Molecular Diagnostics: Technological Advances Fueling Market Expansion

Overview

The molecular diagnostics market is the fastest-growing segment of the in vitro diagnostics industry. In little more than a decade, the clinical market for molecular diagnostic products has increased from less than $50 million to over $1 billion, and sales are expected to exceed $3 billion by 2008. So profitable is the molecular diagnostics market that pharmaceutical companies are increasingly becoming interested in developing tests that can be used to guide prescribing, and they represent new and very influential players in a field typically dominated by a few large diagnostics companies.

Molecular Diagnostics: Technological Advances Fueling Market Expansion is a new Cambridge Healthtech report that analyzes the trends and developments driving this marketplace, and identifies the key challenges and areas of opportunity for companies competing in or contemplating moving into this rapidly growing field. The report examines the clinical applications for molecular diagnostics, reviews the breadth of technologies now used or in development, evaluates the major players in this market, and discusses the business and health care implications of emerging technologies.

Key Areas of Analysis Presented in This Report Include the Following:

• The potential commercialization options that are available to diagnostic companies, as well as possible strategies to meet the federal regulations that are required to commercialize molecular diagnostic tests.
• The range of applications and diseases for which molecular diagnostic tests can be used.
• Technologies that are emerging for applications in genotyping and SNP analysis such as DNA chips, several different DNA sequencing methods, and microfluidic "lab chip" technologies.
• A breakdown of sales of molecular diagnostics products by market segment and an analysis of factors that will drive growth in market segments.

Significant barriers to widespread adoption of molecular diagnostic testing exist—reimbursement, education and awareness of the clinical utility of a test, the inability to fully interpret test data, and the fact that gene patents are preventing widespread adoption of the tests by routine clinical laboratories. However, commercial opportunities for molecular diagnostics abound. Major clinical reference laboratories see molecular diagnostics as the single-most important strategic area for revenue growth for the foreseeable future. The strategic importance of molecular diagnostics is further exemplified by recent alliances between private reference laboratories and biotechnology companies, as well as by the emergence over the last decade of numerous, small "start-up" reference laboratories that specialize in molecular testing. Similarly, hospital laboratories are increasingly adopting molecular diagnostics applications.