The Global Cognitive Impairment Associated With Schizophrenia (CIAS) Market is estimated to be valued at USD 5.2 Bn in 2024 and is expected to reach USD 7.1 Bn by 2031, growing at a compound annual growth rate (CAGR) of 5.1% from 2024 to 2031. This steady growth can be attributed to the increasing awareness about effective treatment options and supportive government initiatives in major markets.

The Cognitive Impairment Associated with Schizophrenia (CIAS) Market focuses on the development and commercialization of therapies targeting the cognitive deficits experienced by schizophrenia patients. These impairments, which include memory, attention, and executive function issues, severely impact daily functioning and quality of life. With a lack of approved treatments specifically for CIAS, pharmaceutical companies are investing in research to develop novel drugs, digital therapeutics, and personalized medicine solutions. The market is driven by unmet clinical needs, increasing awareness, and advancements in neuroscience, offering opportunities for innovative approaches that address both cognitive symptoms and long-term outcomes in schizophrenia care. The CIAS market is expected to witness positive growth over the forecast period. Key growth factors include rising prevalence of schizophrenia and associated cognitive deficits, strong product pipeline with novel mechanisms of action, and growing research & development investments from pharmaceutical companies. Furthermore, improving reimbursement scenario and widening access to healthcare are also expected to boost market revenues during this period.

Market Driver –Therapies Targeting Cognitive Impairments in Schizophrenia Addressing Significant Unmet Medical Needs.

Cognitive impairments associated with schizophrenia pose severe challenges for patients in their daily lives and ability to work and function socially. However, despite its substantial impact, targeting cognitive deficits remains an underserved medical need in schizophrenia patients. Currently approved antipsychotic treatments focus primarily on reducing positive symptoms like hallucinations and delusions but have limited benefits for improving cognitive functions such as attention, learning, and memory. With no approved drugs indicated to treat cognitive impairments of schizophrenia, it continues to be a major source of disability and reduced quality of life for patients.

A variety of factors drive the growing need for cognitive impairment therapies in schizophrenia. One of the main reasons is the inadequacy of existing treatment options. While second generation antipsychotics are commonly prescribed for schizophrenia, their impact on cognitive impairments is limited. For many patients, cognitive symptoms remain largely unimproved despite treatment with antipsychotics. This leaves cognitive deficits as an ongoing concern. The disability caused by cognitive impairments also tends to persist over the long term even when positive symptoms are well controlled. This highlights the importance of directly addressing cognitive deficits to potentially improve long term outcomes for patients.

Market Driver - Advancements in GlyT1 inhibitors, such as Iclepertin, showing promise in improving cognitive symptoms in CIAS.

Glycine transporter-1 (GlyT1) inhibitor compounds targeting the glycine transporter subtype 1 are emerging as a promising new avenue for improving cognitive function in schizophrenia. Glycine is believed to play a modulatory role at N-methyl-D-aspartate (NMDA) glutamate receptors in the brain, critical for cognitive processes. Drugs inhibiting the GlyT1 help increase glycine levels in synaptic clefts and facilitate NMDA receptor function.

Several GlyT1 inhibitors are under clinical development led by companies like Alberio and Intra-Cellular Therapies. One of the leading compounds in development is Iclepertin, which has shown positive results in preliminary studies for its ability to enhance cognition. Iclepertin is a selective, oral small molecule inhibitor of GlyT1 being developed by Alberio. In a Phase 1b clinical trial, Iclepertin demonstrated improvements in measures of cognitive function and working memory in schizophrenia patients without impairing motor coordination. The compound was found to be well tolerated with no serious adverse events reported.

The early success of Iclepertin provides encouraging evidence supporting the therapeutic potential of GlyT1 inhibitors for treating cognitive deficits in schizophrenia. Being able to enhance cognition through a distinct pharmacological mechanism, GlyT1 inhibitors like Iclepertin offer hope in addressing this significant unmet need. Their development remains highly anticipated and could mean an important new class of treatment options for cognitive impairments associated with schizophrenia if trials continue to demonstrate benefits.

Market Challenge - Complex Regulatory Pathways and Safety Concerns Associated with Novel Treatments for Cognitive Impairments in Schizophrenia.

One of the major challenges faced in the CIAS market is the complex regulatory pathways and safety concerns associated with developing novel treatments that specifically target cognitive impairments in schizophrenia. Cognitive impairments can range from impaired working memory, problem-solving abilities, and slow cognitive processing, which hinders a patient's ability to function in daily life. However, gaining regulatory approval for treatments addressing these cognitive deficits proves to be an arduous task for pharmaceutical companies. Regulators require extensive evidence on not only the efficacy of novel treatment options but also on their safety profile, especially considering the delicate balance between cognitive and other psychiatric symptoms in schizophrenia patients. Additionally, treatment emergent adverse effects like extrapyramidal symptoms further complicate the risk-benefit analysis for new molecules. The heterogeneous nature of cognitive impairments also makes it difficult to measure treatment responses in a standardized manner. Pharmaceutical companies must invest heavily in well-designed clinical trials incorporating sensitive cognitive scales along with longer treatment duration to showcase the persistent effects of investigational drugs on broader aspects of daily functioning. This regulatory burden and safety risks associated with novel mechanisms of action continue to pose significant challenges to innovation in this field.

