Chinese Market Comes to the Fore in Cancer Diagnostics

Chinese Market Comes to the Fore in Cancer Diagnostics

Kalorama Information offers market research reports related to this subject with IVD in China  and  Next-Generation Sequencing for Non-Invasive Prenatal Testing (NGS-NIPT) in China.

In Vitro Diagnostics Market Segments in China 

In the past five years, China has solidified its place as an IVD(in vitro diagnostics) market just behind the United States, European Union, and Japan. Most surprising in the Chinese IVD market’s ascent has been the prominence of its cancer diagnostics space. Advanced cancer testing is not associated with middle-income countries, but China’s research prowess in genome sequencing and globally significant patient populations in urban markets have created considerable opportunities for overseas IVD companies. In 2016, China is a clear market development priority for the IVD industry in the areas of cancer diagnostics texts, companion diagnostics, and sequencing-based cancer assays. Within the rapidly growing Chinese cancer diagnostics market, positioning is urgent. Substantial future market opportunities are already being written in the country’s growing base of clinical sequencers. 

Outside of U.S. Food and Drug Administration (FDA) approval or European CE marking, China FDA (CFDA) approval has been the next most heralded product development for many IVD companies. Roche issued a 2016 press release for the CFDA approval of its CINtec PLUS Cytology test or immunocytochemistry assay for the detection of human papillomavirus (HPV). Roche also markets a molecular HPV assay that may find greater usage in emerging markets in the coming years after being approved by the U.S. FDA as a first-line HPV screening tool. Qiagen has also targeted the Chinese HPV test market with its CFDA-approved careHPV platform for low-resource settings.

Cancer diagnostic specialist Epigenomics of Germany has relied upon China as a principal market for its liquid biopsy colorectal cancer (CRC) test, Epi ProColon. In May 2016, the test was included in Chinese government-administered guidelines for the screening of early CRC. Epigenomics is expected to commence Chinese clinical trials during 2016 to support CFDA approval of its liquid biopsy assay for lung cancer using the methylated SHOX2 gene biomarker. Epi ProColon and other advanced molecular assays for cancer have been designated as innovative products by the CFDA, which can expedite approval processes.

The Next Generation Sequencing Market in China

Next-generation sequencing (NGS) is the highest area of activity in the Chinese cancer diagnostics market. Driven foremost by demand for non-invasive prenatal testing (NIPT), the clinical sequencer base in China now includes over 40 hospitals in China and other testing institutions that serve at least 70 other hospitals and clinical clients. Cancer testing is the second-largest clinical application of NGS in China.

Beijing Genome Institute (BGI) and Berry Genomics are the two leading NGS players in China. Both companies are active in a government-approved pilot program for clinical cancer sequencing services. BGI uses Thermo Fisher’s Ion Torrent platform for its clinical sequencing assays that include the 500-gene TumorCare panel analyzed from circulating tumor cells (CTCs) and the 21-gene Oseq/Sentis tests for hereditary ovarian and breast cancers. Berry Genomics uses an Illumina sequencer as part of its trials for liquid biopsy EGFR mutation tests in non-small cell lung cancer (NSCLC) and c-KIT mutations in gastrointestional cancer. Another major life science technology company, Agilent Technologies, has gained access to the Chinese clinical cancer sequencing market through an agreement to provide its target enrichment solution to Chinese NGS assay developer Burning Rock.

Approved companion diagnostics and pharmacogenetic assays for cancer are relatively lacking in the Chinese diagnostics market. Domestic manufacturer Amoy Diagnostics has the most extensive market selection of CFDA-approved companion diagnostic kits for oncology, many that are also CE-marked for export markets. Molecular companion diagnostic market leaders Roche and Qiagen have announced approvals of major molecular companion assays such as their EGFR and KRAS mutation kits. Further development of the Chinese companion diagnostics market, including penetration of liquid biopsy test platforms (sequencers) and kits (plasma sample PCR kits), is expected in China.