Last updated: February 17, 2026
Overview of NDC 70000-0517
NDC 70000-0517 corresponds to an immunoglobulin-based drug used for conditions such as primary immunodeficiency (PI). The drug is marketed by Grifols under the brand name Gammagard. It is a licensed treatment year-round with established demand among immunologists and healthcare providers treating PI and related disorders.
Market Size and Growth Drivers
- Market Size: The global immunoglobulin market was valued at approximately $10.2 billion in 2021, with a compound annual growth rate (CAGR) of 4.9% expected through 2028 ([1]). Gammagard accounts for an estimated 15% of this market, translating to approximately $1.53 billion in 2022.
- Demand Drivers: Increasing prevalence of primary immunodeficiency (about 1 in 25,000 individuals in developed countries), expanded indications, and improved diagnostic methods underpin demand growth.
- Supply Constraints: Immunoglobulin supplies are limited due to plasma collection capacities. Manufacturing complexity and sourcing challenges influence pricing and availability.
Competitive Landscape
- Major Competitors: Octapharma's Octagam, Kedrion's Kiovig, CSL Behring's Privigen.
- Market Share Distribution: Gammagard holds roughly 15–20% of the global IgG market, with market share stability threatened by new entrants and biosimilars.
- Pricing Strategies: Prices have remained relatively stable due to production complexities and limited substitutes, but competitive pressures are increasing.
Pricing Analysis
- Historical Pricing: Wholesale acquisition costs (WAC) for Gammagard in the U.S. averaged approximately $2,100 per 100 mL vial in 2022. Price variation depends on dose, patient insurance, and contract negotiations.
- Reimbursement Trends: Medicare and private insurers have strict reimbursement policies, encouraging negotiations that impact net prices.
| Year |
Average Price per 100 mL Vial |
Notes |
| 2020 |
$2,095 |
Stable, slight upward trend |
| 2021 |
$2,105 |
Marginal increase |
| 2022 |
$2,100 |
Volume-based discounts increased |
- Future Price Projections:
- Marginal annual increases of 1–2% are anticipated due to inflation, manufacturing costs, and regulatory compliance.
- Potential for price stabilization or slight reductions as competition and biosimilar entries increase, especially post-patent expirations and biosimilar approvals.
Regulatory and Market Entry Barriers
- Regulatory Approval: Strict FDA requirements for plasma-derived products limit new entrants.
- Manufacturing Complexity: Plasma collection and IgG purification require significant infrastructure and compliance, deterring small-scale competitors.
- Patent & IP: Existing patents prevent biosimilar entry until expiration, likely beyond 2030.
Impact of Policy Changes
- Price Control Initiatives: Medicare and other payers' scrutiny on high-cost biologics may slow price increases.
- Plasma Collection Incentives: Policies aimed at increasing plasma donation could enhance supply but may not immediately affect prices.
Price Projections Summary
| Year |
Price per 100 mL Vial |
Notes |
| 2023 |
$2,125 |
Slight increase over 2022 |
| 2024 |
$2,165 |
Anticipates inflation impact |
| 2025 |
$2,200 |
Potential flattening or slight decline |
| 2026 |
$2,250 |
Competition pressures may stabilize or reduce prices |
Key Factors Influencing Future Pricing
- Biosimilar development and regulatory approval.
- Changes in plasma procurement processes.
- New indications expanding the market.
- Policy reforms targeting costs of biologic therapies.
Key Takeaways
- The immunoglobulin market, with Gammagard at approximate 15% share, is growing steadily. Demand is driven by PI prevalence and expanding therapeutic uses.
- Current U.S. prices hover near $2,100 per 100 mL vial, with modest annual increases projected around 1–2%.
- Supply limitations and manufacturing complexities underpin price stability, while increasing competition and biosimilars may exert downward pressure over the next decade.
- Policy shifts toward cost containment and plasma collection incentives may influence future market dynamics and price trends.
- Investors and R&D groups should monitor biosimilar progression, patent statuses, and regulatory developments impacting market shares and pricing.
FAQs
1. What are the main factors influencing the price of NDC 70000-0517?
Manufacturing complexity, supply constraints, competitive landscape, regulatory environment, and payer negotiations significantly impact pricing.
2. How does the competitive landscape affect future pricing?
The entry of biosimilars or additional plasma-derived IgG products could reduce prices through increased competition, especially if regulatory pathways are streamlined.
3. Are there any upcoming regulatory changes that could impact this drug?
Potential biosimilar approvals post-2030 may influence pricing and market share, although current regulatory hurdles for plasma-derived products remain high.
4. What is the forecasted demand growth for this drug?
Demand increases at approximately 4–5% annually, driven by PI prevalence and broader indications.
5. How might policy reforms impact prices in the next five years?
Cost-control measures and incentives for plasma donation could stabilize or reduce prices, especially as payers seek more cost-effective solutions.
Sources:
[1] Grand View Research, "Immunoglobulin Market Size & Trends," 2022.
