Last updated: February 20, 2026
What is NDC 00078-0874?
National Drug Code (NDC) 00078-0874 corresponds to Humira (adalimumab), a biologic used primarily for inflammatory diseases including rheumatoid arthritis, Crohn's disease, and psoriasis. It is manufactured by AbbVie. The drug is administered via subcutaneous injection and has a complex patent and biosimilar landscape.
Market Size and Growth Drivers
Global Market Overview
The global biologics market was valued at approximately $370 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.4% through 2028 [1]. Humira accounts for a significant share of this market due to its high sales volume.
Key Therapeutic Areas
- Rheumatoid arthritis (RA)
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Ankylosing spondylitis
Key Market Attributes
- High brand loyalty due to efficacy and safety profile.
- Patents and exclusivity protections extended until at least 2023, with biosimilar entry beginning thereafter.
- Biosimilar competition has eroded Humira’s market share in the U.S. and Europe, but it remains dominant in some markets.
Market Penetration and Competition
| Region |
Market Size (2022) |
Notes |
| United States |
~$20 billion |
Largest market; biosimilars launched in 2023 specific to biosimilar entrants [2] |
| Europe |
~$12 billion |
Entry of biosimilars occurred in 2022; regulatory pathways are mature [3] |
| Rest of World |
$8 billion |
Growing adoption; pricing varies significantly across countries |
Biosimilar Landscape
- November 2022: First biosimilar versions of Humira approved in Europe.
- 2023: Multiple biosimilars launched in the U.S. and Europe following patent expiry.
- Price competition is intense, with biosimilars priced 15-30% below the originator.
Price Projections
Current Pricing Dynamics
| Region |
Humira List Price (per pen or pre-filled syringe) |
Biosimilar Price (approximate) |
% Drop in Price Post-Biosimilar Entry |
| United States |
~$5,000 per injection |
$3,500 - $4,000 |
20-30% |
| Europe |
€400-€600 per dose |
€300-€500 |
20-25% |
Price Trends and Projections (2023-2028)
- U.S.: Anticipate a 5-8% annual decline in Humira prices due to biosimilar competition.
- Europe: Similar downward pressure, with prices decreasing 4-7% annually.
- Rest of the world: Variable; some markets may see limited reductions owing to regulatory and market access barriers.
Revenue Forecast
| Year |
U.S. Sales |
Europe Sales |
Global Sales (approximate) |
| 2022 |
$20 billion |
$12 billion |
$35 billion |
| 2023 |
$17-18 billion |
$9-11 billion |
$30-32 billion |
| 2024-2028 |
Gradual decline to ~$15 billion annually |
Decline to ~$8-9 billion |
Overall decreasing trend, but still substantial |
Future Market Outlook
- Launch of next-generation biosimilars and improvements in biosimilar acceptance could lead to further price erosion.
- New indications and expanded usage may partly offset volume declines.
- Entry of non-originator biologics and personalized medicine approaches pose additional competitive threats.
Regulatory and Patent Landscape
- Patent protections for Humira expired in most key markets by early 2023.
- AbbVie's patent litigation has delayed biosimilar market entry in some regions until patent expiry or settlement.
- Biosimilar approvals in the U.S. are subject to biosimilarity and interchangeability designations, impacting market penetration.
Strategic Implications for Stakeholders
Investors
- Expect revenue decline in Humira sales from 2023 onward.
- Valuations of AbbVie may adjust as biosimilar competition intensifies.
- Opportunities exist in biosimilar markets and companion diagnostics.
Manufacturers
- Focus on biosimilar market entry strategies, including pricing, supply chain optimization, and market access.
- Investment in next-generation biologics and differentiated products.
Payers
- Negotiating lower prices due to biosimilar competition.
- Expanding formulary coverage for biosimilars.
Key Takeaways
- Humira remains a top-selling biologic but faces significant price pressure post-2022.
- Biosimilar entries are driving a 20-30% price reduction in key markets.
- The global market is transitioning toward biosimilars, with regional variations in price decline.
- Revenue forecasts show a gradual decline, emphasizing the importance of biosimilar and next-generation product development.
FAQs
1. When will the patent for Humira expire in the U.S.?
The primary patent expired in early 2023, enabling biosimilar competition.
2. How many biosimilars are approved for Humira globally?
As of early 2023, at least five biosimilars have approval in Europe, with many more approved or anticipated in the U.S.
3. What is the main factor influencing price declines?
The entry of biosimilars and increased market competition, driven by patent expiries and regulatory pathways.
4. Will Humira’s sales decline completely?
Sales are expected to decline but may stabilize with new indications or formulations, or if biosimilar uptake slows.
5. Are biosimilars interchangeable with Humira?
Regulatory designation varies; some biosimilars are designated as interchangeable in the U.S., which can impact substitution at pharmacy level.
References
- Grand View Research. (2022). Biologics Market Size & Trends. Retrieved from https://www.grandviewresearch.com
- U.S. Food and Drug Administration. (2022). Biosimilar approvals. Retrieved from https://www.fda.gov
- European Medicines Agency. (2022). Biosimilar Medicines. Retrieved from https://www.ema.europa.eu
[1] Grand View Research. (2022). Biologics Market Size & Trends.
[2] U.S. Food and Drug Administration. (2022). Biosimilar approvals.
[3] European Medicines Agency. (2022). Biosimilar Medicines.
