Dallas, TX -- (SBWire) -- 02/08/2011 -- New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.

In 2010, the number of clinical trials in the U.S. is 25,992. This number is expected to increase at a 5.7% compound annual growth rate (CAGR) to reach 32,318 in 2014.

Pharmaceutical and biotechnology companies devote a greater percentage of their budgets to R&D than does any other U.S. industry. In 2009, the pharmaceutical industry invested 34.8% of sales in domestic R&D. In 2014, this percentage is projected to increase to 48.8, a 7% compound annual growth rate (CAGR).

INTRODUCTION

STUDY GOALS AND OBJECTIVES
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 2014.

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.

REASONS FOR DOING THE STUDY

The mapping of the human genome has opened new possibilities for the development of new medications to treat disease. Genomics, the emerging field of study resulting from the Human Genome Project, is coupling with bioengineering technology and biotechnology, producing accelerated development of new and novel treatments.

At the same time, existing biochemical techniques are advancing to enhance the process of biotechnological research. X-ray crystallography and combinatorial chemistry are two examples of increased modernization. As discovery technologies more quickly determine greater numbers of targets, greater numbers of compounds will be reaching the clinical trial phase of development sooner.

The clinical trial is that segment of research in the drug development process that tests a product or device to determine such factors as safety, efficacy, and adverse reactions in a human population. This report will focus on the following:

Research and development of drugs and biologics and new applications for old drugs and devices

Major product pipelines in development for the top biotechnology and pharmaceutical companies

The impact of new technologies on the costs and processes of clinical trials.

This report also addresses current and future trends in clinical trial research, how new focuses are driven by epidemiological trends, treatment of rare diseases, and the threat of bioterrorism.

INTENDED AUDIENCE

This report provides a thorough background of the clinical trial process. It is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investor consultants, and anyone interested in the clinical trials business and its future.

METHODOLOGY

Both primary and secondary research methodologies were used in preparing this study. 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

Jon Evans has been involved in business development and research for the medical industry since 1984. Mr. Evans’ career includes 4 years as a diagnostic systems sales representative and over 15 years in market research and strategy analysis with Fortune 500 clients. He has developed expertise in assessing the unique business development challenges facing firms in the medical industry and designing strategies to optimize market performance. Mr. Evans received a BS in biology from Rutgers University in 1983, and an MBA in business analysis from San Francisco State University in 1989.
SCOPE OF REPORT

The report provides an overview of clinical development phases, the regulatory issues involved, and the factors influencing clinical trial costs. An overview is provided of new technologies that will be affecting the clinical trial process in the near future. Major product pipelines are provided by physiological system and company.

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The Clinical Trials Business
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