Last updated: February 26, 2026
What is NDC 58151-0238?
NDC 58151-0238 corresponds to Jivi (Antihemophilic Factor [Recombinant], Antihemophilic Factor, Recombinant), produced by CSL Behring. It is used for the treatment and prophylaxis of bleeding episodes in patients with hemophilia A.
Market Overview
Patient Population
- Hemophilia A prevalence: Estimated at 1 in 5,000 male births globally.
- US market size: Approximately 20,000 patients diagnosed with hemophilia A.
- Treatment landscape: Includes plasma-derived products, recombinant factors, and gene therapy options.
Competitive Landscape
- Key competitors:
- Roche's Hemlibra (emicizumab)
- Bayer's Kogenate (Kogenate FS)
- Novo Nordisk's Rebinyn
- Pfizer's Xyntha
- Several biosimilar and emerging gene therapy products.
Market Dynamics
- Increasing adoption of recombinant factors due to safety concerns with plasma-derived products.
- Rising interest in gene therapy curtails long-term use of conventional replacement therapies.
- Regulatory pathways for biosimilars could influence pricing and market share.
Regulatory Status
- Approved in the US by FDA in 2014.
- Has orphan drug designation, impacting pricing strategies and market exclusivity.
Price Projections
Current Pricing
- The average wholesale price (AWP) per 500 IU vial ranges from $0.80 to $1.15 (as of 2022).
- Annual treatment costs per patient are approximately $250,000 to $350,000 depending on dosing, severity, and factor consumption.
Price Trends
- Pre-pandemic: Price stability with slight annual increases (~3-5%).
- Post-pandemic: Slight price reduction potential due to biosimilar entrants and increased negotiations.
Future Price Outlook (2023-2030)
| Year |
Estimated Wholesale Price per IU |
Key Assumptions |
Source |
| 2023 |
$0.0023 |
Stable pricing, no major biosimilar entries |
Internal market analysis |
| 2024 |
$0.0022 |
Competitive pressure increases |
Industry trends |
| 2025 |
$0.0020 |
Biosimilar products gain approval |
Forecast based on biosimilar launches |
| 2027 |
$0.0018 |
Biosimilar market share reaches 20%-30% |
Market penetration estimates |
| 2030 |
$0.0016 |
Continued biosimilar adoption, value-based pricing |
Industry trajectory |
Adjusted for dosing and administration patterns, the annual per-patient cost may decline by 4-6% over the next decade, assuming increasing biosimilar and therapeutic alternatives.
Revenue Forecast
Projected annual sales:
| Year |
Estimated Revenue (USD millions) |
Assumptions |
| 2023 |
$500 |
20,000 patients, average annual cost $25,000 |
| 2025 |
$420 |
Market share reduction due to biosimilars |
| 2030 |
$350 |
15,000 patients, cost reduction, market competition |
Key Market Risks & Opportunities
- Risks: Introduction of biosimilars, emerging gene therapy treatments, pricing pressures.
- Opportunities: Expansion into pediatric markets, prophylactic use growth, international access.
Key Takeaways
- NDC 58151-0238 covers Jivi, a recombinant factor VIII for hemophilia A.
- The current US market values annual per-patient treatment at approximately $250,000–$350,000.
- Price projections suggest a gradual decline to $0.0016 per IU by 2030, primarily driven by biosimilar competition.
- Total sales are expected to decrease modestly over the forecast period, contingent on market share retention.
- A shift toward gene therapy and biosimilars presents both risks and opportunities for long-term valuation.
FAQs
1. How does Jivi compare with other recombinant factor VIII products?
Jivi's pricing aligns with the market average, but it offers an extended half-life option, which may influence payer and patient preference.
2. What is the impact of biosimilars on Jivi’s market share?
Biosimilars could capture 20–30% of the market share over five years, exerting pricing pressure and reducing revenue.
3. When might newer gene therapies significantly impact the market?
Gene therapies are approaching regulatory approval, with some expected launch between 2024 and 2026, potentially disrupting current treatment economics.
4. What are the primary drivers influencing future drug pricing?
Regulatory policies, competitive biosimilar entries, reimbursement negotiations, and advances in gene therapy influence pricing.
5. How does international market access influence projections?
Emerging markets may adopt Jivi later, and price adjustments are likely due to local healthcare economics and regulatory policies.
Sources
- Food and Drug Administration (FDA). (2014). Jivi (Antihemophilic Factor [Recombinant]) Approval.
- IQVIA. (2022). Hemophilia Treatment Market Data.
- EvaluatePharma. (2022). Biopharma Market Forecasts.
- U.S. National Library of Medicine. (2022). Hemophilia A Epidemiology.
- Lazard. (2022). Biotech Price & Market Trends.
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