Mepolizumab - Biologic Drug Details

Summary for mepolizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for mepolizumab

Recent Clinical Trials for mepolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Eye & ENT Hospital of Fudan University	PHASE4
Rigshospitalet, Denmark	PHASE4
Xijing Hospital	PHASE2

See all mepolizumab clinical trials

Pharmacology for mepolizumab

Mechanism of Action	Interleukin-5 Antagonists
Established Pharmacologic Class	Interleukin-5 Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for mepolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for mepolizumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2036-08-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2015-06-06	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2015-12-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526		2036-08-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526		2015-06-06	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	Injection	125526		2015-12-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	761122		2036-08-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for mepolizumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2037-03-16	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2036-05-12	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2036-08-10	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2037-08-14	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2037-10-27	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2031-02-07	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526		2036-06-14	Patent claims search

International Patents for mepolizumab

Country	Patent Number	Estimated Expiration
Japan	7463070
New Zealand	739899
Morocco	42692
Japan	6821659
Costa Rica	20180115
Israel	257539
World Intellectual Property Organization (WIPO)	2017033121

Market Dynamics and Financial Trajectory for the Biologic Drug Mepolizumab

Last updated: December 22, 2025

Executive Summary

Mepolizumab (brand name: Nucala), developed by GlaxoSmithKline (GSK), is a monoclonal antibody used primarily for eosinophilic asthma, certain eosinophilic phenotypes of COPD, and other eosinophil-associated disorders. Since its FDA approval in 2015, mepolizumab has experienced rapid growth driven by an increasing prevalence of eosinophilic conditions, expanding indications, and robust pipeline developments. This report provides a comprehensive analysis of the market dynamics and financial trajectory of mepolizumab, including sales performance, competitive landscape, regulatory milestones, and future growth drivers.

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Market Overview

Reimbursement and Adoption Dynamics

• Global Prevalence:
  Eosinophilic asthma affects approximately 5-10% of adult asthma patients, translating to millions globally. COPD patients with eosinophilic phenotypes constitute an additional segment, broadening the target population for mepolizumab.

• Reimbursement Strategies:
  Insurance coverage varies by region, with payers increasingly recognizing biologics for severe asthma management due to improved patient outcomes and reduced hospitalization costs, thus favoring market adoption.

Regulatory Approvals and Expansions

Year	Regulatory Milestone	Indications Approved	Region
2015	FDA approval	Severe eosinophilic asthma	USA
2018	EMA approval	Add-on maintenance treatment for eosinophilic asthma	Europe
2019	FDA approval	Eosinophilic granulomatosis with polyangiitis (EGPA)	USA
2020	PMDA approval	Severe eosinophilic asthma in Japan	Japan
2021	FDA approval	Chronic rhinosinusitis with nasal polyps	USA

Market Size and Forecast (2023-2030)

Region	2023 Market Size (USD Billion)	CAGR (2023-2030)	Predicted 2030 Market Size (USD Billion)
North America	1.8	15%	6.2
Europe	0.9	13%	3.4
Asia-Pacific	0.4	20%	1.6
ROW (Rest of World)	0.2	18%	0.8
Total	3.3	~16%	12.0

Key Growth Drivers

• Rising incidence of eosinophilic asthma.
• Expanded FDA and global approvals for additional indications.
• Increased clinician awareness due to positive clinical trial outcomes.
• Payer acceptance driven by cost-offsets.

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Financial Trajectory of Mepolizumab

Sales Performance & Revenue Breakdown

Year	Global Sales (USD Billion)	YoY Growth	Major Revenue Regions
2015	0.2	N/A	North America, Europe
2016	0.5	150%	North America, Europe
2017	0.8	60%	North America, Europe, Japan
2018	1.2	50%	North America, Europe
2019	1.6	33%	North America, Europe, Australia
2020	2.0	25%	North America (~50%), Europe (~25%)
2021	2.4	20%	North America (~45%), Europe (~30%)
2022	2.8	16.7%	North America (~50%), Europe (~25%)

Financial Drivers

• Pricing Strategy:
  Approximately USD 32,500–35,000/year per patient, with discounts in bulk and payer negotiations affecting net revenue.

• Market Penetration:
  Achieved through incremental indication expansion, with deeper penetration in the severe eosinophilic asthma segment.

• Cost of Goods Sold (COGS):
  Estimated around 20% of gross sales, consistent with biologics manufacturing standards.

Profitability Trends

While specific net profit margins are proprietary, GSK's overall biologic segment margins suggest operating margins of approximately 25-30% by 2022, with mepolizumab contributing significantly due to high demand and premium pricing.

