The Clinical Trials Business

Report Highlights

• National spending on clinical trials was nearly $24 billion in 2005. By 2006 this number will rise to $25.6 billion and then $32.1 billion in 2011, an average annual growth rate (AAGR) of 4.6%. In 2005, biotechnology and pharmaceutical companies spent approximately $51 billion on research and development efforts, with $21 billion (41%) spent on clinical trials. In comparison, government contributions to clinical trials were considerably smaller. The National Institutes of Health spent $2.9 billion on clinical trials in 2005 and budgeted $3.0 billion for 2006.
• Total funding for 2005 was $24.4 billion. In 2006 this number will rise to $26 billion and in 2011 to $32.6 billion, an AAGR of 4.6%
• The number of clinical trials performed in 2005 was 8,386. BCC Research predicts this number will reach almost 10,000 by 2006. At an AAGR of 5.8%, the number of clinical trials performed in 2011 will reach more than 13,000.

INTRODUCTION

This report is designed to provide readers with a comprehensive understanding of the clinical trials process and its role in the research and development of new medicines in the U.S. It will provide an overview of clinical trials, including phases of clinical trials, U.S. government regulations, international regulations, costs of clinical trials, technologies, contract research organizations (CROs), and other factors. This report will forecast trends and clinical trial costs through 2011.

Generally, clinical trials are performed on drugs that have undergone a long test period. What are some of the factors that are and will bring drugs/devices as far as the clinical trial? What percentage of new chemical entities/proposals makes it to clinical trial? Who benefits from clinical trials, medically and financially? These areas will be reviewed and analyzed in this report.

SCOPE OF STUDY

This report contains:

• An overview of clinical development phases, the regulatory issues involved and the factors influencing clinical trial costs
• An in-depth analysis of the U.S. market for clinical trials that reviews historical data, market trends, and forecasts through 2011
• report_highlightss for new and upcoming technologies and developments that could have an impact on the clinical trials business
• Profiles of the major players in the business.

METHODOLOGY

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.

ANALYST CREDENTIALS

Kecia Brown holds a Masters of Public Health degree with a concentration in epidemiology and biostatistics. She has participated in medical research and in public health projects at universities and public health agencies. Ms. Brown also has worked in the biotechnology industry and the pharmaceutical industry as a medical writer.

INFORMATION SOURCES

Information contained in this report includes data obtained from government agencies, corporate publications, industry trade publications and various news sources. Interviews were conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA) and professional agencies. Further information was obtained through an extensive literature search and conference attendance. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.