Molecular diagnostics plays an important role in Reprogenetics and Oncology, which has attracted more attention from the public than ever before.
In China, there are about 16 million new births in 2017 with a very high infertility rate approximately 16%. The Preimplantation Genetic Diagnosis (PGD) cost about ￥16,000 (around $2,524). Nationally, the PGD market has a value of ￥10,4 billion ($1.64 billion). Because of technology barrier and a limited number of local manufacturers (noticeably Beijing Genomics Institute and Berry Genomics), the established and reputable foreign equipment manufacturers in the space can expect to have tremendous growth opportunities in the China market.
Next-Generation Sequencing (NGS) for cancer treatment and Noninvasive Prenatal Testing (NIPT) have become commercially viable in China while the after treatment and early detection still have more room to grow. Illumina and Life Medical are the frontrunners of foreign sequencing equipment manufacturers in China.
It is estimated that CFDA will impose more regulations on equipment and assay manufacturers of PGD, NGS and NIPT as well as allowing External Quality Assessment in the molecular diagnostics industry.
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.