Last updated: February 17, 2026
Product Overview:
NDC 00228-2848 corresponds to Immunoglobulin, Intravenous (IVIG), 5 g/50 mL (brand-specific formulations vary). This drug is used primarily for primary immunodeficiency, idiopathic thrombocytopenic purpura, and other autoimmune conditions. It is a plasma-derived biologic, subject to regulation by the FDA, and typically covered under specialized distribution channels.
Market Size and Demand:
The global IVIG market was valued at approximately $8.2 billion in 2022, with a compound annual growth rate (CAGR) around 7% forecasted through 2030 ([1]). North America accounts for about 50% of the market, driven by advanced healthcare infrastructure and high adoption rates.
The demand for IVIG remains stable due to its essential role in treating immune deficiencies and autoimmune diseases. Consumption volumes are approximately 800,000 to 1 million grams annually in the U.S., with upward trends aligned with increased diagnoses and expanding indications.
Competitive Landscape:
Market participants include:
- CSL Behring
- Grifols
- Octapharma
- Takeda Pharmaceuticals (Projects like VePharma)
These competitors have established manufacturing capacities, extensive distribution networks, and competitive pricing strategies.
Pricing Dynamics:
Prices for IVIG products are influenced by several factors:
- Cost of plasma collection
- Manufacturing complexities
- Regulatory compliance
- Distribution logistics
In the U.S., list prices typically range from $10 to $15 per gram. Discounted prices for bulk procurement or insurance negotiations generally fall between $8 and $12 per gram.
For the specific 5 g/50 mL formulation:
- Wholesale acquisition cost (WAC) ranges from $50 to $75 per dose.
- Medicare Part B reimbursements are heavily influenced by national average sales price (ASP), generally around 85-100% of WAC.
Price Projections:
Given current market trends and inflation levels:
| Year |
Projected Price Range per 5 g Dose |
Comments |
| 2023 |
$50 - $75 |
Current market prices; potential slight upward pressure |
| 2025 |
$55 - $80 |
Inflation and supply chain pressures; increased demand |
| 2030 |
$60 - $90 |
Longer-term price stability, volume-driven negotiations |
Market Entry Considerations:
Introducing a biosimilar or a new IVIG formulation could impact pricing by increasing competition. Biosimilars such as Epicel and Carimune entered markets at discounts of 20-40%, putting downward pressure on existing prices ([2]).
Regulatory and Reimbursement Trends:
FDA reviews for plasma-derived products emphasize safety and consistent manufacturing standards. Reimbursement trends favor value-based purchasing, with payers seeking lower-cost alternatives when similar efficacy is established.
Supply Chain and Manufacturing Factors:
The production of plasma-derived therapies depends on plasma donations, which face variability due to donor safety, collection capacity, and pandemic disruptions. These factors influence production costs and, consequently, pricing.
Key Market Drivers:
- Rising prevalence of autoimmune disorders
- Increased diagnosis and treatment adoption
- Technological advances reducing manufacturing costs
- Policy shifts favoring biosimilars
Risks and Challenges:
- Plasma collection limitations
- Stringent regulatory requirements
- Pricing pressures from biosimilars
- Reimbursement changes
Summary of Price Drivers:
Existing IVIG products sell at $8-$12 per gram in bulk, with retail doses around $50-$75 per 5 g. Price projections suggest a moderate increase aligned with inflation and demand, tempered by biosimilar competition.
Key Takeaways
- The IVIG market is stable with a 7% CAGR projected through 2030.
- Current prices for the 5 g/50 mL formulation are approximately $50-$75 per dose.
- Prices are influenced by manufacturing costs, regulatory standards, and competition.
- Biosimilars pose a significant risk to pricing, potentially reducing prices by 20-40%.
- Market growth depends on increasing diagnoses and advancements in plasma collection.
FAQs
1. How are IVIG prices determined in the U.S.?
Prices are set based on wholesale acquisition costs (WAC), negotiated discounts, manufacturer premiums, and payer reimbursement policies, including Medicare ASP calculations.
2. What factors could significantly impact IVIG pricing in the near future?
The introduction of biosimilars, plasma supply constraints, changes in reimbursement policies, and regulatory developments could affect pricing levels.
3. Are there regional differences in IVIG pricing?
Yes. European countries often negotiate lower prices due to government bargaining and pricing regulations, while U.S. prices tend to be higher.
4. Will biosimilars lead to lower prices?
Likely. Biosimilars, entering at a 20-40% discount, can reduce prices of reference products, impacting revenue and pricing strategies.
5. What are the key drivers of demand for IVIG?
Growing autoimmune disease prevalence, improved diagnostic tools, and expanded treatment indications contribute to increasing demand.
Citations
[1] MarketsandMarkets. "Intravenous Immunoglobulin Market by Type, Application, and Region," 2022.
[2] IQVIA. "Biosimilar Market Dynamics," 2022.
