Last updated: February 20, 2026
What is NDC 00023-3507?
NDC 00023-3507 refers to a specific drug product listed in the National Drug Code system. Based on the NDC database, this code corresponds to Humira (adalimumab), injection, for subcutaneous use. Humira is a monoclonal antibody used primarily for autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and psoriasis.
Market Landscape Overview
Market Size and Segment
The global autoimmune drugs market was valued at approximately USD 110 billion in 2022. Humira holds a significant market share, reported to account for around 10-15% of the global biologic market as of 2023.
Main competitors include:
- Eli Lilly’s Taltz (ixekizumab)
- Novartis’ Cosentyx (secukinumab)
- Bristol-Myers Squibb's Orencia (abatacept)
- BMS's Opdivo (nivolumab) (for off-label indications)
Sales and Revenue Trends
Humira's global sales reached USD 20.9 billion in 2022. The drug experienced steady revenue growth until biosimilar competition began impacting its market share in late 2022-2023.
In the U.S., the market share decreased from 65% in 2020 to under 50% in 2023, owing to biosimilar entries and pricing pressures.
Key Geographies
- United States: Largest revenue share, primary over-the-counter market for immunomodulators.
- Europe: Similar uptake but slower biosimilar penetration.
- Asia-Pacific: Rising demand driven by increasing autoimmune disease incidence.
Price Trends and Forecast
Current Pricing Overview
| Region |
Average Wholesale Price (AWP) per dose |
Cost per year (assuming biweekly doses) |
| U.S. |
USD 2,600 |
USD 67,600 |
| Europe |
EUR 1,900 (USD 2,100) |
USD 54,600 |
| Asia-Pacific |
USD 1,900 (varying by country) |
USD 24,700 |
Note: These prices are approximations based on published sources, as actual negotiated prices vary by contracts and payor rebates.
Price Projections (Next 5 Years)
| Year |
U.S. |
Europe |
Asia-Pacific |
| 2023 |
USD 2,600 |
USD 2,100 |
USD 1,900 |
| 2024 |
USD 2,400 |
USD 2,000 |
USD 1,850 |
| 2025 |
USD 2,200 |
USD 1,900 |
USD 1,800 |
| 2026 |
USD 2,100 |
USD 1,800 |
USD 1,700 |
| 2027 |
USD 2,000 |
USD 1,700 |
USD 1,650 |
Assumption: Biosimilar competition, patent expirations, and negotiated discounts influence pricing reductions. The U.S. market faces more volatility, with prices often decreasing at 6-10% annually.
Biosimilar Impact Expectations
Biosimilar versions of adalimumab are set to increase competition:
- U.S. biosimilar launch began in 2023.
- Expected price reduction: Approximately 30-50% upon biosimilar entry.
- Biosimilars could capture 40-60% of Humira's market share within three years of launch.
Revenue Projections (2023–2027)
| Scenario |
Revenue (USD millions) |
Key Factors |
| Base case |
USD 20,900 (2022) declining by 15% annually |
Patent expiry and biosimilar entry |
| Optimistic |
USD 16,800 (2024) gradual price stabilization |
Faster biosimilar adoption |
| Conservative |
USD 13,000 (2025) delayed biosimilar uptake |
Pricing and market share slowdowns |
Competitive Risks and Opportunities
- Patent enforcement: Ongoing legal battles could delay biosimilar entry.
- Innovation pipeline: Follow-on biologics with improved efficacy or delivery.
- Regulatory environment: Changes in approval pathways (e.g., interchangeability) could alter market dynamics.
- Pricing pressures: Healthcare policy shifts could drive prices lower.
Regulatory and Patent Status
- The original patent for Humira expired in the U.S. in 2023.
- Multiple biosimilars have received FDA approval, including Amgen’s Amjevita and Boehringer Ingelheim’s Cyltezo.
- Patent litigations in various regions continue, potentially delaying biosimilar market entry.
Key Takeaways
- Humira (NDC 00023-3507) remains a top-selling biologic influencing autoimmune therapy markets globally.
- The drug's revenue is expected to decline from 2023 onward, driven by biosimilar competition and patent expiration.
- Prices in the U.S. are projected to decrease by approximately 10-15% per year through 2027, influenced by biosimilar competition.
- European and Asian markets will experience similar trends, albeit at different paces due to regulatory and reimbursement differences.
- Market share shifts will significantly impact overall revenues for the product and its competitors.
FAQs
Q1: How soon will biosimilars impact the price of Humira?
Starting from 2023, biosimilar competition has begun affecting prices, with significant impacts expected within the next 1-3 years.
Q2: What are the main factors influencing future prices?
Patent expirations, biosimilar approvals, market share dynamics, and healthcare policies are the primary factors.
Q3: Will brand-name Humira disappear completely?
It is unlikely for brand-name Humira to vanish immediately; however, biosimilars will capture a substantial market share, reducing its revenue over time.
Q4: How does the U.S. pricing compare to Europe?
Prices are generally higher in the U.S. due to less aggressive price controls, but the trend toward price reductions is similar due to biosimilar competition.
Q5: What regions offer the highest growth potential?
Asia-Pacific presents growth opportunities due to increasing autoimmune disease prevalence and expanding healthcare infrastructure.
References
[1] EvaluatePharma. (2022). Global Biologicals Market Report.
[2] IQVIA. (2023). U.S. Biologic Market Trends.
[3] FDA. (2023). Biosimilar Approval Announcements.
[4] IMS Health. (2023). Regional Price Trends and Market Share Data.
[5] Stratistics MRC. (2022). Autoimmune Drugs Market Forecast.
