Last updated: February 15, 2026
Market Analysis and Price Projections for NDC 58406-0032
Product Overview
NDC 58406-0032 corresponds to Rebinyn (coagulation factor IX-vial), a blood clotting factor used in the treatment of hemophilia B. Rebinyn is manufactured by Novo Nordisk and is designated for on-demand treatment and prophylaxis.
Market Size and Revenue Context
The global hemophilia B market, driven by increased diagnosis and advanced treatment options, was valued at approximately $980 million in 2022. The demand for factor IX products, including Rebinyn, has grown at an estimated CAGR of 5.2% from 2018 to 2022.
Key market drivers:
- Increased diagnosis: Advances in genetic testing identify more hemophilia B cases.
- Prophylactic treatment: Growing adoption of regular prophylaxis reduces bleeding episodes, expanding market scope.
- New formulations: Development of extended half-life products and gene therapies influences market dynamics.
Rebinyn accounts for approximately 12-15% of the global market for factor IX therapies, with revenue approximately $117-$147 million in 2022.
Competitive Landscape
Major competitors include:
- Alnylam's Hemophilia B gene therapy (AMT-061)
- Pfizer's Mononine
- Baxter's Rixubis
- Sanofi's Afstyla (short half-life), which slightly overlaps.
Rebinyn is distinguished by its extended half-life compared to traditional factor IX products, providing differentiation and patient convenience.
Pricing Analysis
Rebinyn's list price varies regionally but approximates:
- United States: $0.60 - $0.85 per IU, depending on the dosage and supplier contracts.
- Exact prices depend on negotiated insurance or pharmacy benefit manager agreements.
- The average treatment dose per infusion ranges from 20,000 to 60,000 IU.
In comparison:
- Traditional factor IX products: approximately $0.40 - $0.65 per IU.
- Extended half-life products like Rebinyn typically command a 15-20% premium.
Price Projections (2023–2028)
Key assumptions:
- Continued adoption of prophylactic therapy.
- Incremental improvements in manufacturing efficiency.
- Use of biosimilars and generics remains limited due to patent protections and manufacturing complexities.
| Projected average prices: |
Year |
Price per IU (US) |
Market Shares (% Rebinyn) |
Estimated Revenue (Millions USD) |
| 2023 |
$0.75 |
15 |
$150 |
| 2024 |
$0.78 |
17 |
$170 |
| 2025 |
$0.80 |
20 |
$200 |
| 2026 |
$0.82 |
22 |
$220 |
| 2027 |
$0.83 |
24 |
$250 |
| 2028 |
$0.85 |
25 |
$265 |
The incremental price increase per year reflects inflation, manufacturing efficiencies, and increased demand.
Regulatory and Market Risks
- Patent expirations: Expected around 2028–2030; potential impact if biosimilar products gain approval.
- Regulatory changes: Shift toward gene therapy could reduce demand for factor IX products.
- Pricing pressures: Payers seek discounts and biosimilar competition may influence list prices.
- Manufacturing challenges: Production complexity of biologics influences supply and pricing stability.
Key Takeaways
- Rebinyn holds a significant share of the hemophilia B treatment market, with revenues nearing $150 million in 2022.
- The product's extended half-life offers a competitive edge, justifying a premium price.
- Market growth remains steady at around 5% annually, driven by increased diagnosis and prophylactic use.
- Price per IU is projected to increase modestly, reaching approximately $0.85 by 2028.
- Competitive risks include biosimilar entry and emerging gene therapies, which may diminish future value.
FAQs
1. What factors influence Rebinyn's pricing strategy?
Manufacturing costs, demand growth, competitive pressures, and payer negotiations primarily Determine pricing.
2. How does Rebinyn compare to other factor IX products in price?
It commands a 15-20% premium over traditional factor IX products due to its extended half-life and dosing convenience.
3. What is the impact of biosimilars on the market?
Biosimilar entry, expected post-2028 patent expiry, could lead to significant price reductions and increased competition.
4. How does gene therapy affect the long-term outlook?
Gene therapies may reduce demand for plasma-derived and recombinant factor IX products. However, current approvals are limited and expensive.
5. What regions are most lucrative for Rebinyn sales?
The U.S. leads with approximately 55% of global sales, followed by Europe and Japan. Market penetration in emerging markets remains limited.
Sources
[1] Market data derived from Evaluate Pharma, 2022.
[2] NHF Data & Hemophilia Market Reports, 2022-2023.
[3] Price estimates based on publicly available manufacturer disclosures and regional healthcare payer data.
