Molecular diagnostics represents a revolution postponed, perhaps, but one that is now clearly underway. DNA Testing has emerged fully from research into clinical practice and becoming a dominant platform in clinical medicine.

From Emerging to Emergent Technology

Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. At each step of the way, Kalorama Information has reported on its progress, and in this latest market research report we look at the present state of the market, and the advances that have made DNA testing routine.

Many molecular tests are CE Marked and FDA-cleared and many more are in development. The result is that molecular testing is indicated in many areas of health care.

Molecular Testing Compiled and Analyzed and Explained by a Leading Expert

Authored by lead Kalorama diagnostic analyst Shara Rosen, Kalorama Information’s World Market for Molecular Diagnostics is the most comprehensive global market report available on the emergent field of molecular diagnostics.

This report covers key platforms of molecular diagnostics, including the following :

• Polymerase Chain Reaction (PCR)
• Non-PCR Amplification Technologies, including:
  • bDNA
  • TMA
  • SDA
  • LIPA
  • NASBA
  • Invader
  • Others
• In-situ Hybridization
• Sequencing
• Microarrays
• Laser Capture Microdissection (LCM) and Tissue Arrays
• Mass Spectroscopy
• Other Molecular Platforms

This report provides market estimates and analysis for molecular diagnostics in the following categories:

• Infectious Diseases (including HIV, Hepatitis GC/Chlamydia,Organism ID, MRSA, HAI et al, Mycobacteria, TB Respiratory, Others)
• Blood Screening
• Histology
• Oncology
• Prenatal
• Coagulation
• Tissue Typing
• Inherited Diseases
• Pharmacodiagnostics

The various clinical techniques and trends are discussed from the point of view of their present and potential market impact.

Market analysis in this report covers world markets for in vitro diagnostics, with focus on the developed areas of the globe — North America and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers IVD products related to the globalization of diseases.

As part of its exhaustive coverage of nucleic acid testing, the report includes the following:

• Market Sizes and Forecasts
• Profile and Assessment of Over 140 Key Competitors
• Breakout of Molecular Diagnostic Market by Region (N. America, W. Europe, Asia, ROW)
• Medical and Technological Trends
• Discussion of Globalization of Markets and Diseases
• Information on Reimbursement of New Technologies
• Review of Novel Test Platforms
• Review of New Market Developments, Such as Consumer Genomics and Testing Services
• Discussion of Market Impact of Home Brew Tests
• Discussion of Diagnostic Biomarkers and Genetic Indicators

All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and techniques presented in the report are expected to replace the standard of care in 2007/08, but with healthcare systems’ emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.

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