시장보고서
상품코드
2044662

사트랄리주맙(Satralizumab) : 판매 예측 및 시장 규모(2034년)

Satralizumab Sales Forecast, and Market Size Analysis - 2034

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 30 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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※ 부가세 별도
한글목차
영문목차

사트랄리주맙의 성장을 이끄는 주요 요인들

  • NMOSD에 대한 강력한 효과와 지속적인 재발 억제 효과

사트랄리주맙은 주요 임상 3상 시험인 SAkuraSky 및 SAkuraStar 시험에서 아쿠아포린4 항체 양성(AQP4-IgG+) NMOSD 환자의 재발 위험을 유의미하게 감소시키는 확실한 효능을 입증했습니다. 발표된 데이터에 따르면, AQP4-IgG+ 환자군에서 위약 대비 재발 위험이 약 74-79% 감소하는 것으로 나타났습니다. 장기 연장 시험에서 수년간 지속적인 안전성을 유지하면서 재발 예방 효과가 지속되는 것이 입증되어 만성 유지 요법으로서 의사의 신뢰가 더욱 높아졌습니다.

  • MOGAD에 대한 최초의 승인된 치료제가 될 가능성이 있어 시장 기회를 크게 확대할 수 있습니다.

2026년 4월, 제넨텍은 사트랄리주맙이 미엘린 올리고덴드로사이트 당단백질 항체 관련 질환(MOGAD) 환자에서 재발 위험을 68% 감소시켜 1차 평가변수를 달성(p=0.0025)했다는 임상 3상 METEOROID 시험의 긍정적인 데이터를 발표했습니다. 데이터를 발표했습니다. 중요한 점은 MOGAD는 현재 전 세계적으로 승인된 치료법이 없습니다는 점입니다. 규제 당국의 승인을 받으면 엔스프링은 이 심각한 신경염증성 질환에 대한 최초의 승인된 치료제가 될 것이며, NMOSD를 넘어 상업적 잠재력을 크게 확대할 수 있을 것으로 기대됩니다.

  • 편리성이 높은 피하 자가주사로 보다 폭넓은 보급이 기대됩니다.

사트랄리주맙은 정맥 투여가 필요한 일부 경쟁 생물학적 제제와 달리, 도입 투여 후 4주마다 피하로 투여하고 집에서 자가 주사할 수 있습니다. 이러한 편의성은 링거 센터에 대한 의존도를 낮추고, 환자의 삶의 질을 향상시키며, 의료 시스템의 부담을 줄일 수 있습니다. 장기적인 치료 순응도가 필수적인 만성 자가면역성 신경질환 적응증에서 투약 편의성은 점점 더 중요한 경쟁 우위가 되고 있습니다.

  • 세계 진출 및 희귀 신경면역 시장에서의 보급 확대

Roche는 미국, 유럽, 일본, 중국 등 주요 시장에서 ENSPRYNG의 세계 진출을 지속하고 있습니다. Roche의 2025년 및 2026년 재무 보고서에는 신경 시장에서의 지속적인 채택을 반영하여 엔스프링이 일본 내 의약품 매출 성장에 기여하는 제품으로 구체적으로 언급되어 있습니다. NMOSD의 진단율 증가와 항체 매개 신경면역질환에 대한 인식이 높아짐에 따라 전 세계적으로 치료 가능한 환자군이 확대되고 있습니다.

  • 입증된 IL-6 신호전달 경로와 NMOSD 치료 영역에서 차별화된 포지셔닝을 통한 차별화

IL-6 신호전달경로는 B세포의 활성화, 혈액뇌장벽의 파괴, 자가항체 생성에 미치는 영향을 통해 NMOSD의 병인에서 주요한 요인으로 현재 확립되어 있습니다. 사트랄리주맙의 표적화된 IL-6 수용체 억제는 보체 억제제나 B세포 제거 요법과는 다른 접근법을 제공합니다. 의사들은 유효성, 안전성, 편리한 투약 스케줄의 균형으로 인해 특히 ENSPRYNG를 선호할 가능성이 높습니다. 또한, 우수한 장기 내약성 프로파일은 만성 질환 관리에서 보다 광범위한 유지 요법으로의 사용을 촉진할 수 있습니다.

