누칼라(NUCALA) 판매 예측 및 시장 규모 분석(-2034년)

Key Factors Driving NUCALA Growth

(1) Strong existing commercial base with consistent double-digit sales growth

Nucala already has a well-established revenue base, which lowers commercial risk versus pipeline assets. According to GSK, Nucala generated ~£1.78 billion ($2.3 billion) in 2024 sales, up ~12% YoY, accounting for ~6% of GSK's total revenue. In 2023, sales were approximately £1.7 billion, showing sustained momentum driven by broader biologic adoption in severe eosinophilic diseases.

(2) Major COPD expansion significantly expands addressable market

This is currently the biggest growth catalyst. In May 2025, the U.S. FDA approved Nucala for COPD, making it the first biologic approved for COPD patients with an eosinophilic phenotype (BEC >=150 cells/μL). Approval was based on the Phase III MATINEE and prior METREX studies.

Key MATINEE highlights:

• Significant reduction in annualized moderate/severe exacerbations
• Reduction in exacerbations leading to hospitalization/ER visits
• Patients remained on triple inhaled therapy

GSK noted that nearly 70% of inadequately controlled U.S. COPD patients on triple therapy have eosinophil counts >=150 cells/μL, creating a meaningful new patient pool.

(3) European expansion further strengthens global uptake

In February 2026, the European Commission approved Nucala for COPD, further expanding geographic reach. GSK highlighted that:

• COPD affects ~390 million people globally
• ~40 million people live with COPD in Europe
• Over 35% of uncontrolled COPD patients on triple therapy have eosinophils >=300 cells/μL

This approval materially increases ex-US revenue potential.

(4) Diversified multi-indication revenue stream reduces reliance on one market

Unlike many respiratory biologics dependent on a single indication, Nucala is already approved for:

• Severe eosinophilic asthma
• Eosinophilic Granulomatosis with Polyangiitis
• Hypereosinophilic Syndrome
• Chronic Rhinosinusitis with Nasal Polyps
• COPD

This diversified label helps sustain long-term growth and protects against competitive pressure from rivals like Fasenra and Dupixent.

NUCALA Recent Developments

• In May 2025, GSK announced that the US Food and Drug Administration (FDA) has approved NUCALA (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

"NUCALA Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of NUCALA for approved indication like Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis in the 7MM. A detailed picture of NUCALA'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 NUCALA for approved and potential indications. The NUCALA market report provides insights about NUCALA'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 NUCALA performance, future market assessments inclusive of the NUCALA 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 NUCALA sales forecasts, along with factors driving its market.

NUCALA Drug Summary

NUCALA is a marketed humanized monoclonal antibody developed by GSK plc that targets Interleukin-5, a key driver of eosinophil growth, activation, and survival. By binding to IL-5 and preventing it from interacting with its receptor on eosinophils, NUCALA reduces eosinophilic inflammation and helps control disease exacerbations. It is administered as a subcutaneous injection and is approved for multiple eosinophil-driven conditions, including severe Asthma, Chronic Rhinosinusitis with Nasal Polyps, Eosinophilic Granulomatosis with Polyangiitis, and Hypereosinophilic Syndrome. As one of the first biologics targeting IL-5, NUCALA has established a strong position in the respiratory and immunology markets through its proven efficacy in reducing exacerbations, oral corticosteroid use, and disease burden in patients with eosinophilic disorders. The report provides NUCALA's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the NUCALA Market Report

The report provides insights into:

• A comprehensive product overview including the NUCALA MoA, description, dosage and administration, research and development activities in approved indications like Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis.
• Elaborated details on NUCALA regulatory milestones and other development activities have been provided in NUCALA market report.
• The report also highlights NUCALA'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 NUCALA market report also covers the patents information, generic entry and impact on cost cut.
• The NUCALA market report contains current and forecasted NUCALA sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The NUCALA market report also features the SWOT analysis with analyst views for NUCALA in approved and potential indications.

Methodology:

The NUCALA 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.

NUCALA Analytical Perspective by DelveInsight

• In-depth NUCALA Market Assessment

This NUCALA sales market forecast report provides a detailed market assessment of NUCALA for approved indication like Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis 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 NUCALA sales data uptil 2034.

• NUCALA Clinical Assessment

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

NUCALA 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.

NUCALA Market Potential & Revenue Forecast

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

NUCALA Competitive Intelligence

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

NUCALA Regulatory & Commercial Milestones

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

NUCALA Clinical Differentiation

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

NUCALA Market Report Highlights

• In the coming years, the NUCALA 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 NUCALA companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence NUCALA's dominance.
• Other emerging products for Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis are expected to give tough market competition to NUCALA 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 NUCALA in approved and potential indications.
• Analyse NUCALA cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted NUCALA sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of NUCALA in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of NUCALA? How strong is NUCALA's clinical and commercial performance?
• What is NUCALA's clinical trial status in each individual indications such as Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the NUCALA Manufacturers?
• What are the key designations that have been granted to NUCALA for approved and potential indications? How are they going to impact NUCALA's penetration in various geographies?
• What is the current and forecasted NUCALA market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of NUCALA 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 NUCALA 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 NUCALA? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. NUCALA Overview in approved indications like Asthma, Nasal polyps, Chronic obstructive pulmonary disease, Churg-Strauss syndrome, Hypereosinophilic syndrome; as well as potential indication like Eosinophilic oesophagitis

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

3. NUCALA Competitive Landscape (Marketed Therapies)

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

5. NUCALA Market Assessment

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

6. NUCALA 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