Last updated: February 27, 2026
What is NDC 10702-0044?
NDC 10702-0044 refers to HyQvia (Immune Globulin Subcutaneous [Human], 103 mg/mL, and 77 mg/mL), produced by Grifols. It is a combination of immune globulin and recombinant human hyaluronidase used for primary immunodeficiency (PI) in adults and pediatric patients over 2 years old.
Market Size and Demand Drivers
Target Patient Population
- Primary immunodeficiency (PI) affects approximately 1 in 25,000 individuals globally.
- US estimates: 20,000–25,000 patients on immunoglobulin therapy.
- Growth driven by increased diagnosis and expanded pediatric approval.
Current Treatment Landscape
- Main competitors: Privigen, Hizentra (CSL Behring), and Immunoglobulin products with subcutaneous or intravenous routes.
- Preference for subcutaneous formulations for convenience and home administration.
Market Penetration
- HyQvia entered the US market after FDA approval in 2014.
- Market penetration remains steady, with a 2-3% growth rate annually.
- Adoption influenced by patient preference for subcutaneous over intravenous therapy.
Price Points and Reimbursement Context
Current Pricing
- List price (ASP) for HyQvia varies by dosage and vial size.
- Typical wholesale acquisition cost (WAC): approximately $320–$350 per gram (per recent CMS and other sources).
- Price per therapy cycle (assuming average dose of 0.4 g/kg/week over 52 weeks):
- For a 70 kg patient: 0.4 g/kg × 70 kg = 28 g/week
- Annual dose: 28 g × 52 weeks = 1456 g/year
- Cost estimate per year: 1456 g × $340 = roughly $495,000
Reimbursement Environment
- Medicare, Medicaid, commercial insurers cover immunoglobulin therapies.
- Reimbursement rates align with ASP and WAC, affecting net revenue.
- Price pressure from biosimilar entry expected but limited due to product complexity.
Price Projection Factors
Regulatory and Market Dynamics
- No biosimilar currently approved for HyQvia; biosimilar entry could pressure prices.
- If biosimilars introduced within 3–5 years, expect 10–20% price reductions.
- Increased competition from other immunoglobulin formulations and emerging therapies.
Manufacturing and Supply Chain
- Limited manufacturing capacity could sustain high prices.
- Cost of goods sold (COGS) estimated around 30–40% of WAC, supporting pricing stability.
Pricing Trends
- Historical data suggest gradual price increases (~3–5%) annually for immunoglobulin products.
- Contracted discounts and rebates reduce actual net prices to payers.
Price Projections (Next 3-5 Years)
| Year |
Price Range (WAC per gram) |
Key Assumptions |
| 2023 |
$320–$350 |
Stable, no biosimilar entry, moderate demand growth |
| 2024 |
$330–$360 |
Minor price increases, increased competition potential |
| 2025 |
$340–$370 |
Possible biosimilar approval, price negotiations intensify |
| 2026+ |
$310–$330 (if biosimilar enters) |
Biosimilar market impacts list prices |
Market Entry and Competition Outlook
- Biosimilar competition emergence is the primary downward pressure.
- Innovations in delivery (auto-injectors, novel formulations) might sustain premium pricing.
- Strict regulatory standards limit generic biosimilar types, prolonging exclusivity.
Key Takeaways
- The market for NDC 10702-0044 (HyQvia) is stable with slow growth.
- Pricing remains high due to specialized nature, despite competition.
- Biosimilar development could lead to significant price reductions within 3–5 years.
- Reimbursement policies and supply chain factors influence real-world net prices.
- Continued demand growth hinges on expanded indications and patient preference for subcutaneous therapy.
FAQs
1. What factors influence the pricing of HyQvia?
Regulatory exclusivity, demand among immunodeficiency patients, manufacturer costs, competition, and reimbursement policies.
2. How could biosimilar entry affect HyQvia's price?
Biosimilars could reduce list prices by 10–20%, especially if multiple entrants target the same indication.
3. What is the typical annual treatment cost for a patient on HyQvia?
Approximately $495,000, based on average dosing and current prices.
4. Are there pricing differences between regions?
Yes. US prices are generally higher than those in Europe due to market dynamics, reimbursement, and healthcare systems.
5. What are the barriers to biosimilar entry for immunoglobulins?
Complex manufacturing, regulatory hurdles, and patent protections.
Sources
- [1] Grifols. HyQvia (immune globulin subcutaneous [human]) prescribing information. 2020.
- [2] Centers for Medicare & Medicaid Services. ASP drug pricing. 2022.
- [3] IQVIA. The Global Use of Medicines and Vaccines. 2022.
- [4] U.S. Food and Drug Administration. Drug Approvals. 2014.
- [5] EvaluatePharma. Immunoglobulin Market Reports. 2022.
