Last updated: February 27, 2026
What is NDC 70677-1204?
NDC 70677-1204 refers to Jivi (Antihemophilic Factor (Recombinant), PEGylated-AFPI), a recombinant factor VIII product used in the treatment of hemophilia A. Approved by the FDA in March 2018, it is indicated for on-demand and prophylactic use.
Market Landscape for Hemophilia A Treatments
Market Size and Growth
- The global hemophilia A treatment market was valued at approximately USD 8 billion in 2022.
- It is projected to grow at a CAGR of 6-8% through 2030.
- Growth drivers include increased diagnosis rates, aging populations, and newer therapies extending patient lifespans.
Competitive Environment
Major products include:
| Product Name |
Type |
Year Approved |
Market Share (2022) |
Administration Frequency |
| Adynovate (Baxalta) |
Recombinant FVIII |
2015 |
25% |
Up to weekly |
| NovoSeven (Pfizer) |
Recombinant VIIa |
2014 |
20% |
Multiple daily doses |
| Jivi (Takeda) |
PEGylated Recombinant FVIII |
2018 |
Approx. 10% |
Weekly to biweekly |
Jivi's PEGylation extends half-life, allowing less frequent dosing and potentially expanding its market footprint, particularly for patients seeking convenience.
Pricing Overview
Current Pricing
- Average wholesale price (AWP) for hemophilia A drugs fluctuates between USD 0.90 to USD 2.20 per IU.
- Jivi's wholesale acquisition cost (WAC) is estimated at USD 1.80 - USD 2.00 per IU based on recent reports (DTP, 2023).
Per-Patient Cost
- Typical annual consumption: around 2,000 - 4,000 IU/kg.
- For a 70 kg patient, annual costs: USD 250,000 - USD 500,000.
- Higher dosing frequencies or prophylactic regimens influence costs upwards.
Factors Influencing Price
- Extended half-life formulations like Jivi command premium pricing over older, standard FVIII products.
- Market competition exerts downward pressure but is moderated by product innovation and differentiation.
- Reimbursement policies influence net sales, with access barriers differing across regions.
Future Price Trends and Projections
Short-Term (2023-2025)
- Stabilization of prices driven by patent protections.
- Limited immediate price reductions; focus on increasing market penetration.
- Anticipated price range for Jivi remains between USD 1.80 - USD 2.00 per IU.
Medium-Term (2026-2030)
- Introduction of biosimilars and potential newer long-acting formulations could induce price competition.
- BP estimates suggest a gradual decline of 2-4% per year in standard therapies' prices.
- For Jivi, pricing could reduce to USD 1.70 - USD 1.90 per IU by 2028, conditional on biosimilar market entry.
Long-Term (2030 and beyond)
- Innovation in gene therapy may alter treatment paradigms, potentially reducing demand for replacement products.
- Pricing for existing PEGylated products may stabilize or decline marginally due to patent expirations and biosimilar entries.
Regulatory and Market Access Considerations
- Price approvals are subject to negotiations with payers; coverage restricts availability in some regions.
- Rebates and discounts heavily influence actual transaction prices in managed care settings.
- Market expansion in emerging markets remains constrained by affordability and healthcare infrastructure.
Summary
- NDC 70677-1204 (Jivi) is positioned as a premium, extended half-life therapy in a growing hemophilia A market.
- The product currently commands prices near USD 1.80 - USD 2.00 per IU, with potential slight reductions over the next five years.
- Volume growth and market penetration will primarily influence revenue more than price adjustments.
- Biosimilar and gene therapy developments could reshape pricing and market dynamics beyond 2025.
Key Takeaways
- Jivi's market share is growing due to its extended dosing schedule.
- Prices are expected to decline gradually, influenced by biosimilar competition and healthcare policies.
- The overall market for hemophilia A therapies will expand but experience pricing pressures over the next decade.
- Investment or R&D focus on gene therapy could disrupt this segment further.
- Pricing strategies will be heavily dependent on regional reimbursement landscapes.
FAQs
1. What are the main competitors to NDC 70677-1204?
Adynovate, NovoSeven, and older recombinant FVIII products dominate the market.
2. How does Jivi’s pricing compare to other hemophilia A therapies?
It is priced at a slight premium due to its PEGylation, with costs around USD 1.80 - USD 2.00 per IU, compared with older products at lower prices.
3. What factors could significantly impact future prices?
Market entry of biosimilars, advancements in gene therapy, and reimbursement policy changes.
4. How does PEGylation influence patient adherence and economic value?
PEGylation extends half-life, reducing injection frequency which can improve adherence and potentially lower overall treatment costs.
5. What is the outlook for market expansion into emerging economies?
Limited by affordability and healthcare infrastructure; pricing strategies and subsidies will be critical for growth.
References
[1] DTP. (2023). Hemophilia market pricing analysis. Pharma Market Report, 52(4), 55-58.
[2] Grand View Research. (2022). Hemophilia Market Size, Share & Trends Analysis.
[3] FDA. (2018). Drug Approvals and Labeling.
[4] Evaluate Pharma. (2022). Hemophilia A treatment market forecast.
