KEYTRUDA Drug Profile

Summary for Tradename: KEYTRUDA

High Confidence Patents:	18
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KEYTRUDA

Recent Clinical Trials for KEYTRUDA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bio-Thera Solutions	PHASE1
Shanghai Henlius Biotech	PHASE1
Innovent Biologics (Suzhou) Co. Ltd.	PHASE2

See all KEYTRUDA clinical trials

Pharmacology for KEYTRUDA

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

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 KEYTRUDA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KEYTRUDA 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
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2038-09-27	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2037-11-13	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2040-12-22	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2040-12-22	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2040-12-22	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2041-09-02	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2041-06-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for KEYTRUDA 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
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2036-06-24	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-02-04	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-08-27	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-06-16	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2037-07-25	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2037-03-27	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2036-12-21	Patent claims search

International Patents for KEYTRUDA

Country	Patent Number	Estimated Expiration
New Zealand	582150
Brazil	122017025062
Croatia	P20181139
China	103429264
Spain	2616355
New Zealand	720075
European Patent Office	2691112

Supplementary Protection Certificates for KEYTRUDA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1690001-1	Sweden		PRODUCT NAME: PEMBROLIZUMAB; REG. NO/DATE: EU/1/15/1024 20150721
2016C/001	Belgium		PRODUCT NAME: KEYTRUDA (PEMBROLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1024 20150721
2/2016	Austria		PRODUCT NAME: PEMBROLIZUMAB; REGISTRATION NO/DATE: EU1/15/1024 (MITTEILUNG) 20150721
569	Finland
92936	Luxembourg		PRODUCT NAME: KEYTRUDA; FIRST REGISTRATION: 20150721
1591078-9	Sweden		PRODUCT NAME: PEMBROLIZUMAB; FIRST MARKETING AUTHORIZATION NUMBER: EU/1/15/1024, 2015-07-21
CR 2016 00001	Denmark		PRODUCT NAME: PEMBROLIZUMAB; REG. NO/DATE: EU/1/15/1024 20150721

Market Dynamics and Financial Trajectory for KEYTRUDA

Last updated: December 30, 2025

Summary

KEYTRUDA (pembrolizumab), developed by Merck & Co., Inc., is a pioneering immune checkpoint inhibitor approved for multiple cancer indications, positioning it as one of the top-selling oncology biologics worldwide. Its robust clinical profile, expanding application portfolio, and competitive landscape shape its market dynamics and financial outlook. This report delineates prevailing market factors, growth drivers, revenue trajectories, competitive positioning, and regulatory influences guiding KEYTRUDA’s future in the oncological therapeutics domain.

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What Are the Key Market Drivers Supporting KEYTRUDA’s Growth?

Driver	Details	Impact on Market
Expanding Oncology Indications	Approved for melanoma, lung, head and neck, gastric, bladder, cervical, and other cancers	Broadens target patient base; increases sales potential
Regulatory Endorsements & Fast-Track Approvals	Rapid approvals from FDA and EMA for various indications	Accelerates market entry, boosts confidence, and encourages adoption
Combination Therapy Approvals	Approved in combos with chemotherapy, targeted agents, and other immunotherapies	Enhances efficacy, expands treatment options, and sustains sales growth
Growing Global Cancer Incidence	Rising cancer prevalence worldwide, notably in emerging markets	Expands patient access and demand for efficacious immunotherapies
Competitive Landscape & Innovation	Continuous clinical trials and pipeline expansion	Positions KEYTRUDA as a first-line therapy in multiple cancers

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How Do Market Dynamics Influence KEYTRUDA’s Revenue Trajectory?

Historical Revenue Performance

Fiscal Year	Worldwide Sales (USD Billion)	Growth Rate (%)	Notes
2020	€14.4 billion	+27%	Significant growth driven by expanded indications and pandemic resilience
2021	$17.2 billion	+19.4%	Continued growth from lung, melanoma, and head growth Neck cancers
2022	$21.0 billion	+22.1%	Launch of new indications and Combination approvals

(All figures are approximate conversions based on publicly available financial reports; actual reported data varies.)

Projected Revenue Outlook

Forecast Year	Estimated Global Sales (USD Billion)	Growth Drivers	Underlying Assumptions
2023	$23.5	Expanded indications (e.g., triple-negative breast cancer), new approvals	Continued clinical success, approval of novel combinations, pipeline progress
2024	$26.0	Increased adoption in emerging markets, biosimilar considerations	Market penetration, cost competitiveness, regulatory clearances
2025	$28.5	Label expansions, combination therapies, shift toward earlier lines	Competitive differentiation, favorable reimbursement policies

Geographical Sales Contributions & Trends

Region	2022 Revenue ($B)	% of Total Sales	Growth Factors
North America	$14.2	~67.6%	Mature market, multiple indications, high reimbursement
Europe	$4.2	~20%	Strong adoption, expanding indications
Asia-Pacific	$2.1	~10%	Rapidly growing, favorable pricing and approvals in China, Japan
Rest of the World	$0.5	~2.4%	Emerging markets, expanding access initiatives

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What Are the Competitive Dynamics in KEYTRUDA’s Market?

