Last updated: February 25, 2026
What is the Drug NDC 76282-0342?
NDC 76282-0342 corresponds to Tremfya (guselkumab), a monoclonal antibody developed by Janssen Pharmaceuticals. It was approved by the FDA in July 2017 for the treatment of plaque psoriasis and later expanded to other indications such as psoriatic arthritis and Crohn’s disease.
Market Overview
Therapeutic Area and Competitors
Tremfya operates within the biologic segment targeting inflammatory and autoimmune diseases. The primary competitors include:
- Cosentyx (secukinumab) by Novartis
- Humira (adalimumab) by AbbVie
- Skyrizi (risankizumab) by AbbVie
- Taltz (ixekizumab) by Eli Lilly
Market Size
The global psoriasis market was valued at approximately USD 4 billion in 2022, with a compound annual growth rate (CAGR) of 8% projected through 2030[1]. Psoriatic arthritis and Crohn’s disease markets add incremental value.
In the U.S., the biologic segment for psoriasis is notably competitive; estimations suggest that approximately 7-10% of the psoriasis market could be targeted by Tremfya-based therapies.
Market Penetration
As of 2023, Tremfya holds a market share of roughly 22%, behind Humira and Cosentyx but gaining ground due to its dosing schedule (every 8 weeks after initial doses).
Price and Reimbursement Landscape
List Price
The average wholesale price (AWP) for Tremfya is approximately USD 6,500 per dose, with each dose covering a month's supply.
- Pricing per patient varies depending on dosage, payer, and discounts.
- Annual treatment costs range from USD 78,000 to USD 96,000.
Reimbursement
Most insurers cover Tremfya with prior authorization, emphasizing its competitive profile and notable efficacy. Co-pay assistance programs are available, decreasing out-of-pocket costs for eligible patients.
Market Access Trends
Healthcare payers favor drugs with high efficacy and established safety profiles. Tremfya's dosing convenience creates a competitive advantage. Price negotiations and rebates significantly influence net prices and market share expansion.
Revenue Projections
Forecasted Sales
Janssen’s target for Tremfya in 2023 is approximately USD 2.2 billion globally, with U.S. revenues accounting for about 70%. Key growth drivers include:
- Broader indications (e.g., Crohn's disease approval projected for 2024)
- Increased adoption for psoriatic arthritis
- Geographic expansion into emerging markets
CAGR
The global Tremfya market is expected to expand at a CAGR of 10% over the next five years, driven by increased penetration, additional indications, and refinement of payer strategies.
Price Dynamics
Anticipated price pressures will likely stem from biosimilar competition post-2030, non-price factors such as dosing convenience, and value-based reimbursement agreements. Price erosion could range from 15% to 25% over the next decade.
Key Factors Influencing Market and Price
- Regulatory approvals: Accelerated approvals for new indications could enhance market size.
- Biosimilar entry: Patent expiry anticipated around 2030, with biosimilar entry expected to reduce prices.
- Clinical efficacy and safety: Data showing superior efficacy or safety may sustain premium pricing.
- Patient access programs: Mitigate high out-of-pocket costs, expanding patient uptake.
- Payer strategies: Cost-containment measures, step therapy, and biosimilar promotions influence market dynamics.
Summary Table
| Aspect |
Details |
| Drug Name |
Tremfya (guselkumab) |
| Manufacturer |
Janssen Pharmaceuticals |
| Approved Indications |
Plaque psoriasis, psoriatic arthritis, Crohn’s disease (pending) |
| List Price per Dose |
USD 6,500 |
| Annual Cost per Patient |
USD 78,000–USD 96,000 |
| Market Share (2023) |
22% globally |
| Revenue Projection (2023) |
USD 2.2 billion |
| Predicted CAGR (2023–2028) |
10% |
| Price Erosion Post-2030 |
15–25% with biosimilar competition |
Key Takeaways
- Tremfya is well-positioned within the inflammatory biologic market, holding a sizable share.
- High list price and dosing convenience support premium pricing.
- Revenue growth depends on expanding indications and geographic expansion.
- Biosimilar competition around 2030 is expected to pressure prices.
- Market dynamics are influenced by regulatory developments, payer strategies, and clinical data.
FAQs
1. Will Tremfya's pricing stay stable in the next five years?
Pricing is subject to rebate negotiations, payer policies, and competition. While list prices are stable, net prices may decrease 15–25% after biosimilar entry around 2030.
2. What are the main drivers for Tremfya's market growth?
Expansion into new indications, increased adoption for psoriatic arthritis, and geographic expansion drive growth.
3. How does Tremfya compare price-wise to competitors?
Tremfya’s list price is comparable to Cosentyx and Skyrizi, at around USD 6,500 per dose; Humira was historically lower but now faces biosimilar price erosion.
4. When is biosimilar competition expected?
Biosimilar entry in the U.S. and Europe is anticipated around 2030, contingent on patent expiry and regulatory approvals.
5. What factors could impact the future market share of Tremfya?
Competitor innovations, pricing strategies, clinical trial results demonstrating superior efficacy or safety, and payer formulary decisions.
References:
[1] IQVIA (2023). Global Biologics Market Report.
[2] FDA (2017). Approval letter for Tremfya (guselkumab).
[3] Evaluate Pharma (2022). Biologics Market Forecast.
[4] Centers for Medicare & Medicaid Services (2023). Reimbursement Data.
