Brazil’s contract research organization (CRO) market is said to be fragmented, made up of a handful of large global companies (think Quintiles, Parexel, Kendle), another handful of medium-sized CROs also not based there (i3, Icon), and then a profusion of smaller local firms. To provide a sense of both ends of the spectrum, we spoke with PPD, Brazil’s largest CRO, and with Mmatiss, a small company doing business there.

Wilmington, N.C.-based PPD pretty much owns Brazil. As far as clinical trials go, that is. With 300 employees in its Brazil headquarters of Sao Paulo and 150 trials going on in the country at any one time, the CRO has by far the biggest footprint there. (Next largest in Brazil is Quintiles, with 165 employees.)

Wendy Buckland, PPD’s vice president of clinical development for Latin America since 2005, tells us it all began with a small acquisition in 1996, the year the market in Brazil really took shape after the country’s establishment of regulations in adherence with the International Conference on Harmonization (ICH) guidelines.

Single Acquisition

That fall, PPD bought Q&Q Suporte a Pesquisa Clinica, the first CRO established in Brazil. That five-person outfit, founded in 1995, was lead by Ariye Sidi, a physician who’d worked for Roche for many years. Sidi is now PPD’s executive director of project management for Latin America.

Wendy Buckland of PPD

“We saw the potential in the market. We knew Brazil had good infrastructure, and huge patient volume at a time when the U.S. was becoming more saturated,” says Buckland.

Organic Growth

From there, PPD built up its Brazilian operations organically. The boom hit in 2004, says Buckland, when the rest of the world caught on and the number of Brazilian employees and trials tripled for PPD. Growth still remains high, though not as robust as the mid-2000’s.

With Brazil a solid market for the company, PPD began expanding operations elsewhere in Latin America. The company now has about 700 employees total on the continent—130 in Mexico, 160 in Argentina, 60 in Chile and 30 in Peru, where the company just put down roots 18 months ago.

PPD also says it dominates the CRO markets in Mexico and Chile, but Brazil remains the centerpiece of its Latin American presence. With other CROs there growing larger and nipping at their heels, PPD competes by having robust investigator site development. “We look at how we can develop new sites and support existing sites we work with, to give them more research, to teach them,” says Buckland.

120 Trials

Founded in Mexico City in 1996 by two veterans of the pharmaceutical business who foresaw an opening market in Latin America for CROs, Mmatiss now has small offices all over the continent. Brazil is its second-biggest market, with 10 employees in Sao Paulo (its biggest office is in Mexico City, with 25 employees).

Cristina Mendoza, the company’s quality assurance manager, told us that about 40 percent of the trials Mmatiss does in Brazil are rescue trials—studies that were initially begun in another country, but moved to Brazil to meet recruitment goals. Though start-up times for trials in Brazil are still long (nine months if you’re lucky), Mendoza says the really healthy recruitment and retention generally compensate for any delay.

Off-Putting Regs

However, she worries that the laborious approvals process—though it is soon to change—may have served over the years to turn sponsors off to Brazil. “There is so much interest in doing trials in Brazil, but because of the time lines and the complication of the process through MOH (the Ministry of Health), there are a lot of rejections,” she says. “It’s difficult to match the time lines and the power of the market.”

Mendoza adds that she and her team are excited about Brazil’s new regulatory changes and the possibility that they’ll shave some weeks—maybe months—off start-up times. Across Latin America, where Mmatiss has a presence in 12 countries, the company has done about 350 trials in the last five years, 120 of them in Brazil.

Agility Above All

The main therapeutic areas that Mmatiss works in include cardiovascular, central nervous system, infectious diseases, oncology and nutrition (such as investigations with probiotics and supplements).

How do small CROs like Mmatiss compete with big ones like PPD? Mendoza says Mmatiss is more flexible, more agile, and has better working relationships with regulators. PPD, of course, may beg to differ.

This is the final installment on our series.  The first article was an overview of the clinical trial landscape in Brazil; the second story discussed recent regulatory changes; the third looked at the nation’s CRO association.