Contract research organizations, also known as CROs, provide outsourced clinical research and development services to pharmaceutical, biotechnology and medical device companies as well as government/academic institutions. As drug development continues to grow more complex, costly and time-intensive, CROs have become a major part of the solution for life sciences companies looking to supplement internal resources and expertise.
Types of Services Provided
CROs offer a wide range of specialized services across the entire product development lifecycle. Some of the major service areas include:
Preclinical Research and Testing
In the preclinical stage, CROs conduct toxicology, formulation, pharmacology and safety pharmacology studies using animal and laboratory models to evaluate a product’s metabolism, pharmacokinetics and potential toxicity risks before human clinical trials. This work helps characterize the drug’s behavior and safety profile.
Clinical Trial Design and Management
For the clinical trial phase, CROs are heavily involved in designing and managing all aspects of Phase I-IV human subject studies on behalf of their sponsors. This encompasses tasks such as coordinating with investigative sites, managing clinical supplies, collecting and analyzing data, reporting results and more.
Regulatory Consulting and Submissions
Leveraging expertise in regulatory policy and requirements, U.S. Contract Research Organizations guidance and strategic advisory services related to the approval process. They also assemble and submit various application packages to regulatory agencies like the FDA in the U.S.
Biometrics and Data Management
CRO statisticians and data managers oversee the capture, cleaning, analysis and reporting of clinical data generated during trials. Biometricians apply statistical techniques to evaluate safety and efficacy endpoints.
Medical Writing and Publishing Support
For documentation purposes, CRO medical writers are engaged to complete clinical study reports, investigator brochures, patient consent forms and other protocol-related materials. They may also assist with scientific paper/poster publications.
Laboratory and Diagnostic Testing Services
Using specialized laboratory facilities, CROs conduct analytical and diagnostic testing like microbiology, pathology and central laboratory assessments to support clinical and non-clinical drug development programs.
The U.S. CRO Industry Landscape
The United States is home to many top CROs and remains the largest CRO services market globally. According to estimates, the U.S. CRO industry generated over $37 billion in revenue in 2021 and is projected to reach $57 billion by 2026. Some of the leading publicly-traded U.S. based CROs include:
– IQVIA – Formed from the merger of IMS Health and Quintiles, IQVIA is the largest CRO with over 75,000 employees worldwide providing a full scope of services.
– Laboratory Corporation of America (LabCorp) – Through its Covance drug development business unit, LabCorp is a top player in laboratory testing and clinical trials.
– PPD – A large mid-size CRO offering various solutions across clinical development, laboratory services, biometry and more.
– PRA Health Sciences – Another mid-size CRO with capabilities stretching from early-stage to post-approval including data management support.
– Charles River Laboratories – Primarily known for preclinical research services, Charles River also participates in clinical testing through acquisitions.
– Icon – A fast growing, global full-service CRO based in Dublin, Ireland with a large U.S. workforce presence.
Reasons for Growth
Several factors have contributed significantly to the expansion of the U.S. CRO industry in recent decades:
Increasing R&D Costs- Drug development costs continue rising, putting pressure on biopharma companies to consider outsourcing some functionalities. CROs provide specialized expertise at competitive prices.
Regulatory Complexities- Evolving safety and efficacy guidelines at FDA/EMA have made navigating the approval process more difficult, adding to the appeal of experienced CRO partners.
Technology Adoption- Emerging areas like advanced analytics, virtual trials and decentralized programs require new skillsets that established CROs make large investments to develop.
Globalization of Clinical Trials- As biopharma expands geographically, CROs help manage multinational studies by providing localized regulatory knowledge and site/patient networks.
Outsourcing Trend Maturation- Initially hesitant, sponsors now view CRO relationships more strategically for capabilities beyond cost-cutting like project management and drug development insights.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