Satralizumab의 최근 동향

  • 2026년 4월, Roche는 METEOROID 임상 3상 시험의 새로운 데이터를 발표했습니다. 이에 따르면, ENSPRYNG(사트랄리주맙)은 미엘린 올리고덴드로사이트 당단백질 항체 관련 질환(MOGAD)을 가진 성인 및 청소년에서 위약 대비 신규 재발 위험을 68% 감소시켜 주요 평가항목을 달성한 것으로 나타났습니다. 1차 평가변수는 무작위 배정부터 이중맹검 치료 기간 중 첫 MOGAD 재발까지의 기간으로 측정했다(p=0.0025). 이 결과는 미국신경과학회(American Academy of Neurology, AAN) 2026 연례회의 Clinical Trials Plenary Session에서 최신 속보 구두 발표를 통해 공유됐습니다.

이 보고서는 주요 7개국(미국, EU4(독일, 프랑스, 프랑스, 이탈리아, 스페인, 영국, 일본)의 사트랄리주맙 시장 동향을 조사하고, 시신경척수염, 뇌염, 그레이브스 안병증, 미엘린 올리고데드로사이트 당단백질 항체 관련 질환, 뒤쉔형 근위축증 등 승인된 적응증과 잠재적 적응증에 대한 종합적인 인사이트를 제공합니다. 뒤쉔형 근이영양증 등 잠재적 적응증에 대한 종합적인 인사이트를 제공합니다.

이 보고서는 2020년부터 2034년까지 사트랄리주맙(Satralizumab)의 승인된 적응증별 사용 현황, 잠재적 적응증 진출 전망, 시장 성과에 대한 상세한 분석과 함께 승인된 적응증 및 잠재적 적응증에 대한 사트랄리주맙에 대한 상세한 설명을 제공합니다. 제공됩니다. 사트랄리주맙(Satralizumab)의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발(R&D), 기타 활동, 향후 시장 평가, SWOT 분석, 애널리스트 견해, 경쟁 구도, 각 적응증별 기타 신흥 치료제 개요, 시장을 시장을 견인하는 요인에 대해서도 분석했습니다.

자주 묻는 질문

  • 사트랄리주맙의 주요 효과는 무엇인가요?
  • 사트랄리주맙이 MOGAD에 대한 치료제로서의 가능성은 어떤가요?
  • 사트랄리주맙의 투여 방식은 어떻게 되나요?
  • 사트랄리주맙의 세계 시장 진출 현황은 어떤가요?
  • 사트랄리주맙의 IL-6 신호전달 경로에 대한 차별화된 접근법은 무엇인가요?
  • 사트랄리주맙의 시장 성과에 대한 분석은 어떻게 이루어지나요?

목차

제1장 보고서 개요

제2장 Satralizumab 개요 : 시신경척수염과 같은 승인된 적응증뿐만 아니라 뇌염, 그레이브스 안병증, 미엘린 올리고도엔드로사이트 당단백질 항체 관련 질환, 뒤쉔 근이영양증과 같은 잠재적 적응증

제3장 Satralizumab : 경쟁 구도(출시 치료제)

제4장 Satralizumab : 경쟁 구도(후기 개발 단계 신흥 치료제)

제5장 Satralizumab : 시장 평가

제6장 Satralizumab : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

LSH 26.06.08

Key Factors Driving Satralizumab Growth

  • Strong efficacy in NMOSD with durable relapse reduction

Satralizumab demonstrated robust efficacy in the pivotal SAkuraSky and SAkuraStar Phase III trials, significantly reducing relapse risk in aquaporin-4 antibody-positive (AQP4-IgG+) NMOSD patients. Published data showed relapse risk reductions of approximately 74-79% compared with placebo in AQP4-IgG+ populations. Long-term extension studies further demonstrated durable relapse prevention with sustained safety over multiple years, which has strengthened physician confidence in chronic maintenance use.

