Last updated: February 15, 2026
Overview
NDC 69315-0137 corresponds to Tildrakizumab, marketed as Ilumya. It is a monoclonal antibody approved for moderate to severe plaque psoriasis in adults. The drug was approved by the FDA in March 2018 and is marketed by Sun Pharmaceutical Industries. The product's competitive position, market size, and pricing trend are influenced by the psoriasis therapeutics landscape and regulatory developments.
Market Dynamics
Indication and Market Size
- The primary indication is moderate to severe plaque psoriasis.
- The global psoriasis treatment market was valued at roughly USD 6.2 billion in 2022.
- The compound annual growth rate (CAGR) between 2023 and 2030 is projected at approximately 12%, driven by increasing prevalence and new treatment options.
Prevalence
- Estimated 125 million people affected worldwide; about 7.5 million in the US.
- The US accounts for the largest market share, approximately 40% of global psoriasis treatments.
Existing Competition
- Major biologics include adalimumab (Humira), secukinumab (Cosentyx), ixekizumab (Taltz), and risankizumab (Skyrizi).
- These drugs have established market shares and varying price points, influencing Tildrakizumab’s positioning.
Pricing and Reimbursement
List Price
- The Average Wholesale Price (AWP) for Tildrakizumab is approximately $3,200 per 150 mg dose.
- Tildrakizumab dosing: 100 mg initially at weeks 0 and 4, then every 12 weeks, generally costing around $38,400 annually for a patient.
Market Price Variability
- Actual paid prices vary with negotiated discounts, rebates, and payer arrangements.
- Net prices often range between 20-40% below list prices, resulting in approximately $2,000 to $2,560 per dose after discounts.
Reimbursement Trends
- Insurance coverage favors biologics, but formularies prioritize drugs with favorable pricing and administration benefits.
- Cost-effectiveness studies position Tildrakizumab favorably due to its dosing schedule and efficacy profile.
Revenue Projections
Current Market Share
- Tildrakizumab holds an estimated 3-5% of the biologic psoriasis market (2022-2023).
- Competition from risankizumab and secukinumab limits market penetration.
Projected Growth
- As of 2023, revenues from Tildrakizumab are estimated at $200-300 million annually globally.
- Expected growth rate of 10-12% per year over the next five years, driven by increased adoption and expanding indications.
Potential Uptake Drivers
- Expanded label indications.
- Increased awareness and diagnosis.
- Competitive pricing strategies and formulary inclusion.
Price Projections (2023-2028)
| Year |
Estimated Average Price (USD) per Dose |
Estimated Annual Revenue (USD) |
Market Share Projection |
| 2023 |
$2,500 |
$250 million |
4% |
| 2024 |
$2,600 |
$275 million |
4.5% |
| 2025 |
$2,700 |
$310 million |
5% |
| 2026 |
$2,800 |
$350 million |
6% |
| 2027 |
$2,900 |
$400 million |
6.5% |
| 2028 |
$3,000 |
$450 million |
7% |
Price increases reflect inflation, payor negotiations, and potential biosimilar competition, although biosimilars for Tildrakizumab are not yet commercially available.
Regulatory and Competitive Factors
- The drug faces competition from other biologics with proven efficacy.
- No biosimilars launched as of 2023; upcoming patent expirations may influence pricing.
- Regulatory efforts may expand or restrict indications, affecting revenue.
Key Takeaways
- NDC 69315-0137 (Tildrakizumab) operates in a competitive, high-growth psoriasis market.
- Current list prices are around $3,200 per dose; net prices are lower due to discounts.
- Market share remains limited but should grow 10-12% annually through expanded use.
- Revenue projections suggest increasing revenues reaching approximately $450 million annually by 2028.
FAQs
-
What factors most influence Tildrakizumab's market share growth?
Efficacy comparisons, formulary inclusion, expanded indications, and pricing strategies.
-
How does Tildrakizumab’s pricing compare to competitors?
It is priced similarly to risankizumab and secukinumab but typically has a lower list price than risankizumab.
-
What impact will biosimilar entrants have?
Biosimilars could erode market share and reduce pricing power, but none are launched yet.
-
Are there any recent regulatory changes affecting pricing or approval?
No recent regulatory hurdles; ongoing reviews may expand indications, positively affecting revenue.
-
What is the potential for price increases?
Modest annual increases are possible mainly through negotiations; large hikes are unlikely absent label expansions.
Sources
[1] IQVIA, "Global Psoriasis Market Analysis," 2023.
[2] Sun Pharmaceutical, "Ilumya Product Monograph," 2023.
[3] FDA, "Drug Approvals and Indications," 2018.
[4] MarketWatch, "Biologic Psoriasis Treatments," 2022.
[5] EvaluatePharma, "Biologic Drugs Revenue Data," 2023.
