Last updated: March 14, 2026
What is NDC 49348-0028?
NDC 49348-0028 corresponds to Remicade (infliximab), a monoclonal antibody used to treat autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. The drug is marketed by Johnson & Johnson. It is administered via IV infusion, with packaging typically comprising vials of 100 mg.
Market Overview
Therapeutic Area and Market Size
The infliximab market is part of the larger biologics segment for autoimmune disease therapies. The global anti-TNF alpha biologics market was valued at approximately USD 35 billion in 2022 and is projected to reach USD 50 billion by 2027, growing at a compound annual growth rate (CAGR) of 7.2% (Fortune Business Insights, 2023).
Infliximab specifically accounts for roughly 30-35% of this segment, with sales driven by indications including:
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
In the U.S., the infliximab market was estimated at USD 4.5 billion in 2022, with continued growth fueled by new formulations and expanded indications (IQVIA, 2023).
Competitive Landscape
Primary competitors include:
- Adalimumab (Humira)
- Etanercept (Enbrel)
- Certolizumab pegol (Cimzia)
- Golimumab (Simponi)
Remicade faces biosimilar competition, notably from Samsung Bioepis (Renflexis) and Celltrion (Inflectra). Biosimilar entries began in the U.S. market in 2019 but have experienced limited price erosion in complex outpatient settings due to formulary protections and infusion-center dynamics.
Regulatory and Patent Environment
Johnson & Johnson's patent protections for Remicade expired in 2018 in some jurisdictions, allowing biosimilar entry. However, patent litigations and exclusivity periods have delayed widespread biosimilar adoption in the U.S. until 2023 onwards.
Pricing Dynamics
Historical Pricing Trends
- Launch Price (2003): Approximately USD 1,000 per vial
- 2022 Average Wholesale Price (AWP): USD 1,750 per vial
- Per-dose cost (based on 100 mg dose): USD 1,750
Prices have increased modestly over the last decade, primarily reflecting inflation and manufacturing costs rather than substantial price hikes.
Biosimilar Impact
Biosimilar prices are approximately 15-20% lower than the brand-name drug, but actual payer discounts can vary from 25-40%. For example, Inflectra and Renflexis are priced at approximately USD 1,350-$1,400 per vial in the U.S.
Despite biosimilar availability, market penetration has been sluggish due to:
- Established physician preferences
- Infusion-site contracts
- Limited reimbursement shifts
Price Projections (Next 3-5 Years)
Assuming continued biosimilar competition and negotiated discounts, retail and outpatient prices for infliximab may decline incrementally:
| Year |
Estimated Average Price per Vial (USD) |
Key Drivers |
| 2023 |
USD 1,700 |
Slight downward pressure; biosimilar market entry |
| 2024 |
USD 1,600 |
Increasing biosimilar adoption; payer negotiations |
| 2025 |
USD 1,500 |
Greater biosimilar market penetration; formulary shifts |
Large infusion centers and hospital systems may resist price decline due to infusion service revenues.
Market Demand and Supply Factors
Demand Drivers
- Increasing prevalence of autoimmune conditions
- Approval extensions for pediatric and non-oncology indications
- Growing adoption of biosimilars in Europe and select U.S. states
Supply Dynamics
- Manufacturing capacity adjustments driven by biosimilar competition
- Distribution and reimbursement patterns affecting access and pricing
Regulatory and Payer Trends
- CMS and private payers are favoring biosimilars to control costs
- Enhanced biosimilar prescribing pathways encourage substitution
- Price transparency initiatives may further pressure retail prices
Conclusion
Remicade remains a leading infliximab therapy, although biosimilar competition is poised to reduce prices gradually. Total U.S. market value for infliximab is expected to decline from USD 4.5 billion in 2022 to approximately USD 3.5–3.8 billion by 2025, primarily driven by volume declines and pricing erosion.
Key Takeaways
- NDC 49348-0028 (Remicade) dominates the infliximab segment with USD 4.5 billion in 2022 U.S. sales.
- Price per vial has increased modestly over time, averaging USD 1,750 in 2022.
- Biosimilar competition, active since 2019, has introduced downward pressure but with limited immediate impact.
- Price projections indicate a gradual decline to USD 1,500 per vial by 2025 due to escalating biosimilar adoption.
- Market growth remains constrained by existing formulary protections and infusion-centric distribution models.
FAQs
1. How will biosimilar entry affect Remicade prices?
Biosimilar entry typically results in a 15-20% price reduction. However, due to limited interchangeability and contractual protections, price declines for infliximab may be slower and less significant than with small-molecule generics.
2. What is the outlook for Remicade's market share?
Remicade retains significant market share due to physician familiarity and infusion center contracts. Biosimilar adoption is increasing, especially in outpatient infusion settings, gradually eroding its dominance.
3. Will systemic pricing declines continue beyond 2025?
Long-term declines depend on biosimilar market growth, payer negotiations, and potential new formulations. Unless significant innovations or regulatory changes occur, substantial price reductions are unlikely.
4. How do pricing strategies vary between hospital and outpatient pharmacies?
Hospitals often set higher prices due to associated service fees, while outpatient pharmacies negotiate discounts or rebates. Biosimilar adoption differs between these channels, affecting pricing trends.
5. Are there emerging indications that could affect market demand?
Yes. Expanded FDA approvals for indications like hidradenitis suppurativa and more pediatric uses could sustain or boost demand, offsetting some price pressures.
References
- Fortune Business Insights. (2023). Global Anti-TNF Alpha Biologics Market Size, Share & Industry Analysis.
- IQVIA. (2023). The IQVIA Biopharma Trends and Market Insights Report.
- U.S. Food and Drug Administration. (2022). Infliximab (Remicade) Implementation and Approval Details.
