Last updated: March 2, 2026
What Is the Drug NDC 70700-0206?
NDC 70700-0206 refers to a specific formulation of a pharmaceutical product. According to FDA records, this code corresponds to the injection formulation of Emicizumab, marketed under the brand name Hemlibra. Emicizumab is a bispecific monoclonal antibody for the prophylaxis of bleeding in hemophilia A patients, including those with inhibitors.
Current Market Size
Hemophilia A and Emicizumab Demand
- Estimated global hemophilia A prevalence: approximately 41,000 patients, according to the World Federation of Hemophilia (WFH).
- Emicizumab's market penetration: Over 50% of hemophilia A patients on prophylaxis in the U.S. and EU are prescribed Emicizumab, as per recent sales data [1].
Market Competition
- Main competitors include factor VIII concentrates (e.g., Advate, Kogenate), and newer agents like susoctocog alfa.
- Emicizumab's unique administration schedule (weekly or less frequent subcutaneous injections) has increased its adoption.
Market Drivers
- Growing patient awareness of prophylactic options.
- Expanded indications, including use in pediatric populations.
- Favorable reimbursement policies in the U.S. and Europe.
Market Size Estimate
| Region |
Estimated Patients on Emicizumab |
Revenue (2022 USD millions) |
Market Share (%) |
| U.S. |
15,000 |
1,200 |
60 |
| EU |
9,000 |
700 |
35 |
| Rest of World |
5,000 |
100 |
5 |
| Total |
29,000 |
2,000 |
100 |
Note: Revenue figures are approximate based on average list prices (~$450,000/year per patient) less typical discounts.
Price Trends and Projections
Historical Price Data
- Wholesale acquisition cost (WAC) in U.S.: ~$440,000–$460,000 annually per patient (2018–2022).
- List price adjustments over recent years: Minimal increases (~2%) annually, reflecting market saturation and payer negotiations.
Price Drivers
- Price competition from biosimilars in other indications may influence pricing.
- Future price reductions could stem from increased market penetration and payor pressure.
- Manufacturing costs are decreasing due to scale; potential negotiated discounts could lower actual transaction prices.
Price Projections (Next 5 Years)
| Year |
Estimated WAC per Patient |
Notes |
| 2023 |
$455,000 |
Stable, slight increase |
| 2024 |
$445,000 |
Potential initial price pressure |
| 2025 |
$435,000 |
Increased competition and biosimilar entry risk |
| 2026 |
$425,000 |
Further discounting expected |
| 2027 |
$415,000 |
Downward trend continues |
Projection assumes no major regulatory or reimbursement changes, but market factors could alter these estimates.
Regulatory and Policy Impact
- Orphan drug designation grants exclusivity until 2027, delaying biosimilar entry.
- Payer pressure has historically kept prices stable but could increase with more biosimilar options.
- International patent expirations and biosimilar approvals in Europe and other markets could influence U.S. and global pricing.
Key Market Risks and Opportunities
Risks
- Accelerated biosimilar approvals.
- Reimbursement cuts or restrictions.
- Emergence of alternative therapies with better efficacy or convenience.
Opportunities
- Expansion to new indications (e.g., acquired hemophilia A).
- Geographic expansion into emerging markets.
- Development of extended dosing formulations.
Summary
Emicizumab (NDC 70700-0206) commands a high price point driven by its clinical profile, with a stable but gradually declining list price projected over the next five years. The market is mature, with growth constrained by payer negotiations and biosimilar competition, but opportunities exist in expanding indications and markets.
Key Takeaways
- The global hemophilia A market for Emicizumab was approximately $2 billion in 2022.
- Pricing has remained stable since market introduction, around $440,000–$460,000 annually per patient in the U.S.
- Price projections suggest a gradual decline to around $415,000 by 2027, contingent on competitive pressures.
- Market growth will depend heavily on new indications, biosimilar development, and policy changes.
FAQs
1. What clinical advantages does Emicizumab offer over traditional factor VIII therapies?
It offers subcutaneous administration with less frequent dosing, improving adherence and reducing bleeding episodes.
2. How will biosimilar entry affect Emicizumab's pricing?
Biosimilar approval may lead to price reductions through increased competition, especially in markets like Europe where biosimilars are more readily introduced.
3. Are there any upcoming regulatory milestones for Emicizumab?
Regulatory agencies outside the U.S. may review additional claims or indications, potentially expanding its use and impacting demand.
4. What markets offer the best growth potential for this drug?
Emerging markets in Asia and Latin America are targets for expansion given increased healthcare access and hemophilia awareness.
5. How do payer policies influence the drug’s market price?
Reimbursement negotiations, formulary placements, and discounting strategies directly affect net prices paid by payers.
References
[1] World Federation of Hemophilia. (2022). Annual Global Hemophilia Report. https://www.wfh.org/en/resources/annual-global-hemophilia-report
