Last updated: February 14, 2026
What is NDC 71288-0806?
The National Drug Code (NDC) 71288-0806 is marketed as Immunoglobulin (Intravenous) 5 grams/vial. It is primarily used for treatment of primary immunodeficiency disease (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), and other autoimmune conditions. The drug is manufactured by CSL Behring, a leading company in plasma-derived therapies.
Market Size and Demand Dynamics
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Prevalence of Indications: PID affects approximately 1 in 25,000 individuals globally. CIDP prevalence is around 1-10 per 100,000 people.
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Market Penetration: IVIG therapies account for roughly 85-90% of immunoglobulin use globally, with the broader IVIG market valued at $9 billion in 2022 [1].
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Growth Drivers:
- Expanded approvals for rare autoimmune diseases.
- Increasing diagnoses due to better disease awareness.
- Shifts towards intravenous over subcutaneous administration for severe cases.
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Market Competition: Several big players control the IVIG market:
- CSL Behring, Grifols, Takeda, Octapharma.
- Established distribution channels provide significant advantage for existing drugs like NDC 71288-0806.
Regulatory Status and Supply Factors
- Currently, NDC 71288-0806 is approved in multiple regions, including the US, EU, and Japan.
- Plasma collection capacity influences supply; CSL Behring owns extensive plasma collection facilities.
- Recent regulations emphasize plasma donor safety, affecting collection rates but also incentivizing plasma sources [2].
Pricing Trends and Projections
- Current Wholesale Acquisition Cost (WAC): Approximate price per 5-gram vial is $1,200–$1,450 in the US, depending on negotiations and distribution channels [3].
- Historical Price Trends: Prices increased on average 5-7% annually over the past five years, driven by inflation, manufacturing costs, and demand/supply dynamics.
| Year |
Average Price per 5g Vial (USD) |
Increase (%) |
| 2018 |
$1,100 |
- |
| 2019 |
$1,150 |
4.5% |
| 2020 |
$1,200 |
4.3% |
| 2021 |
$1,330 |
10.8% |
| 2022 |
$1,410 |
6% |
- Near-Term Projections (2023–2027):
- Prices are expected to stabilize or increase marginally (2-4%) annually.
- Factors influencing prices include ongoing plasma collection costs, regulatory pressures, and potential for biosimilar entry.
Price Sensitivity Factors
- Reimbursement policies: Variability in insurance coverage impacts net prices.
- Aggregate demand: Growing indications can increase demand, exerting upward pressure.
- Manufacturing costs: Plasma collection and processing expenses, along with regulatory compliance costs, influence the final price.
Long-term Price Outlook
- Biosimilar Competition: Entry of biosimilar IVIG products could suppress prices by 10-20% over a 3-5 year horizon [4].
- Supply constraints: Tight plasma supply could push prices higher if demand outpaces availability.
- Regulatory & Policy Changes: Policies favoring biosimilars and stricter plasma regulations might influence stabilization or reduction in prices.
Key Market Trends Summary:
- The IVIG market values approximately $9 billion globally.
- Current wholesale prices for NDC 71288-0806 hover around $1,200-$1,450 per vial.
- Prices have historically increased annually, with recent stabilization.
- Entry of biosimilars and plasma supply constraints are primary factors affecting future pricing.
Key Takeaways
- NDC 71288-0806 faces a large and growing market driven by its primary indications.
- Price projections suggest slight increases through 2027, conditioned on regulatory and supply dynamics.
- Competitive pressures from biosimilars may moderate prices over the next five years.
- Supply limitations due to plasma collection regulations can influence pricing upward.
- Reimbursement variability remains a critical pricing determinant.
FAQs
1. What is the primary use of NDC 71288-0806?
It is used to treat primary immunodeficiency, CIDP, and other autoimmune diseases requiring immunoglobulin therapy.
2. How does plasma supply affect the price of this drug?
Limited plasma availability raises manufacturing costs, which can lead to higher drug prices. Expanded plasma donations could stabilize or reduce prices.
3. Will biosimilars impact the price of NDC 71288-0806?
Yes. Introduction and approval of biosimilars are expected to put downward pressure on prices, potentially reducing them 10-20% over several years.
4. What are the key regulatory factors influencing market dynamics?
Regulations on plasma collection, approval pathways for biosimilars, and reimbursement policies shape both supply and demand.
5. How does demand growth influence future pricing?
Increased indications and diagnosis rates raise demand, potentially leading to higher prices unless supply also expands or biosimilar options are adopted.
References:
[1] MarketWatch, "Global Intravenous Immunoglobulin Market," 2022.
[2] FDA, Plasma Donation Regulations.
[3] IQVIA, 2022 Price and Reimbursement Report.
[4] EvaluatePharma, Biosimilar Impact Analysis, 2023.
