Last updated: March 1, 2026
What is NDC 00955-1041?
NDC 00955-1041 is a monoclonal antibody medication marketed under Remicade (Infliximab). It is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis. Approved by the FDA in 1998, it is manufactured by Janssen Pharmaceuticals.
Market Size and Demand Drivers
Current Market Landscape
The global biologics market, which includes infliximab, was valued at approximately $330 billion in 2022. It is projected to reach $620 billion by 2027 at a CAGR of 12.4% (CAGR from 2022 to 2027).
Therapeutic Area
Demand for infliximab remains robust due to the prevalence of autoimmune diseases:
- Rheumatoid arthritis affects 0.5-1% of the global population.
- Crohn’s disease impacts roughly 3 million worldwide.
- Ulcerative colitis affects approximately 1.1 million in the U.S.
- Psoriatic arthritis and ankylosing spondylitis are less prevalent but contribute to overall anti-TNF therapy demand.
Competitive Landscape
Key competitors include adalimumab (Humira), etanercept (Enbrel), and golimumab (Simponi). Among biologics, infliximab maintains a significant market share due to established efficacy and biosimilar options.
Biosimilars
Since 2019, biosimilars such as Inflectra and Renflexis have entered the U.S. market, reducing infliximab pricing and affecting revenue margins.
Pricing Fundamentals
Current Pricing
In the U.S., the average list price per vial (100 mg) for Remicade is approximately $1,300 to $1,400, depending on pharmacy and insurance. The typical dosing regimen is 3-10 mg/kg every 8 weeks, translating to monthly costs of $20,000 to $40,000 per patient.
Reimbursement Trends
Insurance coverage and rebates significantly impact net prices. Medicaid, Medicare, and private insurers negotiate discounts, lowering effective prices.
Biosimilar Impact
The introduction of biosimilars has decreased brand-name infliximab prices by 30-50% in some markets. For example, a biosimilar priced at $1,000 per vial can lead to marked cost savings for health systems.
Revenue and Market Projections
Revenue Estimates (2022 - 2027)
| Year |
Estimated U.S. Revenue |
Global Revenue |
Key Influencers |
| 2022 |
$1.5 billion |
$3 billion |
Post-Biosimilar Competition |
| 2023 |
$1.3 billion |
$2.7 billion |
Biosimilar Adoption Accelerates |
| 2024 |
$1.1 billion |
$2.4 billion |
Price Erosion Continues |
| 2025 |
$900 million |
$2.1 billion |
Patent Cliffs and Generics |
| 2026 |
$800 million |
$1.9 billion |
Market Saturation |
Market Share Dynamics
Biosimilars capturing approximately 50% of infliximab sales in the U.S. by 2025 will reduce brand revenue accordingly.
Regulatory and Patent Outlook
The key patent covering infliximab expired in Europe in 2018, with U.S. patent exclusivity extending into 2027. Patent challenges and biosimilar approvals are shaping future market access.
Price Projection Summary
| Year |
Price per Vial (USD) |
Total Patient Cost |
Market Share of Biosimilars |
| 2023 |
$1,200 – $1,400 |
$20,000 – $40,000 |
50% biosimilar, 50% brand |
| 2025 |
$1,000 – $1,300 |
$15,000 – $30,000 |
60-70% biosimilar |
Key Opportunities and Risks
Opportunities
- Growing demand for biosimilars globally.
- Expansion into emerging markets with increasing healthcare coverage.
- Development of combination therapies.
Risks
- Price erosion driven by biosimilar competition.
- Regulatory delays or restrictions.
- Pricing pressures from payers and health systems.
Key Takeaways
- NDC 00955-1041 (Remicade) remains a high-revenue biologic in complex autoimmune diseases.
- Biosimilar entry, starting in 2019, has materially decreased prices and revenue prospects.
- The market is transitioning toward biosimilars, with a projected 50-70% biosimilar market share by 2025.
- Price per vial is expected to decline by approximately 15-25% over the next three years.
- The expiration of key patents in the U.S. in 2027 will accelerate market penetration by biosimilars.
FAQs
1. How does the entry of biosimilars impact infliximab pricing?
Biosimilar entry generally reduces the price of infliximab by 30-50%, affecting overall market revenues and pushing brand-name prices downward.
2. What are the key factors influencing infliximab's future sales?
Patent expirations, biosimilar competition, market penetration in emerging economies, and evolving treatment guidelines.
3. What is the expected price trend for NDC 00955-1041 over the next five years?
Prices are projected to decrease annually by 3-5% due to biosimilar competition and market dynamics.
4. Which regions present the most growth potential for infliximab?
Emerging markets such as China, India, and Brazil, where expanding healthcare infrastructure supports biologic adoption.
5. How does payer negotiation influence net prices?
Rebates, formularies, and negotiated discounts significantly lower the effective price paid by payers relative to list prices.
References
[1] IQVIA. (2022). The Global Biologics Market Report.
[2] FDA. (2018). Remicade (Infliximab) - Approved by the FDA.
[3] Evaluate Pharma. (2022). Biologics Market Data.
[4] Statista. (2022). Biosimilar adoption in North America and Europe.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for biologics.
