Next-generation Sequencing: Emerging Clinical Applications and Global Markets

Next-generation Sequencing: Emerging Clinical Applications and Global Markets

  • May 2021 •
  • 417 pages •
  • Report ID: 1556799 •
  • Format: PDF
Report Scope
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 2019, 2020 and 2025.

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.

Liquid biopsy formats are discussed. 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 oncology, cardiovascular diseases, clinical microbiology/infectious diseases, Mendelian disorders, metabolic/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 DNA sequencing instruments; long-read sequencing; sequencing informatics; target enrichment; CTC capture and detection; liquid biopsy; cancer screening/early detection; direct to consumer testing; and noninvasive prenatal testing.

More than 200 companies in the clinical NGS industry are profiled in this report.

This report provides a summary of the main industry acquisitions and strategic alliances from January 2019 through April 2021, including key alliance trends.

Report Includes
- 29 data tables and 73 additional tables
- An updated review of the global market for emerging clinical applications of the next-generation sequencing (NGS) based diagnostics and related technologies
- Analyses of the global market trends, with data from 2019-2020, and projections of compound annual growth rates (CAGRs) through 2025
- Discussion of market opportunities for clinical NGS products, clinical applications, industry structure, regulatory scenario, and penetration of NGS-based diagnostics and technologies within the industry
- Estimation of the current market size and revenue forecasts for the global NGS diagnostic markets, and corresponding market share analysis by disease indication, test complexity, test purpose, application and geographic region
- Evaluation of 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 by 2025
- Assessment of main sequencing technologies and explanation of the importance of genetic variation in clinical testing as well as some of the significant research initiatives affecting clinical NGS applications
- A summary of the major acquisitions and strategic alliances in the clinical NGS industry from January 2019 through April 2021, including key alliance trends
- Patent review and significant allotments of the U.S. patents in the liquid biopsy industry
- Company profiles of the major market players, including Agilent Technologies Inc., Becton, Dickinson and Co. (BD), Koninklijke Philips N.V., Merck KGaA, Novogene Co. Ltd., Oxford Nanopore Technologies Ltd., Qiagen NV, Roche Holding AG, and Thermo Fisher Scientific Inc.

Summary
Next-generation sequencing (NGS) has emerged as an essential technology in clinical diagnostics. This rise to prominence is due to many factors, among which include the following - 
- Growing use of precision medicine to treat diseases.
- Demonstration of clinical utility in large-scale prospective clinical trials.
- Steady decrease in sequencing costs.
- Emerging use of liquid biopsy formats.

Several unique aspects of NGS make it a desirable technology for clinical applications.Since NGS platforms can sequence an entire genomic region or even an entire genome, a single test can examine hundreds or thousands of clinically important genetic variations.

This means that one test can replace multiple conventional single-gene tests, providing an advantage in price and in the amount of precious sample needed for the test itself.

NGS is often more accurate and reliable than existing diagnostics.This can result in better clinical outcomes.

For example, NGS can increase the pregnancy success rates in in vitro fertilization applications. Also, in rare genetic diseases, NGS can increase the success rates for determining a molecular diagnosis.

The NGS platform allows companies to expand the menu of disorders/diseases over time after initial launch of a test. This strategy has been employed in reproductive health applications, for example, launching a test to initially screen for aneuploidies, and then later expanding the test to include screening for additional genetic variants.

These features of NGS platforms provide a solid basis for the use of this technology in the clinic.