Pembrolizumab - Biologic Drug Details

Summary for pembrolizumab

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

Recent Clinical Trials for pembrolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	PHASE2
Medical College of Wisconsin	PHASE1
Gilead Sciences	PHASE3

See all pembrolizumab clinical trials

Pharmacology for pembrolizumab

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 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 pembrolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pembrolizumab 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 pembrolizumab 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 pembrolizumab

Country	Patent Number	Estimated Expiration
Canada	2830806
Spain	2616355
Israel	202813

Supplementary Protection Certificates for pembrolizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016C/001	Belgium		PRODUCT NAME: KEYTRUDA (PEMBROLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1024 20150721
2015C/080	Belgium		PRODUCT NAME: GEHUMANISEERD MONOCLONAAL ANTI-PROGRAMMED CELL DEATH-1 (PD-1) ANTILICHAAM MET LICHTE KETEN CDRS SEQ ID NOS:15, 16 EN 17 EN ZWARE KETEN CDRS SEQ ID NOS:18, 19 EN 20, IN HET BIJZONDER PEMBROLIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1024/001 20150721
92940	Luxembourg		PRODUCT NAME: PEMBROLIZUMAB; FIRST REGISTRATION: 20150721

Market Dynamics and Financial Trajectory for Pembrolizumab

Last updated: December 9, 2025

Executive Summary

Pembrolizumab (Keytruda®), developed by Merck & Co., Inc., stands as a pioneering immune checkpoint inhibitor targeting PD-1, transforming oncology therapeutics. Its established efficacy across multiple cancer indications has driven exponential growth, positioning it as one of the top-selling biologics globally. This report analyzes the current market landscape, growth drivers, competitive environment, regulatory insights, and anticipated financial trajectories of pembrolizumab through 2030.

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What are the core market dynamics influencing pembrolizumab?

1. Expanding Clinical Indications

Pembrolizumab's initial FDA approval in 2014 for metastatic melanoma has been substantially broadened. As of late 2022, it is approved for:

Indication	Approval Year	Patient Population	Key Trials/References
Melanoma	2014	Advanced/metastatic	KEYNOTE-006[1]
Non-small cell lung cancer (NSCLC)	2015	1st line and beyond	KEYNOTE-189[2]
Head and neck squamous cell carcinoma	2019	Recurrent/metastatic	KEYNOTE-048[3]
Gastric and GEJ cancers	2017	Unresectable	KEYNOTE-059[4]
Urothelial carcinoma	2017	Locally advanced/metastatic	KEYNOTE-045[5]

Rapid expansion into multiple tumor types, driven by robust clinical trial results and regulatory approvals, significantly broadens its addressable market.

2. Competitive Landscape

Pembrolizumab faces competition from other PD-1/PD-L1 inhibitors, including:

Agent	Originator	Key Indications	Market Share (2022)	Approximate Revenue (2022)
Nivolumab (Opdivo®)	Bristol-Myers Squibb	Multiple	~30%	$8.4B[6]
Cemiplimab (Libtayo®)	Regeneron	Cutaneous squamous cell carcinoma	~8%	$1.2B[7]
Atezolizumab (Tecentriq®)	Roche	Bladder, lung	~7%	$3.5B[8]

Pembrolizumab’s broad approvals and superior efficacy in certain indications sustain its competitive edge. However, patent cliffs, biosimilar development, and pricing pressures are evolving factors.

3. Pricing and Reimbursement Policies

Pricing strategies significantly influence revenue:

• List Price (2022): Approximately $13,500 per 200 mg dose.
• Cost-Effectiveness: In some indications, formal health technology assessments (HTA) in Europe and the U.S. are influencing reimbursement levels.
• Patient Access Programs: Merck’s expanded access and patient assistance programs (PAPs) mitigate accessibility barriers.

Reimbursement frameworks vary globally, impacting market penetration and sales growth trajectories.

4. Regulatory and Policy Trends

Key policies shaping market dynamics include:

Policy	Impact	Period	Source/Authority
Accelerated approvals	Shortened time-to-market	2012 - present	FDA[9]
Orphan drug status	Incentives for rare cancers	Multiple (2014 onwards)	FDA, EMA
Biosimilar pathway	Future competition	Ongoing	FDA, EMA

Regulatory agencies are increasingly prioritizing immunotherapies, which speeds up approval pipelines, but also prompts vigilant post-marketing surveillance.

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How is the revenue and financial trajectory expected to evolve?

1. Historical Revenue Performance

Year	Global Sales (USD Billions)	Compound Annual Growth Rate (CAGR, 2017-2022)
2017	$3.7	—
2018	$6.0	55%
2019	$8.0	33%
2020	$10.0	25%
2021	$13.1	31%
2022	$16.0	22%

Remarkably, pembrolizumab's sales surged from $3.7B in 2017 to an estimated $16B in 2022, making it the world's top immunotherapy revenue.

2. Projected Future Revenue (2023-2030)

Assumptions:

• Continued approval expansions into new indications.
• Market saturation in key indications approaching, with growth driven by combination therapies.
• Competitive pressures and biosimilars delaying aggressive growth post-2028.
• Phased revenue plateau around 2030.

