Last updated: February 27, 2026
What is NDC 00113-0957?
NDC 00113-0957 corresponds to Hemlibra (emicizumab-kxwh), developed by Genentech, a Roche subsidiary. Hemlibra is a monoclonal antibody designed for prophylactic treatment of hemophilia A, including those with factor VIII inhibitors. It was approved by the U.S. FDA in November 2017.
Market Size and Demand Drivers
Hemophilia A Population
- U.S. prevalence: Approximately 20,000 patients (CDC, 2015).
- Global prevalence: Estimated at 250,000 patients (World Federation of Hemophilia, 2020).
- Hemlibra targets both hemophilia A patients with and without inhibitors.
Treatment Landscape
- Traditional treatment involves factor VIII concentrates.
- Hemlibra offers subcutaneous administration, extending prophylactic coverage and improving compliance.
- Adoption driven by efficacy, convenience, and safety profile.
Sales Data
- 2021 U.S. sales reported at approximately $2.2 billion.
- Global sales reached around $3.8 billion in 2022.
Competitive Environment
- Other options: FVIII concentrates, emicizumab biosimilars, and emerging gene therapies.
- Market share for Hemlibra increased from 40% in 2018 to over 70% in 2022 among prophylactic treatments.
Price Analysis
Current Pricing
- U.S. wholesale acquisition cost (WAC): Approximately $469,500 annually per patient (Genentech, 2023).
- Price varies by country based on negotiation and reimbursement policies.
Cost Breakdown
- Hemlibra dosing: 1.5 mg/kg weekly for the first four weeks, then 1.5 mg/kg every two weeks.
- Approximate annual treatment cost per patient: $470,000, assuming median patient weight (~70 kg).
Reimbursement Environment
- U.S.: Primarily covered by insurance, with negotiated discounts and rebates.
- International markets: Prices lower due to government price controls and negotiations.
Price Projections (2023–2027)
| Year |
Estimated Global Sales |
Average Price per Patient |
Key Factors |
| 2023 |
$4.2 billion |
$470,000 |
Market penetration continues; pricing stability |
| 2024 |
$4.8 billion |
$465,000 |
Increased biosimilar competition, slight price erosion |
| 2025 |
$5.2 billion |
$450,000 |
Market saturation; pricing pressures intensify |
| 2026 |
$5.6 billion |
$440,000 |
Entry of biosimilars; broader indications |
| 2027 |
$6.0 billion |
$430,000 |
Additional biosimilar entries; global expansion |
Assumptions
- Sales growth driven by expanding global access and new indications.
- Price declines due to biosimilar competition and payer negotiations.
- Stable demand in primary markets, with growth in emerging markets.
Key Market Risks
- Introduction of biosimilars reducing list prices.
- Regulatory delays or restrictions in certain countries.
- Shifts toward gene therapy potentially reducing long-term demand.
Conclusions
Hemlibra remains a dominant therapy for hemophilia A prophylaxis, with high upfront costs offset by market penetration. Prices are expected to decline gradually as biosimilar competition increases, though total sales will likely grow with expanded indications and geographic reach.
Key Takeaways
- NDC 00113-0957 (Hemlibra) generated $3.8 billion in global sales in 2022.
- U.S. annual treatment costs are approximately $470,000 per patient.
- Sales are projected to reach $6 billion globally by 2027.
- Price erosion will occur due to biosimilar competition but will be offset by expanding global markets.
- The product's competitive advantage remains its convenience and efficacy.
FAQs
What factors influence Hemlibra's pricing?
Reimbursement policies, biosimilar competition, global market dynamics, and negotiated discounts impact pricing.
How does biosimilar competition affect future prices?
Entry of biosimilars typically drives prices downward, with reductions of 20-30% expected over the next five years.
What is the growth potential in emerging markets?
Emerging markets are expected to account for a larger share of sales, driven by increasing awareness and affordability initiatives.
Are there upcoming indications that could boost sales?
Yes, approval for additional indications such as pediatric hemophilia A could expand the patient base.
How might gene therapies impact the market?
Emerging gene therapies could reduce long-term demand for prophylactic treatments like Hemlibra, but their adoption depends on safety, efficacy, and cost.
References
- CDC. (2015). Hemophilia in the United States. Center for Disease Control and Prevention.
- Genentech. (2023). Hemlibra (emicizumab-kxwh) pricing and reimbursement info.
- World Federation of Hemophilia. (2020). Annual Hemophilia Data Report.
- Bloomberg Intelligence. (2023). Hemophilia market analysis and projections.
