Published: May 2010
Published by: BioPerspectives
The multiplexed diagnostics market has grown rapidly and generated sales of approximately $2.4 billon in 2009, but is now balanced on multiple tipping points. Will the FDA finally release the updated IVDMIA guidelines? If so, will the FDA close the CLIA loophole and/or will the FDA require 510(k) approvals for all multivariate diagnostics? Will Genomic Health and Agendia be able to maintain high prices for their flagship tests amidst growing competition? How many new tests will reach the market in 2010? Does the inability of Genomic Health’s new colon cancer diagnostic to predict response to chemotherapy indicate ongoing challenges in developing new multivariate diagnostics or is this an isolated example? Will growing competition lead to market confusion? In situations with similar tests, how will physicians and payers decide? Will they want to see more prospective clinical trials? Will prospective clinical trials be more attractive due to the experience of XDx? As multiplexed diagnostics become more established, will physicians and payers begin to actively seek these new tests to increase the efficiency of healthcare? Will changes in healthcare policies, especially in the US, be a net positive because of the expanded use of tests (for aging and expanding populations) or a net negative because of cost controls? Will new multiplexing technologies, such as MagPix from Luminex and BeadXpress from Illumina, create another shift in the market or are diagnostics laboratories becoming entrenched with current methods? Will new biomarkers, such as microRNA and methylated DNA, be more powerful than gene expression levels? For genetic tests, how far will multiplexing go? Is Counsyl’s combination of 100 genetic tests only the beginning? If so, will the increasing complexity of genetic tests usher in the era of diagnostic DNA sequencing?
On the whole, the multiplexed diagnostics market is expected to tip in favor of continued rapid growth, reaching almost $5.8 billion in 2015, according to a new report, Multiplexed Diagnostics 2010, published by Select Biosciences and written by BioPerspectives and Bachmann Consulting. This report explains the unmet needs, trends, regulations, reimbursement, competition, technologies and business strategies. This 572-page report includes a survey of more than 400 respondents, interviews with 12 experts, a detailed database of more than 190 commercial multiplexed diagnostics and a two-tiered quantitative worldwide market model. In addition, the report comes with one hour of consulting (in the form of a conference call) with one of the authors, Dr. Steven Bodovitz, Principal of BioPerspectives, or Dr. Jutta Bachmann, CEO of Bachmann Consulting.