Molecular Diagnostics - Effective Tools for Disease Management, 3rd Edition

by Sreten Bogdanovic, Ph.D. and Beata Langlands, Ph.D.

Next-generation molecular diagnostics utilize multiplexing platforms (such as DNA and protein microarrays, or bead-based technologies), to perform parallel biomarker analyses in order to obtain more comprehensive clinical information. During 2005 and 2006, the FDA approved the first DNA microarray instrumentation system for IVD use (Affymetrix's GeneChip System 3000Dx), and the first highly multiplexed diagnostic microarrays: Roche's AmpliChip CYP450 test, and two cystic fibrosis tests - Tm Bioscience's Tag-It and Osmetech's eSensor. Although they have not yet been approved by the FDA, tests based on transcriptomic and proteomic profiling have also debuted successfully on the market.

Report Overview

The molecular diagnostic segments analyzed in this Report will significantly outperform the market as a whole, growing from $13.8 billion in 2005 to $22.7 billion in 2010 (AGR of 10.4%). Rapid advances in recent years have led to an increased understanding of the molecular basis of diseases and improved biomarker detection Technologies.

D&MD's Molecular Diagnostics: Effective Tools for Disease Management, 3rd Edition market analysis report offers a comprehensive coverage of the scientific and technological developments which are creating new opportunities for the development of improved molecular diagnostics. This information will benefit developers of in vitro diagnostics as well as drug developers.

The report analyses significant recent developments in molecular diagnostics which have implications for all developers of in vitro diagnostics and drugs. The first generation of molecular diagnostics on the market analyze protein and DNA biomarkers. New tests and services utilizing protein or DNA biomarkers continue to be launched and these are analyzed in the report.

Key Reasons to Purchase

> Receive comprehensive overview of different generic and proprietary platform technologies for molecular diagnostics.

> Examine coverage of diagnostic, predictive, screening, prognostic, monitoring, and pharmacogenomic tests to determine benefits/limitations of developing such tests.

> Explore major disease areas with a special focus on the biggest and expanding markets - infectious diseases, cardiovascular disease, and oncology - identify areas of opportunity and unmet need.

> Review results of a survey covering the last six years of patenting at the US PTO related to the clinical applications of biomarkers to understand the area's evolving IP landscape.

> Obtain analysis of the major world markets for molecular diagnostics, and forecasts for growth to help make strategic decisions and formulate business plans.

Questions Answered

> Which molecular diagnostics have proved most successful?

> How is new genomic, transcriptomic and proteomic information being translated into novel molecular diagnostics?

> Which are the most promising biomarkers and detection technologies currently under investigation?

> Within each disease area, what protein-based molecular diagnostics are under development?

> Within each disease area, what DNA-based molecular diagnostics are under development?

> Within each disease area, what tests based on gene expression profiling are under development?

> Which are the areas of unmet clinical need?

Market Opportunities

> Develop and market new diagnostic and predictive tests by capitalizing on recent technology advances in molecular analysis.

> Develop and market targeted therapies by relying on more specific markers of disease and drug responsiveness to provide safer, more effective, personalized treatments.

> Develop and market novel companion diagnostic-drug products by capitalizing on discoveries of new molecular markers of disease to create synergy between diagnostic and pharmaceutical industries.

Nov-06 Pages 621

Table of Contents - The Authors

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