke cases, there is a critical need for innovative long-term recovery therapies like Reneurish. This landscape positions our therapy to effectively capture a meaningful share of this expanding market.
The Serviceable Available Market (SAM) reflects the segment of the TAM that Reneurish can realistically target based on market conditions and patient eligibility. Europe is recognized as one of the leading regions in stroke care, bolstered by rising healthcare expenditures, proactive government initiatives, and a rapidly ageing demographic. Since Reneurish is specifically designed for ischaemic stroke patients, we first focus on the 85% of stroke cases that fall into this category:
Ischaemic Stroke Market=€36 billion×0.85=€30.6 billion
Given that Reneurish will initially be available to 15% of these ischaemic stroke patients due to eligibility criteria, our SAM is calculated as follows:
SAM=€30.6 billion×0.15=€4.59 billion
This €4.59 billion SAM signifies the portion of the market that Reneurish can effectively address within its target demographic across Europe.
The Serviceable Obtainable Market (SOM) estimates the achievable market share during the initial years following market entry. Stroke care in Spain alone incurs costs exceeding €1.5 billion annually, highlighting substantial opportunities for enhanced treatment efficacy and cost savings [10]. With Spain's advanced healthcare infrastructure, high stroke incidence, and commitment to improving outcomes, Reneurish aims to capture 1% of the SAM in Europe:
SOM=€4.59 billion×0.01=€45.9 million
The projected €45.9 million SOM illustrates the initial revenue potential for Reneurish. As clinical data continue to validate the effectiveness of our therapy, we anticipate expanding our market share and penetrating additional key markets such as France, Italy, and the UK.
Economic and societal value
Based on a 2012 study [11] examining the societal value of stem cell therapies (SCT), the health-economic model in Sweden estimates a societal value of €154.845 for SCT in younger stroke patients with moderate disability. The intervention leads to increased survival (1.06 life years) and improved functional status, resulting in an estimated gain of 1.34 Quality-Adjusted Life Years (QALY). Although the costs associated with SCT rise by €59.513 (excluding stem cell expenses), these are offset by decreased productivity losses, yielding a total saving of €17.706 and making SCT cost-neutral at a stem cell price of €17.706.
These long-term benefits significantly reduce disability, alleviating financial burdens on healthcare systems and enhancing the quality of life for patients, particularly younger stroke survivors.
While this example highlights the potential benefits of SCT, it is important to note that the prices and cost-effectiveness metrics are not directly comparable to those in Spain, where costs per QALY are approximately half those in Sweden. This underscores the need for investment in SCT, which promises substantial economic savings and transformative improvements in patient well-being.
Market gap and unmet needs
Ischemic stroke is a leading cause of disability and death, yet current treatments primarily focus on minimising immediate damage rather than addressing long-term neurological deficits.
The thrombolytics and mechanical thrombectomy treatments do not tackle the long-term consequences of neuronal loss, which can result in substantial and often permanent disability. This gap in post-stroke care underscores the urgent need for innovative therapies aimed at restoring lost brain tissue and promoting neuronal regeneration.