Keytruda Market Size, Share & Trends Analysis Report By Application (Lung Cancer, Breast Cancer, Melanoma, Hodgkin Lymphoma), By Payer (Commercial/Private, Public), By Distribution Channel, By Region, And Segment Forecasts, 2025 - 2030

Keytruda Market Size & Trends

The global Keytruda market size was estimated at USD 29.48 billion in 2024 and is projected to decline at a CAGR of -3.23% from 2025 to 2030. The Keytruda (pembrolizumab) market is expected to face a decline following its patent expiration, as biosimilar competition and pricing pressures impact sales. The market is driven by its increasing adoption across multiple cancer indications. As a leading immune checkpoint inhibitor, Keytruda has demonstrated strong efficacy in treating non-small cell lung cancer, melanoma, head and neck cancers, and other malignancies, leading to broader regulatory approvals worldwide. The steady growth in the market is supported by rising cancer prevalence, expanding clinical trials exploring combination therapies, and continued investments in immuno-oncology research.

Keytruda’s market growth has been largely driven by its expanding indications across various cancer types, positioning it as a cornerstone therapy in modern oncology. Regulatory approvals for new indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, and urothelial carcinoma, have significantly broadened its patient base. The drug's efficacy in both monotherapy and combination regimens has enabled its adoption in multiple treatment settings, including first-line and adjuvant therapy. As clinical trials continue to evaluate its effectiveness in additional cancers such as colorectal, triple-negative breast cancer, and hepatocellular carcinoma, the potential for further expansion remains strong. The continuous exploration of biomarker-driven treatment approaches, particularly through PD-L1 expression and tumor mutational burden, enhances Keytruda’s precision in targeted patient selection, making it a preferred choice in immuno-oncology.

Beyond monotherapy, Keytruda’s role in combination therapy is another key market driver, unlocking new treatment paradigms and improving patient outcomes. Its combination with chemotherapy, targeted therapies, and other immunotherapies has shown promising results, particularly in aggressive and advanced-stage cancers. Partnerships with pharmaceutical companies for combination trials further strengthen its position in the oncology landscape. As combination approaches gain regulatory approval and clinical validation, they present an opportunity to extend Keytruda’s lifecycle and differentiate it from potential biosimilar competition. This strategic expansion not only reinforces its clinical utility but also supports sustained market relevance despite the impending challenges of patent expiry.

Keytruda’s increasing use in earlier treatment lines is a major driver of its market expansion. Initially approved for advanced and metastatic cancers, the drug has progressively gained approvals for first-line and adjuvant settings, where it is used to prevent cancer recurrence following surgery. Studies demonstrating improved survival rates and reduced disease progression have reinforced its role as a preferred treatment in early-stage cancers. Regulatory bodies, including the FDA and EMA, have approved Keytruda for neoadjuvant and adjuvant therapy in cancers such as non-small cell lung cancer, triple-negative breast cancer, and melanoma, significantly expanding its patient pool. As oncologists increasingly adopt immunotherapy in early disease management, Keytruda’s demand continues to grow, reinforcing its market position before biosimilar competition emerges.

Merck’s development of a subcutaneous (SC) formulation of Keytruda represents a significant opportunity to extend the drug’s lifecycle and maintain its dominance in the oncology market. With regulatory filings already submitted in the U.S. and Europe, the anticipated approval by 2025 could lead to a projected 30-40% conversion rate from intravenous to SC administration. ​In January 2025, during the JP Morgan Healthcare Conference, Merck & Co. CEO Rob Davis announced plans to expedite the development of a subcutaneous (SC) formulation of Keytruda (pembrolizumab). The company anticipates filing for regulatory approval and launching the SC version within the year, aiming to enhance patient convenience and extend Keytruda's market exclusivity. This shift enhances patient convenience, reduces healthcare resource utilization, and potentially extends exclusivity beyond Keytruda’s intravenous formulation patent expiry. Additionally, SC Keytruda may serve as a critical defense against biosimilar competition, reinforcing Merck’s position in immuno-oncology. However, the ongoing patent dispute with Halozyme over this formulation introduces a degree of uncertainty, making successful resolution crucial for uninterrupted market adoption.

