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Medical Diagnostic Kits

Report Code: HLC007G

Publish Date: May 2008

Publisher: BCC Publishing

Category: Health Maintenance

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Report Highlights

  • The U.S. market for medical diagnostic kits (MDKs) increased from $11.2 billion in 2007 to an estimated $12.2 billion by the end of 2008. It should reach $18.5 billion in 2013, a compound annual growth rate (CAGR) of 8.7%.
  • MDKs accounted for approximately 23% of all clinical diagnostic testing in the U.S. in 2007. With the increased market share by instrumentation suites, this share is expected to decline to 20% by 2013.
  • Point-of-care (POC) instruments have affected the use of MDKs because of the benefits they offer including improved cost efficiencies and rapid results.

INTRODUCTION  

STUDY GOALS AND OBJECTIVES
 
This study, Medical Diagnostic Kits (MDKs), provides the reader with an intensive examination of the in vitro medical diagnostic kit segment of the medical device market. It will specifically address the changes that have occurred as the result of technological advances and regulatory implementations from 2002 to 2007, and the impact these changes will have on the overall market and key market segments.
 
Beyond focusing on these changes, this report will define the entire MDK industry, including its structure and dynamics. The report will also discuss the major players, their relative market shares, the impact of external market forces, and implications for current and emerging technologies.
 
 REASONS FOR DOING THE STUDY
 
Significant changes have occurred in the MDK market since BCC Research last examined the market in 2002. The market for analytical test kits packaged for use on a single-test basis to test for a wide variety of substances has been affected by dramatic changes in the global environment, as well as changes in demographics and national security issues within the United States. Significant changes include the following: 
  • An extremely large aging population of 78 million so-called “Baby Boomers”
  • Increasing rates of various types of cancer
  • Continued threat of bioterrorism through chemical/biological methods
  • An ever-increasing at-risk population of individuals with diabetes, hepatitis, and human papillomavirus
  • A slow down in HIV/AIDS diagnosed cases
  • A virtual epidemic of substance abuse
  • Introduction of infectious diseases from global migrations of people
  • Re-introduction of infectious diseases such as syphilis, tuberculosis, and measles, thought to be vanquished.
This report will identify and examine these marketplace trends and forecast future market changes from 2007 through 2013.
 
The current marketplace is highly competitive among established companies and new entrants expanding the variety of tests available as MDKs. To differentiate their products from competitors, new technologies and innovative marketing strategies are being used. 
 
In addition to the expansion of the market through new tests, the MDK market is also affected by the development of inexpensive, automated testing devices, known as point-of-care (POC) instruments, which have replaced MDKs in smaller laboratories and physicians’ offices. This trend is definitely present in the clinical testing and veterinary markets. Additionally, clinical testing is being affected by the introduction of automated suites of instruments designed to increase the processing of diagnostic assay kits. All of the major manufacturers of MDKs now have automated suites of instrumentation for the clinical, research, and veterinary markets.
 
 INTENDED AUDIENCE
 
This study of the competitive and evolving MDK industry will be beneficial to diagnostic industry participants holding marketing, management, and technical development positions. It will also benefit readers who are suppliers to this industry. Additionally, investors, venture capitalists, insurance companies, and those interested in diagnostic medical testing will find this report valuable.
  
SCOPE OF REPORT
 
All products classified as MDKs are found in this report. 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). The report specifically excludes tests that involve automated testing or tests that require processing devices and semi-automated batch testing devices.
 
The MDK market encapsulates 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.
 
This study defines the MDK market and provides detailed information on the following: 
  • Products that comprise the MDK industry
  • Emerging and current MDK technologies
  • Analysis of these technologies and their effect on future products and market growth
  • Market structure and current market size, with forecasts through 2013, by each segment
  • Current market dynamics and trends
  • Emerging marketing practices, such as strategic alliances and acquisitions
  • 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
 INFORMATION SOURCES
 
Information sources for this report include company websites and product literature, financial analyst reports, industry association members, and industry sources.
 
The primary data collection methodology for this report focuses on information provided by industry personnel, through Web-based sources or interviews, government agencies, industry observers, and industry professional organizations. In addition to these primary data sources, secondary data research techniques include a literature search of medical, government, and business 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 2007 dollars based on the U.S. manufacturers’ (wholesale) price levels, unless otherwise noted.
 
 ANALYST CREDENTIALS
 
Vicki McConnell and Peggy Lehr were BCC Research co-project directors of this report. Collectively, they have more than 40 years of medical industry experience. Ms. McConnell has written numerous reports and textbook entries on medical equipment components, materials, and manufacturing methods. Ms. Lehr specializes in marketing reports for a variety of industries. 
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Table of Contents

All reports provided in PDF format. For shared licensing options (5+ Users), please call a representative at (+1) 781-489-7301 or contact us at info@bccresearch.com
[+] Show Chapter Details
Title/Chapter NamePagesMember Price
Full Report: Medical Diagnostic Kits 178Free
Chapter- 1: INTRODUCTION4Free
Chapter- 2: SUMMARY4Free
Chapter- 3: THE MDK INDUSTRY34Free
Chapter- 4: TECHNOLOGICAL ASPECTS OF MDK INDUSTRY19Free
Chapter- 5: CLINICAL MDK APPLICATIONS42Free
Chapter- 6: HOME-USE TESTING MARKET10Free
Chapter- 7: U.S. RESEARCH APPLICATIONS6Free
Chapter- 8: VETERINARY APPLICATIONS7Free
Chapter- 9: APPENDIX I CLIA WAIVED TESTS: 2002–200720Free
Chapter- 10: APPENDIX II COMPANY PROFILES10Free
Chapter- 11: APPENDIX III COMPANIES BY PRODUCT TYPE4Free
Chapter- 12: APPENDIX IV DIRECTORY OF MDK COMPANIES18Free

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This is an Excel-only version of the report.

Report Includes

    Total Number of Tables in this Report: 44

  • Summary Table: PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013
  • Table 1: PROJECTED U.S. MDK MARKET COMPARED WITH THE TOTAL DIAGNOSTIC TESTING INDUSTRY, THROUGH 2013
  • Table 2: ALTERNATIVE METHODS TO MDKS AND AREA OF PRIMARY USE
  • Table 3: SELECTED MDK APPLICATIONS
  • Table 4: SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION
  • Table 5: MDK APPLICATIONS BY END-USE FACILITY
  • Table 6: U.S. CLINICAL TESTING FACILITIES WITH POTENTIAL FOR USING MDKS: CLIA VS. NON-CLIA
  • Table 7: SELECTED LISTING OF ANIMAL TESTING MDKS
  • Table 8: SELECTED COMPANY ACQUISITIONS, 1995-2008
  • Table 9: CLIA WAIVED TESTS
  • Table 10: PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING MDKS
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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.

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