Next-Generation Sequencing Trends

Next-Generation Sequencing Trends

NGS is $3.8 billion market when instruments, reagents and related services are counted. This year, the market continued to advance.  Five trends are noticable.  These trends are documented in our report, Next Generation Sequencing Markets  

  1. Solid Investment in NGS Companies – 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.    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.
  1. Three Clinical Targets Dominate: Cancer, non-invasive prenatal and transplantation are the settled areas of clinical opportunity in NGS.  The use of NGS  in cancer relates to the identification of mutated genes that can be targeted or used to guide drug treatment.  
  1. Kits: 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 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.  
  1. Clarity on Regulatory Front– 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 recptor (EGFR) gene.

  2. China Emerges in NGS Industry – 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.  

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.