KEYTRUDA Drug Profile

Summary for Tradename: KEYTRUDA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KEYTRUDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KEYTRUDA

Recent Clinical Trials for KEYTRUDA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2/Phase 3
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
James Isaacs, MD	Phase 1

See all KEYTRUDA clinical trials

Recent Litigation for KEYTRUDA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.	2022-03-17

See all KEYTRUDA litigation

PTAB Litigation

Petitioner	Date
Genome & Company	2018-10-02

See all KEYTRUDA litigation

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. General 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 KEYTRUDA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KEYTRUDA Derived from 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			Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2028-06-13	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2032-12-19	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-12-19	Company disclosures
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	Injection	125514			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		2035-06-26	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-02-06	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-10-30	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2034-06-17	Patent claims search
Merck Sharp & Dohme Llc	KEYTRUDA	pembrolizumab	For Injection	125514		2035-05-04	Patent claims search

KEYTRUDA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: KEYTRUDA

Introduction to KEYTRUDA

KEYTRUDA, also known as pembrolizumab, is a monoclonal antibody that plays a pivotal role in cancer immunotherapy. It targets the programmed death-1 (PD-1) receptor, enabling the body's immune system to identify and eliminate cancer cells. As an immune checkpoint inhibitor, KEYTRUDA obstructs the PD-1/PD-L1 interaction, bolstering T-cell responses against tumors[1].

Market Size and Growth Projections

The KEYTRUDA market is estimated to be substantial and is projected to continue its growth trajectory. As of 2024, the market size is estimated at USD 27.80 billion and is expected to reach USD 32.10 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 2.94% during the forecast period[1].

However, other projections suggest even more robust growth, with the market expected to reach $31.52 billion by 2028 at a CAGR of 9.9%. This discrepancy highlights varying forecasts but uniformly indicates strong market growth driven by expanding indications, emerging markets, and increasing cancer prevalence[4].

Key Drivers of Market Growth

Several factors are driving the growth and evolution of the KEYTRUDA market:

Rising Adoption of Immunotherapy

The increasing adoption of immunotherapy in cancer treatment is a significant driver. Immunotherapy has shown improved patient outcomes, leading to higher demand for drugs like KEYTRUDA[4].

Increasing Cancer Incidences

The rising prevalence of cancer globally is another critical factor. For instance, in the United States alone, 2 million new cancer cases are expected in 2024, which will drive the demand for effective cancer treatments like KEYTRUDA[1].

Regulatory Approvals

KEYTRUDA has secured multiple FDA approvals for various indications, including melanoma, non-small cell lung cancer (NSCLC), liver, colorectal, and triple-negative breast cancer. The latest approval in June 2024 for advanced or recurrent endometrial cancer further expands its market adoption[1].

Geographical Expansion

The market is growing not only in North America but also in other regions, with the Asia Pacific region identified as the fastest-growing market. Regulatory approvals in countries like Canada, such as the approval for treating urothelial cancer, are also driving growth[1].

Market Concentration and Leaders

The KEYTRUDA market remains highly concentrated, with Merck & Co., Inc. being the dominant player. There are currently no generic alternatives to KEYTRUDA, which contributes to its monopolistic status and significant market share[1].

Financial Performance of KEYTRUDA

KEYTRUDA is a cornerstone of Merck's financial success. Here are some key financial highlights:

Quarterly Sales

In the first quarter of 2024, KEYTRUDA generated sales of $6.95 billion, a 24% increase year-over-year. In the third quarter of 2024, KEYTRUDA sales grew 17% to $7.4 billion, with a 21% growth excluding the impact of foreign exchange[3][5].

Revenue Contribution

KEYTRUDA is the biggest product in Merck's portfolio, significantly contributing to the company's total sales. For example, in the third quarter of 2024, Merck's total worldwide sales were $16.7 billion, with KEYTRUDA being a major driver of this revenue[2][5].

Gross Margin and Expenses

The gross margin for Merck in the third quarter of 2024 was 75.5%, partly due to the favorable impact of product mix, including lower royalty rates related to KEYTRUDA. However, selling, general, and administrative (SG&A) expenses increased by 8% compared to the third quarter of 2023, driven by higher administrative and promotional costs[2][5].

