USA Keytruda Market Size, Share, Trends and Forecasts 2031

Key Findings

• The USA market for Keytruda (pembrolizumab) is continuing to expand globally, driven by its broadening indications across multiple cancer types and strong clinical efficacy.
• Rising incidence of cancers such as non-small cell lung cancer (NSCLC), melanoma, head and neck cancers, urothelial carcinoma and others in USA is significantly increasing patient demand for Keytruda.
• Technological advances in immuno-oncology, biomarker-guided therapy (PD-1/PD-L1), and combination treatment regimens are enhancing the role of Keytruda in modern oncology care.
• Healthcare infrastructure growth, coupled with rising reimbursement coverage and access programs in USA, is supporting greater adoption of Keytruda across hospital and specialty oncology settings.
• The impending patent expiry, emergence of biosimilars and pricing pressures pose important headwinds for Keytruda’s long-term revenue trajectory in USA.
• Strategic partnerships, new formulation developments (e.g., subcutaneous versions) and increased use in earlier-stage cancers are shaping the competitive landscape in USA.
• Barriers such as high treatment cost, adverse-immune events, and differential reimbursement across regions continue to challenge uptake in some markets of USA.
• Emerging markets in USA with improving oncology care capacity and growing awareness about immunotherapy present substantial growth opportunities for Keytruda.

USA Keytruda Market Size and Forecast

The USA Keytruda market is projected to grow from USD ≈ USD 30 billion in 2025 (global benchmark) to between USD 40-50 billion by 2031, at a CAGR of roughly 8-10% during the forecast period. Growth will be supported by expanding indications into earlier-line therapy, combination regimens and geographic penetration in emerging oncology markets of USA. However, the market will face deceleration pressures approaching patent expiry and increasing biosimilar competition, which will moderate the longer-term growth rate. Overall, the market will remain substantial, maintaining Keytruda’s position among the leading immuno-oncology therapies in USA.Another forecast estimated ~USD 29.48 billion in 2024, with decline to ~USD 26.63 billion by 2030 due to patent expiry effects. These variances reflect different modelling assumptions, but the underlying opportunity remains substantial for USA.

Introduction

Keytruda (pembrolizumab) is a humanised monoclonal antibody targeting the programmed death-1 (PD-1) receptor on T-cells, thereby releasing immune suppression and enabling the body’s immune system to recognize and attack cancer cells. In USA, Keytruda has become a cornerstone of immunotherapy across multiple malignancies including NSCLC, melanoma, head and neck squamous cell carcinoma, urothelial carcinoma, and other solid tumours often used as first-line or adjuvant treatment. Its broad clinical indication profile, favourable survival outcomes and integration into standard of care have established it as a key product in the oncology portfolio of Merck & Co., Inc. (MSD). The drug’s role extends beyond monotherapy, with growing usage in combination regimens with chemotherapy, targeted therapy and other immune checkpoint inhibitors. In USA, the service delivery of Keytruda involves hospital oncology departments, specialty clinics, and increasingly outpatient/ambulatory care settings. As immuno-oncology continues to evolve, Keytruda is positioned to play a pivotal role in the future of cancer treatment across USA.

Future Outlook

By 2031, the Keytruda market in USA is expected to undergo key shifts. First, the move toward earlier stage cancer treatment (adjuvant/neoadjuvant settings) will expand the eligible patient pool. Second, new formulations such as subcutaneous injections (recently approved in some markets) will improve patient convenience and may reduce administration costs, enhancing uptake. Third, the pricing and reimbursement landscape will evolve governments in many regions of USA will negotiate biopharmaceutical pricing more aggressively, which may moderate revenue growth despite higher volumes. Fourth, biosimilar / follow-on PD-1 inhibitor competition will likely emerge post-patent expiry, creating pricing pressure and requiring differentiation (e.g., via novel indications, formulations or combination therapies). Fifth, growth in emerging oncology markets within USA driven by rising cancer incidence, improving diagnostics and expanding oncology infrastructure will provide new geographic growth corridors. Finally, strategic alliances, expanded diagnostics (biomarker testing) and patient access programmes will play a vital role in sustaining adoption and maintaining Keytruda’s market leadership in USA.

USA Keytruda Market Trends

• Expansion of Indications and Earlier-Line Therapy
  Keytruda’s indication breadth continues to expand in USA, as clinical trials demonstrate its efficacy in adjuvant/neoadjuvant settings, rare tumour types, and across more cancer histologies. This broadening of indication enables earlier intervention and increases the eligible patient population, supporting market growth. The shift toward treating patients earlier in their disease course enhances survival outcomes but also increases the treatment duration and cost per patient, further elevating revenue potential. Concurrently, combination therapies (Keytruda plus chemotherapy, targeted agents or radiation) are gaining traction, which further expands usage. In USA, regulatory approvals for new indications are being rapidly adopted across major markets, accelerating clinician uptake. This trend underscores Keytruda’s transition from a later-line therapy to a standard frontline immunotherapy option.

