Whole Exome Sequencing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

Whole Exome Sequencing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The whole exome sequencing market is expected to register a CAGR of 22.1% over the forecast period.

The outbreak of the COVID-19 pandemic had pushed the pharmaceutical industry into action, with a race to develop both therapeutic and preventive interventions. The onset of the SARS-CoV-2 pandemic had set many pharmaceutical companies to quickly add clinical sequencing to expand beyond their core business of food safety testing that had helped to fight against the COVID-19 pandemic. COVID-19 is anticipated to have a large impact on the whole exome sequencing market. For instance, in August 2020, the Helix COVID-19 next-generation sequencing (NGS) test was authorized by the United States Food and Drug Administration (USFDA) under an Emergency Use Authorization (EUA) for use only by the helix laboratory. It is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19 infection. Hence, owing to the increasing DNA sequencing-based research and development activities in the development of diagnostic tools or effective therapeutics for COVID-19, the market is likely to continue its significant growth rate during the forecast period.

The key factors driving the global whole-exome sequencing market are increasing applications in clinical diagnosis and the growing demand for the diagnosis of rare diseases, increasing R&D in the field of genomics, and next-generation sequencing, and increasing demand for personalized medicine. For instance, in November 2021 an article titled, “Whole genome sequencing helps pinpoint a genetic diagnosis for patients” reported that whole exome sequencing is available for highly selected patients for the routine diagnosis of rare childhood genetic diseases. The article also reported that next-generation sequencing allows hundreds or thousands of genes to be sequenced in a short period at a much lower cost. Thus, fueling the growth of the studied market.

Also, RNA sequencing is used in testing for a genome of viruses of various diseases such as HIV, Cancer, and COVID-19, with the rising prevalence of these diseases, the demand for RNA sequencing is also rapidly increasing. For instance, in July 2022, World Health Organization (WHO) reported that 37.7 million cases of HIV cases were recorded globally. These genomic sequencing methods provide information on genetic variants that can lead to disease due to the increase in the prevalence of such diseases, thereby growing demand for RNA sequencing.​

The, increasing R&D in the field of genomics, and next-generation sequencing is also driving the studied market. For instance, in May 2022, NanoString Technologies, Inc., launched a cloud-based workflow that improves the spatial data analysis experience of customers using Illumina NextSeq 1000 and NextSeq 2000 sequencing systems and the GeoMx Digital Spatial Profiler. This spatial analysis of whole transcriptomes combined with proteome analytes can now be simplified using this integrated, push-button run planning tool.​ Thus, such developments are expected to drive the market.

Thus, owing to the aforesaid mentioned factors the market is expected to show significant growth over the forecast period. However, the high complexity of the technique and lack of skilled personnel, and legal and ethical issues associated with whole exome sequencing may slow down the market growth.

Key Market TrendsPersonalized Medicine Segment is Expected to Witness a Significant Growth Over the Forecast Period.

Personalized medicine aims to provide tailor-made therapies to individual patients, depending on the molecular basis of the disease, and it has become popular over recent years. Precision medicine is a new tailor also known as individualized medicine is a healthcare approach that is based on each patient’s unique genetic makeup as opposed to traditional medicine. Owing to developments and a deeper understanding of genetics and human genetic makeup and how they drive health, development, and drug response enabling medical professionals to develop safer and more effective treatment methods and drugs for various health conditions. Precision is benefitting health and healthcare in different ways.

The rise in the prevalence of various types of cancer, affordability of personalized medicine therapy in cancer drugs and various other disease indications, fewer side-effects of personalized medicine therapy, high adoption in developed markets, and development of innovative drugs are factors driving this personalized medicine segment. For instance, in August 2022, the Medical Device Innovation Consortium launched its somatic reference samples (SRS) initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS). Next-generation sequencing (NGS) is a powerful technology enabling breakthroughs in diagnostics and ultimately therapeutics. These diagnostic tests need to be validated for accurate clinical use, and reference samples are essential to the validation process.

Additionally, the launch of products is also propelling the growth of the market segment. For instance, in May 2022 Genes2Me launched next-generation sequencing (NGS) based clinical panels for oncology, personalized medicine, and hereditary diseases in India.

Thus, due to the aforesaid mentioned reasons, the segment is expected to witness significant growth over the forecast period.

North America is Expected to Witness a Significant Growth Over the Forecast Period.

North America has the large regional market, in terms of revenue. The increasing prevalence of genetic and chronic disorders, such as cancer, the aging population, increasing demand for targeted and personalized medicine, and favorable government initiatives, are the primary factors behind the growth of the whole-exome sequencing market. Also, the major factors contributing to the market growth in the country are supplemented whole genome sequencing (WES) technology is gaining popularity as a routine clinical diagnostic test, particularly with the COVID-19 pandemic in this region and the upsurge in the number of strategic developments by the key market players operational within the region.

The mergers, acquisitions, launches, and partnerships among the key market players are also driving the market in the region. For instance, in January 2021, Helix OpCo, LLC. received de novo authorization from the United States Food and Drug Administration (USFDA) for the Helix Laboratory Platform, a whole exome sequencing platform with coverage of approximately 20,000 genes. This marks the first time such a broad, sequencing-based device has been authorized by the United States Food and Drug Administration (USFDA). Additionally, Helix also received 510(k) clearance for the Helix Genetic Health Risk App for late-onset Alzheimer's Disease for over-the-counter use on the Helix Laboratory Platform.

Similarly, in April 2020, Caris Life Sciences launched MI Exome, a next-generation sequencing-based assay for analyzing the whole exome of 22,000 DNA genes. MI Exome joins the Caris Molecular Intelligence suite of comprehensive profiling services that are designed to detect and characterize the molecular features of cancer to guide more precise individualized treatment decisions for patients.

Thus, due to the aforesaid mentioned reasons, the market is expected to show significant growth over the forecast period in the region.

Competitive Landscape

The whole exome sequencing market is fragmented in nature due to the presence of fewer companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies which hold the market shares and are well known as Ambry Genetics Corp., Bio-Rad Laboratories Inc., Eurofins Scientific Group, F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Boston Scientific Corporation, and QIAGEN.

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