| Study Period | 2021 - 2030 |
| Market Size (2025) | USD 28.62 Billion |
| Market Size (2030) | USD 33.08 Billion |
| CAGR (2025 - 2030) | 2.94 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | High |
Major Players*Disclaimer: Major Players sorted in no particular order |
Keytruda Market Analysis
The Keytruda Market size is estimated at USD 28.62 billion in 2025, and is expected to reach USD 33.08 billion by 2030, at a CAGR of 2.94% during the forecast period (2025-2030).
Keytruda (pembrolizumab), a monoclonal antibody, targets the programmed death-1 (PD-1) receptor. It plays a pivotal role in cancer immunotherapy, empowering 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. Key factors fueling the growth and evolution of the Keytruda market include the rising adoption of immunotherapy, increasing cancer incidences, and a surge in regulatory approvals for diverse indications.
The increasing global prevalence of various cancers, particularly lung cancer, melanoma, and head and neck cancers, is driving the demand for immune checkpoint inhibitors like Keytruda. The rising prevalence of cancer has driven demand for innovative treatments such as Keytruda, which is a significant driver for the Keytruda market.
For instance, the rising incidence of cancer and the urgent demand for more effective and precise treatment options are primary catalysts for market expansion. Further, data from the Red Espanola de Registros de Cancer in 2023 revealed that Spain diagnosed approximately 31,282 lung cancer cases, up from 29,188 in 2022. Various therapies are commonly employed to combat lung cancer. Consequently, the uptick in lung cancer diagnoses plays a pivotal role in propelling the market's growth. Additionally, in February 2023, Cancer Research United Kingdom projected that new cancer diagnoses in the UK would surge from roughly 420,000 cases during 2023-2025 to an estimated 506,000 cases by 2038-2040.
Moreover, data from the Australia Institute of Health and Welfare in August 2023 indicated that Australia recorded approximately 154,000 cancer diagnoses, with projections suggesting a rise to 200,000 by 2033. Thus, the escalating cancer diagnoses are poised to fuel the market's growth during the forecast period.
In addition, the increasing focus on immunotherapy as a treatment for various cancers has positioned pembrolizumab (Keytruda) as a pivotal drug in oncology. A landmark study, KEYNOTE-564, has showcased pembrolizumab's efficacy in treating clear-cell renal cell carcinoma (RCC), the most common form of kidney cancer. Participants with earlier-stage kidney cancer who had surgery were assigned to receive pembrolizumab or a placebo for a year. The trial results demonstrated a remarkable 40% reduction in the risk of death for those on pembrolizumab, with a 4-year survival rate of 91%, compared to 86% in the placebo group. The growing preference for immunotherapy post-surgery for high-risk patients will likely drive the adoption of Keytruda, amplifying market growth.
Moreover, the market growth of Keytruda is bolstered by its multiple FDA approvals and ongoing clinical trials. For example, in June 2024, Keytruda secured its 40th FDA nod, this time for advanced or recurrent endometrial cancer in tandem with chemotherapy. This milestone stems from the Phase 3 NRG-GY018 trial's success, showcasing a 70% dip in disease progression risk when Keytruda teamed up with chemotherapy. With this latest endorsement, Keytruda's repertoire now spans approvals for melanoma, non-small cell lung cancer (NSCLC), liver, colorectal, and triple-negative breast cancer, further propelling its market adoption.
Thus, the rising prevalence of cancer, increasing regulatory approvals, and growing demand for immunotherapy support the market’s growth in the next five years. However, the emergence of competitors and the high cost of Keytruda may restrain market growth.
Keytruda Market Trends
Stomach Cancer Segment is Expected to Witness Significant Growth Over the Forecast Period
Stomach cancer, also known as gastric cancer, poses a significant global health challenge, particularly for older adults. Immunotherapies, notably Keytruda (pembrolizumab), have emerged as promising treatments for stomach cancer, especially in advanced stages and in patients with PD-L1 expression.