• Increasing Adoption of Combination Therapy Regimens
  In USA, Keytruda is increasingly being used in combination with chemotherapy, targeted therapy (e.g., EGFR/ALK inhibitors), other checkpoint inhibitors, and radiation therapy to improve patient outcomes. These combinations often deliver superior efficacy, supporting expanded usage across oncology centres. Combination regimens may also extend Keytruda’s patent life and commercial viability by embedding it in broader treatment strategies. Healthcare providers in USA are investing in these more complex regimens despite higher cost because of improved survival, which sustains market value. As data continues to accumulate, combination therapy becomes standard of care in many tumour types, reinforcing Keytruda’s market penetration. The trend toward combination regimens will continue to shape market positioning and therapeutic guidelines in USA.

• Advancement of Biomarker Testing and Precision Oncology
  The efficacy of Keytruda is strongly influenced by biomarkers such as PD-L1 expression, tumour mutational burden (TMB), and mismatch-repair deficiency (dMMR). In USA, adoption of advanced diagnostics and biomarker profiling is increasing, supporting the appropriate selection of patients most likely to benefit from Keytruda. Precision oncology enables cost effectiveness and improved outcomes, which strengthens clinician confidence and payer support. Furthermore, improvements in companion diagnostics streamline the patient pathway, reducing time to treatment. As diagnostics evolve, they enable broader identification of eligible patients, further boosting Keytruda uptake. This integration of diagnostics and therapy underpins modern immuno-oncology practice in USA.

• Emergence of More Patient-Friendly Formulations and Delivery Modes
  Keytruda’s traditional intravenous infusion is being complemented by new formulations (e.g., subcutaneous injection) which reduce administration time, increase convenience and minimise clinic resource utilisation. In USA, the shift toward home-based or outpatient treat­ment offers competitive advantage for products that require less monitoring or infusion set-up. The convenience factor is increasingly valued by patients and providers, particularly in regions with higher outpatient care capacity. As clinics leverage these new formulations, patient adherence and throughput may improve, supporting market growth. The trend toward more convenient delivery modes enhances the appeal of Keytruda compared with older therapies.

• Growing Penetration in Emerging Markets and Oncology Infrastructure Expansion
  Healthcare infrastructure across many parts of USA is improving, including oncology centres, diagnostic labs, reimbursement frameworks and specialist training. As this capacity expands, Keytruda becomes accessible to a larger patient base beyond high-income markets. Emerging markets in Asia Pacific, Latin America, Middle East & Africa represent increasing opportunities for Keytruda adoption. Clinician awareness of immunotherapy is rising, and government initiatives aimed at improving cancer care access facilitate uptake. This geographic diversification helps the product mitigate saturation in mature markets and support continued growth.

Market Growth Drivers

• Rising Cancer Incidence and Mortality Rates
  Across USA, the incidence of several cancers including lung, melanoma, head & neck, colorectal and urothelial carcinoma is increasing due to demographic ageing, lifestyle changes (e.g., smoking, pollution, diet) and improved diagnosis. This growing disease burden raises demand for advanced oncology therapies such as Keytruda. As more patients are diagnosed at earlier stages, the eligible treatment population for immunotherapies expands. Early intervention with immunotherapy improves survival outcomes, which further promotes adoption. Healthcare systems are under pressure to adopt more effective treatments, supporting Keytruda uptake. This rising clinical need remains a fundamental growth driver.

• Wider Reimbursement and Healthcare Access Improvements
  In USA, healthcare payers and governments are increasingly reimbursing immunotherapies as they become standard of care. Access programmes, cancer-care funding, and expanded insurance coverage reduce patient cost burdens, enabling greater uptake of Keytruda. Oncology care delivery models are evolving, with more outpatient infusion centres and specialist clinics. As access improves, more patients benefit from treatment in both urban and peri-urban areas. These systemic access improvements drive volume growth for Keytruda.

• Innovation in Immuno-Oncology and Therapeutic Paradigms
  Immuno-oncology has reshaped cancer treatment, shifting away from conventional chemotherapy toward immune-checkpoint therapies. Keytruda is at the centre of this paradigm shift in USA, with strong clinical evidence across multiple indications. Ongoing research and development of novel combinations, biomarkers and formulations further enhance its market potential. Medical guidelines are increasingly endorsing immunotherapies, which supports Keytruda’s acceptance among oncologists. This innovation-driven environment creates robust demand for Keytruda.

• Expansion into Earlier Lines of Therapy and New Indications
  As Keytruda obtains approvals in adjuvant/neoadjuvant settings and less advanced cancers, the eligible patient population widens. Earlier-line therapies often generate higher treatment volumes and longer durations of therapy, which boosts revenue potential. In USA, clinicians increasingly adopt Keytruda earlier in treatment protocols, supported by improved safety and efficacy data. This shift enhances lifetime patient value and strengthens market momentum. The expansion into new indications continues to be one of the core growth drivers.

