The global immuno-oncology (IO) market has shown remarkable expansion over the past decade, reaching an unprecedented commercial scale and driving significant innovation and research across the biotech industry.
According to GlobalData, as of May 2025, Phase I/II trials constituted the largest share of the immuno-oncology pipeline, followed closely by therapies in Phase II. For the late-stage pipeline products, 384 clinical trials were ongoing in Phase III, and 63 were in Phase II/III of development. Meanwhile, the total market is expected to reach $220 billion by 2030, driven primarily by checkpoint inhibitors, which currently hold 72% market share.
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There are currently 89 novel marketed immuno-oncology agents available across the US, France, Germany, Italy, Spain, the UK, Japan, and China. China offers the broadest therapeutic access with 74 approved agents available, significantly more than the 53 agents accessible in the US, while non-small cell lung cancer is the indication with the highest number of approved immuno-oncology treatments.
But behind this impressive growth lies a number of pain points that are frequently hindering progress in IO development. From regulatory issues to operational hurdles, clinical trials in immuno-oncology face several challenges that can affect their effectiveness and execution.
Addressing challenges in immuno-oncology trials
All the regulatory principles applied to the clinical development of conventional therapies are also applicable to IO agents. However, immuno-oncology requires extensive technical specificity to assess quality, safety, and efficacy, and there is a long precedent for IO therapies that target cancers of high unmet need to file for regulatory approval with Phase II data.
The FDA is actively evolving its regulatory approach to support the rapid approval of promising IO therapies, including fast-track designation to accelerate the review of therapies that address unmet clinical needs, expedite the review process, and even allow for rolling review if the product is effective. Breakthrough therapy designation, meanwhile, offers all the benefits of the fast-track status but requires preliminary clinical evidence that the therapy is superior to existing treatments.
But the FDA’s limited experience in regulating novel immuno-oncology therapies can also pose a challenge, with the uncertainty in regulatory pathways often slowing down the approval process. Breakthrough therapy products also require a deeper integration with the FDA to optimize the therapy development process and expedite approvals.
Gaining third-party reimbursement and achieving market acceptance for new immuno-oncology products can prove difficult, too, especially given the competitive landscape. According to GlobalData’s Thematic Intelligence: Immuno-oncology (2025) report, a lack of reimbursement is seen as the most significant barrier to access across all specialties and countries, followed by the need for specialist center requirements.
Patient recruitment and site selection
Another critical hurdle for sponsors is site selection and patient recruitment and access. The complex nature of cancer and its treatments results in strict eligibility criteria for trial participants. Those recruited must be willing to participate in the trial and be able to access the study site physically. Given the variations in disease progression rates, this limits the trial timelines and potential patient pools. These factors can lead to small sample sizes, putting the trial at risk of delivering generalized, biased or unreliable results, and even failure.
But it is not only patients who need to be convinced of the viability of oncology research, with over 50% of sites having declined a trial due to concerns about participant access, available resources, or timelines, according to the Society for Clinical Research Sites. What’s more, the complex study designs typically associated with IO add further to the operational burden, often deterring participation and complicating trial management.
Advances in technology, however, have made it easier to collect patient and trial data, although many sites remain concerned about the cost burden of collecting and integrating such large volumes of data across a wide variety of operational and clinical datasets. Gathering information ranging from medical history to demographic, consent, and imaging data is placing an increased burden on patients and an obligation on sites and sponsors to store it safely and use it optimally.
Partnering for success in immuno-oncology trials
Achieving success in immuno-oncology clinical research requires a strong partnership with an established contract research organization (CRO). Key attributes to look for include technical readiness, modern infrastructure, the experience of personnel in the specific market segment, know-how in providing innovative solutions, knowledge of the regulatory aspects of the market of interest, a global presence, and price competitiveness.
Novotech is a leading CRO operating globally with strong clinical teams and deep geographical knowledge that enables it to deliver quality services to biotechnology companies worldwide. It fully leverages its global network by deploying a shared service center in China, where its well-established systems and processes can bring down costs without compromising on quality.
Approximately half of Novotech’s projects are in oncology or immuno-oncology, and, to widen patient participation and source accessible sites, it has forged partnerships with more than 5,000 trial sites and long-standing relationships with investigators who can assist in identifying and recommending suitable trial locations. Novotech also offers access to diverse patient populations, including those from underserved groups who would typically face barriers to participation in clinical trials. As such, trials are more likely to achieve completion, retain patients, produce statistically powerful results, and meet regulatory requirements.
Novotech provides a regulatory consulting service that facilitates gap assessment and strategy, fast-track designations, US agent services, and briefing packages, as well as a drug development consultancy to design clinical trials. It is also making significant investments in artificial intelligence, advanced analytics, and cloud-based software platforms to elevate its clinical research capabilities – supported by strategic partners – to improve data visibility and offer advanced trial capabilities in immuno-oncology and beyond.
To find out how Novotech can support your oncology and immuno-oncology research and development, download the free paper below.
