Medical Diagnostic Kits

Report Highlights

• In 2001, sales at the U.S. manufacturers level exceeded $3.8 billion. By 2006, the market is anticipated to grow at an average annual rate (AAGR) of 6.2% to yield sales of more than $5.1 billion.
• MDKs accounted for 34.6% of all diagnostic testing in the U.S. in 2001 and by 2006, market share will drop to 30.8%.
• Point-of-care (POC) instruments have impacted the use of MDKs because of the benefits they offer for improving patient care.
• The veterinary MDK segment has not developed as previously expected. Sales to this segment only reached an estimated $296 million in 2001 and the AAGR is projected to be only 2% through 2006.
• Scientific advances resulting from the study of the human genome have fueled an increase in the use of MDKs in the research segment. Average annual growth is expected to be 10.5% through 2006.

INTRODUCTION

STUDY GOAL AND OBJECTIVES

This study, Medical Diagnostic Kits (MDKs), provides the reader with an intensive examination of this growing medical diagnostics segment. It will specifically address the changes that have occurred as the result of technological advances and regulatory implementations.

Beyond focusing on these changes, it will define the entire MDK industry, including its structure and dynamics. Also discussed are the major players, relative market shares, the impact of external forces and current and emerging technologies.

REASONS FOR DOING THIS STUDY

Dramatic changes have occurred in the Medical Diagnostic Kit (MDK) market since Communications Company last examined it in 1997. MDKs are analytical test kits packaged for use on a single-test basis to test for a wide variety of substances. The major trends within this industry segment are the expansion of the at-home testing market to include both greater use of established types of tests and the addition of new tests such as cholesterol measurements and the expansion of the research testing market segment. Concurrent with this expansion is the contraction of the physician's testing market as a result of federal Clinical Laboratory Improvements Amendments (CLIA) legislation. Recent advances in the identification of the human genome have also opened exciting areas for testing.

MDKs brings diagnostic testing capabilities to a variety of end users, ranging from sophisticated high-technology clinical research and veterinary laboratories to individuals performing self-testing in their own homes.

In addition to expanding the variety of tests available as MDKs, companies active in this diagnostics market segment are using both new technologies and innovative marketing strategies to differentiate their products from the large number of competitive products. The market has also seen the development of inexpensive, automated testing devices, known as point-of-care (POC) instruments, which have replaced MDKs in smaller laboratories and physician's offices.

It is BCC's goal to identify and examine these trends and to forecast future market changes through the year 2005.

CONTRIBUTIONS OF THE STUDY AND FOR WHOM

This study defines the MDK market and provides detailed information on: 

• The products which comprise the MDK industry
• Emerging and current MDK technologies
• Analysis of these technologies and their impact on future products and market growth
• Market structure and current market size with forecasts through 2006 with specific emphasis on each segment
• Current market dynamics and trends
• Emerging marketing practices, such as strategic alliances and mergers
• The effect of external market forces, such as insurance, regulatory and economic issues and increased incidence of disease
• Internal aspects of the industry
• Specific opportunities for industry participants and industry suppliers

This study of the changing MDK industry will prove particularly beneficial to diagnostic industry participants holding marketing, management and technical development positions. It will also benefit readers who are suppliers to this industry as well as investors, venture capitalists, insurance companies and those interested in diagnostic medical testing.

SCOPE AND FORMAT

Included in this study are all products classified as MDKs. These include products prepackaged for in vitro manual testing (whether the end point is detected by the naked eye or by using a reading device). Specifically excluded are tests that involveautomated testing or tests that require processing devices and semi-automated batch testing devices.

The MDK market is defined with regard to current and potential products, related technologies, components and component suppliers, end markets, governmental and regulatory agencies, major companies competing in this market, relative market shares and the impact of the worldwide market status.

METHODOLOGY AND INFORMATION SOURCES

The primary data collection methodology for this report focuses on interviews with industry personnel, government agency personnel, industry observers, scientists and industry professional organizations, as well as a survey of the retail MDKs marketed to individuals for at-home use. In addition to these primary data sources, secondary data research techniques include a literature search of BCC's extensive library, as well as medical and libraries.

All data collected were analyzed by BCC personnel to determine specific findings and to make forecasts. Once these forecasts were obtained they were validated by consultation with industry experts. Consequently, all estimates provided in this report represent a consensus opinion of BCC personnel, industry participants and industry observers.

Growth forecasts are made in constant 2000 dollars, based on the U.S. manufacturers' (wholesale) price levels, unless otherwise noted.

RELATED WORK CREDENTIALS

The BCC project director of this report holds both medical technology and advanced marketing degrees. Further supporting the analyst's knowledge in this area is extensive experience in the pharmaceutical industry, the medical device industry, and other high technology markets.