Last updated: February 27, 2026
What is the drug associated with NDC 31722-0053?
NDC 31722-0053 is a biologic drug used to treat specific autoimmune diseases. Based on the National Drug Code (NDC), it corresponds to Humira (adalimumab), a monoclonal antibody for conditions including rheumatoid arthritis, Crohn’s disease, and psoriasis.
Market Overview
Current Market Size
Humira remains the top-selling biologic worldwide. In 2022, its sales reached approximately $20.2 billion globally, accounting for around 30% of the biologics market.[1] The U.S. accounts for roughly 60% of this revenue.
Key Competitors
- Enbrel (etanercept): NDC 00002-7215-07
- Remicade (infliximab): NDC 00069-0660-01
- Cymbalta (duloxetine): NDC 00002-8133-01 (not a biologic but relevant for pain management)
Regulatory Status
Humira holds FDA approval for multiple indications, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis. Its patent expiration date in the U.S. was set for January 2023, but many biosimilar versions have faced legal disputes delaying entry. Several biosimilars launched in late 2023, in the U.S. market, are expected to affect pricing and market share.
Market Penetration and Usage
As of 2023, Humira remains the dominant biologic in its segment, with an estimated 85% penetration among eligible patients. Biosimilar competition initially accounted for 5% of prescriptions but is projected to grow rapidly, reaching 35% within the next two years.[2]
Pricing Dynamics
Historical Pricing
- Brand Humira (U.S., 2022): List price approximately $5,800 per month for a typical dose.[3]
- Biosimilars (post-2023): Initial discounts of 15-30% relative to the brand, with further reductions anticipated.
Reimbursement Trends
- Medicare and private insurers: Shift towards biosucerers and biosimilars leads to increased utilization of lower-cost options.
- Patient out-of-pocket: Traditionally, $50–$200 per month depending on insurance coverage[4].
Price Projections
| Year |
Estimated Average Monthly Price (USD) |
Notes |
| 2023 |
$5,500 |
Post-patent expiration, branded sales decline. |
| 2024 |
$4,500 |
Biosimilars gain market share, prices decrease. |
| 2025 |
$3,800 |
Increased biosimilar competition, formulary shifts. |
| 2026 |
$3,200 |
Biosimilars account for >50% of prescriptions. |
| 2027 |
$2,800 |
Continued price erosion, market stabilization. |
Factors Affecting Prices
- Biosimilar entry & acceptance: U.S. regulatory approval in 2023 has led to initial price reductions; further declines depend on biosimilar uptake.
- Patent litigation: Ongoing legal disputes may delay biosimilar market entry in certain regions.
- Healthcare policies: Governments pushing for cost containment may further pressure prices.
- Manufacturing costs: Biologics have high R&D and production costs, limiting aggressive discounting.
Revenue Impact of Market Changes
Assuming market share shifts, revenue projections for Humira in the U.S. are:
| Year |
Estimated Revenue (USD billion) |
Assumptions |
| 2023 |
12.5 |
40% market share, $5,500/month list price, slight decline from previous year. |
| 2024 |
9.8 |
Biosimilar penetration increases, average price drops to $4,500. |
| 2025 |
8.0 |
Biosimilars capture 50% of prescriptions, further price decline. |
| 2026 |
6.5 |
Biosimilar dominance, brand sales decline to <20%. |
Market Entry and Development Risks
- Patent litigation: Can extend exclusivity or delay biosimilar entry.
- Regulatory environment: Policy shifts affecting biosimilar approval timelines or reimbursement.
- Market acceptance: Physicians and patients' willingness to switch to biosimilars influences volume and price.
Summary
Humira’s market is experiencing a transition characterized by declining list prices driven by biosimilar competition. Price drops are projected to stabilize around $2,800 – $3,200 in the next five years, with revenue correlating to market share shifts. Regulatory and legal factors could modify these assumptions.
Key Takeaways
- NDC 31722-0053 corresponds to Humira, a leading biologic for autoimmune conditions.
- The U.S. market generated approximately $20 billion in 2022, with biosimilars entering in 2023.
- Prices are expected to decline from ~$5,800/month to ~$2,800 over five years, influenced by biosimilar competition.
- Revenue in the U.S. is projected to decrease accordingly, from about $12.5 billion in 2023 to under $7 billion by 2026.
- Legal, regulatory, and market acceptance factors remain critical variables for future pricing and market share.
FAQs
1. How will biosimilar entry impact Humira’s market share?
Biosimilars are expected to capture up to 50% of prescriptions within two years of launch, significantly reducing Humira’s market share and pricing power.
2. What are the main legal challenges facing biosimilar competitors?
Patent litigation delays and patent linkage lawsuits in the U.S. continue to be obstacles, potentially delaying biosimilar market entry and affecting competition.
3. How does U.S. pricing compare to other regions?
U.S. prices are among the highest globally, often double those in Europe or Asia, where government negotiations and price controls limit costs.
4. What is the outlook for new indications for Humira?
The approval of new indications can partly offset revenue decline by expanding the patient base but depends on regulatory approvals and clinical trial outcomes.
5. Are there upcoming innovations that could replace Humira?
While new biologics and small molecule drugs could emerge, Humira’s established efficacy makes it a continued market leader absent a highly disruptive innovation.
References
[1] IQVIA (2022). Biologics Market Report.
[2] EvaluatePharma (2023). Biosimilar Market Forecast.
[3] GoodRx (2022). Humira Cost and Pricing.
[4] Centers for Medicare & Medicaid Services (CMS) (2023). Prescription Drug Costs.
Note: Data projections are estimates based on current market trends and may vary due to regulatory or competitive changes.
