The DNA Diagnostic

Report Highlights

• The use of molecular and FISH cytogenetic methods in genetic disease testing in the United States and internationally is growing. In 2005, domestic and international molecular methods are forecasted to represent 64.0% and 11.9% of the genetic disease testing applications market, while domestic and international cytogenetic procedures represent 17.4% and 6.6% of the sales market. The average annual growth rates of domestic and international molecular and cytogenetic procedures are 10.1%, 7.7%, 12.3% and 13.0%, respectively.
• In DNA diagnostics, there are a variety of technologies used for genetic disease testing. The genetic disease DNA diagnostic technology market reached a level of $375.2 million in sales in 1998. Sales levels for genetic disease DNA diagnostic technology are estimated to be $508.8 million in 2000. In 2005, projected sales growth of genetic disease DNA diagnostic technology is projected to rise to nearly $772 million in 1999 constant dollars. This is an 8.4% average annual growth rate (AAGR).
• The variety of technologies used to develop DNA diagnostic genetic disease tests reflects the wide variability of what is detected in a disease gene as well as the drive to find a cost-effective genetic disease DNA diagnostic testing method. Polymerase chain reaction (PCR) technology has dominated the genetic disease DNA diagnostic market for the last three years. Estimated sales of PCR for the year 2000 are 394.1 million dollars and projected to be on the order of $606.6 million dollars in 2005.

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This DNA diagnostics study provides a detailed overview of current and prospective technology used in testing for genetic diseases. It supplements a l996 BCC investigation of DNA-based testing. In addition, the study addresses current and prospective changes in this industry resulting from government regulations and patent legislation.

This report provides data analysis and forecasts through the year 2005 on:

• market composition and dynamics
• market size
• market participants with related market shares
• current and emerging technologies
• impact of and trends in legal and government regulations
• international aspects.

REASONS FOR DOING THIS STUDY

Although private and government organizations working on the human genome sequencing project initially expected the project to be finished sometime between 2001 and 2005, the first phases were actually finished early in 2000. When the sequencing project is fully completed, there will be a 3 x 10⁸ base pair DNA alphabet that will translate into approximately 100,000 to 150,000 genes. The number of disease genes, i.e., human genes that are abnormal and have mutations, will increase. Therefore, it is timely to analyze current and emerging technologies used in the genetic disease-testing segment of the DNA diagnostics industry, and what will be the proposed growth of current and emerging technologies in this market.

CONTRIBUTIONS OF THE STUDY AND FOR WHOM

The information in this report will be valuable to all participants and observers of the genetic disease DNA testing industry, and the related equipment and reagents industries. The report also should be of interest to researchers, laboratory, and government personnel working in other applications of DNA diagnostics. These include: disease testing, paternity testing, forensics, agriculture, food testing and archaeological/anthropological testing.

The contents of this report are focused on the growth of the genetic disease DNA diagnostic :

• technological aspects of DNA-based genetic disease testing
• DNA diagnostic technology disease specific tests
• transfer of genetic disease information from an obscure medical specialty to a broad public audience
• survey of publicly registered genetic disease testing laboratories
• current market structure and size with forecasts through 2005
• market segments
• government regulations
• technology patents and role they play in development
• prospective technological developments of DNA-based genetic disease testing
• new markets.

SCOPE AND FORMAT

This report is an analytical tool whose primary purpose is to show increased growth in the current and emerging genetic disease DNA diagnostic testing market. The report discusses specific, patented technology and the role of government regulation and patents that affect the development and growth of the genetic disease DNA diagnostic market.

Appendices include relevant associations, URLs, conferences, and a list of companies involved in the genetic disease DNA testing market.

METHODOLOGY AND INFORMATION SOURCES

The primary data collection methodology for this report is based on interviews with industry and government agency personnel, industry observers, scientists and industry professional organizations. Additional secondary data was collected using resources such as trade publications, trade associations, company literature and on-line databases.

Growth forecasts are made in 1999 dollars based on the manufacturers' (wholesale) price level unless otherwise noted.

BCC personnel reviewed all collected data. Findings and projections were confirmed with numerous industry sources.