Last updated: March 13, 2026
What is NDC 00597-0029?
NDC 00597-0029 corresponds to Flebogamma DIF, an immune globulin Intravenous (IV), used to treat primary immunodeficiency diseases (PIDD), such as common variable immunodeficiency (CVID), and other immune deficiencies. It is manufactured by Grifols.
Current Market Position
Market Size
The global immunoglobulin market was valued at approximately $12 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.5% through 2028[1].
Key Competitors
Major players include:
- Grifols (Flebogamma DIF)
- CSL Behring (Privigen, Hizentra)
- Octapharma (Octagam)
- Takeda (Hizentra)
Market Drivers
- Increasing prevalence of PIDD and secondary immunodeficiencies.
- Expanding use in autoimmune diseases like Guillain-Barré syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- Advances in manufacturing and purification processes improving safety profiles.
Market Challenges
- High treatment costs.
- Limited supply constraints, especially for plasma donations.
- Regulatory hurdles impacting manufacturing capacity.
Pricing Analysis
Current Pricing Landscape
The average wholesale acquisition cost (AWAC) for IVIG products like Flebogamma DIF hovers around $150,000 to $200,000 per year per patient. Payer reimbursement varies based on negotiated rates, with estimated net prices around $100,000 to $140,000 per patient annually[2].
Price Comparison
| Product |
Indication |
Approximate Annual Price |
Market Share (2022) |
| Flebogamma DIF |
PIDD, autoimmune |
$150,000 - $200,000 |
20-25% (globally) |
| Privigen |
PIDD, autoimmune |
$130,000 - $180,000 |
35-40% |
| Hizentra |
SC infusion, PIDD |
$140,000 - $190,000 |
25-30% |
| Octagam |
PIDD, autoimmunity |
$120,000 - $170,000 |
10-15% |
Cost Components
- Raw material procurement (plasma donations)
- Manufacturing and purification expenses
- Regulatory compliance and quality controls
- Distribution and storage costs
Market Projections
Short-Term Outlook (2023-2025)
- Stable demand driven by current indications.
- Slight price increases due to inflation and supply chain disruptions.
- Estimated price growth: 2-4% annually.
Medium to Long-Term Outlook (2026-2030)
- Potential entry of biosimilars could pressure prices downward by 10-15% within five years of biosimilar approval.
- If plasma collection efforts expand, supply could stabilize, helping control costs.
- Increased utilization in autoimmune indications may expand market size by 15% annually.
Regulatory Impact
- FDA approval of biosimilars in the US and equivalent approvals globally will influence pricing dynamics.
- Increased competition could lower median prices; however, high manufacturing costs for plasma-based products create pricing rigidity.
Key Market Dynamics
- Patent expirations and biosimilar entry: Expected around 2025-2027.
- Technological innovations: Advances in recombinant immunoglobulin manufacturing are under research, but mass-market impact remains uncertain.
- Supply chain: Plasma shortage concerns persist, possibly elevating prices temporarily.
Conclusion
Flebogamma DIF maintains a significant market share within IVIG treatments for immunodeficiencies. Its pricing aligns with the broader IVIG market, with prices stable in the $150,000-$200,000 range annually per patient. Price pressures from biosimilar competition and supply chain factors could moderate growth post-2025.
Key Takeaways
- NDC 00597-0029 (Flebogamma DIF) operates in a $12 billion global market, with steady growth.
- Prices per treatment are approximately $150,000-$200,000 annually; net prices may be lower.
- Market expansion is driven by increased indications and autoimmune applications.
- Biosimilars entering the market post-2025 could reduce prices by up to 15%.
- Supply constraints may temporarily sustain high prices despite competitive pressures.
FAQs
1. When are biosimilars for IVIG expected to enter the market?
Biosimilars are anticipated around 2025-2027, following patent expirations and regulatory approvals.
2. How does plasma donor availability affect prices?
Limited plasma supply constrains manufacturing, leading to higher prices or supply shortages.
3. What therapeutic areas could drive future IVIG demand?
Autoimmune diseases such as CIDP, neurological disorders, and off-label uses significantly contribute.
4. Are there approved recombinant alternatives?
Research exists but no recombinant IVIG is commercially available for widespread clinical use as of 2023.
5. How might policy changes impact the IVIG market?
Pricing regulations, import/export policies, and plasma donation incentives could significantly alter market dynamics.
References
[1] MarketResearch.com. (2022). Global Immunoglobulin Market Report.
[2] IQVIA. (2022). LeadingIVIG Product Cost and Reimbursement Data.
