Last updated: February 22, 2026
What Is the Drug and Its Market Position?
NDC 00093-1920 corresponds to Yervoy (ipilimumab), a monoclonal antibody approved for the treatment of melanoma and several other cancers. It operates by activating the immune system to target tumor cells.
Yervoy was first approved by the FDA in 2011. Its primary indication is unresectable or metastatic melanoma, with extension into other cancers such as non-small cell lung cancer (NSCLC), renal cell carcinoma, and combination therapies.
Market Size and Key Players
Current Market Overview (2023)
| Segment |
Market Size (USD) |
Growth Rate (CAGR) 2022-2027 |
Key Competitors |
| Melanoma |
1.2 billion |
7% |
BRAF inhibitors, PD-1 inhibitors |
| Lung Cancer |
3.5 billion |
6.5% |
PD-1 inhibitors (Keytruda, Opdivo) |
| Renal Cell Carcinoma |
800 million |
8% |
Tyrosine kinase inhibitors, immunotherapy |
| Other indications |
1.1 billion |
6.2% |
Combination therapies |
Market Drivers
- Increasing prevalence of melanoma, NSCLC, and renal cell carcinoma.
- Rising adoption of immunotherapies as first-line treatment.
- Regulatory approvals for expanded indications.
- Patent exclusivity till 2028, with expected biosimilar entry post-expiry.
Market Challenges
- High treatment costs ($150,000–$200,000 per year).
- Competitive pressure from PD-1 inhibitors.
- Enrollment challenges in clinical trials for new indications.
Price Trends and Projections
Current Pricing Data (2023)
| Region |
Cost per Treatment |
Average Annual Cost |
Notes |
| US |
$150,000 |
$150,000–$200,000 |
Based on dosage (typically 3 mg/kg every 3 weeks) |
| EU |
€120,000 |
€120,000–€160,000 |
Slightly lower due to pricing negotiations |
| Asia-Pacific |
$130,000 |
$130,000–$180,000 |
Prices vary significantly across countries |
Price Projection (2023–2028)
| Year |
Estimated Price per Treatment |
Assumptions |
| 2023 |
$150,000 |
Current market price |
| 2024 |
$147,000 |
Slight decreases due to negotiations |
| 2025 |
$145,000 |
Biosimilar competition emerging |
| 2026 |
$140,000 |
Increased biosimilar adoption |
| 2027 |
$135,000 |
Cost pressures intensify |
| 2028 |
$130,000 |
Biosimilar market stabilizes |
Factors Influencing Price Decline
- Introduction of biosimilars, expected post-patent expiration in 2028.
- Negotiation power of payers, especially in Europe and Asia.
- Cost-containment policies in healthcare systems.
Biosimilar Outlook
A biosimilar to ipilimumab is in late-phase development; approval is anticipated post-2028. Biosimilars could reduce costs by 20–40%, accelerating market penetration.
Revenue Forecast
| Year |
Estimated Global Revenue (USD billion) |
Notes |
| 2023 |
2.2 billion |
Current sales across indications |
| 2024 |
2.0 billion |
Market saturation |
| 2025 |
1.8 billion |
Biosimilar competition begins |
| 2026 |
1.5 billion |
Price competition, patent challenges |
| 2027 |
1.4 billion |
Market stabilization |
| 2028 |
1.2 billion |
Biosimilar entry confirmed, price drops |
Key Takeaways
- NDC 00093-1920, ipilimumab, remains a significant immunotherapy.
- Market size for its indication segments approaches USD 6.6 billion in 2023, with growth driven by expanded indications and utilization.
- Current treatment prices average USD 150,000 per dose; projections indicate a gradual decline to USD 130,000 by 2028, mainly due to biosimilar competition.
- Patent expiry in 2028 positions biosimilars as a major future disruptor, potentially reducing costs and expanding access.
- Competitive dynamics favor combination therapies and new indications, possibly offsetting price declines.
FAQs
1. When will biosimilars for ipilimumab enter the market?
Post-2028, following patent expiration.
2. What factors could accelerate price reductions?
Early biosimilar approval, increased payer negotiations, and greater market competition.
3. What are the main indications for ipilimumab?
Melanoma, NSCLC, renal cell carcinoma, and combinational uses in other cancers.
4. How does the competition from PD-1 inhibitors impact ipilimumab’s market?
It creates pressure on pricing and market share but also offers combination therapy opportunities.
5. Are there regulatory hurdles to biosimilar approval?
Yes, biosimilars require demonstration of biosimilarity, which involves extensive comparability studies.
References
[1] IQVIA Institute. (2023). The Use of Immunotherapies in Oncology.
[2] FDA. (2022). Ipilimumab (Yervoy) Prescribing Information.
[3] Evaluate Pharma. (2023). Oncology Market Analysis.
[4] European Medicines Agency. (2022). Biosimilar Guidelines.
[5] PhRMA. (2022). The Emerging Biosimilar Market.
