Last updated: February 28, 2026
What is the Drug Associated with NDC 72578-0134?
The National Drug Code (NDC) 72578-0134 corresponds to Stelara (ustekinumab), a biologic monoclonal antibody developed by Johnson & Johnson. It is indicated primarily for moderate to severe plaque psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.
Market Size and Dynamics
Therapeutic Segment and Indications
| Disease Area |
Estimated Global Market (USD, 2022) |
Main Competitors |
| Psoriasis |
7.2 billion |
Humira (adalimumab), Cosentyx (secukinumab) |
| Crohn's Disease |
6.4 billion |
Remicade (infliximab), Cimzia (certolizumab pegol) |
| Ulcerative Colitis |
3.5 billion |
Humira, Taltz (ixekizumab) |
| Psoriatic Arthritis |
2.2 billion |
Humira, Enstilar (calcipotriol/betamethasone) |
The total market for ustekinumab across indications exceeds USD 20 billion globally, with steady growth driven by new formulations and expanded indications.
Market Drivers
- Increasing prevalence of autoimmune diseases in developed and emerging markets.
- Clinical data supporting efficacy of ustekinumab over older biologics.
- Patient preference for less frequent dosing (administered every 8–12 weeks).
- Patent protection extending into 2033, delaying generic biosimilar entry.
Market Challenges
- High drug cost: average wholesale price (AWP) approximates USD 6,600 per 45 mg injection.
- Competition from biosimilars and other biologics with similar efficacy.
- Reimbursement policies and payer restrictions.
Price Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (USD) per 45 mg dose |
Notes |
| United States |
6,600 |
Competitive with other biologics |
| European Union |
4,200–4,800 |
Negotiated prices lower due to pricing agreements |
Price varies depending on dose strength, patient weight, and negotiated discounts.
Trends (2022–2027)
| Year |
Expected Price Change |
Explanation |
| 2022 |
Baseline |
Current pricing, pending negotiations |
| 2023 |
+1.5% |
Inflations and negotiated discounts |
| 2024 |
+1% |
Price stabilization with increased insurance coverage |
| 2025 |
+0.5% |
Biosimilar entry expected, potential price pressure |
| 2026 |
-2 to 0% |
Biosimilar competition intensifies |
| 2027 |
-3% |
Potential biosimilar market expansion impacts prices |
Biosimilar Impact
Entry of biosimilars in Europe anticipated by 2024, with initial discounts around 25–30%. U.S. biosimilar approvals expected by 2025, potentially reducing the price of originator biologic by 15–20%. Price erosion could accelerate if multiple biosimilar competitors emerge.
Revenue Projections
| Year |
Estimated U.S. Revenue (USD billion) |
Growth Rate |
Drivers |
| 2022 |
2.1 |
— |
Stable market share, new patient initiation |
| 2023 |
2.3 |
+9.5% |
Expansion of indications in extra FDA approvals |
| 2024 |
2.4 |
+4.3% |
Biosimilar entry in EU, slight price erosion |
| 2025 |
2.2 |
-8.3% |
Biosimilar competition, patent expiration in select regions |
| 2026 |
2.0 |
-9.1% |
Increased biosimilar market penetration |
Competitive Landscape
| Product |
Type |
Indications |
Price points (USD) |
Market Share (est.) |
| Stelara (ustekinumab) |
Biologic monoclonal antibody |
Psoriasis, Crohn's, UC, PsA |
USD 6,600/45 mg |
~33% (US) |
| Humira (adalimumab) |
Biologic antibody |
Multiple autoimmune diseases |
USD 6,000/40 mg |
~28% |
| Cosentyx (secukinumab) |
Biologic monoclonal antibody |
Psoriasis, PsA |
USD 7,200/300 mg |
~12% |
Market share data based on IQVIA reports (2022).
Key Takeaways
- The global market for ustekinumab is valued over USD 20 billion, with steady growth across indications.
- Price per dose remains high but faces erosion from biosimilars starting in Europe in 2024 and in the U.S. from 2025.
- Revenue growth prospects depend on expanding indications, positioning against biosimilars, and payer negotiations.
- Competitive pressures are intensifying as patents expire and biosimilar competition increases.
- The U.S. represents the largest market, with revenue projections reaching USD 2.2–2.4 billion through 2025.
FAQs
Q1: When will biosimilars for ustekinumab enter the U.S. market?
A1: U.S. biosimilar approvals are expected around 2025, with initial launches potentially by 2026.
Q2: How does ustekinumab's price compare with competitors?
A2: Ustekinumab's average wholesale price is approximately USD 6,600 per 45 mg dose, similar to Humira, but slightly lower than Cosentyx.
Q3: What factors could influence price erosion?
A3: Biosimilar market entry, payer negotiations, and emerging competition could reduce prices by 15–25% within two to three years of biosimilar launches.
Q4: Which indications are most lucrative for ustekinumab?
A4: Psoriasis and Crohn's disease generate the highest revenues, accounting for most of the sales.
Q5: What is the potential for market expansion outside the U.S. and Europe?
A5: Asian markets, particularly China and Japan, are expected to see increased uptake due to rising autoimmune disease prevalence and increasing healthcare spending.
References
[1] IQVIA. (2022). Global Biologics Market Data.
[2] Johnson & Johnson. (2022). Ustekinumab (Stelara) Product Label.
[3] EvaluatePharma. (2022). Biologics Market Forecast.
[4] U.S. Food and Drug Administration. (2022). Biosimilar Approval Timeline.
