If your portfolio still revolves around oncology, you are in good company, but that is no longer the interesting part of the story. The more uncomfortable truth for 2026 is that rare disease, CNS and cardiovascular studies are quietly rewriting the rules on where you run clinical trials and how much operational chaos your organisation can really absorb.
On paper, the forecasts look reassuring: oncology remains the biggest slice of the market, rare disease trials expand steadily, CNS and cardiovascular build momentum, and global volumes keep climbing. In practice, that mix is colliding with precision and personalised medicine in ways that will break any team still operating with 2016‑era monitoring and quality models.
It’s clear that oncology keeps its place at the top of the food chain. It accounts for a substantial share of global clinical trial revenue, with well over a thousand active mid‑ to late‑stage cancer trials underway and tens of thousands more registered across phases. North America still anchors that activity, holding the largest regional share, with Europe and Asia‑Pacific filling in the rest.
That can lull leadership into a false sense of security. “We’re oncology‑heavy; we’re where the action is” sounds good in an investor deck, but it misses the fact that oncology in 2026 is not oncology in 2015. Precision medicine has shifted cancer trials from relatively broad inclusion criteria to hyper‑specific, biomarker‑driven micro‑populations, often nested inside adaptive basket or umbrella designs. That is a fundamentally different operational game.
Think about the last time a master protocol in your organisation added a new cohort half‑way through, or your feasibility team had to find sites capable of advanced genomic testing across three continents. That is the new normal, not the exception.
Zoom out from oncology and the picture gets even more uncomfortable. Rare disease clinical trials are projected to grow at around high single‑digit to low double‑digit CAGR over the coming years, with the global rare disease trials market expected to nearly double between the early 2020s and 2031. CNS studies are expanding at a similar pace, driven by ageing populations and new diagnostics in Alzheimer’s and other neurodegenerative conditions. Cardiovascular trials are picking up again after recent waves of approvals and guideline changes, especially around obesity and cardiometabolic risk.
On a bar chart, those are just rising lines. In a portfolio review, they are the studies everyone worries about when the slide deck ends:
If you treat those studies as “just more trials” to layer onto an oncology‑centric operating model, you are effectively betting your pipeline on hope.
Precision and personalised medicine are often framed as scientific slogans, but they are now the underlying economic engine of many oncology and rare disease programmes. Multi‑omics profiling, sophisticated biomarkers and tailored treatment algorithms are no longer fringe; they are baked into inclusion criteria, endpoints and even dosing strategies.
A recent economic analysis of precision oncology programmes in childhood cancer illustrates the dynamic clearly: multi‑omics testing raises upfront costs but improves diagnostic yield, and as programmes scale, per‑patient delivery costs fall significantly (more than 40% in some settings). That is fantastic news for patients and long‑term efficiency – but in the transition period, it pushes clinical operations into a tight corner.
You now have to manage:
None of that is trivial. And that is before geography enters the frame.
Most market reports still talk about geographies in familiar terms: North America dominant, Europe stable, Asia‑Pacific the high‑growth region, with Latin America and parts of the Middle East and Africa gaining share as emerging hubs. That is accurate, but it misses the practical reality facing your study teams.
In oncology and rare disease, you may need Asia‑Pacific and Latin America not just for speed and cost, but simply to find enough eligible patients. Yet these same regions can bring variability in diagnostic access, data standards, and health‑system infrastructure. Cardiovascular and CNS trials face similar tensions: high‑throughput Western centres versus emerging‑market sites that promise faster recruitment but require heavier support to maintain consistent quality.
The result is a fragile equilibrium. You are being pushed towards more complex designs, narrower populations and broader geographies at the same time – and then told to deliver faster, cheaper and to ICH E6(R3)’s risk‑based expectations.
If your monitoring and quality model still assumes that more on‑site visits and more listings equal better control, it is not just outdated, it is actively dangerous.
E6(R3) is explicit about proportional, risk‑based quality management and the need to focus oversight on what is truly critical‑to‑quality. In an oncology portfolio dominated by biomarker‑driven master protocols, or in rare disease and CNS trials where every data point matters, a traditional, checklist‑driven approach creates the illusion of control while letting the real risks slip through.
This is precisely why risk‑based quality management (RBQM) and centralised monitoring have moved from “innovative option” to non‑negotiable foundation. Properly implemented, RBQM gives you:
Without that, adding more oncology, rare disease, CNS and cardiovascular complexity into more geographies is like building higher floors on a house with the same old foundations , you might get away with it, but you would not want to be on the top floor when something cracks.
So yes, oncology remains dominant. Rare disease, CNS and cardiovascular trials are growing. Precision and personalised medicine are driving both innovation and cost. Asia‑Pacific and emerging regions offer new opportunities. All of that is true.
But none of it matters if your operating model cannot safely hold the weight of that complexity.
The question to take into your next portfolio and quality review is brutally simple:
If an inspector walked into your most complex global oncology or rare‑disease trial tomorrow, could you convincingly show that your risk and quality decisions are as modern, precise and personalised as the science you are so proud of?
If the honest answer is “not yet,” then this is the year you decide whether your organisation is genuinely ready for the therapy‑area and geography shifts you say you want.