Table of Contents
Marketplace Evolves in Preparation for Clinical Sequencing Windfall
The total market, as defined by this study, includes next-generation sequencing instruments and reagents in the United States. Instruments include those that use newer technology than traditional capillary electrophoresis (CE) sequencing, such as sequencing-by-synthesis, sequencing-by-ligation, single-molecule sequencing, and semiconductor sequencing. This research service offers a discussion of the key market drivers and restraints, revenue forecasts, and product types, as well as important trends affecting growth. This analysis also presents key companies to watch, major market dynamics, and strategic recommendations for competitors.
The majority of the quantitative and qualitative information contained in this research service was acquired through primary research conducted with next-generation sequencing instruments and reagents providers. Most consultations were conducted with vice presidents (VPs) of business units, VPs of marketing, product managers, marketing managers, marketing directors, and business development directors from various competitors in the next-generation sequencing market. Industry-specific information obtained include:
-Next-generation sequencing revenue breakdowns by technology segments and regions
-Company revenues, market share estimates, and projected growth rates of various competitors
-Top-level customer, regional, and technology market trend information
-Market drivers, restraints, and challenges Supplementary research was conducted utilizing secondary sources including scientific journals, online media, Frost & Sullivan databases and research services, and publicly available corporate filings. Forecasts are based on the data and analyses regarding industry challenges, market drivers and restraints, and market trends. If specific revenues or market sizes were unavailable, estimates were derived through the consultations with industry experts, augmented by secondary research. Growth trends specific to certain market participants are based on consultations, past growth rates, and technology reviews.
-The total US market for next-generation sequencing (NGS) instruments and reagents generated revenue of $ million in 2013, it is expected to reach $ million in 2018. The market is expected to grow at a CAGR of % from 2013 to 2018.
-The US market accounted for% of global combined NGS instruments and reagents revenue in 2013, while Europe accounted for % and APAC/ROW generated % of market revenue.
-The US NGS instruments market generated $ million in 2013, with a CAGR of % expected to result in a market size of $ million in 2018. The US NGS reagents market totaled $ million in 2013 and is expected to grow at a CAGR of % to $ million in 2018.
-The United States holds the largest NGS instruments installed base of all countries globally, which continues to drive a large reagent pull-through. Adoption of NGS instruments in clinically applied settings, such as reference laboratories, hospitals, and translational research laboratories, will account for more growth over the next 5 years than in traditional labs.
-The United States leads the world in the use of NGS in clinical diagnostics, with NGS-based laboratory developed tests (LDT) already in use, and an expanding pipeline of NGS-based in vitro diagnostic (IVD) tests in the US Food and Drug Administration (FDA) approval process. Between % and % of clinical sequencing is panel-based, while exome sequencing accounts for % to % and whole genomes roughly % to %.
-Market revenues are restrained by the declining instrument costs and reagent costs per genome, yet this trend is also spurring wider accessibility and larger throughput projects. Increasing competition over the next 3 years will further drive down pricing.
-Key vendors in the NGS instrumentation space are Illumina, Life Technologies, Pacific Biosciences and Roche (until the company exits the market in 2015). Emerging competitors expected to enter the NGS instruments market in 2014 or beyond include Oxford Nanopore, Qiagen (Intelligent BioSystems), GnuBIO (acquired by Bio-Rad in 2014), GenapSys, DNA Electronics, NabSys, Genia Technologies, and Noblegen Biosciences.
-Key vendors in the NGS reagents market include Illumina, Life Technologies, Roche, Agilent, Qiagen, and New England Biolabs. This competitor base includes a number of smaller participants, and is expected to expand as companies develop NGS products to take advantage of strong market growth.
The key factors affecting the US NGS market forecast follows:
oThe price of sequencing falling near the $ genome mark, making large, whole-human genome sequencing projects and population studies feasible
oExpanding use for clinical diagnostics in the form of LDTs, IVD test panels, exome sequencing, and to a lesser extent, whole genome sequencing
oIncreasing use in pharmaceutical applications (i.e., clinical trials, patient stratification, and toxicogenomics)
oFast pace of technological advancements drives new product launches, making older platforms obsolete and spurring upgrades
oLaunch of clinically focused instruments
oAdvancements in commercially available reagents that increase speed of sample preparation, lower sample volume requirement, and improve project accuracy
oImproved and simplified bioinformatics that enable better data analysis and clinical interpretation
oCreation of very large databases of sequencing and clinical data to improve the clinical utility of genomic information
oUS sequestration measures in 2013 negatively affected the academic and government sectors overall, yet the percent of federal funding going to NGS-based projects continues to grow at a much faster pace than funding itself
oGiven the growth potential of NGS and clinical sequencing in particular, this industry is highly advantageous for venture capital funding
oFurther definition of clinical standards and guidelines is needed
oFDA approval of NGS-based IVD tests needs more efficient process
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