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General Information

  • The term “diagnostic enzymes” refers to enzymes used directly or as a component of an assay system for the determination of many different substances.
  • Common enzymes used for clinical diagnosis include: acid phosphatase, alanine aminotransferase , alkaline phosphatase , amylase , angiotensin converting enzyme, aspartate aminotransferase, cholinesterase , creatinine kinase , gamma glutamyltransferase , lactate dehydrogenase , renin.


  • Recent advances in recombinant DNA technology have made it possible to clone numerous genes of interest and to manipulate bacterial, yeast, insect, and mammalian cells to overproduce the desired enzyme.
  • The in-vitro diagnostic (IVD) industry is experiencing rapid technological developments. The IVD market is estimated to grow 25 percent annually.


  • The Diagnostics Products group provides products for use in clinical laboratories and at the point of care in a variety of formats from clinical chemistry products to rapid tests.
  • Diagnostic enzymes are important for analysis of samples of blood, serum, and urine for monitoring and diagnosing diseases.
  • Enzymes are used for signal and target amplification to improve the sensitivityand speed of immunoassays or to enable the multiplication of nucleic acid fragments.


  • The diagnostic and research and biotech markets will post near-average growth, benefiting from  investment in biotechnology and genetics and the continued development of self-diagnostic kits.
  • The various global target markets for diagnostic products are very broad and include individual end users, medical practitioners, small, medium, and large clinics and hospitals, and government agencies.
  • Pharmaceuticals will remain the largest enzyme market, due principally to the rapid expansion of the orphan drug market for treating lysosomal storage disorders.

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