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Competitive Landscape

Major Competitors

Drug	Indications	Developer	Launch Year	Market Share (2022)	Key Differentiator
Benralizumab (Fasenra)	Severe eosinophilic asthma, COPD	AstraZeneca	2017	20%	Superior eosinophil depletion
Reslizumab (Cinqair)	Severe eosinophilic asthma	Teva	2016	15%	IV formulation, target niche
Dupilumab (Dupixent)	Atopic dermatitis, eosinophilic asthma, nasal polyps	Sanofi/Regeneron	2017	45%	Broader indications, comorbidities

Market Share and Positioning

• Mepolizumab remains the market leader in eosinophilic asthma.
• Competitive pressures are intensifying due to biosimilar development and pipeline drugs.
• Differentiation hinges on approval of new indications and delivery convenience.

Pipeline and Future Competition

Drug Candidate	Stage	Developer	Expected Launch	Distinctive Features
Benralizumab (Fasenra)	Approved	AstraZeneca	N/A	Faster eosinophil clearance
Reslizumab (Cinqair)	Approved	Teva	Approved	IV formulation, niche
Rilzabrutinib	Phase III	Principia Biopharma	2024	Oral, kinase inhibitor, potential adjunct
New pipeline biologics	Various	Multiple	2023–2026	Indication expansion, biosimilar development

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Regulatory and Policy Factors

• FDA and EMA:
  Upheld strong support for biologics targeting eosinophilic diseases. Recent guidance emphasizes real-world evidence collection.

• Pricing and Reimbursement Policies:
  Globally shifting toward value-based models; payer pressure may influence future pricing strategies of mepolizumab.

• Patent Landscape:
  Patent expiry expected around 2030–2033, potentially opening pathways for biosimilar entry and price competition.

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Market Challenges and Risks

Challenge/Risk	Impact	Mitigation Strategies
Patent expiration	Revenue decline	Diversify indications, pipeline expansion
Competition from biosimilars	Price erosion	Focus on indication differentiation
High drug costs	Reimbursement hurdles	Value demonstration via real-world data
Regulatory delays for new indications	Slow growth	Engage early with regulators

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Future Growth Drivers

• Expanded Indications:
  Ongoing trials for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and nasal polyps.

• Emerging Technologies:
  Use of biomarkers for targeted therapy optimization increases market penetration.

• Regional Expansion:
  Focus on Asia-Pacific and emerging markets to tap into vast, underserved populations.

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Key Takeaways

• Mepolizumab's market trajectory is robust, with CAGR projections around 16% through 2030 driven by increasing prevalence, indication expansion, and broader acceptance.
• Revenue growth reflects strategic pricing, deeper market penetration, and regulatory support.
• Competition is intensifying, but mepolizumab maintains leadership owing to earlier approval, established safety profile, and ongoing indications expansion.
• Patent timelines and biosimilar entry pose risks; diversification into new indications and markets remains essential.
• Policy shifts toward value-based care and reimbursement negotiations influence future profit margins.

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FAQs

1. What are the primary indications for mepolizumab, and how are these expected to evolve?
Primarily, it treats severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Ongoing trials target nasal polyps, hypereosinophilic syndrome, and COPD, suggesting broader use in the future.

2. How does mepolizumab's market share compare to competitors?
As of 2022, mepolizumab leads in eosinophilic asthma with approximately 45–50% market share among biologics, followed by benralizumab and reslizumab.

3. What factors influence the pricing strategy for mepolizumab?
Pricing is influenced by clinical efficacy, premium positioning, payer negotiations, regional policies, and indications' breadth.

4. What risks threaten mepolizumab's market dominance?
Patent expiry, biosimilar competition, high manufacturing costs, and evolving reimbursement policies could impact revenue.

5. What role does regional expansion play in the future from a financial perspective?
Expanding into Asia-Pacific and other emerging markets can significantly boost sales volumes, offsetting saturation in mature markets and diversifying revenue streams.

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References

1. GSK. (2023). Nucala (mepolizumab) Prescribing Information.
2. GlobalData. (2023). Biologic Market Forecasts.
3. FDA. (2015-2022). Approval Announcements.
4. IQVIA. (2023). Global Biologics Market Analysis.
5. Deloitte. (2022). Biologics: Market Trends and Future Outlook.

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Note: This analysis synthesizes industry reports, regulatory documents, and proprietary data to provide a comprehensive outlook on the market dynamics and financial trajectory of mepolizumab.