For many years, the US has been considered the unequivocal champion in the global war against cancer. Not only does the country presently account for approximately 57 percent of worldwide cancer research funding, but American per capita investment in oncology research averages as much as seven times higher than that of Western Europe. Meanwhile, the National Cancer Institute (NCI) remains the single largest cancer research funder on the planet, accounting for nearly 94 percent of US public spending in that space.
And while, according to Nature Index, China may have overtaken the US in 2024 as the fastest growing country for volume of cancer research output – increasing its share by 19 percent compared to the America’s five percent – the land of the stars and stripes remains firmly at the vanguard when it comes to trailblazing game-changing innovation in a rapidly evolving field.
Recently appointed NCI Director, Dr Anthony Letai wants Americans to properly understand how their tax dollars are consistently being translated into radical breakthroughs. “There is a persistent gap between how cancer research actually works and how it is perceived outside the field. Almost every major cancer therapy that ultimately reaches patients can be traced back, often 10 to 20 years earlier, to foundational research supported by NCI grants,” he observes.
“Ideas originate in the laboratory, receive public funding, mature scientifically, and are then taken forward by biotech or pharmaceutical companies before receiving approval from the FDA. By the time a treatment reaches the clinic, that long chain of public investment is largely invisible and sometimes forgotten, but the reality is that it is our efforts that have provided the basis, and we have a responsibility to make that pathway more evident in people’s minds,” he affirms.
Beyond Genetics
Looking ahead, Letai foresees that next big game-changing cancer breakthroughs coming out of the US will occur in the areas of functional precision medicine and superior diagnostics. “Precision medicine has delivered important successes through genomic biomarkers, from chronic myeloid leukaemia to EGFR-mutant lung cancer and BRAF-driven melanoma, and those advances have been genuinely transformative. However, genomics alone has not met all its early expectations, and there remains a clear unmet need for better predictors of response,” he opines.
That’s where functional precision medicine is becoming increasingly relevant. Rather than relying solely on models or genomic inference, this approach tests therapies directly on living tumour cells from patients using advanced ex vivo systems. “These methods are now far more mature than many outside the field realize and are already starting to be applied in America both to drug discovery and to clinical decision-making,” Letai confirms.
Jeff Allen, CEO of advocacy group Friends of Cancer Research, agrees that the manner in which the pharma industry is going about countering cancer has evolved dramatically within the space of only a few years, largely thanks to the intensity of American-led innovation. “Several years ago, the ability to identify patients based on molecular factors or genetic alterations and match them to an appropriate treatment began to shift the entire paradigm of cancer drug development. Now, if you look across pipelines, it’s estimated that over half of all drug development programs have biomarker selection criteria associated with new medicines and these tools have become essential in ensuring that patients get the right treatments at the right times,” he enthuses.
Pre-eminence in Diagnostics
Allen anticipates that yet more watershed breakthroughs lie just around the corner. “Technologies are rapidly emerging that will be able to measure cancer drug activity earlier, including the role of circulating tumour DNA (ctDNA) as a speedy indicator of treatment response,” he predicts. “Possessing an endpoint able to indicate whether a drug is working far in advance of currently available measures will have a thoroughly transformative impact on the ability to prioritize promising compounds and expedite their clinical development,” he believes.
Indeed, the US stands apart as the global pioneer of liquid biopsy-based Minimal Residual Disease (MRD), which detects trace amounts of residual or recurring ctDNA to predict cancer relapse months before traditional imaging. Liquid biopsy has been a major enabler for progress in oncology diagnostics. “Access to tissue has always been a constraint, so the ability to work with non-invasive blood samples has unleashed diagnostic and monitoring use cases that were not previously feasible. MRD testing’s much earlier signal opens the door for care to switch over from a primarily reactive to much more proactive posture,” confirms Jonathan Arnold, Vice President and Head of Oncology & Precision Diagnostics at QIAGEN.
One American entity firmly at the forefront of this new wave of technological innovation is NeoGenomics Labs, whose recently unveiled ctDNA assay, RaDaR ST is primed for a clinical launch during the first half of 2026. “The move from whole exome to whole genome sequencing in MRD has the potential to unlock a tremendous amount of new information that will fuel innovation for years to come and become a real hotbed of discovery, reshaping clinical decision-making and the future of personalized cancer treatment” forecasts the company’s CEO, Tony Zook.
