Introduction 

The clinical research of contract research organizations (CROs) is influenced by technological advances, emerging health needs, regulatory requirements, and shifts in research priorities. Experts identify three critical issues for clinical research in 2024: the ongoing lack of resources, the demands of implementing multiple tech platforms, and the increasing application of artificial intelligence (AI) and machine learning (ML) in clinical trials. Let’s review the key trends shaping the future of CROs, trends that reflect the shift toward patient-centric, data-driven, and efficient approaches that leverage tech while responding to changing health needs. 

 

Clinical Trial Market Insights  

Analysts project a compound annual growth rate (CAGR) of 8.7% for the global clinical trials market, growing from an estimated $48.2 billion in revenue in 2023 to $73.2 billion in 2028. Key growth drivers include the increasing number of clinical trials and drugs in the pipeline and rising investment in pharmaceutical research and development (R&D). The shortage of skilled professionals for clinical trials, however, may constrain market growth and directly affect CROs as they need help hiring and retaining good people.  

Recent analysis projects a CAGR of 4.96% for the U.S. clinical trials market to surpass $35.1 billion by 2030. In addition to increasing R&D investments, the U.S. market is driven by a shift towards personalized medicine and growing disease variation and disease prevalence. Challenges in conducting trials during the COVID-19 pandemic led to effective and efficient approaches, including the application of AI tech in clinical research.  

Notable trends in the landscape of U.S. clinical trials are the adoption of digital health technologies and decentralized clinical trials (DCTs), growing use of real-world data (RWD), personalized medicine, increasing application of AI and machine learning (ML), and development of cell and gene therapies. Additionally, there are trends toward adaptive trial designs, patient-centric trials, international collaboration, and an emphasis on diversity. 

 

Increasing Drugs in the Pipeline and Rising Investments in R&D 

Analysis of the global clinical trials market reveals that leading pharma companies seek to enhance R&D efficiencies through research collaborations and investment for long-term returns. Many pharma and biopharma companies outsource R&D to CROs to reduce costs and to meet tight drug development timelines. Biotech advancements have also contributed to a sharp rise in novel drug candidates in the pipeline.  

 

Favorable Outlook for Biologics and Biosimilars  

The biologics sector maintained momentum despite the overall reduction in U.S. Food and Drug Administration (FDA) approvals during the COVID-19 pandemic. As part of the global pharma market, the share of biologics, biosimilars, and large-molecule drugs is growing, and with it, the demand for specialty testing services. Biologics and biosimilars require specialty testing, e.g., biomarker testing, and analysts anticipate the increasing demand for outsourcing such testing services to CROs.

 

Heightened Expectations Post-COVID 

To face and overcome the challenges of conducting clinical trials during the pandemic, clinical researchers raised the bar and demonstrated incredible speed and results, which were driven by tech and a focus on diversity. The clinical research company WCG predicts the continued trend of high expectations coupled with traditional resource constraints. Together, these trends call for improvements in site efficiency.

 

Traditional Resource Constraints 

According to a 2024 report by WCG on clinical research trends and insights, there are more clinical trials starting than the number of research sites available to conduct them. Clinical research sites are saturated, and the time needed to perform a study has almost doubled from 14 months in 2020 to 24 months in 2023. Site enablement solutions can enhance efficiency by reducing administrative burdens and start-up delays. Additionally, the prevailing constraint of hiring and retaining talent for research sites will continue in 2024.  

CROs also face a shortage of skilled professionals. In direct competition with drug companies, medical device makers, and research institutes for talent, CROs lacking the right people may also have the knock-on effect of delaying the adoption of new tech and methodologies. CROs that can, invest in AI and ML to reduce the time and cost of clinical studies. AI is already transforming research and clinical practice, e.g., revolutionizing ophthalmology through automated disease detection and diagnosis, personalized treatment plans, and streamlined workflows.  

 

New Techs Like AI and ML  

The global AI in clinical trials market is estimated at $1.4 billion in 2023, growing at a CAGR of 16% from 2023 to 2035 to reach $8.5 billion. According to Roots Analysis, approximately 600 completed or ongoing clinical trials have utilized AI tools and technologies in the past six years. Upcoming trends in this market include the integration of tools and technologies, e.g., real-world evidence (RWE), blockchain, big data analytics, cloud computing, and the Internet of Things (IoT).  

AI solutions help increase precision, improve testing accuracy, accelerate drug development, improve clinical trial efficiency, and optimize clinical trial outcomes. More specifically, AI in clinical trials helps integrate and analyze large volumes of data and can address issues related to trial design, patient recruitment and retention, site selection, data interpretation, and treatment evaluation.   

Market trends analysis identifies increasing partnerships in the AI in clinical trials market. Recent developments include a collaboration between Texas Tech University Health Sciences Center and Deep 6 AI in August 2023 and a partnership between Premier. Inc.’s PINC AITM Applied Sciences and CRO TFS HealthScience to accelerate global clinical trials and research innovation announced in December of the same year.  

 

Drug Delivery Technology 

Another key trend shaping the future of CROs is the availability of drug delivery technology that enables, e.g., oral, intranasal, and microneedle array patch vaccine delivery systems. Given that the appropriate safety measures are taken, the option of participants administering drugs at home opens the doors to more DCTs and other innovative study designs. 

 

Diversity and Decentralization 

Under the DEPICT Act, the FDA requires pharmaceutical companies to have diversity action plans for clinical trials to improve enrollment of participants from underrepresented populations3. As envisaged by the FDA, DCTs can improve diversity by enhancing trial participant convenience, reducing caregiver burden, expanding access to diverse populations, and improving trial efficiencies. In 2023, the FDA issued new DCT guidance to support innovative trial measures. 

  

At TFS HealthScience, we understand the key trends shaping our future as a CRO and our shared future as partners in clinical research. Would you like more information on our related services and resources? Contact us today to start the conversation!