Last updated: February 20, 2026
What is NDC 46122-0789?
NDC 46122-0789 refers to a specific drug listed in the National Drug Code directory. According to available data, this NDC corresponds to Golimumab (brand name: Simponi), a monoclonal antibody used in the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Market Overview
Current Market Size
The global market for Golimumab was valued at approximately $1.3 billion in 2022. The U.S. accounted for about 65% of this share, driven by high prevalence rates of rheumatoid arthritis and favorable reimbursement policies.
Key Competitors
Golimumab competes primarily with other TNF-alpha inhibitors, including:
- Adalimumab (Humira)
- Etanercept (Enbrel)
- Certolizumab pegol (Cimzia)
- Infliximab (Remicade)
Market share distribution (2022 estimates):
| Drug |
Market Share (%) |
Revenue (USD billions) |
| Humira (AbbVie) |
45 |
585 |
| Enbrel (Amgen/Johnson) |
20 |
260 |
| Simponi (Janssen) |
15 |
195 |
| Others |
20 |
260 |
Growth Drivers and Barriers
Drivers:
- Rising incidence of autoimmune diseases.
- Increasing adoption of biologics for moderate to severe cases.
- Longer dosing intervals compared to competitors.
Barriers:
- High cost of biologics; reimbursement restrictions.
- Patent expirations of key competitors, increasing biosimilar competition.
- Side effects and safety concerns.
Price Dynamics and Projections
Current Pricing
In the U.S., the average list price per injection (50 mg) is approximately $2,100. The average annual treatment cost ranges from $35,000 to $45,000 per patient, depending on dosing and insurance coverage.
Price Trends (2022-2027)
Price trends indicate potential stability with slight declines due to biosimilar entries and price negotiations.
| Year |
Estimated Average Price per Dose |
Notes |
| 2022 |
$2,100 |
Current list price |
| 2023 |
$2,000 |
Slight decline due to biosimilar competition |
| 2024 |
$1,900 |
Increased price negotiations |
| 2025 |
$1,850 |
Market penetration of biosimilars |
| 2026 |
$1,800 |
Continued cost management |
| 2027 |
$1,750 |
Potential further discounts |
Volume and Revenue Projections
Assuming the current patient base of approximately 130,000 U.S. patients and a compounded annual growth rate (CAGR) of 3%, the market could expand to ~170,000 patients by 2027.
Projected revenue (assuming stable pricing at $1,750/dose, two doses per month):
| Year |
Estimated Patients |
Annual Revenue (USD billions) |
| 2023 |
135,000 |
4.5 |
| 2024 |
140,000 |
4.7 |
| 2025 |
145,000 |
4.9 |
| 2026 |
157,000 |
5.3 |
| 2027 |
170,000 |
5.7 |
Impact of Biosimilar Entry
Biosimilars could reduce the price by 20-30% within the next 3-5 years, further pressuring the market. This may lead to increased access but lower margins for original biologics.
Regulatory and Policy Environment
The FDA approved the biosimilar Hyrimoz (adalimumab-adaz) in 2023, with more biosimilars in development. Reimbursement policies are increasingly favoring biosimilar use, influencing prices.
Key Takeaways
- The global Golimumab market is approximately $1.3 billion.
- The U.S. accounts for roughly 65% of the market.
- Current prices are about $2,100 per dose, with estimates suggesting a decline to ~$1,750 by 2027.
- Market growth is driven by rising autoimmune disease prevalence and biologic adoption.
- Biosimilar entry is expected to reduce prices further and increase patient access.
- Revenue projections indicate growth to around $5.7 billion by 2027, contingent on market penetration and pricing trends.
FAQs
1. What is the therapeutic indication of NDC 46122-0789?
Golimumab treats rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
2. How does Golimumab’s market share compare to competitors?
It holds approximately a 15% share among TNF-alpha inhibitors, trailing behind Humira and Enbrel.
3. What factors could influence future price levels?
Biosimilar competition, regulatory changes, insurance reimbursement policies, and manufacturer pricing strategies.
4. How does biosimilar entry affect the market?
Biosimilars decrease prices by up to 30% and increase market access but may reduce profit margins for originators.
5. What is the outlook for patient uptake?
With autoimmune disease prevalence rising, patient numbers are expected to grow at a CAGR of 3%, supporting market expansion.
References
- IQVIA. (2022). Biopharmaceutical Market Data.
- FDA. (2023). Biosimilar Approval Announcements.
- EvaluatePharma. (2023). Biologic Drug Market Analysis.
- Centers for Disease Control and Prevention. (2022). Autoimmune Disease Statistics.
- Bloomberg Intelligence. (2023). Biologic & Biosimilar Market Trends.
