한글목차

에쿨리주맙의 성장을 이끄는 주요 요인

1. 시장 점유율 확대 및 신규 환자 수 증가

• 에쿨리주맙은 보체 억제제로서 중요한 위치를 차지하고 있는 생물학적 제제로, 출시 이후 발작성 야간 혈색소뇨증(PNH), 비정형 용혈성 요독 증후군(aHUS) 등 희귀한 보체 관련 질환의 치료제로서 큰 시장 점유율을 확보했습니다. 시장 진입이 빨랐기 때문에 의사들의 인지도가 높고, 적격 환자들의 채택률도 높은 수준을 유지하고 있습니다.
• 이후 전신성 중증근무력증(gMG), 시신경척수염 스펙트럼 질환(NMOSD) 등 추가 적응증 승인 확대로 환자 기반이 확대되고, 전 세계 진단율 향상에 따라 신규 환자 유입이 지속적으로 촉진되고 있습니다.
• 또한, 고가의 희귀질환 생물학적 제제로서, 특히 강력한 희귀질환 프로그램이 있는 선진국 시장에서는 상환 정책 및 의료 접근성 프레임워크도 채택에 영향을 미쳐 지속적인 처방량 증가에 기여하고 있습니다.

2. 주요 적응증 확대

• 발작성 야간 혈색소뇨증(PNH) : 에크리주맙은 PNH 환자의 혈관 내 용혈을 줄이고 삶의 질을 개선하는 주요 치료 옵션으로 자리매김하고 있습니다.
• 비정형 용혈성 요독증 증후군(aHUS) : 이 약은 또 다른 희귀하고 생명을 위협하는 질환인 aHUS에서 보체 의존성 미세혈관 장애를 억제하는 목적으로 승인됐습니다.
• 전신성 중증근무력증(gMG) : 성인 환자 및 최근 규제 개정으로 6세 이상 ACHR 항체 양성 gMG 소아 환자 적응증이 추가되어 치료가 어려운 신경근육질환에 대한 대응이 가능해졌습니다.
• 시신경척수염 스펙트럼 질환(NMOSD) : NMOSD 적응증 확대로 자가면역성 신경질환에 대한 임상적 유용성이 더욱 확대될 것으로 기대됩니다.

3. 지리적 확장

• 북미는 선진화된 의료 시스템, 높은 질병 인식도, 희귀질환 바이오의약품에 대한 종합적인 상환 체계에 힘입어 여전히 에쿨리주맙 시장을 주도하고 있습니다.
• 유럽은 독일, 영국, 프랑스, 이탈리아 등 주요 국가에서 널리 채택되어 적응 확대 및 지원 정책으로 사용을 촉진하여 큰 점유율을 차지하고 있습니다.
• 일본, 중국, 신흥시장을 포함한 아시아태평양에서는 의료 인프라 및 희귀질환 진단이 개선됨에 따라 에크리주맙의 채택이 확대되고 있습니다. 인도 등 신규 시장 출시로 지리적 범위도 확대되고 있습니다.
• 라틴아메리카와 중동 및 아프리카는 규모는 작지만 희귀질환 치료제에 대한 접근성이 개선되면서 성장세를 이어가고 있습니다.

4. 신규 적응증 승인

• 에쿨리주맙의 적응증은 당초 PNH(용혈성요독증후군) 승인을 넘어 aHUS(항인간 C4 수용체 항체 관련 용혈성요독증후군), gMG(범발성교세포증식증), NMOSD(다발성 경화증 유사 시신경척수염) 등으로 확대되어 희귀면역질환 전반에 걸쳐 잠재적 환자군과 임상적 의의가 크게 증가하고 있습니다.
• 최근 규제 당국의 승인(예 : 소아 중증 글리세라제 증후군(gMG) 적응증)으로 인해, 특히 의료 혜택이 부족한 소아 환자군에 대한 적응증이 더욱 확대되고 있습니다.
• 보체 관련 질환에 대한 지속적인 연구는 향후 적응증 확대를 뒷받침할 것입니다.

