The $163 Billion Cancer Drug Problem: Why Keytruda Remains Out of Reach for Most Patients Worldwide

Keytruda, a breakthrough immunotherapy drug for skin cancer and other malignancies, has generated $163 billion in sales since 2014, yet remains financially out of reach for the vast majority of cancer patients worldwide. An investigation by the International Consortium of Investigative Journalists (ICIJ) and 47 media partners across 37 countries reveals how Merck & Co. deployed aggressive but legal tactics to inflate revenues and maintain high prices, even as cancer rates surge in lower-income countries where the drug is largely unaffordable .

How Does Keytruda Work as an Immunotherapy?

Keytruda is the brand name for pembrolizumab, a checkpoint inhibitor that works by removing the brakes on the body's immune system. The drug attaches to receptors called PD-1 on T cells, which are crucial immune cells that fight disease. By blocking these receptors, Keytruda prevents cancer cells from hiding from the immune system, allowing T cells to identify and attack malignant cells . First approved by the US FDA in 2014 for advanced skin cancer, the drug is now used globally for lung cancers, cervical cancer, renal cell cancer, and aggressive breast cancer, among others.

Unlike chemotherapy and radiation, which directly kill cancer cells and damage healthy tissue in the process, immunotherapy is highly targeted. It trains the body's own immune system to recognize and destroy cancer cells while sparing healthy tissue. Keytruda has shown remarkable results in late-stage cancers, with tumors disappearing completely in some patients and extending life even in those with aggressive forms of the disease .

What Are the Global Pricing Barriers Patients Face?

The cost of Keytruda varies dramatically across countries, creating a stark divide in access. In the United States, annual treatment costs approximately $208,000, while in Germany it costs about $80,000 per year. Patients in Lebanon face $93,000 annually, those in Colombia pay roughly $130,000, and in South Africa, where the typical household monthly income is under $500, a single dose costs approximately $4,904, or roughly 10 times the monthly income of most citizens . In India, where Merck markets the drug at over 1.5 lakh rupees (approximately $1,800) per 100-milligram vial, most families cannot afford treatment without assistance programs .

The recommended dosage of 200 milligrams every three weeks means patients without insurance or assistance programs would need to spend over $3 lakh (approximately $3,600) monthly in India alone. Most Indian patients access the drug through Merck's Patient Access Programme, which provides 30 free vials after purchasing five initially for a total cost of around 10 lakh rupees (approximately $12,000). However, this program has strict income limitations, excluding those with annual incomes exceeding 25 lakh rupees (approximately $30,000) .

How Has Merck Maintained High Prices and Market Control?

The ICIJ investigation uncovered multiple strategies Merck employed to keep prices elevated and competition at bay. The company built what researchers describe as a "fortress" around Keytruda using at least 1,212 patent applications across 53 countries, regions, and territories. This stream of follow-on patents could help Merck stifle competition and maintain high prices for 14 years after its original patents expire in 2028 .

Additionally, Merck promoted a higher dosage of Keytruda than some leading cancer researchers say is necessary. This inflated dosing could cost the world an estimated $5 billion just for lung cancer patients by 2040, according to researchers at the World Health Organization . The company also took advantage of industry regulatory shortcuts, orchestrated costly global lobbying campaigns, and operated with minimal transparency in pricing practices.

Ways Merck Has Influenced the Market and Healthcare Systems

  • Patent Strategy: Merck filed over 1,200 patent applications globally to extend market exclusivity well beyond the original 2028 expiration date, potentially blocking generic competitors for more than a decade.
  • Dosage Promotion: The company promoted higher-than-necessary dosages that increase treatment costs substantially, with WHO researchers estimating this could add $5 billion in unnecessary expenses for lung cancer patients alone by 2040.
  • Healthcare Professional Payments: Merck distributed tens of millions of dollars in consulting fees, travel costs, and other Keytruda-related payments to doctors and healthcare professionals in the United States, influencing prescribing patterns.
  • Lobbying Campaigns: The company orchestrated expensive global lobbying efforts to maintain favorable regulatory conditions and pricing structures across multiple countries.

