Neuromyelitis Optica Market

Key Highlights

• Neuromyelitis optica spectrum disorder (NMOSD) is a rare but significant inflammatory and demyelinating condition of the central nervous system.
• The prevalence of neuromyelitis optica ranges from about 0.3 to 4.4 per 100,000 individuals. This condition predominantly affects females.
• Clinical characteristics of neuromyelitis optica for adult patients include optic neuritis, acute myelitis, area postrema syndrome (unexplained hiccups, nausea, or vomiting), acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic clinical syndrome with neuromyelitis optica -typical diencephalic MRI lesions, symptomatic cerebral syndrome with neuromyelitis optica -typical brain lesions.
• The current treatment for the neuromyelitis optica includes SOLIRIS (eculizumab), UPLIZNA (inebilizumab-cdon), ULTOMIRIS (ravulizumab-cwvz), and ENSPRYNG (satralizumab-mwge).
• Recently, there has been a significant advancement in the treatment landscape for neuromyelitis optica. In March 2024, nearly five years after the FDA approved SOLIRIS for neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca introduced its follow-on C5 drug, ULTOMIRIS, into the market for this rare neurological disease. The FDA has approved ULTOMIRIS for patients with anti-AQP4 antibody-positive neuromyelitis optica.
• The pipeline of the disease is limited as most of the clinical trials are conducted in China. Further advancements in research and a deeper understanding of the disease are crucial at this time to enhance the treatment landscape for neuromyelitis optica across the 7MM.

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

 

Neuromyelitis Optica market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM neuromyelitis optica market size from 2020 to 2034. The report also covers current neuromyelitis optica 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

 

Neuromyelitis Optica Understanding and Treatment Algorithm

Neuromyelitis Optica Overview, Country-Specific Treatment Guidelines and Diagnosis

Neuromyelitis optica is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and inflammation of the spinal cord (myelitis). It is sometimes referred to as Devic disease or neuromyelitis optica Spectrum Disorder (NMOSD).

 

It is evaluated by clinical examination, serologic testing for the AQP4-IgG, and MRI with (and without) gadolinium. Diagnosis is based on core clinical characteristics and supplemented by additional testing. The international consensus diagnostic criteria were established in 2015, separating NMOSD into AQP4-IgG status (with testing, without testing, or unknown) and defining clinical and MRI characteristics of neuromyelitis optical.

 

The neuromyelitis optica report provides an overview of neuromyelitis optica pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report

 

Neuromyelitis Optica Treatment

The treatment paradigm generally includes a short course of immunosuppressive therapy (usually a corticosteroid), followed by chronic immunosuppressive therapy. Treatment of the acute phase of neuromyelitis optica flare usually involves intravenous steroids such as methylprednisolone. Chronic immunosuppressive therapy can be accomplished with azathioprine or rituximab as first-line agents. Second-line agents may include mycophenolate or methotrexate. These second-line agents may be advantageous due to their infrequent dosing. Since 2019, eculizumab, inebilizumab, and satralizumab have received FDA approval for the treatment of aquaporin-4 IgG positive (AQP4+) neuromyelitis optica after showing efficacy in reducing attack frequency.

Neuromyelitis Optica Epidemiology

The neuromyelitis optica epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The neuromyelitis optica epidemiology is segmented with detailed insights into Total Prevalent Cases of Neuromyelitis Optica, Diagnosed and treatable Cases of Neuromyelitis Optica, and Gender-Specific Cases of Neuromyelitis Optica

• According to the findings, neuromyelitis optica characteristically occurs in females and younger patients between 30 and 40 years of age. Pediatric cases of neuromyelitis optica are rare but have been reported occasionally.
• According to the findings, over 95% of neuromyelitis optica patients report no family history of the disease. Additionally, there is a strong association with a personal or family history of autoimmunity, which is present in 50% of cases.

Neuromyelitis Optica Drug Chapters

The drug chapter segment of the neuromyelitis optica report encloses a detailed analysis of neuromyelitis optica marketed drugs. It also deep dives into the neuromyelitis optica pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

 

Marketed Drugs

 

SOLIRIS (eculizumab): Alexion Pharmaceutical

In June 2019, the FDA approved SOLIRIS for the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It is the first drug specifically approved by the FDA specifically for neuromyelitis optica spectrum disorder. Eculizumab is an mAb that targets the C5 antibody. FDA granted Priority Review for the application of Soliris by Alexion Pharmaceuticals, expediting the approval of the drug.

 

UPLIZNA (inebilizumab-cdon): Mitsubishi Chemical Group Corporation

The neuromyelitis optica spectrum disorder patients were offered an additional treatment option when the FDA approved a second drug, UPLIZNA injection for intravenous use, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). This drug was approved based on a clinical study of 230 adult patients that evaluated the efficacy and safety of intravenous Uplizna. During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody-positive patients who were treated with UPLIZNA was reduced by 77% when compared to the placebo treatment group.

Neuromyelitis Optica Market Outlook

The recent launch of approved therapies, increasing incidence of neuromyelitis optica disorders, and rising awareness of rare diseases are likely to fuel market growth during the study period.

 

The neuromyelitis optica market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted neuromyelitis optica market trends by analyzing the impact of current neuromyelitis optica therapies on the market, neuromyelitis optica spectrum disorder unmet needs, drivers and barriers, and demand for better technology.

Neuromyelitis Optica 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…

Neuromyelitis Optica Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II 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 neuromyelitis optica 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 10+ 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 neuromyelitis optica. 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.

 

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

 

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 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 neuromyelitis optica, 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 neuromyelitis optica 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 neuromyelitis optica market.

Neuromyelitis Optica Report Insights

• Patient Population
• Therapeutic Approaches
• Neuromyelitis Optica Pipeline Analysis
• Neuromyelitis Optica Market Size and Trends
• Existing and future Market Opportunity

Neuromyelitis Optica Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Neuromyelitis Optica 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

Neuromyelitis Optica 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 neuromyelitis optica treatment market?
• What was the neuromyelitis optica 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?
• What are the current and emerging options for the treatment of neuromyelitis optica?
• How many companies are developing therapies for the treatment of neuromyelitis optica?
• 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 neuromyelitis optica 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.