Global Oncology Based Molecular Diagnostics Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Type;
Breast Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, Liver Cancer, and OthersBy Product;
Instruments, Reagents, and OthersBy Technology;
Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), Sequencing, In-Situ Hybridization, Chips & Microarrays, and Mass SpectrometryBy End-Use;
Hospitals & Clinics, Diagnostic Laboratories, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Oncology Based Molecular Diagnostics Market Overview
Oncology Based Molecular Diagnostics Market (USD Million)
Oncology Based Molecular Diagnostics Market was valued at USD 6,204.55 million in the year 2024. The size of this market is expected to increase to USD 14,265.55 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 12.6%.
Global Oncology Based Molecular Diagnostics Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 12.6 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 12.6 % |
Market Size (2024) | USD 6,204.55 Million |
Market Size (2031) | USD 14,265.55 Million |
Market Concentration | Low |
Report Pages | 365 |
Major Players
- Abbott
- Bayer AG
- BD
- Cepheid
- Agilent Technologies Inc
- Danaher
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Oncology Based Molecular Diagnostics Market
Fragmented - Highly competitive market without dominant players
The Oncology-Based Molecular Diagnostics Market is witnessing rapid growth, fueled by the increasing adoption of personalized medicine and the rising incidence of cancer globally. Molecular diagnostics have emerged as critical tools in cancer detection, tumor profiling, and treatment selection, offering precise insights for targeted therapies that enhance patient outcomes. It is estimated that over 60% of cancer patients now undergo molecular diagnostic tests as part of their treatment journey, reflecting the growing reliance on these advanced technologies.
Growing Demand for Early Cancer Detection
Early cancer detection significantly improves patient survival rates, making it a critical focus in oncology. Molecular diagnostics are pivotal in identifying genetic mutations and biomarkers linked to various cancers. Notably, liquid biopsy technologies, which account for nearly 30% of oncology-based molecular diagnostic procedures, have gained traction due to their minimally invasive approach and high sensitivity, supporting timely cancer diagnosis.
Technological Innovations in Next-Generation Sequencing (NGS)
Technological advancements, particularly in Next-Generation Sequencing (NGS), have revolutionized cancer diagnostics, providing comprehensive genomic insights at unprecedented scales. NGS technologies now account for 40% of molecular diagnostic tests in oncology, offering high-throughput analysis essential for modern cancer management. Additionally, this innovation is driving the growth of companion diagnostics, which help identify patients likely to benefit from specific targeted therapies.
Focus on Biomarker-Based Diagnostics
Biomarker-based diagnostics have become foundational in oncology, offering critical insights into tumor biology and treatment responses. It is estimated that over 65% of ongoing oncology drug development efforts are focused on biomarker-targeted therapies, underscoring the strategic importance of molecular diagnostics in personalized cancer care.
Oncology Based Molecular Diagnostics Market Recent Developments
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In November 2023, Abbott had received U.S. FDA approval for its molecular human papillomavirus (HPV) screening test in the Alinity m family of in-vitro diagnostics. This approval had facilitated the expansion of the company's product portfolio, strengthening sales and revenue.
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In June 2022, Agilent had announced the acquisition of Resolution Bioscience in a deal intended to expand the buyer’s precision medicine offerings by complementing and expanding its capabilities in next-generation sequencing (NGS)-based cancer diagnostics. This acquisition had demonstrated Agilent's commitment to expanding its presence in the liquid biopsy space and advancing its capabilities in the development of in vitro diagnostic tests.
Oncology Based Molecular Diagnostics Market Segment Analysis
In this report, the has been segmented by Oncology Based Molecular Diagnostics Market into Type, Product, Technology, End-Use and Geography.
Oncology Based Molecular Diagnostics Market, Segmentation by Type
The Oncology Based Molecular Diagnostics Market has been segmented by Type into Breast Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, Liver Cancer and Others.
Breast Cancer
This segment holds the largest share of the market, accounting for approximately 25-30%. Rising prevalence of HER2-positive breast cancer and increased adoption of genomic testing for treatment planning are key drivers. The widespread use of companion diagnostics with targeted therapies further strengthens market growth.
