Last updated: March 26, 2026
What is the Drug's Composition and Approved Indication?
NDC: 16714-0398 corresponds to Bavencio (avelumab), a monoclonal antibody approved by the FDA for the treatment of several cancers, including Merkel cell carcinoma, urothelial carcinoma, and metastatic melanoma. It is an immune checkpoint inhibitor targeting PD-L1.
Current Market Landscape
Market Size and Revenue
- The global oncology immunotherapy market reached approximately $150 billion in 2022.
- Avelumab's sales in 2022 totaled $400 million, with steady growth driven by expanded indications and increased adoption.
- Urothelial carcinoma accounts for roughly 50% of sales among avelumab products, with Merkel cell carcinoma and melanoma following.
Competitive Position
- Key competitors include Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Atezolizumab (Tecentriq).
- Avelumab's distinct feature is its approved indication for metastatic Merkel cell carcinoma, which provides a niche but smaller market segment.
Market Drivers
- Rising incidence of bladder, skin, and skin-related cancers.
- Increasing adoption of immunotherapies over chemotherapies.
- Expanded FDA approvals and label updates.
Pricing and Market Penetration
- Wholesale acquisition cost (WAC) for a standard dose (10 mg/kg every 2 weeks) averages $10,000 to $15,000 per infusion.
- Patient treatment courses typically involve 6-12 infusions depending on the indication.
Price Trajectory and Projected Trends
Historical Price Trends
- List prices increased modestly over the last five years, averaging 3-5% annually.
- Major payers negotiate significant discounts, with net prices often 40-60% below list prices.
Short-term (1-3 years) projections
- Price stability expected due to current market penetration and existing patent protections.
- Competition from biosimilars not imminent; biosimilar approval for avelumab has not yet occurred or been announced.
- Future pricing may be influenced by health policy reforms, value-based agreements, and continued broader adoption.
Long-term (3-5 years) projections
- Likely slight decrease in list prices driven by biosimilar emergence, if approved.
- Net prices could fall by 10-20% as payers negotiate discounts.
- Introduction of combination therapies could shift pricing dynamics, potentially increasing costs for combination regimens but decreasing them for monotherapies.
Regulatory and Policy Impact
- Patent expiry expected around 2028, opening potential for biosimilar competition.
- Price negotiations and formulary status may further influence payer coverage and reimbursement levels.
Price Comparison with Competitors
| Drug |
Typical Dose Cost |
Approved Indications |
Market Share (2022) |
Notes |
| Avelumab (NDC: 16714-0398) |
~$10,000 per infusion |
Merkel cell carcinoma, urothelial carcinoma, melanoma |
10-15% |
Niche indications |
| Pembrolizumab (Keytruda) |
~$12,000 per infusion |
Multiple cancers including NSCLC, melanoma |
40-50% |
Broadest indications |
| Nivolumab (Opdivo) |
~$12,000 per infusion |
Melanoma, NSCLC, renal cell carcinoma |
35-40% |
High market penetration |
| Atezolizumab (Tecentriq) |
~$10,000 per infusion |
Urothelial carcinoma, NSCLC |
10-15% |
Competition in lung/urinary |
Strategic Considerations
- Focus on expanding indications and combination therapy approvals.
- Monitor biosimilar development and regulatory pathways.
- Negotiate favorable contracts with payers, especially as biosimilar options emerge.
Key Takeaways
- The immediate market for NDC 16714-0398 has stable pricing supported by ongoing approvals and limited biosimilar competition.
- Revenue growth will depend on expanding indications and clinical application.
- Long-term pricing could decline marginally due to biosimilar entry post-2028.
- Competition from broader immunotherapy agents maintains pressure on price and market share.
- Payer negotiations and policy reforms remain critical in shaping future pricing.
FAQs
1. When is biosimilar entry expected for avelumab?
Biosimilar submissions are not yet filed; patent protection is expected to last until 2028, after which biosimilar competition could influence prices.
2. How does avelumab price compare to other immune checkpoint inhibitors?
Avelumab's list price is broadly comparable to pembrolizumab and nivolumab, but actual net prices are often lower due to discounts and rebates.
3. What factors most influence future pricing?
Regulatory approvals, biosimilar entries, payer negotiation strategies, and emerging combination therapies.
4. How does the drug's indication breadth affect its market?
Limited to specific cancers, which constrains revenue compared to broader-approved immunotherapies.
5. Will price reductions impact patient access?
Potentially, if biosimilars are approved and adopted widely, reduced costs could improve access.
Sources
- IQVIA. (2022). Oncology Immunotherapy Market Data.
- U.S. Food and Drug Administration. (2022). Avelumab (Bavencio) label updates.
- SSR Health. (2022). Net Price Trends for Monoclonal Antibodies.
- EvaluatePharma. (2022). Oncology Market Forecasts.
- Patentscope. (2022). Patent protections for avelumab.
[1] IQVIA. (2022). Oncology immunotherapy market data.
[2] U.S. Food and Drug Administration. (2022). Avelumab (Bavencio) label updates.
[3] SSR Health. (2022). Net price trends for monoclonal antibodies.
[4] EvaluatePharma. (2022). Oncology market forecasts.
[5] Patentscope. (2022). Patent protections for avelumab.
