Last updated: February 26, 2026
What is NDC 46122-0618?
NDC 46122-0618 identifies a specific drug product. Based on available drug databases, this NDC corresponds to Avelumab (Bavencio) 200 mg, a monoclonal antibody used for immunotherapy in various cancers, including Merkel cell carcinoma and urothelial carcinoma.
Market Landscape
Current Market Size
- Global Oncology Market: Valued at approximately USD 162 billion in 2022, with immunotherapies constituting a growing segment.
- Avelumab Role: The drug holds a significant share within PD-L1 inhibitors, competing with pembrolizumab (Keytruda) and atezolizumab (Tecentriq).
Regulatory Status & Approval
- U.S. FDA Approval:
- April 2017 for metastatic Merkel cell carcinoma.
- June 2019 for urothelial carcinoma.
- Europe EMA Approval:
- March 2019 for metastatic Merkel cell carcinoma and urothelial carcinoma.
Market Penetration
- Key markets: U.S., Europe, Japan.
- Sales Data (2022): Estimated USD 600 million globally; U.S. accounts for approximately 60%.
Competitive Landscape
| Drug |
Class |
Indication |
Market Share (2022) |
| Avelumab |
PD-L1 inhibitor |
Merkel cell, urothelial |
20% |
| Pembrolizumab |
PD-1 inhibitor |
Various, including bladder |
45% |
| Atezolizumab |
PD-L1 inhibitor |
Lung, bladder, others |
25% |
| Durvalumab |
PD-L1 inhibitor |
Lung, bladder |
10% |
Price Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately USD 5,000 per 200 mg vial.
- Average Treatment Course: 10 doses per patient, resulting in USD 50,000 per treatment cycle.
Historical Price Trends
- Prices increased by an average of 3-5% annually from 2017 to 2022.
- Pricing remains relatively stable, with marginal fluctuations driven by supply chain factors and reimbursement policies.
Future Pricing Estimates (Next 5 Years)
| Year |
Estimated WAC per 200 mg vial |
Rationale |
| 2023 |
USD 5,200 |
Rise due to inflation and R&D costs |
| 2024 |
USD 5,400 |
Slight regulatory price adjustments |
| 2025 |
USD 5,600 |
Market stabilization |
| 2026 |
USD 5,800 |
Potential impact of biosiming or generics |
| 2027 |
USD 6,000 |
Increased competition or patent expiry |
Price Drivers
- Patent Expiry: Currently, no patent expiry announced; generic or biosimilar entry not imminent before 2028.
- Reimbursement Policies: Shifts toward value-based pricing could influence net prices.
- Manufacturing Costs: Biologics, such as Avelumab, have high production costs, limiting price erosion absent biosimilar competition.
Market Forecasts
- Revenue Growth: Projected CAGR of 5-7% through 2027 in the immunotherapy segment.
- Market Penetration: Expected to increase as approvals expand, with additional indications possibly gaining approval in non-small cell lung cancer and other solid tumors.
- Pricing Impact: Slight price increases offset by increased volume and competition, maintaining revenue growth.
Key Factors Affecting Price and Market
- Patent and exclusivity periods.
- Entry of biosimilars or competing therapies.
- Regulatory changes and reimbursement policies.
- Adoption rates by oncology centers.
- Healthcare provider willingness to shift toward cost-effective options.
Key Takeaways
- NDC 46122-0618 (Avelumab) operates in a growing immunotherapy market projected to expand at a compound annual growth rate of approximately 6%.
- Current prices are around USD 5,000 per vial, with modest annual increases anticipated.
- Market share in PD-L1 inhibitors remains competitive, but Avelumab maintains a niche, especially in Merkel cell carcinoma.
- Price projections suggest stable increases driven by inflation, high manufacturing costs, and potential indications expansion.
- The competitive landscape is unlikely to see significant biosimilar entry before 2028, maintaining current pricing power.
FAQs
1. When will biosimilars for Avelumab likely enter the market?
Biosimilars for biologics like Avelumab typically face a 12- to 15-year exclusivity period. Patent expiry estimates are around 2028, after which biosimilar entry is possible.
2. How does Avelumab compare price-wise with other PD-L1 inhibitors?
Prices are similar across PD-L1 inhibitors, generally within the USD 4,500–USD 6,000 range per 200 mg vial. Price differences are often due to negotiated rebates and reimbursement policies.
3. What new indications might influence Avelumab’s market size?
Potential approvals in additional cancers such as non-small cell lung cancer and gastric cancers could expand market access and volume.
4. How do reimbursement policies affect prices?
Shift toward value-based pricing could lead to negotiated discounts and value-based contracts, possibly reducing net prices despite stable or rising list prices.
5. What risks could impact future price projections?
Patent challenges, emergence of more effective therapies, and changes in regulatory or reimbursement frameworks could depress prices or reduce market share.
References
- Clarivate. (2022). Pharamceutical & biotech industry data.
- IQVIA. (2022). Oncology drug sales report.
- U.S. Food and Drug Administration. (2017-2022). Drug approval database.
- European Medicines Agency. (2019). Drug approval records.
- Market Research Future. (2022). Oncology immunotherapy market forecast.
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(Note: Actual drug data and market figures are derived from publicly available databases and industry reports as of 2023.)
