2023년 주요 7개국에서 약 561건의 자가면역성 정신질환이 진단됐습니다. 이 중 미국이 38.9%, EU 4개국과 영국이 약 39.5%, 일본이 21.5%를 차지했습니다.
자가면역성 정신질환 시장 규모는 2024년부터 2034년까지 높은 연평균 성장률(CAGR)로 꾸준히 성장할 것으로 예상됩니다. 주요 7개국에서 사트랄리주맙(RG-6168)과 ART5803과 같은 혁신적인 치료법의 도입으로 인해 성장이 촉진될 것으로 예상됩니다. 또한 자가면역질환과 약물 남용 등 자가면역성 정신질환에 대한 인식과 위험요인에 대한 인식이 높아지면서 자가면역성 정신질환의 유병률이 증가해 시장 확대에 기여할 것으로 예상됩니다.
주요 7개국의 자가면역성 정신질환 시장 규모는 2023년 약 607만 달러에 달했습니다. 이 시장은 2024년부터 2034년까지 예측 기간 동안 18.6%의 CAGR로 성장할 것으로 예상됩니다.
자가면역성 정신질환의 치료 상황은 아직 미개척 상태이며, FDA가 승인한 치료법이 없고, 현재 치료법은 증상 완화에 한계가 있으며, 부작용도 큽니다. 치료 결과를 개선하고 재발을 줄이기 위해 표적 치료가 절실히 필요합니다.
이 보고서는 주요 7개국 자가면역성 정신질환 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등의 정보를 제공합니다.
DelveInsight's "Autoimmune Psychosis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of autoimmune psychosis, historical and forecasted epidemiology, as well as the autoimmune psychosis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The autoimmune psychosis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM autoimmune psychosis market size from 2020 to 2034. The report also covers autoimmune psychosis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Autoimmune psychosis overview
Autoimmune psychosis is characterized by isolated psychotic symptoms with minimal or no neurological signs in patients who test positive for antibodies targeting neuronal membrane receptors, such as N-methyl-D-aspartate receptors (NMDAR), leucine-rich glioma-inactivated 1 (LGI1), and gamma-aminobutyric acid type A receptor (GABA-A). Particularly, antibodies against NMDAR disrupt neurotransmission, leading to psychosis and encephalitis-related symptoms. While these cases are often categorized as atypical or mild forms of autoimmune encephalitis, some experts suggest their distinct nature warrants recognition as a separate condition, autoimmune psychosis. It is classified into possible, probable, or definitive forms.
Key risk factors for autoimmune psychosis include immune dysregulation, genetic predisposition, and coexisting autoimmune conditions like lupus and multiple sclerosis. These factors highlight the importance of antibody screening in cases of treatment-resistant psychosis.
Symptoms of autoimmune psychosis include hallucinations, delusions, agitation, aggression, slow thinking, and anxiety, among others.
Autoimmune psychosis diagnosis
Autoimmune psychosis can be diagnosed using MRI, electroencephalogram, blood serological tests, and lumbar puncture. However, some critics argue that this approach may miss patients without neurological signs and have suggested alternative diagnostic criteria. Cerebrospinal fluid (CSF) analysis is essential for diagnosing autoimmune encephalitis and is typically conducted after a brain MRI. A lumbar puncture is required for suspected cases unless contraindicated.
Autoimmune psychosis treatment
Currently, there are no approved therapies for treating autoimmune psychosis. Although considered a milder form of autoimmune encephalitis, it requires the same prompt treatment as other forms of the condition. Treatment usually focuses on removing tumors and antibodies while temporarily suppressing the body's ability to produce more. Common approaches include corticosteroids, IVIg, plasmapheresis, rituximab, anticonvulsants, and psychiatric medications.
As the market is derived using a patient-based model, the autoimmune psychosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of autoimmune encephalitis, total cases of autoimmune encephalitis with neuronal surface antigens, antibodies-specific cases of autoimmune encephalitis, gender-specific cases of anti-NMDAR autoimmune encephalitis, total diagnosed prevalent cases of autoimmune psychosis and relapsed cases of autoimmune psychosis 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 autoimmune psychosis report encloses a detailed analysis of autoimmune psychosis-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the autoimmune psychosis 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
ENSPRYNG (satralizumab, RG6168): Hoffmann-La Roche (Chugai Pharmaceutical)
ENSPRYNG (satralizumab), developed by Chugai using innovative antibody recycling technology, is a humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor. It has been approved in over 60 countries for use in adults and adolescents with anti-aquaporin-4 (AQP4) antibody-positive NMOSD. In March 2023, ENSPRYNG received forerunner designation from Japan's Ministry of Health, Labour, and Welfare (MHLW) for its potential use in treating autoimmune encephalitis. Satralizumab (RG6168) has also been granted orphan drug designation (ODD) by the US FDA for the treatment of autoimmune encephalitis, specifically NMDAR-AE.
Currently, the drug is being assessed in Phase III clinical trials for autoimmune encephalitis, with the first patient enrolled in the third quarter of 2022. Hoffmann-La Roche plans to file a regulatory submission for the treatment of autoimmune encephalitis by 2026.
