Last updated: February 16, 2026
Overview
NDC 00113-0186 is the drug Adalimumab (Humira), a monoclonal antibody used primarily for autoimmune conditions like rheumatoid arthritis, Crohn's disease, and plaque psoriasis. It remains one of the highest-grossing biologics globally.
Market Size and Demand
- The global biologics market was valued at approximately $300 billion in 2022.
- Adalimumab accounted for roughly 15% of the biologics revenue in 2022, equating to around $45 billion.
- The drug's primary markets include the US, EU, and Japan, with the US representing approximately 50% of its sales.
Market Trends
- Growth drivers include increasing diagnosis of autoimmune diseases, expanding indications, and patent expirations leading to biosimilar entries.
- Patent expiry in the US occurred in January 2023, with biosimilar competition expected to impact pricing and market share.
Competitive Landscape
| Drug |
Company |
Approval Year |
Biosimilars (Approved/Upcoming) |
Estimated US Market Share (2022) |
| Humira |
AbbVie |
2002 |
Several biosimilars (Amgen, Samsung Bioepis, Sandoz) |
80-85% before patent expiry |
| Amgen/Novartis |
AMGEVITA, Hadlima |
2018/2020 |
Yes |
fragmenting market share post-patent |
| Samsung Bioepis/Biogen |
Imraldi |
2018 |
Yes |
low single-digit percentage |
Price Projections
- Pre-patent expiry, Humira's average wholesale price (AWP) in the US was around $50,000 per year per patient.
- Post-patent, biosimilar entry is expected to reduce list prices by approximately 25-35%.
- Current estimates suggest a biosimilar list price of approximately $32,000–$40,000 per year, a decline from the original list price.
- Volume increases may partially offset price reductions, but overall revenue per user is declining.
Future Revenue Outlook
| Scenario |
Market Share |
Average Price |
Estimated Revenue (US, 2023-2025) |
| Conservative |
60% of original patents' revenue |
$30,000/year |
~$13.5 billion annually |
| Moderate |
75% market share |
$35,000/year |
~$16.5 billion annually |
| Aggressive biosimilar penetration |
50% market share |
$25,000/year |
~$11.25 billion annually |
Key Variables Affecting Revenue and Pricing
- Biosimilar market dynamics, including FDA approvals and formulary preferences.
- Manufacturing costs for biosimilars and originator.
- Price competition, negotiations, and payer strategies.
- New indications expanding market size.
Regulatory Factors
- Biosimilar pathway clarified via FDA guidance in 2015.
- Patent litigation can delay biosimilar market entry.
- Price controls in some regions (EU, Japan) could influence pricing strategies.
Price Trend Projections
| Year |
US Price Range |
Comments |
| 2022 |
$50,000 |
Peak list price |
| 2023 |
$32,000–$40,000 |
Biosimilar entry begins |
| 2024 |
$30,000–$38,000 |
Further biosimilar competition |
| 2025 |
$25,000–$35,000 |
Continued price erosion |
Summary
The launch of biosimilars following patent expiry significantly affects the price and revenue potential of NDC 00113-0186 (Humira). Expect continued price declines with a gradual reduction in revenue per patient. The market will see increased volume due to biosimilar penetration, but the overall growth trajectory depends on regulatory, payer, and competitive responses.
Key Takeaways
- Biosimilar competition is projected to reduce Humira's US list prices by approximately 25-35% by 2024.
- US market share shrinks are expected from 85% pre-patent expiry to under 60%.
- Revenue projections for 2023–2025 indicate a decline from peak levels, depending on biosimilar adoption.
- External factors like patent litigation and regulatory policies significantly influence pricing and market share.
- Expanded indications and healthcare policies remain potential growth levers in emerging markets.
FAQs
1. When did biosimilar competition for Humira begin?
Biosimilars started entering the US market in January 2023 after patent expiry.
2. What factors could accelerate biosimilar uptake?
Regulatory approvals, payer formulary preferences, and pricing strategies favoring biosimilars can accelerate adoption.
3. How does biosimilar pricing compare globally?
Prices vary; biosimilars tend to be priced 20-40% below originator prices, with regional differences influenced by healthcare policies.
4. Will Humira maintain market dominance in the future?
Market share will decline as biosimilars gain acceptance, but the drug will remain significant due to existing patient populations and new indications.
5. What are the opportunities for originator companies?
Innovating with new formulations, expanding into new indications, or developing next-generation biologics can offset erosion of legacy products.
Citations
- IQVIA. "The Global Use of Medicine in 2022."
- FDA. "Biosimilar Development and Approval."
- EvaluatePharma. "Biologics Market Data."
- Fitch Solutions. "Pharmaceutical Price Trends."
- IMS Health. "Biosimilar Outlook and Market Dynamics."
