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.
Contact:
Bruce Carlson
(212) 807-2622
bcarlson@kaloramainformation.com
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SOURCE Kalorama Information