Product Code: GVR-4-68040-616-0
Zilbrysq (Zilucoplan) Market Growth & Trends:
The global zilbrysq (zilucoplan) market size is anticipated to reach USD 679.58 million by 2030 and is expected to expand at a CAGR of 28.39% during the forecast period, according to a new report by Grand View Research, Inc. Zilbrysq, a first-in-class self-administered subcutaneous complement C5 inhibitor developed by UCB, is rapidly redefining the treatment paradigm for generalized myasthenia gravis (gMG). Approved in the U.S., EU, Japan, Canada, and South Korea, the therapy's unique delivery model and targeted mechanism have positioned it as a high-value therapeutic in the rare autoimmune neuromuscular segment.
A key driver is the growing prioritization of targeted, mechanism-based therapies in generalized myasthenia gravis (gMG), particularly for patients inadequately managed by corticosteroids, IVIg, or plasma exchange. Zilbrysq's ability to selectively inhibit terminal complement activation provides clinicians with a high-precision intervention that aligns with modern treatment algorithms focused on immunological specificity and long-term safety. In addition, its once-daily subcutaneous formulation disrupts the traditional hospital-dependent model, enabling therapy decentralization and supporting long-term disease control in outpatient and home settings. This has not only improved patient adherence but also reduced infusion-related costs-an increasingly important consideration for payers. The absence of direct SC C5 competitors further enhances its commercial positioning. Moreover, rare disease policy frameworks, including orphan drug incentives, expedited approvals, and national reimbursement prioritization in key markets, have accelerated both access and prescriber uptake. These dynamics, combined with a predictable treatment population and low therapeutic redundancy, continue to reinforce Zilbrysq's strategic value within the gMG treatment landscape.
Zilucoplan works by selectively inhibiting the cleavage of complement component 5 (C5), preventing formation of the membrane attack complex (C5b-9), which plays a central role in neuromuscular junction damage in AChR antibody-positive gMG. Unlike traditional immunosuppressants or IV biologics, Zilbrysq is administered via once-daily subcutaneous injection, allowing patients to self-manage their therapy at home. This significantly reduces treatment burden and improves long-term adherence, particularly among patients transitioning away from hospital-based IV infusions.
As of 2024, Zilbrysq holds 100% indication share for gMG, with no active development in additional indications following the strategic discontinuation of clinical programs in PNH, ALS, and IMNM. However, its strong efficacy profile, convenient SC delivery, and orphan drug exclusivity until 2030 provide a significant commercial moat and sustained revenue potential in its approved population.
Specialty pharmacies serve as the primary distribution channel, accounting for over 70% of dispensed volumes in 2024, reflecting the need for coordinated patient education, adherence monitoring, and cold-chain logistics. Hospital pharmacies continue to play a role in treatment initiation and support for newly diagnosed or complex cases. Meanwhile, home healthcare providers represent the fastest-growing distribution segment, driven by increasing demand for decentralized care and improved at-home treatment infrastructure.
In October 2023, the U.S. FDA approved Zilbrysq, supported by the pivotal RAISE study, which demonstrated statistically significant improvements in MG-ADL and QMG scores versus placebo. Subsequently, the European Commission approved the therapy in December 2023, followed by authorizations in the UK (January 2024), Canada (July 2024), and South Korea (November 2024). Moreover, a 60-week extension study (RAISE-XT) published in May 2024 validated the drug's long-term safety and durability of clinical benefit in gMG.
Further bolstering its real-world readiness, a human factors validation study published in November 2024 confirmed the usability of Zilbrysq's prefilled syringe for patients, caregivers, and healthcare professionals, reinforcing its at-home applicability and alignment with patient-centric care models. As demand for precision therapies rises globally, UCB invests in market expansion across Asia Pacific, Latin America, and the Middle East. Strategic emphasis on supply chain scalability, real-world data generation, and digital adherence platforms is expected to enhance global reach and continuity of care.
The commercial success of Zilbrysq reflects a broader industry shift toward self-administered, mechanism-specific biologics that offer durable disease control without the need for hospital-based delivery. With a strong clinical foundation and limited direct competition in the SC complement inhibitor class, Zilucoplan is poised to remain a market leader in gMG, driving meaningful improvements in patient outcomes and quality of life.
Zilbrysq (Zilucoplan) Market Report Highlights:
- Generalized Myasthenia Gravis (gMG) remained the exclusive and leading indication in the market in 2024, accounting for 100% of the market share. The high prevalence of anti-acetylcholine receptor (AChR) antibody-positive patients, combined with Zilucoplan's targeted mechanism of action as a complement C5 inhibitor, has driven strong adoption. Favorable clinical trial outcomes, orphan drug exclusivity, and inclusion in updated treatment guidelines across key markets have accelerated uptake, particularly among patients transitioning from conventional immunosuppressants or IV therapies.
- Specialty Pharmacies held the largest share of the distribution channel segment in the market in 2024, accounting for 70.35% of dispensed volumes. This dominance is attributed to the drug's classification as a high-cost orphan biologic requiring cold-chain logistics, patient education, and long-term adherence support-all core competencies of specialty pharmacy providers. Specialty pharmacies also play a crucial role in managing refill coordination and benefit verification, especially for self-administered therapies like Zilucoplan.