Prostate Cancer
Contributing around 15-18% of the market, this segment benefits from growing awareness and increasing availability of non-invasive molecular tests. These diagnostics are crucial for identifying androgen receptor mutations and guiding precision medicine in early and advanced prostate cancer cases.
Colorectal Cancer
This segment represents roughly 12-15% of the market. Demand is fueled by the use of liquid biopsies and methylation-based tests for early detection and monitoring. Rising cases linked to lifestyle factors and increased screening initiatives are accelerating adoption.
Cervical Cancer
Accounting for about 10-12% of the market, this segment is driven by the integration of HPV DNA testing and molecular cytology in diagnostic protocols. Government-led screening programs and efforts to reduce cervical cancer mortality contribute to steady growth globally.
Liver Cancer
This segment holds a share of approximately 8-10%, with diagnostics focusing on biomarker detection and circulating tumor DNA (ctDNA) analysis. The rising burden of hepatocellular carcinoma (HCC) and the need for early-stage detection in high-risk populations are key factors fueling growth.
Others
This category, representing 10-15% of the market, includes molecular diagnostics for lung cancer, pancreatic cancer, and hematologic malignancies. Increasing use of next-generation sequencing (NGS) and expanding clinical applications of liquid biopsy technologies are expected to propel future growth.
Oncology Based Molecular Diagnostics Market, Segmentation by Product
The Oncology Based Molecular Diagnostics Market has been segmented by Product into Instruments, Reagents and Others.
Instruments
This segment accounts for approximately 30-35% of the market, driven by increasing demand for advanced automated platforms and high-throughput analyzers. These tools are essential for performing complex molecular assays such as PCR, NGS, and microarray-based testing. Continuous innovation in diagnostic instrumentation is enhancing speed, accuracy, and integration across clinical workflows.
Reagents
Holding the largest share at around 50-55%, this segment is fueled by the continuous need for consumables like primers, probes, enzymes, and buffers. Reagents are essential for each test run, making them a recurring revenue stream. The rising volume of cancer screening and companion diagnostic testing significantly boosts demand.
Others
This category, contributing approximately 10-15% of the market, includes software solutions, bioinformatics tools, and support accessories required for data analysis and system maintenance. As oncology diagnostics become more data-intensive, the integration of AI-powered analytics and cloud-based platforms is expanding the scope of this segment.
Oncology Based Molecular Diagnostics Market, Segmentation by Technology
The Oncology Based Molecular Diagnostics Market has been segmented by Technology into Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), Sequencing, In-Situ Hybridization, Chips And Microarrays, and Mass Spectrometry.
Polymerase Chain Reaction (PCR)
This segment holds the largest share of approximately 40-45%, owing to its widespread use in cancer gene expression analysis, mutation detection, and viral oncology diagnostics. Real-time PCR and digital PCR offer high sensitivity and speed, making them essential for both clinical and research applications in oncology.
Isothermal Nucleic Acid Amplification Technology (INAAT)
Accounting for about 10-12% of the market, this technology is gaining popularity for its rapid amplification capability without the need for thermal cycling. Its simplicity and suitability for point-of-care cancer diagnostics make it a valuable option in both developed and emerging healthcare settings.
Sequencing
This high-growth segment represents nearly 20-25% of the market, fueled by increasing adoption of next-generation sequencing (NGS) for comprehensive tumor profiling. Sequencing enables precise identification of genetic mutations and biomarkers, making it critical for personalized cancer therapy and clinical decision-making.
In-Situ Hybridization
With a market share of around 8-10%, this technology is essential for the detection of gene amplifications, chromosomal abnormalities, and virus-host interactions in cancer tissues. Techniques like FISH (Fluorescence In-Situ Hybridization) are widely used for visualizing molecular alterations at the cellular level.
Chips and Microarrays
These tools contribute approximately 5-7% of the market and are mainly used in gene expression profiling and oncogene screening. Their ability to analyze thousands of genes simultaneously makes them useful in large-scale cancer research studies and diagnostic panels.
Mass Spectrometry
Representing around 3-5% of the market, this segment is growing steadily due to its role in proteomic profiling and biomarker discovery. It is increasingly used in identifying metabolic signatures of tumors and in validating targeted drug responses.
