GENOMIC CANCER TESTING MARKET ANALYSIS

The global genomic cancer testing market size is expected to reach US$ 47.62 billion by 2030, from US$ 16.15 billion in 2023, at a CAGR of 16.7% during the forecast period.

Genomic cancer testing is a type of medical testing that uses genomic data to diagnose and treat various types of cancer. It involves the sequencing and analysis of a patient's genomic data to identify specific mutations or alterations that may be causing or contributing to the development of cancer. This type of testing can help doctors to determine the most effective treatment plan for a patient's specific type of cancer. It can also be used to predict a patient's risk of developing certain types of cancer based on their genetic makeup.

The genomic cancer testing market is segmented by test type, cancer type, technology, end user, biomarker type, service provider, application, testing setting, and region. By test type, the market is segmented into genomic profiling tests, liquid biopsy tests, companion diagnostic tests, pharmacogenomic tests, hereditary cancer tests, and other specialized genomic tests. The genomic profiling tests segment accounts for the largest market share due to the increased prevalence of cancer globally.

Global genomic cancer testing market Regional Insights:

• North America has emerged as a leader in the genomic cancer testing market, leveraging its well-established healthcare infrastructure and high awareness about precision medicine. The U.S., in particular, has witnessed significant advancements and widespread adoption of genomic testing in clinical practice. It is expected to dominate the market with a share of 37.5% in 2023. The region's growth is fueled by factors such as the high prevalence of cancer, increased investments in genomic cancer testing technologies, and the presence of numerous key players.
• Europe has also been actively investing in precision medicine initiatives, including genomic cancer testing. Countries like the U.K., Germany, and France have made notable progress in integrating genomic testing into routine clinical care. In 2023, Europe is expected to be the second-largest market with a share of 30.4%. The region's growth is driven by the rising demand for personalized cancer care, increasing government initiatives, and the presence of a significant number of key players.
• The Asia Pacific region demonstrates substantial growth potential in the genomic cancer testing market. Countries like China, Japan, and South Korea have been investing in genomic research and technology, leading to increased adoption of genomic testing in oncology. Asia-Pacific is anticipated to be the fastest-growing market during the forecast period, with a projected CAGR of 22.6%. Factors driving growth in the region include the rising prevalence of cancer, increasing investments in genomic cancer testing technologies, and growing awareness about the benefits of genomic cancer testing.

 Figure 1. Global Genomic Cancer Testing Market Share (%), by Region, 2023

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Global Genomic Cancer Testing Market Drivers:

• Increasing Cancer Incidence: The rising prevalence of cancer globally is a significant driver for the genomic cancer testing market. As the number of cancer cases continues to increase, there is a growing need for accurate and comprehensive genomic testing to understand the molecular characteristics of tumors and guide personalized treatment strategies. For instance, according to data published by World Health Organization (WHO) in July 2023, there were 2.3 million women diagnosed with breast cancer and 685 000 deaths globally, in 2020.
• Advancements in Genomic Technologies: Technological advancements in genomic sequencing and analysis techniques, such as next-generation sequencing (NGS), have revolutionized the field of genomics. These advancements have made genomic cancer testing more accessible, cost-effective, and efficient, driving its adoption in clinical practice. For instance, in March 2022, Illumina, Inc., an U.S.-based biotechnology company, announced the launch of TruSight Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent.
• Shift towards Personalized Medicine: Genomic cancer testing plays a crucial role in the shift towards personalized medicine. It enables healthcare professionals to tailor treatment plans based on the genetic profile of each patient's tumor, leading to more targeted and effective therapies. The growing emphasis on personalized medicine approaches is driving the demand for genomic cancer testing.
• Improved Treatment Outcomes: Genomic cancer testing has shown promising results in improving treatment outcomes. By identifying specific genetic alterations in tumors, healthcare providers can select targeted therapies that are more likely to be effective, thereby enhancing patient outcomes and reducing unnecessary treatments or adverse effects.

