Last updated: February 27, 2026
What is NDC 21922-0031?
NDC 21922-0031 refers to Eptacog alfa (Recombinant), a recombinant activated coagulation factor used for hemophilia A and B patients with inhibitors. Manufactured by Bristol-Myers Squibb, it is marketed under the brand name Novoeight in some regions.
Market Overview
The global hemophilia treatment market was valued at approximately $10 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5% through 2030. The increase driven by diagnostic improvements, rising awareness, and expanding indications.
Key Market Drivers
- Growing prevalence: Hemophilia affects approximately 1 in 10,000 births.
- Inhibitor development: 25-30% of hemophilia A patients develop inhibitors, increasing demand for bypassing agents like recombinant factor products.
- Advancement in therapies: Prolonged half-life products, gene therapies gaining approval.
- Pricing policies: Most products are high-cost, reflecting complex manufacturing and limited patient pools.
Competitive Landscape
- Major competitors include Eloctate (Biogen), Damoctocog alfa pegol (Bayer), NovoEight (Novo Nordisk), and Bayer's Kovaltry.
- Market share distribution varies by region; in the U.S., Novoeight is a significant player, especially for inhibitor patients.
Price Analysis of NDC 21922-0031
Current Pricing Data
- Average wholesale acquisition cost (WAC): Approximately $5,000 to $6,000 per vial of 250 units.
- Per IU cost: Roughly $0.10 to $0.12.
- Treatment course: Typically involves multiple vials; annual costs per patient often exceed $300,000.
Regional Price Variability
| Region |
Average Price per Vial |
Price per IU |
Notes |
| US |
$5,200 - $6,000 |
$0.11 - $0.12 |
Includes markup and pharmacy margins |
| Europe |
$4,500 - $5,500 |
$0.09 - $0.11 |
Varies by country |
| Japan |
$4,000 - $4,800 |
$0.08 - $0.10 |
Price controlled by national jurisdiction |
Historical & Projected Price Trends
- 2018-2022: Prices remained stable; minor increases linked to inflation and manufacturing costs.
- 2023-2025 projections: Moderate price declines expected due to biosimilar entry and increased patent expirations in select regions.
- Long-term outlook (2026-2030): Price reductions of 10-15% plausible with increased biosimilar competition, improved manufacturing efficiencies, and policy shifts toward value-based pricing.
Future Market and Price Projections
Patent Status & Biosimilar Development
- Bristol-Myers Squibb’s patent protection for Novoeight is set to expire in the U.S. around 2027.
- Several biosimilars are in development; approval timelines suggest entry into the market by 2025-2026.
- Biosimilar competition could reduce prices by 20-30% over baseline.
Regulatory & Policy Impact
- Countries with strict pricing controls may see slower price declines.
- Expanded use of gene therapies may reduce demand for factor replacement, impacting pricing and volume.
Potential Market Expansion
- Approval for additional indications in pediatric and prophylactic settings.
- Emerging markets (e.g., China, India) may see price reductions due to local manufacturing and pricing reforms.
- Global access initiatives could influence pricing strategies.
Summary
| Aspect |
Current Status |
Future Outlook |
| Market size |
~$10 billion globally in 2022 |
Growth at 5% CAGR, reaching approximately $15 billion by 2030 |
| Price per vial |
$5,200 - $6,000 |
Slight decrease expected, especially around biosimilar entry |
| Patent expiration |
U.S. patents expire around 2027 |
Biosimilar market entry expected 2025-2026 |
| Key price influencers |
Biosimilar competition, regulatory policies, manufacturing costs |
Price reductions of 20-30% possible with biosimilar proliferation |
Key Takeaways
- The hemophilia clotting factor market is mature with high-value, branded products dominating.
- NDC 21922-0031 (Novoeight) maintains a high price point driven by manufacturing complexity and limited patient population.
- Biosimilar entry around 2025-2026 is likely to pressure prices downward by 20-30%, especially in mature markets.
- Pricing will be influenced by regulatory environments, especially in cost-control-focused countries.
- Market growth prospects remain steady, underpinned by increasing diagnosis rates and inhibitor prevalence.
FAQs
Q1: When will biosimilars for NDC 21922-0031 likely become available?
A1: Biosimilars are expected to be approved by regulatory agencies around 2025-2026, following patent expiration.
Q2: How much can prices for NDC 21922-0031 decline with biosimilar competition?
A2: Prices could decrease by 20-30% due to biosimilar entry, depending on regional policies and market dynamics.
Q3: What regions have the highest price for this drug?
A3: The U.S. tends to have the highest prices, followed by Europe, with lower prices in Japan and emerging markets.
Q4: How does the pricing of NDC 21922-0031 compare to other hemophilia treatments?
A4: It is comparable to other recombinant factor products; some newer treatments like gene therapies have higher upfront costs but lower long-term expenses.
Q5: What factors influence future demand for this drug?
A5: Increasing hemophilia diagnoses, inhibitor development, and approval for additional indications influence demand levels.
References
[1] Pharmaceutical Pricing and Market Data, 2022.
[2] Hemophilia Treatment Market Report, MDPI, 2022.
[3] Biosimilar Market Trends, IQVIA Insights, 2023.
[4] U.S. Patent Database, USPTO, 2023.
[5] Regulatory Approvals for Hemophilia Products, FDA and EMA, 2023.
