Last updated: February 16, 2026
What is NDC 27241-0202?
NDC 27241-0202 identifies an immunoglobulin therapy marketed under the brand name Gammaked, used primarily in the treatment of primary immunodeficiency (PI). The product is a pooled human immunoglobulin G (IgG) intravenous (IV) product. It received FDA approval in 2019 and is a relatively recent entrant in the immunoglobulin market.
Market Overview
The immunoglobulin therapy market is growing steadily, driven by an increase in diagnosed primary immunodeficiency and other autoimmune disorders. The global IgG market hit approximately $14 billion in 2022, with a CAGR of 7.4% projected through 2027 [1].
Key players include CSL Behring, Grifols, and Takeda. Gammaked competes with these established brands offering comparable efficacy, but recent approvals and manufacturing efficiencies may influence its market share.
Market Penetration of Gammaked
As a new entry, Gammaked has captured a limited market share, primarily within the U.S. private insurance and hospital settings. Its initial distribution focuses on:
- Hematology and immunology clinics.
- Hospitals with immunoglobulin infusion services.
- Patients with primary immunodeficiency, especially those seeking alternatives to established brands.
Market penetration will depend on physician preference, insurance reimbursement policies, and supply chain stability.
Pricing Landscape
The average wholesale price (AWP) for IVIG products in the U.S. varies between $70 and $150 per gram, influenced by manufacturer, formulation, and volume discounts. For comparison:
| Product |
Average Price Per Gram |
Approval Year |
Estimated Annual Revenue (2022) |
| Gammaked (NDC 27241-0202) |
$110 |
2019 |
Part of the broader IgG market, estimated $250 million globally |
| Privigen (CSL Behring) |
$125 |
1997 |
>$2 billion globally |
| Gamunex-C (Takeda) |
$120 |
2000 |
>$1.5 billion globally |
Gammaked's pricing is likely between $100–$125 per gram initially, aligning with newer products that target similar patient populations. The final price may fluctuate based on:
- Volume discounts.
- Contract negotiations with insurers.
- Regional pricing adjustments.
Price Projections
Forecasting price trends considers current market dynamics, patent or exclusivity periods, and manufacturing costs.
Short-term (0–2 years):
- Gammaked's price remains near initial levels, around $110–$120 per gram.
- Price stability expected unless significant formulation or supply chain disruptions occur.
Medium-term (3–5 years):
- Slight price increases of 2–3% annually due to inflation, manufacturing cost adjustments, and increased demand.
- Possible price reductions if generic or biosimilar immunoglobulins emerge, though biosbimilars in IgG are limited by complex manufacturing and regulatory hurdles.
Long-term (beyond 5 years):
- Market maturity could suppress price growth.
- Pricing may decline if biosimilar competition increases.
- Persistent demand for high-purity, pathogen-inactivated IgG will support stable pricing.
Regulatory Impact on Market and Pricing
The FDA approved Gammaked based on stringent standards for safety, purity, and potency. Regulatory clarity enhances market confidence, supporting steady demand and pricing.
Patent protections typically last 12–20 years, but biologic exclusivity in the U.S. can extend market dominance. If Gammaked benefits from orphan drug designation or other exclusivities, price declines may be delayed.
Risks and Opportunities
Risks:
- Entry of biosimilar immunoglobulins could pressure prices.
- Insurance reimbursement policies evolve, affecting patient access.
- Manufacturing bottlenecks or supply constraints could impact availability and pricing.
Opportunities:
- Increased diagnosis rates of primary immunodeficiency expand market size.
- New indications or better formulation could command premium pricing.
- Strategic partnerships improve market penetration.
Key Takeaways
- Gammaked (NDC 27241-0202) is a relatively recent entrant in the IgG market, positioning with an estimated initial price around $110–$120 per gram.
- The global IgG market is growing at approximately 7% annually, driven by demand in immunodeficiency therapy.
- Prices are expected to remain stable short-term, with potential modest growth, unless biosimilar competition or new regulations alter dynamics.
- Long-term price stability depends on patent life, supply chain stability, and market competition.
FAQs
1. How does Gammaked compare to other IVIG products in price?
Gammaked's initial pricing aligns with newer IVIGs, generally between $100–$125 per gram, slightly below established brands like Privigen or Gamunex-C.
2. What factors influence IVIG pricing?
Pricing depends on manufacturing costs, volume discounts, payer negotiations, regulatory standards, and competitive landscape.
3. Is there potential for price reduction due to biosimilars?
Yes, biosimilars could reduce prices over time, but complex manufacturing limits rapid biosimilar entry in the IgG space.
4. How will demand impact Gammaked's pricing?
Growing primary immunodeficiency diagnosis rates and expanded indications increase demand, supporting stable or rising prices.
5. What is the expected market share for Gammaked?
Initially small, with potential to grow as physicians adopt the product, but facing stiff competition from long-established brands.
Sources
[1] Market research report on global immunoglobulin market, 2022.
