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

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

International Patents for KEYTRUDA

Country	Patent Number	Estimated Expiration
Croatia	P20181139
Mexico	2013011246
Canada	2855098

Supplementary Protection Certificates for KEYTRUDA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20150057 00177	Estonia		PRODUCT NAME: PEMBROLIZUMAB;REG NO/DATE: EU/1/15/1024 21.07.2015
2016C/001	Belgium		PRODUCT NAME: KEYTRUDA (PEMBROLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1024 20150721
C01537878/02	Switzerland		PRODUCT NAME: PEMBROLIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC 65440 10.09.2015

Market Dynamics and Financial Trajectory for the Biologic Drug: KEYTRUDA

Last updated: November 21, 2025

Introduction

KEYTRUDA (pembrolizumab), manufactured by Merck & Co., Inc., is a blockbuster immune checkpoint inhibitor that has revolutionized cancer immunotherapy. Approved initially in 2014 for metastatic melanoma, KEYTRUDA's indications have expanded across multiple oncology indications, establishing it as a central treatment in the evolving landscape of immuno-oncology. Its market dynamics and financial trajectory reflect broader trends in pharmaceutical innovation, regulatory environment, and oncology treatment paradigms.

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Market Landscape and Therapeutic Positioning

Immunotherapy Dominance in Oncology

The advent of immune checkpoint inhibitors, including PD-1 inhibitors like KEYTRUDA, revolutionized oncology by enabling durable responses in cancers previously considered treatment-resistant. The global immuno-oncology market, valued at approximately USD 9 billion in 2020, is projected to grow at a compound annual growth rate (CAGR) of over 15% through 2027, driven principally by innovations and expanding indications [1].

Expanded Indications and Labeling

KEYTRUDA’s regulatory journey illustrates aggressive expansion. It is currently approved for over 20 indications, including non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma, gastric and esophageal cancers, Hodgkin’s lymphoma, and more. These multiple approvals have contributed to consistent revenue growth and a diversified market footprint.

Competitive Pressure and Market Share

Key competitors include Roche's Tecentriq (atezolizumab), Bristol-Myers Squibb's Opdivo (nivolumab), and AstraZeneca's Imfinzi (durvalumab). While competition has increased, KEYTRUDA has maintained a leadership position in several indications, supported by its early market entry and broad label expansion. Market share varies across regions and indications, with KEYTRUDA capturing approximately 70-75% of the PD-1/PD-L1 class market as of 2022 [2].

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Market Dynamics Influencing Growth

Regulatory Approvals and Pipeline

The pathway to commercialization significantly influences market trajectory. Merck’s aggressive pursuit of regulatory approvals, backed by robust clinical trial data, has resulted in over 10 supplemental approvals in a span of five years, extending KEYTRUDA’s reach. Notably, accelerated approvals for new indications and the pursuit of combination therapies maximize market potential.

Pricing Strategies and Reimbursement

Pricing remains a critical factor in market penetration. KEYTRUDA’s premium pricing—ranging from USD 6,000 to USD 16,000 per infusion depending on indication—has been offset by its clinical benefits and reimbursement agreements. Negotiations with payers have focused on value-based pricing and coverage policies, critical for maintaining revenue streams.

Manufacturing and Supply Chain

Manufacturing capacity scaling has been vital to meet global demand. Merck has invested substantially in fill-finish capabilities and supply chain resilience to mitigate shortages and ensure consistent product availability.

Market Penetration in Emerging Economies

While established markets drive the majority of revenues, expansion into emerging economies faces challenges such as pricing, regulatory hurdles, and healthcare infrastructure limitations. Strategic collaborations and tiered pricing models are pivotal for capturing market share in these regions.

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Financial Trajectory and Revenue Forecasts

Historical Financial Performance

Since its launch, KEYTRUDA has achieved extraordinary sales. In 2021, Merck reported approximately USD 17.2 billion in KEYTRUDA sales, representing a 20% YoY increase and constituting over 60% of Merck's total revenues [3]. The drug’s growth trajectory was underpinned by six new indications, a broad pipeline, and strategic marketing.

Forecasted Growth and Revenue Potential

Market analysts project continued revenue growth at a CAGR of 10-12% through 2027, driven by:

• Pipeline Expansion: Pending approvals in first-line NSCLC and combo regimens.
• New Indications: Expansion into additional tumor types, including microenvironment-specific cancers.
• Combination Therapies: Increasing use of KEYTRUDA in combination regimens to improve efficacy and broaden the patient base.

Impact of Patent Expiry and Biosimilars

Patent protection in key markets extends into the late 2020s, but biosimilar competition may emerge thereafter. Merck’s strategies include lifecycle management and developing fixed-dose combinations to sustain market share.

Profitability and Margin Trends

Gross margins for KEYTRUDA have historically been high (approximately 80%), reflecting its biologic nature and pricing power. Operating margins are also robust, supporting continued reinvestment into R&D and pipeline development.

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Market Challenges and Future Outlook

Pricing Pressures and Cost-Effectiveness

Healthcare systems worldwide are increasingly scrutinizing immuno-oncology therapies, questioning high costs against clinical benefits. Demonstrating cost-effectiveness through biomarker-driven treatment selection is essential for retaining reimbursement.

Regulatory and Competitive Challenges

New entrants and emerging therapies, including cell and gene therapies, could reshape the market landscape. Regulatory delays or adverse trial outcomes may temper growth trajectories.

Technological Advancements

Advances in biomarker identification (e.g., PD-L1 expression, tumor mutational burden) influence patient selection, optimizing treatment efficacy and clinical outcomes. These developments support personalized medicine approaches that could enhance KEYTRUDA's market penetration and financial returns.

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Key Takeaways

• Market Leadership: KEYTRUDA remains a dominant player in immuno-oncology, backed by broad indications and strategic pipeline expansion.
• Revenue Growth Potential: Substantial revenue growth forecasted through pipeline approvals, combination therapies, and geographic expansion.
• Competitive Landscape: The competitive environment is intense, with biosimilar threats and premium pricing pressure, yet Merck’s early market entry and extensive label bolster its position.
• Pricing and Reimbursement: Sustained profitability depends on value-based pricing strategies and navigating evolving payer policies.
• Innovation Drive: Continuous innovation in biomarkers and combination strategies will remain central to maintaining growth trajectories.

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FAQs

1. How has KEYTRUDA maintained its market dominance amidst increasing competition?
Early market entry, broad and expanding indications, strategic regulatory approvals, and investments in pipeline development have reinforced KEYTRUDA’s leadership position.

2. What are the primary factors influencing the pricing strategy for KEYTRUDA?
Pricing reflects clinical efficacy, manufacturing costs, reimbursement negotiations, and the cost-effectiveness landscape. Biosimilar competition and payer pressure also influence pricing adjustments.

3. How significant is pipeline expansion for KEYTRUDA’s future revenue?
Pipeline growth is critical; new indications, combination therapies, and biomarker-driven approaches will be key drivers of sustained revenue expansion.

4. What regional challenges does Merck face in expanding KEYTRUDA’s global footprint?
Regulatory hurdles, pricing negotiations, healthcare infrastructure, and local market dynamics pose challenges, especially in emerging economies.

5. How might biosimilars impact KEYTRUDA’s market share?
Introduction of biosimilars post-patent expiry could challenge current market share, but Merck’s lifecycle management and combination strategies aim to mitigate this impact.

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References

[1] Grand View Research. (2021). Immuno-Oncology Market Size, Share & Trends Analysis.
[2] EvaluatePharma. (2022). Oncology Market Share Report.
[3] Merck & Co. Inc. Annual Reports (2021).