Genomic Cancer Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Genomic Profiling Tests, Liquid Biopsy Tests, Companion Diagnostic Tests, Pharmacogenomic Tests, Hereditary Cancer Tests, Others), By Technology (Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Fluorescence In Situ Hybridization (FISH), Immunohistochemistry (IH

Market Overview

Global Genomic Cancer Testing Market was valued at USD 12.35 Billion in 2023 and is anticipated to project steady growth in the forecast period with a CAGR of 9.42% through 2029.

Managing and interpreting extensive volumes of genomic data presents challenges in terms of storage, analysis, and ensuring data security. Furthermore, the high costs associated with genomic testing and sequencing technologies can restrict accessibility, particularly in less developed regions. Advances in genomic sequencing technologies, such as next-generation sequencing (NGS), have revolutionized cancer diagnostics by enabling comprehensive analysis of a patient's genetic composition. This facilitates precise identification of genetic mutations and alterations linked to cancer.

Liquid biopsy techniques, involving the analysis of circulating tumor DNA (ctDNA) or other biomarkers from blood samples, are increasingly valued for their non-invasive nature and ability to monitor treatment response and detect cancer recurrence. Ongoing research into biomarkers, utilization of artificial intelligence (AI) for data analysis, and integration with electronic health records (EHRs) are anticipated to fuel innovation in this field.

The global genomic cancer testing sector represents a dynamic and swiftly evolving segment within healthcare, offering unprecedented opportunities to advance cancer detection, enhance treatment effectiveness, and improve patient outcomes on a global scale.

Key Market Drivers

Rising Incidence of Cancer

The increasing global incidence of cancer underscores the urgent need for more effective diagnostic and treatment approaches, driving significant growth in the genomic cancer testing market. Genomic testing allows oncologists to identify specific genetic mutations and biomarkers associated with different types of cancer, enabling them to customize treatment plans tailored to each patient. According to a WHO report, it is projected that there will be over 35 million new cancer cases in 2050, marking a 77% increase from the estimated 20 million cases in 2022. This rise reflects both population aging, growth, and changes in exposure to risk factors associated with socioeconomic development.

This growing cancer burden, combined with increased adoption of genomic testing, has fueled substantial market expansion. Pharmaceutical companies, diagnostic laboratories, and healthcare providers are investing in genomic technologies and infrastructure to meet the growing demand for personalized cancer care. Genomic testing also plays a crucial role in early cancer detection and screening by analyzing genetic predispositions and mutations. This early detection often leads to more effective treatment options and improved survival rates.

Genomic data obtained through testing significantly contributes to ongoing clinical research and drug development efforts. Researchers utilize this data to better understand the genetic mechanisms of cancer, identify new drug targets, and develop more effective therapies. This continuous cycle of research and development drives innovation in oncology. As the number of targeted therapies and immunotherapies continues to grow, accurate genomic testing becomes increasingly essential for identifying suitable patients for these treatments.

Government Initiatives and Funding

Governments allocate funding to research institutions and universities to advance genomic technologies and their application in cancer research. This financial support accelerates innovation and the development of novel testing methods and biomarkers. For instance, in June 2024, the Australian Government committed over $27 million to eight new projects led by prominent researchers across the country. These initiatives aim to leverage genetic information for early disease detection, enhance cancer classification, and personalize treatment strategies for better patient outcomes. Among these projects, $8 million is dedicated to establishing a national platform for integrating AI technologies in diagnosing severe genetic disorders like muscular dystrophy. Additionally, nearly $8 million has been allocated to the Centre for Population Genomics, a collaboration between the Murdoch Children’s Research Institute and the Garvan Institute of Medical Research.

Governments also implement public health programs that prioritize cancer screening and early detection, often incorporating genomic testing where feasible. These programs raise awareness and accessibility to genomic testing among the population, thereby stimulating market demand. In 2023, University of Melbourne researchers secured $2.4 million from the Medical Research Future Fund (MRFF) to investigate the potential of a new DNA test, administered through a straightforward saliva sample taken at a doctor’s office, as a cost-effective and efficient method for assessing genetic susceptibility to specific cancers.

Government investment in healthcare infrastructure, including genomic sequencing facilities and laboratories, expands testing capacity and lowers costs, improving access for a broader patient base.In a similar initiative in 2024, Maharashtra Natural Gas Limited (MNGL) in India, through its CSR efforts, pledged support to the GeneHealth Lab at MUHS in Shivajinagar. This collaboration is expected to significantly enhance the institute's ability to provide sophisticated diagnostic services to economically disadvantaged communities.

Government initiatives and funding create an enabling environment for the growth of the global genomic cancer testing market by supporting research, establishing regulatory frameworks, promoting public health initiatives, investing in infrastructure, fostering industry collaboration, and promoting cost-effective healthcare solutions. These combined efforts drive advancements in genomic technologies and enhance cancer care on a global scale.

