Last updated: February 16, 2026
What Is the Market Profile for NDC 70677-1130?
NDC 70677-1130 is a drug claimed for use within the therapeutic class of immune globulins, specifically a human immunoglobulin. It is a plasma-derived product used for immune deficiencies and certain autoimmune conditions. The manufacturer is labeled as Grifols Biologicals, Inc. The product’s approved indications include primary immunodeficiency diseases, chronic lymphocytic leukemia, and idiopathic thrombocytopenic purpura, among others.
How Large Is the Current Market?
The global plasma protein therapeutics market, which includes immunoglobulins, was valued at approximately $17 billion in 2022. The immunoglobulin segment represents around $8 billion of this value, growing at a compound annual growth rate (CAGR) of 8.5% projected through 2027[1].
Specifically, for human immune globulin products:
- U.S. sales in 2022 topped $4.5 billion.
- The segment is driven by increased indication approvals, expanding treatment protocols, and shortages of plasma-derived therapies.
- The primary markets include the U.S., European Union, and Japan, with the U.S. accounting for over 50% of the revenues.
Who Are the Key Competitors?
Major competitors for NDC 70677-1130 include:
- Privigen (CSL Behring)
- Gamunex-C (Grifols)
- Flebogamma DIF (Grifols)
- Octagam (Octapharma)
- Gammagard (Baxter)
Market share is distributed roughly as follows:
| Company |
Estimated Share (%) |
Key Products |
| CSL Behring |
35 |
Privigen |
| Grifols |
30 |
Gamunex-C, Flebogamma DIF |
| Octapharma |
15 |
Octagam |
| Baxter |
10 |
Gammagard |
| Others |
10 |
Multiple smaller brands |
What Are the Price Trends?
Wholesale acquisition costs (WAC) for immunoglobulin products have increased an average of 4% annually over the past five years, from approximately $120 per gram in 2018 to over $150 per gram in 2022[2].
Average price projections for 2023 suggest continued growth, with prices possibly reaching $160 per gram as supply constraints persist. Reimbursement rates and insurer negotiations significantly influence net prices, which are estimated to be 10-20% below WAC.
Pricing varies by indication, with treatment for primary immunodeficiency (PID) typically costing more per patient compared to autoimmune uses, due to extended and higher dosing regimens.
What Are Future Market and Price Projections?
The immunoglobulin market is expected to grow at a CAGR of 8% from 2023 to 2028, reaching approximately $12 billion globally[1]. U.S. sales are anticipated to trend toward $6 billion in 2028, driven by increased awareness, expanded indications, and new patient accessibility.
Pricing is projected to increase at a similar rate, with the average price per gram reaching $180-$200 by 2028, assuming continued supply chain stability and inflation adjustments.
How Do Regulatory and Supply Factors Impact the Market?
Regulatory approvals for new indications or formulations could expand the market. Conversely, plasma collection bottlenecks, manufacturing capacity constraints, and import/export policies influence availability and pricing.
Recent regulatory developments include the FDA’s approval of new immunoglobulin indications, which could boost demand:
- Expanded use in neurology and neuromuscular disorders.
- Continued efforts to streamline plasma collection processes.
In 2022, global plasma supply shortages led to price increases and rationed distributions, impacting treatment access.
What Are the Key Takeaways?
- The immunoglobulin market for NDC 70677-1130 faces strong growth, with projected revenues around $6 billion in the U.S. by 2028.
- Pricing trends indicate an annual increase of roughly 4-5%, reaching $180-$200 per gram.
- Competition is concentrated among a handful of large players, with CSL Behring and Grifols leading.
- Supply constraints and emerging indications are significant drivers of market dynamics.
- Future expansion depends on regulatory approvals, plasma collection capacities, and healthcare reimbursement policies.
FAQs
1. What determines the price of immunoglobulin products?
Prices are influenced by manufacturing costs, supply-demand dynamics, negotiation with payers, and regulatory factors.
2. How do shortages impact pricing and availability?
Shortages tend to drive prices upward and limit patient access, causing reliance on existing inventories and potential substitution.
3. Are biosimilars or generics entering this market?
Biosimilars are under development but face regulatory challenges; current competition is primarily among branded products.
4. What are the main hurdles for expanding plasma collection?
Regulatory compliance, donor recruitment, and manufacturing capacity are primary challenges, especially during pandemic-related disruptions.
5. How do indications influence market size?
Expanded indications increase the patient population, directly boosting demand and capacity utilization.
References
[1] Grand View Research. "Plasma Protein Therapeutics Market Size, Share & Trends Analysis Report." 2022.
[2] IQVIA. "Monthly Drug Price Report," 2022.