Patent Expiry Challenges and Market Sustainability

The looming patent expiration of Keytruda poses a significant challenge to Merck’s long-term revenue stream. Given that Keytruda has been a primary driver of Merck’s financial performance, the entry of biosimilars could lead to substantial pricing pressures and market share erosion. To counteract this, Merck is focusing on lifecycle management strategies such as expanding Keytruda’s use in earlier-line treatments and combination therapies. Additionally, the success of SC Keytruda could play a pivotal role in delaying revenue decline. The company’s broader oncology portfolio and ongoing clinical trials evaluating Keytruda in new indications may further cushion the impact of patent loss.

Combination Therapy And Expanded Indications

Keytruda’s market expansion has been significantly driven by its integration into combination therapies and new treatment indications. Merck continues to explore its use alongside chemotherapy, targeted therapies, and other immune checkpoint inhibitors to enhance treatment outcomes. Recent partnerships, including collaborations with Hansoh Pharma, aim to strengthen Keytruda’s presence in combination regimens, particularly in markets where competition is intensifying. Additionally, ongoing clinical trials assessing its efficacy in new cancer types, including gastrointestinal and genitourinary malignancies, could provide fresh avenues for market growth. These strategies are essential in maintaining Keytruda’s relevance amid rising competition and the patent cliff.

Competitive Pressures And Future Market Positioning

The oncology market is becoming increasingly competitive, with multiple PD-1/PD-L1 inhibitors entering the space. Companies such as Bristol-Myers Squibb (Opdivo) and Roche (Tecentriq) continue to challenge Keytruda’s market share, while new entrants and biosimilars post-patent expiry will further intensify pricing pressures. To mitigate these risks, Merck is investing heavily in next-generation immunotherapies, such as novel checkpoint inhibitors and personalized medicine approaches. Strategic acquisitions and pipeline diversification into non-oncology segments, including cardiovascular and metabolic diseases, will also play a crucial role in sustaining Merck’s overall growth as it transitions beyond Keytruda’s exclusivity period.

Keytruda (pembrolizumab) continues to play a pivotal role in cancer therapy. However, its dominance is now threatened due to upcoming patent expirations, biosimilar competition, and legal battles over its subcutaneous (SC) formulation. The intravenous (IV) version of Keytruda is set to lose patent protection in 2028. To extend exclusivity, Merck is developing a subcutaneous version, but this strategy faces hurdles due to a patent dispute with Halozyme Therapeutics over its hyaluronidase enzyme technology.

Halozyme Therapeutics over its hyaluronidase enzyme technology

Market Concentration & Characteristics

The immuno-oncology landscape continues evolving, with advancements in biomarker-driven therapies, combination regimens, and novel drug formulations. Keytruda remains at the forefront of innovation, with research focusing on expanding indications, optimizing treatment sequencing, and integrating next-generation immunotherapy strategies. The development of a subcutaneous (SC) formulation represents a key innovation to improve patient convenience and treatment accessibility. Additionally, combination trials exploring Keytruda with targeted therapies, chemotherapy, and other immune checkpoint inhibitors are enhancing therapeutic efficacy across various cancer types.

Mergers and acquisitions play a crucial role in strengthening Merck’s oncology pipeline and maintaining its competitive position post-Keytruda patent expiration. The company has pursued strategic acquisitions and partnerships to enhance its immuno-oncology portfolio, including agreements for combination therapies with emerging biotech firms. Industry-wide, pharmaceutical companies are leveraging M&A activities to expand into new cancer indications, secure promising pipeline assets, and develop novel formulations that extend product lifecycles. As competition intensifies in the PD-1/PD-L1 inhibitor space, consolidation efforts are expected to increase, focusing on innovative immunotherapy solutions.

Regulatory approvals significantly influence Keytruda’s market trajectory, with agencies such as the FDA and EMA expanding its indications based on robust clinical evidence. The approval process for immunotherapies involves rigorous clinical trials, long-term safety monitoring, and biomarker validation, contributing to extended development timelines and substantial R&D investments. Reimbursement policies play a critical role in market adoption, as high treatment costs require strong insurance coverage and favorable pricing negotiations. Additionally, regulatory challenges, including intellectual property disputes over the SC formulation, may impact commercialization strategies and market access in key regions.

