STUDY GOALS AND OBJECTIVES
BCC Research’s goal for this study is to provide an in-depth analysis of the clinical next generation sequencing (NGS) industry, an emerging industry with enormous market potential. The approach of analyzing the industry is taken in terms of workflow (e.g., sequencers, sequence capture, informatics) and key indications where NGS diagnostics will have market share by 2018.
BCC Research examines the markets for NGS diagnostics for the years 2012, 2013 and 2018.
The global NGS diagnostic markets are characterized and quantified by disease indication, test complexity, test purpose and geography.
Market segments that provide exciting growth opportunities include cancer, rare genetic diseases and prenatal screening.
The report provides a comprehensive discussion of NGS technologies, clinical applications, industry structure, important clinical sequencing initiatives, global markets, patent status and companies. The report is designed to aid companies in their strategic planning efforts for clinical genetic testing.
REASONS FOR DOING THE STUDY
The Human Genome Project (HGP) moved DNA sequencing technology to the forefront of life science research as a genetic analysis tool. The HGP relied heavily on Sanger sequencing by capillary electrophoresis to decipher the DNA sequence of the bases in the human genome.
The HGP led to significant improvements in the efficiency and costs of DNA sequencing. During this time period, the sequencing industry consolidated, resulting in one dominant company, Applied Biosystems (now Life Technologies).
Beginning in 2005, the launch of next generation sequencing technologies radically changed the structure of the industry and opened up exciting new market applications. The costs of sequencing have rapidly reduced to the point where it is now feasible for complex NGS tests to be priced in the range of other multiplex genetic tests.
As a result, opportunities emerged in clinical applications that are currently reaching fruition. The NGS clinical market is still relatively young and emerging, yet it holds great commercial promise.
Clinical value has been shown for many applications, and several launched tests are having good commercial success. This shows that both patients and physicians are recognizing the value of NGS tests. Several molecular genetic tests that have been successful on non-NGS formats will run on NGS platforms in the future.
At the same time, payors and insurance companies are beginning to provide coverage for these tests, further enhancing their commercial potential.
These technical and market factors are driving this market so that in 2013, it is timely to examine the clinical segment of the sequencing industry.
CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE
This report fills a gap in the industry because its sole focus is on clinical applications run on next generation sequencing instruments. The industry is still emerging, so there is little information available regarding the applications for which NGS platforms will be used.
The report provides a roadmap for understanding the ways in which next generation sequencing will be used in the diagnostic business during the next five years. It is a useful guide for strategic and business planning, as well as for learning about the impact new sequencing technologies will have in clinical diagnostics.
This market report will be useful to many companies involved in the clinical, genetic testing and sequencing industries. It will be particularly valuable for companies in such industries as life science research tools, NGS instruments, molecular diagnostics, informatics clinical laboratories, pharmaceutical, biotechnology, microfluidics, lab-on-a-chip and sample preparation.
SCOPE AND FORMAT
The scope of the report includes clinical NGS technologies, applications, industries, initiatives, patents and companies. The markets for NGS-based diagnostics are given for the years 2012, 2013 and 2018.
This report reviews the main sequencing technologies and explains why genetic variation is important in clinical testing. It then discusses some of the top research initiatives that are contributing to clinical NGS applications. Market driving forces are also discussed.
The report examines the markets by test complexity, indication and test purpose. Test complexity refers to the multiplexing (e.g., the number of genes covered) and coverage (e.g., the extent to which the genome is covered) of the test. Examining the market by test complexity provides valuable insight into which products (e.g., sample preparation, NGS instrument, informatics) will be in demand in the future.
The report provides market data and forecasts for NGS diagnostics by specific applications, including those for cancer, rare diseases, common diseases, and pre- and post-natal screening.
Specific geographic markets are discussed, including North America, Europe, China, Japan and the rest of the world.
Market data covers the years 2012, 2013 and 2018.
Industry sectors analyzed include NGS instruments, target enrichment, informatics, clinical laboratories and the prenatal screening industry.
More than 110 companies in the clinical NGS industry are profiled in this report.
BCC Research provides a summary of the main industry acquisitions and strategic alliances from 2011 through 2013, including key alliance trends.
Both primary and secondary research methodologies were used in preparing this study. BCC Research examined each of the key end-user market segments that will be commercially important during the next five years: cancer, rare genetic disorders, common disorders, and pre- and post-natal screening.
Based on this analysis, the current and future applications of NGS technologies are evaluated in each of the major clinical market segments and sales revenues are forecast for 2013 through 2018.
Based on analysis of both secondary and primary market sources, as well as the key trends in the industry, the report provides the current and projected market size for the various clinical NGS segments for the years 2012, 2013 and 2018.
BCC Research performed both primary and secondary research for this report. Primary sources included key industry companies and leading research institutions. In addition, data were compiled from secondary sources, including company websites and industry, trade and government publications.
John Bergin is the author of previous BCC biotechnology reports titled Epigenomics: Emerging Opportunities in Biomarkers, Diagnostics and Therapeutics; Global Biochip Markets: Microarrays and Lab-on-a-chip; RNA Interference in the Post-Genomics Era: Markets and Technologies; DNA Sequencing: Emerging Technologies and Applications; Biologic Imaging Reagents: Technologies and Global Markets; and Synthetic Biology: Emerging Global Markets.
Mr. Bergin has held business development, sales and marketing positions with a Fortune 500 advanced materials company, as well as executive management positions with an emerging nanotechnology company. Mr. Bergin holds a BS degree in Chemistry, an MS degree in Biotechnology and a Masters of Business Administration.
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The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal or accounting advice; nor should it serve as a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or from its use.