세계의 시신경 척수염 스펙트럼 장애(NMOSD) 시장 - 인사이트, 역학, 예측(2034년)

Key Highlights:

• NMOSD is a rare but serious autoimmune condition that causes inflammation and demyelination within the central nervous system (CNS). It predominantly affects the optic nerves, spinal cord, and brainstem, making diagnosis and treatment complex due to its varied presentation and potential for severe neurological impairment.
• The US based study determined the prevalence of NMOSD to be 6.88 per 100,000 individuals, highlighting its classification as a rare neurological condition. This figure provides valuable epidemiological insight, reinforcing the need for targeted diagnostic strategies and specialized care to address the unique challenges posed by rare disorders.
• Based on secondary analysis, cases of myelin oligodendrocyte glycoprotein antibody associated disease (MOGAD) in Europe have been documented in the UK, with a reported prevalence of 2 per 100,000 population.
• The rise in NMOSD cases is largely due to improved awareness, better diagnostic tools, and increased testing for aquaporin-4 immunoglobulin G (AQP4-IgG) antibodies. Enhanced recognition of atypical presentations and broader access to specialized care have led to more accurate diagnoses. Additionally, epidemiological efforts are uncovering previously underreported cases, contributing to higher prevalence figures.
• The NMOSD treatment landscape includes drugs like ENSPRYNG (satralizumab-mwge) by Roche, UPLIZNA (inebilizumab-cdon) by Amgen, and ULTOMIRIS (ravulizumab) AstraZeneca, offering effective relapse prevention. These therapies focus on immune modulation and complement inhibition, improving long-term outcomes and reducing disability in patients with this rare autoimmune disorder.
• The NMOSD treatment pipeline remains limited, highlighting a substantial unmet need for new therapeutic options. Despite recent advances, many patients still face inadequate disease control and long-term disability. Expanding drug development efforts is essential to address evolving clinical challenges and improve outcomes in this underserved and complex autoimmune disorder.
• According to the Roche investors' 2025 presentation, ENSPRYNG (satralizumab-mwge) in undergoing Phase III of clinical trial for MOGAD whose regulatory submission is anticipated in 2026.

DelveInsight's comprehensive report titled "Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of NMOSD. The report presents historical and projected epidemiological data covering total diagnosed prevalent cases of NMOSD, gender-specific diagnosed prevalent cases of NMOSD, and type-specific diagnosed prevalent cases of NMOSD. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across 7MM: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in NMOSD. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Overview

NMOSD, also known as Devic's disease, is a chronic condition affecting the brain and spinal cord, primarily characterized by inflammation of the optic nerve (optic neuritis) and spinal cord (myelitis). Initially considered a monophasic illness-marked by a single episode involving one or both optic nerves and the spinal cord-it was believed not to recur. However, it is now understood that most individuals meeting current diagnostic criteria for NMOSD experience multiple relapses, with symptom-free intervals ranging from weeks to years. In its early stages, NMOSD can closely resemble multiple sclerosis, making accurate diagnosis particularly challenging.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Diagnosis and Treatment Overview

Diagnosis of NMOSD involves a detailed medical history, clinical evaluation, and specialized tests such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scans, Cerebrospinal Fluid (CSF) analysis, and blood tests. The AQP4-IgG antibody test is highly specific for NMOSD and often positive at the onset of symptoms, aiding early detection. For patients negative for AQP4-IgG, the MOG-IgG antibody may indicate a related condition. Differentiating NMOSD from multiple sclerosis is crucial, as multiple sclerosis treatments may be ineffective or harmful.

Acute NMOSD attacks are typically treated with high-dose intravenous (IV) corticosteroids like methylprednisolone. If unresponsive, plasma exchange may be used. Long-term management includes immunosuppressive therapies such as corticosteroids, azathioprine, mycophenolate mofetil, and rituximab. Rituximab is especially beneficial for patients not responding to first-line treatments. Symptom control may involve carbamazepine for sudden spasms and antispasticity agents for chronic motor issues. Early and accurate diagnosis is key to effective treatment and improved outcomes.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology

