Outsourcing Drug Development Increasingly Global

Fueled by rising market pressures, companies are increasingly outsourcing the drug development process. In the United States, not only the complexity of conducting clinical trials has grown over the last 20 years, but also the number of drugs in development increased, government regulations tightened, and patient recruitment became more difficult.

A new report from Kalorama Information (New York, NY, USA), an international market research company, revealed that in 2007 34% of global research and development spending, or US$26.4 billion, was committed to outsourcing, up from 22% in 2002, an increasing amount of which is going offshore.

Developing and bringing a drug to market costs over $900 million and takes as long as 15 years, whereas over 80% of drugs that enter clinical trials fail to be approved by the U.S. Food and Drug Administration (FDA). Now, in order to decrease research and development (R&D) expenses and accelerate drug discovery and development, developers are outsourcing more of their R&D functions. However, a key obstacle remains--the patient recruitment and retention process--particularly as clinical trial protocols become more complicated, delays can result in millions of dollars of lost sales.

In response, the outsourcing trend has begun to move offshore as drug developers seek patient recruitment in large populations of people eager to take part in clinical trial research, especially in Eastern Europe, Asia, and Latin America. These regions can often produce the required number of participants in half the time, with better compliance and less expensive medical professionals.

"Pharmaceutical marketing is truly global right now,” noted Kalorama Information's publisher Bruce Carlson. "Developers need to submit new drugs for approval in multiple countries simultaneously, rather than in succession, in order to maximize revenue and reduce costs. Recruiting volunteers in multiple countries is essential.”

Currently, however, the United States remains the world's largest clinical research market with just over half of all worldwide trial sites still located there.

Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of research services.

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