Real World Evidence In Clinical Trials In The Global CRO Market

1 Oct, 2019

Contract Research Organizations (CROs) are increasingly incorporating real world evidence in their clinical studies. Real world evidence (RWE) is the data collected from sources outside clinical trials, including the monitoring of social media, mobile and wearable health tracking devices, and electronic medical records. These insights from patients can better help CROs tailor clinical protocols to apply to real world circumstances. According to the Tufts Center for the Study of Drug Development, large pharmaceutical, biotechnology and CROs plan to increase staff for collection and analysis of real-world data by 25% between 2017 and 2020.

Contract Research Organizations offer end-to-end solutions in conducting clinical trials for pharmaceutical, biotechnology and medical device companies, collectively referred to as sponsors. The core services offered by CROs to biopharmaceutical companies include initial drug discovery solutions, toxicology studies, bio-analytical services, central laboratory, site monitoring, data management services, vigilance, bio-statistics, study and development program design and consulting, regulatory affairs and a variety of post-marketing surveillance services. The global CRO market is expected to grow from $49.6 billion in 2018 to $70.2 billion in 2021 at an annual growth rate of more than 12%.

CROs are forming strategic partnerships with large biopharma companies to establish a strong CRO-sponsor relationship. Strategic partnerships help CROs by providing them with improved visibility, higher network utilization and expanded capabilities. On the other hand, strategic deals offer sponsors attractive pricing, expertise in disease areas and regulatory compliance, improved global reach and accelerated time to market. For instance, in 2015, Parexel International formed a strategic alliance with Optum, a business division of UnitedHealth Group. Other strategic partnerships between CROs and their sponsors include Quintiles-Ascendancy Healthcare, CRS-Bayer, LabCorp-BMS and ICON-Pfizer. According to a study from Parexel International, about 85% of biopharmaceutical executives viewed strategic partnerships as positively impacting CRO-sponsor relationships.

Increase in merger and acquisition activity has also been a significant trend in the CRO market. With contract research organizations becoming indispensable to the pharmaceutical industry, CROs are trying to be the one stop solution for all the needs of its sponsors in order to attract business from all aspects of drug development lifecycle. Many CRO mergers are driven by the desire to add additional therapeutic expertise and service capabilities to their offerings or to expand their geographical presence. Historically, the CRO market was fragmented but increasing M&A activity has led to the consolidation of the market, with a few CROs holding a considerable share of the market. A recent example of such an acquisition was Laboratory Corp of America acquiring a privately-owned contract research organization called Chiltern, for $1.2 billion in July 2017.