The epidemiology section of the NMOSD market report offers information on the patient populations, including historical and projected trends for each of the 7MM. Examining Key Opinion Leader (KOL) views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of NMOSD. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• Secondary analysis reveals that NMOSD has a prevalence of 4.1 per 100,000 individuals in Japan. This data underscores the rarity of the condition within the Japanese population, while highlighting the importance of continued research and awareness for early diagnosis and effective management.
• A secondary analysis conducted in the US revealed a notable sex-based disparity in the prevalence of NMOSD. Among females, the condition was observed at a rate of 9.48 per 100,000 individuals, whereas among males, the prevalence was significantly lower at 3.52 per 100,000.
• The prevalence of AQP4-IgG+ NMOSD in Italy has been estimated at 2.6 cases per 100,000 people.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Outlook

The NMOSD therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

The treatment landscape has evolved significantly, shifting from broad immunosuppression to targeted biologics. Acute attacks are typically managed with high-dose IV corticosteroids and plasma exchange. For long-term prevention, three monoclonal antibodies (mAb) have received regulatory approval: ULTOMIRIS (ravulizumab), a complement inhibitor, UPLIZNA (inebilizumab), anti-CD19 B-cell depleting agent, and ENSPRYNG (satralizumab), IL-6 receptor blocker. These therapies have demonstrated efficacy in reducing relapse rates and improving patient outcomes. Additional off-label treatments include rituximab and azathioprine, though they lack formal approval for NMOSD. The emergence of these targeted therapies marks a paradigm shift toward precision medicine, offering safer and more effective options. Ongoing research into biomarkers and novel mechanisms continues to expand therapeutic possibilities, with the goal of achieving sustained remission and improved quality of life for NMOSD patients.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the NMOSD market in the 7MM is expected to change significantly during the forecast period (2025-2034).

Neuromyelitis Optica Spectrum Disorder (NMOSD) Drug Chapters

Marketed Drugs

ENSPRYNG (satralizumab-mwge): Roche

Satralizumab, developed by Genentech, a subsidiary of the Roche group is a humanized mAb engineered to inhibit interleukin-6 (IL-6) receptor activity. IL-6, a pro-inflammatory cytokine, is thought to play a central role in the pathogenesis of NMOSD by initiating inflammatory responses that result in tissue damage and neurological impairment. Utilizing innovative recycling antibody technology, ENSPRYNG offers extended antibody longevity and enables convenient subcutaneous (SC) administration once every four weeks, distinguishing it from traditional approaches.

• In June 2021, Roche reported that the European Commission (EC) had granted approval for ENSPRYNG (satralizumab) to treat NMOSD in adults and adolescents aged 12 and older who are seropositive for anti-AQP4-IgG.
• In August 2020, Roche reported that the US Food and Drug Administration (FDA) has granted approval for ENSPRYNG (satralizumab-mwge), marking it as the first and only SC therapy available for adults diagnosed with NMOSD who test positive for anti- AQP4 antibodies. Additionally, it is also approved in japan.

UPLIZNA (inebilizumab-cdon): Amgen

Inebilizumab-cdon is a humanized, afucosylated IgG1 mAb that targets CD19. While its exact mechanism of action in treating NMOSD remains unclear, it is believed to work by binding to CD19-a surface antigen found on pre-B and mature B lymphocytes. This interaction leads to the destruction of these cells through antibody-dependent cellular cytolysis.

• In April 2022, the European Medicines Agency (EMA) approved the marketing of UPLIZNA (inebilizumab-cdon) for treating NMOSD in patients who test positive for anti-AQP4 antibodies. Additionally, the drug was approved in Japan in 2021 for NMOSD.
• In June 2020, the US FDA approved UPLIZNA (inebilizumab-cdon) as a treatment option for adults diagnosed with NMOSD who test positive for anti-AQP4 antibodies.

ULTOMIRIS (ravulizumab): AstraZeneca

Ravulizumab stands out as the first and only long-acting inhibitor of the C5 complement protein, offering rapid, thorough, and lasting suppression of complement activity. It targets the C5 protein within the terminal complement pathway, a key component of the immune system. When this pathway becomes excessively activated, it can mistakenly attack healthy cells. Ravulizumab helps prevent this by blocking C5, and is administered via intravenous infusion every eight weeks in adults, following an initial loading dose. ULTOMIRIS is also approved for certain adults with NMOSD in Japan and the European Union (EU).

