The Western European next-generation sequencing (NGS) market is poised for steady growth, owing to the emergence of new applications such as non-invasive prenatal testing and comprehensive oncology panels. NGS manufacturers are further tapping into this space by forming partnerships with molecular diagnostic companies to quicken NGS adoption in clinics, particularly for oncology-based testing.
New analysis from Frost & Sullivan, Western European Next-generation Sequencing Markets, finds that the market earned revenues of $381.9 million in 2013 and estimates this to reach $697.3 million in 2018. Major growth areas will include pre-implantation genetic diagnosis, oncology testing, infectious disease, human leukocyte antigen typing, and companion diagnostics. The total market, as defined by this study, includes next-generation sequencers and reagents for both research and diagnostic use.
“Companies within the space of personalised healthcare are designing instruments to target specific needs across the clinical diagnostic spectrum, therefore adding NGS capabilities to their portfolio,” said Frost & Sullivan Healthcare Senior Industry Analyst Divyaa Ravishankar. “As long as the genomic era interfaces with personalised medicine, NGS uptake will continue.”
A key restraint curbing market potential is the lack of reimbursement norms, which leads to geographical disparity in terms of NGS test availability. The consequent need for the cross-border shipping of samples, prominent in Belgium, France, Italy, Spain, the UK, and Germany, makes gauging the reimbursement scenario extremely tough for market participants.
Hence, NGS vendors must establish early, robust partnerships with regulatory bodies and devise effective business models to gain rapid regulatory clearance. Manufactures must also look to adhere to the CE marking rather than laboratory developed test (LDT) policies to enable the easy generation of reimbursement codes.
“Given the recent technology advancements in Europe, the future of DNA sequencing will move away from a laboratory-based setup to point of care testing,” predicted Ravishankar. “Frost & Sullivan expects NGS to become an area of interest to all market leaders within the point of care testing domain, as they strive to bring sequencing from ‘bench to bedside’.”
As the applications of NGS and molecular diagnostics expand to include crop improvement as well as food and safety testing, ready-to-use sequencing-based tests that generate data from raw samples will emerge as important tools in the Western European market.