The polymerase chain reaction (PCR) technologies market reached over $6.5 billion at the end of 2013. PCR enables quantification and detection of target DNA. PCR is a valuable tool in diagnosis, clinical trials and drug discovery. PCR application in critical research areas such as gene expression analysis, genotyping, viral quantification, HIV DNA detection and quantification etc. have provided valuable data to the field of medical science. Quantitative real-time PCR (qPCR) is being used largely by bio-pharma and academic labs. However, digital PCR (dPCR) are gaining focus currently.
FDA approvals for clinical diagnosis and drugs depend on the clarity and consistency of results. For example qPCR based tests may have issues with respect to amplification efficiency that could vary with PCR primers and type of patient. Therefore, in such cases dPCR produces results that are more consistent. dPCR provide higher level of precision and greater sensitivity. This can directly affect the time span of FDA approvals.