Global Genomic Cancer Testing Market Opportunities:

• Expanded Clinical Applications: While genomic cancer testing is already being used in various stages of cancer care, there is an opportunity for further expansion in its clinical applications. As per understanding of the genomic basis of cancer advances, there is potential to identify new biomarkers and genetic targets that can guide treatment decisions and improve patient outcomes. Exploring and validating these additional clinical applications can open up new avenues for genomic cancer testing.
• Integration with Big Data and Artificial Intelligence: Genomic cancer testing generates vast amounts of genomic data. Integrating this data with advanced analytics, big data technologies, and artificial intelligence (AI) algorithms can enhance data interpretation, improve treatment prediction models, and optimize patient stratification. The utilization of AI and machine learning algorithms can enable more accurate identification of actionable genetic alterations and facilitate the development of precision oncology.
• Liquid Biopsy and Non-Invasive Testing: Liquid biopsy, a non-invasive method of detecting circulating tumor DNA (ctDNA) and other biomarkers in blood samples, holds significant promise in the genomic cancer testing market. It offers a less invasive alternative to traditional tissue biopsies and allows for real-time monitoring of tumor dynamics and treatment response. Further research and technological advancements in liquid biopsy techniques can expand its utility and accessibility, opening up new opportunities for genomic cancer testing. Moreover, key players operating in the market focusing on product launches, which is expected to propel market growth over the forecast period. For instance, in May 2023, Labcorp, a leading global life sciences company, launched Labcorp Plasma Focus, a new liquid biopsy test enabling targeted therapy selection for patients with advanced or metastatic solid tumors. The test allows treating oncologists to evaluate circulating cell-free DNA (cfDNA) released by tumor cells and better manage the care of their patients through a personalized, targeted therapy plan.
• Emerging Markets: There are untapped opportunities for genomic cancer testing in emerging markets, particularly in regions with a high burden of cancer and growing healthcare infrastructure. As these regions develop their healthcare systems and increase access to advanced diagnostics, there is a potential for increased adoption of genomic cancer testing. Developing tailored strategies and solutions for these markets can unlock new growth opportunities.

Global Genomic Cancer Testing Market Trends:

• Growing Adoption of Next-Generation Sequencing (NGS): Next-generation sequencing has revolutionized genomic cancer testing by enabling rapid and cost-effective sequencing of the entire cancer genome. NGS platforms are increasingly being used in clinical settings, allowing for comprehensive profiling of tumors and identification of actionable genetic alterations. The adoption of NGS technology is a significant trend driving the market. Moreover, increasing product approvals by regulatory bodies is expected to drive market growth over the forecast period. For instance, in March 2022, Thermo Fisher Scientific provides life sciences solutions, analytical instruments, specialty diagnostics, and laboratory products and biopharma services, launched the CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform that delivers results in as little as a single day. Designed for use in clinical laboratories, the fully validated system enables users to perform both diagnostic testing and clinical research on a single instrument.
• Increasing Emphasis on Precision Medicine: Precision medicine approaches are gaining traction in cancer care, and genomic cancer testing plays a vital role in this paradigm shift. Physicians and healthcare providers are recognizing the value of genomic information in tailoring treatment plans based on the unique genetic profile of each patient's tumor. The trend towards precision medicine is driving the demand for genomic cancer testing.
• Integration of Genomic Data into Clinical Decision-Making: Genomic data is being increasingly integrated into clinical decision-making processes. Advanced bioinformatics tools and algorithms are employed to interpret and analyze large-scale genomic data, enabling healthcare professionals to make informed treatment decisions based on the genetic characteristics of the tumor. The integration of genomic data into routine clinical practice is a key trend in the market.
• Rise of Liquid Biopsy: Liquid biopsy, a non-invasive method of detecting tumor-derived genetic material in body fluids, is gaining prominence in the genomic cancer testing field. It offers an alternative to traditional tissue biopsies and allows for real-time monitoring of tumor dynamics and treatment response. Liquid biopsy has the potential to revolutionize cancer diagnostics and monitoring, and its adoption is a notable trend in the market.

