Last updated: February 24, 2026
What is the drug associated with NDC 00024-1171?
NDC 00024-1171 refers to Humira (adalimumab), a monoclonal antibody used primarily to treat autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. It is marketed by AbbVie.
Market Size and Therapeutic Indications
Humira remains one of the top-selling biologics globally. In 2022, worldwide sales exceeded $20 billion, with key markets including the U.S., Europe, and Japan.
Key Indications and Patient Population Estimates:
| Indication |
US Patient Estimate |
Global Patient Estimate |
Market Share (%) |
| Rheumatoid arthritis |
1.3 million |
3.4 million |
35 |
| Psoriasis |
7 million |
15 million |
20 |
| Crohn’s disease |
1.5 million |
4 million |
10 |
| Ulcerative colitis |
1 million |
2.5 million |
8 |
| Other (ankylosing spondylitis, uveitis) |
2 million |
4.5 million |
27 |
Note: Total eligible patient counts approximate based on market reports[1].
Competitive Landscape:
- Biologics Drugs: Stelara, Enbrel, Cosentyx, Skyrizi.
- Biosimilars: The entry of biosimilars has increased competition. In the U.S., multiple Humira biosimilars launched starting 2023, which have reduced biosimilar pricing by approximately 20-30% initially.
Current Market Dynamics
-
Price Trends:
- Original Humira retail price in the U.S. was approximately $6,000 per year per patient in 2022.
- Post biosimilar entry (from January 2023), list prices for Humira dropped by around 25%.
- Biosimilar prices now range between $4,200 and $4,800 per year per patient in the U.S. (varies by manufacturer and payor contract).
-
Market Penetration:
- Approximately 60% of patients transitioned to biosimilars in the first year post-launch.
- Contract negotiations with insurers favor biosimilars, further pressuring list prices of originator products.
-
Regulatory Environment:
- Patent cliff officially occurred in 2023, enabling biosimilar competition.
- Certain markets such as the EU managed biosimilar entry in 2018-2020, leading to earlier price reductions.
Price Projections (2023-2028)
| Year |
Estimated U.S. List Price |
Biosimilar Price Range |
Estimated Market Share of Biosimilars |
Key Factors |
| 2023 |
$4,800 |
$4,200 - $4,800 |
60% |
Biosimilar market entry, insurance negotiations |
| 2024 |
$4,600 |
$4,100 - $4,600 |
70 |
Increased biosimilar adoption, contracting |
| 2025 |
$4,400 |
$3,900 - $4,400 |
80 |
Price competition, patent expiry effects |
| 2026 |
$4,200 |
$3,700 - $4,200 |
85 |
Continued biosimilar penetration |
| 2027 |
$4,000 |
$3,500 - $4,000 |
90 |
Market saturation of biosimilars |
| 2028 |
$3,800 |
$3,200 - $3,800 |
95 |
Dominance of biosimilar products |
Note: Actual list prices depend on negotiated contracts and regional health policies. The trend assumes sustained biosimilar market penetration with declining list prices for originator.
Revenue Impact Analysis
- With approximately 3 million globally treated patients, and an assumed 55% market share for biosimilars by 2025, revenue for Humira could decline by approximately 25% from peak levels in 2022.
- Sales in the U.S. will diminish faster than in Europe due to earlier biosimilar rollout.
Strategic Market Factors to Watch
- Pricing Strategies: Transitioning to value-based pricing and contracting reflects market pressure.
- Regulatory Changes: Patent litigation and regulatory barriers influence biosimilar launch timelines.
- Market Acceptance: Physician and patient acceptance of biosimilars accelerates market share shifts.
Key Takeaways
- Humira remains a leading biologic, but biosimilar competition significantly impacts pricing.
- List price reductions of 25% since biosimilar entry are expected to continue, with further declines as biosimilar market share grows.
- Revenue projections indicate sustained decline through 2028, with potential stabilization as biosimilar market penetration approaches 95%.
- The US market's high price sensitivity and insurance negotiations accelerate the shift to biosimilars.
- Global market dynamics vary, with earlier biosimilar adoption in Europe driving significant price downward pressure there.
FAQs
1. How quickly did biosimilars penetrate the Humira market?
Biosimilars achieved approximately 60% market share in the U.S. within the first year of launch, from January 2023 onwards.
2. Will the list price of Humira return to pre-2023 levels?
Unlikely; biosimilar availability and increased price competition have permanently lowered the list prices.
3. How does biosimilar pricing compare internationally?
European biosimilar prices are typically 20-30% lower than the original, with North American discounts similar post-2023 launch.
4. What factors could slow biosimilar market share growth?
Brand loyalty, physician prescribing behaviors, and patent disputes could delay biosimilar adoption.
5. When is the potential market stabilization expected?
Market stabilization may occur around 2026, as biosimilar market share approaches 90-95% and prices plateau.
References
[1] IQVIA. (2022). Worldwide Medicine Sales Data.
[2] FDA. (2022). Biosimilar Approval Reports.
[3] Evaluate Pharma. (2023). Biologic and Biosimilar Market Outlook.
[4] European Medicines Agency. (2020). Biosimilar Market Approvals.
[5] CMS. (2023). Medicare Part B Drug Pricing and Policy Updates.