Keytruda faces competition from alternative cancer therapies, including other PD-1/PD-L1 inhibitors such as Opdivo (nivolumab) and Tecentriq (atezolizumab), as well as chemotherapy, targeted therapies, and emerging cell-based immunotherapies. While biosimilars are expected to enter the market post-patent expiration, Keytruda’s established efficacy, extensive clinical data, and combination therapy potential continue to reinforce its market position. The shift toward personalized medicine and biomarker-driven treatment selection further differentiates Keytruda from traditional therapies, supporting its continued adoption in various oncology indications.

Merck is actively expanding Keytruda’s presence in high-growth regions, including Asia-Pacific, Latin America, and the Middle East, where rising cancer prevalence and improving healthcare infrastructure drive demand. Regulatory approvals in emerging markets, alongside increased investment in cancer treatment accessibility, are fueling market penetration. However, regional growth is influenced by pricing pressures, reimbursement constraints, and competition from local pharmaceutical players. Merck’s strategy includes strengthening partnerships with healthcare providers, enhancing distribution networks, and leveraging real-world data to optimize Keytruda’s adoption across diverse healthcare systems.

Application Insights

Lung cancer dominates the Keytruda market, accounting for the largest share of 27.4% in 2024. The strong market presence is driven by Keytruda’s established role as a first-line and adjuvant treatment for non-small cell lung cancer (NSCLC), supported by extensive clinical evidence demonstrating superior survival benefits over chemotherapy. Its approval across different stages of lung cancer, including metastatic and early-stage disease, has expanded its patient base. The widespread adoption of immunotherapy in lung cancer management, combined with continued research into novel combination regimens, reinforces the segment’s market leadership. Favorable reimbursement policies and increasing awareness among oncologists further drive demand.

Breast cancer represents the fastest-growing segment in the Keytruda market, fueled by its expanding approval for triple-negative breast cancer (TNBC) and ongoing trials in hormone receptor-positive subtypes. The high unmet need for effective immunotherapy in breast cancer has led to increasing adoption of Keytruda in combination with chemotherapy for high-risk early-stage and metastatic TNBC. Emerging clinical data on immunotherapy’s role in breast cancer treatment, coupled with regulatory endorsements, are accelerating market penetration. Growing investments in biomarker-driven approaches, particularly PD-L1 testing, enhance patient selection, driving rapid adoption and segment growth.

Payer Insights

The commercial/private insurance segment dominates the Keytruda market with a share of 91.0% due to strong coverage for immunotherapies across developed healthcare systems. Private insurers play a significant role in reimbursing high-cost oncology treatments, ensuring patient access to Keytruda in both early and advanced-stage cancers. The segment benefits from established agreements between pharmaceutical companies and insurers, allowing for broader treatment adoption. As immunotherapy becomes a standard-of-care treatment, private payers continue to support its integration into cancer management, reinforcing the segment’s leadership.

The public insurance segment holds the second-largest share, driven by government-backed reimbursement programs such as Medicare, Medicaid, and national healthcare systems in regions like Europe and Canada. As public health agencies expand coverage for immunotherapies, particularly for life-threatening cancers, Keytruda’s accessibility has improved. However, pricing negotiations and cost-effectiveness assessments by health authorities impact reimbursement rates, influencing market growth. Expanding immunotherapy guidelines and government funding for oncology treatments continue to drive demand within the public payer segment.

Distribution Channel Insights

Hospital pharmacies lead the Keytruda market with a share of51.8% due to the complex nature of cancer treatment, which often requires administration in controlled clinical settings. Hospitals ensure proper dosing, patient monitoring, and management of adverse effects associated with immunotherapy. Given that Keytruda is frequently used in combination with chemotherapy and other systemic treatments, hospital pharmacies play a crucial role in ensuring coordinated cancer care. Strong supply chain networks and direct procurement agreements further reinforce hospital pharmacies’ dominant position in the distribution landscape.

Specialty pharmacies are the fastest-growing distribution channel for Keytruda, driven by increasing outpatient treatment models and patient preference for convenient medication access. As immunotherapy becomes more integrated into long-term cancer care, specialty pharmacies enable streamlined distribution to oncology clinics and outpatient infusion centers. Advances in at-home administration, including the upcoming subcutaneous formulation of Keytruda, are expected to further boost specialty pharmacy sales. Additionally, dedicated patient support programs and reimbursement assistance offered by specialty pharmacies enhance treatment adherence and accessibility, fueling rapid growth in this segment.

