Autoimmune Encephalitis (AIE) Market

• Autoimmune encephalitis (AIE) refers to brain inflammation and includes variants like acute disseminated encephalomyelitis, anti-NMDAR receptor encephalitis, Hashimoto’s encephalopathy, LG11/CASPR2-antibody encephalitis, limbic encephalitis, and Rasmussen’s encephalitis.
• Herpes simplex virus encephalitis (HSVE) can induce an immune response leading to Anti-NMDAR encephalitis. Additionally, genetic factors, such as human leukocyte antigen (HLA), are strongly linked to specific antibody production, triggering autoimmune responses like IgLON 5 antibody encephalitis.
• The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of therapies, and raised awareness.
• Approximately 70% of patients have prodromal manifestations of headache, fever, and other symptoms resembling viral etiology.
• The United States accounts for the largest market size of Autoimmune Encephalitis, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Currently there are no approved drugs for Autoimmune Encephalitis.
• Takeda’s GLOVENIN-I, and Chugai/Roches’ ENSPRYNG are some of the emerging therapies that are anticipated to contribute to the Autoimmune Encephalitis market during the forecast period (2024-2034). 

DelveInsight's “Autoimmune Encephalitis (AIE) – Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Autoimmune Encephalitis, historical and forecasted epidemiology as well as the Autoimmune Encephalitis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Autoimmune Encephalitis market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Autoimmune Encephalitis market size from 2020 to 2034. The report also covers current Autoimmune Encephalitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Autoimmune Encephalitis Understanding and Treatment Algorithm

Autoimmune Encephalitis Overview, Country-Specific Treatment Guidelines and Diagnosis

Autoimmune encephalitis (AE) is a group of disorders characterized by inflammation of the brain caused by an autoimmune response. The immune system mistakenly produces antibodies that attack proteins on the surface of brain cells, leading to neurological symptoms.

Common manifestations include: Behavioral and psychiatric changes, altered mental status and memory deficits, seizures, movement disorders like ataxia, dystonia, and myoclonus, autonomic disturbances affecting heart rate, blood pressure, and breathing, sleep problems.

Diagnosis involves ruling out other causes and meeting certain criteria, such as subacute onset of symptoms, new neurological findings, cerebrospinal fluid abnormalities, and MRI changes consistent with encephalitis. Antibody testing can help identify the specific type of AE, but a significant proportion of cases are seronegative.

Autoimmune Encephalitis Treatment

Treatment typically involves immunotherapy to suppress the aberrant immune response. First-line therapies include corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange. Second-line agents like rituximab or cyclophosphamide may be added for refractory cases.

Further details related to diagnosis and treatment are provided in the report

Autoimmune Encephalitis Epidemiology

The Autoimmune Encephalitis epidemiology chapter in the report provides historical as well as forecasted epidemiology in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Autoimmune Encephalitis epidemiology is segmented with detailed insights into prevalent cases, type-specific cases, age-specific cases, gender-specific cases, line-wise treated cases of Autoimmune Encephalitis.

• Approximately 80% of patients with anti-NMDAR encephalitis are female.
• Children were more prone to movement disorders, while memory deficits and central hypoventilation were more prevalent in adults.
• Autoimmune encephalitis (AIE) primarily affects individuals aged from early teenage years to around 50, with a median onset age of 21 years.
• Around 92% underwent first-line immunotherapy, with approximately 27% receiving second-line immunotherapy.

Autoimmune Encephalitis Drug Chapter 

The drug chapter segment of the Autoimmune Encephalitis report encloses a detailed analysis of Autoimmune Encephalitis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Autoimmune Encephalitis pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Emerging Drugs

Satralizumab: Hoffmann-La Roche

Satralizumab targets B cells, which are involved in the production of autoantibodies. It is used to reduce inflammation and mitigate the immune response in autoimmune encephalitis. Satralizumab is administered subcutaneously, which allows for a more targeted and controlled delivery. Satralizumab is currently being investigated in Phase III (NCT05503264) study, aimed at evaluating its efficacy and safety in patients with anti-NMDAR or anti-LGI1 encephalitis.

GLOVENIN-I (TAK-961): Takeda Pharmaceutical

TAK-961 (NCT05177939), also known as GLOVENIN-I, is an IVIG product developed by Nihon Pharmaceutical (a subsidiary of Takeda Pharmaceutical Company), currently in Phase III trials for autoimmune encephalitis in Japan. It has multiple therapeutic classifications and mechanisms of action, including amyloid beta-protein inhibition and immunostimulation. It holds orphan drug designations for Stevens-Johnson syndrome and toxic epidermal necrolysis. 

It is currently marketed in Japan for various conditions, including agammaglobulinemia, bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barré syndrome, motor neuron disease, pemphigus, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Note: Detailed emerging therapies assessment will be provided in the final report.

Autoimmune Encephalitis Market Outlook

Key players, such as Takeda, Hoffmann-La Roche and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Autoimmune Encephalitis.

• Immunomodulatory Therapy, Antibody Removal, Anticonvulsants, Antipsychotics, Mood Stabilizers and Supportive Care (Physical therapy, occupational therapy, speech therapy, etc.) are generally used for the treatment of Autoimmune Encephalitis.
• The market is expected to grow due to the increasing research and development activities, investments by government and private organizations, and the high unmet need for current treatments. First-line therapy consists of high-dose corticosteroid and IVIG/plasmapheresis

Autoimmune Encephalitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Autoimmune Encephalitis Activities

The report provides insights into different therapeutic candidates in Phase III stages. 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 Autoimmune Encephalitis emerging therapies. 

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Autoimmune Encephalitis. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. 

Conjoint Analysis analyzes multiple approved and 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.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 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

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Autoimmune Encephalitis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Autoimmune Encephalitis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Autoimmune Encephalitis market.

Autoimmune Encephalitis Report Insights

• Patient Population
• Therapeutic Approaches
• Autoimmune Encephalitis Pipeline Analysis
• Autoimmune Encephalitis Market Size and Trends
• Existing and future Market Opportunity 

Autoimmune Encephalitis Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage 
• Autoimmune Encephalitis Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies 
• Key Cross Competition 
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Autoimmune Encephalitis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM Autoimmune Encephalitis treatment market?
• What was the Autoimmune Encephalitis total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Autoimmune Encephalitis? 
• How many companies are developing therapies for the treatment of Autoimmune Encephalitis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Autoimmune Encephalitis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.