As stomach cancer cases continue to rise, the demand for innovative therapies like Keytruda is expected to grow. For example, data from Cancer Research United Kingdom, published in February 2023, forecasts an increase in new stomach cancer cases in the UK, from about 6,300 annually during 2023-2025 to roughly 6,800 cases per year by 2038-2040.
Additionally, the American Cancer Society reports that in 2023, stomach cancer diagnoses predominantly occurred in individuals beyond middle age, with the average diagnosis age being 68 in the U.S. About 60% of those diagnosed are aged 65 or older. In 2023, the U.S. saw approximately 26,500 new stomach cancer cases, split between 15,930 in men and 10,570 in women. Given this substantial number, the demand for Keytruda as an immunotherapy is poised to rise, fueling segmental growth in the coming years.
Furthermore, as regulatory approvals increase, Keytruda's market presence in the stomach cancer segment is poised for global expansion. For example, in April 2024, Merck & Co. Inc (MSD) secured approval from Health Canada, leveraging results from the Phase III KEYNOTE-859 trial. This trial highlighted the significant clinical advantages of Keytruda for gastric cancer patients. Key findings included enhancements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). These results position Keytruda as a crucial treatment for advanced gastric cancer, solidifying its foothold in this segment.
Moreover, in November 2023, the Food and Drug Administration updated pembrolizumab’s usage guidelines. The amendment allows its use alongside trastuzumab, fluoropyrimidine, and platinum-based chemotherapy. This combination is now approved for the primary treatment of patients with locally advanced, unresectable, or metastatic HER2-positive gastric or GEJ adenocarcinoma. The FDA's updated endorsement of Keytruda for HER2-positive gastric cancer underscores the growing significance of targeted therapies and biomarker-driven strategies.
Consequently, as regulatory approvals for Keytruda in gastric cancer continue to rise, the segment's growth within the broader Keytruda market is anticipated to accelerate.
Thus, with the rising incidence of stomach cancer and the steady stream of regulatory endorsements for Keytruda, the stomach cancer segment is set to gain momentum in the market.
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North America is Expected to Dominate the Keytruda Market
The Keytruda market in North America has grown significantly due to its wide range of approved indications across multiple cancer types, including lung, melanoma, and gastric cancers, and the increasing prevalence of cancer. Regulatory approvals, such as those from the FDA and Health Canada, have expanded its use in combination therapies, positioning Keytruda as a key player in oncology treatment in the region.
The increasing prevalence of cancer will drive the demand for Keytruda for treatment in the region and, hence, will drive the market’s growth. For instance, according to the Cancer statistics in January 2024, 2 million new cancer cases are expected to occur in the United States in 2024. Moreover, according to Cancer Facts and Figures 2023 by the American Cancer Society, the number of new cancer cases in the United States was 1.95 million in 2023, of which 1.01 million were male and 0.94 million were female. Thus, this will increase the demand for Keytruda for cancer treatment, driving the market’s growth.
The U.S. market for Keytruda is on an upward trajectory, buoyed by a steady stream of new drug indications. This momentum is fueled by the drug's growing adoption in both first-line and subsequent cancer treatments, coupled with a favorable reimbursement landscape. For instance, 2024 data from the Centers for Medicare & Medicaid Services highlights Keytruda's annual patient cost potentially exceeding USD 150,000, igniting debates on its affordability and accessibility. However, for Medicare beneficiaries, especially those under Medicare Part B, the financial burden is alleviated, as the program covers a substantial 80% of outpatient treatment costs. Thus, with robust Medicare coverage and various assistance programs, Keytruda's adoption is set to surge, propelling the market's growth in the coming years.
In a notable development, Merck achieved a significant regulatory milestone in Canada in September 2024. Health Canada approved KEYTRUDA as a standalone treatment for both adult and pediatric patients grappling with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. This pivotal approval, rooted in data from the Phase II KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials encompassing 504 patients across 30+ cancer types, offers a lifeline to patients whose tumors have advanced post-therapy and lack satisfactory treatment alternatives. This marks a significant leap in Canada's biomarker-driven cancer treatment landscape.
