Last updated: October 19, 2025
Introduction
The National Drug Code (NDC) 00409-0122 corresponds to a specific pharmaceutical product, which, based on current data, is identified as Infliximab (Remicade), a monoclonal antibody used predominantly in the treatment of autoimmune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis. As a biologic therapy with complex manufacturing processes, infliximab holds significant market relevance, and analyzing its market dynamics and pricing trends offers valuable insights for industry stakeholders.
Market Landscape
Global and U.S. Market Overview
The infliximab market is a mature segment within biologic therapeutics. The U.S. remains the largest consumer, powered by high prevalence rates of autoimmune disorders and the adoption of biologics as a first-line treatment. According to IQVIA data, biologic drugs account for approximately 40% of total prescription drug sales in the U.S., with key products like infliximab constituting substantial revenue streams.
Globally, the market is expanding, driven by increased diagnostic rates, broader regulatory approvals, and rising prevalence of chronic inflammatory conditions. Issues related to biosimilar entry, patent expiries, and manufacturing costs significantly influence market dynamics.
Market Drivers
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Patent Expirations and Biosimilar Competition: The expiration of patents has led to the emergence of biosimilars, which are anticipated to influence pricing and market share. Notably, biosimilars such as Inflectra and Renflexis entered the U.S. market around 2019-2020, providing lower-cost alternatives.
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Growing Indications: Expanded approvals for various indications, including pediatric Crohn's disease and ulcerative colitis, have expanded market utilization.
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Patient Access and Reimbursement Policies: Favorable insurance coverage and government reimbursement schemes support access to infliximab, stabilizing demand.
Market Challenges
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Pricing Pressures: Payers and healthcare providers are increasingly negotiating drug prices, especially for biologics with biosimilar options.
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Manufacturing Complexity: The production process of biologics raises costs and supply chain considerations, impacting pricing strategies.
Pricing Trends and Projections
Current Pricing Landscape
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Brand-Name Infliximab (Remicade):
As of late 2022, the average wholesale price (AWP) per vial (100 mg) ranges from $1,200 to $1,500, depending on the supplier and geographic region. Actual patient out-of-pocket costs vary based on insurance, discounts, and patient assistance programs.
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Biosimilars:
Introduced in the past few years, biosimilars are priced approximately 20-30% lower than the originator. For instance, Inflectra and Renflexis are typically priced at $900 to $1,100 per vial, representing substantial savings for healthcare systems.
Price Trends
Over the last five years, the price of originator infliximab has remained relatively stable, with modest adjustments primarily accounting for inflation and manufacturing costs. Biosimilar prices, however, have declined robustly, leading to increased market penetration.
Future Price Projections (2023–2027)
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Market Stabilization and Slight Decrease:
Industry forecasts suggest biosimilar competition will intensify, driving prices down by approximately 10-15% annually for the originator product as market share shifts.
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Impact of New Entry and Evolving Regulations:
As new biosimilars gain approval and gain market acceptance, originator prices are expected to gradually decline to $1,000–$1,200 per vial within the next 3-4 years.
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Emerging Biosimilars and International Market Factors:
In emerging markets and regions with less stringent patent protections, prices may drop further, potentially below $800 per vial, broadening access but exerting downward pressure on U.S. pricing.
Market Segmentation and Key Stakeholders
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Healthcare Providers:
Prescribing patterns are increasingly influenced by biosimilar availability, reimbursement policies, and cost-effectiveness considerations.
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Patients:
Out-of-pocket costs depend heavily on insurance coverage, with biosimilars offering a significant reduction.
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Manufacturers:
Biopharmaceutical companies are investing in biosimilar development and lifecycle management strategies to maintain market competitiveness.
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Insurers and Payers:
Focused on controlling expenditures, payers often negotiate discounts or prefer biosimilars over originators.
Regulatory and Competitive Dynamics
The FDA’s approval pathway for biosimilars has streamlined the regulatory process. As of 2023, multiple biosimilars for infliximab are available, leading to increased competition and price erosion.
Moreover, patent litigation and authorized biosimilars under patent settlement agreements influence market availability and pricing stability.
Key Factors Influencing Price Trajectory
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Biosimilar Market Penetration:
Higher biosimilar adoption accelerates price reductions.
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Regulatory Environment:
Pathways like interchangeability designation can impact substitution practices and pricing.
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Manufacturing Improvements:
Innovations in production techniques can lower costs, aiding in further price declines.
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Policy and Reimbursement Changes:
Structuring incentives toward lower-cost biologics affects pricing strategies.
Conclusion
The market for NDC 00409-0122 (Infliximab) is characterized by increasing biosimilar competition, leading to downward pressure on prices over the next 3-5 years. While originator prices are relatively stable currently, projections indicate a gradual decline driven by market penetration of biosimilars, regulatory developments, and healthcare policy changes.
Healthcare providers and payers should anticipate continued evolution in pricing dynamics, emphasizing the importance of strategic procurement, formulary management, and patient access considerations.
Key Takeaways
- Biosimilar competition is the primary force shaping infliximab pricing from 2023 onward, with projected decreases of 10-15% annually.
- Originator prices are expected to decline modestly, stabilizing around $1,000–$1,200 per vial within the next few years.
- Regional and international market factors may create disparities in pricing, with lower prices in emerging markets.
- Regulatory pathways and policy incentives will significantly influence market share and pricing trajectories.
- Stakeholders should monitor biosimilar approval statuses and reimbursement policies to optimize procurement and patient access strategies.
FAQs
1. What are the main factors affecting the price of infliximab (NDC 00409-0122)?
Market competition from biosimilars, regulatory policies, manufacturing costs, and payer negotiations primarily influence infliximab pricing.
2. How does biosimilar entry impact the pricing of infliximab?
Biosimilars typically provide similar therapeutic options at lower costs, exerting competitive pressure that usually results in a 20-30% price reduction for originator products.
3. Will infliximab prices decrease significantly in the next five years?
Yes, ongoing biosimilar adoption and increased competition are expected to reduce prices by approximately 10-15% annually, banking on further biosimilar market entry and policy incentives.
4. Are there regional variations in the pricing of infliximab?
Absolutely. International markets with less patent enforcement or different regulatory frameworks often see lower prices compared to the U.S.
5. What strategies can healthcare providers employ to optimize costs related to infliximab?
Providers should consider biosimilar options, negotiate discounts, utilize formulary management, and stay informed about regulatory and market developments to achieve cost-effective patient care.
Sources:
- IQVIA Institute for Human Data Science, 2022.
- FDA Biosimilar Approval Database, 2023.
- Red Book Online, 2022.
- EvaluatePharma, 2022.
- Centers for Medicare & Medicaid Services (CMS), 2023.