Regional Insights

North America keytruda market leads global market with a share of 38.0% due to high cancer prevalence, widespread adoption of immunotherapy, and strong R&D investments. The region benefits from early regulatory approvals and extensive clinical research, particularly in lung cancer and melanoma. Ongoing trials exploring Keytruda’s use in earlier treatment stages and combination therapies further support market expansion. However, pricing pressures, regulatory scrutiny, and impending biosimilar competition pose challenges to sustained growth.

U.S. Keytruda Market Trends

The U.S. Keytruda market dominates the North American region, driven by high biopharmaceutical investments, strong healthcare infrastructure, and broad insurance coverage. The anticipated launch of subcutaneous Keytruda could enhance patient accessibility and extend market exclusivity. However, the market faces challenges from reimbursement complexities, cost-effectiveness assessments, and growing competition from alternative immunotherapies.

Europe Keytruda Market Trends

Europe’s Keytruda market is expanding, led by Germany, France, and the UK, supported by strong oncology research, favorable reimbursement policies, and regulatory approvals for new indications. The rising adoption of biomarker-driven treatment approaches is enhancing immunotherapy’s effectiveness. However, government-imposed drug pricing regulations, stringent reimbursement criteria, and competition from local manufacturers may limit growth potential.

The UK’s Keytruda market is supported by NHS-backed funding for immunotherapy, increasing focus on personalized medicine, and clinical trials exploring new cancer indications. Expanding use in breast cancer and earlier-stage lung cancer is driving adoption. However, cost-effectiveness assessments by the National Institute for Health and Care Excellence (NICE) and budget constraints in public healthcare may impact broader market penetration.

Keytruda market in Germany is growing and has become key player in European market, benefiting from robust biotech investments and advanced clinical research. Strong government support for oncology innovations and rapid approval of immunotherapies enhance market growth. However, pricing pressures from healthcare authorities and the increasing preference for locally manufactured oncology drugs may create market challenges.

France’s Keytruda market is growing due to increasing adoption in lung, gastric, and bladder cancers, along with government initiatives promoting immunotherapy. Regulatory approvals and expanded public healthcare coverage support market growth. However, cost-containment policies, stringent drug pricing negotiations, and competition from emerging biologics could hinder long-term expansion.

Asia-Pacific Keytruda Market Trends

Asia-Pacific is witnessing rapid growth in the keytruda market, led by China, Japan, and India. Rising cancer prevalence, improving healthcare infrastructure, and increasing regulatory approvals are driving demand. Growing investments in local immunotherapy production and biomarker-based patient selection are further supporting market expansion. However, high treatment costs, pricing negotiations with government payers, and the need for stronger reimbursement frameworks present challenges.

Japan Keytruda market is expanding due to government-backed oncology research, increasing immunotherapy adoption, and approvals for new cancer indications. A rapidly aging population and high lung cancer incidence further fuel demand. However, strict pricing controls imposed by Japan’s healthcare system and competition from domestic pharmaceutical companies pose market challenges.

Keytruda market in China is growing rapidly, supported by strong government initiatives, rising investment in biotech manufacturing, and expanding access to cancer immunotherapies. Increasing awareness and participation in global clinical trials strengthen market penetration. However, pricing restrictions, domestic immunotherapy competitors, and challenges in public insurance coverage remain key hurdles.

India Keytruda Market is witnessing slightly slow growth due tothe high cost which restricts patient access, as it is approved for 17 indications across 10 tumor types. With patents set to expire soon, Indian pharmaceutical companies are actively developing more affordable biosimilar versions to improve accessibility.

Latin America Keytruda Market Trends

Latin America is seeing increased adoption of Keytruda, particularly in Brazil, as healthcare investments and awareness of immunotherapy grow. Expanding regulatory approvals and oncology infrastructure development are contributing to market expansion. However, economic instability, limited access to high-cost treatments, and reimbursement challenges hinder widespread adoption.

Brazil Keytruda market is growing due to rising cancer cases and government-backed initiatives improving healthcare access. Local investments in oncology research and immunotherapy partnerships are supporting market expansion. However, high treatment costs, limited reimbursement options, and reliance on public healthcare funding present barriers to market penetration.

Middle East & Africa Keytruda Market Trends

The Middle East & Africa region is experiencing increased demand for Keytruda, driven by improving healthcare infrastructure and rising cancer prevalence. Countries like Saudi Arabia are leading the market with government-driven investments in cancer care. However, limited healthcare accessibility, high treatment costs, and regulatory delays remain significant challenges.

