Clinical Oncology Next Generation Sequencing Market Size, Share & Trends Analysis Report By Workflow, By Technology (WGS, WES), By Application (Screening, Companion Diagnostics), By End-use, And Segment Forecasts, 2021 - 2028

Report Overview

The global clinical oncology next generation sequencing market size was valued at USD 297.9 million in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 14.70% from 2021 to 2028. The technology facilitates time- and cost-effective sequencing of tumor DNA, which, in turn, has brought about a “genomic era” of cancer treatment as well as research. Next generation sequencing (NGS) has brought noteworthy developments in personalized medicine for oncology. This is because the technology enables the identification of resistance mechanisms, germline, and somatic mutations, and allows quantification of mutational burden of cancers. These factors are anticipated to aid in increasing the clinical utility of NGS in precision oncology care.

Rise in clinical applications of next-generation sequencing in precision oncology has driven the efforts of the key companies to develop novel platforms that can be used for genomic assays. For instance, in February 2021, Congenica collaborated with Gabriel Precision Oncology Ltd. to manufacture an automatic clinical oncology interpretation software platform.

This product will facilitate NGS-based molecular diagnostics of tumors in routine clinical practice. In January 2021, 4baseCare; a precision oncology start-up collaborated with Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), India to develop ClinOme - an AI-driven clinical interpretation platform.

This platform analyses NGS raw data, which is used by clinicians to categorize and interpret genomic alterations along with experimental and approved therapies for each resistant and responsive genotype-drug combination. This further increases the use of NGS data analysis platforms for personalized oncology treatment.

Clinical Oncology Next Generation Sequencing Market Trends

Technological advances in next generation sequencing along with increasing adoption of personalized medicine and companion diagnostics is anticipated to drive the market growth. In addition, increasing the usefulness of NGS for liquid biopsy is expected to contribute to revenue generation in the market. This technology is used to sequence circulating tumor DNA for liquid biopsy sample analysis. This leads to effective profiling of cancers, which in turn, enables non-invasive, real-time monitoring of cancer.

Furthermore, growing market competitiveness and increasing research & development activities to develop solutions could potentially fuel the market progression. For instance, in May 2022, Berry Oncology launched HIFI System, an innovative self-iterative liquid biopsy technology. This technology could further help in early screening for cancer and providing timely treatment to the patients.

Next-generation technology enables time and cost-effective sequencing of cancerous DNA, which has revolutionized research on cancer treatment. The broad application of NGS integrated with bioinformatics tools, promises to transform cancer diagnosis, research, and therapy. An increase in the clinical application of NGS in precision oncology is driving the efforts of major companies to develop new platforms that could be used for genomic assays.

NGS has been the most advanced technology and has rapidly evolved to the point where various genomes can be simultaneously sequenced in a single instrument. Adoption of NGS technology especially in the cancer field considering the genetic aspects of the disease is expected to positively impact the market growth. Moreover, the NGS is now reaching the point where many laboratories are contemplating its routine diagnostic use. Its speed, sensitivity, and reduced cost per sample are some of the factors that are contributing to the higher adoption of NGS technology for research purposes.

Sequencing helps to find the proper treatment for cancer patients with current mutations and targeting mutations. However, in oncology, WGS is still not widely implemented owing to the ambiguities such as required expertise, infrastructure, reimbursement and costs, and unknown cancer clinical utility. These factors may hamper the market’s growth in the coming years.

NGS-based testing technologies have the potential to be novel tools for clinical genomics and personalized medicine implementation. However, the presence of huge uncertainty about future health plan coverage policies for genomics and their application to speed up the development of this testing is causing growth to be slowed to some extent. In addition, the lack of consistent coverage and reimbursement regulations for new genomic techniques are also anticipated to restrict market growth by certain extent.

Technology Insights

The targeted sequencing & resequencing segment dominated the market with a revenue share of over 72% in 2020. Targeted cancer sequencing panels help reduce the cost, time, and amount of data analyzed during the sequencing of tumor samples. Moreover, the efficiency of targeted panels to detect malignant tumors increases their clinical utility. According to a study published in JCO Precision Oncology, 2020, NGS panels are clinically useful in 64% of cancer cases.

In addition, the rise in development and adoption of targeted panels that focus on tumor‐associated microorganisms and oncology‐related genes drives the segment growth. The 523-gene panel offered by Illumina includes all the possible genes that have the potential to cause the development of malignant tumors. The product is adopted by clinical laboratories to diagnose patients suffering from acute myeloid leukemia.

Whole-Genome Sequencing (WGS) is projected to be the fastest-growing technology segment from 2021 to 2028 owing to the utility of this technology to differentiate and compare normal tissues from tumor tissues. Moreover, whole-genome sequencing of cancer patients helps in finding treatments for current mutations and also helps in targeting mutations in advance. This also helps analyze cancer prognosis and develop a treatment regimen based on the affected genes.

Workflow Insights

Sequencing was the highest revenue-generating workflow segment in 2020 and accounted for a revenue share of over 54%. Sequencing involves the use of advanced platforms and is a vital step of the entire workflow. An increase in the number of cancer sequencing projects also augments the segment growth. For instance, the Pan-Cancer Analysis of Whole Genomes (PCAWG) Consortium analyzed 38 different cancer types by sequencing more than 2,600 tumor samples.

