In 2023, the global clinical trials market size was worth over US$57 billion and is projected to reach nearly US$91 billion by 2033, with a compound annual growth rate (CAGR) of 4.67% between 2024 and 2033. In the United States (U.S.) specifically, the clinical trials market was valued at U.S. $28 billion. Every January, the drug development industry kicks off the new year with the JP Morgan (JPM) Healthcare Conference, which often serves as a barometer to set the tone for market predictions and expectations over the upcoming year in clinical development and research. The meeting reflected a sense of cautious optimism, coupled with the uncertainty of what the new year could hold for the healthcare and biopharma industries as the US acclimates to its change in federal administration. 

Here, we will discuss the top five market predictions and trends to anticipate this year in the biopharma and biotech sectors, as well as input from TFS HealthScience CRO’s (Contract Research Organization) January poll series. Continue reading to learn more about the key trends to expect in 2025 for clinical trials and global clinical trial management! 

 

1. Growing Interest in Functional Service Provider (FSP) CROs for Clinical Trials

CROs that feature services based on functional service provider (FSP) models offer sponsors a dedicated team of clinical research professionals with specialized expertise in clinical trials; these services have expanded in recent years and are predicted to become more popular in 2025. Long-standing FSP CROs like TFS use a strategic outsourcing approach to deliver access to experts in niche functions, such as data management, biostatistics, clinical monitoring, or medical writing. The anticipated surge in FSP adoption this year is likely due to the need for more flexible and cost-effective solutions as clinical trials become progressively more complex and resource intensive.  

FSP models are especially beneficial in an uncertain market, which appears to be the current tone of the clinical research industry, because they allow biopharma companies the flexibility to adjust resource utilization based on project demands. The rise of inflation in recent years has also introduced changes to economic priorities, pushing several industries to streamline costs where possible. Based on this, sponsors are increasingly interested in using FSP models to avoid the overhead costs associated with maintaining full-time staff for certain trial functions, while still maintaining access to high-quality global talent pools.  

To learn more about the FSP services model, click here. 

 

2. Artificial Intelligence Continues to Shape the Evolution of Clinical Trials

The growing influence of artificial intelligence (AI) in the clinical research industry undoubtedly represents another market prediction for 2025, with its practical applications helping clinical trials become more automated, efficient, and results-driven. AI garnered significant public interest in 2024, and a survey from GlobalData’s State of the Biopharmaceutical Industry 2024 Mid-Year Update, found that 16% of industry professionals ranked AI as the third most impactful industry trend for 2025, behind anti-obesity drugs and real-world evidence (RWE).  

Several sponsors and innovative CROs in therapeutic research are already exploring how trials can be integrated with AI-powered solutions to significantly reduce the time and cost associated with patient recruitment, data analysis, and protocol optimization. For example, this 2024 Nature article introduces TrialGPT, an end-to-end AI-powered framework that uses large language models to match potentially eligible patients with suitable clinical trial options. It first performs large-scale filtering to retrieve candidate trials, then predicts patient eligibility based on trial criteria, and finally generates trial-level scores to indicate the best matches. Read more about TrialGPT here! 

Additionally, the ability of machine learning (ML) models to analyze vast amounts of unstructured data from multiple sources, such as electronic health records (EHRs), can automate routine tasks, such as medical coding and adverse event reporting, to help free up valuable staff resources for more complex trial management activities. Earlier this month on January 6, the U.S. Food and Drug Administration (FDA) released this draft guidance emphasizing key considerations and recommendations for AI-enabled medical devices going into 2025 and beyond. As more guidance on these new technologies emerges, we will likely see greater transparency and more standardized, validated approaches to AI integration in clinical trials this year.  

 

3. Wearable Technology Becomes a Staple for Patient-Focused Trials

Remote trial technologies like mobile health (mHealth) or wearables are also expected to become more important as the industry increasingly embraces the concept of patient-centric clinical trials. This patient-focused approach to clinical research highlights the need for more convenient and accessible ways to collect real-world data. Wearable technology offers a solution by providing continuous, real-time health monitoring without requiring frequent clinic visits, reducing transportation burdens and making trial participation more convenient for patients.  

Coupled with the growing role of AI- and ML-powered digital tools, wearables are becoming equipped with more sophisticated analysis and predictive capabilities that aid in faster clinician decision-making, especially when integrated with EHRs or trial management systems. This ability to collect continuous, objective data through wearables is also reducing reliance on subjective patient-reported outcomes, leading to more reliable trial results. As regulatory acceptance and guidance becomes more commonplace for digital health technologies and patient-centric clinical trials, offering these tools will likely provide a competitive edge for CROs in the 2025 market.  

 

4. Rare Disease Research Garners Increasing Attention in Clinical Development

The increasing focus on rare disease research in clinical development represents another significant shift anticipated in the biopharma industry for 2025. With over 7,000 known rare diseases affecting approximately 400 million people globally, more pharma companies are choosing to expand into this space to address the therapeutic gaps faced by these underserved disease populations. The combination of regulatory incentives, such as orphan drug designations and expedited review pathways, has made rare disease research far more commercially viable despite smaller patient pools. Based on this, the projected sales revenue for rare disease therapies could be as high as US$135 billion by 2027.  

Other factors driving research into previously untreatable conditions include the emergence of advanced technologies, such as gene therapy and precision medicine approaches, as well as a greater availability of RWE. Improved diagnostic capabilities because of more widespread genetic testing opportunities are also enabling earlier and more accurate identification of rare conditions, making recruitment for these clinical trials more feasible. Although sponsors and CROs would need to manage the high clinical development costs in this therapeutic area, the potential for premium pricing could offset this caveat and offer a sizable return on investment. Most importantly, as researchers better understand rare diseases, these insights could lead to important applications for more common diseases as well.  

Read more here about the landscape of rare diseases from 2024. 

 

5. R&D Efforts Shift Towards Targeted Approaches over Traditional Cancer Therapies

The final market prediction for 2025 involves the biopharma industry’s strategic pivot towards more targeted therapeutic approaches in cancer treatment. The reason being recent clinical successes with antibody-drug conjugates (ADCs) and bispecific antibodies have demonstrated superior efficacy compared to traditional chemotherapy. This is leading sponsors to reallocate a greater proportion of their R&D resources towards these promising platforms. With researchers gaining a better understanding of tumor-specific molecular markers and advances in biomarker testing and companion diagnostics, patient selection for targeted therapies is becoming more precise, making them more commercially valuable. Throughout the year, we could see many companies adjust their oncology pipelines to prioritize precision oncology approaches with targeted therapeutic clinical development. 

To learn more about the recent successes in clinical trials for targeted cancer therapies, click here. 

 

TFS CRO’s January Poll Series: Insights into Key Trends in Clinical Trials for 2025 

To kickstart the new year, TFS CRO conducted a series of January polls to gain valuable insights into key market trends expected by industry experts in clinical trials in 2025. Clinical research professionals from various CROs, biotech or biopharma companies, and academic institutions were surveyed for their input across four polls. 

Here is a summary of our primary findings:  

1. Top Priority for Driving Impactful Progress in Clinical Research: “Leverage AI for smart trials” (40.7% of respondents) was deemed the greatest priority, followed equally by “Expand access to patients” and “Accelerate trial timelines” (both 22.2%), then “Design patient-first studies” (14.8%).  
2. Biggest Driver of Progress in CNS (Central Nervous System) Research: “AI-driven trial success” (39.4% of respondents) was the most significant trend identified, followed by “Breakthroughs in Alzheimer’s” (33.3%), “Access to rare disease trials” (15.2%), and “Decentralized trial methods” (12.1%).  
3. Area with Most Progress Expected in Dermatology Research: “AI for skin treatments” (51.2% of respondents) was overwhelmingly chosen as the research area most expected to see progress, followed by “Advances in atopic dermatitis” (20.9%), “Faster rare disease trials” (16.3%), and “Real-world patient data” (11.6%). 
4. Biggest Driver of Progress in Oncology Clinical Trials: “Optimizing trials with AI” (50.0% of respondents) was the most significant trend identified, followed by “Expanding immunotherapy access” (22.2%), “Approving rare cancer drugs” (19.4%), and “Using decentralized methods” (8.3%). 

 

Conclusion 

As we progress through 2025, the biopharma and clinical research industry can expect to see several exciting new developments, spanning increasing adoption of FSP models, AI integration, wearable technologies, rare disease research, and targeted therapeutic approaches. These collectively represent a promising market shift towards more efficient, patient-centric, and technologically advanced clinical development. Based on market predictions, sponsors and CROs will continue to streamline trial operations and reduce costs, while striving to accelerate the development of innovative treatments that could significantly impact patient care.  

To read more about the current trends expected in the research and healthcare sectors this year, visit this summary of recent insights from JPM 2025. 

 

About TFS HealthScience CRO 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey across several therapeutic areas, including Rare Diseases & Orphan Drugs, Oncology, Neuroscience, and more. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients with robust FSP services and strategic resourcing solutions (SRS). Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!