Saudi Arabia’s Keytruda market is expanding due to healthcare modernization initiatives, increased funding for cancer treatments, and growing patient access to immunotherapy. The government’s focus on biotechnology research further supports market growth. However, affordability concerns, reimbursement constraints, and regional pricing policies pose challenges to broader adoption.

Key Keytruda Company Insights

Merck & Co., Inc. dominates the Keytruda market, as it is the exclusive manufacturer and patent holder of the blockbuster PD-1 inhibitor. Keytruda’s strong clinical efficacy, broad indications, and continuous expansion into new treatment areas have made it the leading immunotherapy in oncology. However, as the drug approaches patent expiration, the market landscape is expected to shift, with biosimilar competition and alternative immunotherapies challenging its dominance.

Competitive Landscape & Emerging Players

• Bristol-Myers Squibb (BMS) - Opdivo (nivolumab): Keytruda’s primary competitor in the PD-1/PD-L1 space, Opdivo, continues to secure regulatory approvals across various cancers, challenging Keytruda in lung, renal, and melanoma treatments.

• Roche - Tecentriq (atezolizumab): A key player in immuno-oncology, Tecentriq competes with Keytruda in lung cancer and bladder cancer, leveraging a differentiated mechanism and combination approaches.

• Regeneron/Sanofi - Libtayo (cemiplimab): Although a smaller player, Libtayo has gained approvals in skin cancers and is expanding into lung cancer, intensifying competition in the PD-1/PD-L1 segment.

• Pfizer/Seagen - Novel Immunotherapy Combinations: Pfizer’s acquisition of Seagen has bolstered its oncology pipeline, with a focus on antibody-drug conjugates that could emerge as competitors to checkpoint inhibitors like Keytruda.

• Upcoming Biosimilars: As Keytruda’s patent nears expiration, biosimilar manufacturers, including major generic and biotech firms, are preparing to enter the market. Companies such as Amgen, Samsung Bioepis, and Bio-Thera Solutions are exploring biosimilar versions, which could reshape the market landscape post-2028.

Recent Developments

• In March 2025, BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration to evaluate BC3195 in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic solid tumors. The partnership aims to assess the safety and efficacy of BC3195, an innovative immunotherapy candidate, alongside Merck’s blockbuster PD-1 inhibitor. This trial reflects the growing trend of combination immunotherapy strategies to enhance treatment outcomes in oncology.

• ​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.

• ​In January 2025, China's National Medical Products Administration (NMPA) approved the combination of Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for treating adult patients with locally advanced or metastatic urothelial cancer. This marks the first non-platinum-based first-line treatment option for Chinese patients with advanced urothelial carcinoma. The approval is based on the Phase 3 EV-302/KEYNOTE-A39 trial, which demonstrated that the combination nearly doubled median overall survival and improved progression-free survival, overall response rate, and complete response rate compared to platinum-based chemotherapy.

• ​In November 2024, Merck & Co. announced that a Phase 3 clinical trial demonstrated that a new subcutaneous (under-the-skin) injection formulation of Keytruda (pembrolizumab) showed similar pharmacokinetics, efficacy, and safety profiles compared to the existing intravenous version when combined with chemotherapy in patients with non-small cell lung cancer. This development aims to offer a more convenient administration method for patients and potentially extend Keytruda's market exclusivity as it approaches patent expiration in 2028. Merck plans to discuss these findings with regulatory authorities to seek approval for this new formulation.

• ​In August 2024, the European Commission approved the combination of Astellas' Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer eligible for platinum-containing chemotherapy. This approval was based on the Phase 3 EV-302 clinical trial, which demonstrated that the combination significantly extended overall survival and progression-free survival compared to standard platinum-based chemotherapy.

Keytruda Market Report Scope

Global Keytruda Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global Keytruda market report based on application, payer, distribution channel, and region:

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Lung Cancer

  • Breast Cancer

  • Melanoma

  • Hodgkin Lymphoma

  • Head & Neck Cancer

  • Gastric Cancer

  • Urothelial Cancer

  • Others

• Payer Outlook (Revenue, USD Million, 2018 - 2030)

  • Commercial/Private

  • Public

• Distribution Channel Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital Pharmacy

  • Specialty Pharmacy

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait