Last updated: February 27, 2026
What is NDC 16714-0213?
NDC 16714-0213 corresponds to Mepolizumab (Nucala), marketed by GlaxoSmithKline. It is a monoclonal antibody used for severe eosinophilic asthma and other eosinophil-related conditions.
Market overview: Mepolizumab has received FDA approval since 2015, with expanding indications over time. Its primary competitors include Reslizumab and Benralizumab, other monoclonal antibodies targeting eosinophil pathways.
What is the current market size for Mepolizumab?
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Global sales (2022): Estimated at approximately $2.1 billion, with US sales comprising nearly 60% of this figure.
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US market share: Dominant, driven by approval for severe eosinophilic asthma, particularly among patients inadequately controlled on corticosteroids.
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Growth rate: Compound Annual Growth Rate (CAGR) projected at 8-10% through 2027, driven by increased diagnosis rates and expanding payer coverage.
How does the competitive landscape impact pricing?
| Drug |
Indication |
List Price per Year |
Market Share (2022) |
| Mepolizumab (Nucala) |
Severe eosinophilic asthma |
~$37,000 |
40-45% |
| Reslizumab (Cinqair) |
Eosinophilic asthma |
~$37,500 |
15% |
| Benralizumab (Fasenra) |
Severe eosinophilic asthma |
~$36,000 |
30-35% |
All three target similar patient populations. Mepolizumab’s higher price reflects its earlier market entry and slight differentiation in formulation and dosing.
What are the key factors influencing future price projections?
Patent and exclusivity timeline:
- Patent for Mepolizumab expiring in 2027 in the US.
- Competition from biosimilars potentially entering the market by 2028–2030.
Market expansion:
- Broader approval for indications like eosinophilic granulomatosis with polyangiitis (EGPA) has expanded use.
- Growing diagnosis rates support increased revenue.
Cost pressures:
- Payer negotiations prioritize value-based pricing.
- Biosimilar entries could initiate price reductions by 2028.
Pricing trends:
- Expect continued slight decreases in list prices due to biosimilar competition and price negotiations.
- Actual net prices post-discounts and rebates are significantly lower than list prices, typically by 20-40%.
What are the price projections for the next five years?
| Year |
Estimated List Price |
Estimated Net Price (after discounts) |
Notes |
| 2023 |
~$37,000 |
~$24,000–29,600 |
Steady with recent trends |
| 2024 |
~$36,800 |
~$23,500–28,800 |
Slight reduction from 2023 |
| 2025 |
~$36,500 |
~$23,000–28,000 |
Continued pricing pressure |
| 2026 |
~$36,200 |
~$22,500–27,200 |
Biosimilar entry anticipated |
| 2027 |
~$36,000 |
~$22,000–26,400 |
Near patent expiry, additional biosimilar entries |
Note: These projections assume no major regulatory or market disruptions and are based on current trends and competitive dynamics.
Key considerations influencing future market value:
- Rising adoption driven by expanded label indications.
- Price reductions due to biosimilar competition.
- Payer restrictions and prior authorization protocols.
Final considerations for stakeholders
- Manufacturers should monitor biosimilar entry and patent outcomes.
- Payers will continue to negotiate discounts heavily.
- Pharmacies and providers should consider shifting to biosimilars once available, reducing cost burdens.
Key Takeaways
- The US market for NDC 16714-0213 was approximately $1.26 billion in 2022.
- List prices are expected to decline marginally through 2027, with net prices affected more by discounts.
- Entry of biosimilars around 2028–2030 will likely accelerate price reductions.
- Expanding indications and increasing diagnosis rates support market growth through 2027.
- Competitive pressures will influence pricing strategies and revenue projections.
Frequently Asked Questions (FAQs)
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When will biosimilars for Mepolizumab likely enter the US market?
Biosimilars are projected to enter between 2028 and 2030, pending patent decisions and regulatory approvals.
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How does the manufacturing cost influence pricing?
Manufacturing costs for monoclonal antibodies remain high but are not directly reflected in list prices due to negotiated discounts; economies of scale and biosimilar competition impact pricing more.
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What factors could accelerate or slow down price declines?
Accelerators include biosimilar entry and regulatory changes; slowdowns depend on patent litigation, supply chain issues, or regulatory delays.
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How do payer policies impact the drug’s market share?
Payer policies favor biosimilars, leading to increased adoption and potential substitution that could erode Mepolizumab’s market share.
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Are new indications expected to impact pricing or market size?
Yes, expanded indications can increase market size but may also attract downward pressure on pricing due to increased competition.
References
[1] IQVIA. (2023). Pharmaceutical market outlook.
[2] FDA. (2022). Approval history of Mepolizumab.
[3] EvaluatePharma. (2023). Top 100 pharma & biotech products.
[4] Centers for Medicare & Medicaid Services. (2022). Drug pricing negotiations and policies.
