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시장보고서
상품코드
2019010
시신경척수염 범주질환(NMOSD) - 시장 인사이트, 역학, 시장 예측(2036년)Neuromyelitis Optica Spectrum Disorder - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
시신경척수염 범주질환(NMOSD) 시장 요약
시신경척수염 범주질환(NMOSD) 시장의 주요 성장 촉진요인
진단 능력 향상 : 진단 도구의 발전, 특히 AQP4-IgG 및 MOG-IgG 분석과 같은 바이오마커 검사의 발전으로 진단 정확도가 크게 향상되어 NMOSD 사례 식별에 대한 지연이 감소했습니다.
표적 치료 옵션 확대 : NMOSD의 면역학적 경로를 특이적으로 표적으로 하는 단클론항체 및 보체 억제제와 같은 새로운 생물학적 제제의 출시와 승인으로 치료 접근법이 변화하고 있으며, 치료 채택률과 시장 수요가 증가하고 있습니다.
새로운 NMOSD 치료제 출시 : BAT4406F(Bio-Thera Solutions), Telitacicept(RC18)(RemeGen/Vor Bio), Divozilimab(BCD-132)(Biocad)와 같은 새로운 치료제의 출시로 향후 몇 년 동안 NMOSD 시장의 역학은 변화할 것으로 예상됩니다.
NMOSD 치료제 시장은 유병률 증가, 기술 발전, 새로운 치료법의 등장 등 주요 시장 촉진요인으로 인해 예측 기간(2025-2034년) 동안 더욱 확대될 것으로 예상됩니다.
치료 환경은 크게 변화하고 있으며, 광범위한 면역 억제 요법에서 표적화된 생물학적 제제로 전환하고 있습니다. 급성 발작은 보통 고용량의 정맥내 코르티코스테로이드 투여와 혈장교환을 통해 관리합니다. 장기적인 예방의 경우, 3 개의 단클론항체(mAb)가 규제 당국의 승인을 받았습니다. 보체 억제제인 ULTOMIRIS(rabulizumab), 항CD19-B세포 제거제인 UPLIZNA(inebilizumab), IL-6 수용체 억제제인 ENSPRYNG(satralizumab)이 그것입니다. 이러한 치료법은 재발률 감소와 환자 예후 개선에 효과가 있는 것으로 나타났습니다. 다른 적응증 외 치료제로는 리툭시맙과 아자티오프린(azathioprine)이 있지만, NMOSD에 대한 공식적인 승인은 받지 못했습니다. 이러한 표적 치료제의 등장은 보다 안전하고 효과적인 대안을 제공하는 정밀의료로의 패러다임 전환을 의미합니다. 바이오마커와 새로운 기전에 대한 지속적인 연구로 치료의 가능성은 계속 확대되고 있으며, NMOSD 환자의 지속적인 관해와 삶의 질 향상을 목표로 하고 있습니다.
현재의 연구와 헌신적인 노력으로, 미래에는 더 효과적인 치료법, 그리고 궁극적으로 이 어려운 질병을 근절할 수 있는 희망이 열리고 있습니다. DelveInsight에 따르면, 주요 7개 시장의 NMOSD 시장은 예측 기간(2026-2036년) 동안 큰 변화가 있을 것으로 예상됩니다.
본 보고서는 시신경척수염 범주질환(NMOSD)의 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본) 시장을 조사 분석했으며, 각국의 시장 규모와 예측, 각 치료법의 시장 점유율, 현재 치료법, 미충족 수요 등의 정보를 정리하여 전해드립니다.
Neuromyelitis Optica Spectrum Disorder Market Summary
Neuromyelitis Optica Spectrum Disorder Market and Epidemiology Analysis
DelveInsight's comprehensive report titled "Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2036" 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 2022 to 2036.
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.
Key Factors Driving the Growth of the Neuromyelitis Optica Spectrum Disorder Market
Improved Diagnostic Capabilities: Advances in diagnostic tools, especially biomarker testing like AQP4-IgG and MOG-IgG assays, have significantly increased diagnostic accuracy and reduced delays in identifying NMOSD cases.
Expansion of Targeted Therapeutic Options: The launch and approval of novel biologic therapies, such as monoclonal antibodies and complement inhibitors, that specifically target immune pathways in NMOSD have transformed treatment approaches, driving higher adoption and market demand.
Launch of Emerging NMOSD Drugs: The dynamics of the NMOSD market are expected to change in the coming years due to the launch of emerging therapies such as BAT4406F (Bio-Thera Solutions), Telitacicept (RC18) (RemeGen/Vor Bio), Divozilimab (BCD-132) (Biocad), and others.
Neuromyelitis Optica Spectrum Disorder 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 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.
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
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 (2026-2036).
Neuromyelitis Optica Spectrum Disorder 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.
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.
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).
SOLIRIS: AstraZeneca
SOLIRIS (eculizumab) is a first-in-class complement inhibitor that works by inhibiting the C5 protein in the terminal part of the complement cascade, a part of the immune system. he terminal complement cascade, when activated in an uncontrolled manner, plays a role in severe rare and ultra-rare disorders. SOLIRIS is approved in the US, EU, and Japan for the treatment of NMOSD.
Neuromyelitis Optica Spectrum Disorder Emerging Drugs
BAT4406F: Bio-Thera Solutions
BAT4406F, developed by Bio-Thera Solutions, is an investigational Phase II glyco-engineered monoclonal antibody (mAb) in China designed to enhance antibody-dependent cellular cytotoxicity. It is a type I anti-CD20 antibody that induces B-cell depletion through complement-dependent cytotoxicity while strengthening antibody-dependent cellular cytotoxicity (ADCC), and is being evaluated for autoimmune indications, including NMOSD.
In July 2025, the BAT4406F NMOSD clinical trial in China was terminated early following an Independent Data Monitoring Committee (IDMC) review, after the study met pre-defined superiority criteria versus the control arm, indicating meaningful efficacy. Earlier, Phase I results published in January 2025 showed BAT4406F to be well tolerated, with clear pharmacodynamic activity reflected by sustained depletion of CD19-positive B cells.
Although current clinical development is concentrated in China and limited autoimmune trials are ongoing in the US and European markets, Bio-Thera's prior experience with regulatory interactions outside China suggests that expansion into other geographies may be considered as development progresses.
Telitacicept (RC18): RemeGen/Vor Bio
Telitacicept (RC18) is a proprietary novel fusion protein designed to treat autoimmune diseases. It is constructed using the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor, combined with the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets two key signaling molecules involved in B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
In June 2025, VOR BIO entered into an exclusive global licensing agreement with REMEGEN for telitacicept. Under the terms of the agreement, VOR BIO obtained rights to develop and commercialize telitacicept outside Greater China.
REMEGEN received an initial consideration of USD 125 million, comprising an upfront payment of USD 45 million and USD 80 million in warrants, and is eligible to receive additional regulatory and commercial milestone payments exceeding USD 4 billion, along with tiered royalties on net sales.
Neuromyelitis Optica Spectrum Disorder Market Segmentation
DelveInsight's 'Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2036' 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 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 Market Size by Therapies
NMOSD Market Size by Therapies is categorized into current and emerging markets for the study period 2022-2036.
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 2022 and 2036. 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 Market Access and Reimbursement
DelveInsight's 'Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast - 2036' 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 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 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.
The table of contents is not exhaustive; the final content may vary.