Last updated: April 15, 2026
What is the Drug NDC 42858-0610?
NDC 42858-0610 refers to Avelumab, a monoclonal antibody marketed under the brand name Bavencio. It is approved for treating metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma. Avelumab is part of the immune checkpoint inhibitor class, targeting PD-L1 to enhance immune response against tumors.
Market Overview
Current Market Size
The global oncology immune checkpoint inhibitor market was valued at approximately $15 billion in 2022 and is projected to reach $30 billion by 2027, with a compound annual growth rate (CAGR) of around 15%. Avelumab's share of this market is smaller compared to pembrolizumab (Keytruda) and nivolumab (Opdivo), but it holds a significant niche due to its approved indications.
Geographical Distribution
| Region |
Market Share (2022) |
Growth Rate (2022-2027) |
| North America |
45% |
12% |
| Europe |
25% |
10% |
| Asia-Pacific |
20% |
20% |
| Rest of World |
10% |
15% |
North America accounts for nearly half of the current market, driven by healthcare infrastructure, reimbursement policies, and approval rate. Asia-Pacific demonstrates faster growth potential due to increasing cancer prevalence and expanding healthcare access.
Competitive Landscape
Key competitors include:
- Pembrolizumab (Merck)
- Nivolumab (Bristol-Myers Squibb)
- Atezolizumab (Genentech/Roche)
- Durvalumab (AstraZeneca)
Avelumab's differentiation lies in its approved indications and confirmed safety profile for specific cancers.
Market Drivers
- Rising incidence of Merkel cell carcinoma and urothelial carcinoma
- Increasing adoption of immunotherapies as first-line treatment
- Expanding clinical trial data for new indications
- Growing acceptance in developing regions
Market Barriers
- High treatment costs (~$150,000 to $180,000 annually)
- Limited indications compared to competitors
- Reimbursement challenges in emerging markets
- Safety concerns and immune-related adverse events
Price Projections
Current Pricing Dynamics
Brand-name Avelumab (Bavencio) retails at approximately $180,000 per year for a typical treatment course in the US. Biosimilars are not yet available, but biosimilar development could alter prices in the next 3-5 years.
Price Trends (2023-2030)
| Year |
Estimated Average Cost |
Rationale |
| 2023 |
$180,000 |
Current price, no biosimilar competition yet |
| 2025 |
$160,000–$170,000 |
Biosimilar entry possible, pricing pressure expected |
| 2028 |
$130,000–$150,000 |
Increased biosimilar competition, manufacturing efficiencies |
| 2030 |
$110,000–$130,000 |
Price reductions driven by biosimilars, market saturation |
Price Impact Factors
- Biosimilar entry could reduce prices by 30-40%
- Price regulation policies in Europe and emerging markets could cap prices
- Expanded indications and combination therapies could maintain price levels temporarily
Revenue Projections
Assuming a market share of 10-15% in relevant indications and annual sales of around 2,000–3,000 patients globally, revenue could range from $300 million to $540 million annually by 2030. This projection considers stabilization of prices amid biosimilar competition.
Conclusion
Avelumab's market presence remains steady, driven by its specific approved indications. Prices are expected to decline gradually due to biosimilar entry and market pressures, but total revenue may remain substantial through expanding indications and geographic expansion.
Key Takeaways
- The immunotherapy market is projected to double by 2027, with Avelumab holding a niche share.
- Current pricing is approximately $180,000 annually per treatment course.
- Biosimilar competition could reduce prices by up to 40% by 2028.
- Revenue forecasts suggest sustained growth, totaling hundreds of millions of dollars annually by 2030.
- Market expansion involves overcoming reimbursement hurdles and broadening approved indications.
FAQs
Q1: When are biosimilars for Avelumab expected?
A1: Biosimilars are likely to enter the market between 2023 and 2025, pending regulatory approval and development timelines.
Q2: What are the primary indications for Avelumab?
A2: Metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial carcinoma.
Q3: How does the pricing of Avelumab compare to other checkpoint inhibitors?
A3: Avelumab's pricing is comparable, with most monoclonal antibodies costing around $150,000–$180,000 annually per treatment course.
Q4: Which regions show the highest growth potential?
A4: Asia-Pacific exhibits higher CAGR (~20%) due to increasing cancer rates and expanding healthcare infrastructure.
Q5: What factors could sustain higher prices for Avelumab in the future?
A5: Expanded indications, successful combination therapies, and limited biosimilar penetration in certain markets.
References
- Grand View Research. (2022). Oncology Immunotherapy Market Size, Share & Trends Analysis Report.
- IQVIA. (2022). Global Oncology Market Report.
- U.S. Food and Drug Administration. (2017). Bavencio (Avelumab) Prescribing Information.
- EvaluatePharma. (2022). Oncology drug market forecast.
- World Health Organization. (2022). Global Cancer Statistics.
