Last updated: February 15, 2026
Product Overview
NDC 00054-0639 corresponds to Gammagard Liquid, a licensed intravenous immunoglobulin (IVIG) used in the treatment of immune deficiencies and certain autoimmune disorders. Produced by its patent holder (currently Takeda and previously associated with other manufacturers), it is a high-demand biologic with a well-established market position.
Market Dynamics
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Market Size
The global IVIG market, valued at approximately $10.5 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of 7% through 2030, driven by rising autoimmune disease incidence, aging populations, and expanded indications [1].
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Key Indications
- Primary immunodeficiency (PI): 80% of use
- Autoimmune conditions (e.g., Guillain-Barré syndrome, myasthenia gravis): 15%
- Hemolytic disease, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP): smaller segments
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Market Players
- Takeda (Gammagard Liquid, Kiovig)
- CSL Behring (Privigen, Hizentra)
- Grifols (Gamunex-C, Flebogamma)
- Octapharma (Octagam)
Takeda holds a significant share, with Gammagard Liquid being a leading product.
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Supply Chain Trends
Supply margins fluctuate due to plasma collection constraints, manufacturing complexity, and regulatory considerations. In recent years, plasma donor availability impacted supply reliability.
Pricing Overview
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Historical Pricing
- U.S. average wholesale price (AWP): approximately $120 to $150 per gram (2022)
- Per-dose costs for standard treatment (e.g., 30g per infusion): $3,600 to $4,500
- Price variations stem from manufacturing, dosing, and contractual discounts
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Pricing Drivers
- Limited competition for specific formulations enhances pricing power
- Regulatory pressures and biosimilar entry influence price trajectories
- Cost of plasma procurement and manufacturing efficiencies affect gross margins
Future Price Projections
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Short-term (Next 2 years)
Prices are expected to stabilize or slightly increase (3-5%) due to inflation, raw material costs, and ongoing supply constraints. Existing contracts may suppress price fluctuations.
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Medium-term (3-5 years)
Possible price pressure from biosimilars or next-generation products could lead to 10-15% price reduction for some markets. However, for established IVIG products like Gammagard Liquid used in rare indications, prices may remain relatively stable.
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Long-term (Beyond 5 years)
The emergence of recombinant or engineered immunoglobulin therapies could threaten traditional plasma-derived products, potentially reducing average prices by up to 20-30%. However, breakthroughs in manufacturing or indication expansions could offset this trend.
Regulatory and Policy Impact
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FDA Guidance & Trends
Emphasis on biosimilar development and interchangeability designations may influence pricing models and market share toward 2025-2030.
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Government & Payer Policies
Laws promoting plasma donation and reimbursement adjustments could influence net pricing and access strategies.
Conclusion
The NDC 00054-0639's primary market remains stable with moderate growth. Price projections suggest slight increases in the near term, influenced by inflation and supply dynamics, but medium to long-term trends anticipate pressure from biosimilar competition and technological advances.
Key Takeaways
- Gammagard Liquid, linked to NDC 00054-0639, dominates the IVIG segment with a substantial market share.
- The total IVIG market advances at a 7% CAGR through 2030, driven by autoimmune and immunodeficiency indications.
- Current U.S. wholesale prices range between $120 and $150 per gram, with annual per-patient costs around $30,000 to $45,000.
- Price stability persists in the short term, but biosimilars and recombinant products may drive reductions in the longer term.
- Supply constraints and plasma procurement costs continue to influence pricing and availability.
FAQs
1. What are the main indications for Gammagard Liquid?
Primary immunodeficiency, autoimmune disorders like CIDP, Guillain-Barré syndrome, and Kawasaki disease.
2. How does the market share of Gammagard compare to rivals?
Takeda’s Gammagard holds approximately 30-40% of the IVIG market, leading due to longstanding presence and supply stability.
3. Are biosimilars impacting IVIG prices?
Potentially, but currently biosimilar Entry is limited for IVIG; next-generation therapies may influence future pricing.
4. What manufacturing challenges affect the supply of IVIG?
Plasma collection limitations, complex manufacturing processes, and regulatory hurdles restrict supply growth.
5. How will regulatory policies shape future pricing?
Increased focus on biosimilar approval and reimbursement reforms could exert downward pressure on prices.
Sources
[1] MarketsandMarkets, "IVIG Market by Type, Application, and Region," 2022.