Market Opportunity - Collaborations Between Pharmaceutical Companies and Academic Institutions to Drive Innovation In CIAS Treatment.

One key opportunity for growth in the CIAS market lies in fostering greater collaborations between pharmaceutical industry players and academic research institutions. Significant progress has been made in understanding the neurobiological underpinnings of cognitive dysfunction through advancements in domains like neuroimaging, neuropsychology, and computational modeling by researchers in academic settings. However, this wealth of knowledge is yet to translate into meaningful therapeutic options for patients. Strong partnerships that bring together industry expertise in drug development and the disease insights from academic research can help overcome some of the current challenges. Joining forces in research focusing on novel targets, biomarkers, and specialized trial designs holds potential to accelerate drug discovery for cognitive dysfunctions. Such alliances can also facilitate sharing of clinical trial data to aid research beyond traditional molecule-based approaches. With combined efforts, collaborative models are well-positioned to drive more efficient innovation and expand the treatment landscape for this significantly debilitating symptom domain of schizophrenia.

Cognitive impairment is a core feature of schizophrenia and a major determinant of functional outcome. Prescribers typically follow a stepped care approach to treating this condition.

In mild cases, prescribers may start with second-generation antipsychotics (SGAs) like Rexulti (brexpiprazole) or Abilify (aripiprazole), which have modest effects on cognition. SGAs are often preferred over first-generation antipsychotics due to their relatively milder side effect profile.

For moderate-severe cognitive impairment, prescribers frequently combine an SGA like Rexulti, Abilify or Vraylar (cariprazine) with an adjunctive agent shown to enhance cognition. Common adjuncts include the cholinesterase inhibitor Galantamine (Razadyne), the N-methyl-D-aspartate receptor modulator Namenda (memantine), or second-generation antidepressants like Sarafem (fluoxetine).

In treatment-resistant cases, prescribers may use clozapine, an SGA considered the gold standard for its superior efficacy. However, its side effect burden and need for blood monitoring limits use. Another approach is to trial a cognitive-enhancing SGA like Invega Trinza (paliperidone palmitate), which provides 3-month dosing with purported extra-pyramidal benefits.

Other factors influencing prescribers include patients' symptom severity, prior medication history, side effect profile, adherence, insurance coverage and cost of treatment. A multimodal approach addressing biological and psychosocial aspects is often deemed optimal to optimize quality of life.

Cognitive impairment is a core symptom in schizophrenia and significantly impacts patients' functional recovery and quality of life. Treatment approaches vary depending on the stage of the disease. For first-episode patients, atypical antipsychotics are preferred due to their advantageous cognitive side effect profile compared to typical agents. Aripiprazole, lurasidone, and ziprasidone are commonly used as they exert minimal cognitive dysfunction. Long-acting injectable formulations ensure compliance with treatment.

In patients with stable symptoms, adjunctive agents targeting specific cognitive domains are utilized. Donepezil, a cholinesterase inhibitor, demonstrates benefits in attention, working memory and processing speed. Galantamine may also improve cognition. For persistent functional impairment, cognitive remediation therapy teaches compensatory strategies and is recommended in addition to pharmacotherapy.

For treatment-resistant cases, clozapine remains the gold standard due to its superior efficacy on general cognition as well as specific domains of working memory and verbal learning. Rare but potentially life-threatening side effects require close monitoring. Combining clozapine with cognitive-enhancing drugs like donepezil may provide additional improvement beyond clozapine alone.

Furthermore, lifestyle modifications including cognitive exercises, social skills training and vocational rehabilitation are essential components of long-term management aimed at optimizing functional recovery in schizophrenia patients with cognitive deficits.

Innovative Drug Development: Focus on developing novel therapeutics that target cognitive impairments specific to schizophrenia, using advanced techniques such as neurostimulation, neurogenetics, or neuroplasticity.

Personalized Medicine: Implementing personalized or precision medicine approaches that tailor treatments based on genetic profiles, patient biomarkers, or specific subtypes of cognitive impairments.

Collaboration and Partnerships: Engaging in strategic collaborations between pharmaceutical companies, academic institutions, and research organizations to enhance drug discovery, clinical trials, and access to new technologies.

Regulatory Approvals and Fast-Track Designations: Seek regulatory approvals and fast-track designations to accelerate the development and commercialization of therapies, especially those addressing unmet needs in cognitive impairment.

Digital Therapeutics and Cognitive Training: Incorporating digital therapeutics or cognitive training platforms that complement drug therapies, offering holistic treatment solutions for patients.

Focus on Long-Term Cognitive Outcomes: Develop treatments that not only alleviate cognitive symptoms but also show efficacy in improving long-term cognitive function and quality of life in patients with schizophrenia.