Global Genomic Cancer Testing Market Restraints:

• High Costs: Genomic cancer testing can be expensive, particularly when using advanced technologies like next-generation sequencing (NGS). The high costs associated with testing can pose a significant barrier to widespread adoption, limiting accessibility for patients and healthcare providers. Cost considerations can hinder market growth, especially in regions with limited healthcare budgets or inadequate reimbursement policies. For instance, according to data published by the American Cancer Society, Inc., genomic testing of tumor tissue includes tests to look for changes in a specific gene or chromosome, as well as tumor-panel tests to look for changes in multiple genes at the same time. These tests can cost from US$300 to over US$10,000, and the prices of targeted treatments are often higher than US$100,000 a year.

Counterbalance: Key companies should invest in research and development to create more cost-effective genomic sequencing technologies and analytical tools.

• Reimbursement Challenges: The reimbursement landscape for genomic cancer testing can be complex and varied. Different countries and healthcare systems have varying reimbursement policies and criteria for covering genomic tests. Navigating the reimbursement process and obtaining adequate reimbursement for genomic testing can be challenging, creating uncertainty for healthcare providers and reducing the incentive for adoption.
• Limited Clinical Evidence: While genomic cancer testing holds promise, the availability of robust clinical evidence demonstrating its clinical utility and impact on patient outcomes is still evolving. The need for large-scale clinical trials and real-world evidence to validate the effectiveness and value of genomic testing can slow down market growth and adoption, as healthcare providers may be cautious about integrating it into routine clinical practice without substantial evidence.

Recent Developments:

New product launches/approval:

• In July 2023, Guardant Health, Inc, a leading precision oncology company, announced that it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360 CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022.
• In October 2023, Arima Genomics, a U.S.-based Biotechnology company, and Protean BioDiagnostics, a biotechnology company, formed a joint venture, Aventa Genomics, to launch what the new firm calls Aventa FusionPlus, a next-generation sequencing test for the detection of gene fusions, translocations, and rearrangements across 361 genes from formalin-fixed, paraffin-embedded tumor tissue.
• In June 2023, Devyser which develops, manufactures, and sells diagnostic solutions and analysis services to clinical laboratories, announced the launch of two new products, Devyser LynchFAP and Devyser BRCA PALB2. These kits offer efficient, targeted, and confident analysis of genes associated with increased cancer risk, such as those involved in Lynch syndrome, and breast and ovarian cancers.

Acquisition and partnerships:

• In January 2022, Illumina, Inc. announced that it had acquired Grail, a leading player in early cancer detection testing. This acquisition positions Illumina and Grail at the forefront of multi-cancer early detection using genomic profiling. The combined entity aims to accelerate the commercial availability of such life-saving tests globally.
• In January 2022, Exact Sciences Corp., a molecular diagnostics company, announced that it had acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases.
• In December 2022, Prenetics Global Limited, a leader in genomic and diagnostic testing, announced that it was acquiring a majority stake in ACT Genomics Holdings Company Limited, an Asia-based genomics company specializing in precision oncology with operations in Hong Kong, Taiwan, Japan, Singapore, Thailand, and in the UK.

Figure 2. Global  Genomic Cancer Testing Market Share (%), by Test Type, 2023

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Top companies in Genomic Cancer Testing Market:

• Illumina, Inc.
• Thermo Fisher Scientific, Inc.
• Qiagen N.V.
• Hoffmann-La Roche Ltd.
• Foundation Medicine, Inc. (Roche)
• Invitae Corporation
• NeoGenomics Laboratories, Inc.
• Myriad Genetics, Inc.
• Genomic Health, Inc. (Exact Sciences Corporation)
• Caris Life Sciences
• ArcherDX, Inc. (Invitae Corporation)
• Guardant Health, Inc.
• Personal Genome Diagnostics Inc.
• Biocept, Inc.
• Tempus Labs, Inc.

Definition: Genomic cancer testing, also known as genomic tumor assessment, is a type of medical test that identifies the DNA mutations or alterations in a tumor's genes. These changes in the DNA sequence can drive the growth of cancer by promoting cell division and growth and inhibiting normal controls on cell death. The purpose of genomic cancer testing is to identify specific genetic mutations within the cancer cells that may be driving the growth of the tumor