Oncology Based Molecular Diagnostics Market, Segmentation by End-Use
The Oncology Based Molecular Diagnostics Market has been segmented by End-Use into Hospitals and Clinics, Diagnostic Laboratories and Others.
Hospitals and Clinics
This segment leads the market with a share of approximately 45-50%, driven by the rising number of in-house molecular diagnostic facilities and integration of personalized oncology care. Hospitals are increasingly using companion diagnostics for targeted cancer therapies, supported by advanced infrastructure and access to multidisciplinary care teams.
Diagnostic Laboratories
Holding around 35-40% of the market, these labs are key providers of high-throughput testing services for cancer detection, monitoring, and prognosis. Their ability to offer specialized tests, such as NGS panels and liquid biopsies, makes them crucial in both centralized and outsourced diagnostic workflows.
Others
This category, contributing roughly 10-15%, includes academic institutions, contract research organizations (CROs), and biotech firms conducting cancer biomarker studies and clinical research. The demand for molecular diagnostics in oncology trials and drug development pipelines is expanding this segment’s relevance.
Oncology Based Molecular Diagnostics Market, Segmentation by Geography
In this report, the Oncology Based Molecular Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
Regions and Countries Analyzed in this Report
Oncology Based Molecular Diagnostics Market Share (%), by Geographical Region
North America
This region dominates the global market with a share of approximately 40-45%, driven by strong healthcare infrastructure, early adoption of advanced molecular technologies, and significant investment in oncology research. High prevalence of cancer and widespread implementation of personalized medicine further fuel demand across the U.S. and Canada.
Europe
Europe holds a substantial share of around 25-30%, supported by growing use of companion diagnostics, expanding clinical trials, and strong public health initiatives. Countries like Germany, France, and the UK lead in adopting NGS-based oncology diagnostics and integrating them into national cancer care protocols.
Asia Pacific
This fast-growing region accounts for nearly 20-25% of the market. Factors such as rising cancer incidence, growing healthcare expenditure, and increasing awareness of early detection methods are driving growth. Countries like China, India, and Japan are expanding access to molecular diagnostic services through both public and private sector initiatives.
Middle East & Africa
Representing about 5-7% of the market, this region is witnessing gradual adoption of oncology diagnostics due to improving healthcare infrastructure in the Gulf Cooperation Council (GCC) countries. Ongoing efforts to enhance cancer screening programs and partnerships with global diagnostic firms are helping to expand market reach.
Latin America
This region contributes approximately 5-8%, with countries like Brazil, Mexico, and Argentina investing in cancer diagnostics infrastructure. Government-backed initiatives to promote early cancer detection and the growing role of private diagnostic laboratories are supporting the market’s steady development.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Oncology Based Molecular Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
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Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers
- Technological Advancements in Molecular Diagnostics
- Increasing Incidence and Prevalence of Cancer
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Growing Demand for Personalized Medicine in Oncology - The increasing demand for personalized medicine in oncology is a key driver of the oncology-based molecular diagnostics market. As cancer treatments shift from one-size-fits-all approaches to individualized therapies, molecular diagnostics are essential for identifying specific genetic mutations, biomarkers, and tumor profiles. These tools enable oncologists to tailor treatment strategies based on a patient’s unique molecular signature, improving outcomes and minimizing adverse effects.
Technological advancements in genomics and next-generation sequencing have further accelerated the adoption of precision oncology. Molecular diagnostics facilitate early detection, real-time monitoring, and prediction of treatment responses, making them indispensable in clinical decision-making. As healthcare providers increasingly prioritize personalized approaches, the demand for molecular diagnostic tests in oncology is expected to grow rapidly across both clinical and research settings.
Restraints
- High Cost of Molecular Diagnostics Tests
- Regulatory Challenges and Approval Processes
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Limited Access to Advanced Molecular Diagnostic Technologies - Limited access to advanced molecular diagnostic technologies remains a major restraint in the growth of the oncology-based molecular diagnostics market, particularly in low- and middle-income countries. High equipment costs, lack of specialized infrastructure, and shortage of trained professionals make it challenging for many healthcare systems to adopt cutting-edge diagnostic platforms. As a result, a large portion of the global population remains underserved, delaying diagnosis and reducing the effectiveness of personalized cancer treatments.