Patient Advocacy and Education: Partnering with patient advocacy groups to raise awareness of cognitive impairment in schizophrenia and educate patients, caregivers, and healthcare providers on new treatments.

Insights, By Drug Class, Clinical Efficacy Drives Demand for Cognitive Enhancers in the Forecast Period.

By Drug Class, cognitive enhancers are expected to account for 55.3% market share in 2024 owing to their proven clinical effectiveness in improving cognitive deficits. Cognitive enhancers help address symptoms such as lack of concentration, impaired memory and executive dysfunction that significantly impact quality of life for patients. Drugs belonging to this class work by targeting specific neurotransmitter systems and modulating neuroplasticity in the brain. Compared to other classes such as antipsychotics, cognitive enhancers demonstrate superior efficacy in remediating cognitive impairment with minimal side effects. They are well-tolerated and do not cause extrapyramidal symptoms that are commonly associated with older generation antipsychotics. The oral administration of these drugs ensures high compliance from patients. With the growing understanding of the pathogenesis of cognitive dysfunction in psychotic disorders, cognitive enhancers are becoming the mainstay of therapy to holistically manage symptoms and functional outcomes. The need to improve occupational and social functioning drives high demand for these innovative drugs.

Insights, By Indication, Prevalence of Comorbid Conditions Boosts Schizophrenia with Cognitive Impairment Segment.

By Indication, Schizophrenia with Cognitive Impairment is expected to contribute 57.5% market share in 2024 due to its close linkage with the condition. Schizophrenia often co-occurs with cognitive impairment that affects around 75% of patients. Deficits persist even during clinical remission of psychotic symptoms. Patients facing challenges in memory, attention and executive functions leads to poorer response to psychosocial rehabilitation efforts. The high prevalence of comorbid schizoaffective disorder and bipolar disorders among schizophrenia patients exacerbate underlying cognitive dysfunction. These multi-dimensional syndromes are more treatment-resistant in nature. Growing recognition of cognitive impairment as a core symptom domain rather than secondary outcome is driving focus towards dedicated treatment of schizophrenia-associated cognitive deficits.

Insights, By Distribution Channel, Role of Hospitals as Healthcare Hubs Boosts the Hospital Pharmacies Segment.

By Distribution Channel, Hospital Pharmacies contributes the highest share of the market owing to their central position within healthcare infrastructure. As tertiary care centers, hospitals serve as the major point of contact for management of chronic disorders like schizophrenia. They provide comprehensive assessment, medication management and therapy services. Presence of multidisciplinary mental healthcare teams in hospitals facilitates ease of access to cognitive impairment drugs. Given the complex dosing schedules and need for monitoring required with most cognitive impairment therapies, hospital pharmacy dispensing ensures proper administration. They also offer valuable counseling to educate patients. Risk of non-adherence is mitigated through direct dispensing of medicines to in-patients. This strengthens the hospital pharmacies segment. Growth in healthcare expenditure and recent policies supporting scaling up of mental health facilities further their prominent market role.

Cognitive impairment is a core feature of schizophrenia, affecting patients' memory, attention, and executive functioning. Despite the availability of antipsychotic medications for treating the positive symptoms of schizophrenia, cognitive deficits remain largely unaddressed by current treatments. Iclepertin, a GlyT1 inhibitor being developed by Boehringer Ingelheim, shows promise in targeting these cognitive symptoms by modulating glycine levels in the brain and enhancing NMDA receptor function. This innovative approach could potentially revolutionize CIAS treatment by directly addressing the cognitive impairments that limit patients' functional abilities. The market for CIAS therapies is anticipated to grow significantly as more attention is given to the unmet needs in cognitive treatments for schizophrenia. With the FDA granting Iclepertin Breakthrough Therapy Designation, the drug is on a fast track to approval, bringing hope to patients suffering from the cognitive challenges associated with schizophrenia.

The major players operating in the Cognitive Impairment Associated With Schizophrenia (CIAS) Market include Boehringer Ingelheim International GmbH, Neurocrine Biosciences, Recognify Life Sciences, Atai Life Sciences, Kynexis, Eli Lily and Company, Pfizer Inc., AbbVie Inc., Otsuka Pharmaceutical Co. Ltd, AstraZeneca Plc, Alkermes Plc and Takeda Pharmaceutical Co. Ltd.

In May 2024, Boehringer Ingelheim has advanced its CIAS treatment, Iclepertin, to Phase III. Iclepertin is a GlyT1 inhibitor designed to target cognitive symptoms associated with schizophrenia by modulating glycine levels and improving NMDA receptor function. The drug has received FDA Breakthrough Therapy Designation and aims to address a significant unmet need in CIAS therapy.

• By Drug Class
  • Cognitive Enhancers
  • NMDA Receptor Antagonists
  • Antipsychotic Medications
• By Indication
  • Schizophrenia with Cognitive Impairment
  • Bipolar Disorder with Cognitive Impairment
  • Major Depressive Disorder with Cognitive Impairment
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies