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Keytruda Market Size To Reach $24.95 Billion By 2033

Keytruda Market Size To Reach $24.95 Billion By 2033

December 2025 | Report Format: Electronic (PDF)

Keytruda Market Growth & Trends

The global Keytruda market size is anticipated to reach USD 24.95 billion by 2033 and is projected to decline at a CAGR of -3.80% from 2026 to 2033, according to a new report by Grand View Research, Inc. 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.

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Keytruda Market Report Highlights

The lung cancer segment dominated the Keytruda market, accounting for the largest share of 26.91% in 2025.
The commercial/private insurance segment dominated the Keytruda market, accounting for a 90.74% share in 2025, primarily due to the strong coverage for immunotherapies across developed healthcare systems.
Hospital pharmacies lead the Keytruda industry with a 51.18% share in 2025, due to the complex nature of cancer treatment, which often requires administration in controlled clinical settings.