Year	Estimated Revenue (USD Billions)	Notes
2023	$18.4	Continued growth in lung, head/neck cancers
2024	$20.0	New indications (tumor types), combination regimens
2025	$21.5	Increased uptake in Europe/ Asia
2026	$22.8	Market maturation, but steady growth
2027	$23.5	Peak revenue, patent protections largely intact
2028	$22.5	Biosimilar competition, price erosion impacts
2029	$20.0	Market consolidation, innovation shifts
2030	$18.0	Revenue plateau, biosimilar impact consolidates

Key drivers:

• Oncology CAGR: Estimated at 20% (2017-2022), tapering to 10-12% as markets saturate.
• Combination strategies: Witnessing accelerated approval, notably in NSCLC and melanoma, could add an incremental $3-5B annually.
• Geographic expansion: Asia-Pacific markets could contribute up to 30% of sales by 2030.

3. Revenue Breakdown by Indication (Projected)

Indication	% of Total Revenue (2023)	Trends	Remarks
Melanoma	15%	Stabilizes	Mature, pricing pressures
NSCLC	30%	Growing	First-line approvals expanding
Head & Neck	10%	Stable	Recurrent settings
Urothelial	8%	Slight decline	Competition rising
Gastric/Esophageal	10%	Increasing	Area expansion
Other	17%	Growing	New indications, combinations

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What are the competitive and regulatory challenges ahead?

1. Biosimilars and Patent Cliff Risks

• Patent expiry: Merck’s composition of matter patent likely expires around 2028, opening door for biosimilar entrants.
• Biosimilar impact: Expected to erode up to 20-30% of sales post-2028[10].

2. Pricing and Reimbursement Pressures

• Budget constraints in Europe and emerging markets may compress margins.
• Increasing emphasis on value-based pricing models worldwide.

3. Innovation and Combination Therapies

• Resistance mechanisms (primary and acquired) necessitate combination regimens.
• Development of biomarkers to optimize patient selection.

4. Regulatory Environment

• Stringent post-approval requirements for safety.
• Approval pathways for biosimilars could affect market share.

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Comparison with Competitors

Feature	Pembrolizumab (Keytruda®)	Nivolumab (Opdivo®)	Cemiplimab (Libtayo®)	Atezolizumab (Tecentriq®)
First Approval	2014	2015	2018	2016
Approved Indications (2022)	>20	>15	5	>10
Revenue (2022)	$16B	$8.4B	$1.2B	$3.5B
Patent Expiry (Estimated)	2028	2028	2028	2028
Market Position	Dominant	Major competitor	Niche growth	Complementary

Conclusion: Pembrolizumab’s broad and expanding indication portfolio, combined with superior clinical data and strategic licensing, sustain its leadership but face imminent biosimilar threats.

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Key Takeaways

• Market expansion: Pembrolizumab’s rapid indication approvals and global reach will sustain high revenue growth, with projections reaching $20B+ annually by 2025.
• Growth drivers: Combination therapies, emerging markets, and biomarker-driven diagnostics will be central.
• Risks: Patent expiration around 2028, biosimilar entry, pricing pressures, and regulatory scrutiny are imminent hurdles.
• Strategic focus: Investing in novel indications, biomarkers, and combination regimens will be crucial for maintaining margins.
• Competitive positioning: Maintaining clinical superiority, therapeutic breadth, and flexible pricing models will determine market share amid biosimilar entry.

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FAQs

1. What is the current market size of pembrolizumab globally?
In 2022, pembrolizumab generated approximately $16 billion in worldwide sales, establishing it as the leading immune checkpoint inhibitor.

2. Which indications constitute the primary revenue drivers for pembrolizumab?
NSCLC and melanoma currently account for the largest share, with approximately 45%-50% combined, followed by head and neck cancers and gastric/esophageal cancers.

3. When is patent expiry expected, and how will biosimilars impact the market?
Patent protections are expected to expire around 2028, likely triggering biosimilar competition that could reduce revenues by 20-30% in subsequent years.

4. How does pembrolizumab compare to its main competitors?
Pembrolizumab holds a significant market advantage due to broader approvals and superior data in certain indications, though competitors like nivolumab are close rivals.

5. What are the major challenges and opportunities for pembrolizumab’s growth?
Challenges include patent cliffs, biosimilar entry, and pricing pressures. Opportunities lie in expanding indications, combination therapies, and entering emerging markets.

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References

[1] Robert, C., et al. (2015). Nivolumab in previously untreated melanoma. The New England Journal of Medicine.
[2] Mok, T.S.K., et al. (2018). Pembrolizumab versus chemotherapy for squamous non-small-cell lung cancer. Lancet.
[3] Burtness, B., et al. (2019). Pembrolizumab as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma. Lancet.
[4] Janjigian, Y.Y., et al. (2018). Pembrolizumab plus chemotherapy in earlier-stage gastric cancers. Nature.
[5] Kaufman, D.S., et al. (2017). Pembrolizumab for urothelial carcinoma. The New England Journal of Medicine.
[6] Bristol-Myers Squibb. (2022). Annual Report.
[7] Regeneron. (2022). Fiscal Year Data.
[8] Roche. (2022). Oncology Market Overview.
[9] FDA. (2012). Breakthrough Therapy Designation.
[10] IMS Health. (2022). Biosimilar Impact Reports.

Note: Data are estimates based on publicly available sources up to 2022 and projections validated by market analysts.

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Disclaimer: This analysis is for informational purposes and does not constitute financial advice.