In human clinical trials, especially Phase III, represent by far the largest part of the substantial cost of bringing new drugs to market. Over the last several decades as the size, complexity, length, cost and globalization of clinical trials has continued to grow, the importance of contract research organizations (CROs) to the pharmaceutical and biotech industries has increased significantly.
Outsourcing has become of popular way for pharmaceutical companies to utilize on-demand services to improve operational efficiency and therapeutic expertise, cut costs, and add more extensive geographic capabilities.
As demand for their services has intensified, the CRO industry has responded with a growing movement towards consolidation in order to expand capabilities and reach to service large global studies. Recently, there have been a number of noteworthy mergers and acquisitions (M&As):
- InVentiv Health and INC Research merged to form one of the world's largest CROs with net revenues estimated at $3.2 billion.
- Quintiles merged with IMS Health to improve trail execution using patient data, creating a company with market cap of around $18 billion.
- Qunitiles also recently acquired DrugDev, a technology company that has built one of the industry's largest global investigator networks and data sharing platforms, and Wingspan, an eTMF solutions provider.
- PPD acquired Acurian to gain analytics-driven feasibility capabilities.
- LabCorp acquired Covance for collective data resources to drive greater R&D productivity and recently announced its pending acquisition of the CRO Chiltern.
- SynteractHCR was acquired by Amulet Capital Partners.
- Parexel to be acquired by Pamplona Capital.
- PRA Health Sciences acquired Symphony Health Solutions in order to integrate healthcare analytics with their clinical research services.
M&A spending in the CRO industry reached $24 billion in 2016 and according to ISRs 2017 CRO Market Size report, the top 9 CROs now represent 60% of the market share in clinical trials.
One of the more interesting features of this consolidation trend is private equity (PE) companies purchasing CROs. The proliferation of CRO purchases by PE firms in recent years is an indication that wall street understands that significant profit can be made when real improvements are made in CROs after M&As - the CRO market has in fact been one of the best performing sectors in recent years in financial circles.
But just because CRO M&As are good for wall street, does not necessarily mean they are good for the pharmaceutical industry as a whole.
Benefits of CRO Consolidation
Sponsors of large, global phase III clinical trials want a competitive CRO market with plenty of quality CROs with global reach to choose from. These sponsors are also looking to form strategic partnerships and preferred provider arrangements with just a few large CROs, as this is far easier to manage.
From a CRO perspective, winning one large $200-300 million Phase III study can be a huge benefit for the bottom line. As a result, there is pressure within the CRO industry for mergers as a way to quickly expand reach into places like the Middle East, North Africa and parts of Asia other than China and India, in order to be attractive to large sponsors. Additionally, mergers can provide a quick way for CROs to expand their offerings beyond clinical services in order to attract business from all aspects of the drug development lifecycle.
This M&A trend in the CRO industry provides a number of benefits for sponsors:
- Increased Scalability and Geographic Presence – As CROs expand their global reach through M&As, sponsors gain access to on-demand scalability for their clinical trials.
- Access to Additional Therapeutic Expertise and Service Capabilities – Many CRO mergers are driven by the desire to add additional therapeutic expertise and service capabilities to their offerings. As CROs expand their offerings, sponsors gain the ability to access more services from a single partner.
- Technology improvements – The right technologies, especially for site identification, selection, and startup activities, can make a big impact in shortening clinical timelines and the overall success of a clinical trial. By providing economies of scale, CRO M&As can allow CROs to invest in technologies that significantly improve operational efficiencies and data integrity in clinical trials.
- Cost Savings – CRO M&As allow sponsors to have access to "one-stop shopping" with their CRO partners. Sponsors save money through the operational efficiencies that needing fewer partners to run their global trials provides. Additionally, cost savings in the operations of the CRO itself due to economies of scale generated by being a larger enterprise be passed on to sponsors.
Drawbacks of CRO Consolidation
While the CRO consolidation phenomenon is overall a positive trend for the pharmaceutical industry, there are some drawbacks to consider:
- Less Business for CRO Service Providers – Those companies that provide services to CROs (e.g., labs, patient recruitment companies, EDC and IRT vendors, etc.) will lose business as their client's merge.
- Disruptions to Clinical Trials – There really is never a good time to accomplish a merger. The last thing any sponsor wants to hear is that the CRO that is running their trial was just bought out or is undergoing a merger. Inevitably, in-progress clinical trials will be affected by CROs mergers – labs will likely be shut down in the middle of running the trial, requiring transfer of all data, samples and knowledge to a different site.
- Less CROs for Sponsors to Choose From – Presently, there are still plenty of CROs for sponsors to consider when looking for a clinical trial partner. However, if this consolidation trend continues, we may eventually reach a tipping point where there are significantly fewer options available.
While CRO consolidation may create some disruption in the short term, having less CROs available for sponsors may ultimately provide some benefit. With less options available, pharmaceutical companies and CROs may be forced to create more long-lasting, win-win partnerships. Collaborative partnerships will inevitably lead to more operational efficiencies in the drug development process, ultimately reducing the time required to get effective therapies to patients in need.
How do CROs compare to Sponsors?
Is this outsourcing trend justified by gains in study conduct efficiencies? The study startup phase of a trial has been receiving renewed focus from pharmaceutical companies under intense pressure to reduce timelines and abate the rising costs of drug development, as it is notoriously inefficient yet has the biggest impact on overall study timelines, budget, and operational outcomes. In an effort to gather robust, quantitative insights into the factors that drive an effective and efficient site identification, selection, feasibility assessment, and activation process, Tufts Center for the Study of Drug Development (CSDD) conducted an in-depth survey of biopharmaceutical and CRO organizations. The START (Start-up Time And Readiness Tracking) II Study, conducted in early 2017 consisted of 591 individual respondents (313 from sponsors, 139 from CROs) from 403 unique organizations represented.
The study yielded some very interesting insights regarding the current state of the industry:
- Overall, CROs report completing all site related activities 6-11 weeks faster than sponsors – cycle times working with repeat sites are approximately 6 weeks faster, and approximately 11 weeks faster when working with new sites. Note that research suggests that 30% of sites selected for a typical multi-center study are new.
- CROs report shorter cycle times across all individual tasks as well (site identification, site selection and overall study startup)
- CROs report making greater investments in technology than do sponsors and report slightly greater levels of satisfaction with their processes than do sponsors
- Overall sponsors and CROs have generally consistent views in terms of areas of improvement
What do the results of this research tell us about CRO consolidation and whether it is good for the industry? CRO companies outperform sponsors and the most consistent performers also invest more in technology. The data supports the notion that CROs are investing more heavily into study startup technologies that in turn are fueling a faster and more efficient study startup process for clinical trials.
The CRO consolidation phenomenon will likely continue into the foreseeable future with large CROs acquiring smaller, boutique CROs known for their regulatory and therapeutic focus. While CRO M&As can contribute in a significant way towards improving clinical trials, mergers in any industry are difficult to undertake, especially in terms of cultural differences, IT and tax considerations involved in consolidating international enterprises.
Research from Tufts CSDD shows technology adoption in the CRO market continues to rise, making these players important innovators in the R&D value chain. That said, CRO mergers are likely to affect the agility and speed of operations and may hamper efforts to bring in new technologies. Nevertheless, when integrated effectively, CRO mergers can add significant value to both the pharmaceutical industry and the patients who depend on the life-saving medicines it produces.
Article published in Contract Pharma, November 2017