5. 견조한 판매량 추이

• 솔리리스 자체는 여전히 널리 사용되고 있지만, 판매량 추이는 차세대 약물(예 : 알토미리스/라브릴주맙)과 바이오시밀러의 진입으로 인한 경쟁의 영향을 많이 받고 있으며, 시장 전체에서 이용 동역학이 변화하고 있습니다.
• 에쿨리주맙은 기존 적응증에서 높은 수요를 유지하고 있으며, 희귀질환의 진단율 증가와 치료 접근성 향상에 따라 지속적인 성장이 예상됩니다.
• 신흥 의료 환경에서의 채택 확대와 비용 장벽을 낮추는 바이오시밀러의 진입이 판매량 추이에 더욱 영향을 미칠 것으로 예상됩니다.

6. 경쟁 차별화 및 시장 동향

• 에쿨리주맙은 최초로 승인된 보체 C5 억제제 중 하나로, 여러 희귀질환에 대한 다년간의 임상적 근거를 바탕으로 많은 치료 가이드라인에서 표준 치료제로 자리매김하고 있습니다.
• 희귀질환에 대한 인식의 증가, 진단 기술의 발전, 맞춤형 의료 접근법 등 광범위한 트렌드가 치료 패러다임에 대한 지속적인 연관성과 통합을 뒷받침하고 있습니다.
• 바이오시밀러와 차세대 보체 억제제(예 : 라브릴주맙/ULTOMIRIS)의 등장으로 투여 간격이 길어지고 다양한 투여 방법이 제공되면서 처방자와 환자의 선호도 변화를 반영하여 시장 역학이 변화하고 있습니다.
• 특히, 보다 저렴한 바이오시밀러 대체품이 출시됨에 따라 지불자는 비용 효율성과 가치 기반 치료 프레임워크에 점점 더 초점을 맞추고 있습니다.

이 보고서는 용혈성 요독 증후군, 중증근무력증, 시신경척수염, 발작성 야간 혈색소뇨증 등 승인된 적응증과 이식편대숙주병, 길랭 바레 증후군, 신장 이식 거부반응 등 잠재적 적응증에 대한 종합적인 인사이트를 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국)에서 에크리주맙의 잠재적 적응증에 대한 종합적인 인사이트를 제공합니다. 2020년부터 2034년까지 주요 7개국에서 에쿨리주맙의 승인된 적응증과 잠재적 적응증에서 에쿨리주맙의 사용 현황, 진입 전망, 성과에 대한 상세한 전망과 함께 승인된 적응증과 잠재적 적응증에서 에쿨리주맙에 대한 자세한 설명을 제공합니다. 또한 이 약물의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발 및 기타 활동에 대한 정보를 제공합니다. 또한, 과거 및 현재 에쿨리주맙의 실적, 향후 시장 평가, SWOT 분석, 애널리스트의 견해, 경쟁사 개요, 각 적응증별 다른 신흥 치료제의 개요, 매출 예측 분석, 시장 견인 요인 등을 정리하여 수록했습니다.

목차

제1장 보고서 개요

제2장 에쿨리주맙 개요 : 용혈성 요독 증후군, 중증근무력증, 시신경척수염, 발작성 야간혈색소뇨증 등의 승인 적응증 및 이식 기능 지연, 길랭 바레 증후군, 신장 이식 거부반응 등의 잠재적 적응증

제3장 에쿨리주맙 : 경쟁 구도(시판 치료제)

제4장 에쿨리주맙 : 경쟁 구도(개발 후기 치료제)

제5장 에쿨리주맙 : 시장 평가

제6장 에쿨리주맙 : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 보고서 구입 옵션

영문목차

Key Factors Driving Eculizumab Growth

1. Market Share Gains and New Patient Starts

• Eculizumab has been a cornerstone complement-inhibitor biologic, capturing significant market share in the treatment of rare complement-mediated disorders such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) since its launch. Its early first-to-market leadership established strong physician familiarity and high uptake among eligible patients.
• Over time, expanded approvals into additional indications including generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) have broadened its patient base and driven continued new patient starts as diagnosis rates increase globally.
• As a high-cost orphan biologic, adoption has also been influenced by reimbursement policies and healthcare access frameworks, particularly in developed markets with strong rare disease programs, contributing to sustained prescription volumes.

