Mumbai, India – June 3, 2014 – The Molecular Diagnostic market has emerged as one of the largest and fastest growing segments in the USD 50 billion IVD industry. It now ranks 4th in overall market size behind the immunoassay, whole blood glucose and clinical chemistry segments in terms of overall manufacturer sales. In the last 20 years, the molecular diagnostics market has burgeoned from a practically non-existent market with approximately USD 10 million in manufacturer sales in 1990 to USD 4.2 billion worldwide in 2011. This represents a remarkable 33% annual growth rate over this time frame.
The market has already begun to expand in new directions with IVD test kits for genetic diseases (e.g. cystic fibrosis), blood donor screening tests for HIV and hepatitis, HPV testing for cervical cancer, and quantitative viral load testing for HBV, HCV and CMV. Consequently, the rapid growth of the market has attracted dozens of IVD manufacturers. This has already resulted in numerous mergers and acquisitions. Small companies with unique technology are continuously bought by the major companies and new companies continue to enter the market with novel technology and products.
This report: Molecular Diagnostics: An Insight to Rising Markets and Trends in Cancer and Prenatal Technologies, focuses on the cancer testing segment trends which includes tests for mutations and chromosome changes related to cancer predisposition, diagnosis, prognosis, monitoring and selection of therapy. In terms of PCR and sequencing cancer tests, there are at least 25 different assays available. Many are for the various leukemias and lymphomas including B and T-cell clonality, JAK-2 mutation, FLT3 mutation, BCL-1, BCL-2 and PML-RARa. There are also tests for solid tumor gene mutations, such as p53 and microsatellite instability (MSI). Even though IVD manufacturer sales of MDx tests for cancer are small today, this segment holds significant market potential because the clinical value of the tests is pretty high. Notably, the genetic testing segment is relatively small in terms of overall manufacturer sales. There literally are hundreds of different genetic disease tests performed, but the volumes are so low that the majority are performed as LDTs. Inspite of this current market condition, additional market growth is expected from the continued discovery of genes or gene expression profiles associated with specific diseases such as inflammatory bowel disease and rheumatoid arthritis.
The molecular diagnostics market is now becoming increasingly crowded with competitors. More than 100 companies compete in this market segment. Companies like Qiage, BD and Hologic Gen-Probe have purchased several small and large molecular diagnostic companies over the last five years. Thus, this USD 4.2 billion market is expected to continue to experience healthy growth for the rest of the decade.
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