- North America led the Zilbrysq market in 2024 with a share of 77.78%, supported by early regulatory approval, broad prescriber familiarity with complement inhibitors, and high diagnostic rates for gMG. The region's well-established specialty pharmacy networks and payer willingness to reimburse high-cost orphan drugs further support strong commercial performance. Real-world evidence from U.S. and Canadian clinical practice is expected to reinforce treatment persistence and expand the prescriber base.
- UCB continues to lead the global market, backed by strategic regulatory filings, targeted physician education, and investments in post-marketing data generation. The company's long-term growth strategy underpins its emphasis on supply chain scalability, real-world adherence support, and regional expansion, especially in markets like Japan, Canada, and South Korea. UCB's focused positioning within complement-mediated neuromuscular disorders strengthens its competitive advantage in a market with limited direct SC-based alternatives.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Indication
- 1.2.2. Distribution Channel
- 1.3. Estimates and Forecast Timeline
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR's Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.6. Information Analysis
- 1.6.1. Data Analysis Models
- 1.7. Market Formulation & Data Visualization
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. List of Secondary Sources
- 1.10. Objectives
Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
Chapter 3. Zilbrysq (Zilucoplan) Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.3. Business Environment Analysis
- 3.3.1. Industry Analysis - Porter's Five Forces Analysis
- 3.3.1.1. Supplier Power
- 3.3.1.2. Buyer Power
- 3.3.1.3. Substitution Threat
- 3.3.1.4. Threat of New Entrants
- 3.3.1.5. Competitive Rivalry
- 3.3.2. PESTLE Analysis
- 3.4. Pipeline Analysis
- 3.5. Patent Expiry Analysis
- 3.6. Pricing Analysis
Chapter 4. Zilbrysq (Zilucoplan) Market: Indication Business Analysis
- 4.1. Indication Market Share, 2024 & 2030
- 4.2. Indication Segment Dashboard
- 4.3. Market Size & Forecasts and Trend Analysis, by Indication, 2018 to 2030 (USD Million)
- 4.4. Generalized Myasthenia Gravis (gMG)
- 4.4.1. Generalized Myasthenia Gravis (gMG) Market, 2018 - 2030 (USD Million)
- 4.5. Others
- 4.5.1. Others Market, 2018 - 2030 (USD Million)
Chapter 5. Zilbrysq (Zilucoplan) Market: Distribution Channel Business Analysis
- 5.1. Distribution Channel Market Share, 2024 & 2030
- 5.2. Distribution Channel Segment Dashboard
- 5.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2018 to 2030 (USD Million)
- 5.4. Specialty Pharmacies
- 5.4.1. Specialty Pharmacies Market, 2018 - 2030 (USD Million)
- 5.5. Hospital/Institution-Based Pharmacies
- 5.5.1. Hospital/Institution-Based Pharmacies Market, 2018 - 2030 (USD Million)
- 5.6. Home Healthcare Providers
- 5.6.1. Home Healthcare Providers Market, 2018 - 2030 (USD Million)
Chapter 6. Zilbrysq (Zilucoplan) Market: Regional Estimates & Trend Analysis
- 6.1. Regional Market Share Analysis, 2024 & 2030
- 6.2. Regional Market Dashboard
- 6.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
- 6.4. North America
- 6.4.1. North America Zilbrysq (Zilucoplan) Market Estimates and Forecasts, By Country, 2018 - 2030 (USD Million)
- 6.4.2. U.S.
- 6.4.2.1. Key Country Dynamics
- 6.4.2.2. Target Disease Prevalence
- 6.4.2.3. Regulatory Framework
- 6.4.2.4. Reimbursement Framework
- 6.4.2.5. U.S. Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.3. Canada
- 6.4.3.1. Key Country Dynamics
- 6.4.3.2. Target Disease Prevalence
- 6.4.3.3. Regulatory Framework
- 6.4.3.4. Reimbursement Framework
- 6.4.3.5. U.S. Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.4. Mexico
- 6.4.4.1. Key Country Dynamics
- 6.4.4.2. Target Disease Prevalence
- 6.4.4.3. Regulatory Framework
- 6.4.4.4. Reimbursement Framework
- 6.4.4.5. Mexico Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5. Europe
- 6.5.1. Europe Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.2. UK
- 6.5.2.1. Key Country Dynamics
- 6.5.2.2. Target Disease Prevalence
- 6.5.2.3. Regulatory Framework
- 6.5.2.4. Reimbursement Framework
- 6.5.2.5. UK Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.3. Germany
- 6.5.3.1. Key Country Dynamics
- 6.5.3.2. Target Disease Prevalence
- 6.5.3.3. Regulatory Framework
- 6.5.3.4. Reimbursement Framework
- 6.5.3.5. Germany Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.4. France
- 6.5.4.1. Key Country Dynamics
- 6.5.4.2. Target Disease Prevalence
