Last updated: February 27, 2026
What is NDC 00904-7553?
NDC 00904-7553 corresponds to Immunoglobulin (Human), Subcutaneous (SC), 10% Solution. It is primarily used to treat primary immunodeficiencies by supplementing deficient immunoglobulin levels. The drug is manufactured by Grifols and is marketed under various brand names like Hizentra.
Market Size and Growth Dynamics
Current Market Landscape
- The global immunoglobulin market was valued at approximately $9 billion in 2021.
- Expected compound annual growth rate (CAGR): 8-10% over the next five years.
- Subcutaneous immunoglobulin (SCIG) formulations represent about 30% of total immunoglobulin sales.
- The U.S. leads demand, accounting for roughly 50% of the global market.
Key Drivers
- Increasing prevalence of primary immunodeficiency diseases (PID): estimates suggest 1 in 1,200 to 1 in 2,000 individuals affected globally.
- Growing preference for SC administration due to fewer adverse effects and improved patient compliance.
- Expanding approval for off-label uses, including autoimmune and inflammatory conditions.
- Ongoing shortages of intravenous immunoglobulin (IVIG) supply, which intensifies demand for SCIG alternatives.
Competitive Landscape
| Company |
Product Name |
Market Share (estimated) |
Key Differentiator |
| Grifols |
Hizentra |
~40% |
Proven efficacy, global reach |
| CSL Behring |
Vivaglobin |
~30% |
Longstanding market presence |
| Octapharma |
Octagam SC |
~10% |
Flexibility in dosing |
| Other Suppliers |
Various |
~20% |
Niche or regional players |
Price Points and Revenue Projections
Current Pricing Trends
- Average wholesale price (AWP) for Hizentra ranges from $180 to $220 per gram.
- Typical monthly treatment dose: 0.4 to 0.5 g/kg of patient weight.
- For a standard 70 kg adult, monthly cost: approximately $5,000 to $7,700.
Price Drivers
- Manufacturing complexities, including plasma sourcing and purification.
- Market competition and patent expirations, notably the expiration of Hizentra’s primary patent in 2024.
- Regulatory changes, particularly in Europe and the U.S., impacting reimbursement and pricing.
Revenue Projection for 2023–2027
| Year |
Estimated Global Revenue (USD millions) |
Assumptions |
| 2023 |
1,200 |
Steady growth, minor price adjustments |
| 2024 |
1,350 |
Patent expiry leads to increased competition; price erosion begins |
| 2025 |
1,500 |
Market penetration and off-label use expands |
| 2026 |
1,650 |
Supply stabilize, new markets develop |
| 2027 |
1,800 |
Market maturity, pricing stabilizes |
Note: These projections consider the anticipated impact of increased competition from biosimilars and new formulations, as well as potential price reductions due to policy changes.
Regulatory and Policy Factors
- The U.S. FDA approved Hizentra for pediatric use in 2007 and for adult use.
- The European Medicines Agency (EMA) approved Hizentra in 2010.
- Biosimilar development faces a complex regulatory environment; biosimilars to IG products are gaining approval but encounter hurdles related to interchangeability.
Market Challenges and Risks
- Potential biosimilar entry, particularly after patent expiration.
- Supply chain disruptions affecting plasma collection.
- Reimbursement pressure from payers, especially in cost-sensitive healthcare systems.
- Manufacturing regulatory hurdles across different regions.
Key Takeaways
- NDC 00904-7553 (Hizentra) operates in a growing segment driven by increased immunodeficiency prevalence and preference for SC administration.
- The global market is expected to reach approximately $12 billion by 2027, with immunoglobulin products accounting for a significant portion.
- Price per gram remains high, with monthly costs around $5,000–$7,700 for typical adult doses.
- Patent expiration in 2024 is poised to introduce biosimilar competition, which could pressure prices and market shares.
- Regulatory landscape and supply chain stability are critical risk factors.
FAQs
1. How will biosimilar entry affect Hizentra’s market share?
Biosimilar competition starting after patent expiry will likely reduce market shares and pricing power, with potential discounts of up to 30-50%.
2. Are there emerging therapies that could replace immunoglobulin treatments?
No direct replacements presently exist; alternative management strategies include enzyme replacement and gene therapies, but they are not yet mainstream.
3. What regions will see the fastest growth?
Asia-Pacific countries, driven by increasing immunodeficiency recognition and healthcare investments, will see accelerated growth.
4. How is reimbursement influencing prices?
Payers are increasingly negotiating lower prices, with policies favoring biosimilar use and cost containment measures.
5. What are the prospects for new formulations?
Extended half-life formulations or subcutaneous home infusion products could further expand market size and improve patient convenience.
References
[1] Grand View Research. (2022). Immunoglobulin Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Global Immunoglobulin Market Report.
[3] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[4] European Medicines Agency. (2022). Marketing Authorization Applications and Approvals.
[5] ClinicalTrials.gov. (2022). Trials related to immunoglobulin therapies.
