USD 10.3 Billion
Report ID:
SQMIG35I2403 |
Region:
Global |
Published Date: July, 2025
Pages:
193
|Tables:
94
|Figures:
76
Global Keytruda Market size was valued at USD 10.3 Billion in 2023 poised to grow from USD 11.4 Billion in 2024 to USD 27.21 Billion by 2032, growing at a CAGR of 11.4% in the forecast period (2025-2032).
The global Keytruda market is expanding rapidly due to its increasing number of indications approved in lung, melanoma, gastric, cervical and endometrial cancers. Its continued showing of clinical efficacy in early-stage disease and combination therapy continues to promote extensive uptake. Merck's upcoming launch of a subcutaneous formulation expected by 2025, also is a significant contributor to the accumulation of market share, supporting greater patient convenience, quicker dosing and longer lifecycle value despite approaching patent expiration.
However, the market will also face challenges moving forward. The expected loss of exclusivity in 2028 is expected to usher in biosimilar competition in both developed and emerging markets. At the same time, the high cost of therapy and payer backlash against high-cost drugs and restricted reimbursement (in target markets including those most cost sensitive) will threaten volume growth. While the drug remains a pillar of first line cancer treatment, market analysts are expecting a shift from aggressive market share acquisition to cautious mitigation anticipated by the reformulated and indication launches.
In What Ways is Artificial Intelligence Redefining Innovation and Therapeutic Optimization in the Keytruda Market?
Artificial intelligence (AI) is changing the dynamics of the Keytruda market by accelerating drug development, personalizing treatment plans, and enhancing the design of clinical programs. AI continues to be implemented in the identification of biomarkers that can predict the patient's response to immunotherapy, which allows for more accurate targeting to limit unnecessary exposure to patients who will not respond. Furthermore, AI-based platforms are enhancing clinical trials by improving patient selection and stratification based on genetic and immunologic profiles. With these advances, we are further establishing the clinical position of Keytruda in a competitive oncology landscape while improving therapeutic outcomes for patients and enhancing operational cost-efficiency across health care systems, contributing significantly to the global keytruda market outlook.
In May 2024, Merck partnered with Tempus, AI a precision medicine company, to integrate real-world evidence and AI-powered genomic profiling to execute on the clinical strategy for Keytruda. This partnership will specifically use Tempus's adaptive AI models to predict response to immunotherapy in patients with non-small cell lung cancer (NSCLC), and to refine eligibility for ongoing trials. This agreement also allows Merck to enhance datasets, accelerate trial recruitment, and align future applications of Keytruda with new diagnostic technologies. This agreement represents a shift in the use of AI-guided approaches to developing immunotherapy, which will further allow Merck to meet its goal of developing Keytruda clinically, while preparing for the competitive landscape of biosimilars after the expiration of Merck's patents.
Market snapshot - 2025-2032
Global Market Size
USD 10.3 Billion
Largest Segment
Non-Small Cell Lung Cancer
Fastest Growth
Endometrial cancer
Growth Rate
11.4% CAGR
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The global Keytruda market is segmented based on cancer type, treatment phase, drug formulation & treatment approach, and region. In terms of cancer type, the market is divided into non-small cell lung cancer (NSCLC), endometrial cancer, melanoma, renal cell carcinoma, and head & neck squamous cell carcinoma (HNSCC). Based on treatment phase, the market is bifurcated into first-line therapy, second-line therapy, neoadjuvant therapy, and adjuvant therapy. Based on drug formulation & treatment approach, the market is grouped into intravenous (IV) formulation, subcutaneous (SC) formulation (in development), combination regimens (with chemotherapy or TKIS), and monotherapy. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America and the Middle East & Africa.
Non-Small Cell Lung Cancer (NSCLC) is dominating the global Keytruda market. The regulatory approvals for monotherapy or combination regimens for the different stages of NSCLC have propelled the growth of this indication. The inclusion of PD-L1 testing has further enhanced its precision use, and there are numerous Phase III trials ongoing to broaden its applicability in the early stage or locally advanced settings. This indication has achieved widespread inclusion in guidelines and the associated survival data has translated into Keytruda being commonly used as first-line therapy, particularly in markets such as the U.S., EU5 and Japan, solidifying NSCLC as the most commercially relevant indication in the global keytruda market outlook.
Endometrial cancer is among the fastest-growing indications for Keytruda, particularly since it was approved to treat patients with advanced disease in conjunction with Lenvatinib. Increasing incidence, limited alternatives and promising real-world survival data are establishing this indication. The combination of PD-1 inhibition with a tyrosine kinase inhibitor has shown rapid uptake in the U.S. and EU to significantly enhance volume in a previously relatively underserved cancer subtype.
First-Line Therapy has remained the predominant line of treatment for Keytruda, especially in the patient populations we can treat now with metastatic and advanced disease (NSCLC, melanoma, and bladder cancer) because of Keytruda’s clinical strength as a first-line agent evidenced by label approvals, response rate, and tolerability. Increasing survival rates in the early line of treatment not only benefit our patients but also provide favourability for formulary placement and reimbursement support. With the motivation swing in oncology toward early treatment intervention, this market shift is critical for global keytruda market growth and Keytruda’s ability to retain market share and clinical utility as an approved frontline immunotherapy.