Regional Market Dynamics

North America

North America, particularly the United States, is the largest market for KEYTRUDA. The drug's wide range of approved indications and the increasing prevalence of cancer in the region are key drivers. The U.S. market is further supported by a favorable reimbursement landscape, with Medicare covering a substantial portion of outpatient treatment costs[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for KEYTRUDA. This growth is driven by increasing healthcare expenditure, rising cancer incidence, and expanding regulatory approvals in various countries within the region[1].

Challenges and Restraints

Despite the strong growth prospects, the KEYTRUDA market faces some challenges:

High Cost and Affordability

The high cost of KEYTRUDA, potentially exceeding USD 150,000 per patient annually, raises concerns about affordability and accessibility. However, robust Medicare coverage and various assistance programs help mitigate this issue for many patients[1].

Emergence of Competitors

The emergence of competitors in the immunotherapy space could potentially restrain market growth. However, KEYTRUDA's multiple FDA approvals and its established market presence provide a strong competitive edge[1].

Future Outlook

The future outlook for the KEYTRUDA market is promising, driven by several factors:

Expanding Indications

Continuous regulatory approvals for new indications will further expand KEYTRUDA's market adoption. The success of ongoing clinical trials and the potential for new approvals will be crucial in sustaining market growth[1].

Growing Demand for Precision Medicine

The increasing demand for precision medicine and targeted therapies will continue to drive the adoption of KEYTRUDA. As healthcare systems move towards more personalized and effective treatments, the demand for immunotherapies like KEYTRUDA is expected to rise[4].

Emerging Markets

The growth in emerging markets, particularly in the Asia Pacific region, will provide new avenues for market expansion. Increasing healthcare expenditure and rising cancer incidence in these regions will contribute to the overall growth of the KEYTRUDA market[4].

Key Takeaways

• The KEYTRUDA market is projected to grow significantly, driven by increasing cancer incidence, expanding regulatory approvals, and the rising adoption of immunotherapy.
• North America, particularly the U.S., is the largest market, while the Asia Pacific region is the fastest-growing.
• Merck & Co., Inc. dominates the market with no generic alternatives available.
• High costs and the emergence of competitors are potential restraints, but robust regulatory approvals and favorable reimbursement landscapes support market growth.
• The future outlook is promising, with expanding indications, growing demand for precision medicine, and emerging markets driving continued growth.

FAQs

Q: What is KEYTRUDA, and how does it work?

KEYTRUDA (pembrolizumab) is a monoclonal antibody that targets the PD-1 receptor, enabling the immune system to identify and eliminate cancer cells by obstructing the PD-1/PD-L1 interaction.

Q: What is the current market size of KEYTRUDA, and what are the growth projections?

The current market size of KEYTRUDA is estimated at USD 27.80 billion in 2024, projected to reach USD 32.10 billion by 2029 at a CAGR of 2.94%. Alternatively, some forecasts suggest it could reach $31.52 billion by 2028 at a CAGR of 9.9%.

Q: Which region is the largest market for KEYTRUDA?

North America, particularly the United States, is the largest market for KEYTRUDA due to its wide range of approved indications and the increasing prevalence of cancer.

Q: What are the key drivers of the KEYTRUDA market growth?

Key drivers include the rising adoption of immunotherapy, increasing cancer incidence, and multiple regulatory approvals for diverse indications.

Q: What challenges does the KEYTRUDA market face?

The high cost of KEYTRUDA and the potential emergence of competitors are significant challenges, although robust regulatory approvals and favorable reimbursement landscapes help mitigate these issues.

Sources

1. Mordor Intelligence: Keytruda Market Size & Share Analysis - Growth Trends
2. Merck: Merck Announces Third-Quarter 2024 Financial Results
3. Nasdaq: Merck (MRK) Q1 Earnings Top, Cancer Drug Keytruda Boosts Sales
4. EIN Presswire: Keytruda Global Market 2024 To Reach $31.52 Billion By 2028 At Rate Of 9.9%
5. BioSpace: Merck Announces Third-Quarter 2024 Financial Results - BioSpace