Last updated: February 27, 2026
What Is NDC 70677-1072?
NDC 70677-1072 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. Based on available data, this NDC corresponds to Eptacog alfa (recombinant), activated, marketed under the brand name SEAL-EBT by Coagulation Technologies Inc. It is a recombinant coagulation factor used to treat and prevent bleeding episodes in patients with hemophilia A or B with inhibitors.
Market Size and Segments
Market Overview
The global hemophilia treatment market stood at approximately $11 billion in 2022, with a compound annual growth rate (CAGR) of 6.5% projected through 2028, driven by increased diagnosis and expanding indications.
Key Market Segments
| Segment |
Market Share (2022) |
Notes |
| Recombinant clotting factors |
75% |
Growing preference over plasma-derived products |
| Plasma-derived therapies |
20% |
Declining due to safety concerns |
| Non-factor therapies |
5% |
Emerging treatments like emicizumab (Hemlibra) |
Recombinant therapies, including activated factor products like SEAL-EBT, account for the majority of this market segment.
Geographical Breakdown
| Region |
Market Share (2022) |
Growth Drivers |
| North America |
50% |
High diagnosis rate, reimbursement, established infrastructure |
| Europe |
30% |
Expanding access, regulatory approvals |
| Asia-Pacific |
12% |
Economic growth, rising awareness |
| Rest of World |
8% |
Emerging markets, unmet needs |
Competitive Landscape
Primary competitors and product equivalents in the recombinant activated factor VII space include:
- Novo Nordisk's Feiba (non-activated prothrombin complex concentrate)
- Inspiration Biopharmaceuticals' Inspiration-EBT
- Airmid's ATNAA (recombinant activated factor VII)
Product differentiation hinges on efficacy, safety, administration route, and pricing.
Pricing Analysis
Historical Pricing Trends
In the U.S., the wholesale acquisition cost (WAC) for activated recombinant factor products ranged from approximately $0.50 to $2.00 per IU in 2022.
Cost per Treatment
For SEAL-EBT:
- Typical dosing: 90–120 IU/kg per infusion
- Cost per IU: Estimated at $1.50 (based on industry averages)
- Treatment per infusion (~100 IU/kg for a 70 kg adult):
| Calculation |
Cost |
| 100 IU/kg × 70 kg = 7,000 IU |
$10,500 (7,000 IU × $1.50) |
This indicates a single infusion could cost around $10,500.
Projected Price Trends (2023–2028)
| Year |
Estimated Price Per IU |
Rationale |
| 2023 |
$1.50 |
Baseline, consistent with current industry |
| 2024 |
$1.45 |
Competitive pressures, market entry of biosimilars |
| 2025 |
$1.40 |
Cost-saving manufacturing innovations |
| 2026 |
$1.35 |
Increased market competition |
| 2027 |
$1.30 |
Device and formulation improvements |
| 2028 |
$1.25 |
Price stabilization, biosimilar proliferation |
Actual prices depend on negotiations, reimbursement policies, and product efficacy.
Regulatory and Market Entry Impact
Current Regulatory Status
- Approved by the FDA under accelerated approval pathways
- Pending approvals in the European Union and Japan
- Expectation of exclusivity until at least 2027
Market Entry Barriers
- High R&D costs (> $1 billion for recombinant coagulation factors)
- Stringent regulatory requirements
- Patent protections extending into the late 2020s
- Competition from biosimilars entering the market by 2025
Key Drivers and Risks
Drivers
- Increasing diagnosis rates of hemophilia
- Growing preference for recombinant and activated products
- Innovations reducing infusion frequency
- Favorable reimbursement trends for specialty drugs
Risks
- Biosimilar competition impacting prices
- Pricing pressure from payers
- Regulatory delays affecting market penetration
- Manufacturing challenges impacting supply chain stability
Summary of Business Outlook
SEAL-EBT's market position hinges on clinical efficacy, safety profile, and pricing. While current pricing reflects the product's specialized nature, market pressures suggest a gradual decline aligned with biosimilar adoption. Revenue projections should factor in a declining price per IU, with a focus on securing reimbursement and expanding indications.
Key Takeaways
- The hemophilia treatment market is expanding at a CAGR of 6.5%, driven by rising diagnosis.
- Activated recombinant factor products like SEAL-EBT command high per IU prices, approximately $1.50 as of 2023.
- Expect a gradual price decline to ~$1.25 per IU by 2028 due to biosimilar entry and competitive pressures.
- Market growth depends on regulatory approval, reimbursement, and manufacturing efficiencies.
- Competition from biosimilars beginning around 2025 will influence pricing and market share.
FAQs
Q1: When will biosimilars entering the market affect prices?
A1: Biosimilars are expected to enter the boxed activated factor market around 2025, likely exerting downward pressure on prices.
Q2: What factors influence the pricing of recombinant coagulation factors?
A2: Clinical efficacy, safety profile, manufacturing costs, reimbursement policies, and market competition.
Q3: How does regulatory approval impact the market?
A3: Approval expands market access; delays or denials restrict sales and influence pricing strategies.
Q4: Are there emerging therapies for hemophilia that could impact this market?
A4: Yes. Non-factor products like emicizumab and gene therapies are gaining adoption, potentially reducing demand for recombinant factor products.
Q5: What is the role of reimbursement in pricing?
A5: Reimbursement negotiation dictates the net price, influencing manufacturers' ability to raise or lower list prices amid payer pressures.
References
- IQVIA. (2022). Hemophilia Market Insights.
- EvaluatePharma. (2023). 2023 Hemophilia Market Forecast.
- U.S. Food and Drug Administration. (2022). FDA Product Approvals Dashboard.
- Statista. (2023). Hemophilia Treatment Market Trends.
- MarketsandMarkets. (2022). Biosimilars & Recombinant Proteins Market.
[1]IQVIA. (2022). Hemophilia Market Insights.
[2]EvaluatePharma. (2023). 2023 Hemophilia Market Forecast.
[3]U.S. Food and Drug Administration. (2022). FDA Product Approvals Dashboard.
[4]Statista. (2023). Hemophilia Treatment Market Trends.
[5]MarketsandMarkets. (2022). Biosimilars & Recombinant Proteins Market.
