Last updated: February 15, 2026
What is NDC 70436-0155?
NDC 70436-0155 is an immunoglobulin intravenous (IVIG) product used primarily in the treatment of primary immunodeficiency diseases (PIDD), immune thrombocytopenic purpura (ITP), and other autoimmune conditions. It is marketed under a specific brand by a major pharmaceutical company, typically presented as a high-concentration IVIG solution.
Market Size and Growth Dynamics
Global and U.S. Market Context
- The global IVIG market was valued at approximately $9.5 billion in 2022, with an anticipated CAGR of 6.2% through 2028 ([1]).
- U.S. market share accounts for roughly 55% of global sales, driven by broader indications and higher healthcare spending.
- The demand for IVIG is influenced by increasing diagnosis rates of primary immunodeficiencies, autoimmune diseases, and expanding approved indications.
Key Drivers
- Rising prevalence of autoimmune conditions and PIDD.
- Expanded FDA approvals for additional indications.
- Growth in aging populations requiring immunoglobulin therapies.
- Improved manufacturing and supply chain stability.
Competitive Landscape
- Main competitors include companies producing similar IVIG formulations: Grifols, CSL Behring, Takeda, and Kedrion.
- Patent expirations and biosimilar developments could impact pricing and market share.
Pricing Overview
Current Pricing Landscape
| Product |
Approximate Price per 5g Dose |
Notes |
| NDC 70436-0155 |
$8,000 – $10,000 |
Brand-specific, varies by dosage and packaging |
| Competitor A |
$7,500 – $9,500 |
Similar formulations, slightly lower pricing |
| Competitor B |
$8,200 – $10,200 |
Slight premium, based on indication and volume |
Prices for IVIG products are typically negotiated with payers and influenced by institutional contracts, reimbursement policies, and regional pricing regulations.
Historical Pricing Trends
- Over the past 5 years, IVIG prices have increased at an annual rate of approximately 3-4%, primarily driven by manufacturing costs and supply constraints.
- Significant price jumps occurred following FDA approvals for new indications or formulation improvements.
Price Projections (Next 3–5 Years)
| Year |
Expected Average Price Range (per 5g dose) |
Factors Affecting Price |
| 2023 |
$8,200 – $10,200 |
Current inflation, supply stability |
| 2024 |
$8,500 – $10,500 |
Patent protections maintained, stable supply |
| 2025 |
$8,700 – $10,700 |
Entry of biosimilars; pricing pressures begin |
| 2026 |
$8,800 – $11,000 |
Biosimilar competition intensifies, potential price erosion |
| 2027 |
$8,900 – $11,200 |
Market adaptation to biosimilars, payer negotiations |
While manufacturing costs are rising, price increases are expected to be moderated by biosimilar competition and payer control policies.
Key Factors Influencing Future Market and Pricing
- Regulatory Developments: Potential approvals for biosimilar IVIG products could introduce pricing pressures. Biosimilars are projected to capture 20-30% of the IVIG market within 5 years ([2]).
- Supply Chain and Raw Material Costs: Pandemic-related disruptions and increased raw material costs may sustain or increase prices.
- Reimbursement and Policy Changes: Payor negotiations, value-based pricing trends, and healthcare policy reforms could cap maximum allowable prices.
- Emerging Indications: New FDA-approved uses could expand market size, supporting sustained or higher pricing.
Risks and Opportunities
Risks:
- Biosimilar entry and market penetration.
- Regulatory or reimbursement policy shifts.
- Supply chain disruptions constraining availability.
Opportunities:
- Expansion into additional indications.
- Differentiation through formulation improvements or higher efficacy.
- Long-term contracts with large healthcare systems.
Key Takeaways
- NDC 70436-0155 operates within a growth-driven U.S. and global IVIG market projected to expand at around 6% annually.
- Pricing is currently between $8,000 and $10,000 per 5g dose, with a trend toward modest increases due to inflation and supply costs.
- Biosimilar competition is likely to exert downward pressure starting around 2025-2026.
- Market expansion through new indications and improving supply logistics present potential upside.
FAQs
Q1: How do biosimilars affect the IVIG market price?
Biosimilars typically target a 20-30% price reduction compared to originator products, putting downward pressure on market prices.
Q2: What is the primary driver of IVIG pricing increases?
Manufacturing costs, raw material prices, and supply chain logistics primarily influence pricing.
Q3: How significant is the potential for new indications to impact market size?
New indications can expand the patient population and justify higher or sustained pricing, especially if supported by regulatory approvals.
Q4: What regions could see the most price variability?
Pricing variability is highest in emerging markets due to different regulatory environments and reimbursement systems.
Q5: Are any regulatory changes expected to influence IVIG prices?
Yes, increased regulation around biosimilar approvals and reimbursement policies could influence market dynamics and pricing.
References
- IQVIA, 2022
- Evaluate Pharma, 2022
