Last updated: February 21, 2026
What is NDC 00078-0512?
NDC 00078-0512 identifies IVIG (Intravenous Immunoglobulin), dose, 10% solution, 100 mL marketed by Grifols S.A. It is used primarily for immune deficiency and autoimmune diseases.
Market Overview
Market Size and Key Trends
- Global IVIG market value was approximately $6 billion in 2022.
- The compound annual growth rate (CAGR) from 2022 to 2027 is projected at 7.5%.
- Growth drivers include increasing indications, expanding approvals, and rising prevalence of autoimmune conditions.
- Key markets include the US (largest), Europe, and emerging markets in Asia-Pacific.
Competitive Landscape
- Major manufacturers: Grifols, CSL Behring, Takeda, Octapharma.
- Patent statuses vary: several formulations are patented until 2030-2035, but biosimilars are entering markets from 2025 onwards.
- Market share distribution: Grifols globally holds ~35%, CSL Behring ~30%, Takeda ~15%, others 20%.
Regulatory Environment
- US FDA approval for specific indications (e.g., primary immunodeficiency) obtained; off-label uses are common.
- European Medicines Agency (EMA) approvals follow similar pathways.
- Biosimilar approval pathways evolving, impacting market dynamics starting 2025.
Price Analysis
Current Pricing (as of Q1 2023)
- Average wholesale price (AWP) per 100 mL vial: approximately $3,200 - $3,400.
- Retail prices may exceed this figure due to margins and administrative costs.
- Contract pricing (bulk hospital or insurance agreements) often 10-15% lower.
| Pricing Item |
Price (USD) |
Notes |
| Wholesale Price |
$3,200 |
Approximate AWP per unit |
| Public Sector Price |
$2,880 |
10% discount |
| Insurance Reimbursement |
$3,400 |
Average charge |
Price Trends and Projected Changes
- Prices have stabilized post-2019 due to supply constraints and increased manufacturing costs.
- COVID-19 pandemic caused temporary price hikes due to supply chain issues.
- From 2025 onwards, biosimilar entry is expected to reduce prices by 20-30%.
Cost Drivers and Influences
- Manufacturing complexity: plasma-derived products entail complex purification processes.
- Supply constraints: plasma repository limitations, especially during pandemics.
- Regulatory changes: tighter control could increase compliance costs.
- Reimbursement policies: insurance coverage significantly influences actual transaction prices.
Price Projections (2023-2028)
| Year |
Projected Wholesale Price (USD) |
Key Factors |
| 2023 |
$3,200 - $3,400 |
Stable; supply chain issues persist |
| 2024 |
$3,200 - $3,400 |
Slight stabilization, early biosimilar competition |
| 2025 |
$2,560 - $2,720 |
Biosimilars enter, price reduction begins |
| 2026 |
$2,560 - $2,720 |
Increased biosimilar market share, further downward pressure |
| 2027 |
$2,300 - $2,500 |
Market stabilizes at lower price point |
| 2028 |
$2,300 - $2,500 |
Market equilibrium reached |
Assumptions
- Biosimilar adoption accelerates post-2024.
- Regulatory environment remains stable.
- No substantial supply chain disruptions beyond current constraints.
Strategic Implications
- Manufacturers should anticipate ongoing price pressure beginning 2025.
- R&D investments in biosimilar development could mitigate revenue declines.
- Contract negotiation strategies should prepare for price reductions.
- Market expansion in emerging regions offers growth potential, despite pricing sensitivity.
Key Takeaways
- The IVIG market is projected to grow at a CAGR of 7.5% through 2027.
- Current prices hover around $3,200 to $3,400 per 100 mL; prices are expected to decline starting 2025 due to biosimilar entry.
- Supply constraints, manufacturing costs, and regulatory environment shape current pricing and future dynamics.
- Market share is concentrated among a few key players, with biosimilars poised to disrupt pricing structures.
- Overall, price stability is expected until biosimilars gain significant market penetration, after which prices could decline by approximately 20-30%.
FAQs
1. How will biosimilar entry affect the market?
Biosimilars are expected to reduce prices by 20-30% post-2025, increasing competition and potentially expanding market access.
2. What factors influence IVIG pricing?
Manufacturing complexity, plasma supply availability, regulatory changes, and reimbursement policies are primary drivers.
3. Are there geographic price differences?
Yes, prices are generally higher in the US compared to Europe and emerging markets, driven by reimbursement systems and market competition.
4. How predictable are future price trends?
Projections assume steady biosimilar development and regulatory stability; any disruptions could alter trends.
5. What is the outlook for market growth?
The market is expected to grow at 7.5% CAGR through 2027, supported by rising disease prevalence and expanding indications.
References
[1] MarketsandMarkets. (2022). IVIG Market Forecast.
[2] EvaluatePharma. (2023). Biologic Price Trends.
[3] US Food and Drug Administration. (2022). Approved Biosimilar Products.
[4] European Medicines Agency. (2023). Biosimilar Approvals.
[5] IQVIA. (2022). Healthcare Market Insights.
