Last updated: February 24, 2026
Overview of NDC 00009-5181
NDC 00009-5181 corresponds to Remicade (Infliximab), a biologic drug approved for multiple autoimmune conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis. Approved by the FDA since 1998, it is marketed by Janssen Pharmaceuticals and is supplied as a 100 mg/4 mL intravenous infusion.
Market Size and Dynamics
Current Market Landscape
- Global Market Value: Estimated at $7.3 billion in 2022, with a compound annual growth rate (CAGR) of 6% projected through 2027 (IQVIA, 2022).
- Key Therapies Competing:
- Biosimilars: Inflectra (adalimumab), Renflexis, and others.
- Originator products: Humira (adalimumab), Actemra (tocilizumab).
Regional Breakdown
| Region |
Market Size (2022) |
CAGR (2022-2027) |
Dominant Competitors |
| North America |
$3.9 billion |
5.8% |
Humira, Remicade, biosimilars |
| Europe |
$2.1 billion |
6.5% |
Remicade, biosimilars |
| Asia-Pacific |
$0.6 billion |
8.2% |
Remicade, biosimilars, Actemra |
Key Drivers
- Increased prevalence of autoimmune diseases.
- Patent expirations of biologics like Humira.
- Growing acceptance of biosimilars.
Pricing Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 100 mg |
Notes |
| 2019 |
$2,200 |
Before biosimilar entry |
| 2020 |
$2,150 |
Slight reduction due to competition |
| 2021 |
$2,050 |
Biosimilar launches impact prices |
| 2022 |
$2,000 |
Further reductions observed |
Price Outlook (2023-2027)
- 2023: Prices expected to decline 3-5% to approximately $1,900-$1,950 per 100 mg vial.
- 2024-2025: Continued decline of 4-6% annually due to increased biosimilar adoption.
- 2026-2027: Stabilization anticipated at around $1,700-$1,800, depending on biosimilar market penetration and payer policies.
Factors Influencing Pricing
- Biosimilar Competition: Entry of biosimilars reduces originator prices. For example, biosimilars to Remicade launched in the US in 2016-2017 have eroded the original's market share.
- Payer Negotiation Power: Payers negotiate rebates and discounts, often decreasing net prices by 20-30%.
- Regulatory Changes: Potential biosimilar pathways or price controls in major markets could accelerate price declines.
Revenue and Market Share Projections
| Year |
Estimated Global Revenue ($ billion) |
Estimated Market Penetration of Biosimilars |
Remarks |
| 2023 |
6.5 |
50% |
Biosimilar uptake accelerates |
| 2024 |
6.2 |
55% |
Market shares stabilize |
| 2025 |
5.8 |
60% |
Pricing pressures persist |
| 2026 |
5.5 |
65% |
Biosimilar dominance increases |
| 2027 |
5.2 |
70% |
Continued market consolidation |
Key Considerations for Stakeholders
- Investors should monitor biosimilar approval pathways and market entry strategies, especially in Europe and Asia.
- Pharmaceutical companies must navigate pricing strategies amid patent litigations and biosimilar launches.
- Healthcare providers will evaluate biosimilar efficacy and cost-effectiveness, influencing adoption rates.
Key Takeaways
- Remicade (NDC 00009-5181) faces significant price pressure driven by biosimilar competition.
- Pricing reductions of approximately 3-6% annually are projected through 2027.
- Market value is expected to decline from a peak of $7.3 billion in 2022 to around $5.2 billion by 2027.
- Increased biosimilar penetration and payer negotiations will continue to influence revenue and market share.
- Geographic variations in price and uptake are significant, with slower adoption in Asia compared to North America and Europe.
FAQs
1. What biosimilars are approved for Remicade?
Several biosimilars, including Inflectra, Renflexis, and others, launched globally between 2016 and 2018, targeting market share in North America and Europe.
2. How does biosimilar entry impact pricing?
Biosimilar competition typically results in initial price reductions of 15-30%, with further decreases as market penetration increases.
3. Are there regulatory differences affecting global pricing?
Yes. The US FDA, EMA, and other agencies have varying biosimilar approval processes, impacting launch timelines and price competition.
4. What are the primary factors influencing the US market?
Patent litigation, payer negotiations, and brand loyalty influence US pricing and uptake.
5. How might legislation affect future prices?
Legislation promoting biosimilar use, including price controls or incentives, could accelerate price declines beyond current projections.
Sources
[1] IQVIA (2022). The Global Use of Medicines in 2022. IQVIA Institute.
[2] U.S. Food and Drug Administration (2023). Remicade (Infliximab) approved indications.
[3] EvaluatePharma (2022). Sector reports on biologic drugs.
