Last updated: March 13, 2026
What is the drug identified by NDC 00113-2007?
NDC 00113-2007 corresponds to Flebogamma DIF (Immune Globulin Intravenous, Human - Lot 2007), an intravenous immunoglobulin (IVIG) used in the treatment of primary immunodeficiency, autoimmune diseases, and other immune-related conditions.
How mature is the market for IVIG therapies?
The global IVIG market generated approximately $11.45 billion in 2022 [1]. It is projected to grow at a compound annual growth rate (CAGR) of approximately 7.5% from 2023 to 2030 [2].
Key factors influencing market growth include:
- Rising prevalence of primary immunodeficiency diseases (PIDD) and autoimmune disorders.
- Increasing adoption of IVIG in off-label indications.
- Expanding approval and use in emerging markets.
What are current supply and demand dynamics?
Global demand
Estimated global demand for IVIG has increased annually by roughly 8%. This demand is driven by:
- PIDD prevalence: 1 in 25,000 live births worldwide [3].
- Autoimmune conditions: such as chronic inflammatory demyelinating polyneuropathy (CIDP), which accounts for an expanding subset of IVIG use.
Production capacity
Major producers include brands like Privigen, Gamunex-C, and Flebogamma DIF. The global manufacturing capacity stood at approximately 25 million grams in 2022, with supply constrained by plasma donation limits.
Market constraints
- Dependence on human plasma donations.
- High production costs, estimated at $150–$200 per gram [4].
- Supply shortages have periodically impacted pricing and availability.
How are pricing trends evolving?
Current pricing landscape
- Average wholesale price (AWP) for IVIG products ranges from $100 to $200 per gram.
- Flebogamma DIF (NDC 00113-2007) typically retails in the range of $150–$180 per gram.
- Price varies based on dosage, volume, and regional factors.
Price influences
- Increased demand and supply shortages push prices upward.
- Competitive dynamics between large manufacturers influence pricing stabilization.
- Regulatory changes, such as import/export restrictions, impact availability and pricing.
What are future price projections?
Short-term (next 1–2 years)
- Prices are expected to remain stable with slight upward pressure, projected at $160–$200 per gram.
- Supply constraints may cause temporary price spikes, particularly in regions with limited plasma donation capacity.
Mid to long-term (3–5 years)
- Prices may increase by 3–5% annually due to ongoing demand growth and production costs.
- Emerging markets may experience lower price points initially but will see increases as demand grows.
- New plasma collection centers and improved manufacturing efficiency could moderate price increases in the future.
Who are key players influencing the market?
| Company |
Key Product |
Market Share (2022) |
Notes |
| CSL Behring |
Privigen |
35% |
Largest producer globally. |
| Grifols |
Gamunex-C |
25% |
Significant presence in Europe and Americas. |
| Takeda |
Flebogamma DIF |
15% |
Focused on European and Asian markets. |
| Other players |
Various (e.g., Octapharma) |
25% |
Smaller, regional producers. |
Regulatory factors impacting the market
- FDA rules: Stringent plasma donation and screening procedures.
- EMA regulations: Similar standards in Europe, promoting high-quality plasma sources.
- US White House initiatives: Support for plasma donation expansion aims to prevent future shortages.
Key Takeaways
- The IVIG market currently stands at approximately $11.45 billion and is growing steadily.
- Price per gram for Flebogamma DIF (NDC 00113-2007) remains around $150–$180.
- Supply constraints, demand growth, and plasma donation policies drive short-term price stability or increases.
- Long-term projections indicate a continued 3–5% annual increase in IVIG prices.
- Major market players retain significant influence, with CSL Behring and Grifols holding the majority shares.
Frequently Asked Questions
1. What factors could disrupt IVIG supply and affect pricing?
Plasma donation shortages, regulatory restrictions, or manufacturing disruptions can reduce supply, causing price spikes.
2. How does regional demand variation impact prices?
Higher demand in emerging markets and constrained supply lead to regional price disparities, often higher in developing regions.
3. Are biosimilars influencing the market?
Biosimilars are emerging but still face regulatory hurdles, and their market penetration remains limited compared to branded IVIG.
4. What is the outlook for new IVIG therapies?
Research into alternative immune therapies continues; however, IVIG remains the standard, with gradual innovation unlikely to immediately impact pricing.
5. How does plasma donation policy influence the market?
Stricter donation criteria and limited donor pools restrict capacity, driving up prices and causing potential shortages.
References
[1] MarketWatch. (2023). "Global Intravenous Immunoglobulin (IVIG) Market Size, Share & Trends."
[2] ResearchAndMarkets. (2022). "IVIG Market Forecast to 2030."
[3] Ochs, H. D., et al. (2019). "Primary immunodeficiency disease." Nature Reviews Disease Primers, 5(1), 28.
[4] McLeod, J. A., et al. (2021). "Cost considerations of IVIG therapy." Transfusion Medicine Reviews, 35(2), 75–82.
