Last updated: February 22, 2026
What is NDC 00591-4050?
NDC 00591-4050 is a drug product marketed under the label "Baxalta" (now part of Takeda Pharmaceuticals) for the treatment of hemophilia A. It is a recombinant factor VIII, a clotting factor used for prophylaxis and on-demand treatment of bleeding episodes in hemophilia A patients. The formulation is a lyophilized powder requiring reconstitution. It typically contains 250 IU of factor VIII per vial.
Market Landscape
Indication and Patient Population
- Hemophilia A affects approximately 1 in 5,000 male births globally.
- The drug addresses a niche market with an estimated patient population of 100,000 to 150,000 in the U.S. and Europe.
- Market access is driven by reimbursement policies, treatment guidelines, and adoption rates.
Competitors
Key competitors include:
| Product Name |
Manufacturer |
Type |
Price Point (USD/vial) |
Market Share (est.) |
| Advate (sharpened) |
Takeda (formerly Baxalta) |
Recombinant factor VIII |
$1,200 - $1,600 |
35% |
| Jivi |
Bayer |
Extended half-life factor VIII |
$1,300 - $1,700 |
15% |
| Eloctate |
Bioverativ (AbbVie) |
Extended half-life factor VIII |
$1,500 - $1,800 |
20% |
| Kogenate (haFF) |
Takeda (Kedrion, Shire) |
Recombinant factor VIII |
$1,000 - $1,300 |
10% |
Market Trends
- Increasing adoption of extended half-life products reduces infusion frequency and improves quality of life.
- The rise of gene therapy pipelines may disrupt traditional prophylactic treatments.
- Reimbursement policies favor innovative, longer-acting therapies, influencing market share shifts.
Regulatory and Reimbursement Context
- The product is approved in the U.S., EU, and Japan.
- Reimbursement predominantly through national health services and private insurers.
- Price negotiation typically occurs at the national level; list prices may differ significantly from net prices.
Price Projections
Current Pricing
- Per vial prices range from $1,200 to $1,800.
- Average estimate: approximately $1,500 per vial.
Near-term Price Trends (Next 3 Years)
- Stable pricing assumption: For established products, list prices are expected to remain stable with minor adjustments (~3-5%) annually.
- Potential discounts or rebates: Operators and payers may negotiate rebates of 10-15%, reducing net prices.
- Impact of biosimilars: Entry of biosimilar recombinant factor VIII products could drive prices down by 20-30%, occurring within the next 2-3 years.
Forecasted Market Value
Using an estimated patient base of 125,000 globally, with 60% actively treated, and an average of 10 vials per patient annually:
| Calculation Step |
Result |
| Patients treated worldwide (active) |
75,000 |
| Vials used annually per patient |
10 |
| Total vials sold annually |
750,000 |
| Average price per vial |
$1,500 |
| Total market value |
$1,125,000,000 (approx. $1.1 billion) |
Adjustments for reimbursement discounts and regional pricing could reduce net revenue to $800-900 million.
Long-term Outlook
- Price declines of 20-30% are expected if biosimilars gain market traction.
- Innovations like gene therapy may eventually replace recombinant products, reducing long-term market size.
- R&D investments in extended half-life and gene therapy will influence future pricing dynamics.
Key Drivers and Risks
Drivers
- Growing patient population due to better diagnosis and treatment awareness.
- Preference for therapies with less frequent dosing.
- Competitive pressure from biosimilars and gene therapies.
Risks
- Regulatory delays for biosimilars or gene therapies.
- Litigation or patent disputes.
- Market saturation and price erosion.
Conclusion
NDC 00591-4050 currently commands a premium pricing tier at approximately $1,500 per vial. Market size stands around $800 million to $1 billion using conservative estimates. Price erosion is anticipated over the next 2-3 years due to biosimilar competition and next-generation therapies.
Key Takeaways
- The product is a leading recombinant factor VIII for hemophilia A, with a sizable but niche market.
- Current U.S. list prices or equivalents are around $1,200-$1,800 per vial.
- Competition, biosimilar entry, and advances in gene therapy are key factors influencing future price trajectories.
- Market value estimates suggest a global revenue of approximately $800 million to $1 billion.
- Long-term prospects depend heavily on biosimilar uptake and new treatment modalities.
FAQs
Q1: How likely is biosimilar competition to impact prices for NDC 00591-4050?
A1: Highly likely within 2-3 years, biosimilar recombinant factor VIII products are entering markets in the U.S. and Europe, with expected price reductions of 20-30%.
Q2: What impact could gene therapy have on the market?
A2: Gene therapy, if approved broadly, could replace prophylactic factor VIII treatments, reducing demand for recombinant products and exerting downward pressure on prices.
Q3: What regions have the highest market potential for this drug?
A3: The U.S. and European markets lead in size and reimbursement access, accounting for approximately 75% of the global market.
Q4: Are price discounts typical in this market?
A4: Yes, rebates and confidential discounts often reduce net prices by 10-15% from list prices, especially in negotiated reimbursement contracts.
Q5: What factors could delay the entry of biosimilars or biosimilar pricing pressures?
A5: Patent protections, regulatory hurdles, manufacturing complexities, and market entry barriers can delay biosimilar availability and impact on prices.
References
[1] Market research reports and industry analyses, 2022-2023.
[2] FDA and EMA drug approval and pricing datasets, 2023.
[3] Publicly available pricing information from pharmaceutical databases, 2023.
[4] Competitor product literature, 2022-2023.
[5] Hemophilia treatment guidelines, World Federation of Hemophilia, 2023.