2. Expansion Across Key Indications

• Paroxysmal Nocturnal Hemoglobinuria (PNH): Eculizumab remains a key treatment option for reducing intravascular hemolysis and improving quality of life in PNH patients.
• Atypical Hemolytic Uremic Syndrome (aHUS): The drug is approved to inhibit complement-mediated microangiopathy in aHUS, another rare, life-threatening condition.
• Generalized Myasthenia Gravis (gMG): Indicated for adults and, following recent regulatory updates, pediatric patients aged >=6 years with AChR antibody-positive gMG, addressing a challenging neuromuscular disorder.
• Neuromyelitis Optica Spectrum Disorder (NMOSD): Expansion into NMOSD further broadens clinical utility in autoimmune neurologic disease.

3. Geographic Expansion

• North America continues to dominate the Eculizumab market, driven by advanced healthcare systems, high disease awareness, and comprehensive reimbursement frameworks for rare disease biologics.
• Europe holds a significant share with broad uptake across major countries such as Germany, the UK, France, and Italy, where expanded indications and supportive policies bolster use.
• The Asia-Pacific region - including Japan, China, and emerging markets - is increasingly adopting Eculizumab as healthcare infrastructure and rare disease diagnosis improve; launches in new markets like India are expanding geographic reach.
• Latin America and Middle East & Africa represent smaller but growing segments as access to orphan drugs improves.

4. New Indication Approvals

• Eculizumab's label has expanded well beyond its original PNH approval to include aHUS, gMG, and NMOSD, significantly increasing its potential patient population and clinical relevance across rare immune-mediated diseases.
• Recent regulatory actions (e.g., pediatric gMG approval) further broaden eligibility, particularly in underserved pediatric subgroups.
• Continued investigation into additional complement-mediated disorders supports future indication expansions.

5. Strong Volume Momentum

• While SOLIRIS itself remains widely used, volume patterns are increasingly shaped by competition from next-generation agents (e.g., ULTOMIRIS/ravulizumab) and biosimilar entries, which are reshaping utilization dynamics across markets.
• Eculizumab maintains strong demand in established indications, with continued growth expected as diagnosis rates for rare diseases rise and treatment access improves.
• Adoption in emerging healthcare settings and the entry of biosimilars that reduce cost barriers are anticipated to further influence volume trends.

6. Competitive Differentiation and Market Trends

• Eculizumab was one of the first complement C5 inhibitors approved, establishing a long track record of clinical evidence in multiple rare diseases and anchoring it as a standard of care in many treatment guidelines.
• Broader trends such as increased rare disease awareness, improved diagnostic techniques, and personalized medicine approaches support continued relevance and integration into treatment paradigms.
• Market dynamics are shifting with the entry of biosimilars and next-generation complement inhibitors (e.g., ravulizumab/ULTOMIRIS) that offer longer dosing intervals or different delivery options, reflecting evolving prescriber and patient preferences.
• Payers are increasingly focused on cost-effectiveness and value-based care frameworks, particularly as more affordable biosimilar alternatives become available.

Eculizumab Recent Developments

Eculizumab Biosimilars Launching & Available:

• EPYSQLI (eculizumab), a biosimilar referencing Soliris, became available in the US in 2025 via a strategic partnership between Teva Pharmaceuticals and Samsung Bioepis, offering cost savings and expanded access for patients with PNH, aHUS, and adult gMG.
• The FDA approved Bkemv (eculizumab), the first interchangeable biosimilar to Soliris for PNH and aHUS, facilitating broader patient access in the US and further intensifying competition.

Expanded Indications:

• The US FDA approved expanded use of Soliris to include pediatric generalized myasthenia gravis (anti-AChR antibody-positive patients aged >=6 years), broadening treatment options for a younger patient population.