What Are the Real-World Consequences of Keytruda's High Cost?

The pricing crisis has created desperate situations for cancer patients worldwide. In India, families seeking Keytruda have turned to a burgeoning black market, purchasing counterfeit versions of the drug because they cannot afford legitimate supplies. An investigation by The Indian Express in association with ICIJ found that this counterfeit market was fueled by lack of access to the drug for most patients, with hospital-level breaches and insider involvement documented by police investigators .

In Brazil, the world's seventh most populous country, thousands of cancer patients have turned to the courts to obtain Keytruda, facing harrowing bureaucratic obstacles. Some patients do not survive long enough to learn the court's ruling. In Guatemala, Dr. Julio Ramirez, head of the oncology unit at the regional public hospital in Quetzaltenango, described the impossible situation he faces .

"What's left for me to do? To play God. The first patient who arrives, that's who I'm going to give the treatment to because that's all I can do," stated Julio Ramirez, head of the oncology unit at the regional public hospital in Quetzaltenango, Guatemala.

Julio Ramirez, Head of Oncology Unit, Regional Public Hospital, Quetzaltenango, Guatemala

In the United Kingdom, research shows that Keytruda tops the list of drugs for which the cash-strapped National Health Service overpays. For some lung cancer patients, the NHS has been paying five times as much for Keytruda than it should, according to cost-effectiveness data from the University of York shared with the Bureau of Investigative Journalism .

Why Is India Particularly Important to This Story?

India represents a critical market for Merck's future growth. With one of the largest populations in the world and a rising cancer burden, access to immunotherapies in India remains largely constrained by cost. Although India's cancer incidence rate is currently below the global average, it is climbing steadily. The latest Global Burden of Disease estimates indicate that the rate of cancer occurrence rose from 84.8 per 100,000 population in 1990 to 107.2 per 100,000 in 2023 .

The WHO's Global Cancer Observatory shows that India recorded 14.13 lakh (1.413 million) cancer cases in 2022, a figure projected to surge by 73.8 percent to 24.56 lakh (2.456 million) cases by 2045. By contrast, Australia, which has one of the world's highest incidence rates at 462.5 per 100,000, is expected to see a comparatively modest 49.9 percent increase by 2045 . To make Keytruda more affordable, the Indian government decided to eliminate basic custom duty on the drug, with Union Finance Minister Nirmala Sitharaman noting in her Budget speech that Keytruda and its patient access program were among 36 drugs and 13 programs exempt from the duty .

What Does the Financial Impact Reveal About Merck's Priorities?

Since 2014, Merck has generated approximately $163 billion in Keytruda sales, reaching more than 3 million people globally. However, the company funneled nearly $75 billion in dividends to shareholders and $43 billion into share buybacks while reducing its US taxes by recording profits in lower-tax jurisdictions. In its 2025 annual report, Merck disclosed it paid around $1.6 billion in US income taxes, compared with $4.5 billion in other countries .

Keytruda accounted for $31.7 billion in sales in 2025 and represents nearly half of Merck's total revenue. About 60 percent of Keytruda sales come from the United States, where prices remain among the highest globally. When Merck's CEO Robert M. Davis appeared at the White House in December 2025 to announce drug price reductions, he pledged to lower prices on a diabetes drug and a cardiovascular pill but made no commitment to reducing Keytruda's cost .

The investigation by ICIJ and its media partners reveals a system where one of the world's largest drugmakers has prioritized shareholder returns and revenue growth over equitable access to a lifesaving cancer treatment. As cancer rates continue to rise globally, particularly in lower-income countries, the affordability crisis surrounding Keytruda underscores the tension between pharmaceutical innovation and public health equity .