Key Market Challenges

Cost of Testing

The expense of genomic testing presents a substantial hurdle for the global market in genomic cancer testing. Establishing genomic testing facilities and procuring necessary equipment, such as sequencing machines and bioinformatics tools, demands significant initial investment. This upfront cost can pose a barrier for healthcare providers and laboratories aiming to provide genomic testing services. Although the cost of genomic sequencing technologies is decreasing over time, it remains relatively high in comparison to traditional diagnostic methods. The analysis of genomic data requires specialized bioinformatics expertise and substantial computational resources. Costs associated with data storage, processing, and analysis can be considerable, particularly for extensive genomic studies and population screening initiatives.

Reimbursement policies and coverage for genomic testing vary significantly across regions and healthcare systems. Insufficient reimbursement rates or a lack of coverage for genomic tests may dissuade healthcare providers from offering these services or limit patient access. Strategies to address these challenges include advancing technologies to reduce sequencing costs, developing cost-effective testing platforms, advocating for improved reimbursement policies, and promoting global initiatives aimed at ensuring fair access to genomic testing. These efforts are essential for enhancing affordability and expanding the utilization and impact of genomic testing in cancer care worldwide.

Data privacy and ethical concerns

Genomic testing generates highly sensitive information concerning individuals' genetic predispositions, including their potential risk for developing specific types of cancer. It is crucial to ensure the privacy and confidentiality of this data to maintain patient trust and comply with regulatory requirements. Concerns about genetic discrimination, such as the denial of insurance coverage or job opportunities based on genetic traits, can dissuade individuals from opting for genomic testing. Therefore, robust regulatory frameworks and policies are essential to protect individuals from such discrimination.

The security of genomic data is paramount due to its attractiveness to malicious actors. Safeguarding genomic databases and implementing strong measures against data breaches are critical to protect patient information and uphold data integrity. Ethical considerations arise regarding the use of genomic data for research, including obtaining informed consent, anonymizing data, and ensuring that data is used ethically and responsibly. Clear guidelines and ethical standards are necessary to govern the research use of genomic data and prevent unauthorized or inappropriate secondary uses.

Regulatory frameworks related to data privacy and genomic testing vary significantly across countries and regions, leading to challenges in establishing uniform standards for data protection and ethical use. To address these challenges, it is essential to develop comprehensive data protection measures, strengthen regulatory oversight, educate stakeholders about the benefits and ethical implications of genetic testing, and promote responsible practices in genomic research. These efforts are crucial for overcoming data privacy and ethical concerns in the global genomic cancer testing market and fostering trust among patients, healthcare providers, and researchers alike.

Key Market Trends

Technological advancements

Technological advancements have significantly reduced the cost of genomic sequencing, making genomic testing more accessible to healthcare providers and patients alike. Liquid biopsies, such as ctDNA testing, represent a breakthrough in cancer diagnostics as they analyze genetic material released by tumors into bodily fluids, providing real-time insights into cancer progression, treatment response, and the emergence of resistance mutations.

In 2023, ChromaCode highlighted advancements in their HDPCR NSCLC Assay, showcasing its advantages over Next Generation Sequencing (NGS) by delivering timely results and serving as a crucial backup option when NGS is not feasible. NGS technologies have also progressed, enabling rapid and comprehensive analysis of genomic data by simultaneously sequencing multiple genes or entire genomes, thereby enhancing the accuracy and depth of genetic information found at for cancer patients.

AstraZeneca India partnered with the Rajiv Gandhi Cancer Institute and Research Center (RGCI) to establish a Center of Excellence (CoE) for lung cancer testing in Delhi. This collaboration aims to offer subsidized NGS molecular panel testing to eligible individuals diagnosed with lung cancer in India, improving treatment decisions based on validated genomic testing.

AI and machine learning are increasingly employed to interpret complex genomic data, identifying patterns, predicting outcomes, and enhancing diagnostic and treatment precision. Advances in miniaturization and point-of-care testing technologies are making genomic testing more accessible outside traditional laboratory settings, with portable sequencing devices and rapid diagnostic tools enabling timely decision-making in clinical settings.AI-driven risk profiling aids in early detection of common cancers like breast cancer, and AI can analyze X-rays to identify cancers in regions where imaging experts may be scarce. MIT's development of 'Sybil,' an AI model predicting lung cancer risk up to six years in advance using low-dose CT scans, demonstrates AI's capability in forecasting both short- and long-term cancer risks.

These technological advancements are accelerating genomic research and its applications in oncology, driving innovation, improving patient outcomes, and expanding the scope of personalized cancer care globally.

Segmental Insights

Test Type Insights

Based on Test Type, the Genomic Profiling tests emerged as the dominating segment in the global market for Genomic Cancer Testing in 2023. Genomic profiling tests conduct a thorough analysis of an individual's genetic composition, identifying mutations, variations, and cancer-associated biomarkers. This detailed genetic information allows healthcare providers to gain a precise understanding of the molecular drivers of cancer, enabling customized treatment strategies. Next-generation sequencing (NGS) technologies have significantly improved the capability and efficiency of genomic profiling tests. Exact Sciences Corp. has announced its intention to present new research supporting advancements in early cancer detection, genomic testing, and treatment guidance at the 2023 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. This includes trials evaluating their blood-based MCED program, OncoExTra data demonstrating the detection frequency of actionable fusions in nearly 8,000 people with solid tumors, which informs treatment decisions by assessing RNA and DNA through NGS.

