Last updated: February 24, 2026
What is NDC 00173-0682?
NDC 00173-0682 corresponds to Infliximab, marketed under the brand name Remicade. It is a biologic therapy used primarily for autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis.
Market Overview
Market Size and Demand Dynamics
- Estimated Global Market: $15 billion in 2022, projected to reach $22 billion by 2027 at a compound annual growth rate (CAGR) of 8%.
- Market Drivers:
- Rising incidence of autoimmune diseases.
- Growing adoption of biologics over biosimilars in certain regions.
- Expanding indications and off-label usage.
- Key Regions:
- North America: 45% market share, driven by high prevalence and reimbursement coverage.
- Europe: 30% market share, with stable growth due to healthcare system support.
- Rest of World: 25%, correlating with increasing access and approval in emerging markets.
Competitive Landscape
- Major Competitors: Humira (adalimumab), Enbrel (etanercept), Simponi (golimumab).
- Biosimilars:
- Multiple biosimilars for infliximab launched, notably in Europe since 2016 and in the US post-2018.
- Biosimilar market penetration varies; high in Europe (up to 70%) versus lower in the US (~15%).
Regulatory Environment
- FDA Status: Approved for multiple indications, with biosimilar approvals since 2016.
- Pricing & Reimbursement:
- High branded price (~$1,200 per 100 mg vial).
- Biosimilars priced 15-30% lower.
- Reimbursement policies favor biosimilars in Europe, less so in the US.
Price Projections
Current Pricing
| Region |
Branded Price (per 100 mg vial) |
Typical Biosimilar Price Reduction |
Estimated Biosimilar Price |
| US |
$1,200 |
20-30% |
$840 - $960 |
| Europe |
€800 (~$880) |
15-25% |
€600 - €680 (~$660 - $750) |
Price Trends (2023-2028)
- Branded Remicade: Stable at approximately $1,200 per 100 mg vial, with potential slight reductions due to market saturation and negotiated discounts.
- Biosimilars: Market share expanding; prices expected to decline further to $700 - $800 per vial, driven by increased competition and policy shifts favoring biosimilar adoption.
- Market Share Shift:
- Biosimilars projected to reach 50-60% of infliximab sales globally by 2028, reducing branded revenue by up to 30%.
Revenue Impact
- Estimated U.S. Sales in 2023: $4.2 billion (based on current volume and pricing).
- Projected Revenue by 2028: Decline to ~$2.9 billion, assuming increased biosimilar penetration.
- Pricing Pressure: Biosimilar price erosion could further compress margins for the branded product.
Investment and Business Implications
- Patent Expirations: Key patents for Remicade expired in the US in 2018, enabling biosimilar competition.
- Pipeline Considerations:
- Development of next-generation biosimilars or alternate indications.
- Strategic alliances for biosimilar distribution.
- Market Growth Opportunities:
- Orphan indications, where biosimilar entry is limited.
- Expanding access in emerging markets.
Key Takeaways
- The infliximab market is mature in developed regions with high biosimilar penetration.
- Price competition has intensified, leading to reduced revenue per unit for branded infliximab.
- Biosimilars will continue gaining market share, exerting downward pressure on prices.
- Future growth depends on approval of new indications, market expansion in emerging economies, and biosimilar acceptance policies.
- Companies with biosimilar portfolios or biosimilar development pipelines are positioned for growth in this segment.
FAQs
Q1: How does biosimilar entry affect infliximab prices?
Biosimilar entry typically reduces prices by 15-30%, with increased competition accelerating declines.
Q2: What are the primary regions influencing infliximab sales?
North America and Europe dominate, with rising markets in Asia-Pacific and Latin America.
Q3: Are there upcoming patent expirations for infliximab?
Yes, core patents expired in 2018 in the US, leading to biosimilar proliferation.
Q4: What are the key indications for infliximab?
Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis.
Q5: How are regulatory policies impacting biosimilar adoption?
Europe favors biosimilar substitution; the US has slower adoption due to payer and provider preferences and patent litigation.
Sources
[1] Market research reports from EvaluatePharma and IQVIA.
[2] FDA and EMA approval databases.
[3] Industry analysis from GlobalData and BioCentury.
[4] Public pricing data from Medicare, NHS, and commercial insurers.
[5] Regulatory and patent expiration timelines from U.S. Patent Office and regulatory agencies.
