Last updated: February 20, 2026
What is NDC 00904-7236?
NDC 00904-7236 identifies a specific biologic product approved by the U.S. Food and Drug Administration (FDA). Based on the National Drug Code (NDC) directory, this code corresponds to Plasma-Derived Human Coagulation Factor VIII used for hemophilia A. The product is manufactured by Bio Products Laboratory Limited.
Market Overview
Epidemiology
- Hemophilia A affects approximately 1 in 5,000 male births in the United States.
- Estimated patient population: roughly 20,000 to 25,000 in the U.S.
- Global prevalence: estimated at 1 in 5,000 male births, with broader estimates around 400,000 cases worldwide.
Market Drivers
- Increasing diagnosis rates due to improved screening.
- Rising demand for prophylactic treatments to reduce bleeding episodes.
- Adoption of biosimilars and biosimilar-like biologics impacting pricing dynamics.
- Developments in gene therapies are influencing long-term treatment strategies.
Competitive Landscape
| Product |
Manufacturer |
Formulation |
Price Range (per IU) |
Status |
| Advate |
Takeda |
Lyophilized powder |
$1.20 – $1.60 |
Established recombinant product, market leader |
| Recombinate |
Shire (AbbVie) |
Lyophilized powder |
$1.40 – $1.80 |
Biosimilar options emerging |
| Nuwiq |
Bioverativ (Sanofi) |
Liquid |
$1.50 – $2.00 |
Newly approved, expanding indications |
| Human Plasma-Derived Factor VIII |
Bio Products Laboratory |
Liquid/lyophilized |
Estimated ~$0.50 – $1.00 |
Limited by supply, older technology |
Regulatory Status
- Marketed since early 2000s.
- Approved for hemophilia A, with indications expanding into perioperative management.
- Slight variations in formulation (plasmapheresis vs. recombinant).
Price Trends and Projections
Historical Price Data
| Year |
Average Price per IU |
Notes |
| 2015 |
~$1.50 |
Predominantly recombinant products |
| 2018 |
~$1.45 |
Slight decline due to biosimilar entries |
| 2020 |
~$1.40 |
Market stabilization, biosimilar impact |
| 2022 |
~$1.35 |
Slight downward pressure, pricing competition |
Factors Influencing Future Prices
- Biosimilar Competition: Entry of biosimilar and follow-on biologics has exerted pricing pressure.
- Manufacturing Costs: Plasma-derived products face pricing variance based on plasma collection expenses and purification technology.
- Regulatory Advances: Additional approvals for long-acting formulations could shift pricing strategies.
- Market Demand: As gene therapies become more available, demand for traditional factor VIII may decline, impacting pricing strategies.
Forecasting Price Trends (2023–2028)
| Year |
Projected Price per IU |
Key Drivers |
| 2023 |
~$1.25 |
Biosimilar entry, supply chain stabilization |
| 2025 |
~$1.10 – $1.20 |
Increased biosimilar market penetration |
| 2027 |
~$1.00 |
Potential obsolescence from gene therapies |
| 2028 |
~$0.80 – $1.00 |
Market shift towards gene therapy-preferred options |
Revenue Projections
Assuming the annual demand remains stable at approximately 300 million IU, with an average price of $1.35 per IU, then:
- 2023 revenue: ~$405 million
- 2025 revenue: ~$330 million
- 2028 revenue: ~$240 million
Market contraction expected as gene therapy approvals increase and influence treatment paradigms, notably with agents like Valoctocogene Roxaparvovec.
Strategic Considerations
- Existing plasma-derived products will face pricing pressure but maintain niche markets.
- Biosimilar entry will likely lead to further discounts.
- Long-term shifts towards gene therapies may limit traditional factor VIII market size.
- Manufacturers should innovate in long-acting formulations to sustain pricing power.
Key Takeaways
- NDC 00904-7236 corresponds to plasma-derived factor VIII, used in hemophilia A treatment.
- The market is mature with a global footprint, facing sustained price pressure from biosimilars.
- Average price per IU has declined from ~$1.50 in 2015 to ~$1.35 in 2022, with projections to fall below $1.00 by 2028.
- Revenue estimates forecast a decline consistent with market shifts towards gene therapy.
- Strategic positioning involves balancing existing product portfolio maintenance against innovation in gene therapy.
FAQs
1. How does the plasma-derived factor VIII compare to recombinant versions?
Plasma-derived factor VIII costs less, approximately $0.50–$1.00 per IU, but faces declining demand due to recombinant products' safety profile.
2. What is the impact of biosimilars on pricing?
Biosimilars have driven prices down by 10-20%, increasing competition and applying downward pressure on established products.
3. How soon will gene therapies replace traditional factor VIII products?
Long-term adoption varies, but approvals like BioMarin's valoctocogene roxaparvovec suggest significant shifts may occur within 5-10 years.
4. Are there regulatory barriers to plasma-derived products?
Stringent plasma safety regulations and donor screening are mandatory; however, these factors impact supply more than approval.
5. What are the key risks to market stability?
Risks include the rapid adoption of gene therapies, supply chain disruptions, and regulatory changes affecting plasma donation or product approval.
Citations
[1] U.S. Food and Drug Administration. (2022). Hemophilia Products Labeling. https://www.fda.gov
[2] IQVIA. (2022). Hemophilia Market Data and Forecast. https://www.iqvia.com
[3] Global Hemophilia Market Report 2022. MarketsandMarkets. https://www.marketsandmarkets.com
[4] FDA. (2020). Guidance for Industry and FDA Staff: Biosimilar Product Development. https://www.fda.gov
