Last updated: February 16, 2026
What is NDC 00054-8724?
NDC 00054-8724 refers to Remicade (infliximab), a biologic therapy indicated for autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis. Developed by Janssen Biotech, Inc., it received FDA approval in August 1998.
Market Size and Growth Dynamics
1. Market Revenue and Volume Estimates
- The global infliximab market was valued at approximately $10.5 billion in 2022.
- Projected Compound Annual Growth Rate (CAGR) stands around 4.2% from 2023 to 2028.
- U.S. market segments account for roughly 45% of the global market.
2. Key Market Drivers
- Increasing prevalence of autoimmune diseases.
- Expanded indications, including biosimilars.
- Rising adoption of biologics over traditional therapies.
- Improved access to healthcare infrastructure.
3. Competitive Landscape
- Original biologic: Johnson & Johnson’s Janssen.
- Biosimilars introduced: Several European and U.S. biosimilars entered the market since 2019, including Inflectra (infliximab-dyyb) and Remaloce (infliximab-abda).
Price Trends and Projections
1. Historical Pricing Data
- The average list price for a 100 mg vial of Remicade in the U.S. was approximately $1,300 in 2022.
- Price reductions from biosimilar entries have decreased the cost by approximately 20-30% across markets.
2. Current Pricing Dynamics
- Manufacturer prices remain relatively stable in branded form, with periodic discounts and rebates.
- Biosimilar prices in the U.S. are roughly 40-50% lower than the originator.
- List prices for biosimilars range between $700 and $900 per 100 mg vial.
3. Forecasted Price Changes (2023-2028)
| Year |
Average Price per 100 mg Vial |
Notes |
| 2023 |
$1,200 |
Slight decline anticipated due to biosimilar competition |
| 2024 |
$1,150 |
Continued erosion of brand pricing with biosimilars gaining market share |
| 2025 |
$1,100 |
Market stabilization, increased biosimilar uptake |
| 2026 |
$1,050 |
Potential further price pressure, possibly driven by negotiated reimbursement |
| 2027 |
$1,000 |
Marginal decrease expected as biosimilar presence expands |
Market Entry and Regulatory Considerations
- Biosimilar approvals in the U.S. since 2016 have disturbed pricing equilibrium.
- The FDA has approved multiple infliximab biosimilars, with no significant patent opposition currently.
- Patent litigation has largely concluded, with expiration dates guiding biosimilar entry (patent expiry for the original biologic was in 2023).
Revenue Projections
- U.S. market revenue for infliximab in 2023 is estimated at $4.2 billion.
- Biosimilar market share could approach 30-40% by 2025, driven by price sensitivity and payer negotiations.
- Total global revenue for infliximab could reach $11-12 billion by 2028, accounting for growth and biosimilar penetration.
Key Takeaways
- The infliximab market, including NDC 00054-8724, remains sizeable, with steady growth driven by expanding indications.
- Biosimilar competition has caused sustained price declines, especially in the U.S. and Europe.
- Prices are expected to decrease marginally over the next five years, with biosimilars capturing increasing market share.
- Revenue growth will depend on market penetration of biosimilars and new indications adopted by healthcare providers.
- Market entry barriers are low due to patent expiration, but manufacturing quality and reimbursement strategies influence market dynamics.
Frequently Asked Questions
1. How do biosimilars impact the pricing of infliximab?
Biosimilars tend to reduce the list prices of infliximab products by 40-50%, increasing market competition and pressuring the originator to lower prices or offer discounts to maintain market share.
2. What are the primary indications for infliximab?
It is approved for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
3. When are new biosimilars expected to enter the U.S. market?
Several biosimilars have already entered since 2019; additional entries are anticipated over the next few years as patents expire and regulatory pathways continue.
4. What factors influence the price of infliximab in different markets?
Reimbursement policies, market competition, manufacturing costs, and negotiated discounts influence pricing variations across countries.
5. How might emerging therapies affect the infliximab market?
Biologic agents with novel mechanisms, oral formulations, or personalized medicine approaches could limit infliximab’s growth if they demonstrate superior efficacy or safety.
References
- MarketWatch. "Infliximab Market Size, Share & Trends." 2022.
- FDA Biologics License Applications. "Approval of Biosimilar Infliximab." 2016-2022.
- IQVIA Institute. "The Global Use of Medicines in 2023."
- EvaluatePharma. "2022 Outlook for Biologics and Biosimilars."
- U.S. Patent and Trademark Office. "Patent Expiry Data for Remicade." 2023.
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