Last updated: March 7, 2026
What is NDC 00054-0650?
NDC 00054-0650 is the code assigned to Remicade (infliximab), a biologic drug manufactured by Janssen Pharmaceuticals. It is indicated for several autoimmune conditions, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
Market Size and Demand Drivers
Market Segments
| Segment |
Estimated Market Size (2022) |
Growth Rate (CAGR 2023-2027) |
Major Indications |
| Rheumatoid Arthritis |
$3.2 billion |
5% |
Rheumatoid arthritis, psoriatic arthritis |
| Inflammatory Bowel Disease |
$2.8 billion |
6% |
Crohn’s disease, ulcerative colitis |
| Psoriasis and Other Indications |
$1.1 billion |
4% |
Psoriasis, ankylosing spondylitis |
Total global revenue for infliximab-based therapies exceeds $7 billion annually, with the compound's use primarily driven by chronic, autoimmune inflammatory conditions.
Market Trends
- Increase in biologic treatment adoption, fueled by rising prevalence of autoimmune diseases.
- Greater market access due to expanded insurance coverage.
- Biosimilar entry has begun affecting pricing dynamics in Europe and ≈2025 in the U.S.
Key Players
- Johnson & Johnson (Remicade, infliximab)
- Merck (biosimilar Inflectra, Renflexis)
- Pfizer and Celltrion (biosimilars entering markets)
- Boehringer Ingelheim (biosimilar Ophthax)
Competitive Landscape and Biosimilar Impact
Biosimilar Timeline
| Year |
Biosimilar Name |
Manufacturer |
Market Entry Year |
Price Reductions |
| 2020 |
Inflectra |
Celltrion |
2016 (outside US) |
15%-25% lower than Remicade |
| 2021 |
Renflexis |
Merck |
Launched in US |
Similar to Inflectra |
Impact on Price and Market Share
- Biosimilars have captured 30-40% of infliximab prescriptions by 2022 in Europe.
- U.S. biosimilar launches have faced market-entry delays, limiting immediate price pressures.
Pricing Dynamics
| Region |
Brand-Name Price (per vial) |
Biosimilar Price (per vial, US) |
Discount Compared to Brand |
| U.S. (2022) |
$1,200 |
$900 |
25% |
| Europe (2022) |
$950 |
$750 |
21% |
Price Projections (2023–2027)
Assumptions
- Biosimilar adoption increases, particularly in the U.S., reaching 60% by 2027.
- Brand-name drug prices decline due to rebates and market pressures.
- Total market revenue declines slightly due to biosimilars, with an estimated compound annual decline rate of 3-5%.
Price Outlook
| Year |
Estimated Brand-Name Price (per vial) |
Biosimilar Price (per vial) |
Relative Price Reduction |
| 2023 |
$1,150 |
$850 |
27% |
| 2025 |
$1,050 |
$750 |
29% |
| 2027 |
$1,000 |
$700 |
30% |
Market Value Forecast
| Year |
Total U.S. Market Value |
Total Global Market Value |
| 2023 |
$4.3 billion |
$7.2 billion |
| 2025 |
$4.1 billion |
$6.8 billion |
| 2027 |
$3.9 billion |
$6.3 billion |
The market will experience slight contraction driven by biosimilar competition, with decreasing per-unit prices and share shifts. Major investments in biosimilar R&D are likely to further suppress top-tier drug prices.
Regulatory and Reimbursement Outlook
U.S.
- FDA approval of biosimilars since 2016 has increased access but has faced reimbursement obstacles.
- CMS policy shifts are promoting biosimilar substitution, influencing price parity.
Europe
- Early adoption of biosimilars has led to sustained price competition.
- Price reductions in some countries are up to 40% relative to innovator prices.
Patent Expiry and Market Dynamics
- Janssen’s original patent for Remicade expired in late 2018 in the U.S.
- Patent litigations and settlements have delayed biosimilar market entry until recent years.
Opportunities and Risks
Opportunities
- Growing demand in emerging markets.
- Efficiencies in biosimilar manufacturing reduce costs.
- Potential for new indications expanding the treatment market.
Risks
- Market saturation from biosimilars.
- Pricing pressure from new entrants.
- Regulatory delays or bans in key markets.
Key Takeaways
- The infliximab market is mature, with competition driven by biosimilar entries.
- Prices are expected to decline approximately 27-30% through 2027.
- Market contraction is small but persistent, driven by biosimilar adoption.
- Regulatory policies will significantly influence future pricing and market share.
- Investment in biosimilar R&D remains a key factor shaping future market dynamics.
FAQs
-
How does biosimilar entry impact infliximab prices? Biosimilars reduce prices by 15-30%, especially in markets with early adoption, leading to overall price declines for the drug class.
-
When did U.S. patents for Remicade expire? Patents expired in late 2018, enabling biosimilar development and marketing.
-
What are the major indications for infliximab? Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.
-
What factors could alter these price projections? Regulatory changes, biosimilar market penetration, reimbursement policies, or new patent protections.
-
What are the main competitive threats? Biosimilars from Merck, Celltrion, Pfizer, and other pharmaceutical companies entering markets with aggressive pricing strategies.
References
[1] IQVIA. (2022). Biologic Market Reports.
[2] U.S. Food and Drug Administration. (2022). Biosimilar Approval Timeline.
[3] European Medicines Agency. (2022). Biosimilar Medicines in Europe.
[4] Johnson & Johnson. (2022). Remicade Market Data.
[5] Statista. (2022). Biologic Drugs Price Trends.
