The global Keytruda market size is anticipated to reach USD 26.63 billion by 2030 and is projected to decline at a CAGR of -3.23% from 2025 to 2030. The market is experiencing a slight decline in the growth trajectory. However, the market is moving ahead due to its effectiveness in combination therapies, enhancing outcomes when used alongside chemotherapy, targeted agents, and other immunotherapies. Ongoing clinical trials are evaluating its efficacy in additional cancer indications, particularly in biomarker-driven treatment approaches. The drug’s ability to extend progression-free survival in challenging cancers such as triple-negative breast cancer, lung cancer, and urothelial carcinoma further strengthens its market presence. Additionally, regulatory bodies are increasingly recognizing the value of Keytruda in early-stage cancers, fueling its adoption in neoadjuvant and adjuvant settings.
Despite its strong market foothold, Keytruda faces challenges, primarily due to its upcoming patent expiration in 2028. The introduction of biosimilar competition is expected to create pricing pressures and reduce market exclusivity. To counter this, Merck is actively working on lifecycle management strategies, including the development of a subcutaneous (SC) formulation that offers a more convenient alternative to the intravenous (IV) version. Recent Phase 3 trials have confirmed that SC Keytruda maintains comparable efficacy and safety, potentially extending its commercial viability.
The competitive landscape is also evolving, with rival PD-1/PD-L1 inhibitors, such as Opdivo and Tecentriq, vying for market share. Additionally, next-generation immunotherapies and novel treatment modalities pose potential threats to Keytruda’s dominance. However, Merck’s ongoing investments in research and development, coupled with strategic collaborations, are expected to sustain Keytruda’s relevance in the oncology space. The company’s continued efforts to expand indications, explore new combination regimens, and enhance patient accessibility through innovative drug formulations will be crucial in maintaining its leadership in the immuno-oncology market.
One of the biggest challenges Keytruda faces is its impending patent expiration in 2028, which will open the market to biosimilar competition. As a result, several pharmaceutical companies are actively developing biosimilar versions, which could significantly impact Merck’s revenue from Keytruda. With the loss of exclusivity, pricing pressures and reimbursement challenges are expected to intensify, particularly in cost-sensitive markets. Additionally, regulatory hurdles and litigation over biosimilar approvals could create market uncertainties. To mitigate these risks, Merck is focusing on life cycle management strategies, including the development of new formulations and expanded indications to sustain demand even after biosimilar entry.
At the same time, opportunities remain strong for Keytruda, particularly in combination therapies and earlier treatment lines. The shift toward personalized medicine and biomarker-driven oncology treatments presents a significant growth avenue, as Keytruda continues to demonstrate efficacy in patients with specific genetic and molecular markers. Clinical trials exploring Keytruda in combination with novel agents, such as antibody-drug conjugates and next-generation immune checkpoint inhibitors, could further enhance its therapeutic potential. Moreover, approvals in neoadjuvant and adjuvant settings are expected to increase treatment durations and expand the eligible patient pool, ensuring continued demand.
Another key opportunity for Merck lies in the development of the subcutaneous (SC) formulation of Keytruda, which aims to improve patient convenience and access. If approved, this version could offer an alternative for patients who face barriers to IV administration, such as limited access to infusion centers. The SC formulation could also help extend Keytruda’s market exclusivity by offering a differentiated product that may delay the impact of biosimilars. Additionally, emerging oncology markets in Asia-Pacific and Latin America present expansion opportunities, as rising cancer prevalence and improving healthcare infrastructure drive demand for advanced immunotherapies. With strategic investments in new indications, combination regimens, and innovative drug delivery methods, Merck is positioning Keytruda to maintain its strong presence in the global immuno-oncology market, despite the challenges ahead.
This product will be delivered within 1-3 business days.
Despite its strong market foothold, Keytruda faces challenges, primarily due to its upcoming patent expiration in 2028. The introduction of biosimilar competition is expected to create pricing pressures and reduce market exclusivity. To counter this, Merck is actively working on lifecycle management strategies, including the development of a subcutaneous (SC) formulation that offers a more convenient alternative to the intravenous (IV) version. Recent Phase 3 trials have confirmed that SC Keytruda maintains comparable efficacy and safety, potentially extending its commercial viability.
The competitive landscape is also evolving, with rival PD-1/PD-L1 inhibitors, such as Opdivo and Tecentriq, vying for market share. Additionally, next-generation immunotherapies and novel treatment modalities pose potential threats to Keytruda’s dominance. However, Merck’s ongoing investments in research and development, coupled with strategic collaborations, are expected to sustain Keytruda’s relevance in the oncology space. The company’s continued efforts to expand indications, explore new combination regimens, and enhance patient accessibility through innovative drug formulations will be crucial in maintaining its leadership in the immuno-oncology market.
