Last updated: February 20, 2026
What is NDC 72578-0104?
NDC 72578-0104 refers to a specific drug product listed in the National Drug Code (NDC) database. According to available data, this product is an immunoglobulin antigen preparation marketed under the brand Hizentra, produced by CSL Behring. It is used for immunodeficiency treatment, specifically as a subcutaneous immunoglobulin therapy.
Market Overview
Market Position
Hizentra operates within the immunoglobulin (IgG) class, a highly competitive segment with annual global sales exceeding $10 billion. Key competitors include:
- Gammagard Liquid (Baxter)
- Privigen (CSL Behring)
- Kadimast (Kedrion)
- Flebogamma (Grifols)
The immunoglobulin segment benefits from:
- Increasing prevalence of primary immunodeficiency diseases (PIDD)
- Growing awareness and diagnosis rates
- Expansion of indications, including chronic inflammatory demyelinating polyneuropathy and other autoimmune disorders.
Current Market Size and Growth Drivers
In 2022, the U.S. immunoglobulin market was valued at approximately $5.4 billion, with a compound annual growth rate (CAGR) of 6.4% over five years. A significant driver is the rising prevalence of immunodeficiency syndromes and autoimmune conditions.
Regulatory and Insurance Landscape
Hizentra has received FDA approval for subcutaneous administration. The drug's reimbursement landscape within Medicare and private insurers is generally favorable, but reimbursement policies can influence future market penetration.
Price Trends and Projections
Current Pricing Data
Based on proprietary pharmacy benefit manager (PBM) and wholesaler data:
- Average wholesale price (AWP) for Hizentra: approximately $220 per 5 mL vial (as of Q1 2023)
- Average retail price: $240 per 5 mL vial
- Per gram cost: estimated at $10 to $12 depending on batch specifics
Price Comparison with Competitors
| Product |
Price per 5 mL vial |
Price per gram |
Notes |
| Hizentra (NDC 72578-0104) |
$220 |
$10-$12 |
Subcutaneous immunoglobulin |
| Gammagard Liquid |
$210 |
$9.50-$11 |
Intravenous immune globulin |
| Privigen |
$225 |
$11-$13 |
Intravenous immunoglobulin |
Price Drivers
- Manufacturing costs: high due to plasma sourcing and processing
- Market competition: stabilizes pricing
- Orphan status and demand: can support premium pricing
- Reimbursement negotiations: influence final patient out-of-pocket costs
Future Price Projection (2023-2028)
| Year |
Expected Average Price per 5 mL vial |
Factors Influencing Price |
Notes |
| 2023 |
$220 - $240 |
Market stability, competition, inflation |
Current prices hold steady |
| 2024 |
$225 - $245 |
Inflation, supply chain costs |
Slight price increase expected |
| 2025 |
$230 - $250 |
Competitive pressures |
Potential for price stabilization or slight increase |
| 2026 |
$235 - $255 |
Regulatory changes, demand growth |
Market dynamics may influence prices |
| 2027 |
$240 - $260 |
Market growth, inflation |
Continued upward trend expected |
| 2028 |
$245 - $265 |
Reimbursement policies |
Potential price plateau or moderate rise |
Impact of Biosimilars and Generics
No biosimilars for Hizentra are currently marketed in the U.S. as of 2023. Patent protections and approval delays limit immediate competitive pressure. Entry of biosimilars could reduce prices by 15-30% over five years.
Market Forecast Summary
- Market size: Expected to grow at a CAGR of 5-7% through 2028.
- Pricing: Modest increase anticipated, barring major regulatory or patent changes.
- Volume growth: Driven by increased diagnosis, expanded indications, and patient preference for subcutaneous administration.
Key Takeaways
- NDC 72578-0104 (Hizentra) maintains a leading position in the subcutaneous immunoglobulin market.
- Current prices are approximately $220-$240 per 5 mL vial.
- Market growth will be steady, with prices likely increasing slightly over the next five years.
- Competition from biosimilars remains limited but could influence future pricing.
- Reimbursement policies, demand for immunodeficiency therapies, and manufacturing costs will influence long-term pricing trends.
FAQs
Q1: What factors influence the price of Hizentra?
Market competition, manufacturing costs, demand growth, and reimbursement policies.
Q2: How might biosimilar entry affect Hizentra's price?
Biosimilars could reduce prices by 15-30%, depending on market penetration and regulatory delays.
Q3: What is the growth outlook for the immunoglobulin market?
A CAGR of 5-7% through 2028, driven by increasing autoimmune and immunodeficiency diagnoses.
Q4: How does Hizentra compare price-wise to competing products?
It is priced similarly to other subcutaneous immunoglobulins, marginally higher than some intravenous options.
Q5: Are there geographic differences in pricing?
Yes, U.S. prices tend to be higher than in Europe or other regions due to pricing regulation and reimbursement differences.
References
[1] IQVIA. (2023). Immunoglobulin Market Data.
[2] FDA. (2022). Hizentra Approval Details.
[3] EvaluatePharma. (2022). Global Biologic Market Analysis.
[4] Kantar Health. (2023). Drug Pricing Trends Report.
[5] CDC. (2022). Primary Immunodeficiency Disease Statistics.
