2009: Light at the End of a Tough Year

2009 was a difficult year in the clinical trial space as CROs and sites contended with a half dozen pharmaceutical company mergers, project cancellations and tighter study budgets. Some investigators went out of business. But there was also opportunity amid the turmoil and hope that things were turning around late in the year with pharmaceutical companies ramping up R&D again.

Those opportunities came for companies that could take advantage of their global footprint and move more strongly into emerging markets such as Latin America and China. The top dozen or so CROs that have global reach have about half of the outsourcing market wrapped up. Consolidation came in waves in the eClinical space, which will mean more opportunity for the top players in that space.

Medical Device Outsourcing Grows as U.S., EU Regs Become Stricter

Global medical device outsourcing is expected to reach $26.7 billion by 2014, growing at a compound annual growth rate of 13.9% from 2009 to 2014.While regulatory services has become one of the fastest growing areas, CROs have seen increasing demand for a full range of clinical services, including study design, patient recruitment, monitoring and data management as large medical device companies have shifted to a full outsourcing model.

Historically, regulatory uncertainty, delays in 510(k) approvals and the financial pressures facing medical device companies have led them to test many products in Europe before seeking marketing approval in the U.S., which can save both time and money. This strategy may shift, however, as the new EU medical device directive takes effect in March 2010.

European Acquisition Ends 2009 with a Bang

Despite the global economic downturn, 2009 began on a promising note as European contract research organizations (CROs) merged or acquired U.S. companies, and one global CRO made a big play in Central and Eastern Europe.

Just when it looked as though 2009 acquisitions in Europe were going to fizzle to nothing, the year ended with a bang when Synexus acquired ClinPharm.

Eye On: Infectious Disease

While the development of antibiotics represents a major milestone in the history of medicine, therapeutic progress in the area of infectious diseases has been hindered by rapid development of microbial resistance to available pharmacotherapy. Widespread global travel, overcrowding and poor sanitary conditions in underdeveloped countries has also contributed to recent increases in the morbidity and mortality of infectious diseases.

Each year, annual influenza epidemics affect 5%to 15%of the world population. In the United States, more than 200,000 hospitalizations and 36,000 deaths each year are attributed to influenza and its complications, according to the U.S. Centers for Disease Control and Prevention (CDC).Worldwide, annual influenza epidemics cause 3 to 5 million cases of severe illness and 250,000 to 500,000 deaths, based on estimates from the World Health Organization (WHO).

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