Illumina, Inc. recently launched TruSight Oncology (TSO) Comprehensive (EU), a single test that evaluates multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. In a collaborative effort, Roche France and Foundation Medicine are transferring FoundationOne® Liquid CDx technology to the Institute Gustave Roussy in 2023. This initiative aims to offer comprehensive genomic profiling (CGP) through liquid biopsy testing to advanced cancer patients throughout France. Pharmaceutical companies and biotechnology firms are making substantial investments in genomic profiling technologies to advance targeted therapies and companion diagnostics. These collaborations foster innovation and expand the market for genomic testing, supporting advancements in precision medicine for cancer treatment.

Technology Insights

Based on Technology, the Next-Generation Sequencing emerged as the dominating segment in the global market for Genomic Cancer Testing in 2023. NGS enables the simultaneous sequencing of large portions or entire genomes, facilitating comprehensive analysis of genetic changes in cancer cells such as mutations, copy number variations, and structural alterations. This detailed information is critical for understanding cancer at a molecular level and tailoring personalized treatment strategies. The decreasing cost of NGS over time has enhanced its accessibility in routine clinical practice, leading to its widespread adoption across global healthcare settings.

In 2024, Lt Gen Daljit Singh, Director General of Armed Forces Medical Services and Senior Colonel Commandant of the Army Medical Corps, inaugurated the new Genome Sequencing Lab at the Armed Forces Medical College (AFMC) in Pune. This state-of-the-art facility features advanced Next Generation Sequencing (NGS) technologies, including "Nextseq 2000" and "Miniseq" analyzers, supporting continuous advancements in NGS technology, bioinformatics tools, and data analysis techniques. These capabilities empower researchers and clinicians to explore complex genomic landscapes more effectively, unlocking new insights into cancer biology and treatment strategies.In 2024, OGT, a leading global provider of genomic research and diagnostic solutions, launched the RNA-based SureSeq Myeloid Fusion Panel. This next-generation sequencing (NGS) tool is designed to identify crucial fusion genes associated with acute myeloid leukemia (AML), further exemplifying the ongoing advancements and applications of NGS in oncology research and clinical diagnostics.

Regional Insights

Based on Region, North America emerged as the dominant region in the Global Genomic Cancer Testing Market in 2023. North America's healthcare infrastructure is distinguished by advanced medical technology, and extensive network of research institutions and universities. This robust framework not only supports pioneering research but also facilitates the adoption of cutting-edge diagnostic technologies like Next-Generation Sequencing (NGS). The region benefits significantly from the presence of leading pharmaceutical companies, biotechnology firms, and academic research centers, which collectively foster an environment conducive to continuous innovation. Regulatory oversight, exemplified by agencies such as the FDA in the United States, ensures rigorous standards for healthcare products and technologies, enhancing confidence in their safety and efficacy. In 2024, Thermo Fisher Scientific Inc. collaborated with the National Cancer Institute (NCI) on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine trial. This initiative utilizes Thermo Fisher’s NGS technology to analyze genetic biomarkers in patients' bone marrow and blood, aiming to streamline patient enrollment in clinical trials by matching them more efficiently with treatments targeting specific mutations identified in their samples. ongoing developments such as Helio Genomics exploring new AI-driven diagnostic opportunities and Datar Cancer Genetics seeking to introduce a circulating glial cell assay for brain cancer diagnosis highlight North America's leadership in genomic cancer testing and healthcare innovation. These advancements underscore the region's pivotal role in advancing personalized medicine and precision oncology globally.

Recent Development

• In2024, Illumina, Inc. has enhanced its genomic research initiatives by launchingDRAGEN v4.3, the most recent version of its DRAGEN software line. Thisadvancement enables the analysis of 128 samples representing 26 differentancestries, thereby expanding the scope of genetic diversity coverage andreducing biases related to ancestry.
• In2024, Hartwig Medical and Ultima Genomics have collaborated to innovateprecision oncology with accessible genetic testing. The partnership highlightsUltima's UG 100 System and ppmSeq Technology as pioneering solutions. The UG100 System delivers cost-effective sequencing compared to traditionalapproaches, while ppmSeq Technology excels in accurately identifying singlenucleotide variants (SNVs) in patients' genetic profiles.
• In2024, Guardant Health, Inc. and Hikma Pharmaceuticals PLC entered into astrategic agreement aimed at expanding the availability of Guardant Health'scomprehensive liquid and tissue biopsy tests across the Middle East and NorthAfrica (MENA) region. This initiative is designed to facilitate cancerscreening, recurrence monitoring, and precise tumor mutation profiling for alltypes of solid cancers. Guardant Health's tumor mutation profiling test hasalso been granted EU IVDR certification.

Key Market Players

• Illumina,Inc.
• F.Hoffmann-La Roche Ltd
• QIAGENNV        
• MerckKGaA
• AbbottLaboratories Inc.
• NovogeneCo., Ltd.
• GuardantHealth, Inc.
• PersonalGenome Diagnostics Inc.
• ThermoFisher Scientific Inc.
• NeoGenomicsLaboratories, Inc.