PUBLISHER: Grand View Research | PRODUCT CODE: 1771583
PUBLISHER: Grand View Research | PRODUCT CODE: 1771583
U.S. Ultomiris Drug Market Size, Share & Trends Analysis Report By Indication (Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome ), By End Use, By Distribution Channel, And Segment Forecasts, 2025 - 2033
U.S. Ultomiris Drug Market Size & Trends:
The U.S. ultomiris drug market size was estimated at USD 1.46 billion in 2024 and is projected to reach USD 8.14 billion by 2033, growing at a CAGR of 19.93% from 2025 to 2033. Ultomiris continues to gain traction due to its extended dosing interval, which improves patient compliance and convenience, making it a preferred choice among healthcare providers. In addition, its expanding clinical indications, including generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD), are contributing to market growth.
The rising prevalence of rare autoimmune and hematologic conditions, such as PNH, atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG), fuels market growth. For instance, the FDA's approval of Ultomiris for adults with anti-AChR antibody-positive gMG in April 2022 has expanded its therapeutic reach, strengthening its position in the neurology segment. In addition, the FDA's priority review in March 2024 for Ultomiris in neuromyelitis optica spectrum disorder (NMOSD) underscores its robust pipeline. Strategic marketing by AstraZeneca and Alexion, coupled with advanced medical infrastructure and high diagnosis rates in the U.S., supports sustained market expansion. The drug's role as a long-acting C5 complement inhibitor, administered intravenously every 8 weeks, positions it as a preferred choice for managing complement-mediated disorders.
Ultomiris (ravulizumab-cwvz), developed by Alexion Pharmaceuticals and acquired by AstraZeneca in 2021, has significantly impacted the U.S. rare disease market. In the first half of 2024, Ultomiris generated USD 1.032 billion in U.S. sales, marking a 27% increase over the previous year. This growth is attributed to expanding indications and a shift from its predecessor, Soliris.
In the U.S. hematological disorders market, Ultomiris (ravulizumab), Hemlibra (emicizumab), and Vafseo (vadadustat) collectively contributed 45% of the market's sales growth in 2023. Ultomiris alone accounted for 21% of this growth, driven by its expanded indications and regulatory approvals.
AstraZeneca's strategic expansion of Ultomiris into neuromyelitis optica spectrum disorder (NMOSD) underscores its commitment to broadening the drug's therapeutic applications. In March 2024, the U.S. FDA approved Ultomiris for NMOSD, making it the first and only long-acting C5 complement inhibitor for this indication. The approval was based on the CHAMPION-NMOSD trial, which demonstrated zero relapses among patients treated with Ultomiris over a median duration of 73 weeks.
U.S. Ultomiris Drug Market Report Segmentation
This report forecasts revenue growth in the U.S. and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. Ultomiris drug market report based on indication, end use, distribution channel, and region:
- Indication Outlook (Revenue, USD Million, 2021 - 2033)
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Generalized Myasthenia Gravis (gMG)
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
- End Use Outlook (Revenue, USD Million, 2021 - 2033)
- Adult
- Pediatric
- Distribution Channel Outlook (Revenue, USD Million, 2021 - 2033)
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Indication
- 1.2.2. End Use
- 1.2.3. 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. U.S. Ultomiris Drug 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
- 3.3.3. Pipeline Analysis
- 3.3.4. Patent Expiry Analysis
