3-Child Policy Stimulates the Layout of the NIPT on IVD Industry

A key meeting of the Communist Party of China unveiled on the last day of May a policy that would allow all couples to have up to three children, in place of the current universal two-child policy, in a bid to cope with an increasingly aging society. It also pledged stronger support for families. The decision signaled a stronger emphasis from the nation's top leadership to stabilize births and respond to the aging population after recent national census data showed an aging demographic structure.

The opening of three-child childbirth gives the family more autonomy in childbearing and improves the prevention and treatment of birth defects. China is one of the countries with high incidence of birth defects in the world. Certain experts point out that there are 800 thousand-1.2 million birth defects in China every year with an average of one birth defect every 30 seconds, among which trisomy 13, 18 and 21 and aneuploidy of sex chromosome are the most common.

Non-invasive prenatal testing, NIPT is a clinical detection method for screening related diseases of fetus by using fetal DNA in maternal blood. Since the discovery of free fetal DNA in pregnant women's peripheral blood in 1997, with the development of high-throughput sequencing, non-invasive prenatal gene testing has been widely used in clinical prenatal screening of fetal birth defects and other related medical research.

Noninvasive prenatal genetic testing can be used to detect whether the fetus has abnormal chromosome number. Except the 3 screening of Down` s syndrome, Edwards syndrome and Patau syndrome in normal, variation of Sex chromosome aneuploidy and Chromosome copy number and Monogenic disease genetics screening can be applied.

Around 2014, after the clinical application of NIPT in China experienced three stages of "termination, pilot and standardization", many enterprises successively obtained the registration certificate of noninvasive prenatal screening equipment and reagents, and the industry also entered the stage of industrialization, standardization and large-scale promotion. Up to now, there are less than 10 approved manufacturers of non-invasive prenatal testing kits, and the products are mainly focused on 21, 18 and 13 chromosome aneuploidy screening.

Hangzhou Matridx Biotechnology Co., Ltd.

Hangzhou Berry Genomics Diagnostic Technology Co., Ltd.

Dongguan CapitalBio Genomics Technology Co., Ltd.

Annoroad Gene Technology (Beijing) Co., Ltd.

Chengdu Findgene Medical Equipment Co., Ltd.

BGI Bio-Technology Co., Ltd.

Guangzhou Darui Biotech Co., Ltd.

Suzhou Basecare Medical Equipment Co., Ltd.

DaAn Gene Co., Ltd.

Manufacturers for producing analyzing software of fetal chromosome aneuploidy:

SANSURE BIOTECH INC.

Shenzhen BGI Bio Medicine Engineering Co., Ltd.

Hangzhou Berry Genomics Diagnostic Technology Co., Ltd.

NIPT is a huge market. In the future, NIPT market in China is expected to maintain a market scale of about 10 billion per year. Under the background of "healthy China 2030", with the opening of the three-child policy and the urgent need for the family for excellent birth and good education, enterprises with the advantages of technology and channel first development are expected to benefit from the dividend brought by the expansion of the industry.