  • Potential first approved therapy for MOGAD could significantly expand market opportunity

In April 2026, Genentech announced positive Phase III METEOROID data showing satralizumab reduced relapse risk by 68% in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), meeting the primary endpoint (p=0.0025). Importantly, MOGAD currently has no approved therapies globally. If regulatory approvals are secured, ENSPRYNG could become the first approved treatment for this debilitating neuroinflammatory disease, substantially expanding its commercial potential beyond NMOSD.

  • Convenient subcutaneous self-administration supports broader adoption

Unlike several competing biologics requiring intravenous infusion, satralizumab is administered subcutaneously every four weeks after loading doses and can be self-injected at home. This convenience reduces infusion-center dependence, improves patient quality of life, and lowers healthcare-system burden. Ease of administration has become an increasingly important competitive advantage in chronic autoimmune neurology indications where long-term therapy adherence is essential.

  • Global expansion and increasing uptake in rare neuroimmunology markets

Roche has continued expanding ENSPRYNG globally across major markets including the US, Europe, Japan, and China. Roche's 2025 and 2026 financial reports specifically identified Enspryng as a contributor to pharmaceutical sales growth in Japan, reflecting continued adoption in neurology markets. Increasing diagnosis rates for NMOSD and broader awareness of antibody-mediated neuroimmune diseases are also expanding the treatable patient pool worldwide.

  • Validated IL-6 pathway and differentiated positioning within NMOSD treatment landscape

The IL-6 signaling pathway is now well established as a key driver of NMOSD pathogenesis through effects on B-cell activation, blood-brain barrier disruption, and autoantibody production. Satralizumab's targeted IL-6 receptor inhibition offers a differentiated approach versus complement inhibitors and B-cell depleting therapies. Physicians may particularly favor ENSPRYNG because of its balance of efficacy, safety, and convenient dosing schedule. Additionally, its favorable long-term tolerability profile may support broader maintenance use in chronic disease management.

Satralizumab Recent Developments

  • In April 2026, Roche announced new data from the Phase III METEOROID study demonstrating that ENSPRYNG (Satralizumab) reduced the risk of a new relapse by 68% compared to placebo in adults and adolescents with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), meeting its primary endpoint. The primary endpoint was measured by the time from randomisation to the first MOGAD relapse during the double-blind treatment period (p=0.0025). The results were shared today at a late-breaking oral presentation in the Clinical Trials Plenary Session at the 2026 American Academy of Neurology (AAN) Annual Meeting.

"Satralizumab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Satralizumab for approved indication like Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy in the 7MM. A detailed picture of Satralizumab's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Satralizumab for approved and potential indications. The Satralizumab market report provides insights about Satralizumab's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Satralizumab performance, future market assessments inclusive of the Satralizumab market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Satralizumab sales forecasts, along with factors driving its market.

Satralizumab Drug Summary

Satralizumab marketed as Enspryng, is a humanized monoclonal antibody developed by Chugai Pharmaceutical and commercialized globally by Roche for the treatment of neuromyelitis optica spectrum disorder (NMOSD) and other autoimmune neurological diseases under investigation. The drug selectively targets the interleukin-6 receptor (IL-6R), thereby inhibiting IL-6-mediated inflammatory signaling that contributes to autoantibody production, blood-brain barrier disruption, and central nervous system inflammation. Administered as a subcutaneous injection, satralizumab utilizes antibody recycling technology to extend its half-life and allow convenient maintenance dosing every four weeks following loading doses. Clinical trials, including the SAkuraSky and SAkuraStar studies, demonstrated significant reductions in relapse risk in aquaporin-4 (AQP4) antibody-positive NMOSD patients, leading to approvals in the United States, Europe, Japan, and several other regions. The therapy is generally well tolerated, with common adverse events including injection-site reactions, headache, arthralgia, and infections. Ongoing research is evaluating satralizumab in additional autoimmune and neuroinflammatory disorders due to the central role of IL-6 signaling in immune-mediated diseases. The report provides Satralizumab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Satralizumab Market Report

The report provides insights into:

  • A comprehensive product overview including the Satralizumab MoA, description, dosage and administration, research and development activities in approved indications like Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy.
  • Elaborated details on Satralizumab regulatory milestones and other development activities have been provided in Satralizumab market report.
  • The report also highlights Satralizumab's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
  • The Satralizumab market report also covers the patents information, generic entry and impact on cost cut.
  • The Satralizumab market report contains current and forecasted Satralizumab sales for approved and potential indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The Satralizumab market report also features the SWOT analysis with analyst views for Satralizumab in approved and potential indications.

