Last updated: February 5, 2026
What is the drug associated with NDC 68001-0668?
NDC 68001-0668 corresponds to Stelara (guselkumab), a biologic developed by Janssen Pharmaceuticals. It is used to treat conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and inflammatory bowel disease.
What is the current market size for Stelara?
Global Market Valuation (2022-2023)
| Region |
Estimated Market Size (USD billions) |
Growth Rate (CAGR 2022-2027) |
| North America |
8.5 |
8.2% |
| Europe |
3.1 |
7.5% |
| Asia-Pacific |
1.2 |
12.4% |
| Others |
0.6 |
6.8% |
| Total |
13.4 |
8.3% |
The global biologics market for inflammatory diseases is expanding with a CAGR of approximately 8.3% through 2027, driven by increasing prevalence of psoriasis and Crohn’s disease.
Key Factors Driving Market Expansion
- Rising incidence of autoimmune diseases in aging populations.
- Expanded label indications, including newer formulations.
- Increased healthcare access and reimbursement policies.
- Advancements in biologic manufacturing.
What are the key competitors?
- Humira (adalimumab) — AbbVie
- Cosentyx (secukinumab) — Novartis
- Taltz (ixekizumab) — Eli Lilly
- Skyrizi (risankizumab) — AbbVie
Stelara maintains a significant market share among IL-23 inhibitors, with a competitive position secured by its dosing regimen and established efficacy.
What are the price dynamics?
Current Pricing (U.S., wholesale)
| Product |
Avg. List Price/Unit (USD) |
Dosing Schedule |
Annual Cost (approximate) |
| Stelara (Guselkumab) |
$4,500 per 100 mg dose |
100 mg every 8 weeks post loading |
$39,000 - $45,000 |
| Humira |
$4,300 per 40 mg pen |
Weekly or biweekly |
$35,000 - $45,000 |
| Cosentyx |
$5,400 per 150 mg injection |
Monthly |
$45,000 |
Stelara's price tends to be slightly below or comparable with other IL-17 and IL-23 inhibitors, influenced by dosing and administration frequency.
Price Trends (2022-2023)
- Slight price increases averaging 3%-5% annually, tied to inflation and manufacturing costs.
- Payor negotiations influence net prices, often lowering list price by discounts and rebates.
What are the future price projections?
Factors influencing future prices:
- Patent expirations: No immediate expiry for Stelara until 2025 (U.S.).
- Biosimilar entry: No biosimilars available for Stelara in the U.S. yet.
- Regulatory changes: Potential for value-based pricing models.
- Manufacturing costs: Expected to stabilize or decrease with advances in biosynthetic production.
Projected Pricing in 2027
| Scenario |
List Price Estimate (USD) per dose |
Annual Cost Estimate (USD) |
| Stable Market (no biosimilar) |
$4,600 - $4,900 |
$40,000 - $50,000 |
| Increased Competition |
$4,200 - $4,500 |
$35,000 - $45,000 |
List prices are projected to trend upward minimally, with net prices possibly decreasing due to payer pressures.
Market adoption and sales trends forecast
- Sales expected to grow at a CAGR of 9% from 2023 to 2027.
- Key drivers include increased diagnosis rates, expansion into new indications, and evolving treatment guidelines favoring IL-23 inhibitors.
- Market penetration is near maximum for approved indications, with incremental growth driven by off-label uses and biosimilar competition.
Key Takeaways
- NDC 68001-0668 (Stelara) remains a leading biologic in inflammatory disease therapy.
- The market is expanding, with an expected CAGR of approximately 8.3% to 9% through 2027.
- Current annual costs for Stelara range from $39,000 to $45,000 in the U.S.
- Future pricing will likely stabilize with slight increases; biosimilar competition is not imminent in the U.S.
- Market growth is supported by rising prevalence, expanded indications, and ongoing innovation in biologic therapies.
FAQs
1. When will biosimilars for Stelara become available in the U.S.?
Biosimilar development is in progress, but approval and commercialization are unlikely before 2025 due to patent protections and regulatory processes.
2. How does Stelara's efficacy compare to other biologics?
Stelara has demonstrated strong efficacy, particularly in psoriasis and Crohn's disease, with a favorable safety profile. It provides long-lasting relief with dosing every 8 weeks after loading.
3. What factors could influence Stelara’s market share?
Entry of biosimilars, new competitors with better efficacy or safety profiles, and changes in healthcare reimbursement policies.
4. How are pricing negotiations conducted for biologics like Stelara?
Pricing involves negotiations between manufacturers, payers, and pharmacy benefit managers, often resulting in rebates and discounts that reduce net prices.
5. What are the prospects for global expansion?
Emerging markets show increasing adoption, especially where biosimilars are accessible, but pricing and reimbursement policies vary significantly by region.
References
- Market data sourced from IQVIA (2022-2023)
- Price estimates based on publicly available drug pricing databases and manufacturer disclosures.
- Competitive landscape and regulatory updates from FDA and EMA reports.
- Industry reports from EvaluatePharma and Novartis, 2023 outlook.
[1] IQVIA, "Global Bioscience Market Report," 2022.
[2] U.S. FDA Drug Approvals, 2022-2023.
[3] EvaluatePharma, "Biologic Drugs Market Forecast," 2023.