In addition, logistical challenges such as inadequate laboratory networks, inconsistent quality standards, and fragmented healthcare delivery models further restrict widespread implementation. Even in developed regions, disparities in reimbursement policies and insurance coverage can limit patient access to molecular diagnostic testing. Addressing these access issues is crucial to expanding the reach and impact of precision oncology across diverse patient populations.
Opportunities
- Expansion of Molecular Diagnostics into Emerging Markets
- Development of Novel Biomarkers for Cancer Detection and Monitoring
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Integration of Molecular Diagnostics with Next-Generation Sequencing Technologies - The growing integration of molecular diagnostics with next-generation sequencing (NGS) technologies presents a powerful opportunity for advancing the oncology-based molecular diagnostics market. NGS enables comprehensive genetic profiling by simultaneously analyzing multiple genes, mutations, and biomarkers associated with different cancer types. When combined with molecular diagnostics, it provides deeper insights into tumor biology, enabling more accurate diagnosis, prognosis, and treatment selection.
This integration supports the development of targeted therapies and immuno-oncology solutions by identifying actionable mutations and resistance patterns. It enhances the clinical utility of liquid biopsies, companion diagnostics, and tumor mutation burden analysis, expanding the scope of non-invasive and real-time cancer monitoring. As a result, oncologists can adopt more precise, data-driven approaches tailored to individual patients' molecular profiles.
Advancements in automation, bioinformatics, and cost-efficient sequencing platforms are making NGS-based diagnostics more accessible across research institutions and clinical laboratories. Moreover, regulatory approvals and growing reimbursement support for NGS-based assays are encouraging broader adoption. As this convergence continues to evolve, the market is poised for robust expansion through the delivery of personalized, scalable, and high-throughput oncology diagnostic solutions.
Competitive Landscape Analysis
Key players in Global Oncology Based Molecular Diagnostics Market include:
- Abbott
- Bayer AG
- BD
- Cepheid
- Agilent Technologies Inc
- Danaher
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Type
- Market Snapshot, By Product
- Market Snapshot, By Technology
- Market Snapshot, By End-Use
- Market Snapshot, By Region
- Global Oncology Based Molecular Diagnostics Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
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Technological Advancements in Molecular Diagnostics
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Increasing Incidence and Prevalence of Cancer
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Growing Demand for Personalized Medicine in Oncology
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- Restraints
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High Cost of Molecular Diagnostics Tests
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Regulatory Challenges and Approval Processes
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Limited Access to Advanced Molecular Diagnostic Technologies
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- Opportunities
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Expansion of Molecular Diagnostics into Emerging Markets
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Development of Novel Biomarkers for Cancer Detection and Monitoring
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Integration of Molecular Diagnostics with Next-Generation Sequencing Technologies
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- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Oncology Based Molecular Diagnostics Market, By Type, 2021 - 2031 (USD Million)
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Breast Cancer
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Prostate Cancer
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Colorectal Cancer
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Cervical Cancer
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Liver Cancer
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Others
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- Oncology Based Molecular Diagnostics Market, By Product, 2021 - 2031 (USD Million)
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Instruments
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Reagents
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Others
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- Oncology Based Molecular Diagnostics Market, By Technology, 2021 - 2031 (USD Million)
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Polymerase Chain Reaction (PCR)
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Isothermal Nucleic Acid Amplification Technology (INAAT)
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Sequencing
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In-Situ Hybridization
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Chips and Microarrays
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Mass Spectrometry
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- Oncology Based Molecular Diagnostics Market, By End-Use, 2021 - 2031 (USD Million)
- Hospitals and Clinics
- Diagnostic Laboratories
- Others
- Oncology Based Molecular Diagnostics Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Oncology Based Molecular Diagnostics Market, By Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Abbott
- Bayer AG
- BD
- Cepheid
- Agilent Technologies Inc
- Danaher
- Company Profiles
- Analyst Views
- Future Outlook of the Market