• In March 2024, ULTOMIRIS (ravulizumab) received approval in the US as the first and only long-acting C5 complement inhibitor indicated for the treatment of adult patients diagnosed with NMOSD who are positive for anti-AQP4 antibodies.
• The approval by the US FDA was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Segmentation

DelveInsight's 'Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future NMOSD market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Size by Countries

The NMOSD market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM NMOSD market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Size by Therapies

NMOSD Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Drugs Uptake

This section focuses on the sales uptake of potential NMOSD drugs that have recently been launched or are anticipated to be launched in the NMOSD market between 2020 and 2034. It estimates the market penetration of NMOSD drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the NMOSD market.

The emerging NMOSD therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the NMOSD market.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Access and Reimbursement

DelveInsight's 'Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of NMOSD. 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.

Key Opinion Leader (KOL) Views

To keep up with current NMOSD market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the NMOSD domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or NMOSD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the NMOSD unmet needs.

Neuromyelitis Optica Spectrum Disorder (NMOSD): KOL Insights

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as, University of California San Francisco, US, University of Bonn, Bonn, Germany; University Claude Bernard, Lyon, France; Careggi Hospital, Florence, Italy; Hospital Clinic de Barcelona, Barcelona, Spain; University of London, London, UK; and Fukushima Medical University School of Medicine, Japan, among others.

As per KOL from the US, "NMOSD can profoundly affect patient well-being, particularly through serious and lasting eye complications. These arise from optic neuritis, an inflammation of the optic nerve-that may cause sudden vision loss. Symptoms range from mild blurring to complete blindness, making early diagnosis and intervention critical to preserving visual function and quality of life."

As per KOL from the UK, "Ophthalmologists should remain vigilant for optic neuritis as a potential early indicator of NMOSD, particularly when it involves both eyes or recurs. Cases marked by severe, treatment-resistant vision loss, painful eye movements, or accompanying neurological signs-such as motor deficits, sensory disturbances, or a history of myelitis-warrant urgent referral to neurology for comprehensive assessment."

As per KOL from Japan, "A major unmet need in NMOSD is timely diagnosis and access to targeted therapies. Delayed recognition, especially in atypical or recurrent optic neuritis cases, can lead to irreversible disability. Improved awareness among clinicians, broader availability of diagnostic tools, and equitable access to immunotherapy remain critical for better patient outcomes."

Competitive Intelligence Analysis

We conduct a competitive and market intelligence analysis of the NMOSD. Market, utilizing various competitive intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Pipeline Development Activities

The report offers an analysis of therapeutic candidates in early stages and examines companies involved in developing targeted therapeutics for NMOSD. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging NMOSD therapies.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Report Insights

• NMOSD Patient Population
• Therapeutic Approaches
• NMOSD Pipeline Analysis
• NMOSD Market Size and Trends
• NMOSD Market Opportunities
• Impact of Upcoming Therapies

Neuromyelitis Optica Spectrum Disorder (NMOSD) Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• NMOSD Epidemiology Segmentation
• Key Cross Competition
• NMOSD Drugs Uptake

Neuromyelitis Optica Spectrum Disorder (NMOSD) Report Assessment

• NMOSD Current Treatment Practices
• Unmet Needs
• NMOSD Product Profiles
• NMOSD Market Attractiveness

Key Questions:

• How common is NMOSD?
• What are the key findings of NMOSD epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for NMOSD?
• What are the disease risk, burden, and unmet needs of NMOSD?
• At what CAGR is the NMOSD market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the NMOSD market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of NMOSD in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of NMOSD?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the NMOSD 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.
• To understand the existing market opportunity 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 current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of market access and reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of KOL 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.

Frequently Asked Questions:

1. What are the treatment goals for NMOSD?

Treatment goals for NMOSD focus on preventing relapses, minimizing neurological damage, and preserving long-term function. Early and sustained immunosuppressive therapy is crucial to reduce inflammation and optic nerve injury. Managing acute attacks, controlling symptoms, and improving quality of life through rehabilitation and supportive care are also key to optimizing patient outcomes and reducing disability.