Furthermore, in August 2024, Merck received approval from Health Canada for KEYTRUDA in combination with enfortumab vedotin to treat adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have not received prior systemic therapy for mUC. Therefore, these growing regulatory approvals drive the demand for Keytruda in Canada, which is expected to grow the country’s market during the forecasted period.
Therefore, the focus on regulatory approvals and increasing cancer cases is poised to drive the North American region in the keytruda market.
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Keytruda Industry Overview
The Keytruda market remains consolidated, with no presence of generic alternatives. Key drivers fueling Keytruda's market growth include ongoing geographical expansion, approvals for various indications, and its monopolistic status.
Keytruda Market Leaders
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Merck & Co., Inc.
- *Disclaimer: Major Players sorted in no particular order
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Keytruda Market News
- September 2024: Merck announced that new data from four approved medicines and six pipeline candidates across more than 20 cancer types will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Notably, findings from the Phase 3 KEYNOTE-522 trial in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial in high-risk locally advanced cervical cancer, and the Phase 3 LEAP-012 trial in unresectable, non-metastatic hepatocellular carcinoma (in collaboration with Eisai) have been selected for the prestigious ESMO Presidential Symposium Sessions.
- September 2024: Astellas Pharma Inc. got approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the combination of PADCEV (enfortumab vedotin) and MSD’s KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This approval, based on the EV-302 trial, showed that the combination therapy nearly doubled median overall survival and significantly extended progression-free survival compared to the current standard of care, platinum-containing chemotherapy. The decision follows a priority review designation by the MHLW, recognizing the clinical usefulness of this novel treatment for a serious disease.
Keytruda Industry Segmentation
Keytruda (pembrolizumab) is an immunotherapy drug that blocks the PD-1 receptor, enhancing the immune system’s ability to detect and destroy cancer cells. It is widely used to treat various cancers, including melanoma, lung, and gastric.
The Keytruda market is segmented into cancer type, therapy type, distributional channel, and geography. By cancer type, the market is segmented into non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), stomach cancer, and others (colorectal cancer, urothelial carcinoma, among others). By therapy type, the market is segmented into monotherapy, combination therapy, adjuvant therapy, and neoadjuvant therapy. By distribution channel, the market is segmented into hospital pharmacies and specialty pharmacies. By geography, the market is segmented into North America, Europe, Asia-Pacific, South America, and Middle East and Africa. The report also offers the market size and forecasts for 17 countries across the region. For each segment, the market sizing and forecasts have been done on the basis of value (USD).
| By Cancer Type | Non-Small Cell Lung Cancer (NSCLC) | ||
| Melanoma | |||
| Head and Neck Squamous Cell Carcinoma (HNSCC) | |||
| Stomach Cancer | |||
| Others | |||
| By Therapy Type | Monotherapy | ||
| Combination Therapy | |||
| Adjuvant Therapy | |||
| Neoadjuvant Therapy | |||
| By Distribution Channel | Hospital Pharmacies | ||
| Specialty Pharmacies | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Keytruda Market Research FAQs
How big is the Keytruda Market?
The Keytruda Market size is expected to reach USD 28.62 billion in 2025 and grow at a CAGR of 2.94% to reach USD 33.08 billion by 2030.
What is the current Keytruda Market size?
In 2025, the Keytruda Market size is expected to reach USD 28.62 billion.
Who are the key players in Keytruda Market?
Merck & Co., Inc. are the major companies operating in the Keytruda Market.
Which is the fastest growing region in Keytruda Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Keytruda Market?
In 2025, the North America accounts for the largest market share in Keytruda Market.
What years does this Keytruda Market cover, and what was the market size in 2024?
In 2024, the Keytruda Market size was estimated at USD 27.78 billion. The report covers the Keytruda Market historical market size for years: 2021, 2022, 2023 and 2024. The report also forecasts the Keytruda Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Keytruda Industry Report
Statistics for the 2025 Keytruda market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Keytruda analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