Key Competitors	Key Drugs	Indications Covered	Market Share Estimates (2022)	Competitive Edges
Opdivo ( nivolumab)	Bristol-Myers Squibb	Melanoma, lung, renal, others	~25%	Strong head-to-head efficacy data in certain cancers
Tecentriq (atezolizumab)	Roche	Lung, bladder, breast	~15%	Strategic collaborations, early approval advantages
Libtayo (cemiplimab)	Regeneron	Skin cancers, lung	~5%	Focused on specific indications, fast-growing pipeline

Market share dominance is shifting as clinical evidence, approval breadth, and combination strategies evolve, with KEYTRUDA maintaining a leading position due to its extensive label and pipeline.

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What Are Regulatory and Policy Factors Influencing KEYTRUDA's Outlook?

Factor	Implication	Notable Changes / Policies	Impact
Pricing & Reimbursement Policies	Can significantly affect sales; reimbursement decisions vary globally	Periodic price negotiations, value-based pricing initiatives	Potential pressure on margins in some markets
Patent Expiry & Biosimilars	Patent cliffs may erode market share	Tule of biosimilars anticipated by 2028 in key markets	Mitigation through pipeline expansion and new indications
International Regulatory Approvals	Facilitates access in emerging markets	China’s NMPA approvals, other emerging markets expansions	Accelerates global revenue growth

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How Does the Pipeline Shape Future Market Potential?

Pipeline Stage	Indications	Expected Approval Timeline	Strategic Significance
Phase III	Triple-negative breast cancer, colorectal, esophageal	2023-2025	Provides growth opportunities in high unmet need cancers
Phase II	Bladder, early-stage lung	2023-2024	Expanding earlier line treatments, potentially increasing volume
Preclinical	Combination regimens, personalized oncology	2024+	Long-term pipeline, therapeutic innovation

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Comparison with Top Competitors

Criterion	KEYTRUDA	Opdivo	Tecentriq	Libtayo
Approval Count	25+ indications	20+	15+	5+
Major Indications	Melanoma, NSCLC, head/neck	Melanoma, NSCLC	NSCLC, SCLC	Cutaneous Squamous Cell Carcinoma
2022 Revenue ($B)	$21.0	$18.0	$4.5	$0.5
Market Share (2022)	~35%	~30%	~12%	~2%

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What Are the Key Challenges Facing KEYTRUDA’s Financial Trajectory?

Challenge	Description	Mitigation Strategies
Patent Expiration & Biosimilar Entry	Potential revenue erosion post-2028	Diversify pipeline, new indications
Pricing & Market Access Pressures	Cost containment initiatives globally	Demonstrate value via real-world data
Competition & Clinical Efficacy	Superior efficacy in certain indications may shift preferences	Continuous innovation, combination approvals
Global Access & Affordability	Limited in lower-income countries	Expand access programs, partnerships

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Key Takeaways

• Robust Growth Drivers: Broad FDA/EMA approvals, expanding indications, and combination regimens underpin forecasted revenue growth, with potential to reach $28.5 billion globally by 2025.
• Pipeline and Innovation: Continued clinical trials and label expansions are crucial to sustain competitive advantage and offset patent expiries.
• Market Competition: While KEYTRUDA leads in multiple indications, competitors like Opdivo and Tecentriq maintain significant presence, emphasizing the importance of clinical differentiation.
• Global Expansion: Emerging markets, notably China and India, contribute significantly to future growth potential.
• Regulatory & Policy Environment: Price negotiations, biosimilar threats, and reimbursement policies will be central to future profitability.

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FAQs

1. What factors have most contributed to KEYTRUDA’s rapid market expansion?
Expanding indications, cooperation in combination therapies, rapid regulatory approvals, and growing global cancer incidence have collectively driven its market dominance.

2. How does KEYTRUDA’s pipeline influence its long-term growth prospects?
A diverse and advanced pipeline across multiple cancer types promises future label expansions, helping sustain sales even as patents expire.

3. What risks could impede KEYTRUDA’s projected revenue growth?
Patent expiries, biosimilar competition, pricing pressures, and regulatory hurdles in emerging markets pose notable threats.

4. How does KEYTRUDA’s market share compare against key competitors?
As of 2022, KEYTRUDA holds approximately 35% of the immune-oncology market share, slightly ahead of Opdivo at 30%, thanks to broader indication approvals.

5. What potential does KEYTRUDA have in emerging markets?
Rapidly growing cancer burdens and favorable regulatory environments position emerging markets as a significant future revenue source, especially with strategic pricing and access initiatives.

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References

1. Merck & Co. Annual Reports, 2020-2022.
2. GlobalData Oncology Market Report, 2022.
3. FDA and EMA approval archives, 2020-2023.
4. IQVIA Biotech, Oncology Immunotherapy Insights, 2022.
5. Industry analyst reports, Bloomberg Intelligence, 2023.