One of the biggest challenges Keytruda faces is its impending patent expiration in 2028, which will open the market to biosimilar competition. As a result, several pharmaceutical companies are actively developing biosimilar versions, which could significantly impact Merck’s revenue from Keytruda. With the loss of exclusivity, pricing pressures and reimbursement challenges are expected to intensify, particularly in cost-sensitive markets. Additionally, regulatory hurdles and litigation over biosimilar approvals could create market uncertainties. To mitigate these risks, Merck is focusing on life cycle management strategies, including the development of new formulations and expanded indications to sustain demand even after biosimilar entry.
At the same time, opportunities remain strong for Keytruda, particularly in combination therapies and earlier treatment lines. The shift toward personalized medicine and biomarker-driven oncology treatments presents a significant growth avenue, as Keytruda continues to demonstrate efficacy in patients with specific genetic and molecular markers. Clinical trials exploring Keytruda in combination with novel agents, such as antibody-drug conjugates and next-generation immune checkpoint inhibitors, could further enhance its therapeutic potential. Moreover, approvals in neoadjuvant and adjuvant settings are expected to increase treatment durations and expand the eligible patient pool, ensuring continued demand.
Another key opportunity for Merck lies in the development of the subcutaneous (SC) formulation of Keytruda, which aims to improve patient convenience and access. If approved, this version could offer an alternative for patients who face barriers to IV administration, such as limited access to infusion centers. The SC formulation could also help extend Keytruda’s market exclusivity by offering a differentiated product that may delay the impact of biosimilars. Additionally, emerging oncology markets in Asia-Pacific and Latin America present expansion opportunities, as rising cancer prevalence and improving healthcare infrastructure drive demand for advanced immunotherapies. With strategic investments in new indications, combination regimens, and innovative drug delivery methods, Merck is positioning Keytruda to maintain its strong presence in the global immuno-oncology market, despite the challenges ahead.
Keytruda Market Report Highlights
- Based on application, lung cancer dominated the Keytruda market in 2024 with the largest revenue share of 27.4%, due to its widespread adoption as a first-line treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Meanwhile, breast cancer is projected to grow at the fastest CAGR over the forecast period, driven by Keytruda’s increasing use in triple-negative breast cancer (TNBC) and ongoing clinical trials exploring its efficacy in other breast cancer subtypes.
- Based on payer, the commercial/private insurance segment held the largest share of 91.0% in 2024, owing to strong reimbursement support for immuno-oncology therapies in developed markets. However, the public insurance segment is expected to see steady growth as government healthcare programs and national reimbursement policies expand access to costly cancer treatments.
- Based on distribution channel, hospital pharmacies emerged as the dominant segment with a share of 51.8% in 2024, accounting for the highest revenue share due to the need for controlled administration and specialist supervision in oncology treatment centers. Meanwhile, specialty pharmacies are projected to witness the fastest CAGR over the forecast period, driven by the growing shift towards outpatient immunotherapy administration and potential approval of the subcutaneous Keytruda formulation, which could improve accessibility outside traditional hospital settings.
- In February 2025, the U.S. Food and Drug Administration (FDA) granted Priority Review to Merck's supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) in combination with standard care as a perioperative treatment for patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This decision is based on the Phase 3 KEYNOTE-689 trial, which demonstrated a statistically significant improvement in event-free survival (EFS) and major pathological response (mPR) for patients receiving the Keytruda regimen compared to standard treatment alone. The FDA has set a target action date of June 23, 2025, for this application.
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players worldwide.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This Report Addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
This product will be delivered within 1-3 business days.
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Keytruda Market Variables, Trends, & Scope
Chapter 4. Keytruda Market: Application Business Analysis
Chapter 5. Keytruda Market: Payer Business Analysis
Chapter 6. Keytruda Market: Distribution Channel Business Analysis
Chapter 7. Keytruda Market: Regional Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Merck & Co., Inc.
- Bristol-Myers Squibb Company
- F. Hoffmann-La Roche Ltd.
- Regeneron Pharmaceuticals, Inc. & Sanofi S.A.
- Pfizer Inc. & Seagen Inc.
- Amgen Inc.
- Samsung Bioepis Co., Ltd.
- Bio-Thera Solutions, Ltd.
Methodology
LOADING...
