Market Introduction

The global cancer profiling market was valued at USD 12.44 billion in 2024 and grew at a CAGR of 8.76% from 2025 to 2034. The market is expected to reach USD 28.80 billion by 2034. The increasing incidence and prevalence of cancer will drive the growth of the global cancer profiling market.

Tumour profiling or molecular profiling or cancer profiling represents a complete strategy that evaluates multiple tumours and their unique characteristics including genetic profiles alongside molecular and biochemical data. This approach reveals the particular mutations together with gene expressions and protein interactions responsible for cancer growth. Personalized medicine depends heavily on this test because it helps doctors prescribe individualized treatments by examining specific tumour characteristics instead of using standardized methods. Next-generation sequencing (NGS), polymerase chain reaction (PCR), immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and mass spectrometry serve as main cancer profiling techniques. they provide different insights into tumour biology. Physicians use this tool to forecast disease evolution together with the ability to evaluate progress of various treatments administered. The identification of suitable candidates for experimental drugs in clinical trials depends heavily on the results of cancer profiling. Cancer profiling enables physicians to make early cancer detection along with risk assessment in people showing genetic susceptibility for developing cancer. Modern oncology needs cancer profiling because increasing advances in artificial intelligence and machine learning as well as bioinformatics boost its accuracy and efficiency.

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Recent Development

• Leading AI-driven drug discovery company Predictive Oncology Inc. said it will expand its availability in the US and introduce its proven flagship live cell ChemoFx drug response assay in Europe.  Over time, testing of other significant tumour types of interest may be added to the ChemoFx treatment selection marker and tumour profile assay, which will initially concentrate on ovarian and other gynaecological cancers.  The ChemoFx drug response assay measures each cancer patients in vitro tumour response to different chemotherapeutic drugs, making it a therapy selection marker for chemotherapies.
• At the 2024 annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, Exact Sciences Corp., a prominent supplier of cancer screening and diagnostic assays, showcased ten abstracts that showcased the scope of its Precision Oncology portfolio.

Market Dynamics

Drivers

The increasing incidence and prevalence of cancer – WHO statistics show cancer as one of the primary causes worldwide that results in many deaths and will continue to rise based on the increasing geriatric population, lifestyle changes, environmental hazards and inherited genetic risk factors. Cancer diagnostics and treatments require advanced methods because the increasing number of cancer patients require better detection and therapy solutions. Industrial development together with urbanization practices expose individuals to carcinogens while lifestyle choices including smoking habits as well as unhealthy diet, insufficient exercise and alcohol consumption are risk factors for cancer occurrence. Current improvements in cancer screenings and early diagnosis programs have resulted in more cases being diagnosed which creates an imperative need for accurate molecular profiling. The urgent requirement for individualized therapy emerges due to limited operational and safety aspects of conventional treatments including chemotherapy along with radiation. Through cancer profiling doctors can study tumour-based genetic mutations for personalized treatment programs. The rising number of difficult-to-treat and immune-resistant cancer cases reinforces the urgent need to use molecular diagnostic methods for therapy selection. Global cancer case increases indicate rising technological demand for cancer profiling that supports precision medicine development as well as superior cancer treatment strategies.

Restraints

High costs of cancer profiling – The expensive nature of cancer profiling serves as the main obstacle for general implementation because it restricts availability to patients and healthcare systems worldwide. Next-Generation Sequencing (NGS) liquid biopsy and gene expression profiling need advanced technological equipment paired with costly reagents and specialized facilities with experts. A single comprehensive genomic profiling test costs anywhere from several hundred dollars to thousands of dollars so many patients and especially people from low- and middle-income countries cannot afford this service. These tests need trained professionals who specialize in genomics which drives up the total cost. Costs associated with data interpretation and analysis presentations also present substantial financial challenge. Genetic data output from cancer profiling needs specialized bioinformatics equipment with powerful computational capabilities as well as databases and skilled professionals to review the findings thus creating increased costs for software systems and staffing. Small hospitals and diagnostic centres avoid adopting cancer profiling technologies because they need to invest heavily in sequential facilities while meeting regulatory compliance requirements. Lack of sufficient insurance coverage and inadequate reimbursement policies from healthcare systems makes patients cover their molecular diagnostic costs on their own finances which hampers the market’s growth.

Opportunities

Increasing research and development expenditure – Public and governmental financial support leads the way toward increasing cancer profiling needs because it boosts research progress and develops precision oncology technology and accessibility. Public authorities across the globe dedicate major monetary resources for cancer studies as well as early detection screening and sophisticated diagnostic systems. The development of cancer profiling technologies receives support through national cancer research efforts combined with genomics projects which operate across Europe and Asia. Standard cancer care receives support for molecular diagnostic adoption through public health agencies together with regulatory bodies who provide financial backing for massive genomic sequencing projects and clinical trials. Cancer profiling receives substantial financial support from both private pharmaceutical companies and biotechnology firms along with venture capital groups at present. The pharmaceutical industry uses molecular diagnostic methods to understand genetic variations for creating new medicine treatments that lead to better treatment effects. The success of startups and research organizations dedicated to next-generation sequencing (NGS) and liquid biopsy together with artificial intelligence-based bioinformatics receives higher funding support for advancing cancer diagnostic methods. The market keeps growing as both sectors increase their financial backing of cancer profiling technology which has made these systems more sophisticated while improving accessibility and enhancing their role in individualized cancer therapy.

