The huge market growth is predicted to be fuelled by the push for 'personalised medicine', with treatment selection being the most useful application of molecular diagnostics over the short term.
The term "molecular diagnostics" can be applied to clinical chemistry or immunoassay with equal validity, as both technologies analyse molecular species. It has, however, been reserved for techniques that identify and/or quantify genetic materials in the determination of pathological states.
The latest report from Kalorama Information, entitled "Molecular Diagnostics: Major World Markets" states that the molecular diagnostics industry offers the opportunity for the revival of what has for many years been "a less than stellar" industry.
Dr Kenneth Krul, author of the report and senior analyst with Kalorama Information believes the key to the market lies in the saying "Diagnostics follow Therapeutics" as he believes there is no sense in having the data if you can't do anything with it.
"It makes no sense to test babies for 400+ genetic metabolic diseases when you can't do anything for 99.999% of them"
"Personalised medicine and public health issues, the detection and treatment of communicable/drug resistant diseases, provide the key market growth potential."
As new therapeutic treatments emerge, molecular diagnostics will increasingly spin off products from drug development data to compliment the therapies – allowing a more and more targeted approach to drug selection.
According to Dr Krul, the human genome project has been the basis of every bit of work in molecular diagnostics since its completion.
"While the data from the human genome project may not have been directly useful, it pointed the developers in the right direction for functional genomics studies to assign genetic significance and designate pathological mutations."
The market is predicted to grow in size from its 2006 level of approximately $17.9bn to over $92.1bn by 2016 with an average annual growth rate of 41.5 per cent.
The huge growth in the market is will be driven by the addition of new diagnostics in high volume testing. Dr Krul continued: "there will be growth in the pharmacogenetics aspects of molecular testing, particularly with regard to HIV due to the urgency of the situation and the plain need to keep adjusting HIV patients' regimens."
Dr Krul believes another big contributing factor will be the rapid emergence of drug resistant pathogens, such as the methicillin-resistant Staphylococcus aureus (MRSA) bacterium, with current selection and susceptibility tests being regarded as too slow.
The growth in the pharmacogenetic market is expected to dwarf that of other sectors with annual growth predicted at a rate of 184 per cent, with the segment expected to reach over $60bn by 2016. The expected growth is based on the new understanding of the relationship between the genetic signatures of neuropsychiatric disorders and optimal treatment procedures, advances in the viral infection market and advances in cancer therapy.
The use of molecular diagnostics in oncology is predicted to be the second fastest growth application sector, expected to grow at a rate of over 68 per cent per year, reaching $9.8bn by 2016. The growth in this area is expected to be fuelled by the use of molecular diagnostics to assess cancer susceptibility, diagnosis and management.
The report highlights the fact that only a few companies dominate the molecular diagnostics market as the technology is so young. It also highlights several manufacturers as market leaders, including Roche Molecular Diagnostics, Bayer Diagnostics, Vysis (Abbot), Gen-Probe and Biotest.
Several companies that do not actively supply diagnostics assays, but provide the technology that make the assays possible are also mentioned: Affymetrix, Agilent and Applied Biosystems.
According to the report, the concept of using molecular diagnostics for susceptibility testing will remain a contentious issue, especially in the hands of medical insurance companies.
