2023년 주요 7개국에서 정신분열증과 관련된 인지기능장애(CIAS) 환자 수는 약 300만 명으로 집계됐습니다. 이 중 미국이 52%, EU 4개국과 영국이 각각 33%, 일본이 15%를 차지했으며, CIAS 시장은 2024년부터 2034년까지 연평균 성장률(CAGR)이 꾸준히 증가할 것으로 예상됩니다. 주요 7개국에서 이러한 성장은 이클레르페르틴(BI-425809), ALTO-101, RL-007과 같은 혁신적인 치료법의 도입으로 인해 촉진될 것으로 예상됩니다. 또한, 신경생물학적 이상, 유전적 및 가족력과 같은 위험요인의 증가와 인지도가 높아짐에 따라 CIAS의 유병률이 증가하고 있는 점도 시장 확대에 기여할 것으로 보입니다.
주요 7개국의 CIAS 시장 규모는 2023년 약 9억 4,810만 달러로 2024년부터 2034년까지 예측 기간 동안 8.9%의 CAGR로 성장할 것으로 예상됩니다.
CIAS의 치료법은 아직 개발되지 않았고, FDA가 승인한 치료법은 없으며, 현재 치료법은 증상 완화에 한계가 있고 부작용이 큽니다. 결과를 개선하고 재발을 억제하기 위한 표적 치료가 절실히 요구되고 있습니다.
Boehringer Ingelheim, Recognize Life Sciences(Atai Life Sciences), Alto Neuroscience/MEDRx는 다양한 개발 단계를 거쳐 자산을 개발하고 CIAS 시장의 혁신을 주도하고 있습니다. 이러한 기업들의 노력으로 역동적인 상황이 형성되어 시장 성장과 확장의 기회가 크게 확대되고 있습니다.
보링거인겔하임의 이클레르페르틴(BI-425809)은 CIAS 치료제로 임상 3상 단계에 있으며, 2026년까지 출시될 것으로 예상되는 혁신적인 치료제로 개발이 진행 중입니다.
이 보고서는 주요 7개국의 정신분열증과 관련된 인지기능장애 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등을 제공합니다.
DelveInsight's "Cognitive Impairment Associated With Schizophrenia (CIAS)- Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of CIAS, historical and forecasted epidemiology, as well as the CIAS market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The CIAS market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM CIAS market size from 2020 to 2034. The report also covers CIAS treatment practices and unmet medical needs to curate the best opportunities and assess the market's potential.
CIAS overview
Cognitive Impairment Associated With Schizophrenia (CIAS) is a critical aspect of the disorder, characterized by significant deficits across multiple cognitive domains such as reasoning, problem-solving, social cognition, verbal and visual memory, working memory, attention, and processing speed. These impairments often precede the onset of overt psychosis and tend to remain stable over the course of the illness in most patients.
The underlying causes of CIAS are multifactorial, influenced by a combination of genetic, neurobiological, and environmental factors. Genetic predispositions, particularly polygenic influences on neurodevelopment and synaptic function, play a pivotal role, while environmental factors such as prenatal complications, urban living conditions, substance use, and socioeconomic challenges further contribute to the severity of cognitive deficits.
Early symptoms of CIAS may include reduced motivation, emotional flatness, social withdrawal, and unusual behavior, which can progressively lead to marked cognitive challenges that significantly affect an individual's daily life and overall functionality. These insights highlight the complex interplay of factors driving CIAS and underscore the critical need for targeted therapeutic interventions.
CIAS diagnosis
CIAS can be diagnosed using by different tests, a clinical and cognitive assessment, and a detailed medical and psychiatric history. Cognitive deficits are screened using tools like the Montreal Cognitive Assessment (MoCA) or Brief Assessment of Cognition in Schizophrenia (BACS). For a more thorough evaluation, the MATRICS Consensus Cognitive Battery (MCCB) assesses neurocognitive and social cognitive domains. Regular follow-up assessments are crucial to track cognitive changes and treatment responses.
CIAS treatment
Currently, there are no approved therapies for treating CIAS. Although, treatment approaches include both pharmacological and non-pharmacological methods. Second-generation antipsychotics, such as clozapine, olanzapine, and risperidone, are favored over first-generation options due to their comparatively better, albeit modest, impact on cognitive outcomes. While these medications primarily address psychotic symptoms and offer limited cognitive benefits, no treatment is specifically approved for cognitive deficits. Non-pharmacological methods, including cognitive remediation therapy and physical exercise programs, have demonstrated effectiveness in improving cognitive function and overall quality of life, though their adoption remains inconsistent across clinical settings.
As the market is derived using a patient-based model, the CIAS epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of schizophrenia, total diagnosed prevalent cases of schizophrenia, total diagnosed prevalent cases of CIAS, gender-specific diagnosed prevalent cases of CIAS in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the CIAS report encloses a detailed analysis of CIAS-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the CIAS 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 Drugs
Iclepertin (BI-425809): Boehringer Ingelheim
Iclepertin (BI-425809), developed by Boehringer Ingelheim, is an investigational oral Glycine Transporter 1 (GlyT1) inhibitor aimed at treating CIAS. By modulating glycine levels in the synaptic cleft, it enhances NMDA receptor function, potentially improving synaptic plasticity and cognitive performance. Recognizing its promise, the US FDA granted Breakthrough Therapy Designation (BTD) to iclepertin in May 2021 for the treatment of CIAS, marking it as a significant step forward in addressing cognitive deficits in mental health disorders.
