Last updated: February 27, 2026
What Is NDC 00169-1913?
This National Drug Code (NDC) refers to a specific pharmaceutical product. According to FDA records, NDC 00169-1913 is a branded medication manufactured by Grifols that is used for plasma protein therapies. Its precise formulation and indication, such as immunoglobulins or albumin, influence its market dynamics.
Market Size and Current Demand
Indication and Patient Population
- The drug targets patients with immunodeficiency, autoimmune conditions, and other plasma protein deficiency states.
- U.S. prevalence estimates:
- Primary immunodeficiency: approximately 1 in 1,200–2,000 births (~2,500–4,700 patients).
- Autoimmune diseases: up to 2.5 million affected Americans.
- Albumin deficiency in critical care: relevant patient subset estimated at 200,000 annually.
Market Volume
- The global plasma protein therapeutics market reached $23.9 billion in 2022.
- The U.S. accounted for around 50% ($12 billion).
- The demand for plasma-derived products, including immunoglobulins, increased by 7% CAGR over past five years.
Distribution of NDC 00169-1913
- Estimated that NDC 00169-1913 accounts for approximately 3%–5% of the U.S. immunoglobulin market.
- Annual sales volume approximates 200,000–300,000 units, with the average dose costing around $10,000–$15,000 per treatment course.
Competitive Landscape
Major Competitors
| Company |
Product Name |
Class |
Market Share |
Approval Year |
Notable Features |
| Grifols |
Flebogamma, Gamunex-C |
IV Immunoglobulin |
40% |
2010s |
High purity, high stability |
| CSL Behring |
Privigen |
IV Immunoglobulin |
30% |
2000s |
Long-standing market presence |
| Octapharma |
Octagam |
IV Immunoglobulin |
15% |
2010s |
Multiple formulations, global reach |
| Others |
Various biosimilars |
IV Immunoglobulin |
5–15% |
2015–2020s |
Biosimilar entrants, pricing pressure |
Pricing Trends
- The average wholesale price (AWP) per gram for immunoglobulins has increased by about 3% annually over the past five years.
- Packaged courses typically retail at $10,000–$15,000 per treatment, with higher prices for specialty formulations.
Price Projections
Factors Influencing Price
- Supply chain dynamics: plasma availability impacts product prices.
- Competition: Biosimilars entering the market exert pricing pressure.
- Regulations: The FDA's regulatory policies influence approval and labeling, impacting pricing strategies.
- Reimbursement policies: Medicare, Medicaid, and private insurers' coverage affect net prices.
Forecasting Price Trends (2023–2028)
| Year |
Estimated Average Price per Treatment |
Key Assumptions |
| 2023 |
$12,500 |
Stable demand; slight supply chain constraints; residual impact from COVID-19 |
| 2024 |
$12,875 |
Entry of biosimilars increases price competition slightly; manufacturing costs rise |
| 2025 |
$13,250 |
Slight demand growth; market consolidates around key players |
| 2026 |
$13,600 |
Regulatory adjustments favoring biosimilars; increased use in emerging markets |
| 2027 |
$14,000 |
Higher plasma collection yields; improved manufacturing efficiencies |
| 2028 |
$14,400 |
Expansion into new indications; potential biosimilar price reductions |
Total Market Value Projection
- Assuming 250,000 treatment courses annually at $14,400 by 2028, total U.S. market value could reach approximately $3.6 billion, representing a sustained growth trend driven by increased demand and new indications.
Regulatory and Policy Impacts
- The FDA's approval of biosimilars, such as implicating products like Octagam biosimilars, aimed to promote price competition.
- Policies favoring domestic plasma collection influence supply stability and pricing.
- Reimbursement adjustments could either compress margins or promote premium product positioning.
Key Takeaways
- NDC 00169-1913 is part of a mature but expanding plasma protein therapeutics market.
- Sales volume remains stable but faces pressure from biosimilars and new entrants.
- Prices are expected to grow modestly at around 3% annually, reaching approximately $14,400 per treatment by 2028.
- Market size in U.S. sales could approach $3.6 billion in the same period, contingent on demand, competition regulation, and supply chain factors.
FAQs
Q1: How does biosimilar competition affect pricing for NDC 00169-1913?
Biosimilars typically reduce prices through market entry. Their presence can lead to a 10–20% price decrease, depending on market adoption and regulatory incentives.
Q2: What are the main growth drivers for this market?
Increase in plasma collection, expansion of indications, improving supply chain stability, and evolving reimbursement policies drive growth.
Q3: Are there regional variations in pricing?
Yes. Prices tend to be higher in the U.S. due to less price regulation compared to Europe or other regions with government-controlled pricing.
Q4: How might regulatory changes impact future prices?
Accelerated approvals and biosimilar policies may compress prices; stricter regulations or supply constraints could boost prices.
Q5: What are the risks to market stability?
Supply chain disruptions, plasma shortages, regulatory hurdles, and aggressive biosimilar market entry pose risks.
References
- FDA. (2022). Approved Drugs Database. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
- MarketWatch. (2023). Plasma Protein Therapies Market Size and Forecast.
- IQVIA. (2022). The Global Use of Medicine in 2022.
- Deloitte. (2021). Biosimilars: Market Entry and Pricing Trends.
- Kantar Healthcare. (2022). U.S. Immunoglobulin Market Analysis.
