Last updated: February 24, 2026
What is NDC 21922-0020?
NDC 21922-0020 corresponds to Albumin (Human), 5% solution. This drug is used mainly for volume expansion, treatment of hypoproteinemia, and plasma exchange procedures.
Market Overview
The global albumin market was valued at approximately USD 2.4 billion in 2021 and is projected to reach USD 3.2 billion by 2028, growing at a CAGR of around 4.0% (Research and Markets, 2022). Albumin's primary uses in hospitals, especially in intensive care units, underpin steady demand.
Key Market Drivers
- Rising prevalence of liver cirrhosis, sepsis, and trauma cases.
- Increased use in plasma exchange and dialysis procedures.
- Expansion in emerging markets due to increased healthcare access.
- New indications and biosimilar entries.
Competitive Landscape
The main players include:
- Grifols S.A.
- CSL Limited
- Sanofi
- Octapharma AG
- Biotest AG
The market has high barriers due to production complexity, strict regulation, and limited biosimilar development.
Price and Cost Structure
Current Pricing
Average wholesale price (AWP) for albumin 5% solutions varies widely by market and healthcare setting:
| Region |
Estimated Price per 10 mL (USD) |
Notes |
| United States |
$12 - $15 |
Reimbursement-based, varies by payer |
| European Union |
€8 - €11 (approx. $9.5 - $13) |
Price controlled, varies by country |
| Australia |
AUD 18 - 22 per 50 mL |
Supply chain and procurement factors |
| Emerging Markets |
$8 - $10 per 50 mL |
Price sensitivity impacts |
Cost of Production
Production involves human plasma collection, fractionation, and rigorous purification, contributing to a high production cost:
- Plasma collection costs around USD 300–500 per liter.
- Processing and quality control add USD 200–400 per liter.
- Estimated manufacturing cost per gram: USD 4–6.
Profitability Calculation
Given typical dosage (e.g., 50 mL vial of 5% albumin):
- Cost per vial: approximately USD 5–8.
- Wholesale price: USD 12–15.
- Margin: roughly 50-70%.
Price Projections (2023-2028)
Factor in inflation, new biosimilars, and regulatory changes.
| Year |
Estimated Wholesale Price (USD per 50 mL vial) |
Drivers |
| 2023 |
$12.50 - $15 |
Stable demand, limited biosimilar presence |
| 2024 |
$12.75 - $15.25 |
Slight price increase, growth in emerging markets |
| 2025 |
$13.00 - $15.50 |
Early biosimilar entries in select regions, price competition expected |
| 2026 |
$13.25 - $15.75 |
Price pressure from biosimilar development |
| 2027 |
$13.50 - $16.00 |
Market consolidation, new indications |
| 2028 |
$13.75 - $16.25 |
Continued biosimilar uptake, potential price reductions |
Regulatory and Economic Factors
- US FDA and EMA approval processes for biosimilars significantly impact prices.
- Increasing adoption of biosimilars aims to reduce costs, potentially decreasing prices by 10-20% by 2028.
- Healthcare policies favoring cost containment influence procurement strategies.
Key Takeaways
- The demand for albumin 5% remains stable due to its critical hospital applications.
- Market growth is moderate, influenced by biosimilar competition and regulatory pressures.
- Prices are expected to see minimal increases throughout the next five years, with potential declines as biosimilars gain approval.
- Cost structures limit the potential for significant price decreases unless biosimilar manufacturers achieve cost efficiencies.
- Market dynamics vary across regions due to regulatory environments and healthcare system differences.
FAQs
Q1: What factors influence the price of albumin 5% solutions?
A: Demand, manufacturing costs, regulatory approval, biosimilar competition, and market-specific reimbursement policies.
Q2: How will biosimilars impact the market for NDC 21922-0020?
A: Biosimilars are expected to reduce prices by 10-20%, increase competition, and potentially shift market share away from originators.
Q3: Are there regional differences in pricing?
A: Yes. Prices are generally higher in the US and Europe due to healthcare systems' differences, with emerging markets experiencing lower prices.
Q4: What are the key drivers of demand for albumin 5%?
A: Use in critical care, volume expansion, plasma exchange, and treatment of hypoproteinemia.
Q5: What are the regulatory challenges affecting pricing projections?
A: Approval pathways for biosimilars, quality standards, and reimbursement policies influence pricing and market entry.
References
[1] Research and Markets. (2022). Global Albumin Market by Application, Region, and Company.
[2] IQVIA. (2022). US Hospital Market Data on Plasma-derived Therapies.
[3] European Medicines Agency. (2022). Biosimilar Guidance and Approvals.
