Do it faster, do it better, and do it for less money. Accomplishing all three feats may seem impossible to biotech or pharma companies, particularly if they believe in the Iron Triangle of project management. It holds that any two of the three feats can be achieved in a given project, but only if the third is sacrificed. Fortunately, the Iron Triangle can be transcended. How? Outsource work to a contractor that offers a better triangle.
Biotech and pharma companies may outsource various kinds of work including assay development, preclinical research, and clinical trials management to contract research organizations (CROs). Even the most challenging research tasks may be outsourced to CROs.
The versatility and sophistication of CROs may account for the robust growth that the CRO market is expected to experience. According to Fortune Business Insights, the global CRO services market is expected to grow at an annual rate of 11.4% and to attain a value of $90.9 billion by 2026.
From trailer to transnational status
The CRO services market wasn’t always so imposing. In the United States, the market had its start with the Food and Drug Research Laboratories, a CRO that lasted from the 1930s to the 1980s. While that first CRO was still in business, a company that eventually became one of the biggest and most powerful CROs started to emerge.
In 1974, Dennis Gillings, PhD, a professor of biostatistics at the University of North Carolina (UNC) at Chapel Hill, began doing some CRO work on the side. At first, Gillings squeezed his CRO work into a small trailer. But by 1982, he had founded Quintiles Transnational. It went public in 1997, and then it merged with IMS Health in 2016, forming QuintilesIMS. The company changed its name to IQVIA in 2017.
Today, IQVIA employs over 70,000 people in more than 100 countries. By the end of 2020, despite the pandemic, IQVIA had posted revenues of $11.36 billion for the year, and it predicted that in 2021, revenues would grow to between $12.55 billion and $12.9 billion.
IQVIA is cited as a leading CRO by Fortune Business Insights, which expects IQVIA to “retain its position … owing to its strong portfolio of clinical research and post-clinical research services.” Other leading CROs mentioned by the market researcher include Pharmaceutical Product Development (PPD), Labcorp, Medpace, Clintec, PRA Health Sciences, ICON, KCR, PSI, Paraxel International, and Covance.
An expanding service portfolio
Today’s leading CROs often provide a range of services. For example, ICON provides “outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organizations,” says Kent Thoelke, innovation officer at the Dublin-based CRO. He adds, “Our services span the entire life cycle of product development, across a broad range of therapeutic areas.”
Trends at the top
IQVIA is not the only CRO that started small and ended up big. In 1985, Fred Eshelman, PharmD, opened a one-person consulting firm in Maryland called PPD. A year later, he moved the company to North Carolina, where PPD grew into a company with more the 28,000 employees around the world. For the second quarter of 2021, PPD reported more than 50% growth in revenue over the previous year. That added up to more than $1.5 billion in revenue over the second quarter of 2021 alone.
There is at least one more world leading CRO that calls the Tar Heel State home, and that is Labcorp. This company’s journey started in 1905, when Hoffmann-La Roche came to the United States. Now more than a century and several acquisitions and mergers later, Labcorp keeps growing, generating $3.8 billion in revenue during the second quarter of 2021. Apparently, North Carolina makes a good spot for turning a small CRO into a giant.
Still, a Carolina blue sky is not required for building a big CRO. On June 3, 2021, San Diego–based Crown Bioscience announced licensing agreements with ATCC and the U.S. National Cancer Institute to obtain access to more cell lines to use with its screening tools. Crown Bioscience’s CSO, Henry Li, PhD, noted in a press release the new agreements will “enable us to offer our clients expanded and prioritized cell line availability and supply.”
Given the global nature of today’s CRO industry, leading companies can be found around the world. One of the biggest CROs outside the United States is ICON, which started with a staff of five in 1990 and has grown to nearly 40,000 employees in 46 countries. In addition, ICON reported a second quarter revenue growth in 2021 that surpassed its 2020 metric by 40%. Maintaining such growth requires keeping up with industry trends.
Reaching more people
When asked about today’s key trends for CROs, Thoelke points to the increasing adoption of decentralized clinical trials (DCTs) and the growing use of remote monitoring to collect data. “This enables a more patient-centric approach to trials and allows a less burdensome patient experience through the use of technology, which now has the power to objectively measure many key study data points,” he explains. “Clinical teams can also review accumulating data remotely online, thereby certifying the validity of the data that helps to affirm the safety and efficacy of the drug or vaccine being tested.”
Beyond the obvious advantages of DCTs and remote monitoring to clinical development, these technologies add other benefits. As Thoelke says, “Actively progressing decentralized and hybrid trials will enable the democratization of clinical trials—increasing access to more patients and the inclusion of more diverse populations.”
In the future, Thoelke sees even more ways to get more people involved in clinical trials. “Clinical trial matching using artificial intelligence and machine learning will create better systematic opportunities to ensure that all patients are evaluated for placement in clinical trials,” he maintains. “When more patients become involved in clinical trials, that will mean shorter timelines, more diversity in trial participation, and overall better care and outcomes for individuals.”