Last updated: July 28, 2025
Introduction
The drug identified by the National Drug Code (NDC) 61314-0225 is a prescription medication. Conducting an in-depth market analysis and projecting future pricing dynamics requires understanding its formulation, target indications, competitive landscape, regulatory environment, and distribution channels. This report synthesizes current market conditions, historical pricing trends, and future projections to support strategic decision-making.
Product Overview
NDC 61314-0225 corresponds to Brentuximab Vedotin (ADCETRIS), a monoclonal antibody-drug conjugate developed by Seattle Genetics, primarily indicated for relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Approved by the FDA in 2011, ADCETRIS has since become a cornerstone in targeted cancer therapy, with expanded indications and dosing regimens.
Pharmacological Profile:
- Mechanism: Antibody-drug conjugate targeting CD30-expressing cells
- Administration: Intravenous infusion
- Indications: Hodgkin lymphoma, systemic anaplastic large cell lymphoma, primary cutaneous T-cell lymphoma, among others
Market Landscape and Competitive Environment
Market Size & Demand Drivers
The global oncology drug market is projected to reach $186.4 billion by 2026, with targeted therapies representing a significant share of this growth driven by precision medicine advancements [1]. Hematologic cancers like Hodgkin lymphoma account for a substantial portion of this demand.
In 2022, the U.S. market for ADCETRIS was estimated at $1.2 billion, reflecting robust demand owing to its established efficacy and expanded label indications [2]. Factors influencing demand include:
- Increasing incidence of Hodgkin lymphoma and CD30-positive lymphomas
- Growing adoption of targeted therapies for relapsed or refractory cases
- Regulatory approvals for new indications, broadening patient eligibility
Competitive Products
ADCETRIS faces competition from other antibody-drug conjugates and immunotherapies:
- Polatuzumab vedotin (Roche): Indicated for diffuse large B-cell lymphoma
- Brukinsa ( zanubrutinib): Emerging targeted therapy for B-cell malignancies
- CAR-T cell therapies: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) for relapsed lymphomas
While these therapies occupy overlapping niches, ADCETRIS maintains a unique position owing to its earlier approval and established clinical data.
Pricing Strategies and Reimbursement
The wholesale acquisition cost (WAC) for ADCETRIS in the U.S. has historically been around $6,500 to $7,000 per 50 mg vial, with treatment courses often requiring multiple vials depending on patient weight and indication. This translates into a typical course costing between $60,000 and $150,000, depending on dosing regimens.
Reimbursement is primarily through private insurers, Medicare, and Medicaid, with payers enforcing formulary restrictions and prior authorizations. Price adjustments are influenced by negotiations, preferred formulary status, and biosimilar developments.
Regulatory & Patent Landscape
ADCETRIS is protected by multiple patents extending into the 2030s, covering conjugation techniques, formulations, and indications. Regulatory pathways for biosimilar entry are evolving, with several biosimilars currently in development, which could impact pricing and market share in the coming decade.
Pricing Trends & Historical Data
Historical Price Trends
- Steady rise in unit cost since approval, driven by inflation, manufacturing costs, and value-based pricing strategies.
- Price reductions have been observed in some markets following patent expiration or biosimilar licensure.
Key Factors Influencing Future Pricing
- Biosimilar market entry: Expected to exert price pressure, with biosimilar versions potentially 15-30% cheaper than originator products.
- Market penetration and volume increases: Expanded indications and label updates will likely drive higher volumes, possibly offsetting unit price declines.
- Reimbursement policies: Stricter coverage policies may incentivize manufacturers to adopt pricing strategies emphasizing value.
Price Projection for 2023-2030
| Year |
Estimated Average Price per 50 mg Vial |
Comments |
| 2023 |
$6,800 – $7,200 |
Stable with minor inflation adjustments |
| 2024 |
$6,500 – $7,000 |
Potential slight decrease due to biosimilar entry preparations |
| 2025 |
$6,200 – $6,800 |
Biosimilar approvals may influence pricing dynamics |
| 2026 |
$6,000 – $6,500 |
Increasing biosimilar competition, market penetration |
| 2027 |
$5,800 – $6,200 |
Growing biosimilar presence, negotiated discounts |
| 2028 |
$5,600 – $6,000 |
Continued price erosion, policy-driven adjustments |
| 2029 |
$5,500 – $5,900 |
Market stabilization at lower price points |
| 2030 |
$5,300 – $5,800 |
Mature biosimilar market, pricing plateau |
Note: These projections reflect current trends, anticipated biosimilar competition, and inflation rates. External factors, such as patent litigation or regulatory changes, could accelerate or delay these trends.
Implications for Stakeholders
- Manufacturers: Opportunity to maintain margins through lifecycle management and biosimilar development.
- Payers: Increasing pressure to negotiate discounts and enforce formulary restrictions.
- Patients: Potential cost reductions with biosimilar availability, improving access.
- Investors: Market stability expected through volume growth, offsetting pricing pressures.
Conclusion
The market for NDC 61314-0225, representing Brentuximab Vedotin (ADCETRIS), is characterized by steady demand within hematologic oncology, driven by clinical efficacy and expanding indications. While pricing has historically increased, looming biosimilar competition suggests a downward trend in unit costs over the next decade. Strategic positioning for manufacturers involving biosimilar development and lifecycle extension will be essential to sustain profitability.
Key Takeaways
- ADCETRIS commands a premium price based on its clinical value, with unit costs around $6,500 to $7,000 per vial.
- Market growth is driven by increasing lymphoma incidence and expanded treatment guidelines.
- Biosimilar entry starting around 2025-2026 is expected to exert significant downward pressure on prices.
- Pricing across the lifecycle will depend on regulatory developments and payer negotiations.
- Stakeholders should focus on biosimilar pipeline tracking, reimbursement trends, and value-based pricing strategies.
FAQs
1. When are biosimilars for ADCETRIS expected to enter the market?
Biosimilar development is underway, with projections indicating potential market entry around 2025-2026, aligning with patent expirations and regulatory approvals.
2. How does the pricing of ADCETRIS compare to similar therapies?
ADCETRIS's price per vial is generally higher than traditional chemotherapies but justified by targeted mechanisms and clinical benefits. Biosimilars may reduce overall treatment costs by 15-30%.
3. What factors could influence future demand for ADCETRIS?
Increased approvals for new indications, early adoption of combination regimens, and evolving standards of care will drive demand.
4. How are reimbursement policies affecting the pricing of ADCETRIS?
Stringent payer negotiations, formulary restrictions, and value-based care models may pressure manufacturers to modify pricing and discount strategies.
5. What strategic actions should manufacturers consider to maintain profitability?
Investing in biosimilar pipelines, optimizing supply chains, engaging in value-based pricing negotiations, and expanding indication portfolios are essential strategies.
References
[1] MarketsandMarkets. (2022). Oncology Drugs Market Analysis.
[2] IQVIA. (2022). U.S. Oncology Market Trends & Drug Sales Data.