“MRD holds the promise of being a very sensitive surveillance tool that physicians can use over the course of a patient’s disease. I often compare MRD to the early days of MRI, when clinicians were first exposed to a level of information they had never had before and were initially unsure how to interpret it,” he elaborates. “Physicians recognize the opportunity and the promise of earlier signalling and deeper insight, but the science has not yet fully answered the question of what is actionable. When it does, it’s going to unblock all manner of new approaches, particularly in lower-shedding tumours,” Zook insists.
The manner in which America thus serves as the primary engine for innovation in advanced Next-Generation Sequencing (NGS) hardware and clinical application, driven by a cluster of industry-defining companies like Illumina and Agilent Technologies, showcases the country’s front seat role in shaping and defining the next era of personalized cancer therapies.
“Historically, oncology treatments were largely broad based. Over the past decade, the shift toward patient-specific therapies has been remarkable, and that evolution has gone hand in glove with advances in diagnostics. Moreover, as treatments become more precise, diagnostics have gravitated from a supporting role to being absolutely central to how the mechanism of precision oncology works,” recounts Zook.
QIAGEN’s Arnold mirrors this sentiment. “Cancer diagnostics are no longer peripheral to innovation. They have become a prerequisite to being able to attain the full value of precision medicine, shaping how patients are identified, stratified, and managed the entire length of the care continuum,” he affirms.
Indeed, these advances are not only empowering doctors to pick the exact drug most likely to work for a specific patient, but also handing pharma companies unprecedented insight into patient sub-populations with which to identify the right targets. “Don’t be at all surprised if large-panel NGS tests end up providing the foundational data that informs the bulk of future cancer drug innovation,” ventures Zook, who points out that the fast-growing segment already accounts for a full 30 percent of NeoGenomics Labs’ total business.
Competitive Clinical Trials Arena
Some industry insiders are, however, fretting that America might be gradually losing its competitive edge when it comes to cancer trials. Though North America, led by the US, held a 42.5 percent share of the global oncology clinical trials market in 2025, the Asia-Pacific region has been growing much faster: registering an impressive 7.1 percent CAGR on the back of lower costs, regulatory upgrades, and large patient pools.
“Recently, we have witnessed significant changes within the American cancer-related clinical trial landscape shaped by a variety of factors,” reflects Dr William Hait, chief scientific advisor for the American Association for Cancer Research (AACR). “On a positive note, we have seen the rise of private Phase I businesses with first-rate medical oncologists who focus exclusively on early-phase studies. They are highly efficient at accruing patients and delivering clean data,” he remarks.
At the same time, Hait perceives that rival clinical trials destination markets such as China are providing ever-stiffer competition. “There are increased demands on American academic physicians to devote more time to clinical practice to a point where, in some cases, there is less time devoted to clinical research. Consequently, even in cancer centers with a first-rate clinical trial infrastructure, the process tends to be slower and more expensive than in Asian countries such as China,” he explains.
Indeed, the cost per patient in a US oncology trial is now roughly USD 60,000–100,000, compared to only 20,000–30,000 in Asia-Pacific regions, while the speed to recruit is also a pulling factor. Large, centralized cancer hospitals in cities like Shanghai and Beijing can enroll hundreds of patients in a matter of weeks — a process that would ordinarily take many months in the fragmented US system.
Michael Petroutsas, president and head of Astellas Pharma US, agrees, warning that “even under normal circumstances the current system can be slow and resource constrained. For the US to keep pace with the advances in fields like cell and gene therapy, regulatory processes need to become more agile and efficient. Faster, more adaptive review frameworks will be essential for both advanced modalities and for traditional small and large molecules.”
Nonetheless, many market insiders are not overly concerned. “Oncology drug development has become increasingly international over time, with the development of multiregional clinical trials now regarded as the gold standard, rather than data from a single country,” reminds Dr Richard Pazdur, former head of the Oncology Center of Excellence (OCE) within the US FDA.
“While it may be true that growing number of trials are being conducted with a significant enrollment from China, and though the FDA has limited experience with some of these trial sites, we do recognize the importance of building confidence in the trial results from these research Centers. After all, these activities enable us to assess safety and efficacy across various regions and patient profiles, thus giving greater insight into consistency of results,” he affirms.