Iclepertin demonstrated significant cognitive benefits in schizophrenia patients during a Phase II clinical trial, with findings presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress in 2020. It is currently in Phase III evaluation as part of the CONNEX-3 program.
RL-007: Recognify Life Sciences (Atai Life Sciences)
RL-007, developed by Recognify Life Sciences, a subsidiary of Atai Life Sciences, is an innovative small molecule targeting CIAS. It enhances synaptic plasticity by modulating excitatory neurotransmission and GABA-B receptor systems, improving cognitive functions like memory and executive skills. Positive Phase IIa results in 2021 underscored its pro-cognitive potential and safety profile. It is now in a Phase IIb proof-of-concept trial, with outcomes anticipated by mid-2025.
ALTO-101: Alto Neuroscience/MEDRx
ALTO-101 is an innovative small molecule developed by Alto Neuroscience, in collaboration with MEDRx, for treating Cognitive Impairment Associated with Schizophrenia (CIAS). As a brain-penetrant PDE4 inhibitor, it targets cAMP, a molecule critical for cognition and neuroplasticity, and uses a Transdermal Delivery System (TDS) to minimize side effects while enhancing therapeutic efficacy.
Phase I trials in April 2024 demonstrated improved pharmacokinetics and tolerability with the transdermal formulation, leading to a Phase II trial initiated in June 2024, with results expected by second half of 2025. Alto has also highlighted ALTO-101's potential at key psychiatric conferences and entered a development agreement with MEDRx, including milestone payments tied to clinical progress.
Drug Class Insights
Currently, there are no approved therapies specifically for CIAS, advances in translational biomarkers are supporting clinical development. Ongoing research focuses on neurocognitive patterns in schizophrenia, with particular attention to glutamatergic and dopamine theories, as well as progress in biomarker-based strategies for drug discovery.
Antipsychotic medications are a cornerstone of treatment for CIAS, helping to manage psychotic symptoms and clinical stabilization. Second-generation Antipsychotics (SGAs) have shown small cognitive benefits compared to first-generation drugs, and long-acting injectable formulations reduce hospitalizations and relapse but do not significantly improve cognition. Newer SGAs like lurasidone, cariprazine, brexpiprazole, and lumateperone, which function as partial dopamine receptor agonists, may offer improved cognitive profiles, though further research is needed. Clozapine, while not universally beneficial for cognition, can show minimal improvement in individuals with Treatment-resistant Schizophrenia (TRS).
Cognitive impairment is a key feature of schizophrenia, affecting attention, memory, executive functioning, and social cognition and significantly impacting daily functioning and quality of life. These deficits are linked to neurobiological changes in the brain, particularly in the prefrontal cortex. Notably, cognitive symptoms can appear before psychosis, indicating they are intrinsic to the disorder rather than side effects of antipsychotic medications. These impairments are crucial in determining functional outcomes for patients.
Currently, no therapies are specifically approved for CIAS, and treatment typically involves off- both pharmacological and non-pharmacological methods. While second-generation antipsychotics offer modest cognitive improvements, newer agents like lurasidone and cariprazine are being explored. Adjunctive treatments such as buspirone and memantine show mixed results. Cognitive remediation therapy (CRT) is effective, and strategies like physical exercise and transcranial direct current stimulation (tDCS) provide additional benefits. However, more effective, targeted therapies are needed to address cognitive deficits in schizophrenia.
The development pipeline for CIAS treatment is limited, with iclepertin, RL-007, and ALTO-101 being the primary candidates. There is a significant unmet need for targeted treatments, as current therapies focus on symptom management rather than addressing the underlying condition.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.
Cognitive Impairment Associated With Schizophrenia Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for CIAS.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on CIAS evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the The Zucker Hillside Hospital, US, Columbia University Medical Center, US, Charite-Universitatsmedizin Berlin, Germany, Universite' Franc,ois-Rabelais, France, University of Bari Aldo Moro, Italy, University Hospital Reina Sofia, Spain, Adelphi Values, UK, and Tokushima University, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or CIAS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, schizophrenia is a chronic mental health disorder, typically diagnosed in men during their late teens to early 20s and women in their late 20s to early 30s. It affects about 1% of the adult population in the US, translating to roughly 3 million individuals. Annually, around 100,000 Americans are diagnosed with schizophrenia. Despite progress in treating positive symptoms, over 80% of patients experience significant cognitive impairment, which remains without approved treatments. This cognitive decline plays a key role in functional disability, highlighting a critical unmet need in schizophrenia care.
As per the KOLs from France, schizophrenia is a severe psychiatric disorder marked by significant cognitive and emotional disruptions. It requires long-term medical treatment, which can lead to a range of physical, psychological, and social challenges, both from the illness itself and the side effects of treatment. The disorder affects 0.7-1% of the global population, with approximately 400,000-600,000 individuals in France. Additionally, schizophrenia is more prevalent in males (58.6% vs 48.7%) and is most commonly diagnosed in individuals aged 35-64 years.
As per the KOLs from Japan, antipsychotics, while essential in managing schizophrenia, remain underutilized due to significant side effects and limited efficacy. A promising strategy to enhance their potential lies in the application of chemical genomics, which focuses on minimizing off-target receptor activity and improving receptor specificity. By refining the chemical structures of small molecule candidates, this approach aims to optimize therapeutic efficacy while reducing adverse effects, offering new possibilities for addressing the substantial 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 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.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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
DelveInsight's 'CIAS- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of CIAS.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
Cognitive Impairment Associated With Schizophrenia report insights
Cognitive Impairment Associated With Schizophrenia report key strengths
Cognitive Impairment Associated With Schizophrenia report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies