The top 10 bio­phar­ma CROs in the world—mid-2017 edi­tion

Huddled with five employees in a tiny Chapel Hill house, Quintiles Transnational founder Dennis Gillings began breaking down the many things drug companies needed done when testing in humans and started doing them much more reliably than his clients could, and with that, gave rise to the modern CRO industry. The year was 1982 and the company has dominated clinical outsourcing for the 35 years since.

Now, after a wave of consolidation in the CRO space has transformed countless smaller competitors into a handful of big public players, the company is still out front, but it no longer enjoys a vast gulf between it and the rest of the pack vying for a piece of biopharma’s massive R&D budget.

To keep pace and stay in front, Quintiles engineered a big M&A deal of its own, but it had nothing to do with typical CRO work. QuintilesIMS is the brand now thanks to last year’s merger with IMS Health — the largest vendor of physician prescribing data, which biopharma companies use to price and market drugs.

Ari Bousbib is QuintilesIMS’ CEO, the position he held at pre-merger IMS Health. Bousbib was not a shoo-in choice to lead the combined firm. Tom Pike had been the CEO at Quintiles since 2012, successfully taking the reins of the company from an enigmatic founder and ramped up its main Research and Development Solutions business. In 2016 the workhorse division accounted for 65% of the combined company’s revenue, yet IMS insisted Bousbib — a highly regarded executive who made his name over a 14-year stint at aerospace and building giant United Technologies Corp — be installed as CEO and chairman as a condition of the merger. Pike retired rather than take a diminished role at QuintilesIMS.

Bousbib’s emergence at the top is a sign pointing where the industry is headed. “Traditional CRO services have become commodities,” says Jason Monteleone, president of Pivotal Financial Consulting, who has advised CRO boards on M&A transactions. So big players are looking for new ways to stand out.

QuintilesIMS wants to compete in what it describes in regulatory filings as a $130 billion market opportunity completely outside of clinical development. It ranges from collecting so-called Real-World Evidence to sales force training, while mining billions of healthcare transactions for lucrative signals. In these areas and the traditional clinical work it has a sizeable but shrinking advantage against the only other truly global, can-do-pretty-much-everything CROs in the world: PPD, Parexel, Icon, PRA Health Sciences, Covance, and the soon-to-be rebranded INC Research/inVentiv Health.

The payoff comes from following a drugmaker’s molecule from early clinical R&D on through to commercialization, selling ever more expensive arrangements each step of the way — without assuming the risk endemic to drug development. The promise of the new CRO services — which grew as Big Pharma and a booming group of biotechs looked to outsource the clinical work — is that the harmonization of disparate data is finally possible, leading to clients’ clinical trials recruiting faster,  their drug products positioned better for both regulators and the commercial opportunity that might come later. And if it reaches market? Collect, analyze, and act on even more data.

It’s a tall order. Lab testing giant LabCorp turned heads by acquiring Covance in 2015. It added Chiltern earlier this summer for $1.2 billion in order to expand its clinical offerings. INC Research, founded in 1998 with roots in neurology trials, closed their $7.4 billion merger with the commercial-focused inVentiv Health this month.

Is there more M&A in the works? Monteleone is leaning towards no — at least at the top end of the market — unless a non-traditional player comes in like LabCorp did with Covance.  “Most likely we’ll see strategic deals like PRA Health Sciences’s acquisition of Symphony Health,” he adds, where the Raleigh-based CRO acquired a healthcare data and analytics provider. The mid-tier market, a few of which we name in our list below, is always ripe for action.

Two CROs in the top 9 — PPD and BioClinica —  are private, making a definitive ranking here impossible, so our proxy is the valuation paid recently by their primary owners.

There are no comparable metrics for the CROs listed in the #10 position, but after asking several industry sources their opinions who belonged there, we’ve added a few contenders.

We’ll update this entire list again in the fall, when surely, the names and places will have changed.

Subscribe or log-in to Endpoints News for free, instant access to this article.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

John Houston, Arvinas CEO

Pfiz­er bets $1B cash on the orig­i­nal pro­tein de­graders as tech­nol­o­gy nears prime time

As one of the largest multinational corporations in the world, Pfizer has its tendrils in everything. The Big Pharma has potentially hundreds of billions of dollars to play with, and when it decides to go big, it can go as big as it wants.

And did Pfizer ever on Thursday.

Returning to one of its partners in protein degradation, Pfizer is teaming up again with Arvinas to advance and vastly expand a program for breast cancer. As part of the deal, Pfizer is handing over $1 billion immediately — $650 million in upfront cash and $350 million in an equity investment — and promising up to another $1.4 billion in regulatory and commercial milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Mod­er­na es­tab­lish­es pub­lic health-fo­cused char­i­ty; FDA ap­proves As­traZeneca di­a­betes drug for pe­di­atric use

To help promote public health and healthcare in underserved areas of the world, Moderna will establish a charity with a $50 million endowment.

The Cambridge, MA-based company announced the board of directors’ approval Thursday. The foundation will focus on “charitable, scientific and educational endeavors” with an emphasis on promoting public health and the access to healthcare, the press release said. The foundation will start operations once its status as a 501(c)(3) is approved.