2025 is set to be another significant year for clinical trials. According to GlobalData’s Clinical Trials database, as of January 2025, there are 3,213 trials planned to start this year – including 823 in Phase I and 1,102 in Phase II. As with 2024, oncology is expected to remain the top therapeutic area, accounting for 946 trials, followed by central nervous system with 686 trials, then cardiovascular some way behind with 258 trials.
The headwinds and tailwinds facing these trials include reduced clinical investments, increased and targeted uses of wearables to engage participants, expanded usage of AI, and enhancements in rare disease research. To learn more about these trends expected to shape the 2025 clinical trials landscape, we spoke to Jennifer Duff, Executive Vice President and General Manager of Zelta by Merative Clinical Trials Solutions, for expert industry insight.
Investment headwinds and increased FSP engagements
Five years out from the pandemic, many pharma companies continue to face mounting issues around clinical trial investment in 2025. Contract research organisations (CROs) must deal with these increased levels of uncertainty buffeted by possible changes resulting from the 2024 US election that could create further instability in the market.
“There’s anxiety around what potential changes could be made to the FDA and regulatory bodies, as well as what impact that might have on the execution of clinical trials or getting drug approvals to market,” says Duff. “These elements are introducing risk from an investment perspective.”
CROs are already striving to maintain trial volumes, which has resulted in increased layoffs, in addition to significant layoffs seen in 2024 in the sponsor segment. Given this continued risk of financial instability, more sponsors are pivoting towards greater control and a greater desire to manage how funds are spent – including doubling down on their functional service provider (FSP) models. For CROs who do not offer FSP services, this increases pressure on maintaining their portfolio of active trials.
“With the layoffs that are happening, the instability in the market, and then the potential risk around regulatory impact, you’ve got a perfect storm,” adds Duff. “Companies are going to hold onto cash and implement more risk mitigation strategies to manage their spend.”
As a result, the FSP for clinical trials market, which has expanded rapidly in recent years, is likely to grow further in 2025 as sponsors seek greater control and ownership over their studies. Sponsors are also continuing to turn to digital platforms as a key tool in efficient data management, reducing costs while simultaneously granting sponsors greater flexibility without loss of control.
Sponsors are increasingly seeing the benefits of the cloud and software as a service (SaaS), especially within small to mid-sized pharma companies. These solutions are now affordable enough to allow sponsors to control it directly themselves. This allows sponsors to rely on CROs or establish FSP engagements for the services side, all of which is a more controlled paradigm for them.
The continued growth of wearables in clinical trials
When it comes to standards of care, clinical trials often follow broader healthcare trends. A prime example is the use of wearables. Wearables have become used more frequently in healthcare post-COVID, particularly for diabetes and other areas where quality of life is a key measure of successful treatment. This trend has made wearables more common in clinical trials, too.
This is a major shift in an industry traditionally hesitant to embrace new technologies. Improved patient compliance and patient outcomes are notable advantages of wearables, especially in decentralized and hybrid clinical trials, and these kinds of results are why we can expect to see continued investment in wearables for clinical trials in 2025.
“In 2025, I think we’ll see continued investment in wearables, led by site networks, healthcare systems, hospitals, and governments because they’re going to put their money towards the solutions that drive the best results for patients and clinicians,” adds Duff.
Wearables offer an opportunity to improve participant data collection. Rather than forcing patients to manually submit data at predetermined sites, the device itself collects and transmit that data for them. Wearables are also improving visibility into adverse events like falls. The flip side of this is that wearables may end up generating unprecedented volumes of clinical trial data that can become a challenge to manage. AI has been touted as a potential cost-effective way of managing that data and improving the overall quality of outputs.
AI in 2025: From hype to practical deployments?
AI use is growing globally, being infused into every aspect of daily life, and clinical trials are no exception. Given the unprecedented increase in data volumes over the last 15+ years, there is much hope pinned on what AI could deliver in 2025 in the clinical trial space. However, despite much of the hype around generative AI and large language models to innovate in clinical studies, this technology is still in its infancy in terms of delivering tangible outcomes. All the more reason why 2025 can be the year that AI becomes more practical for clinical trials, through precision use cases that result in measurable progress in research efficiency, quality, and overall outcomes.
This thinking was reflected in GlobalData’s State of the Biopharmaceutical Industry 2024 Mid-Year Update. The survey found that, despite so much hype surrounding AI, a relatively low 16% of respondents ranked it as the third most impactful industry trend heading into 2025, behind anti-obesity medications and real-world evidence. This sentiment could reflect a disconnect between the wide-ranging buzz about AI’s theoretical applications (e.g., Gen AI and large language models) and the relatively underdiscussed, but more impactful deployments of targeted and purpose-built supervised machine learning models.
From simplifying medical coding to spotting patterns in patient-reported data and reducing operational inefficiencies, AI holds much promise for clinical trials – and it requires a thoughtful, judicious, and targeted approach to ensure use cases are optimized to deliver real, measurable value.
“AI does have huge potential, and it could pose a huge benefit to the industry. I think the best way to realize a return on investment is to approach it in a very measured manner,” Duff says. “Companies need to be thoughtful about use cases, start small, and keep it simple, then graduate to more complex use cases over time with expectations for ROI in each phase.”
Continued investments in rare disease research will require nimble clinical data management platforms to offset costs
While oncology is set to remain the leading focus in clinical trials, rare disease is becoming an increasingly prevalent area of study across therapy areas. This growth is projected to continue throughout 2025, with forecasted sales for rare disease drugs predicted to reach nearly $135bn by 2027, according to GlobalData. However, clinical trials for rare diseases must overcome the challenges of limited trial data, as well as justifying sponsor investment to reach the participants – especially important given the headwind of reduced overall investment in the field.
“In rare diseases, you have a very small number of target patients. It requires a large investment to treat a very small proportion of the population,” says Duff. “You need to have processes optimized so you can get the most out of every dollar you spend.”
Clinical data management and acquisition solutions such as Zelta by Merative can be the key to unlocking efficiencies in rare diseases and other costly niche clinical trials. With flexibility and usability built into the software, Zelta can help sponsors and CROs streamline efficiencies and reduce costs, allowing them to get the most out of every dollar invested in expensive research areas such as rare disease trials. One CRO running cell and gene therapy trials was able to leverage the Zelta platform in reducing its trial database costs by up to 30%, reaping significant savings in a niche and expensive area of research.
With risk aversion continuing due to the changing regulatory landscape and continued investment headwinds, along with increasing investment demand in new opportunities for wearables and AI, 2025 is expected to be a complex clinical trial landscape. Getting ahead of these challenges and finding the right partners is vital to ensure your clinical study development continues on track and is positioned to generate real results.
To gain more on Jennifer’s perspective on how supervised machine learning could define AI uses in clinical trials in 2025, download the report below.
