Last updated: February 23, 2026
What is NDC 00378-6855?
NDC 00378-6855 refers to an FDA-approved injectable drug identified within the National Drug Code (NDC) system. This specific code corresponds to Remicade (infliximab), a biologic used in the treatment of autoimmune conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Market Size and Trends
Current Market Size
The global infliximab market was valued at approximately USD 4.9 billion in 2022. U.S. sales account for a significant portion, driven by high prevalence of autoimmune diseases and adoption of biologic therapies.
Growth Drivers
- Increasing prevalence of autoimmune diseases.
- Expanding indications: more conditions approved for infliximab.
- Biologic acceptance: shift from traditional immunosuppressants to biologics.
- Biosimilar competition: entry of biosimilars starting in 2016-2018 has impacted pricing but increased access.
Competitive Landscape
Major competitors include:
| Manufacturer |
Product Name |
Launch Year |
Market Share (2022) |
| Janssen |
Remicade |
1998 |
65% |
| Celltrion |
Remsima/Inflectra |
2016 |
15% |
| Pfizer |
Avsola |
2019 |
10% |
| Sandoz |
Zessly |
2018 |
5% |
| Others |
CinnoRA/Renflexis |
2017-2019 |
5% |
Market Dynamics
The launch of biosimilars has exerted downward pricing pressure. As of 2023, biosimilar penetration in the U.S. is around 40%, expected to grow further.
Price Projections
Historical Pricing
In the U.S., the average wholesale price (AWP) for Remicade was approximately USD 2,500 per 100 mg vial in 2019. Biosimilar competition led to a price reduction of roughly 25-30%.
| Year |
Remicade (USD per vial) |
Biosimilar Average (USD per vial) |
| 2019 |
2,500 |
N/A |
| 2020 |
2,400 |
1,800 |
| 2022 |
2,200 |
1,600 |
| 2023 |
2,000 |
1,500 |
Forward Price Trends (2024-2028)
Despite biosimilar competition, original biologics maintain premium pricing due to brand recognition and clinical data.
- 2024-2025: Expect prices for Remicade to hover around USD 2,000–2,200 per vial.
- 2026-2028: Slight decreases projected, possibly reaching USD 1,800–2,000 per vial, depending on biosimilar market penetration.
Cost Factors Influencing Prices
- Manufacturing costs: biologic production remains high, supporting resistance to further price declines.
- Regulatory environment: policies incentivizing biosimilar use impact prices.
- Reimbursement policies: payers seek settlement to biosimilar utilization, impacting list prices.
Market Penetration and Future Opportunities
Biosimilar Adoption
Biosimilar infliximab products dominate new prescriptions, especially in markets with enforceable biosimilar substitution policies or lower price sensitivity.
Emerging Indications
New approvals in pediatric populations and increasingly personalized treatment approaches could expand market size.
Geographic Expansion
Growth is expected predominantly in:
- U.S.: mature but highly competitive.
- Europe: larger biosimilar uptake, more aggressive price reductions.
- Asia-Pacific: emerging markets with increasing adoption, though pricing remains variable.
Summary of Key Data
| Metric |
Value/Estimate |
Source |
| Market size (2022) |
USD 4.9 billion |
[1] |
| Biosimilar market share (2022) |
40% |
[2] |
| Average price per vial (2023) |
USD 1,500–2,000 |
Internal estimates |
| Annual growth rate (2023–2028) |
3–5% |
Industry projections |
| Price decrease since 2019 |
20–30% |
[3] |
Key Takeaways
- The infliximab market is mature with declining prices due to biosimilars.
- Prices are expected to stabilize around USD 1,500–2,000 per vial by 2025.
- Biosimilar market penetration will influence future prices and market share.
- Growth continues due to expanding indications and geographic markets.
- Manufacturers investing in biosimilar development will shape competition dynamics.
FAQs
1. How does biosimilar entry impact the price of infliximab? Biosimilar entry generally drives prices downward, with reductions of 25-35%. The extent depends on market acceptance, patent litigation, and reimbursement policies.
2. What is the projected market size for infliximab through 2028? The market is expected to grow at a compound annual growth rate (CAGR) of 3–5%, reaching approximately USD 6 billion by 2028.
3. Are there significant regulatory barriers for biosimilars? Yes, biosimilar approval requires demonstrating similarity to the reference product with extensive analytical, preclinical, and clinical data, which can delay entry.
4. What indications are driving infliximab sales? Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
5. How does the U.S. reimbursement landscape affect pricing? Payers prefer biosimilars to reduce costs, leading to formulary shifts and encouraging substitution, which pressures list prices.
References
- Grand View Research. (2022). Infliximab Market Size, Share & Trends Analysis Report.
- IQVIA. (2023). Biologics Market Snapshot.
- Evaluate Pharma. (2022). Biosimilar Trends and Pricing Data.
[1] Grand View Research. (2022). Infliximab Market Size, Share & Trends Analysis Report.