India Market Launch (2025):

• AstraZeneca Pharma India announced plans to launch Eculizumab (Soliris) in India in August 2025 after receiving regulatory approval earlier in the year, marking a key geographic expansion.
• Additionally, a post-marketing surveillance study of Soliris in India was approved by local regulators, indicating ongoing efforts to monitor safety and support real-world usage

"Eculizumab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Eculizumab for approved indication like Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject in the 7MM. A detailed picture of Eculizumab'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 Eculizumab for approved and potential indications. The Eculizumab market report provides insights about Eculizumab'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 Eculizumab performance, future market assessments inclusive of the Eculizumab 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 Eculizumab sales forecasts, along with factors driving its market.

Eculizumab Drug Summary

Eculizumab (Soliris) is a recombinant humanized monoclonal antibody that specifically binds to complement protein C5, preventing its cleavage into C5a and C5b fragments to inhibit the terminal complement pathway and formation of the membrane attack complex (MAC), thereby reducing intravascular hemolysis, endothelial damage, and inflammation in complement-mediated diseases. It is approved for paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis risk, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, generalized myasthenia gravis (gMG) in anti-acetylcholine receptor antibody-positive adults, neuromyelitis optica spectrum disorder (NMOSD) in anti-aquaporin-4 antibody-positive patients, and certain transplant rejections. Administered via intravenous infusion (loading dose followed by maintenance every 1-2 weeks, e.g., 900 mg weekly then 1200 mg biweekly for adults), it requires meningococcal vaccination and prophylaxis due to increased Neisseria meningitidis infection risk from preserved upstream complement opsonization. The report provides Eculizumab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Eculizumab Market Report

The report provides insights into:

• A comprehensive product overview including the Eculizumab MoA, description, dosage and administration, research and development activities in approved indications like Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject.
• Elaborated details on Eculizumab regulatory milestones and other development activities have been provided in Eculizumab market report.
• The report also highlights Eculizumab'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 Eculizumab market report also covers the patents information, generic entry and impact on cost cut.
• The Eculizumab market report contains current and forecasted Eculizumab sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Eculizumab market report also features the SWOT analysis with analyst views for Eculizumab in approved and potential indications.

Methodology:

The Eculizumab 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.

Eculizumab Analytical Perspective by DelveInsight

• In-depth Eculizumab Market Assessment

This Eculizumab sales market forecast report provides a detailed market assessment of Eculizumab for approved indication like Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject 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 Eculizumab sales data uptil 2034.

• Eculizumab Clinical Assessment

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

Eculizumab 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.

Eculizumab Market Potential & Revenue Forecast

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

Eculizumab Competitive Intelligence

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

Eculizumab Regulatory & Commercial Milestones

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

Eculizumab Clinical Differentiation

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

Eculizumab Market Report Highlights

• In the coming years, the Eculizumab 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 Eculizumab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Eculizumab's dominance.
• Other emerging products for Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject are expected to give tough market competition to Eculizumab 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 Eculizumab in approved and potential indications.
• Analyse Eculizumab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Eculizumab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Eculizumab in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Eculizumab? How strong is Eculizumab's clinical and commercial performance?
• What is Eculizumab's clinical trial status in each individual indications such as Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Eculizumab Manufacturers?
• What are the key designations that have been granted to Eculizumab for approved and potential indications? How are they going to impact Eculizumab's penetration in various geographies?
• What is the current and forecasted Eculizumab market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Eculizumab 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 Eculizumab 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 Eculizumab? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Eculizumab Overview in approved indications like Haemolytic uraemic syndrome; Myasthenia gravis; Neuromyelitis optica; Paroxysmal nocturnal haemoglobinuria; as well as potential indications like Delayed graft function; Guillain-Barre syndrome; and Renal transplant reject

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

3. Eculizumab Competitive Landscape (Marketed Therapies)

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

5. Eculizumab Market Assessment

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

6. Eculizumab 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