Written in June 2008, this report has been amended. We have added a preface addressing the state of the IVD market in 2009, and demonstrating why Kalorama Information will hold to its diagnostic industry forecasts made at the time of publication despite the condition of the general economy.

This edition of Kalorama’s comprehensive and indispensable report covers the breadth of traditional IVD testing. The report contains complete market statistics and analysis for all areas of IVD, including:

• Point-of-Care
• Core Lab
• Immunoassays
• Molecular Assays
• Hematology
• Coagulation
• Microbiology and Virology
• Blood Banking
• Histology and Cytology

Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Projections are made through 2012.

Six Times Kalorama Has Examined the IVD Market in Full

This 900-page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on:

• The status of POC and decentralization in lab medicine
• Miniaturization and molecularization of devices
• Geo-economic and demographic influences on markets
• Non-invasive sampling
• Greatly expanded market data on PGx and SNP testing
• Revamped segmentation for clinical chemistry to include workstations and immunoanalyzers
• More information about more immunoassays
• Focus on the renewed interest in microbiology/virology based on resistance and the re-emergence of serious hospital- and community-based organisms
• World blood banking developments
• Expanded sections on histology/cytology developments including emerging areas such as tissue microarrays, circulating tumor cells, and genomics-fueled innovation.

In addition, there are now profiles of established and emerging players in IVD, more than 276 companies, from the top tier to emerging and niche competitors to watch.

As part of its coverage, the report breaks down the IVD market for the following regions.

• North America
• Europe (EU)
• Eastern Europe
• South America
• Asia (China and India as subsegments)
• Rest of World

A Report Designed for a Changing Industry

In this sixth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information has reorganized the presentation of the IVD market in a manner that better reflects how the industry has evolved since the first edition was published in 1997. At that time, molecular testing was a small emerging discipline that related to chlamydia, gonorrhea, TB, and some inherited diseases.

That first edition didn’t even have a chapter for molecular diagnostics; it was a miscellaneous. Now, molecular tests are common in several segments - infectious diseases, bacterial identification, coagulopathologies, blood unit screening, histology and soon as POC devices. Therefore the molecular chapter in this report presents technology and market issues that are common to all segments and concentrates on purely molecular tests for inherited diseases. Molecular tests used in other segments are included in the appropriate chapter. In 1997, POC testing meant glucose testing.

Similar to molecular testing, rapid and POC tests are becoming an important part of testing on all fronts. Here too the POC chapter presents technology and market issues that are common to all segments and concentrates on blood glucose monitoring.

A Note About The Economy in 2009 and our Forecasts

This report was completed in 2008 before the economic meltdown of 2008/2009 was fully apparent. The report estimates the world market for IVD products. Kalorama Information anticipates that this estimate holds true in spite of the current financial situation. There are many reasons for this rationale. In vitro diagnostics were the first products targeted for cutbacks in the major markets, the IVD industry did not experience the explosive growth seen in some medical devices, purchases are through group purchasing organization, new healthcare initiatives proposed by the new U.S. administration under the guidance of President Barack Obama further bolster the use of IVDs, and demand for healthcare and thus diagnostic tests in all the major markets. A special appendix to this report is included to address the economy

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