Limited insurance coverage.

Both limited insurance coverage and low awareness and adoption patterns among developing regions restrict the wide implementation of cancer profiling. A significant number of healthcare institutions which operate primarily in developing nations currently lack insurance coverage provisions for molecular diagnostic tests. Medical organizations in developed countries apply inconsistent reimbursement standards to cancer profiling services because insurers restrict payments only to tests linked to approved therapies. Standardized reimbursement policies that cover advanced genetic testing are missing which requires patients to bear out-of-pocket expenses too expensive for numerous patients. The lack of proper reimbursement policies deters medical providers along with diagnostic companies from funding cancer profiling thus reducing access opportunities for patients. Cancer profiling has limited adoption in developing regions because financial constraints intersect with insufficient infrastructure and insufficient training about the technology. Healthcare organizations in many areas do not have proper genomic testing infrastructure or trained personnel or support from regulatory bodies to perform molecular diagnostic analysis routinely in oncology practices. The standard cancer diagnostic methods based on biopsy and imaging techniques persist dominating healthcare settings because they have affordable prices and broad accessibility. Inadequate knowledge among medical personnel and patients about cancer profiling benefits decreases the market demand for sophisticated testing solutions.

Segment Analysis

Regional segmentation analysis

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America emerged as the most significant global cancer profiling market, with a 41% market revenue share in 2024.

The region has advanced healthcare systems which treat many cancer cases while prioritizing precise medicine methods. Cancer profiling solution markets are predominantly led by United States and Canada because both countries have fully developed systems for molecular diagnostics drug development and cancer research focused on biomarkers. The main reason behind North America’s leadership position in the global cancer profiling sector stems from its large number of individuals afflicted with cancer. New market growth stems from robust investments conducted by both public institutions and private corporations. Market adoption increases through regulatory approvals of NGS-based tests together with companion diagnostics. Medical innovation in personalized oncology advances rapidly through joint endeavours of research centres with pharmaceutical companies as well as healthcare institutions. The North American market maintains its leadership position in global cancer profiling because genomics technology continues advancing together with AI-driven diagnostic systems.

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• In the United States, xT CDx, an in vitro diagnostic tool based on next-generation sequencing (NGS), is now accessible statewide for solid tumour profiling. For solid tumour profiling, including microsatellite instability status and companion diagnostic claims for patients with colorectal cancer (CRC), the FDA authorised xT CDx, a 648-gene NGS assay.  The in vitro diagnostic device detects substitutions, including single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs), as well as insertion/deletion alterations in 648 genes using DNA isolated from FFPE tumour tissue samples and DNA isolated from matched normal blood or saliva samples obtained from patients diagnosed with solid malignant neoplasms.

Technology Segment Analysis

The technology segment is divided into Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Microarrays and Others. The Next-Generation Sequencing (NGS) segment dominated the market, with a market share of around 35% in 2024. The cancer profiling market leads with Next-Generation Sequencing (NGS) due to its precise large-scale analysis of simultaneous gene evaluation. Personalized cancer care based on precision medicine becomes feasible through the genomic insights made possible by NGS instead of using obsolete sequencing approaches like Sanger sequencing and PCR. The extensive use of NGS technology mainly results from its ability to help choose targeted therapies. Large-sequence analysis with NGS proves cheaper than conventional techniques for sequencing programs. The technological progress in laboratory automation together with reduced sequencing expenses has driven clinical laboratories and research institutions to choose NGS for cancer profiling. The market penetration of NGS-based companion diagnostics intensified due to regulatory approvals by the FDA and EMA along with other authorities.

Cancer type Segment Analysis

The cancer type segment is divided into breast cancer, lung cancer, colorectal cancer, prostate cancer, melanoma and others. The breast cancer segment dominated the market, with a market share of around 33% in 2024. The cancer profiling market is dominated by breast cancer patients because it has the highest worldwide incidence rates. Breast cancer stands as the WHO-recognized leading cancer form worldwide because thousands of individuals receive breast cancer diagnoses every year globally. The rising cancer incidence has made cancer profiling necessary because this approach provides essential support for timely detection and treatments. The introduction of breast cancer-targeted medications along with PARP inhibitors for patients with BRCA-mutations creates additional medical need for breast cancer profiling. The rise in breast cancer screening activities along with public awareness initiatives lead to increased adoption of molecular profiling. Breast cancer detection rates have increases elevated because government entities and healthcare institutions run routine screening programs that involve mammography and genetic evaluation.

