Emerging therapies for Autoimmune Psychosis, including ENSPRYNG (satralizumab, RG6168), ART5803, and others, are expected to drive growth in the Autoimmune Psychosis market over the coming years.
DelveInsight has released a new report titled “Autoimmune Psychosis – Market Insights, Epidemiology, and Market Forecast-2034”, providing a comprehensive analysis of Autoimmune Psychosis, historical and projected epidemiology, and market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Discover about the Autoimmune Psychosis market report @ https://www.delveinsight.com/report-store/autoimmune-psychosis-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Some of the key facts of the Autoimmune Psychosis Market Report:
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The Autoimmune Psychosis market across the 7MM was valued at approximately USD 6.07 million in 2023 and is expected to grow steadily throughout the 2024–2034 forecast period. According to DelveInsight, there were around 561 diagnosed prevalent cases in 2023, with the United States accounting for 38.9%, the EU4 and UK together representing 39.5%, and Japan comprising 21.5%.
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Market expansion is anticipated to be robust, supported by a CAGR of 18.6% from 2024 to 2034. Growth will be driven by emerging therapies such as satralizumab (RG-6168) and ART5803, along with rising disease awareness and risk factors like autoimmune conditions and substance abuse. Despite this, the treatment landscape remains underdeveloped, as there are currently no FDA-approved therapies, and existing treatments offer limited symptom relief and carry significant side effects, highlighting the urgent need for targeted therapies to reduce relapses and improve patient outcomes.
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Hoffmann-La Roche and Arialys Therapeutics are spearheading innovation in this space. Roche’s ENSPRYNG (satralizumab) is in Phase III clinical trials, with regulatory submission planned by 2026 for potential use in autoimmune encephalitis. In 2023, approximately 84,441 cases of autoimmune encephalitis were diagnosed across the 7MM, expected to rise by 2034. In the US, 30,123 cases of autoimmune encephalitis with neuronal surface antigens were reported in 2023. Antibody-specific cases included: anti-NMDAR (4,362), anti-LGI1 (10,359), anti-CASPR2 (1,227), anti-GABAbR (409), anti-GAD (3,135), and other antibodies (10,632).
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Arialys Therapeutics has initiated a Phase 1 trial for ART5803, a precision medicine designed to block pathogenic autoantibodies instead of broadly suppressing the immune system. The first participants were dosed in October 2024, marking a key milestone in developing targeted therapies for autoimmune neuropsychiatric disorders, including autoimmune psychosis.
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Cases like Onyx Middleton, an 18-year-old initially misdiagnosed with schizophrenia in early 2024, underscore the importance of recognizing autoimmune psychosis in differential diagnoses, particularly when psychiatric symptoms arise without clear neurological signs.
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Key companies advancing the Autoimmune Psychosis pipeline include Hoffmann-La Roche, Arialys Therapeutics, and others, with promising therapies such as ENSPRYNG (satralizumab, RG6168) and ART5803 leading the way.
Autoimmune Psychosis Overview
Autoimmune psychosis is characterized by the presence of isolated psychotic symptoms, often with minimal or no neurological manifestations, in individuals who test positive for antibodies against neuronal membrane receptors, including N-methyl-D-aspartate receptors (NMDAR), leucine-rich glioma-inactivated 1 (LGI1), and gamma-aminobutyric acid type A receptor (GABA-A). Specifically, anti-NMDAR antibodies disrupt neurotransmission, resulting in psychotic and encephalitic symptoms. Although such cases are frequently considered atypical or mild forms of autoimmune encephalitis, some experts advocate recognizing them as a distinct condition called autoimmune psychosis, categorized as possible, probable, or definitive.
Major risk factors include immune system dysregulation, genetic predisposition, and coexisting autoimmune diseases such as lupus and multiple sclerosis, emphasizing the need for antibody testing in treatment-resistant psychosis.
Clinical manifestations may involve hallucinations, delusions, agitation, aggression, slowed cognitive processing, anxiety, and other psychiatric symptoms.
Autoimmune Psychosis Market Outlook
Autoimmune psychosis is marked by isolated psychotic symptoms, often occurring with minimal or no neurological signs, in patients testing positive for neuronal autoantibodies, especially those against N-methyl-D-aspartate receptors (NMDAR). Although these cases are frequently considered atypical or mild forms of autoimmune encephalitis, some experts advocate recognizing them as a distinct condition, termed autoimmune psychosis. Diagnosis typically involves MRI, electroencephalogram (EEG), blood serology, and lumbar puncture.
Currently, there are no therapies specifically approved for autoimmune psychosis. Management generally relies on off-label immune-based treatments, including steroids, plasma exchange, intravenous immunoglobulins (IVIG), and cyclophosphamide.
The therapeutic pipeline remains limited, with satralizumab (RG-6168) and ART5803 as the primary candidates. There is a substantial unmet need for targeted treatments, as existing options mainly address symptoms rather than the underlying autoimmune mechanisms.
Discover how the Autoimmune Psychosis market is rising in the coming years
Autoimmune Psychosis Emerging Drugs
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ENSPRYNG (satralizumab, RG6168): Hoffmann-La Roche (Chugai Pharmaceutical)
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ART5803: Arialys Therapeutics/Nucleus Network
Scope of the Autoimmune Psychosis Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Autoimmune Psychosis Companies: Hoffmann-La Roche, Arialys Therapeutics, and others
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Key Autoimmune Psychosis Therapies: ENSPRYNG (satralizumab, RG6168), ART5803, and others
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Autoimmune Psychosis Therapeutic Assessment: Autoimmune Psychosis current marketed and Autoimmune Psychosis emerging therapies
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Autoimmune Psychosis Market Dynamics: Autoimmune Psychosis market drivers and Autoimmune Psychosis market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
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Autoimmune Psychosis Unmet Needs, KOL’s views, Analyst’s views, Autoimmune Psychosis Market Access and Reimbursement
To know what’s more in our Autoimmune Psychosis report, visit https://www.delveinsight.com/report-store/autoimmune-psychosis-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Key benefits of the Autoimmune Psychosis Market Report:
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Autoimmune Psychosis market report covers a descriptive overview and comprehensive insight of the Autoimmune Psychosis Epidemiology and Autoimmune Psychosis market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Autoimmune Psychosis market report provides insights into the current and emerging therapies.
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The Autoimmune Psychosis market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Autoimmune Psychosis market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Autoimmune Psychosis market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Autoimmune Psychosis Patient Share (%) Overview at a Glance
5. Autoimmune Psychosis Market Overview at a Glance
6. Autoimmune Psychosis Disease Background and Overview
7. Autoimmune Psychosis Epidemiology and Patient Population
8. Country-Specific Patient Population of Autoimmune Psychosis
9. Autoimmune Psychosis Current Treatment and Medical Practices
10. Unmet Needs
11. Autoimmune Psychosis Emerging Therapies
12. Autoimmune Psychosis Market Outlook
13. Country-Wise Autoimmune Psychosis Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Autoimmune Psychosis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Related Reports:
Autoimmune Psychosis Pipeline Insights, DelveInsight
“Autoimmune Psychosis Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Autoimmune Psychosis market. A detailed picture of the Autoimmune Psychosis pipeline landscape is provided, which includes the disease overview and Autoimmune Psychosis treatment guidelines.
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