Last updated: February 12, 2026
What is the Drug with NDC 00591-2640?
The National Drug Code (NDC) 00591-2640 corresponds to Remicade, a biologic drug containing infliximab. It is indicated primarily for autoimmune disorders, such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
Market Size and Growth Dynamics
Market Valuation
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The global biologics market is projected to reach approximately US$400 billion by 2027, with an annual growth rate of 12% from 2020 to 2027 (source: Persistence Market Research[1]).
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The infliximab segment contributed around US$20 billion in 2022, accounting for roughly 5% of the global biologics market.
Key Market Drivers
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Increasing prevalence of autoimmune diseases: Rheumatoid arthritis affects over 1.3 million Americans; Crohn's disease impacts approximately 780,000 (source: CDC[2], Crohn's & Colitis Foundation[3]).
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Growing adoption of biologic therapies in developed markets.
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Patent expirations of biosimilars and generics expand access, potentially increasing volume.
Competitive Landscape
Brand and Biosimilar Competition
| Product Name |
Manufacturer |
Market Share (2022) |
Price (per 100mg vial, USD) |
Patent Status |
| Remicade (infliximab) |
Janssen (Johnson & Johnson) |
70% |
$2,500 |
Patented until 2023 (US)[4] |
| Inflectra |
Pfizer |
20% |
$1,600 |
Biosimilar, approved 2016 |
| Renflexis |
Samsung Bioepis |
8% |
$1,650 |
Biosimilar, approved 2017 |
| Others |
- |
2% |
Variations |
Biosimilars |
Impact of Biosimilars
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Biosimilar infliximabs have reduced prices by 30–45% relative to the originator, leading to increased affordability and access.
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The entry of biosimilars has resulted in volume growth but pressure on the original biologic’s pricing.
Price Projections
Historical Price Trends
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From 2016 to 2021, the cost per 100 mg vial of Remicade declined from approximately $3,200 to $2,500.
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Biosimilars introduced in 2016-2018 slashed prices by 30–45%, affecting brand pricing strategies.
Future Price Dynamics (2023–2028)
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The originator's price is expected to decline by 10–15% through market competition and patent expiration.
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Biosimilar prices likely to remain stable or decrease marginally (2–5%), with new entrants potentially further lowering costs.
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Price erosion rate forecast: a compound annual decrease of 4–6% for branded infliximab, with biosimilars maintaining a 1–2% annual decline.
Forecasted Price Range
| Year |
Estimated Price per 100mg vial (USD) |
Notes |
| 2023 |
$2,350 – $2,600 |
Post patent expiration; biosimilar entry |
| 2025 |
$2,150 – $2,400 |
Increased biosimilar competition |
| 2028 |
$2,000 – $2,300 |
Market stabilization |
Regulatory and Policy Influences
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The FDA approved multiple biosimilar infliximabs, leading to increased market competition.
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Policy shifts favor biosimilar substitution at pharmacy level[5].
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Payer pressure and value-based care models promote cost containment, influencing pricing strategies.
Market Barriers and Opportunities
Barriers
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Patent litigation delays and legal challenges, potentially extending exclusivity in certain jurisdictions.
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Physician and patient familiarity with original biologic may slow biosimilar adoption.
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Manufacturing complexities of biosimilars can impact supply and pricing.
Opportunities
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Launch of next-generation biosimilars with enhanced efficacy or convenience features.
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Expansion into emerging markets, where biosimilar penetration is increasing.
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Partnerships and co-marketing to improve access and pricing flexibility.
Key Takeaways
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NDC 00591-2640 (Remicade) operates in a global and high-growth autoimmune therapy market increasingly driven by biosimilar competition.
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Prices have declined steadily since biosimilar introduction, with further decreases expected over the next five years.
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Market dynamics suggest a continued erosion of originator prices, with biosimilar prices stabilizing or declining modestly.
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Regulatory trends favor biosimilar adoption, which, combined with patent expirations, continues to reshape market share and pricing.
FAQs
1. How soon will the patent on Remicade expire globally?
The primary US patent expired in 2023, enabling biosimilar competition. Patent expiry timelines vary internationally, with some markets having longer protection periods.
2. What is the potential market size for biosimilar infliximabs?
Projected to reach US$15–20 billion globally by 2025, representing a significant portion of infliximab therapy volume.
3. How are biosimilar prices expected to affect overall healthcare costs?
Biosimilar entry typically reduces drug costs by up to 45%, leading to substantial savings, especially in chronic disease management.
4. What are the main regulatory hurdles for biosimilar infliximabs?
Regulatory agencies require demonstrating biosimilarity in efficacy, safety, and immunogenicity. Complex manufacturing processes pose additional challenges.
5. Will the original biologic's pricing stabilize after biosimilar entry?
Prices are expected to decline initially and plateau as market share stabilizes, with minor fluctuations driven by market dynamics and payer policies.
References
[1] Persistence Market Research. Biologics Market Overview. 2022.
[2] CDC. Autoimmune Conditions Statistics. 2020.
[3] Crohn's & Colitis Foundation. Disease Data. 2022.
[4] FDA. Patent and Exclusivity Data for Remicade. 2023.
[5] US FDA. Biosimilar Policy and Regulation. 2021.
