BAVENCIO Drug Profile

Summary for Tradename: BAVENCIO

High Confidence Patents:	6
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BAVENCIO

Recent Clinical Trials for BAVENCIO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mirror Biologics, Inc.	PHASE2
Erasmus Medical Center	Phase 2
NRG Oncology	Phase 2

See all BAVENCIO clinical trials

Pharmacology for BAVENCIO

Mechanism of Action	Programmed Death Ligand-1 Antagonists Programmed Death Ligand-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Ligand-1 Blocker
Chemical Structure	Antibodies, Monoclonal

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 company disclosures

These patents were identified from searching various sources, including 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 BAVENCIO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BAVENCIO 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
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,487,147	2037-03-09	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,759,856	2037-03-09	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	11,058,769	2036-12-05	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	11,884,724	2040-08-04	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	8,709,416	2031-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	9,624,298	2032-11-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for BAVENCIO 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
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,001,483	2036-06-24	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,143,723	2038-06-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,172,808	2038-06-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,195,175	2037-04-06	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,195,188	2037-09-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049	10,206,910	2035-11-06	Patent claims search

International Patents for BAVENCIO

Country	Patent Number	Estimated Expiration
European Patent Office	3763741
Ukraine	106050
Peru	20110435
European Patent Office	2785375
Hong Kong	1257781
Eurasian Patent Organization	023148

Supplementary Protection Certificates for BAVENCIO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C202030069	Spain		PRODUCT NAME: AVELUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1214; DATE OF AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1214; DATE OF FIRST AUTHORISATION IN EEA: 20170918
2090058-5	Sweden		PRODUCT NAME: AVELUMAB; REG. NO/DATE: EU/1/17/1214 20170920
122020000082	Germany		PRODUCT NAME: AVELUMAB; REGISTRATION NO/DATE: EU1/17/1214 20170918
CR 2020 00062	Denmark		PRODUCT NAME: AVELUMAB; REG. NO/DATE: EU/1/17/1214 20170920
301081	Netherlands		PRODUCT NAME: AVELUMAB; REGISTRATION NO/DATE: EU/1/17/1214 20170920
PA2021001,C2785375	Lithuania		PRODUCT NAME: AVELUMABAS; REGISTRATION NO/DATE: EU/1/17/1214 20170918

Market Dynamics and Financial Trajectory for BAVENCIO (Avelumab)

Last updated: October 28, 2025

Introduction

BAVENCIO (avelumab) is a programmed death ligand-1 (PD-L1) inhibitor developed by Merck KGaA and Pfizer, primarily approved for the treatment of various cancers, including urothelial carcinoma, Merkel cell carcinoma, and certain metastatic solid tumors. As immuno-oncology continues to reshape cancer treatment paradigms, BAVENCIO's market dynamics and financial trajectory embody broader industry trends in targeted immunotherapies. This analysis examines the factors influencing its commercial performance, evolving competition, pipeline prospects, and future revenue potential.

Market Landscape and Competitive Positioning

Immuno-oncology Market Overview

The immunotherapy segment has significantly expanded, driven by FDA approvals of PD-1/PD-L1 inhibitors—notably pembrolizumab (Keytruda) and nivolumab (Opdivo). The global oncology immunotherapy market was valued at approximately $150 billion in 2022 and projects a compound annual growth rate (CAGR) exceeding 10% through 2030, supported by rising cancer incidence and the approval of novel checkpoint inhibitors [1].

BAVENCIO’s Competitive Edge

BAVENCIO was among the first PD-L1 inhibitors approved, with initial FDA approval in 2017 for Merkel cell carcinoma. Its differentiating features include a manageable safety profile, durable responses in specific indications, and combination potential with other therapies. However, in many markets, pembrolizumab and nivolumab dominate due to broader indications and higher familiarity.

Market Penetration

Despite being a first-in-class agent, BAVENCIO's adoption has remained more niche relative to blockbuster competitors. Its primary indications, such as urothelial carcinoma and Merkel cell carcinoma, have smaller patient populations compared to lung or melanoma indications. Merck KGaA and Pfizer have focused on expanding BAVENCIO’s label to include front-line treatments and combination regimens, which could enhance uptake.

Market Dynamics Influencing Valuation

Regulatory Approvals and Label Expansion

The trajectory of BAVENCIO hinges on secure and expanded approvals:

• Urothelial Carcinoma: BAVENCIO gained accelerated approval for locally advanced or metastatic urothelial carcinoma post-platinum chemotherapy, with subsequent full approvals in several jurisdictions.
• Combination Regimens: Trials combining BAVENCIO with chemotherapy (e.g., in first-line bladder cancer) or other immunotherapies. Success in these areas would catalyze growth by positioning BAVENCIO as a versatile backbone in combination strategies.

Pipeline Development and Data Accrual

Ongoing trials, such as KEYNOTE and CheckMate series, evaluate BAVENCIO’s efficacy across multiple tumor types, including non-small cell lung cancer (NSCLC), gastric, and head & neck cancers. Positive clinical data could drive regulatory approvals and broaden market scope.

Competitive Dynamics

While BAVENCIO was a pioneer, the rapid rise of PD-1 inhibitors impacts its market share:

• Pembrolizumab and nivolumab have broader indications, higher market penetration, and established revenue streams.
• Emerging competitors and biosimilars pose potential threats, especially if they offer superior efficacy, safety, or cost advantages.

Pricing and Reimbursement Environment

The high costs associated with immunotherapies influence reimbursement decisions. Payers increasingly assess value, favoring therapies with proven survival benefits, real-world efficacy, and manageable costs. These factors directly impact BAVENCIO’s market access and long-term revenue stability.

Market Entry Barriers and Adoption Challenges

• Physician familiarity and institutional preferences favor established agents.
• The need for robust comparative effectiveness data to justify BAVENCIO’s use over existing therapies.
• Pending approvals for novel indications and combinations remain critical for scaling adoption.

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Since its launch, BAVENCIO's revenues have grown modestly, constrained by its targeted indication base. Merck KGaA reports that in 2022, BAVENCIO generated approximately €1 billion (~$1.1 billion), reflecting steady but limited growth compared to multi-billion-dollar hits like Keytruda (~$20 billion global sales in 2022) [2].

Forecasted Growth Drivers

• Expanded Indications: Regulatory approvals in new tumors (e.g., NSCLC, gastric cancers).
• Combination Strategies: Incorporation into first-line treatment protocols and synergistic regimens.
• Geographic Expansion: Increased access in emerging markets through licensing and partnerships.
• Label Extensions: Approvals for earlier treatment lines, boosting patient populations.

Revenue Projections (2023-2030)

Analysts forecast BAVENCIO’s revenues to grow at a CAGR of 12-15%, reaching between $2.5 billion and $4 billion by 2030. This growth depends on successful label expansions, positive trial outcomes, and competitive positioning. Nonetheless, the trajectory remains contingent on industry dynamics and regulatory soundness.

Risks and Challenges

• Market Saturation: Entrenched competitors limit incremental share.
• Clinical Trial Outcomes: Negative or inconclusive data could preclude new approvals.
• Pricing Pressures: Payer restrictions and value-based models threaten revenue stability.

Strategic Outlook

BAVENCIO’s future hinges on optimizing its clinical development, expanding indications, and integrating into combination regimens. Strategic alliances and co-development deals may bolster its pipeline, while innovative trial designs could differentiate it amidst fierce competition. Additionally, vaccine developments targeting immune-related adverse events or biomarkers could refine patient selection and improve outcomes.

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Key Takeaways

• BAVENCIO operates in a competitive, rapidly evolving immuno-oncology landscape marked by significant growth potential but limited market share expansion compared to leading PD-1 inhibitors.
• The drug’s valuation trajectory relies heavily on successful regulatory expansions, positive clinical trial outcomes, and strategic positioning within combination therapies.
• The outlook is cautiously optimistic; revenues are projected to grow steadily but face headwinds from pricing pressures, entrenched competition, and market saturation.
• Broader industry trends, including personalized medicine and biomarker-driven patient selection, will play crucial roles in shaping BAVENCIO's market trajectory.
• Strategic collaborations and pipeline management remain vital to unlocking sustained long-term growth.

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FAQs

1. How does BAVENCIO’s mechanism of action differ from other PD-1/PD-L1 inhibitors?
BAVENCIO uniquely targets PD-L1, the ligand for PD-1, disrupting immune checkpoint signaling and enabling T-cell attack on tumors. While similar to PD-1 inhibitors like pembrolizumab, its distinct mechanism offers potential advantages in certain tumor environments.

2. What are the major indications for BAVENCIO currently?
BAVENCIO is approved for Merkel cell carcinoma, urothelial carcinoma post-platinum therapy, and certain metastatic solid tumors. Its clinical trials explore applications in NSCLC, gastric cancers, and head & neck cancers.

3. What factors could accelerate BAVENCIO’s revenue growth?
Regulatory approval for new indications, success in combination therapies, expansion into early-line treatment, and broader geographic access could significantly boost sales.

4. How does BAVENCIO’s market share compare to leading competitors?
While a pioneer in PD-L1 inhibition, BAVENCIO’s market share remains limited compared to pembrolizumab and nivolumab, which benefit from broader indications and longer market presence.

5. What are the principal risks to BAVENCIO’s financial trajectory?
Key risks include intense competition, failure to secure regulatory approvals for additional indications, reimbursement challenges, and potential emergence of more effective or cost-efficient therapies.

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References

[1] Grand View Research, "Immunotherapy Market Size, Share & Trends Analysis Report," 2022.
[2] Merck KGaA Annual Report 2022.
[3] Food and Drug Administration (FDA) approvals and label updates.
[4] Industry analyst reports and market research forecasts (2023-2030).