Building or investing in the immuno-oncology market? Get our report

Immuno-oncology is the biggest business in cancer drugs, and it's at a turning point: the drug that built it is nearing its patent cliff, while new approaches are starting to win approvals.

We've found a lot of interesting signals. For example, Merck reported $31.7B in 2025 sales for Keytruda, the world's top-selling drug, and reorganized its business in February 2026 as the drug's main US patent nears its 2028 expiry. Then in August, after two rejections, the FDA granted accelerated approval to Replimune's Tudriqev, an oncolytic virus given with Opdivo to melanoma patients whose PD-1 treatment had stopped working. The checkpoint era still pays the bills, and the next wave is starting to reach the patients it leaves behind.

In this section, we look at what happens when copies of the leading checkpoint drugs arrive, which new approaches are closest to patients, and why so many of them are built to work alongside a checkpoint drug, not replace it.

Checkpoint drugs changed the outlook for some cancers, but many patients don't respond, and others stop responding after a while.

We look at six types of companies, from checkpoint makers and cancer vaccine developers to cell therapy, oncolytic virus, cytokine and myeloid-cell specialists. Their buyers include cancer centers, insurers and the big drugmakers that license programs. For each, we rank the biggest pains, like tumors that hide from the immune system, serious immune side effects, and the lack of tests that show who will benefit.

This shows which problems doctors and partners will pay to solve first, and which still need better science.

Most immuno-oncology revenue still comes from checkpoint drugs sold per dose, often for a year or more per patient. Around them, companies earn money from combination deals, licensing, milestones and royalties.

We compare who pays and how each model works. A checkpoint drug sells in huge volumes across many cancers, but faces cheaper copies once its patents end. A personalized vaccine has to be made for each patient, which raises costs. A small biotech often needs a big company's checkpoint drug for its trials, so its plans depend on that partner.

You'll see which models can still make money as checkpoint prices fall, and which only work as an add-on to someone else's drug.

A growth rate in immuno-oncology means little unless you know where the new patients come from. Here, we lay out each driver.

Some drivers are clear: immunotherapy moving earlier, before and after surgery, into more cancer types, and in under-the-skin versions that are faster to give. Others feed each other. Each new combination reaches patients that checkpoints alone missed. Better tests pick the right patients, which makes trials smaller. And cheaper copies may let more health systems pay for immunotherapy at all.

Before building or investing, you should know what it takes for a new immune therapy to earn a place next to checkpoint drugs, and get paid for it.

Merck owns the biggest name in this market, but immuno-oncology has far more players than one checkpoint drug.

Many smaller companies work on narrower ideas. Some design vaccines from the mutations in each patient's own tumor. Others engineer viruses that infect only cancer cells, or cytokines that switch on only inside the tumor. A growing number in China develop new checkpoint drugs and license them to Western companies before late trials.

They're hard to compare because most test their drug alongside someone else's checkpoint, in different cancers and at different stages of treatment. Small early trials also tend to make results look better than they turn out later.

Below, you'll find the market grids and ecosystem maps we've built to show which approach each company takes, in which cancer, and where new players are getting in.

Iovance Biotherapeutics, ImmunityBio, BeOne Medicines… a few immuno-oncology companies have turned new ideas into approved drugs. They sell them in very different ways, and their models are still being tested.

Iovance makes Amtagvi, the first cell therapy approved for a solid tumor, from immune cells taken out of a patient's own melanoma, and posted record sales in mid-2026. ImmunityBio sells Anktiva, an immune-boosting drug given with BCG for bladder cancer, and its sales nearly doubled in a year. BeOne Medicines developed its PD-1 drug Tevimbra in China and now sells it in the US and Europe, while a blood cancer pill brings in most of its profit.

We'll look at how these teams picked a first cancer where checkpoints fall short, built what they needed to deliver the treatment, and paid for growth before turning a profit.