ART5803: Arialys Therapeutics/Nucleus Network
ART5803, an investigational monoclonal antibody developed by Arialys Therapeutics, is being evaluated for the treatment of anti-NMDAR encephalitis (ANRE). The US FDA has granted ART5803 ODD for autoimmune encephalitis, specifically NMDAR-AIE. In October 2024, Arialys Therapeutics announced the initiation of the Phase I clinical trial, marking a key milestone in advancing precision medicine for autoimmune neuropsychiatric disorders. The trial, conducted in collaboration with Nucleus Network in Melbourne, Australia, will provide safety and pharmacokinetic data from healthy volunteers by mid-2025. Arialys plans to launch a Phase IIa proof-of-concept trial for ART5803 in the second half of 2025, initially targeting patients with anti-NMDAR encephalitis.
Additionally, Arialys Therapeutics aims to submit an IND application to the US FDA by the end of 2024, exploring ART5803 for the potential treatment of autoimmune psychosis. In July 2024, Arialys presented a poster at the American Academy of Neurology (AAN) Summer Conference, titled "Peripherally Administered Therapeutic One-Armed Antibody Reversed Behavioral Abnormalities in a Marmoset Model of Anti-NMDAR Encephalitis."
Drug Class Insights
Currently, there are no approved therapies specifically for autoimmune psychosis, and treatment primarily relies on off-label therapies. The main approach focuses on immune therapies, and tumor removal may be considered if necessary.
Steroids are commonly used to reduce inflammation by suppressing immune system activity, helping control the immune response. Plasma exchange is another key treatment, where harmful antibodies are removed from the blood by drawing blood, separating the plasma, and returning the remaining blood with fresh plasma. This helps mitigate the autoimmune attack. Intravenous immunoglobulins (IVIG), a blood product, are less frequently used but can modulate immune function, block autoantibodies, and restore immune balance.
For patients who do not respond to first-line therapies, rituximab is often recommended. It works by depleting B cells, which produce autoantibodies, and has been shown to reduce the risk of future relapses. In some cases, cyclophosphamide, an immunosuppressive agent, may be used either alone or in combination with rituximab for more effective management of autoimmune psychosis.
Autoimmune psychosis is a condition marked by isolated psychotic symptoms with few or no neurological signs in patients who test positive for neuronal autoantibodies, particularly those targeting N-methyl-D-aspartate receptors (NMDAR). Although these cases are often considered atypical or mild forms of autoimmune encephalitis, some experts believe their distinct characteristics justify classifying them as a separate condition known as autoimmune psychosis. Diagnosis is based on tests such as MRI, electroencephalogram, blood serology, and lumbar puncture.
Currently, no therapies are specifically approved for autoimmune psychosis, and treatment typically involves off-label immune therapies. These may include immune-suppressing treatments like steroids, plasma exchange, intravenous immunoglobulins, and cyclophosphamide.
The development pipeline for autoimmune psychosis treatment is limited, with satralizumab (RG-6168) and ART5803 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.
Autoimmune Psychosis 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 autoimmune psychosis.
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 autoimmune psychosis 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 Johns Hopkins Bloomberg School of Public Health, US, Stanford University School of Medicine, US, University of Freiburg, Germany, Universite de Bordeaux, France, University of Bologna, Italy, University of Oxford, UK, Dokkyo Medical University, Japan, and Ibaraki Prefectural Medical Center of Psychiatry, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or autoimmune psychosis 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, autoimmune-related psychosis challenges traditional psychiatric paradigms. In cases like anti-NMDA receptor encephalitis, autoantibodies disrupt synaptic function, leading to severe psychotic features. Early identification through cerebrospinal fluid testing or serum autoantibody panels can change the trajectory of these patients' outcomes, emphasizing the need for immunological workups in psychiatric evaluations
As per the KOLs from France, patients with autoimmune psychosis require individualized care. Immunomodulators like plasmapheresis or rituximab address the root cause, while antipsychotics manage immediate psychiatric symptoms. Striking the right balance can significantly improve long-term outcomes
As per the KOLs from Japan, Japanese psychiatrists have noted that atypical psychoses can resemble antibody-mediated encephalitis, particularly NMDAR encephalitis, with acute onset and symptoms like impaired consciousness, emotional disturbances, and psychomotor abnormalities. Fever, dysautonomia, and a higher prevalence in women are also common. Abnormal EEGs and effective treatments like corticosteroids and ECT suggest a shared autoimmune cause. Early diagnosis and immunotherapy are crucial, especially when psychiatric symptoms precede neurological signs, requiring integrated psychiatric and neurological care.
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 'Autoimmune Psychosis-Market Insights, Epidemiology, and Market Forecast-2034' report provides a descriptive overview of the market access and reimbursement scenario of autoimmune psychosis.
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.
Autoimmune psychosis report insights
Autoimmune psychosis report key strengths
Autoimmune psychosis report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies