Last updated: July 29, 2025
Introduction
Understanding the market dynamics and pricing trajectory of pharmaceuticals is essential for stakeholders across the healthcare ecosystem. This report examines the specific drug identified by the National Drug Code (NDC) 59137-0510, evaluating its market landscape, competitive positioning, regulatory environment, and projected pricing trends. While detailed product specifics are essential, typical analysis frameworks include assessing demand drivers, manufacturing costs, regulatory status, competitive alternatives, and payer pressures.
Drug Profile Overview
NDC 59137-0510 corresponds to Avelumab (Bavencio), an immunotherapy agent approved for various oncological indications, notably metastatic Merkel cell carcinoma and urothelial carcinoma. As a monoclonal IgG1 antibody targeting PD-L1, Avelumab exemplifies peg-in-the-market biologics, characterized by high development costs but limited generic competition.
Key Features:
- Indicated for multiple cancer types
- Administered via intravenous infusion
- Biologic, subject to biosimilar competition upon patent expiration
- Approved by FDA in 2017
Market Dynamics
1. Market Size and Demand Drivers
The global oncology market is expanding, driven by increasing cancer incidence rates, evolving treatment guidelines favoring immunotherapy, and expanding approval indications for agents like Avelumab. The global cancer immunotherapy market was valued at approximately USD 37 billion in 2020, projected to grow at a CAGR exceeding 12% through 2027 [1].
Specifically, Merkel cell carcinoma has an annual incidence of about 0.7 cases per 100,000, with the majority diagnosed in older populations. The urothelial carcinoma segment remains substantial, with roughly 81,000 new cases annually in the U.S. alone.
This rising demand, especially in advanced/metastatic settings, supports sustained sales volume for Avelumab.
2. Competitive Landscape
Avelumab faces competition primarily from other PD-1/PD-L1 inhibitors such as pembrolizumab (Keytruda), nivolumab (Opdivo), durvalumab, and atezolizumab. These agents differ in indications, efficacy profiles, and pricing strategies.
- Key competitors:
- Pembrolizumab: Leading first-line therapy, broader indications.
- Nivolumab: Similar scope, often preferred due to established efficacy.
- Durvalumab & Atezolizumab: Focused on certain indications like lung and bladder cancers.
While Avelumab holds a niche in Merkel cell carcinoma, competition in broader oncology indications limits its market share potential.
3. Regulatory Environment and Patent Landscape
Avelumab’s patent protections expire gradually over the next 5-7 years. Patent cliffs generally lead to biosimilar entries, exerting downward pressure on prices. The biologics landscape in the U.S. incentivizes biosimilar development, although regulatory pathways are more complex than for small-molecule generics.
4. Pricing and Reimbursement
List prices for biologics like Avelumab are high, often exceeding USD 7,000 to 10,000 per infusion, depending on dosage. Actual transaction prices are generally lower due to discounts, rebates, and payer negotiations. Coverage by Medicare, Medicaid, and private payers significantly influences net pricing.
Price Projection Framework
Given current industry trends, the following factors influence future pricing:
- Patent Expirations and Biosimilar Entry: Expected to stimulate price erosion beginning in the late 2020s.
- Market Penetration and Volume Gains: Expansion in approved indications and clinical adoption can offset unit price decline to some extent.
- Manufacturing Efficiency: Advances in bioprocessing may reduce production costs, enabling more competitive pricing.
- Regulatory and Policy Changes: Increased emphasis on value-based pricing and biosimilar substitution could lead to further discounts.
Short to Medium-Term (Next 3-5 Years):
Price stability is anticipated, with small reductions due to negotiated discounts and payer coverage policies. List prices may see a decline of 10-15% by 2025.
Long Term (beyond 5 Years):
In the face of biosimilar competition, prices could decrease by 30-50%, aligning with trends observed in other biologics post-patent expiry [2].
Market Executors and Risks
Potential Growth Opportunities:
- Expansion into new indications
- Combination therapies to enhance efficacy
- Biomarker-driven patient selection
Risks:
- Entry of biosimilars reducing pricing power
- Competitive saturation from other PD-L1/PD-1 inhibitors
- Regulatory and reimbursement hurdles
Conclusion
NDC 59137-0510 (Avelumab) maintains a strong, albeit specialized, position within the oncological treatment landscape. Its current market value is driven by high demand for immunotherapies, especially in niche indications like Merkel cell carcinoma. Future pricing trajectories will largely hinge on biosimilar regulatory developments and evolving reimbursement policies.
Investors and manufacturers should monitor patent statuses, biosimilar pipelines, and payer strategies to navigate potential price declines and market shifts effectively.
Key Takeaways
- Avelumab's market size benefits from growing oncology indications but faces stiff competition from PD-1 inhibitors.
- Current prices are high but subject to downward adjustments due to biosimilar entry within the next decade.
- Expansion into additional indications offers revenue growth potential despite pricing pressures.
- Industry shifts toward value-based care and biosimilar adoption will shape future price trajectories.
- Stakeholders should plan for gradual erosion of list prices and develop strategies around biosimilar pathways and indication expansion.
FAQs
1. When are biosimilars for Avelumab expected to enter the market?
Biosimilar development timelines suggest potential entry within 5-7 years post-approval, contingent upon patent expirations and regulatory approval processes.
2. How does competitive pressure affect Avelumab’s pricing?
Increased competition from other PD-L1 inhibitors and biosimilars will lead to significant price reductions, especially in broader indications like lung and bladder cancers.
3. What factors could sustain higher prices for Avelumab?
Limited biosimilar options for specific niche indications, improved clinical outcomes, and contractual agreements can help maintain premium pricing temporarily.
4. How do payer negotiations influence actual transaction prices?
Rebates, discounts, and formulary placement negotiations reduce gross list prices, resulting in lower net prices paid by payers and providers.
5. What strategic considerations should manufacturers prioritize regarding Avelumab?
Investing in expanding approved indications, optimizing biosimilar development, and engaging in value-based pricing models will be crucial for market share retention and profitability.
Sources:
[1] Grand View Research, "Cancer Immunotherapy Market Size & Share Analysis," 2021.
[2] IQVIA, "Biologic Price Trends and Biosimilar Entry," 2022.
