PCR Market Expands in Clinical Segment

4/18/17

The PCR testing market is a large and diverse market according to Kalorama Information. The healthcare market research firm said that total PCR market (polymerase chain reaction) was over 9 billion and will exceed 12 billion by 2021. Kalorama focused on both the life science PCR market(research and drug development applications) and clinical PCR market (patient diagnostics) in its three-month long study of the PCR industry. Kalorama Information made its finding in its new report, PCR Market for Life Sciences and Diagnostics (qPCR, dPCR and Other NAAT).

"The life sciences market has been the backbone of the market but ten percent revenue growth per year is attractive for many companies, and there's migration to the clinical sector." said Bruce Carlson, Publisher of Kalorama Information. "Large IVD concerns such as Abbott, Roche sell into clinical laboratory segment, as do mid-size IVDs such as Luminex and Quidel."

The life science market grew steadily for over two decades, although this growth is leveling off now, according to the report. This is a large, diverse market that is now facing competition from next generation sequencing for a number of applications. The clinical polymerase chain reaction and other NAAT market is almost two-thirds of the entire market and will grow at almost ten percent per year. The clinical segment includes both NAAT-based based tests for infectious disease, cancer testing, genetic testing, transplantation diagnostics, and a small segment of other tests. The first and largest segment of the clinical diagnostic market is the infectious disease segment. This large market is continuing to grow, fueled by the introduction of rapid point-of-care or near patient tests, and also by the development of syndromic infectious disease tests.

Example of products on the NAAT market that are sold to clinical labs:

  • Abbott Diagnostics's m2000 RealTime System includes the m2000sp (for medium throughput sample processing) and the m2000rt (which automates the amplification and detection parts of the qPCR reaction).
  • Roche's IVD platforms for performing PCR assays including cobas® 6800/8800 Systems, cobas® Liat® System and COBAS® TaqMan® 48
  • Spartan Bioscience Inc.'s RX CYP2C19 System that tests for a a liver enzyme that acts on 10-15% of drugs
  • Quidel Corporation's AmpliVue assays, Lyra Real-time PCR assays and Solana System
  • Luminex Corporation's ARIES® System - A sample to answer real-time PCR platform
  • Curetis's Unyvero System includes the Unyvero L4 Lysator, the Unyvero A50 Analyzer and the Unyvero C8 Cockpit; uses Unyvero cartridges. On the market in Europe.
  • DiaSorin/Focus Diagnostics's 3M Integrated Cycler and Simplexa products

PCR has become a widely used research tool. In addition, diagnostic companies have used nucleic acid amplification technologies to develop and commercialize diagnostic tests based on the detection of DNA and RNA. PCR is owned by Roche. Cetus, which sold the rights to the technology Hoffmann-La Roche for $300 million in 1991.In addition, the technology has been widely licensed to other companies for both research and diagnostic applications, and many companies are now active in these fields. Molecular diagnostics has emerged to become a major segment of the overall in vitro diagnostics (IVD) market.

Real-time PCR (qPCR) has become the most widely used DNA amplification method today.

Companies are continuing to develop improved PCR methods. One significant improvement discussed in this report is digital approaches(dPCR). Unlike qPCR, dPCR does not require the use of a standard curve for quantification. Instead, the sample is divided into partitions, and single PCR reactions are performed in each partition. With the method known as digital dropet PCR (ddPCR), these partitions are individual droplets. The reactions are detected by fluorescence, and droplets are scored as positive (containing the targeted sequence) or negative. Statistical analysis of the droplets provides an absolute quantitation of the amount of the targeted sequence that is present in the sample.

Kalorama Information's report breaks out the qPCR market and the dPCR market as a unit of the market, and also breaks out the market for TMA, and other NAAT technologies. The report profiles companies competing in the market. The report can be found at: https://www.kaloramainformation.com/PCR-Testing-Life-10777547/

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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