This article is from the WeChat public account: Biodiscover (ID: biodiscover) , author: Gu Lulu, head FIG from: IC photo
On July 25, 1978, Louise Brown, the world’s first test-tube baby, was born in the UK. In the past 40 years, more than 8 million test-tube babies worldwide have come to the world, and the number of people born through test-tube baby technology has grown much faster than people expected. In contrast, according to data released by the National Health and Health Commission, the infertility rate of Chinese couples of childbearing age has increased from nearly 3% 20 years ago to about 15% in recent years. The number of patients has exceeded 50 million, of which more than 10 million patients Fertility needs to be assisted with assisted reproductive technology.
Infertility growth rate in China from 1995 to 2020
Assisted reproduction is a highly demanding technology. According to the “Administrative Measures for the Management of Human Assisted Reproductive Technology”, assisted reproduction technology must be implemented in approved and registered medical institutions. In other words, without the approval of the health administrative department, no unit or individual may implement or exceed the scope of human assisted reproductive technology.
In addition, the State and local health commissions have strictly controlled the number of institutions providing assisted reproductive technology through the preparation of plans for the deployment of assisted reproductive technology. According to statistics from the National Health and Family Planning Commission, as of the end of 2018, there were a total of 498 medical institutions approved to carry out human assisted reproductive technology in China. There are only nearly 80 medical institutions that provide pre-implantation genetic diagnosis technology (commonly known as the third-generation test tube technology, PGS) .
Image source: Foresight Industry Research Institute
For a long time, there have been no compliant products available in the third-generation test tube clinical application in China. Recently, the State Drug Administration approved the first domestic third-generation test-tube PGS test kit (Guo Ji An Zhuan: 20203400181) to break the market Awkward situation. This product was developed by Suzhou Beikang Medical Devices Co., Ltd. After 4 years of multi-center clinical trials, it has completed the detection of nearly 10,000 embryo samples. Clinical data statistics show that the application of this PGS product can increase the average pregnancy rate of IVF to 72% and reduce the abortion rate to 6.9%.
According to the announcement of the State Drug Administration, Become Medical obtained the first domestic third-generation test-tube PGS test kit registration certificate, and is currently the only third-generation test-tube product officially recognized. With the approval of this product, it means that China’s three generations of IVFs have officially entered the era of compliance and certification. It is foreseeable that the State Food and Drug Administration will further strengthen the strict supervision of the third-generation test tube PGS test kits.
According to the Assisted Reproductive Industry Investment Report released by the Foresight Industry Research Institute, the potential size of China’s assisted reproductive market in 2020 is about 107.2 billion yuan. Due to the rising prevalence of infertility, the stimulation of the two-child policy, the increase in the penetration rate of assisted reproductive therapy, the improvement of patient’s ability to pay, and the continuous advancement of assisted reproductive technology, China’s assisted reproductive industry has continued to expand and release huge market space.
With the opening of the era of three generations of test tube certification, the reshuffle of the assisted reproduction industry will accelerate, and compliance is an inevitable trend and will also be the biggest threshold. Under the strict supervision system of assisted reproductive application standards, the three-generation test tube clinical application in China will continue to mature, formalize and industrialize the road in the future.
For more than 10 million infertility patients in China, assisted reproduction technology is their last hope for fulfilling their fertility dreams. Three generations of test tube technology are expected to allow more families to successfully produce healthy babies. However, due to the lack of compliance products in the previous three generations of IVF clinical application fields, the PGS testing kits of various institutions were mainly developed using scientific research reagents. Because of the uneven quality and lack of supervision of each reagent, patient disputes occurred frequently. For example, in the non-invasive prenatal testing market before the official launch of the domestic NIPT test kit before 2014, doctor-patient disputes caused by false negative events were frequent.
Legal compliance is the basis for the development of health standards in China’s medical industry. Therefore, for patients, in order to have a healthy baby with peace of mind, they must choose legal, compliant and qualified assisted reproductive medical technology institutions for treatment; and major medical institutions should also develop under the premise of legal compliance Clinical diagnosis and treatment work to effectively protect the interests of patients and reduce doctor-patient disputes.
This article comes from WeChat public account: Biodiscover (ID: biodiscover) , Author: Gu Lulu