- 3.3.5. Pricing Analysis
- 3.3.1. Industry Analysis - Porter's Five Forces Analysis
Chapter 4. U.S. Ultomiris Drug Market: Indication Business Analysis
- 4.1. Indication Market Share, 2024 & 2033
- 4.2. Indication Segment Dashboard
- 4.3. Market Size & Forecasts and Trend Analysis, by Indication, 2021 to 2033 (USD Million)
- 4.4. Paroxysmal Nocturnal Hemoglobinuria (PNH)
- 4.4.1. Paroxysmal Nocturnal Hemoglobinuria (PNH) Market, 2021 - 2033 (USD Million)
- 4.5. Atypical Hemolytic Uremic Syndrome (aHUS)
- 4.5.1. Atypical Hemolytic Uremic Syndrome (aHUS) Market, 2021 - 2033 (USD Million)
- 4.6. Generalized Myasthenia Gravis (gMG)
- 4.6.1. Generalized Myasthenia Gravis (gMG) Market, 2021 - 2033 (USD Million)
- 4.7. Neuromyelitis Optica Spectrum Disorder (NMOSD)
- 4.7.1. Neuromyelitis Optica Spectrum Disorder (NMOSD) Market, 2021 - 2033 (USD Million)
Chapter 5. U.S. Ultomiris Drug Market: End Use Business Analysis
- 5.1. End Use Market Share, 2024 & 2033
- 5.2. End Use Segment Dashboard
- 5.3. Market Size & Forecasts and Trend Analysis, by End Use, 2021 to 2033 (USD Million)
- 5.4. Adult
- 5.4.1. Adult Market, 2021 - 2033 (USD Million)
- 5.5. Pediatric
- 5.5.1. Pediatric Market, 2021 - 2033 (USD Million)
Chapter 6. U.S. Ultomiris Drug Market: Distribution Channel Business Analysis
- 6.1. Distribution Channel Market Share, 2024 & 2033
- 6.2. Distribution Channel Segment Dashboard
- 6.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2021 to 2033 (USD Million)
- 6.4. Hospital Pharmacies
- 6.4.1. Hospital Pharmacies Market, 2021 - 2033 (USD Million)
- 6.5. Retail Pharmacies
- 6.5.1. Retail Pharmacies Market, 2021 - 2033 (USD Million)
- 6.6. Online Pharmacies
- 6.6.1. Online Pharmacies Market, 2021 - 2033 (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. Alexion Pharmaceuticals (AstraZeneca)
- 7.5.1.1. Overview
- 7.5.1.2. Financial Performance
- 7.5.1.3. Product Benchmarking
- 7.5.1.4. Strategic Initiatives
- 7.5.1. Alexion Pharmaceuticals (AstraZeneca)
List of Tables
- Table 1 List of secondary sources
- Table 2 List of abbreviations
- Table 3 U.S. Ultomiris Drug market, by indication, 2021 - 2033 (USD Million)
- Table 4 U.S. Ultomiris Drug market, by end use, 2021 - 2033 (USD Million)
- Table 5 U.S. Ultomiris Drug market, by distribution channel, 2021 - 2033 (USD Million)
List of Figures
- Fig. 1 Ultomiris Drug market segmentation
- Fig. 2 Market research process
- Fig. 3 Data triangulation techniques
- Fig. 4 Primary research pattern
- Fig. 5 Market research approaches
- Fig. 6 Value-chain-based sizing & forecasting
- Fig. 7 Market formulation & validation
- Fig. 8 Market snapshot
- Fig. 9 Therapeutic approach and application outlook (USD Million)
- Fig. 10 Competitive landscape
- Fig. 11 Ultomiris Drug market dynamics
- Fig. 12 Ultomiris Drug market: Porter's five forces analysis
- Fig. 13 Ultomiris Drug market: PESTLE analysis
- Fig. 14 Indication market, 2021 - 2033 (USD Million)
- Fig. 15 Paroxysmal Nocturnal Hemoglobinuria (PNH) market, 2021 - 2033 (USD Million)
- Fig. 16 Atypical Hemolytic Uremic Syndrome (aHUS) market, 2021 - 2033 (USD Million)
- Fig. 17 Generalized Myasthenia Gravis (gMG) market, 2021 - 2033 (USD Million)
- Fig. 18 Neuromyelitis Optica Spectrum Disorder (NMOSD) market, 2021 - 2033 (USD Million)
- Fig. 19 End Use market, 2021 - 2033 (USD Million)
- Fig. 20 Adult market, 2021 - 2033 (USD Million)
- Fig. 21 Pediatric market, 2021 - 2033 (USD Million)
- Fig. 22 Distribution Channel market, 2021 - 2033 (USD Million)
- Fig. 23 Hospital Pharmacies market, 2021 - 2033 (USD Million)
- Fig. 24 Retail Pharmacies market, 2021 - 2033 (USD Million)
- Fig. 25 Online Pharmacies market, 2021 - 2033 (USD Million)
- Fig. 26 Company market position analysis
- Fig. 27 Strategic framework