• The launch of PANProfiler Colon, an AI-driven software solution for profiling Microsatellite instability (MSI) and mismatch repair deficiency (dMMR) entirely digitally and directly from Haematoxylin and Eosin (H&E)-stained images of colon cancer tissue samples, was announced by Panakeia, a leader in AI-driven multi-omic biomarker profiling.  The second clinical product from Panakeia's PANProfiler multi-omic biomarker profiling technology, PANProfiler Colon, uses artificial intelligence (AI) and exclusive knowledge of colorectal cancer biology.  While the PANProfiler platform is accessible for Research Use Only (RUO) and can profile biomarkers in more than 30 cancer types for patient screening and clinical trials, PANProfiler Colon is registered for use in the UK (UKCA-marked).

Biomarker type Segment Analysis

The biomarker type segment is divided into genetic biomarkers, protein biomarkers, epigenetic biomarkers and others. The genetic biomarkers segment dominated the market, with a market share of around 40% in 2024. The cancer profiling market primarily uses genetic biomarkers because these biomarkers play essential roles in precision medicine, early detection and selecting specific therapeutic approaches. The specific and sensitive nature of genetic biomarkers makes them the selection preference for oncologists and researchers above protein and epigenetic biomarkers. Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) with liquid biopsy technologies have expanded the success of genetic biomarkers through their ongoing technological improvements. The combination of these technical methods enables rapid cost-efficient genetic screening from blood as well as tissue samples which increases cancer diagnosis capabilities. The FDA along with EMA granted regulatory approval for NGS-based companion diagnostics which boosted the implementation of genetic biomarkers throughout medical practice. The profiling market for cancer will be led by genetic biomarkers because scientists continue their investigation of new oncogenic mutations.

Application Segment Analysis

The application segment is divided into diagnostics, prognostics, personalized medicine, drug development and others. The diagnostics segment dominated the market, with a share of around 42% in 2024. Cancer profiling functions as an essential tool for medical practitioners to determine genetic mutations along with biomarkers and molecular patterns which affect disease advancement and therapeutic selection processes. The rising global incidence of cancer together with an increased desire for sophisticated diagnostic instruments has led to substantial growth because early disease detection creates better outcomes for patients. Routine cancer screening together with diagnostic features has established molecular profiling as the dominant factor in medical diagnostics practice. The market has experienced expansion due to governmental programs together with biomarker-based cancer diagnostic approval processes. The FDA along with the EMA approved various diagnostic tests that can now be routinely used for standard care in oncology. The development of precision medicine will keep fuelling the growing market need for cancer profiling diagnostics so they become increasingly dominant across worldwide cancer diagnostics.

End user Segment Analysis

The end user segment is divided into hospitals & diagnostic laboratories, pharmaceutical & biotechnology companies and academic & research institutes. The hospitals & diagnostic laboratories segment dominated the market, with a share of around 43% in 2024. Hospitals and laboratories maintain their position as primary user facilities for cancer profiling solutions as they have access to advanced diagnostic technologies along with specialized oncologists who support their access to large numbers of cancer patients. Hospitals together with diagnostic laboratories gain access to governmental financial support along with payments from insurance providers and pharmaceutical company partnerships which contribute to precision oncology development. Many research hospitals work together with biotech firms to develop new biomarker-based tests for medical markets through validation processes and increase industry expansion. The combination of infrastructure capabilities and technical expertise coupled with advanced technological access keeps hospitals and diagnostic laboratories as the top players in the global cancer profiling market.

• With CAP (College of American Pathologists) accreditation for its genomics lab at Dubai Science Park, which was built in collaboration with Innovate Life Sciences Fz-LLC, 4baseCare, a pioneer in precision oncology, has reached a significant milestone. Thanks to this accreditation, cancer patients in the United Arab Emirates can now receive top-notch genomic profiling locally that satisfies the strictest international quality and accuracy requirements.  4baseCare reinforces its dedication to improving cancer care by making data-driven, individualised treatment decisions by obtaining CAP accreditation.  The laboratory in Dubai fills a significant void in precision oncology by removing the requirement for patients to look for genomic testing options outside of the United Arab Emirates.

Some of the Key Market Players

• Agilent Technologies, Inc. 
• Bio-Rad Laboratories, Inc. 
• Caris Life Sciences 
• Exact Sciences Corporation 
• Foundation Medicine, Inc. 
• Guardant Health, Inc. 
• Illumina, Inc. 
• NeoGenomics Laboratories, Inc. 
• Personalis, Inc.
• QIAGEN N.V. 
• Roche Diagnostics 
• Thermo Fisher Scientific, Inc. 

Report Description

• Market Introduction
• Market Dynamics
• Segment Analysis
• Some of the Key Market Players