Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. From the pre-clinical testing and lead discovery, to human testing and post-marketing surveillance, CROs offer a comprehensive array of services that sponsors now commonly seek out. There’s no doubt the market value for CROs is trending upwards; in 2022 alone, the CRO market was estimated to be worth US$56.7 billion, projected to grow at a compound annual growth rate (CAGR) of 6.9% between 2023 and 2032. By 2032, this value is expected to reach US$108 billion. However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? In this article, we will explore this question, discussing what role CROs play, what growth factors are driving their prevalence, and expected trends influencing CRO partnerships in the future.
What is the Role of the Contract Research Organization (CRO)?
CROs function as a strategic partner, taking on the responsibility associated with managing and conducting a clinical trial, as needed by the sponsor. Any one or more of these trial-related duties and functions can be transferred by the sponsor to the CRO, as long as it is specified clearly in writing. However, it is important to note that even when the conducting of a clinical study is outsourced entirely to CROs, the sponsor in question is still ultimately responsible for maintaining quality throughout all stages of the clinical trial lifecycle.
The greatest advantage of relying on a CRO’s expertise and what has helped make them indispensable is their ability to offer specialized services that are too niche or costly for pharma or biotech companies to obtain in-house. For example, leading CROs will typically provide teams of experts who assist with various complex clinical trial tasks, from biostatistical analysis and data management, to site selection and regulatory submission guidance. These services, and others, are key elements for achieving successful trial outcomes when attempting to bring an interventional product to market and CROs play a significant role in ensuring this success.
Understanding the Numbers: How Many Clinical Trials Utilize CROs?
Every year, thousands of clinical trials take place, and a large percentage of these are overseen by CROs. According to The New Trends of Global Clinical Development Outsourcing Market report, data collected between 2015 and 2020 estimated CRO outsourcing would account for 72% of all clinical trials, suggesting nearly three in every four clinical trials are run by a professional CRO partner. As of 2023, ten large, mid-size, and smaller CROs were included in a review of studies registered in clinicaltrials.gov, in which they were listed as collaborators.
Although clinicaltrials.gov does not represent the entirety of the clinical trial landscape, it does suggest that more studies are outsourced to larger CROs. However, it is important to consider that, although major CROs may have a wider global reach with larger facilities, small to mid-sized players are also needed in the market to address the need for an organization with niche technical capability in specific research areas.
| Largest CROs | Mid-Size CROs | Smaller CROs |
|---|---|---|
| Quintiles: 111 studies | Labcorp: 31 studies | inVentiv Health: 8 studies |
| Parexel: 63 studies | Medpace: 26 studies | Chiltern: 6 studies |
| INC Research: 50 studies | PRA Health Sciences: 28 studies | Charles River Laboratories: 2 studies |
| PPD: 56 studies |
Overall, these numbers reflect the growing importance of CROs in the field of clinical research, underscoring the critical role their strategic partnership with sponsors plays.
Factors Driving the Growing Prevalence of CROs
Several factors contribute to the mounting reliance on CROs for the management of clinical trials.
Cost efficiency for greater R&D investments
One of the primary reasons sponsor companies are turning to CROs is the potential for significant cost savings. Developing a new drug is an expensive and time-consuming process, taking up valuable resources for sponsors that could otherwise be put towards supporting R&D innovation and strengthening the company’s core competencies.
Rising complexity of clinical trials
Another key driver is the escalating complexity and cost of conducting these trials. As regulatory requirements become more stringent and drug development processes become more complex and specialized, sponsor companies often lack the necessary expertise to manage these trials effectively and efficiently. Because CROs have established considerable knowledge and experience in specific therapeutic areas or in conducting certain types of clinical trials, sponsor companies are able to access a level of expertise that may not be available in-house.
Increasing globalization of clinical research
As trials are increasingly conducted in multiple countries simultaneously, the need for an organization with a global presence becomes more pressing. Many CROs have operational sites in multiple countries, allowing sponsor companies to conduct trials in diverse locations and access a broader pool of potential trial participants. Having a global presence also allows CROs to navigate the regulatory complexities of different regions.
The Future of Contract Research Organization Partnerships
As the competitive and rapidly evolving clinical research industry continues to become more specialized, sponsors will require the unique expertise of CROs, driving their demand well into the future. The Clinical Trials Outsourcing Market – Global Outlook & Forecast 2022-2027 report lists the following key trends in the future of the CRO global market.
- A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.
- The growth of patient populations worldwide will increase the demand for advanced treatments, driving the need for CRO services and support.
- AI is revolutionizing clinical trials, especially among large CROs, providing technological advancements for sponsors in a competitive research landscape.
- The rise of start-ups in the biotech industry will increase the demand for outsourcing clinical trials.
Conclusion
Outsourcing of clinical trials to CROs is not only a trend that is expected to continue in coming years, but it is also projected to grow significantly in value. A primary reason driving strong partnerships between a sponsor and its CRO is the ongoing need for efficiency and expertise in the clinical trial space. As a result of their specialized expertise, as well as the numerous factors driving the need for CRO outsourcing, these organizations have become an irreplaceable asset in the drug development process. CROs will continue to play a dominant role in influencing the clinical trial landscape, contributing to future advancements in pharmaceutical research and innovation.
About Vial: The CRO for Biotech, Powered by Technology
Vial is a next-generation, tech-first CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors. Our mission is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives. Our proactive team of innovators, engineers, and ClinOps (Clinical Operations) leaders have built a global, full-service CRO powered by intuitive end-to-end technology. Contact a Vial representative today to discover how we can make a difference for your next clinical trial!
