Brentuximab vedotin - Biologic Drug Details

Summary for brentuximab vedotin

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for brentuximab vedotin

Recent Clinical Trials for brentuximab vedotin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE3
The First Affiliated Hospital with Nanjing Medical University	PHASE2
Chinese PLA General Hospital	PHASE1

See all brentuximab vedotin clinical trials

Pharmacology for brentuximab vedotin

Mechanism of Action	CD30-directed Antibody Interactions
Physiological Effect	Microtubule Inhibition
Established Pharmacologic Class	CD30-directed Immunoconjugate
Chemical Structure	Immunoconjugates

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for brentuximab vedotin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for brentuximab vedotin Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,179,183	2037-05-30	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,314,878	2035-07-17	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,596,245	2038-09-19	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,808,039	2039-07-10	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,857,218	2036-05-25	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	11,123,447	2038-09-27	DrugPatentWatch analysis and company disclosures
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	11,141,480	2038-06-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for brentuximab vedotin Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,022,451	2035-05-11	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,065,934	2035-07-16	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,111,968	2036-08-10	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,159,675	2036-12-01	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,201,615	2036-01-27	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,259,859	2036-08-05	Patent claims search
Seagen Inc.	ADCETRIS	brentuximab vedotin	For Injection	125388	10,261,083	2034-01-03	Patent claims search

International Patents for brentuximab vedotin

Country	Patent Number	Estimated Expiration
Australia	2021201967
World Intellectual Property Organization (WIPO)	2014191521
Hong Kong	1253706
Spain	2976558
China	109312255
Eurasian Patent Organization	201990575
Japan	2015525065

Market Dynamics and Financial Trajectory for Brentuximab Vedotin

Last updated: July 31, 2025

Introduction

Brentuximab vedotin (brand name: Adcetris) is an antibody-drug conjugate (ADC) targeting CD30-positive malignancies, notably Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). Developed by Seattle Genetics and marketed globally, brentuximab vedotin has transformed treatment paradigms for certain hematologic cancers. Its market dynamics are shaped by evolving clinical landscapes, regulatory pathways, competitive forces, and the drug’s revenue trajectory.

This analysis explores current market factors influencing brentuximab vedotin, alongside its financial outlook, emphasizing drivers, challenges, and opportunities for stakeholders.

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Market Overview and Clinical Positioning

Brentuximab vedotin entered the oncology landscape as a targeted therapy with a novel mechanism—delivering monomethyl auristatin E via anti-CD30 monoclonal antibodies—to specifically eradicate CD30-expressing tumor cells. Since its FDA approval in 2011 for relapsed/refractory Hodgkin lymphoma and sALCL, the drug has established a critical niche in hematologic oncology.

Clinical trials have expanded its reach, integrating it into frontline regimens for HL (notably in combination with chemotherapy) and as consolidation therapy post-autologous stem cell transplant. The approvals extend to other CD30-positive malignancies, including peripheral T-cell lymphomas, fuelling an expanded market scope.

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Market Drivers

1. Expanding Indications and Label Approvals

The drug’s growth trajectory benefits from continuous expansion of indications. In 2018, the FDA approved brentuximab vedotin for frontline treatment of HL in combination with AVD (adriamycin, vinblastine, and dacarbazine), thus broadening its use from salvage therapy to initial treatment settings. Additionally, regulatory bodies in Europe, Japan, and other jurisdictions have approved similar indications, expanding geographic access.

2. Growing Burden of CD30-Positive Hematologic Malignancies

The incidence of Hodgkin lymphoma approximates 9.2 per 100,000 globally, with over 80% of cases diagnosed at early stages—yet relapsed/refractory cases significantly impact patients. The unmet need in this segment sustains demand for targeted therapies like brentuximab vedotin. Moreover, systemic ALCL accounts for a smaller but significant subset of T-cell lymphomas, with CD30 expression as a hallmark.

3. Combination Regimens and Consolidation Therapy

Adoption of brentuximab vedotin in combination with other agents, especially in frontline settings, presents a major growth avenue. The ECHELON-1 trial demonstrated improved progression-free survival (PFS) when combined with ABVD (adriamycin, bleomycin, vinblastine, dacarbazine), prompting shifts in standard-of-care standards. Such combinations are expected to sustain steady revenue streams.

4. Strategic Partnerships and Market Expansion

Seattle Genetics’ licensing agreements with pharmaceutical juggernauts like Takeda, and recent collaborations with Merck for combination trials, push the drug into diverse markets. These collaborations facilitate market penetration, especially in Asia and emerging markets.

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Market Challenges

1. Competitive Landscape

While brentuximab vedotin remains a leader among ADC therapies targeting hematologic malignancies, it faces competition from emerging agents such as anti-PD1 checkpoint inhibitors (nivolumab, pembrolizumab), which have demonstrated superior or comparable efficacy in relapsed/refractory HL. These immunotherapies, often with favorable side effect profiles and oral administration, threaten the market share of brentuximab vedotin.