Efforts taken by key players to reduce the cost of NGS library preparation propels the pre-sequencing segment. For instance, in January 2021, Thermo Fisher Scientific signed a co-marketing initiative with SPT Labtech to reduce the cost of NGS library preparation for variant detection of cancer, infectious diseases, and other clinical conditions.

NGS data analysis is anticipated to grow at a significant rate. Efforts taken by key market participants to develop advanced computational tools propels the segment growth. For instance, in January 2021, scientists from the MD Anderson Cancer Center developed CopyKAT, a new computational tool to differentiate between normal as well as cancer cells in a tumor.

Application Insights

Screening accounted for the largest revenue share of over 79% as NGS is highly employed in cancer screening programs across the globe. Currently, NGS-based testing is considered the most efficient method of identification of genetic alterations that can be targeted for clinical benefit in cancer patients. This technology allows clinicians to simultaneously assess multiple gene alterations.

In addition, the technology requires fewer tumor tissues as compared to other pathology techniques. The companion diagnostics segment is projected to register the fastest CAGR from 2021 to 2028. Continuous product developments and collaborations & partnerships among the key players are expected to boost the adoption of NGS for companion diagnostics.

For instance, in February 2020, Resolution Bioscience, Inc. formed an agreement with LabCorp to increase the access of its Resolution ctDx Lung assay to clinicians and patients. This diagnostic assay is an accurate, fast, and noninvasive test that detects the actionable mutations in Non-Small Cell Lung Cancer (NSCLC). The assay is powered by the company’s cell-free DNA platform, which involves NGS biochemistry and cloud-based bioinformatics.

End-use Insights

The laboratories segment led the market with a revenue share of over 65% in 2020. It is a time-consuming procedure for laboratories to set up complex workflows. Therefore, most of the advanced laboratories have developed pre-existing workflows that are based upon standard procedures.

In addition, with the tremendous development and release of NGS assays for clinical purposes, specific guidelines have been developed for procedures utilizing NGS testing. Therefore, most of the FDA-approved tests come with established controls, standards, and performance characteristics to demonstrate the validity of the results.

Clinical laboratories are regulated by several governing bodies in the U.S. The CMSs regulate laboratory testing through Clinical Laboratory Improvement Amendments (CLIA). In addition, these are further governed by state-level bodies that may have stringent regulations than CLIA. Moreover, other organizations, such as the Association of Molecular Pathology (AMP), American College of Medical Genetics and Genomics (ACMG), and College of American Pathologists (CAP), have further set the best guidelines for clinical laboratories.

Regional Insights

North America dominated the global clinical oncology NGS market with a share of more than 49%. Significant efforts taken by regulatory bodies to increase cancer screening diagnosis in the U.S. account for this growth. For instance, The Cancer Genome Atlas program initiated by the U.S. National Cancer Institute (NCI) has performed next-generation sequencing of more than 20,000 primary cancer samples from 33 different types of cancers.

The U.S. clinical oncology next-generation sequencing market is driven by the growing adoption of sequencing platforms for clinical diagnosis as a consequence of the significant reduction in the cost of installation. Furthermore, the easy availability of genomic and proteomic data has poised this market to display possibly high-value opportunities for growth in the coming years.

China has witnessed significant growth in recent years owing to the huge reduction in the sequencing cost when compared to the previous years. The major players in the country offer NGS products and services at a highly competitive price when compared to other countries. Favorable government policies along with high investment by key market players are driving the growth of the market.

Key Companies & Market share Insights

The market is marked by the presence of several small- and mid-sized entities that have taken substantial efforts to strengthen their market presence. For instance, in May 2020, Burning Rock Biotech Limited; a China-based cancer test provider, partnered with Illumina to promote the standardization and development of NGS-based cancer therapy selection within China. The company also signed an agreement with Myriad Genetics, Inc. to develop and commercialize myChoice tumor testing in China. Some of the key companies in the global clinical oncology next generation sequencing market are:

• Illumina, Inc.

• Thermo Fisher Scientific

• F. Hoffmann-La Roche Ltd.

• Agilent Technologies

• Myriad Genetics

• Beijing Genomics Institute (BGI)

• Perkin Elmer

• Foundation Medicine

• Pacific Bioscience

• Oxford Nanopore Technologies Ltd.

• Paradigm Diagnostics

• Caris Life Sciences

• Partek, Inc.

• Eurofins Scientific S.E.

• Qiagen N.V.

Clinical Oncology Next Generation Sequencing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global clinical oncology next generation sequencing market report on the basis of technology, workflow, application, end-use, and region:

• Technology Outlook (Revenue, USD Million, 2017 - 2028)

  • Whole Genome Sequencing

  • Whole Exome Sequencing

  • Targeted Sequencing & Resequencing Centrifuges

• Workflow Outlook (Revenue, USD Million, 2017 - 2028)

  • Pre-Sequencing

  • Sequencing

  • Data Analysis

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Screening

    • Sporadic Cancer

    • Inherited Cancer

  • Companion Diagnostics

  • Other Diagnostics

• End-use Outlook (Revenue, USD Million, 2017 - 2028)

  • Hospitals

  • Clinics

  • Laboratories

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia