In Vitro Diagnostic Industry in China - Immunoassay Ⅶ

4.2  Main Automatic Chemiluminescence Immunoassay Detection Items and Markets in China

Main Items and Market Situation

Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy. The detection items presently carried out using chemiluminescence immunoassay mainly include: 

(1) infectious diseases (hepatitis A, hepatitis B, hepatitis C, hepatitis E, hepatitis D, AIDS, syphilis, etc.)

(2) tumor markers

(3) thyroid functions

(4) hormones (sex hormone, growth hormone)

(5) prenatal and postnatal care (ToRCH, EB virus, etc.)

(6) diabetes, hypertension, liver fibrosis, and other chronic diseases

(7) cardiac markers

(8) anemia

(9) allergens

(10) drug concentration monitoring

(11) inflammatory factors

(12) other items.

Although there are more than 100 items that can be detected using chemiluminescence, 70%-80% of the market share is occupied by tumors, thyroid functions, hormones, and infectious diseases; and the remaining other items only account for 20%-30%. In addition, manufacturers still continuously introduce new assays.

The China's chemiluminescence market is occupied by Roche, Abbott, Beckman, Siemens, and other excellent foreign enterprises; and the detection focuses on such items as infectious diseases, tumor markers, hormones, and cardiovascular disease markers. Chinese manufacturers are not inferior in the number of assays, but there are still some gaps between the Chinese products and the imported excellent products in terms of performance quality, high-end antigen/antibody raw materials development as well as basic research, clinical application, or evaluation research on disease-specific biomarkers. They have certain competitive advantages in some fields such as quantitative determination of hepatitis B markers. 

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