2. Cost and Reimbursement Access

High manufacturing costs associated with ADCs influence pricing strategies. The price of brentuximab vedotin—approximately $11,000 per infusion—limits access in lower-income settings and constrains reimbursement policies, particularly in countries with constrained healthcare budgets. This influences prescriber preferences and limits market expansion.

3. Resistance and Safety Concerns

Emerging data suggest instances of resistance through CD30 downregulation, which could limit the drug’s effectiveness over time. Additionally, adverse effects such as peripheral neuropathy and myelosuppression influence treatment adherence and patient quality of life, impacting usage patterns.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Brentuximab vedotin's revenue trajectory exhibits consistent growth, driven primarily by expanding indications and geographic penetration. In 2021, Seattle Genetics reported approximately $535 million in net sales for Adcetris, marking sustained year-over-year increases (around 12-15%), reflecting robust market acceptance.

Projections and Growth Drivers

Industry analysts forecast the compound annual growth rate (CAGR) for brentuximab vedotin to hover between 8-12% over the next five years. Key contributing factors include:

• The increased adoption of combination regimens in frontline therapy.
• Approval for additional indications, including cutaneous T-cell lymphomas and pediatric Hodgkin lymphoma.
• Market expansion into Asia and Latin America, driven by strategic partnerships.

Revenue Risks and Opportunities

While revenue streams are promising, potential risks include:

• Increased competition from immunotherapies with broader immune checkpoint activity.
• Pricing pressures under healthcare reforms and cost-containment policies.
• Slower-than-anticipated approval of new indications.

Conversely, opportunities for revenue boost hinge on:

• Development of next-generation ADCs that improve efficacy and safety.
• Direct-to-patient delivery models, reducing healthcare system burdens.
• Expansion into non-Hodgkin lymphomas expressing CD30 variants.

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Regulatory and Market Expansion Strategies

Regulatory agencies globally have shown receptiveness to expanding brentuximab vedotin’s indications, notably accelerated approvals in Japan for cutaneous T-cell lymphomas. Strategic market entries, especially via collaborations in emerging markets, ensure revenue diversification.

Additionally, ongoing clinical trials assessing brentuximab vedotin combinations with PD-1 inhibitors and novel agents aim to secure first-line or salvage therapy positions, extending commercial lifecycle.

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Conclusion

Brentuximab vedotin's market dynamics are characterized by steady growth fueled by expanding clinical applications, strategic partnerships, and geographic dissemination. However, the landscape is increasingly competitive, particularly from immune checkpoint inhibitors, necessitating continuous innovation and differentiation.

Financial prospects remain favorable, with robust revenue growth expected contingent on successful indication expansions and market penetration. Nonetheless, pricing pressures, resistance mechanisms, and safety considerations require vigilant management.

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Key Takeaways

• The expansion of brentuximab vedotin into frontline and additional indications sustains strong demand and revenue growth.
• Competition from immune checkpoint inhibitors presents both a challenge and an opportunity for combination therapies.
• Geographic expansion, especially in emerging markets, is critical to revenue diversification.
• Cost management and safety profile improvements will influence adoption and reimbursement landscapes.
• Strategic clinical development and partnerships remain essential to prolong product lifecycle and enhance profitability.

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FAQs

1. How does brentuximab vedotin compare clinically to immune checkpoint inhibitors in treating Hodgkin lymphoma?
While brentuximab vedotin offers targeted cytotoxicity against CD30-positive cells, immune checkpoint inhibitors like nivolumab and pembrolizumab activate the immune system, often producing durable responses. Combination approaches are increasingly examined to leverage the strengths of both, though monotherapy efficacy varies.

2. What are the main factors influencing the pricing strategy of brentuximab vedotin?
Factors include manufacturing costs of ADC components, clinical efficacy, competitive landscape, reimbursement policies, and healthcare system budgets. Its high price reflects its complexity and targeted nature but presents access challenges.

3. Are there emerging resistance mechanisms to brentuximab vedotin?
Yes, resistance can develop through downregulation of CD30 expression or drug efflux mechanisms. Ongoing studies aim to understand and overcome these challenges.

4. What is the outlook for brentuximab vedotin in non-hematologic cancers?
Currently, its use is confined mainly to hematologic malignancies; research into solid tumors expressing CD30 is ongoing, but significant clinical impact remains to be seen.

5. How do regulatory bodies influence brentuximab vedotin’s market potential?
Accelerated approvals, label expansions, and orphan drug designations enhance market access. Conversely, delays or restrictions can impede growth.

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References

1. [1] Seattle Genetics. (2022). Adcetris (brentuximab vedotin) Prescribing Information.
2. [2] International Agency for Research on Cancer. (2021). Hodgkin Lymphoma Incidence.
3. [3] Beri, J. et al. (2022). Emerging Role of ADCs and Immunotherapies in Hematology. Journal of Hematologic Oncology.
4. [4] MarketWatch. (2022). Global Brentuximab Vedotin Market Forecast.
5. [5] U.S. Food and Drug Administration. (2011). Approval of Brentuximab Vedotin for Hodgkin Lymphoma.