Neoadjuvant & Adjuvant Therapy is the fastest growing segment by treatment setting with Keytruda, reflecting a strategic realignment toward intervention at earlier stages of disease. Recent approvals for adjuvant use in NSCLC and triple-negative breast cancer (TNBC) are expanding Keytruda’s non-metastatic disease footprint. These adjuvant approvals are occurring framed from the science of long-term reduction in relapses, growing acceptance of immunotherapy in curative-intent treatment protocols designed, and importance in early-stage relative to longer-term costs in healthcare. This treatment segment is poised for accelerated growth across global healthcare as systems favour early-stage survival and same time consider the long-run cost-related benefits.
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North America is the leader in the Keytruda market. Factors driving this position include a large-scale oncology infrastructure, earlier regulatory approvals, and more supportive payers. The U.S. specifically has a major advantage from the integration of clinical trials and fast-track FDA approvals in expanding indications for clinical trial students. Every major pharmaceutical company is making significant investments in immuno-oncology research and development which provides a significant long-term commercial advantage and supports global keytruda market statistics and presence.
The U.S. is dominating the North America Keytruda market, and it has advantageous payer coverage, plus a large population of eligible patients for Keytruda. In 2024, the FDA approved Keytruda for the adjuvant treatment of stage IIB and IIC melanoma which added to the early-stage applications for Keytruda. Merck began development of a subcutaneous formulation of Keytruda in U.S. clinical trials to minimize the time of infusion and advance patient access.
Canada is fastest growing country in the North America Keytruda market because of Health Canada's rapid approval of immunotherapy protocols and the high provincial reimbursement rates for first-line NSCLC and melanoma indications. In 2025, the Canadian Agency for Drugs and Technologies in Health (CADTH) released an update to its guidelines to include Keytruda as part of a neoadjuvant plan for triple-negative breast cancer. New indications reflect the acceptance of clinical use and growing reimbursement agreement positions for ascending oncology practices.
The Asia Pacific region is experiencing the fastest growth due to multiple factors, including increased cancer diagnosis, investment in cancer care, and systematic expansion of national drug reimbursement programs which includes access to immunotherapies. These programs and strategic alliance partnerships with Merck through localized trailing approaches has increased Keytruda's reach within critical oncology centers in the region. In addition, there is strong government support for increased early diagnosis and biologics production, which has increased the adoption of immunotherapies in both the public and private hospital system, aligning with the global keytruda regional forecast.
Japan has become a major player in immunotherapy, with an obvious and coordinated regulatory pathway for oncology product approvals and ecosystem engagement between the regulated industry and academic partners. With Keytruda receiving expanded approval in 2024 for advanced endometrial carcinoma with warm lenvatinib, this product had universal reimbursement under Japan's national insurance system, improving accessibility in all cancer centers in Japan.
South Korea is faster drug approval system and expanding cancer care facilities have had a big impact on Keytruda's use. In May 2025, the Korean Ministry of Food and Drug Safety (MFDS) previously approved Keytruda's expanded use in the adjuvant non-small cell lung cancer based on encouraging data following Phase III clinical phase. The Korean implementation of local real-world evidence programs used to inform reimbursement decisions for combination regimen has created sustainable market growth.
Europe remains strategically critical to Keytruda, largely due to EMA centralization, robust diagnostic levels, and the increasing focus on early intervention treatments. The variable multistakeholder models across Europe are generating real-world evidence and flexible reimbursement for policy decisions. Increased investment in clinical infrastructure and national cancer screening programs is allowing Keytruda’s clinical impact and regional opportunity to be reinforced, reflecting trends seen in the global keytruda industry analysis.
Germany is leading in immunotherapy uptake across Europe, especially with enhanced institutional research support and access to advanced diagnostics. In 2024, Merck began a collaboration with Charité University Hospital to examine the long-term outcomes associated with Keytruda for early-stage NSCLC within a public-private partnership. Moreover, efforts to track real-world outcomes are being employed to assist in a wider guideline recommendation and reimbursement strategy.
The UK continues to add Keytruda into practice across its multiple indications under the doe of the National Health Service (NHS). In 2025, NICE (the National Institute for Health and Care Excellence) recommended Keytruda as adjuvant treatment for patients with resected melanoma stages IIB–IIC which represents a new extension into curative treatment settings. Inclusion of Keytruda at scale for NHS clinical trial platforms further establishes visibility and in the market.
France has established itself as a primary destination for immunotherapy development, due to a structured national cancer strategy and an established pricing structure to hug manufacturers’ margins. In 2024, Keytruda was added to the reimbursable drug list with the French payer under social security for advanced renal cell carcinoma in combination. The French National Authority for Health (HAS) supported even early access schemes for Keytruda in rare cancers, permitting a fast-track mechanism early on access prior to a full marketing authorization. These regulatory and funding mechanisms are expanding the adoption of clinical practice in the country and augmenting France’s contribution to the European Keytruda market.
