Forecast Period | 2025-2029 |
Market Size (2023) | USD 12.35 Billion |
CAGR (2024-2029) | 9.42% |
Fastest Growing Segment | Liquid Biopsy |
Largest Market | North America |
Market Size (2029) | USD 20.97 Billion |
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. Genomic cancer testing, also referred to
as genetic testing or molecular profiling, entails the examination of a cancer
patient's DNA to pinpoint specific mutations or changes in their genes that may
be influencing the progression of their cancer. The primary objective of
genomic testing in oncology is to identify genetic alterations that can inform
treatment decisions. This enables oncologists to select targeted therapies that
are more likely to be effective based on the unique genetic profile of the tumor.
Moreover, it provides insights into the cancer's aggressiveness and its
potential responsiveness to specific treatments. Additionally, it identifies
inherited genetic mutations that could indicate an elevated risk of developing
other types of cancer, thereby guiding strategies for monitoring and
prevention.
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.
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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
available 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,
introduced 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.
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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
- In
2024, Illumina, Inc. has enhanced its genomic research initiatives by launching
DRAGEN v4.3, the most recent version of its DRAGEN software line. This
advancement enables the analysis of 128 samples representing 26 different
ancestries, thereby expanding the scope of genetic diversity coverage and
reducing biases related to ancestry.
- In
2024, Hartwig Medical and Ultima Genomics have collaborated to innovate
precision oncology with accessible genetic testing. The partnership highlights
Ultima's UG 100 System and ppmSeq Technology as pioneering solutions. The UG
100 System delivers cost-effective sequencing compared to traditional
approaches, while ppmSeq Technology excels in accurately identifying single
nucleotide variants (SNVs) in patients' genetic profiles.
- In
2024, Guardant Health, Inc. and Hikma Pharmaceuticals PLC entered into a
strategic agreement aimed at expanding the availability of Guardant Health's
comprehensive liquid and tissue biopsy tests across the Middle East and North
Africa (MENA) region. This initiative is designed to facilitate cancer
screening, recurrence monitoring, and precise tumor mutation profiling for all
types of solid cancers. Guardant Health's tumor mutation profiling test has
also been granted EU IVDR certification.
Key Market Players
- Illumina,
Inc.
- F.
Hoffmann-La Roche Ltd
- QIAGEN
NV
- Merck
KGaA
- Abbott
Laboratories Inc.
- Novogene
Co., Ltd.
- Guardant
Health, Inc.
- Personal
Genome Diagnostics Inc.
- Thermo
Fisher Scientific Inc.
- NeoGenomics
Laboratories, Inc.
|
By
Test Type
|
By
Technology
|
By
End User
|
By Region
|
- Genomic Profiling
Tests
- Liquid Biopsy
Tests
- Companion
Diagnostic Tests
- Pharmacogenomic
Tests
- Hereditary Cancer
Tests
- Others
|
- Next-Generation
Sequencing (NGS)
- Polymerase Chain
Reaction (PCR)
- Fluorescence In
Situ Hybridization (FISH)
- Immunohistochemistry
(IHC)
- Others
|
- Hospitals
- Diagnostic
Laboratories
- Academic and
Research Institutions
- Cancer Centers
- Others
|
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Genomic Cancer Testing
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Genomic Cancer Testing Market, By Test Type:
o Genomic Profiling Tests
o Liquid Biopsy Tests
o Companion Diagnostic Tests
o Pharmacogenomic Tests
o Hereditary Cancer Tests
o Others
- Genomic Cancer Testing Market, By Technology:
o Next-Generation Sequencing (NGS)
o Polymerase Chain Reaction (PCR)
o Fluorescence In Situ Hybridization (FISH)
o Immunohistochemistry (IHC)
o Others
- Genomic Cancer Testing Market, By End User:
o Hospitals
o Diagnostic Laboratories
o Academic and Research Institutions
o Cancer Centers
o Others
- Genomic Cancer Testing Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Genomic
Cancer Testing Market.
Available Customizations:
Global Genomic Cancer Testing Market report with
the given market data, Tech Sci Research offers customizations according to a
company's specific needs. The following customization options are available for
the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
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