Last updated: February 21, 2026
What is NDC 13107-0083?
NDC 13107-0083 is the National Drug Code identifier for Avelumab (Bavencio). Avelumab is a monoclonal antibody used in cancer immunotherapy, specifically approved for metastatic Merkel cell carcinoma, urothelial carcinoma, and other solid tumors.
Market Overview
Therapeutic Area and Competitors
Avelumab operates in the immune checkpoint inhibitor market. Key competitors include:
- Pembrolizumab (Keytruda, Merck)
- Nivolumab (Opdivo, Bristol-Myers Squibb)
- Atezolizumab (Tecentriq, Genentech)
- Durvalumab (Imfinzi, AstraZeneca)
These agents have broader FDA approval spectra, which influence Avelumab's market share.
Market Size
In 2022, the global oncology immunotherapy market was valued at approximately $115 billion. Avelumab's specific segment is estimated at $1 billion, with expected growth aligned with the broader PD-1/PD-L1 inhibitor market.
Approvals and Indications
-
US FDA approvals:
- Merkel cell carcinoma (first approved in 2017)
- Urothelial carcinoma (2018)
- Other solid tumors under development or in trials
-
Pricing in the US:
- Per 200 mg dose: Approximately $7,150 (as of 2023) [1]
- Treatment duration: Often 10-20 cycles depending on therapy response
Price Determination Factors
Production Costs
- Manufacturing monoclonal antibodies involves complex cell-culture techniques.
- Estimated production cost per dose: $1,000–$2,500, depending on scale efficiencies [2].
Pricing Strategies
- Price set higher than production costs to account for R&D, regulatory expenses, and profit margins.
- Contract terms, payer negotiations, and competitive landscape influence actual sale prices.
Reimbursement Dynamics
- Insurance coverage, especially Medicaid and Medicare in the US, significantly impacts net revenue.
- Patient access programs and discounts reduce effective price.
Market Penetration and Forecasts
| Scenario |
2023 Revenue |
2027 Revenue |
Compound Annual Growth Rate (CAGR) |
| Conservative (low uptake) |
$850 million |
$1.2 billion |
8% |
| Moderate growth |
$1 billion |
$1.7 billion |
14% |
| Aggressive (market expansion) |
$1.1 billion |
$2 billion |
18% |
Growth driven by approval expansion, increased adoption in early lines, and new indications under clinical trials.
Key Drivers
- Expanded indications including combination therapies.
- Increased competition from solid tumor treatments.
- Patent expiration prospects around 2030 might influence price and market share.
Price Projection Summary
Based on current data, the average transaction price in the US is around $7,150 per 200 mg dose. Under aggressive expansion, pricing could reduce slightly due to increased competition and patent expiry threats. Conversely, new indications or combination regimens could sustain higher prices.
Risks and Challenges
- Patent expiries and biosimilar development may erode market share.
- Entry of novel immune checkpoint inhibitors could drive down prices.
- Cost containment policies and payer negotiations are increasing pressure on pricing.
Key Takeaways
- NDC 13107-0083 (Avelumab) is present in a mid-sized segment of the melanoma and urothelial carcinoma market.
- Current US prices hover around $7,150 per dose, with a treatment cost of approximately $70,000–$140,000 annually.
- Market growth anticipates CAGR between 8% and 18% through 2027.
- Competition and patent expiries are primary price and market share risk factors.
FAQs
Q1: When will patent expiration affect Avelumab’s pricing?
A1: Patent protections are expected to expire around 2030, which may lead to biosimilar competition and price reductions.
Q2: What are the main competitive advantages of Avelumab?
A2: Approved for Merkel cell carcinoma with a favorable safety profile; ongoing trials aim to expand indications.
Q3: How do reimbursement policies influence pricing?
A3: Reimbursement rates negotiated with payers directly impact net pricing and market access.
Q4: Are biosimilars likely for Avelumab?
A4: Biosimilars are probable post-patent expiration, potentially reducing treatment costs.
Q5: What factors could accelerate market growth for Avelumab?
A5: New indications, combination therapy approvals, and increased clinical adoption.
References
[1] GoodRx. (2023). Bavencio (Avelumab) Prices.
[2] Pharmaceutical Manufacturing and Packaging. (2021). Cost analysis of biologics.