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Expanding Clinical Indications Across Cancer Types
Subcutaneous Formulation Development and Lifecycle Extension
Patent Expiry and Rising Biosimilar Competition
Reimbursement and Budgetary Constraints in Emerging Markets
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Global competition for the Keytruda market is intensifying as pharma titans chase indication expansion, new delivery forms, and alliance partnerships. Roche continues to build its global footprint with Tecentriq, which initiated new combination trials for triple-negative breast cancer in Asia and Europe in 2024. AstraZeneca, in turn, bolstered Imfinzi's leadership in adjuvant therapy by collaborating with Daiichi Sankyo on antibody-drug conjugate trials for lung and digestive cancers, reflecting evolving global keytruda market strategies.
There are also new entrants altering the competitive landscape. BeiGene is rapidly gaining market share with its PD-1 inhibitor tislelizumab, approved initially in China and later in the European market under a Novartis deal in 2025. Innovent Biologics has expanded its Sintilimab trials to cover numerous solid tumours, forming international collaborations to enable accelerated access to Latin American and Southeast Asian markets—hence creating a multi-regional challenge to entrenched Western brands.
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As per SkyQuest analysis, the key driver of keytruda market growth is the drug's ongoing penetration into earlier-stage cancer and adjuvant therapy indications, underpinned by strong survival data and regulatory clearance. The creation of a subcutaneous formulation is a secondary driver, boosting patient convenience and perhaps delaying biosimilar effect. Nevertheless, the threat of patent loss before 2028 is a severe restraint, with biosimilar competition anticipated to put pressure on global pricing and availability. North America continues to be the dominant region, fuelled by widespread reimbursement coverage and clinical infrastructure, while the Non-Small Cell Lung Cancer (NSCLC) segment continues to be the most commercially dominant segment, owing to extensive label coverage and volume.
Report Metric | Details |
---|---|
Market size value in 2023 | USD 10.3 Billion |
Market size value in 2032 | USD 27.21 Billion |
Growth Rate | 11.4% |
Base year | 2024 |
Forecast period | 2025-2032 |
Forecast Unit (Value) | USD Billion |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Keytruda Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Keytruda Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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Global Keytruda Market size was valued at USD 10.3 Billion in 2023 poised to grow from USD 11.4 Billion in 2024 to USD 27.21 Billion by 2032, growing at a CAGR of 11.4% in the forecast period (2025-2032).
Global competition for the Keytruda market is intensifying as pharma titans chase indication expansion, new delivery forms, and alliance partnerships. Roche continues to build its global footprint with Tecentriq, which initiated new combination trials for triple-negative breast cancer in Asia and Europe in 2024. AstraZeneca, in turn, bolstered Imfinzi's leadership in adjuvant therapy by collaborating with Daiichi Sankyo on antibody-drug conjugate trials for lung and digestive cancers, reflecting evolving global keytruda market strategies. 'Merck & Co. Inc. (United States)', 'Bristol Myers Squibb (United States)', 'Roche Holding AG (Switzerland)', 'AstraZeneca plc (United Kingdom)', 'Pfizer Inc. (United States)', 'Novartis International AG (Switzerland)', 'Regeneron Pharmaceuticals, Inc. (United States)', 'Sanofi S.A. (France)', 'Eli Lilly and Company (United States)', 'BeiGene Ltd. (China)', 'Innovent Biologics, Inc. (China)', 'Gilead Sciences, Inc. (United States)', 'Amgen Inc. (United States)', 'Zymeworks Inc. (Canada)', 'Daiichi Sankyo Co. Ltd. (Japan)', 'Sumitomo Pharma Co. Ltd. (Japan)', 'BioVistria Therapeutics (India)', 'ImmunoMind (United States)', 'MacroGenics, Inc. (United States)', 'Incyte Corporation (United States)'
Keytruda's rapid growth across multiple cancers, including NSCLC, melanoma, head and neck, endometrial, and triple-negative breast cancer, has firmly established Keytruda's footprint in the global market. Each new FDA and EMA approval that increases patient eligibility and physician confidence has propelled Keytruda to become a "backbone" therapy through all oncology care pathways. The expanding role of PD-I inhibitors and Keytruda in precision oncology is increasing in early-stage and adjuvant settings supporting ongoing revenue and use across developed and emerging markets.
Shift Toward Early-Stage Treatment and Adjuvant Therapy Expansion: One major trend in the Keytruda market includes a strategic shift by Merck from late-stage metastatic indications toward early-stage and adjuvant settings. Regulatory agencies in the U.S. and Europe and Asia have approved Keytruda in earlier stage diseases of the melanoma, non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC). This shift is a function of strong clinical data demonstrating improvement disease-free survival (DFS) and long-term cost-effectiveness. This transition creates a longer duration of therapy for patients and strengthens Merck's position by putting Keytruda deeper into oncology pathways or guidelines of care.
What Strategic and Clinical Conditions Make North America the Dominating Region in the Keytruda Market?
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