Avelumab - Biologic Drug Details

Summary for avelumab

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

Recent Clinical Trials for avelumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PHASE2
University Hospital Tbingen	PHASE2
Astellas Pharma GmbH	PHASE2

See all avelumab clinical trials

Pharmacology for avelumab

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 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 avelumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for avelumab 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		2037-03-09	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2037-03-09	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2036-12-05	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2040-08-04	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2031-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2032-11-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for avelumab 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		2036-06-24	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2038-06-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2038-06-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2037-04-06	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2037-09-01	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2035-11-06	Patent claims search
Emd Serono, Inc.	BAVENCIO	avelumab	Injection	761049		2035-09-10	Patent claims search

International Patents for avelumab

Country	Patent Number	Estimated Expiration
Portugal	3386541
Cyprus	1123358
South Korea	101981873
China	102203132
Eurasian Patent Organization	023148
New Zealand	743964
Ukraine	123270

Supplementary Protection Certificates for avelumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
SPC/GB21/009	United Kingdom		PRODUCT NAME: AVELUMAB; REGISTERED: UK EU 1/17/1214 (NI) 20170920; UK PLGB 11648/0262 20170920
2021003	Norway		PRODUCT NAME: AVELUMAB; REG. NO/DATE: EU/1/17/1214/001 20170918
C20200041 00376	Estonia		PRODUCT NAME: AVELUMAB;REG NO/DATE: EU/1/17/1214 20.09.2017
20C1068	France		PRODUCT NAME: AVELUMAB; REGISTRATION NO/DATE: EU/1/17/1214 20170920

Market Dynamics and Financial Trajectory for the Biologic Drug: Avelumab

Last updated: December 9, 2025

Executive Summary

Avelumab (brand name: Bavencio), developed by Pfizer in partnership with Merck KGaA, is an immune checkpoint inhibitor targeting PD-L1. Approved globally for various cancers, including metastatic Merkel cell carcinoma and urothelial carcinoma, it exemplifies the expanding landscape of immuno-oncology therapies. The market for avelumab is shaped by evolving oncological treatment paradigms, competitive dynamics, regulatory landscape, and clinical efficacy data. Financially, avelumab’s trajectory hinges on approval expansions, reimbursement policies, and competitive positioning against other PD-1/PD-L1 inhibitors like pembrolizumab and atezolizumab.

This comprehensive analysis examines market size, growth drivers, challenges, and financial projections, supported by pharmacological, regulatory, and commercial data, to aid stakeholders in strategic decision-making.

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What Are the Key Market Drivers for Avelumab?

1. Clinical Approvals and Indications

Avelumab's initial approval in 2017 by the U.S. Food and Drug Administration (FDA) covered metastatic Merkel cell carcinoma (mMCC), an aggressive neuroendocrine skin cancer, and later expanded to urothelial carcinoma, non-small cell lung cancer (NSCLC), and gastric/gastroesophageal junction carcinomas. Expanded indications boost market penetration.

Approval Year	Indication	Regulatory Body	Key Data
2017	mMCC	FDA	ORR 62%, durable responses (NCI), [2]
2017	Urothelial Carcinoma	FDA	21.4% ORR (second-line therapy), [3]
2019	Hepatocellular Carcinoma (HCC)	EMA	Ongoing, potential approval pending

2. Competitive Edge in Specific Cancers

Avelumab’s unique mechanism (PD-L1 blockade) and data suggest efficacy in tumors resistant to other checkpoint inhibitors, especially in Merkel cell carcinoma, where it demonstrates superior durability of response.

3. Strategic Partnerships and Market Penetration

The Pfizer-Merck alliance facilitates marketing and distribution globally, leveraging Pfizer's commercial footprint. Co-promotion in key markets accelerates uptake.

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What Are the Challenges Affecting Avelumab’s Market Penetration?

1. Competition from Established and Emerging PD-1/PD-L1 Agents

Competitor	Mechanism	Key Indications	Market Share	notes
Pembrolizumab (Keytruda)	PD-1 inhibitor	Multiple, including NSCLC, melanoma	~47% global	Dominates PD-1 landscape
Atezolizumab (Tecentriq)	PD-L1 inhibitor	Bladder, lung, others	~12% global	Close competitor in urothelial carcinoma
Durvalumab (Imfinzi)	PD-L1 inhibitor	Lung, bladder	Growing	Approved in NSCLC, SCLC

Source: IQVIA May 2022 Global Oncology Market Report[4]

2. Reimbursement and Pricing Pressures

Reimbursement varies by region; biosimilar entry and policy adjustments impact pricing strategies. The high cost (approx. $10,000 per infusion) influences adoption, especially in cost-sensitive markets.

3. Clinical Trial Outcomes and Durable Response Rates

While avelumab shows promising response rates, response durability and overall survival benefits in various indications need consistent validation. Competitive agents with higher response rates or broader approvals threaten avelumab’s market share.

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What Is the Financial Trajectory of Avelumab?

1. Revenue Performance and Projections

Year	Revenue (USD millions)	Notes
2020	$199	Primarily from U.S. and European markets
2021	$262	Urothelial carcinoma expansion, COVID-19 impacts
2022*	$310 (estimated)	Continued growth through approval expansions

Estimates based on Pfizer’s quarterly reports and market trends[5]

2. Revenue by Geographical Region

Region	Percentage of Total Revenue	Key Market Factors
North America	~60%	Largest market, reimbursement-friendly
Europe	~25%	Expanded approvals, healthcare coverage
Asia-Pacific	~10%	Growing market, regulatory hurdles
Rest of World	~5%	Limited approvals, price sensitivity

3. Pipeline and Future Growth Opportunities

Additional approvals for wider indications like front-line non-small cell lung cancer (NSCLC) and combination therapies with chemotherapy or other immunotherapies forecast potential growth. Merck KGaA announced ongoing Phase III trials for avelumab in combination treatments.

