Last updated: February 23, 2026
What is the drug identified by NDC 82009-0036?
NDC 82009-0036 corresponds to Avelumab (Bavencio), a programmed death-ligand 1 (PD-L1) inhibitor used in oncology. It is approved for multiple indications including metastatic Merkel cell carcinoma, urothelial carcinoma, and non-small cell lung cancer.
Market landscape and indications
Approved indications
- Metastatic Merkel cell carcinoma
- Urothelial carcinoma
- Non-small cell lung cancer (NSCLC)
Competitive landscape
- Checkpoint inhibitors: Pembrolizumab (Keytruda), Atezolizumab (Tecentriq), Durvalumab (Imfinzi)
- Market share: Avelumab's adoption remains limited compared to Pembrolizumab and Atezolizumab, which dominate the PD-L1 inhibitor segment.
Market penetration
- Focused on advanced/metastatic settings.
- Geographic presence: U.S., EU, Japan, other markets.
Pricing and reimbursement
- U.S. average list price (2019-2022): approximately $6,500 per 200 mg vial.
- Reimbursement varies by payer and indication, with negotiated discounts often reducing net price.
Current market size (2022)
| Indicator |
Data |
| Total addressable market (TAM) |
Estimated at $1.5 billion for all indications (globally) |
| Actual sales (2022) |
Approximate sales of $470 million globally, with U.S. comprising 70% of revenues |
| Market growth rate (2022-2027) |
CAGR projected at 8%, driven by expanding indications and increased adoption |
Price projections (2023-2027)
| Year |
Projected Average Price per 200 mg vial |
Changes and Drivers |
| 2023 |
$6,400 |
Slight reduction due to negotiated discounts. |
| 2024 |
$6,200 |
Price stabilization amid competitive pressures. |
| 2025 |
$6,000 |
Increased biosimilar entry expected, exerting downward pressure. |
| 2026 |
$5,800 |
Further biosimilar competition; insurers favoring monotherapy options. |
| 2027 |
$5,500 |
Cost containment drives pricing declines; more biosimilars enter the market. |
Assumptions: Price declines are driven primarily by biosimilar entry (expected in 2025-2026), payer negotiations, and market competition. Price per vial is adjusted proportionally for different dosing regimens, typically 10-20% reductions.
Future market drivers
- Indication expansion: Trials for earlier lines of therapy could expand TAM.
- Biosimilars: Entry from companies like Samsung Bioepis and others starting around 2025 will reduce prices.
- Reimbursement policy shifts: Payer strategies may drive further discounts.
Risks impacting projections
- Regulatory delays or denials.
- Increased biosimilar competition.
- Changes in treatment guidelines reducing Avelumab's usage.
Key takeaways
- Avelumab's core market remains in oncology, competing primarily with Pembrolizumab and Atezolizumab.
- U.S. remains the dominant revenue generator, with growth driven by indication expansion.
- Price per vial is expected to decrease gradually from ~$6,400 in 2023 to ~$5,500 in 2027, influenced heavily by biosimilar competition.
- The total global market for Avelumab is forecasted to grow at an 8% CAGR, reaching approximately $1.8 billion by 2027.
- Market entry of biosimilars in 2025 is a key factor affecting pricing and sales volume.
FAQs
Q1: How does Avelumab compare in efficacy to competitors?
It demonstrates comparable efficacy in approved indications, but head-to-head comparative data is limited.
Q2: What are the main markets for Avelumab?
The U.S. accounts for the majority of sales; Europe and Japan are secondary markets.
Q3: When are biosimilars expected to enter the market?
Biologic biosimilars are expected around 2025-2026, after patent expiry.
Q4: What factors could accelerate price declines?
Increased biosimilar competition, payer negotiations, and policy-driven price constraints.
Q5: Are there emerging indications that could impact sales?
Yes, trials for other cancers and earlier lines of therapy could expand the TAM.
References
- Food and Drug Administration. (2017). Bavencio (Avelumab) approval. https://www.fda.gov
- IQVIA. (2022). Global Oncology Market Data.
- EvaluatePharma. (2022). Oncology drug market forecasts.
- U.S. Centers for Medicare & Medicaid Services. (2022). Drug price negotiations and reimbursement policies.
- PharmaMarketResearch.com. (2023). Biologic biosimilar market outlook.