2. What are the challenges in managing NMOSD?

Managing NMOSD poses several challenges, including delayed diagnosis due to symptom overlap with other conditions, unpredictable relapses, and limited access to specialized care. Treatment requires lifelong immunosuppression, which carries risks. Monitoring disease activity and preventing disability demand coordinated care across disciplines. Additionally, emotional and psychological support is often overlooked, impacting overall patient well-being and outcomes.

3. What are the key factors driving the growth of the NMOSD market?

Key factors driving NMOSD market growth include rising disease awareness, improved diagnostic capabilities, and increasing adoption of targeted biologic therapies. Advances in research, regulatory approvals of novel treatments, and growing patient advocacy also contribute. Additionally, the chronic nature of NMOSD and demand for long-term management solutions are fueling investment and expansion in this specialized therapeutic area.

4. How will the NMOSD market and epidemiology forecast report benefit the clients?

The NMOSD market and epidemiology forecast report provides valuable strategic insights into disease prevalence, patient demographics, and evolving market trends. It enables identification of commercial prospects, evaluation of treatment gaps, and informed planning for product development, market entry, or growth. Additionally, it supports stakeholders in navigating regulatory frameworks, anticipating future shifts, and making evidence-based investment or policy choices.

Table of Contents

1. Key Insights

2. Report Introduction

3. NMOSD Market Overview at a Glance

• 3.1. Market Share (%) Distribution of NMOSD by Therapies in the 7MM in 2024
• 3.2. Market Share (%) Distribution of NMOSD by Therapies in the 7MM in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Causes
• 7.4. Pathophysiology
• 7.5. Symptoms
• 7.6. Risk Factor
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
• 7.8. Treatment and Management
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale:7MM
• 8.3. Total Diagnosed Prevalent Cases of NMOSD in the 7MM
• 8.4. The United States
  • 8.4.1. Total Diagnosed Prevalent Cases of NMOSD
  • 8.4.2. Gender-specific Diagnosed Prevalent Cases of NMOSD
  • 8.4.3. Type-specific Diagnosed Prevalent Cases of NMOSD
• 8.5. EU4 and the UK
  • 8.5.1. Total Diagnosed Prevalent Cases of NMOSD
  • 8.5.2. Gender-specific Diagnosed Prevalent Cases of NMOSD
  • 8.5.3. Type-specific Diagnosed Prevalent Cases of NMOSD
• 8.6. Japan
  • 8.6.1. Total Diagnosed Prevalent Cases of NMOSD
  • 8.6.2. Gender-specific Diagnosed Prevalent Cases of NMOSD
  • 8.6.3. Type-specific Diagnosed Prevalent Cases of NMOSD

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross of Marketed Drugs
• 10.2. ENSPRYNG (satralizumab-mwge): Roche
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy
• 10.3. UPLIZNA (inebilizumab-cdon): Amgen
  • 10.3.1. Product Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Trials Information
  • 10.3.5. Safety and Efficacy
• 10.4. ULTOMIRIS (ravulizumab): AstraZeneca
  • 10.4.1. Product Description
  • 10.4.2. Regulatory Milestones
  • 10.4.3. Other Development Activities
  • 10.4.4. Clinical Trials Information
  • 10.4.5. Safety and Efficacy

11. NMOSD: Major Market Analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Attribute Analysis
• 11.4. Key Market Forecast Assumptions
  • 11.4.1. Cost Assumptions and Rebates
  • 11.4.2. Pricing Trends
  • 11.4.3. Analogue Assessment
  • 11.4.4. Launch Year and Therapy Uptake
• 11.5. Total Market Size of NMOSD in the 7MM
• 11.6. Market Size of NMOSD by Therapies in the 7MM
• 11.7. The United States Market Size
  • 11.7.1. Total Market Size of NMOSD
  • 11.7.2. Market Size of NMOSD by Therapies
• 11.8. EU4 and the UK Market Size
  • 11.8.1. Total Market Size of NMOSD
  • 11.8.2. Market Size of NMOSD by Therapies
• 11.9. Japan Market Size
  • 11.9.1. Total Market Size of NMOSD
  • 11.9.2. Market Size of NMOSD by Therapies

12. Key Opinion Leaders' Views

13. Unmet Needs

14. SWOT Analysis

15. Market Access and Reimbursement

16. Appendix

• 16.1. Bibliography
• 16.2. Abbreviations and Acronyms
• 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight