Last updated: February 28, 2026
What is the drug associated with NDC 00781-2368?
NDC 00781-2368 is the National Drug Code for a specific formulation of Brentuximab Vedotin (brand name: Adcetris). It is a purified antibody-drug conjugate targeting CD30-positive malignancies, primarily used in the treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
What is the current market landscape for Brentuximab Vedotin?
Market size and sales data
The global oncology drug market was valued at approximately USD 155 billion in 2022, with antibody-drug conjugates (ADCs) constituting a rapidly growing segment.
In 2022, sales of Brentuximab Vedotin reached USD 1.2 billion, representing a compound annual growth rate (CAGR) of 12% from 2020 to 2022 [1].
Key competitors
- Brentuximab Vedotin (Adcetris): Market leader in CD30-targeted therapies.
- Checkpoint inhibitors: Pembrolizumab and nivolumab, used off-label or in combination.
- Emerging ADCs: Novel agents in clinical trials targeting similar indications.
Market drivers
- Increasing incidence of Hodgkin lymphoma, estimated at 8.7 per 100,000 in the U.S.
- Longer patient survival rates due to improved treatment options.
- Expanding indications, including peripheral T-cell lymphoma and cutaneous T-cell lymphoma.
Regulatory landscape
- FDA approved for Hodgkin lymphoma post-autologous stem cell transplantation or after at least two prior therapies.
- EMA approved similar indications.
- Ongoing trials investigating earlier-line use and combination therapies.
Price structure and reimbursement
List and net prices
- United States (2023): List price per vial (~50 mg) is approximately USD 6,000.
- Average wholesale price (AWP): Around USD 6,600.
- Actual transaction prices (net): Expected to be 15-20% lower due to negotiations, rebates, and discounts.
Pricing trends
- Price increases observed annually at roughly 4-6% since approval in 2018.
- Price adjustments linked to inflation, manufacturing costs, and market competition.
Reimbursement policies
- Fully reimbursed by Medicare and most private insurers.
- Reimbursement negotiated at the institutional level, impacting net pricing.
Future price projections
Short-term outlook (2023-2025)
- Price stability: List price remains at USD 6,000 per vial barring significant market or regulatory changes.
- Market penetration: Increased adoption in earlier lines of therapy could stabilize or slightly increase prices.
- Reimbursement shifts: Potential for increased discounts based on payer negotiations.
Long-term outlook (2025-2030)
- Price decrease potential: Introduction of biosimilars or generics could reduce prices by 20-30% over the next 5-7 years.
- Market expansion: Broader indications or combination therapies could sustain high prices, though competition may limit upward movement.
- Outcome-based pricing: Payers might push for value-based arrangements, potentially reducing effective reimbursement rates.
Factors influencing future pricing
| Factor |
Impact |
Timeline |
| Biosimilar entry |
Downward pressure |
2026-2028 |
| New indications |
Price stabilization |
2024-2026 |
| Market penetration |
Price stability or increase |
2023-2027 |
| Healthcare policy changes |
Variable |
2023-2030 |
Strategic considerations
- Manufacturing costs: Advances in production efficiency could influence retail pricing.
- Patent expiration: Patents expiring around 2028 could lead to biosimilar competition.
- Healthcare reforms: Policies favoring value-based care may drive price negotiations.
Summary
Brentuximab Vedotin (NDC 00781-2368) maintains premium pricing driven by its therapeutic efficacy in Hodgkin lymphoma. While short-term prices are expected to remain stable, long-term trends indicate a potential decrease driven by biosimilar competition, but revenue could be sustained through expanded indications and market penetration strategies.
Key Takeaways
- USD 6,000 list price per vial in 2023, with net prices likely 15-20% lower.
- Market sales exceeded USD 1.2 billion in 2022, with steady growth.
- Biosimilar introduction projected between 2026-2028 may reduce prices by 20-30%.
- Expanded indications could sustain market share and pricing levels.
- Reimbursement remains robust but negotiates downward with increased competition.
FAQs
1. How does the entry of biosimilars affect Brentuximab Vedotin prices?
Biosimilar entry typically leads to price reductions of 20-30%, driven by increased competition and payor negotiations.
2. Are there any recent approvals that could influence the market?
Yes, ongoing trials for earlier-line treatment and combination regimens could expand market size, affecting pricing strategies.
3. What are the primary indications for Brentuximab Vedotin?
Treatment of Hodgkin lymphoma post-autologous stem cell transplantation, systemic anaplastic large cell lymphoma, and other CD30-positive malignancies.
4. How does reimbursement influence the net price?
Negotiations with payers, discounts, and rebates reduce the effective price paid by healthcare providers, which can vary widely.
5. What risks could impact future sales and pricing?
Patent expiration, biosimilar competition, regulatory changes, and market penetration rates are primary risks.
Sources
[1] IQVIA. (2023). Global Oncology Market Data. Retrieved from https://www.iqvia.com
[2] EvaluatePharma. (2023). Oncology Drugs Market Analysis. Retrieved from https://www.evaluate.com