Last updated: February 15, 2026
Summary
NDC 31722-0131 corresponds to Remicade (Infliximab), a bioengineered monoclonal antibody used to treat autoimmune conditions. The drug's market size, competitive landscape, and pricing trends are influenced by patent exclusivity, biosimilar entry, and healthcare policies. Price projections suggest a gradual decline with biosimilar competition, but Remicade maintains a significant market share due to brand loyalty and patent protections until recent patent expirations.
Market Landscape
Indications and Usage
Infliximab is approved for Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. The breadth of approved indications sustains high demand, with estimates indicating over 800,000 US patients treated annually.
Market Size (US and Global)
- US Market (2022): Estimated sales of $2.2 billion.
- Global Market (2022): Approximately $6.5 billion, with growth driven by expanding approvals and increased autoimmune disease prevalence.
Market Drivers
- Rising autoimmune disease prevalence.
- Physician and patient familiarity with biologics.
- Favorable insurance coverage for rheumatoid and Crohn’s indications.
- Growing adoption of biosimilars in Europe and emerging markets.
Competitive Environment
- Biosimilars: Several approved in the US and Europe, including Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), and others.
- Patent Status: Original patents expired in the US in 2018, with secondary patents expiring in 2023-2024.
- Market Share: Remicade held approximately 55-60% of the infliximab market in early 2022, with biosimilars rapidly gaining share post-exclusivity.
Pricing Trends
Historical Pricing (US)
- List Price (2022): Approximately $3,000 to $4,000 per infusion.
- Wholesale Acquisition Cost (WAC): Around $2,300 per vial.
- Discounted cash prices vary based on insurance negotiations and patient assistance programs.
Impact of Biosimilar Entry
- Discounts: Biosimilars launched at 15-25% lower than originator.
- Market Share Shift: Rapid penetration in Europe, with US adoption steady but increasing.
- Price Decay: Forecasted to decline 10-15% annually in the US as biosimilars gain acceptance.
| Upcoming Price Projections (Next 3-5 Years) |
Year |
Estimated Average Price per Infusion |
Notes |
| 2023 |
$3,200 |
Maintains premium due to brand loyalty. |
| 2024 |
$2,700 |
Biosimilar market expansion accelerates. |
| 2025 |
$2,200 |
Further biosimilar penetration. |
| 2026 |
$1,800 |
Price stabilization at lower levels. |
Note: Prices are in current USD and exclude discounts or patient assistance programs.
Regulatory and Policy Influences
- Patent expiration in 2018 triggered biosimilar entry.
- The Biologics Price Competition and Innovation Act (BPCIA) encourages biosimilar development, leading to increased competition.
- Medicaid and Medicare policies incentivize biosimilar substitution, impacting originator pricing.
Biopharmaceutical Industry Trends
- Increasing adoption of biosimilars reduces costs but also challenges profitability of originator biologics.
- Price erosion will affect revenue streams, especially in primary indication markets like rheumatoid arthritis.
Key Market and Pricing Risks
- Patent litigation delays or settlements could extend exclusivity.
- Healthcare policy shifts such as price controls or biosimilar interchangeability rules.
- Market saturation and slowed adoption of biosimilars in certain regions.
Conclusion
Remicade (NDC 31722-0131) maintains a robust market presence in the US and globally. Its pricing has declined modestly over the past few years in response to biosimilar competition. Over the next five years, prices are projected to decrease further, driven by increasing biosimilar acceptance. Nevertheless, the brand retains significant market share due to clinical preference, patient loyalty, and existing contracts.
Key Takeaways
- Remicade remains a top-selling biologic with over $2 billion US sales in 2022.
- Patent expirations have paved the way for biosimilar competition, decreasing prices.
- US prices are projected to decline 10-15% annually over the coming three years.
- Biosimilars will account for a growing share of infliximab sales, impacting originator revenues.
- Policy trends favor biosimilar uptake, but brand retention persists through clinical and contractual factors.
FAQs
1. What factors influence infliximab pricing over the next five years?
Patent expirations, biosimilar market entry, healthcare policies, and insurance coverage play major roles.
2. How does biosimilar penetration affect Remicade’s market share?
Biosimilars are expected to capture a significant portion of the infliximab market, decreasing Remicade's share from approximately 55-60% in 2022 to below 40% by 2026.
3. Will the price decline vary across regions?
Yes. Europe has experienced more aggressive biosimilar adoption and price reductions. The US will see slower declines due to regulatory and contracting differences.
4. Are there upcoming patent protections or exclusivities that could influence pricing?
Secondary patents are expiring in 2023-2024, opening the market further to biosimilars and compressing prices.
5. How should R&D investments adapt given market trends?
Focus on biosimilar development, next-generation biologics, and indications with unmet needs to mitigate revenue declines.
Citations
[1] IQVIA, 2022 Pharmaceutical Market Reports.
[2] FDA, Biologics License Application Approvals.
[3] BioPharmadive, Biosimilar Market Analysis.
[4] GoodRx, Infliximab Pricing Data.
[5] U.S. Patent and Trademark Office, Patent Expiry Dates for REMICADA.
