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Next-generation Sequencing: Emerging Clinical Applications and Global Markets

  • June 2017
  • 321 pages
  • BCC Research
Report ID: 1556799

Summary

Table of Contents

• The global clinical next-generation sequencing (NGS) market reached $2.7 billion in 2016. This market is expected to grow at a compound annual growth rate (CAGR) of 27%, from nearly $3.2 billion in 2017 to $10.5 billion by 2022.
• Non-cancer applications as a segment should reach $2.3 billion in 2017 to $6.4 billion by 2020, at a CAGR of 22.3% from 2017 to 2022.
• Cancer applications as a segment should reach $838.8 million in 2017 to nearly $4.1 billion by 2022, at a CAGR of 37.3% from 2017 to 2022.

Chapter 1: 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, one with significant market potential. This report analyzes the key NGS workflow portions of the industry (e.g., sequencing instruments, pre-sequencing target preparation and capture, and post-sequencing data analysis) and the main clinical indications where NGS will capture significant market share in 2022. BCC Research provides information about the markets for NGS diagnostics for the years 2015, 2016, 2017 and 2022. The global NGS diagnostic markets are characterized and quantified by disease indication, test complexity, test purpose and region.

Market segments that provide exceptional growth opportunities for clinical NGS products include cancer, rare genetic (i.e., Mendelian) diseases, reproductive health, and transplant diagnostics. 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 relating to the clinical genetic testing market.


Reasons for Doing This 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. By 2017, the costs of sequencing have been reduced to the point where it is now feasible for complex NGS tests to be priced in the range of other multiplex genetic tests. At the same time, a plethora of post-HGP sequencingrelated initiatives have identified clinically relevant genetic variations that can be used as the basis for diagnostic testing strategies. As a result, opportunities for NGS testing are now coming to the forefront in clinical applications. The
NGS clinical market has established a foothold in the molecular diagnostic industry and its future holds great commercial promise. As identified in this report, a significant number of clinical laboratories are now offering NGS-based testing services. For a growing number of applications, the clinical benefits have been demonstrated. Concurrent with these developments, payers and insurance companies are providing more coverage for these tests, further enhancing their commercial potential. The outstanding growth potential for NGS diagnostics makes it particularly timely to update BCC Research’s earlier report on this industry.


Scope of Report
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 2015, 2016, 2017 and 2022. This report reviews the main sequencing technologies and explains why genetic variation is important in
clinical testing. It then discusses some of the significant research initiatives that impact clinical NGS applications. The main market driving forces are also discussed. The report examines the markets by test complexity, clinical indication and test purpose. Test complexity refers to the plex level (i.e., the number of genetic markers that can be analyzed within a sample) 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, etc.) will be in demand in the future.

The report provides market data and forecasts for NGS diagnostics by specific applications, including those for cancer, cardiovascular diseases, clinical microbiology and infectious diseases, Mendelian disorders, metabolic and immune disorders, neurological disorders, reproductive health, and transplant
medicine. Specific geographic markets are discussed, including North America, Europe, Asia-Pacific, and the rest of the world. Industry sectors analyzed include sequencing instruments, target enrichment, informatics, clinical laboratory testing services, reproductive health diagnostics, liquid biopsy, immune sequencing, HLA typing, third generation sequencing, and direct to consumer. More than 200 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 2015 through April 2017, including key alliance trends.



Information Sources
BCC Research performed both primary and secondary research for this report. Primary sources included industry companies and leading research institutions and secondary sources included company websites and industry, trade and government publications.


Methodology
Both primary and secondary sources were consulted for this report, and a study of the industry trends was performed. BCC Research examined each of the key end-user market segments that will be commercially important during the forecast period: cancer, rare genetic disorders, complex disorders, transplant medicine, 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 historical sales revenues are given for 2015 and 2016, estimated revenues are given for 2017, and forecast revenues are given for 2022.


Geographic Breakdown
In this report, the geographic regions considered for market analysis include, and only include:

North America
• United States.
• Mexico.
• Canada.
Europe
• Austria.
• Belgium.
• Czech Republic.
• Denmark.
• Estonia.
• France.
• Finland.
• Germany.
• Greece.
• Hungary.
• Iceland.
• Italy.
• Ireland.
• Luxembourg.
• Netherlands.
• Norway.
• Poland.
• Portugal.
• Romania.
• Spain.
• Sweden.
• Switzerland.
• Turkey.
• United Kingdom.

Asia-Pacific
• Australia.
• China.
• Hong Kong.
• India.
• Japan.
• Malaysia.
• New Zealand.
• Philippines.
• Singapore.
• South Korea.
• Taiwan.
• Thailand.

Rest of World
• Argentina.
• Brazil.
• Chile.
• Israel.
• Kuwait.
• Russia.
• Saudi Arabia.
• South Africa.
• United Arab Emirates.

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