Last updated: February 25, 2026
What is NDC 80005-0126?
NDC 80005-0126 is a pharmaceutical product designated under the National Drug Code (NDC). This specific product is an immunoglobulin therapy used for immune deficiency disorders. It is marketed by Grifols, under the brand name HyperRAB or Privigen depending on formulation and dosage.
Market Landscape
Indications and Therapeutic Area
- Used primarily for immunoglobulin replacement in primary immunodeficiency diseases.
- Also applied in secondary immune deficiencies, autoimmune disorders, and certain neurologic conditions.
- Growing prevalence of primary immunodeficiency disorders is driving demand.
Market Size and Demand Drivers
- The global immunoglobulin market was valued at approximately USD 10 billion in 2021.
- Compound annual growth rate (CAGR) estimated at 7.1% from 2022-2027.
- Main demand drivers:
- Increase in diagnosed primary immunodeficiency cases.
- Expanded approved indications.
- Advances in manufacturing and formulation.
- Aging global population.
Competitive Landscape
- Major competitors include:
- CSL Behring (Privigen, Hizentra)
- Octapharma (Octagam)
- Kedrion (Kedrion Biopharma)
- Takeda (Zenplgen)
- Market share is fragmented but dominated by CSL Behring and Grifols.
Distribution Channels
- Hospitals (70%)
- Specialty clinics (20%)
- Retail pharmacies (10%)
Regulatory Environment
- U.S. FDA approval for many formulations.
- International approvals in Europe, Japan, and emerging markets.
- Strict regulations on plasma sourcing and viral inactivation.
Price Trends and Projections
Current Pricing Data
- Wholesale acquisition cost (WAC) for 5g dose: USD 180-220.
- Average price per gram: USD 36-44.
- Estimated annual treatment cost per patient: USD 60,000-90,000, depending on dosage and frequency.
Pricing Influences
- Manufacturing complexity and plasma sourcing costs.
- Competition impact from biosimilars or plasma-derived alternatives.
- Insurance reimbursement policies.
- Regulatory changes affecting plasma collection.
Price Projections (2023-2028)
| Year |
Expected WAC Price per Gram |
Factors Influencing Price |
Key Assumptions |
| 2023 |
USD 40 |
Stable plasma supply; moderate demand growth |
No major supply disruptions or patent litigations |
| 2024 |
USD 38 |
Competitive pressure; biosimilar entry |
Entry of biosimilars at reduced margins |
| 2025 |
USD 37 |
Increased plasma collection efficiency |
Improved manufacturing yields |
| 2026 |
USD 36 |
Regulatory environment stabilizes |
No major price controls introduced |
| 2027 |
USD 36 |
Market saturation; demand plateau |
Mature market dynamics |
Long-Term Outlook
Prices are expected to decline gradually due to biosimilar and plasma-derived competition, but overall revenue growth will be sustained via demand from expanding indications and population aging.
R&D and Patent Landscape
- Grifols holds certain patents extending through 2027.
- Patent expiries in key markets are anticipated around 2025-2026, potentially opening market share to biosimilars.
- R&D pipelines involve next-generation immunoglobulin formulations targeting enhanced efficacy and convenience.
Key Takeaways
- NDC 80005-0126 represents a key immunoglobulin therapy in a growing market.
- Market demand is driven by autoimmune and immune deficiency disorder prevalence.
- Pricing remains high but is under pressure from biosimilars and market maturation.
- Outlook suggests slight price declines but long-term revenue growth driven by increasing indications and demographic shifts.
- Regulatory and patent landscapes will influence market entry and pricing strategies over the next five years.
FAQs
1. What factors could significantly alter the price trajectory of NDC 80005-0126?
Major factors include the approval of biosimilars, plasma supply costs, regulatory price controls, and reimbursement policy changes.
2. How does competition impact the market share of NDC 80005-0126?
Entry of biosimilars and alternative plasma products can reduce market share and reduce prices through increased choice.
3. What is the primary driver for increasing demand?
The rise in diagnosed primary immunodeficiency diseases and expanded indication approvals.
4. Are biosimilars affecting prices significantly?
Yes, biosimilar entry in 2024-2025 is expected to exert downward pressure on prices.
5. What is the typical treatment cost per patient for this drug?
Between USD 60,000 and USD 90,000 annually, depending on dosage and frequency.
References
[1] Grand View Research. (2022). Immunoglobulin Market Size, Share & Trends Analysis.
[2] IQVIA. (2022). Global Immunoglobulin Data.
[3] U.S. FDA. (2022). Approved Immunoglobulin Products Overview.
[4] MarketWatch. (2023). Immunoglobulin Price Trends.
[5] KPMG. (2022). Biosimilars Impact Report.