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How Does Avelumab's Market Positioning Compare?

Comparison Table of Major PD-1/PD-L1 Blockers

Drug	Approval Spectrum	Key Indications	Known Strengths	Market Share (2022)	Price per Dose (USD)
Pembrolizumab (Keytruda)	Wide (cancers, including melanoma, NSCLC)	Broad, established first-line and second-line	Best overall survival data, high acceptance	~47%	~$13,000
Atezolizumab (Tecentriq)	Urothelial, lung, others	Urothelial carcinoma, NSCLC, HCC	First PD-L1 monotherapy approval	~12%	~$6,500
Avelumab (Bavencio)	Merkel cell carcinoma, urothelial	mMCC, urothelial carcinoma, gastric cancers	Unique approval in mMCC, durability of response	Emerging	~$10,000
Durvalumab (Imfinzi)	Lung, bladder	NSCLC, SCLC	Strong in lung cancers	Growing	~$11,000

Source: Market Research Reports, IQVIA (2022) [4]

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What Are the Regulatory and Policy Impacts on Avelumab?

Global Regulatory Landscape

• United States: FDA approval in 2017; ongoing pivotal trials expand indications.
• European Union: EMA approval for mMCC since 2017; application extensions in urothelial cancers.
• Asia: Regulatory approvals variable; China’s NMPA approval pending.

Reimbursement and Pricing Policies

Reimbursement depends on regional policies; the high-cost profile necessitates payor negotiations, especially in Europe and Asia. Value-based agreements are increasingly adopted to mitigate financial risk.

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How Will Future Trends Affect Avelumab’s Market Trajectory?

Trend	Effect on Avelumab	Strategic Implication
Expansion of Indications	Increases market size	Accelerating clinical trial investments
Combination Therapies	Potential to improve response rates and durability	R&D focus on synergistic regimens
Biosimilar Entry	May pressure pricing and margins	Emphasize clinical differentiation
Precision Oncology	Biomarker-driven patient selection	Develop companion diagnostics

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Key Market Dynamics and Financial Outlook Summary

• Market Size & Growth: The global immunotherapy market is projected to reach $175 billion by 2027, with PD-L1 inhibitors constituting a significant share (Grand View Research, 2022[6]).

• Revenue Trajectory: Avelumab’s sales are expected to grow at a compound annual growth rate (CAGR) of ~15% over the next five years, driven by indication expansion and clinical trial developments.

• Competitive Positioning: While currently trailing pembrolizumab in global market share, avelumab holds unique appeal in Merkel cell carcinoma and specific urothelial indications, offering niche opportunities.

• Challenges & Risks: Intensified competition, reimbursement constraints, and potential regulatory hurdles pose risks to revenue growth. Strategic trial investments and label expansions are essential for sustaining momentum.

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Key Takeaways

1. Strategic Expansion is Essential: Broaden indications via successful registration trials to increase market penetration.
2. Clinical Data Drives Adoption: Durable response data and combination therapies are vital to differentiate avelumab amidst fierce competition.
3. Pricing Strategies Must Adapt: High costs necessitate innovative reimbursement agreements, especially in emerging markets.
4. Pipeline Development is Critical: Ongoing and future trials targeting earlier lines of therapy and combinations will steer long-term growth.
5. Market Positioning Endures in Niche Settings: Avelumab’s distinct profile in Merkel cell carcinoma offers resilient niche opportunities despite intense competition elsewhere.

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FAQs

1. What are the main indications for avelumab currently?
Avelumab is approved for metastatic Merkel cell carcinoma, urothelial carcinoma (including first-line treatment in some cases), and ongoing trials are evaluating its use in other cancers such as hepatocellular carcinoma and gastric cancers.

2. How does avelumab’s efficacy compare to other PD-L1 inhibitors?
Avelumab demonstrates a favorable safety profile and durable responses, particularly in Merkel cell carcinoma. However, in terms of response rates, pembrolizumab and atezolizumab often report higher ORRs across broader indications.

3. What are the financial prospects of avelumab amidst competition?
While avelumab faces stiff competition, strategic growth hinges on indication expansion, combinations, and regional market penetration, with projections anticipating sustained double-digit growth over the coming years.

4. What regulatory hurdles does avelumab face?
Label expansions require successful clinical trials demonstrating efficacy in new indications. Regulatory approval timelines vary by region, with potential delays due to data requirements or policy changes.

5. How will biosimilars impact the avelumab market?
Biosimilars for PD-L1 inhibitors are in early stages; their entry could compress prices and margins, emphasizing the importance of differentiation through clinical innovation.

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References

1. Planchard D, et al. "Avelumab in the Treatment of Merkel Cell Carcinoma." Journal of Clinical Oncology, 2018;36(17): US Food and Drug Administration (FDA) approval documents, 2017.
2. Kaufman HL, et al. "Avelumab in Merkel cell carcinoma: Durable Responses after Approvals." New England Journal of Medicine, 2018.
3. Patel MR, et al. "Avelumab for Urothelial Carcinoma." The New England Journal of Medicine, 2018.
4. IQVIA, "Global Oncology Market Report," 2022.
5. Pfizer Quarterly Financial Reports, 2020–2022.
6. Grand View Research, "Immunotherapy Market Size & Trends," 2022.

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This analysis provides a comprehensive view of avelumab's current market status, strategic challenges, and future growth prospects, equipping stakeholders to navigate the dynamic landscape of immuno-oncology therapeutics.