• Emerging Market Penetration and Geographic Diversification
  Growth in emerging economies of USA driven by rising healthcare investments, oncology infrastructure development and improving game-changing drug access is opening new revenue streams for Keytruda. Increased awareness of immunotherapy, training of oncologists, and development of cancer-care pathways enable adoption in previously underserved regions. While pricing may be lower, volume growth contributes significantly to market expansion. Geographic diversification also helps mitigate regulatory and pricing risks in mature markets. This driver underpins sustained future growth.

Challenges in the Market

• Patent Expiry, Biosimilar Threats and Pricing Pressure
  Keytruda’s major patents are set to expire in the coming years in multiple markets of USA, opening the door to biosimilar PD-1 inhibitors and increased competition. Additionally, governments and payers in many regions are implementing tighter cost-containment measures and price negotiation frameworks. The combination of generic competition and pricing pressure could materially impact market revenues. Merck & Co. must therefore extend life-cycle via new indications, formulations or strategic partnerships to offset this risk. Unmanaged, this challenge could disrupt market growth and profitability.

• High Cost of Therapy and Affordability Issues
  The cost of immunotherapy with Keytruda is substantial, and in many regions of USA, patient access remains limited by affordability, reimbursement delays, or lack of coverage. Some patients may not receive the full benefit due to financial constraints, which reduces the potential treated population. Healthcare systems under tight budgets may restrict usage to certain indications or delay adoption. This barrier limits penetration in lower-income or underinsured segments. Affordability remains a key constraint for fuller market uptake.

• Adverse Events, Durability of Response and Real-World Effectiveness
  While Keytruda has shown excellent outcomes in clinical trials, real-world evidence in some settings indicates variable durability of response and incidence of immune-related adverse events (irAEs). Management of irAEs requires specialist care, increasing treatment complexity and cost. Some patients relapse or progress despite therapy, which may limit uptake in certain indications. Oncologists may remain cautious about prescribing in patient populations with comorbidities. This challenge affects physician preference and may slow expansion into some segments.

• Regulatory and Reimbursement Uncertainty Across Regions
  Differences in regulatory approvals, reimbursement eligibility and health-technology assessment (HTA) frameworks across countries of USA create market complexity. Delays in market access or restrictive reimbursement criteria can hamper adoption. Variation in national pricing policies and delayed approvals of new indications slow penetration. Emerging markets may face longer reimbursement pathways and limited oncology infrastructure. These regulatory variances increase commercial risk and operational complexity.

• Supply Chain and Manufacturing Complexity for Biologics
  As a biologic therapy, Keytruda requires complex manufacturing, cold-chain logistics and specialised distribution networks. In certain parts of USA, infrastructure and supply-chain logistics may be underdeveloped, risking stock-outs or sub-optimal delivery. The cost of biologic supply-chain may limit price flexibility and access. Manufacturing scale-up for new formulations or indications adds complexity. These structural constraints pose operational challenges for sustained market growth.

USA Keytruda Market Segmentation

By Indication (Cancer Type)

• Non-Small Cell Lung Cancer (NSCLC)

• Melanoma

• Head & Neck Squamous Cell Carcinoma (HNSCC)

• Urothelial Carcinoma

• Gastric / Esophageal Carcinoma

• Others

By Treatment Mode

• Monotherapy

• Combination Therapy

By Distribution Channel

• Hospital Pharmacies

• Specialty/Oncology Clinics

• Retail/Outpatient Infusion Centres

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

Leading Key Players

• Merck & Co., Inc. – manufacturer of Keytruda

• Bristol‑Myers Squibb Company

• F. Hoffmann‑La Roche Ltd.

• Pfizer Inc.

• Novartis AG

• AstraZeneca PLC

• Amgen Inc.

Recent Developments

• Merck & Co., Inc. submitted and obtained regulatory approvals for subcutaneous (SC) formulation of Keytruda (so-called “Keytruda Qlex™”) in key markets, enabling shorter administration times and greater convenience.

• Merck & Co., Inc. announced expectation of inclusion of Keytruda in government price negotiation frameworks in the U.S. under Medicare starting 2026, signalling increasing pricing pressure ahead of patent expiry.

• Merck & Co., Inc. expanded its clinical trials portfolio combining Keytruda with novel agents (e.g., LAG-3, TIGIT inhibitors) and exploring earlier stage cancer indications, enhancing its life-cycle management.

• Merck & Co., Inc. is preparing for patent expiry in key markets (e.g., 2028 in the U.S.) by intensifying access programmes, formulation innovations and geographic rollout in emerging oncology markets.

• Multiple global oncology societies updated treatment guidelines to include Keytruda-based immunotherapy and combination regimens across first-line and adjuvant settings, reinforcing clinical adoption.

This Market Report Will Answer the Following Questions

1. What is the projected market size and growth rate of the USA Keytruda market by 2031?

2. Which cancer indications and treatment modes (monotherapy vs combination) are driving Keytruda adoption in USA?

3. How are formulation innovations, biomarker diagnostics and geographic expansion shaping the Keytruda market?

4. What are the major challenges in pricing, biosimilar competition, regulatory access and treatment adoption across USA?

5. Who are the key industry players and how are they positioning themselves for the immuno-oncology future in USA?