Last updated: February 23, 2026
What is NDC 49348-0076?
NDC 49348-0076 corresponds to Brentuximab Vedotin, a monoclonal antibody-drug conjugate approved for treating certain hematologic cancers, including Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL). It is marketed under the brand name Adcetris by Seattle Genetics.
Current Market Landscape
Market Size and Demographics
The global oncology drug market reached approximately USD 177 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030, driven by increasing cancer incidence and new therapeutic approvals (Grand View Research, 2023).
Brentuximab Vedotin primarily targets adult patients with relapsed/refractory Hodgkin lymphoma, with an estimated incidence of 2.3 per 100,000 annually in the U.S., translating to about 8,000-10,000 treated patients annually domestically. Globally, the number of eligible patients exceeds 50,000.
Market Penetration and Competitive Landscape
Brentuximab Vedotin entered the market in 2011. It competes primarily with chemotherapeutic agents, alternative antibody-drug conjugates, and emerging immunotherapies like PD-1 inhibitors (e.g., pembrolizumab, nivolumab).
Key competitors include:
- Pembrolizumab (Keytruda, Merck), approved for certain relapsed Hodgkin lymphomas.
- Nivolumab (Opdivo, Bristol-Myers Squibb).
Market penetration varies regionally: the U.S. accounts for approximately 50% of sales, with Europe and emerging markets following.
Sales Data
In 2021, sales of Brentuximab Vedotin exceeded USD 900 million globally. The drug's revenue increased approximately 10% annually from 2018-2021. The US accounted for roughly USD 500 million in 2021.
Price Analysis and Projections
Current Price per Dose
The wholesale acquisition cost (WAC) for Brentuximab Vedotin is approximately USD 3,700–USD 5,500 per 50 mg vial, with treatment courses typically requiring multiple vials. The average treatment regimen involves approximately 1.8 mg/kg administered every 3 weeks over a course of 6-8 cycles, leading to a treatment cost of roughly USD 30,000–USD 70,000 per patient.
Pricing Trends
Pricing has remained relatively stable since initial approval, though discounts and institutional negotiations can lower the effective price. The high cost limits broader adoption, despite clinical benefits.
Price Projections (2023-2030)
Projected price per treatment course assumes no drastic price erosion. It is estimated to remain within USD 25,000 to USD 70,000 per patient annually, depending on dose, treatment duration, and regional negotiations.
Factors influencing future prices include:
- Market competition: Entry of biosimilars or new conjugates may pressure prices downward.
- Reimbursement policies: Increased coverage could stabilize or reduce out-of-pocket costs.
- Patent protections: Patent expiry is expected around 2028-2030, potentially enabling biosimilar entry and price reduction.
Impact of Patent Expiry and Biosimilar Entry
The patent expiration of Brentuximab Vedotin is scheduled for 2028 in major markets. Biosimilar development is ongoing, with several candidates in late-stage development. The entry of biosimilars could reduce prices by 20-40%, depending on market dynamics.
Future Market Drivers
- Expansion into first-line therapy settings may increase volume.
- Broader indications, such as peripheral T-cell lymphomas, could drive new sales.
- Advances in immunotherapy may limit long-term market share but could also lead to combination treatments, boosting revenue.
Regulatory and Policy Environment
- The FDA approved combination therapies involving Brentuximab Vedotin, expanding its use.
- Cost-effectiveness assessments by agencies like NICE influence uptake and reimbursement.
Summary Table
| Metric |
Current Data |
Future Projections |
| Annual global sales |
USD 900 million (2021) |
USD 1.2–USD 1.5 billion (2025) |
| Price per treatment course |
USD 25,000 – USD 70,000 |
Stable, with potential decrease post-patent expiry |
| Patent expiry |
2028–2030 |
Potential biosimilar entry from 2028 |
| Cost per vial |
USD 3,700–USD 5,500 |
Expected to decline with biosimilars |
Key Takeaways
- Brentuximab Vedotin remains a high-cost treatment with steady sales amid increasing competition.
- Prices are contingent on regional negotiations, patent status, and biosimilar development.
- Market growth depends on expanded indications, regulatory approvals, and competitive dynamics.
Frequently Asked Questions
- What factors could significantly reduce Brentuximab Vedotin's price? Entry of biosimilars post-2028, competitive pressure, and reimbursement negotiations.
- How does the current pricing compare globally? U.S. prices are higher, averaging USD 4,000–USD 5,500 per vial; European prices are often lower due to negotiated discounts.
- What potential indications could expand its market? Frontline treatment of Hodgkin lymphoma, peripheral T-cell lymphomas, and combination therapies.
- How does the competition from immunotherapies affect Brentuximab Vedotin? It could limit growth but also offer combination use cases, supporting sales.
- What is the primary driver of future revenue growth? Increased patient access, expanded indications, and biosimilar competition.
References
[1] Grand View Research. (2023). Oncology Drugs Market Size & Share Report.
[2] FDA. (2011). Approved Drug Label: Adcetris.
[3] IQVIA. (2022). Global Oncology Market Data.
[4] NICE. (2021). Technology appraisal of Brentuximab vedotin.
