The report, issued earlier this week, finds that the Latin American market earned revenues of $438.5m (€406.7m) in 2013 and estimates this to reach $661.3m (€613.3m) in 2019. The study covers Phase I, II, III and late phase clinical development as well as biostatistics, central laboratory services and data management.
One part of late-phase trials -- health economics studies – are expected to gain significant traction in the coming years, Frost found, especially since they can help companies decide which new molecules to include in the list of reimbursed drugs considered by public health services and private insurance plans.
"Multinational pharmaceutical companies tend to outsource about 70 percent of their trials by adopting either a fully outsourced or function-to-function model," said Frost & Sullivan Healthcare Consultant Sanjeev Kumar. "However, local pharmaceutical companies have lower outsourcing rates that range from 50 to 70 percent in countries across LATAM."
Breakdown
More specifically, Frost notes that in Argentina and Brazil, regulatory issues have restrained clinical development, thereby dampening the prospects of CROs in the region. Bottlenecks in Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA) submission and approval processes have meant that protocol approval takes 12 to 15 months, and an average of six months is expected in Argentina.
Another restriction for CRO market growth: limited outsourcing among big pharma clients that can conduct in-house R&D and clinical drug testing. However, Frost says that pharma clients' reliance on in-house R&D is likely to reduce considerably as large, well-established CROs have begun to use specialized research tech to cater to new drug development. An increase in innovative therapeutic options as well as the need for increased drug efficacy and safety is also expected to promote market development.
Recent CRO activity in Latin America includes PRA Health Services’ merger with RPS, which added to PRA’s Latin American capacity.
"In order to better serve and become the preferred partner of bio-pharmaceutical companies, CROs in [Latin America] must make an effort to expand their range of services," added Kumar. "Mergers and acquisitions with local CROs will be a cost-effective approach to achieve this end."