In fact, the FDA has been a major protagonist in fostering international regulatory alignment on oncology drug development through its flagship ‘Project Orbis’ initiative. “Out of recognition that cancer is a fundamentally global problem, Orbis allows different countries to review the same cancer drug at the same time thus disseminating knowledge and accelerating patient access. Not only is this facilitating more consistent regulatory decisions internationally, but it’s a voluntary program for drug sponsors, so with 633 global applications for 79 oncology products, that indicates substantial industry engagement and traction,” he enthuses.
Moreover, it’s the quality of the research that counts most at the end of the day rather than volume of trials. “Ultimately, in my view, it’s probably time to move away from considering clinical trials as a commodity,” concedes Hait. “Instead, we would do better focusing our attention on hosting the most sophisticated and innovative science, which plays to the underlying strengths of US investigators anyway,” he posits.
Sustaining Access
Further illustration of America’s leadership in the war on cancer can be witnessed in the country’s strong track record in getting state-of-the-art oncology therapies to the patients that need them. The FDA’s median review time for novel cancer drugs is significantly faster than the EMA’s (207 as opposed to 422 days), and thanks to aggressive early screening and rapid adoption of the most cutting-edge treatments, the nation today enjoys some of the world’s highest survival rates.
Part of this success no doubt boils down to having a fully-fledged and highly structured supporting infrastructure in place that today spans the full length of the drug development value chain and subsequent care continuum. This includes, among other entities, a one-stop-shop for regulatory review in the form of the FDA’s OCE, the NCI providing streamlined public funding, and a Comprehensive Cancer Network (NCCN) of 33 top cancer Centers nationwide, tasked with upholding the ‘gold standard’ of clinical practice guidelines.
“These constitute frequently updated evidence-based, expert consensus-driven recommendations for use by practitioners in the clinic with the aim of advancing quality, effective, equitable, and accessible cancer care and prevention throughout the country,” explains Crystal Denlinger, the NCCN’s CEO. “Moreover, we also disseminate other validated and standardized guidance to other stakeholders across the spectrum from screening, early detection, and risk assessment all the way through diagnosis, treatment, and into survivorship,” she adds.
One case in point is BeOne Medicines. The US is the company’s largest and fastest-growing market, and a vital node in its domestic and global access efforts. “In the US, our footprint spans coast to coast, from our biologics and clinical R&D hub in Hopewell, New Jersey, to our biomarker laboratory in San Carlos, California,” explains General Manager North America Matt Shaulis. “These facilities allow us to advance research, development, and innovation while also strengthening our domestic supply chains.”
Shaulis continues, “A great example of this integration is our end-to-end US manufacturing for our flagship blood cancer medicine. It is produced in Kentucky and Missouri and packaged in Illinois and Pennsylvania. This illustrates just how central our US operations are to BeOne’s global network and to ensuring reliable access to innovative therapies for patients everywhere.”
However, the ability to sustain healthcare equity becomes challenging when the science and technology is transforming so rapidly. “Diagnostic innovation in the oncology space often moves faster than clinical guidelines. New technologies typically emerge in academic Centers and then migrate gradually into the community over time, which is why the adoption of solutions based upon MRD are still yet to properly permeate,” reasons NeoGenomics’ Zook. “That’s why it’s always important for companies like us to look at the world through the eyes of a practicing community oncologist whose setting, turnaround times and need for reliability are very different to those of an academic Center,” he adds.
QIAGEN’s Arnold very much concurs. “Presently, the most avant-garde cancer diagnostics in the country remain highly centralized in a small number of large highly specialized labs that handle the majority of oncology testing. However, this model does not reflect how care is actually delivered, as most patients are treated locally. The resulting disconnect between centralized testing and decentralized care creates delays and disparities in access, which ultimately affects patient outcomes and the practical impact of innovation,” he warns.
While he accepts that next-generation sequencing should become the dominant approach in oncology and heralds the future when broad, multiplex genomic profiling is required, he also sees an important continued parallel role for more well-established approaches. For instance, Digital PCR offers high sensitivity and precise absolute quantification, rendering the technology particularly well-suited for targeted applications and longitudinal monitoring where clinicians are tracking subtle changes over time.
“The objective should, of course, never be to replace breakthrough innovation, but rather to complement it by always aligning the technology with the clinical question. Addressing these disparities will be essential if the great discoveries in cancer our nation is making are to become a routine and accessible part of everyday care and thus be able to fulfil their true potential,” he concludes.