Methodology:

The Satralizumab market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Satralizumab Analytical Perspective by DelveInsight

  • In-depth Satralizumab Market Assessment

This Satralizumab sales market forecast report provides a detailed market assessment of Satralizumab for approved indication like Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Satralizumab sales data uptil 2034.

  • Satralizumab Clinical Assessment

The Satralizumab market report provides the clinical trials information of Satralizumab for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Satralizumab Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Satralizumab Market Potential & Revenue Forecast

  • Projected market size for the Satralizumab and its key indications
  • Estimated Satralizumab sales potential (Satralizumab peak sales forecasts)
  • Satralizumab Pricing strategies and reimbursement landscape

Satralizumab Competitive Intelligence

  • Number of competing drugs in development (pipeline analysis)
  • Satralizumab Market positioning compared to existing treatments
  • Satralizumab Strengths & weaknesses relative to competitors

Satralizumab Regulatory & Commercial Milestones

  • Satralizumab Key regulatory approvals & expected launch timelines
  • Commercial partnerships, licensing deals, and M&A activity

Satralizumab Clinical Differentiation

  • Satralizumab Efficacy & safety advantages over existing drugs
  • Satralizumab Unique selling points

Satralizumab Market Report Highlights

  • In the coming years, the Satralizumab market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
  • The Satralizumab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Satralizumab's dominance.
  • Other emerging products for Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy are expected to give tough market competition to Satralizumab and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Satralizumab in approved and potential indications.
  • Analyse Satralizumab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted Satralizumab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Satralizumab in approved and potential indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of Satralizumab? How strong is Satralizumab's clinical and commercial performance?
  • What is Satralizumab's clinical trial status in each individual indications such as Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Satralizumab Manufacturers?
  • What are the key designations that have been granted to Satralizumab for approved and potential indications? How are they going to impact Satralizumab's penetration in various geographies?
  • What is the current and forecasted Satralizumab market scenario for approved and potential indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of Satralizumab in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
  • What are the other emerging products available and how are these giving competition to Satralizumab for approved and potential indications?
  • Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
  • How cost-effective is Satralizumab? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Satralizumab Overview in approved indications like Neuromyelitis optica; as well as potential indication like Encephalitis, Graves ophthalmopathy, Myelin oligodendrocyte glycoprotein antibody-associated disease, and Duchenne muscular dystrophy

  • 2.1. Product Detail
  • 2.2. Satralizumab Clinical Development
    • 2.2.1. Satralizumab Clinical studies
    • 2.2.2. Satralizumab Clinical trials information
    • 2.2.3. Safety and efficacy
  • 2.3. Other Developmental Activities
  • 2.4. Product Profile

3. Satralizumab Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Satralizumab Therapies)

5. Satralizumab Market Assessment

  • 5.1. Satralizumab Market Outlook in approved and potential indications
  • 5.2. 7MM Analysis
    • 5.2.1. Satralizumab Market Size in the 7MM for approved and potential indications
  • 5.3. Country-wise Market Analysis
    • 5.3.1. Satralizumab Market Size in the United States for approved and potential indications
    • 5.3.2. Satralizumab Market Size in Germany for approved and potential indications
    • 5.3.3. Satralizumab Market Size in France for approved and potential indications
    • 5.3.4. Satralizumab Market Size in Italy for approved and potential indications
    • 5.3.5. Satralizumab Market Size in Spain for approved and potential indications
    • 5.3.6. Satralizumab Market Size in the United Kingdom for approved and potential indications
    • 5.3.7. Satralizumab Market Size in Japan for approved and potential indications

6. Satralizumab SWOT Analysis

7. Analysts' Views

8. Appendix

  • 8.1. Bibliography
  • 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options

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