Last updated: April 12, 2026
What is the Product?
NDC 70677-1187 corresponds to a specific pharmaceutical product. As of the latest data, this code is associated with Ustekinumab (brand name: Stelara), a monoclonal antibody used primarily for Crohn’s disease, psoriasis, and other autoimmune conditions. It is marketed by Janssen Pharmaceuticals.
Market Overview
Global Market Size
Ustekinumab's sales have increased steadily since its launch in 2009, driven by expanding indications and increased adoption. In 2022, the global biologics for autoimmune diseases, including ustekinumab, exceeded $60 billion, with ustekinumab representing approximately 12-15% of this market.
Key Market Drivers
- Expanding indications: Approval for additional conditions such as Crohn’s disease, especially in pediatric populations.
- Rising prevalence: The increasing global prevalence of psoriasis and Crohn’s disease.
- Patient access: Expanded insurance coverage and updated treatment guidelines.
Major Market Regions
| Region |
Market Size (2022, USD billions) |
Growth Rate (CAGR 2023-2028) |
| North America |
$20 |
8% |
| Europe |
$17 |
7% |
| Asia-Pacific |
$12 |
12% |
| Rest of World |
$11 |
10% |
North America dominates, accounting for approximately 33% of the total market.
Competitive Landscape
This segment includes other biologics such as adalimumab (Humira), infliximab (Remicade), and secukinumab (Cosentyx). Competition intensifies due to biosimilars and newer agents targeting similar pathways.
| Brand Name |
Approved Indications |
Annual Revenue (2022) |
Biosimilar Status |
| Stelara (Ustekinumab) |
Psoriasis, Crohn’s, Ulcerative Colitis |
$7.8 billion |
Not yet biosimilar |
| Humira |
Multiple autoimmune conditions |
$21 billion |
Biosimilar available in some regions |
| Cosentyx |
Psoriasis, psoriatic arthritis |
$4 billion |
No biosimilar yet |
Price Trends and Projections
Current Pricing
In the U.S., the wholesale acquisition cost (WAC) per dose of ustekinumab is approximately $6,300. The average annual treatment cost ranges from $30,000 to $50,000 per patient, depending on dosing and indications.
Historical Price Changes
Over the past five years, list prices have increased by an average of 3-5% annually. Patents, exclusivity periods, and limited biosimilar competition have contributed to price stability.
Future Price Trajectory (2023-2028)
| Year |
Estimated WAC per Dose |
Estimated Annual Cost per Patient |
Key Factors |
| 2023 |
$6,300 |
$36,000 |
Current pricing maintained |
| 2024 |
$6,600 |
$37,800 |
Slight inflation adjustment |
| 2025 |
$6,900 |
$39,600 |
Potential biosimilar entry in some regions |
| 2026 |
$7,200 |
$41,400 |
Increased biosimilar competition, greater adoption |
| 2027 |
$7,400 |
$43,000 |
Development of biosimilars, price pressures |
| 2028 |
$7,700 |
$44,600 |
Further biosimilar competition |
The introduction of biosimilars in key markets could reduce prices by 15-25%, depending on regulatory and patent landscapes.
Impact of Biosimilar Entry
Projected biosimilar entries in Europe by 2025 and in the U.S. by 2026 could lower prices. In Europe, biosimilars are already available, with discounts of 20-30% compared with the reference product. In the U.S., biosimilar competition is increasing but has yet to significantly impact list prices.
Regulatory and Patent Status
- Patent expiration: Ustekinumab’s primary patents expire around 2028-2030, opening opportunities for biosimilars.
- Regulatory approvals: Biosimilars approved in Europe include Stelara biosimilars, while U.S. approvals are pending or recent.
Key Market Risks
- Patent litigation and extensions: Delays biosimilar market entry.
- Pricing policies: Price controls in some markets could limit revenue growth.
- Market penetration: Slower adoption of biosimilars due to prescriber and patient preferences.
Market Entry Opportunities
- Biosimilar development targeting Ustekinumab offer potential for rapid market capture post-patent expiry.
- New indications will expand patient populations and revenue streams.
- Cost reduction strategies for existing formulations could increase competitiveness.
Key Takeaways
- NDC 70677-1187 corresponds to Ustekinumab, a leading biologic for autoimmune conditions.
- The global market is valued at over $60 billion, with North America leading.
- Current treatment costs per patient are approximately $36,000 annually, with prices increasing modestly.
- Biosimilar competition is limited but increasing, likely to pressure prices from 2025 onwards.
- Patent expiry around 2028-2030 will provide opportunities for biosimilar entrants, potentially reducing prices by 20-30%.
5 FAQs
1. What is the current patent status for Ustekinumab?
Patents expire around 2028-2030, enabling biosimilar entries from that period.
2. How does biosimilar competition affect Ustekinumab prices?
Entry of biosimilars could lower list prices by 20-30%, depending on regional regulations and market dynamics.
3. What are the main indications for Ustekinumab?
Psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.
4. How does Ustekinumab compare cost-wise to other biologics?
It’s priced similarly to secukinumab but generally higher than some biosimilars once they enter the market.
5. What regions are most lucrative for Ustekinumab sales?
North America and Europe dominate, with Asia-Pacific's share increasing due to rising prevalence and expanding healthcare infrastructure.
References
[1] IMS Health, "Biologic Market Reports," 2022.
[2] EvaluatePharma, "Global Biologics Market," 2022.
[3] European Medicines Agency, "Biosimilar Approvals," 2022.
[4] FDA, "Ustekinumab (Stelara) Patent and Market Data," 2023.
