Kalorama: Noninvasive Prenatal Sequencing Succeeds in China

NEW YORK, Oct. 6, 2015 /PRNewswire/ -- Despite slackened economic growth, China remains a source of tremendous demand for clinical innovation, according to Kalorama Information, and that includes non invasive prenatal tests.  The healthcare market researcher said that sequencing-based assays have recently been approved by government regulators and are entering an enormous marketplace.   Kalorama Information offers comprehensive subject reports that variously treat the Chinese IVD, global cancer diagnostics, prenatal testing, circulating tumor cells (CTCs), and next-generation sequencing (NGS) markets.

China is already home to an estimated 8% of all laboratories worldwide providing clinical genetic testing services; 9% of all NGS systems used in research or applied testing; and 5% of global revenue from cancer testing services. Outside of North America, Europe and Japan, China is primed to emerge as the leading market for clinical NGS and molecular cancer testing.  In 2014, the Chinese Food & Drug Administration (CFDA; SFDA) and National Health and Family Planning Committee (NHFPC) mandated CFDA approval for NGS-based assays, primarily used in the booming domestic market for non-invasive prenatal tests (NIPTs). Regulators also established hospital pilot sites for the development and assessment of additional NGS-based assays prior to CFDA approval. The formalization of the clinical NGS market in China may restrict market entry and perhaps more broad-based industry innovation, but should help nurture more stable and diversified demand for clinical NGS assays such as in oncology.

"The stakes are high for clinical next-generation sequencing (NGS) platform vendors in the Chinese market," said Emil Salazar.  

One market leader in the Chinese clinical NGS market, Illumina, characterized the opportunity available for its CDFA-approved, Berry Genomics-co-developed NextSeq CN500 instrument as a 'huge opportunity,' given the 20 million babies born every year and expectations that half of them will be screened.   Including other CFDA-approved NGS platforms for NIPT such as BGI's BGISEQ-100 and -1000, DaAn's DA8600 (Life Technologies instrument), CapitalBio's Bioelectron Seq 4000 (Life Tech) and HYK Gene's HYK-PSTAR-IIA, a clinical NGS instrument base has developed among Chinese urban hospitals. Kalorama Information estimates that China overall is home to nearly 10% of the world's NGS systems.

NGS-based cancer testing may in the future leverage the clinical instrument base developed for the NIPT market, but for now is limited to pilot sites associated with domestic NGS leaders. Beijing Genome Institute (BGI) offers two oncology tests: the 500-gene TumorCare panel analyzed from circulating tumor cells for treatment decisions and the Oseq/Sentis test for 21 genes related to hereditary ovarian and breast cancers. The CFDA NGS pilot program will be integral to BGI to expand assay claims and capabilities, including early cancer detection with the TumorCare panel. Other NGS pilot participants include Berry Genomics and Novogene. Berry Genomics may use the domestic NGS pilot program in conjunction with its current trials to introduce circulating tumor DNA (ctDNA) assays for lung cancer (EGFR gene) and gastrointestinal cancer (CKIT gene).

Kalorama Information's report, Next Generation Sequencing (NGS) Markets 2015 (Systems, Consumables, Services, Acquisitions, Agreements, Competitive Analysis, Platforms, Applications, Brand Ownership and Other Trends) has more information on this important market worldwide, including regional market breakouts, segment markets and company profiles.  The report is available at: http://www.kaloramainformation.com/redirect.asp?progid=87870&productid=8743599.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.  

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SOURCE Kalorama Information