NC dominates in clinical research and diagnostic testing

Taking a medicine from initial idea to market takes more than a decade, and a company must prove to federal regulators that each medicine they develop is both safe and effective.

Contract research organizations, or CROs, support pharma and biotech companies along that path, providing expertise that saves time and money. CRO activities include validating the target for a treatment, optimizing leads or potential treatments and developing assays or tests. They also include clinical and pre-clinical research, as well as regulatory filings.

The idea to contract this expertise came from North Carolina — in fact, the state is the global epicenter of contracted services. More than 150 CROs call North Carolina home, employing 24,000 people here and tens of thousands around the world.

"These careers exist at the intersection between idea and application. The ability to play a role in bringing a new drug to market or performing an innovative diagnostic test that improves patient care can be incredibly rewarding." said Laura Rowley, Ph.D., director of life science economic development at the North Carolina Biotechnology Center. "North Carolina's clinical research, diagnostics and testing companies have historically played an important role in global drug discovery and development. These services are more in demand now than ever."

In particular, clinical research and diagnostic testing companies are growing rapidly to support the expanding global life sciences. These fields offer a variety of high-paying jobs and rewarding career paths for people across the state.

The global clinical research industry, rapidly consolidating with a spate of recent mergers and acquisitions, is growing dramatically and is projected to surpass $74.2 billion in revenues by 2027, according to a new research report by Global Market Insights, a Delaware-based market research and management consulting company.

That growth is being driven by advancements in technologies, increasing research and development expenditures and a greater reliance on outsourcing by pharmaceutical, biotech and medical device companies, the report says.

North Carolina's heavy hitters in clinical research include IQVIA, LabCorp Drug Development, PPD, ICON, Syneos Health and Parexel.

Small-scale contracts and agreements for clinical support work had been part of pharmaceutical research practice across the nation and around the world for years before the CRO industry took flight in North Carolina in the early 1980s.

That's when Dennis Gillings, London born and newly minted as a University of North Carolina at Chapel Hill biostatistics professor, and fellow biostatistics faculty member Gary Koch, co-founded a consulting company they called Quintiles to apply their data-analytics skills to pharmaceutical development. Gillings resigned his faculty post to devote full time to building what is today known as IQVIA, the world's largest provider of biopharmaceutical development and commercial outsourcing services.

IQVIA, headquartered in Durham, has 72,000 employees in 100 countries and logged $11.3 billion in revenue in 2020. The company has one of the largest and most comprehensive collections of healthcare information in the world, featuring more than one billion non-identified patient records. Based on its data, IQVIA provides information and insights on over 85% of the world's pharmaceuticals.

In 1985, just three years after Quintiles' founding in Chapel Hill, Fred Eshelman, a Glaxo executive who'd earned a bachelor's degree at UNC, founded a one-man pharmaceutical consulting business called Pharmaceutical Product Development (PPD).

He grew the company into a publicly traded company that today employs more than 28,000 people worldwide and books more than $4.6 billion in annual revenue. PPD has conducted clinical trials in more than 100 countries and in the last five years has supported more than 400 drug approvals worldwide. PPD's success is capped by the 2021 announcement that Thermo Fisher would acquire the Wilmington company for $17.4 billion.

Since then, dozens of CROs have set up operations and expanded in North Carolina. For example:

In 2008 PRA Health Sciences located its global headquarters in Raleigh. Earlier this year the company was acquired by Dublin-based ICON for about $12 billion, boosting the combined company's global presence to 38,000 employees at 150 sites in 47 countries.

Syneos Health, headquartered in Morrisville and with operations in Charlotte and Wilmington, was created in 2017 through the merger of Raleigh-based INC Research and Boston-based inVentiv Health. The combined company has more than 28,000 employees in 110 countries and reported $5,213.0 million in revenue in 2021.

Parexel, with co-US headquarters in Durham and Boston, has more than 17,000 employees who serve clients in more than 100 countries. The company has helped develop 198 of the 200 top-selling biopharmaceuticals in the market. Parexel announced in July it would be acquired by a private-equity partnership for $8.5 billion.

Burlington-based LabCorp, traditionally known as a diagnostic testing company, expanded into the drug-development industry in a big way in 2015 with the purchase of Covance, a major CRO, for about $5.6 billion, and two years later with the purchase of Chiltern International, a British CRO with North American headquarters in Wilmington, for $1.2 billion.

North Carolina also claims a large and growing diagnostic testing sector of more than 100 companies scattered across the state, from Asheville to Wilmington.

The companies offer a multitude of tests that can detect or monitor medical conditions, diagnose genetic diseases including cancer or detect infectious illnesses such as COVID-19. In fact, the first at-home test for COVID-19, dubbed Pixel, was developed by North Carolina's LabCorp.

On the medical side, these tests allow physicians to better understand patient conditions, and sometimes act to prevent serious disease. Outside of medicine, diagnostic tests monitor the food supply for microorganisms, detect illicit drug use or perform many other functions across many industries.

The global clinical diagnostics market was valued at around $56 billion in 2020 and is expected to grow at a steady compound annual growth rate of 8.59 percent by 2026, according to a report by Dublin-based Research and Markets.

North Carolina's largest diagnostics company is LabCorp, a company founded in the Piedmont Triad basement of a Burlington hospital in 1969. Today the company's Burlington headquarters supports 70,000 employees worldwide and more than 7,000 across North Carolina, including RTP. It reported more than $14 billion in revenue in 2020.

If you've ever had a urinalysis, blood screening or other diagnostic test at your doctor's office or hospital, the chances are good that it was analyzed by LabCorp. The company processes more than 3 million patient specimens every week.

Another major long-time player in the industry is Becton, Dickinson and Company, founded in 1897 and today known as BD. BD, a global medical technology company with 70,000 employees worldwide, produces molecular diagnostic products for various cancers and women's health in Mebane and Durham and has a corporate technology R&D and innovation center in Research Triangle Park.

Up-and-coming BioAgilytix provides testing of large molecules for companies developing these more complex medicines. The company announced an 878-job expansion in November 2020, and it continues to add to its portfolio with the recent acquisition of Australia's 360biolabs.

Additionally, GRAIL is opening a lab, office and warehouse facility in RTP for its groundbreaking test kit that detects more than 50 different cancers, while medical genetics testing company Invitae is bringing 374 jobs to Morrisville, the location of its new East Coast lab and office facility.