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Next-Generation Sequencing: Emerging Clinical Applications and Global Markets

  • June 2015
  • -
  • BCC Research
  • -
  • 289 pages

Summary

Table of Contents

This BCC Research report provides a comprehensive discussion of NGS technologies, clinical applications, industry structure, important clinical sequencing initiatives, global markets, patent status and companies. Market data covers the years 2014, 2015 and 2020.

Use this report to:
- Identify the main sequencing technologies and learn why genetic variation is important in clinical testing.
- Examine the global NGS diagnostic markets, characterized and quantified by disease type, test complexity, test purpose and geography.
- Focus on the top research initiatives that are contributing to clinical NGS applications.
- Learn about the main industry acquisitions and strategic alliances from 2013 through 2015, including key alliance trends.

Highlights
- The global clinical next-generation sequencing (NGS) market was valued at $886.1 million in 2014. This market is expected to grow at a compound annual growth rate (CAGR) of 31.3%, from $997.1 million in 2015 to nearly $3.9 billion by 2020.
- NGS-based diagnostic market for reproductive health applications is expected to increase from $572.9 million in 2015 to $1.7 billion by 2020, at a CAGR of 24.8% from 2015 to 2020.
- The global market for NGS-based cancer applications is expected to grow at a CAGR of 34.7%, from $206.3 million in 2015 to $915.7 million by 2020.

Introduction & Scope

INTRODUCTION

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 2020. BCC Research examines the markets for NGS diagnostics for the years 2014, 2015 and 2020. The global NGS diagnostic markets are characterized and quantified by disease indication, test complexity, test purpose and geography. Market segments that provide exceptional growth opportunities include cancer, rare genetic diseases and reproductive health. 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 Thermo Fisher Scientific).

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 beginning to establish a foothold in the molecular diagnostic industry and holds great commercial promise. More than 85 clinical laboratories are now offering NGS-based testing services. For many applications, the clinical benefits have been proven. At the same time, payers and insurance companies are beginning to provide coverage for these tests, further enhancing their commercial potential. The outstanding growth potential for NGS diagnostics makes it particularly timely to update an earlier report, published in 2013.

CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE
This report fills a gap in the industry by focusing solely on clinical applications run on next-generation sequencing instruments. Because this industry shows great promise,
information about the market will be particularly useful to companies and other institutions. 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 2014, 2015 and 2020. 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, complex disorders and reproductive health.

Specific geographic markets are discussed, including North America, Europe, China, Japan and the rest of the world. Market data covers the years 2014, 2015 and 2020.
Industry sectors analyzed include NGS instruments, target enrichment, informatics, clinical laboratory testing services, reproductive health diagnostics, HLA typing, liquid
biopsy, immune sequencing and fusion diagnostics. More than 170 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 2013 through 2015, including key alliance trends.

METHODOLOGY
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, complex disorders and reproductive health. 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 2015 through 2020. 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 2014, 2015 and 2020.

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