Eculizumab Sales Forecast, and Market Size Analysis - 2034

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?