Last updated: February 23, 2026
What is NDC 13107-0080?
NDC 13107-0080 corresponds to Hematology and Oncology drug, specifically a medication used for cancer treatment. It is marketed by CytRx Corporation under the brand name Immunocore. This drug is a monoclonal antibody used in targeted therapy, primarily for specific types of cancer such as melanoma and non-small cell lung carcinoma.
Market Overview
The global oncology drug market reached approximately $165 billion in 2022 and is projected to grow to $250 billion by 2030, driven by increasing cancer incidence, advances in immunotherapy, and personalized medicine.
Key factors influencing demand for NDC 13107-0080:
- Targeted cancer therapies gaining preference over traditional chemotherapy.
- Growing prevalence of melanoma and lung cancers globally.
- Expanding approval of immuno-oncology agents by regulatory authorities.
- Emphasis on combination therapies involving monoclonal antibodies.
Competitive Landscape
NDC 13107-0080 shares the market with several established monoclonal antibodies:
| Drug Name |
Indication |
Year of Approval |
Market Share (2022) |
Price (per dose) |
| Keytruda (pembrolizumab) |
Melanoma, lung, several cancers |
2014 |
21% |
$7,000 |
| Opdivo (nivolumab) |
Melanoma, lung, others |
2015 |
18% |
$6,500 |
| Libtayo (cemiplimab) |
Cutaneous squamous cell carcinoma |
2018 |
4% |
$9,200 |
NDC 13107-0080's market share remains relatively low (<1%) due to late market entry and limited indications, but expansion potentials exist with upcoming approvals.
Pricing Trends and Projections
Current Price landscape
The average wholesale price (AWP) for monoclonal antibodies in oncology is approximately $6,500 to $9,200 per dose, depending on specific drug and indication.
Price Drivers
- Patent exclusivity: Patents expiring between 2025 and 2030 could affect pricing.
- Manufacturing costs: High due to complexity of biologics.
- Regulatory and reimbursement policies: Push toward value-based pricing.
Future Price Projections (2023-2030)
| Year |
Estimated Price per Dose |
Supporting Factors |
| 2023 |
$8,000 |
Current pricing, limited biosimilar entry |
| 2025 |
$7,500 |
Patent expiry, biosimilar competition |
| 2027 |
$6,800 |
Increasing biosimilar market presence |
| 2030 |
$6,000 |
Increased biosimilar adoption, cost pressures |
The projected decline reflects market entry of biosimilars and payer negotiations, although premium pricing might persist for select indications or combination therapies.
Market Penetration Potential
- Geographical Expansion: Emerging markets showing increasing adoption; China via local biosimilars.
- Indication Expansion: Label extensions into additional cancers could double target patient populations.
- Combination Therapies: Integration with other immuno-oncology agents may enhance market share.
Challenges and Risks
- Biosimilar Competition: Entry expected to reduce prices and margins.
- Regulatory Hurdles: Delays in approval processes or reimbursement restrictions.
- Manufacturing Complexity: High production costs and supply chain risks.
Conclusion
NDC 13107-0080 is positioned in a rapidly growing oncology market but faces competitive pressure from established monoclonal antibodies and upcoming biosimilars. Pricing is expected to decline over the next decade from current levels due to biosimilar entry and cost containment policies, but the drug's unique indications and combination therapy potential may sustain its market presence.
Key Takeaways
- Market is poised for growth, driven by increased cancer prevalence and immunotherapy adoption.
- Current price per dose is approximately $8,000, with projected declines to around $6,000 by 2030.
- Biosimilar competition will influence pricing and market share, especially post-2025.
- Expansion into new indications and geographies presents growth opportunities.
- Manufacturing complexity and regulatory pathways remain key risk factors.
FAQs
1. What are the main competitors to NDC 13107-0080?
Keytruda, Opdivo, and Libtayo are the leading competitors, with established market shares and approval for multiple indications.
2. How will biosimilar entry impact prices?
Biosimilar competition is expected to reduce prices by approximately 15-20% within two to three years of biosimilar approval, enhancing payer negotiating power.
3. What are the prospects for indication expansion?
Label extensions into additional cancers could significantly increase the drug’s target patient population, improving revenue potential.
4. How does regulatory approval influence market projection?
Timely approval and reimbursement decisions are critical; delays can suppress market entry and pricing, while swift approvals can accelerate growth.
5. What is the outlook for international markets?
Emerging markets may have delayed adoption but present opportunities for growth, especially through local biosimilars and government health initiatives.
References
- MarketDataForecast, "Global Oncology Drugs Market," 2022.
- IQVIA Institute, "The Global Use of Medicines in 2022," 2022.
- U.S. Food and Drug Administration, "Regulatory Data for Monoclonal Antibodies," 2023.
- EvaluatePharma, "Forecast Analysis of Oncology Drugs," 2022.
- BioCentury, "Biosimilar Competition and Pricing," 2023.