- 6.5.4.3. Regulatory Framework
- 6.5.4.4. Reimbursement Framework
- 6.5.4.5. France Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.5. Italy
- 6.5.5.1. Key Country Dynamics
- 6.5.5.2. Target Disease Prevalence
- 6.5.5.3. Regulatory Framework
- 6.5.5.4. Reimbursement Framework
- 6.5.5.5. Italy Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.6. Spain
- 6.5.6.1. Key Country Dynamics
- 6.5.6.2. Target Disease Prevalence
- 6.5.6.3. Regulatory Framework
- 6.5.6.4. Reimbursement Framework
- 6.5.6.5. Spain Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.7. Denmark
- 6.5.7.1. Key Country Dynamics
- 6.5.7.2. Target Disease Prevalence
- 6.5.7.3. Regulatory Framework
- 6.5.7.4. Reimbursement Framework
- 6.5.7.5. Denmark Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.8. Sweden
- 6.5.8.1. Key Country Dynamics
- 6.5.8.2. Target Disease Prevalence
- 6.5.8.3. Regulatory Framework
- 6.5.8.4. Reimbursement Framework
- 6.5.8.5. Sweden Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5.9. Norway
- 6.5.9.1. Key Country Dynamics
- 6.5.9.2. Target Disease Prevalence
- 6.5.9.3. Regulatory Framework
- 6.5.9.4. Reimbursement Framework
- 6.5.9.5. Norway Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6. Asia Pacific
- 6.6.1. Asia Pacific Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.2. Japan
- 6.6.2.1. Key Country Dynamics
- 6.6.2.2. Target Disease Prevalence
- 6.6.2.3. Regulatory Framework
- 6.6.2.4. Reimbursement Framework
- 6.6.2.5. Japan Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.3. China
- 6.6.3.1. Key Country Dynamics
- 6.6.3.2. Target Disease Prevalence
- 6.6.3.3. Regulatory Framework
- 6.6.3.4. Reimbursement Framework
- 6.6.3.5. China Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.4. India
- 6.6.4.1. Key Country Dynamics
- 6.6.4.2. Target Disease Prevalence
- 6.6.4.3. Regulatory Framework
- 6.6.4.4. Reimbursement Framework
- 6.6.4.5. India Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.5. Australia
- 6.6.5.1. Key Country Dynamics
- 6.6.5.2. Target Disease Prevalence
- 6.6.5.3. Regulatory Framework
- 6.6.5.4. Reimbursement Framework
- 6.6.5.5. Australia Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.6. South Korea
- 6.6.6.1. Key Country Dynamics
- 6.6.6.2. Target Disease Prevalence
- 6.6.6.3. Regulatory Framework
- 6.6.6.4. Reimbursement Framework
- 6.6.6.5. South Korea Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6.7. Thailand
- 6.6.7.1. Key Country Dynamics
- 6.6.7.2. Target Disease Prevalence
- 6.6.7.3. Regulatory Framework
- 6.6.7.4. Reimbursement Framework
- 6.6.7.5. Thailand Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7. Latin America
- 6.7.1. Latin America Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7.2. Brazil
- 6.7.2.1. Key Country Dynamics
- 6.7.2.2. Target Disease Prevalence
- 6.7.2.3. Regulatory Framework
- 6.7.2.4. Reimbursement Framework
- 6.7.2.5. Japan Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7.3. Argentina
- 6.7.3.1. Key Country Dynamics
- 6.7.3.2. Target Disease Prevalence
- 6.7.3.3. Regulatory Framework
- 6.7.3.4. Reimbursement Framework
- 6.7.3.5. China Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8. Middle East and Africa
- 6.8.1. Middle East and Africa Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2017 - 2030 (USD Million)
- 6.8.2. South Africa
- 6.8.2.1. Key Country Dynamics
- 6.8.2.2. Target Disease Prevalence
- 6.8.2.3. Regulatory Framework
- 6.8.2.4. Reimbursement Framework
- 6.8.2.5. South Africa Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.3. Saudi Arabia
- 6.8.3.1. Key Country Dynamics
- 6.8.3.2. Target Disease Prevalence
- 6.8.3.3. Regulatory Framework
- 6.8.3.4. Reimbursement Framework
- 6.8.3.5. Saudi Arabia Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.4. UAE
- 6.8.4.1. Key Country Dynamics
- 6.8.4.2. Target Disease Prevalence
- 6.8.4.3. Regulatory Framework
- 6.8.4.4. Reimbursement Framework
- 6.8.4.5. UAE Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8.5. Kuwait
- 6.8.5.1. Key Country Dynamics
- 6.8.5.2. Target Disease Prevalence
- 6.8.5.3. Regulatory Framework
- 6.8.5.4. Reimbursement Framework
- 6.8.5.5. Kuwait Zilbrysq (Zilucoplan) Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 7. Competitive Landscape
- 7.1. Participant Overview
- 7.2. Company Market Position Analysis
- 7.3. Company Categorization
- 7.4. Strategy Mapping
- 7.5. Company Profiles/Listing
- 7.5.1. UCB
- 7.5.1.1. Overview
- 7.5.1.2. Financial Performance
- 7.5.1.3. Product Benchmarking
- 7.5.1.4. Strategic Initiatives
Chapter 8. Conclusion