Dec. 12, 2016 /PRNewswire/ — 2016 was a strong year for next-generation sequencing according to healthcare market research firm Kalorama Information. The estimated $3.8 billion in product revenues in 2015 saw revenue growth, new applications, regulatory advances and investment. Kalorama covers next-generation sequencing in its report, Next Generation Sequencing Markets.
To view information on Kalorama Information’s report: www.kaloramainformation.com
- Investors Continue to Bet on NGS – Over $800 million in investor capital went into companies with a next-generation sequencing focus in 2016. Among 2016 deals – N-of-One announced that it had received $7 million in a Series B financing from Providence Ventures and Excel Venture Management. AccuraGen announced that it had raised $40 million in a Series B financing round to support development and commercialization of Firefly, the company’s liquid biopsy technology. Omicia announced completion of a $23 million Series B financing round. ACT Genomics announced that the company had raised US$ 12.5 million in Series B funding. The announcement reported that Hotung Group and CDIB Capital Management led the round. Human Longevity, L.L.C announced earlier in the year it had raised 220 million in Series B financing. The company claims the HLI Knowledgebase has more than 20,000 complete genomes coupled with phenotype data.
- Clinical Opportunity in Three Areas: Cancer, non-invasive pre-natal and transplantation are the settled areas of clinical opportunity in NGS. DNA sequencing has successfully penetrated the research market, but future growth is expected in diagnostic applications of next generation sequencing in clinical laboratories and companies with CLIA-certified laboratories, and also in IVD companies that sell kits to clinical labs. Among the three, transplantation is a specialty area. NIPT is the established opportunity and cancer is the growth area. The use of NGS in cancer relates to the identification of mutated genes that can be targeted or used to guide drug treatment.
- NGS-IVD: While next generation sequencing has been used for some clinical applications for a while, this is becoming more widespread and some next generation sequencing companies are starting to develop and commercialize kits that can be produced and sold to clinical laboratories following the traditional in vitro diagnostic (IVD) model. Illumina’s MiSeqDx was the first cleared in vitro diagnostic next generation sequencing system. MiSeqDx is also CE marked, and FDA-cleared tests are currently available on this platform. Illumina is continuing to develop products for the IVD market. In August 2014, Illumina announced collaborative strategic partnerships with AstraZeneca, Janssen, and Sanofi to develop a next-generation sequencing based test for use during clinical trials, and eventually resulting in a multi-gene panel to be used to select therapies.
- Regulatory Picture Getting Clearer – Positive regulatory decisions for NGS product launches bode well for future efforts. Recent regulatory decisions include: Vela Diagnostics obtained Chinese FDA (CFDA) approval of the Sentosa SX 101 multi-purpose automated liquid handling platform for clinical use. The company also received Emergency Use Authorization (EUA) from the US FDA for its Sentosa SA ZIKV RT-PCR Test, a real-time PCR test for qualitative detection of RNA from Zika virus. Asuragen announced that it received premarket clearance from the US FDA for the QuantideX qPCR BCR-ABL IS Kit for the monitoring of molecular response in Chronic Myeloid Leukemia (CML) patients. HTG Molecular Diagnostics received CE-IVD marking for its HTG EdgeSeq DLBCL Cell of Origin Assay and the NGS-based HTG EdgeSeq system. And Roche Molecular Systems received FDA approval for the cobas EFGR Mutation Test v2 for detection of substitution mutations in the epidermal growth factor receptor (EGFR) gene.
- China a Major NGS Player in 2016 – Chinese companies and labs have rapidly expanded China’s role in the market both on the supplier side and the customer side. BGI played a big role in this trend, along with the rapidly growing life science community. NIPT has become a large market in China. The BGI sequencer systems are now available, although they cancelled the Revolocity system; the systems are based upon Ion Torrent and Complete Genomics technologies. Direct Genomics is a Chinese company developing a diagnostic sequencer platform that uses the now-defunct Helicos’ technology. BGI BGISEQ-100 and BGI-SEQ-1000 (Life Technologies and Complete Genomics, respectively, CapitalBio BioelectronSeq 4000 (Life Technologies), DaAn DA8600 (Life Technologies) and HYK Gene HYK-PSTAR-IIA are among the CFDA-cleared systems available.
Kalorama Information’s Next Generation Sequencing Markets contains market estimates and forecasts for DNA sequencing as well as detailed lists of investments in NGS, partnerships and collaborations and other data.
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