Oncology-Based Molecular Diagnostics Market By Product Type (Kits & Reagents, Instruments & Platforms, Companion Diagnostics (CDx), Laboratory Developed Tests (LDTs), Consumables, Software & Bioinformatics Tools), By Cancer Type (Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Hematologic Malignancies, Melanoma, Others), By Sample Type (Tissue Biopsy, Liquid Biopsy, Urine, Buccal Swab, Cerebrospinal Fluid (CSF), Bone Marrow Aspirate), By Technology (Next-Generation Sequencing, Polymerase Chain Reaction, Chromogenic In Situ Hybridization, Microarrays, Methylation & Epigenetic Assays, Immunoassays, Spatial Transcriptomics), By Test Purpose (Early Detection, Molecular Characterization, Prognostic Testing, Companion Diagnostics, Therapy Monitoring, Minimal Residual Disease (MRD) & Recurrence Monitoring, Pharmacogenomics, Others), By End User (Hospitals & Oncology Centers, Central Laboratories, Academic & Research Institutes, Clinical Research Organizations (CROs) & Pharma Companies, Community Clinics, Others), Global Market Size, Segmental Analysis, Regional Overview, Company Share Analysis, Leading Company Profiles And Market Forecast, 2025 – 2035.

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What trends will shape the Oncology-Based Molecular Diagnostics Market in the coming years?

The Oncology-Based Molecular Diagnostics Market accounted for USD 3.85 Billion in 2024 and USD 4.07 Billion in 2025 and is expected to reach USD 7.14 Billion by 2035, growing at a CAGR of around 5.78% between 2025 and 2035. The oncology-based molecular diagnostics market is set to experience high growth due to factors like increasing adoption of liquid biopsy and minimally invasive testing, greater focus on early cancer detection and precision oncology, and broadening of next-generation sequencing (NGS) panels used for tumour profiling.

Emerging technologies such as methylation assays, single-cell sequencing, and spatial transcriptions will create new opportunities in molecular diagnostics; an extension of government initiatives, programmes that reimburse tests, and awareness programmes will continue to augment the adoption. Development of personalised medicine and multi-cancer early detection tests will drive the evolution of the market. The integration of molecular diagnostics into clinical workflow and electronic health records will streamline cancer care management.

What do industry experts say about the Oncology-Based Molecular Diagnostics market trends?

"The oncology molecular diagnostics market is experiencing transformative growth, driven by advancements in genomic profiling, the rise of liquid biopsy technologies, and a shift towards personalized medicine. As we move forward, the integration of artificial intelligence and machine learning into diagnostic workflows will further enhance the precision and efficiency of cancer detection and treatment monitoring."

• Francis deSouza, CEO of Illumina.

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Oncology-Based Molecular Diagnostics market?

How is the increasing adoption of liquid biopsy technology accelerating early cancer detection globally?

The Oncology-Based Molecular Diagnostics Market is experiencing a drastic increase in growth owing to the growing use of liquid biopsy technology, which is catalyzing the early detection of cancer in every region of the world. Liquid biopsy refers to the analysis of blood samples to identify tumor-associated substances, including circulating tumor DNA, circulating tumor cells, and exosomes, in place of more invasive procedures used to perform tissue biopsy. The technology can be used to detect genetic mutations and changes linked to different types of cancer at an early age to help provide an appropriate response and a specific treatment plan. Up to now, in high-risk patients, early-stage cancer is detected with the help of testing body fluids (blood, urine, saliva, stool, and sputum) in accordance with the Liquid Biopsy Consortium of the U.S. National Cancer Institute.

The consortium aims to identify the difference between cancer and benign diseases and aggressive and indolent tumors, which underlines the clinical relevance of liquid biopsy. With the introduction of the new sequencing technology and bioinformatics, the sensitivity and specificity of these tests have been improved in order to increase the accuracy of the diagnosis. Once liquid biopsy is incorporated into the daily clinical routine, it can track the reaction to treatment and the development of the disease in real time. Liquid biopsy can be used to detect the disease at an early stage and provide patients with increased chances of survival and positive outcomes. The procedure also reduces invasive operations and patient pain, and medical costs. Overall, liquid biopsy is revolutionizing oncology diagnostics, as it allows us to treat cancer worldwide preemptively, accurately, and individually.

How are precision medicine initiatives driving demand for targeted molecular oncology diagnostic tests?

The Oncology-Based Molecular Diagnostics Market is growing rapidly because of the rise in the implementation of precision medicine programs, which is fueling the call to develop targeted molecular oncology diagnostics tests. Precision medicine techniques make cancer treatment personalized to a patient's genetic composition and lifestyle, allowing for better and more personalized patient care. The U.S. National Cancer Institute identified precision medicine as a way that enables clinicians to choose treatments with the highest potential to help patients as a result of genetic changes in their tumors. The technique maximizes the effectiveness and minimizes the side effects by removing unproductive treatments.

Molecular diagnostics that can be incorporated in clinical practice will help identify certain biomarkers that can guide oncologists to choose the most suitable treatment options. As a result, the need to utilize molecular diagnostic tests that could identify these biomarkers with accuracy and efficiency is increasing. Further acceleration in uptake has been made possible through the advances of next-generation sequencing technologies, allowing high-throughput and cost-effective genomic profiling. The growing number of treatments has further increased the demand for companion diagnostics to select the right patients. Consequently, the targeted molecular oncology diagnostic market is growing at an alarming pace. In conclusion, precision medicine is revolutionizing the oncology care system at a global level by enabling more individualized and targeted treatment decisions and improving patient outcomes.

How do high costs of molecular diagnostic tests limit adoption in emerging economies?

Emerging economies are seeing lower than expected uptake of the oncology-based molecular diagnostics because of the high expense associated with molecular diagnostic tests. For many of the more sophisticated tests, such as next-generation sequencing and the more advanced liquid biopsy panels, the cost of the reagents, the instruments, and the skilled labour to run them will increase your cost of testing to high levels. Countries in emerging economies with constrained budgets will see patients who are potentially good candidates for this sophisticated testing, unable to pay out of their pocket for the test. This limits the market for these advanced cancer diagnostic tests. Systemic reimbursement and public state-funded healthcare in some of these regions provide poor coverage or little reimbursement for high-cost molecular tests.

There is also a substantial investment into laboratory infrastructure, which may or may not be pre-installed, plus ongoing maintenance investment, which will limit the number of small hospitals and clinics able to offer this type of specialised medical care to cancer patients. Limited awareness of the benefits that molecular diagnostics provides compared to standard tests will lead to a lack of demand for the most part in population sectors that are cost-sensitive. Because of the higher price for molecular diagnostics, these populations and the government health care systems will expect us to work at a lower price than they presently pay for conventional diagnostic tests, because the prices make the adoption curve longer. As such, many patients will still rely on the less accurate but traditional options of biopsy and/or imaging to detect their cancer, which may delay the timely and accurate detection of cancer or personalised therapy. Therefore, until affordability and insurance coverage increase, the affordability of diagnostics is the greatest barrier to uptake in oncology-based molecular diagnostics in emerging economies.

How can AI-driven bioinformatics enhance diagnostic accuracy and interpretation in oncology testing?

The Oncology-Based Molecular Diagnostics Market is rapidly developing due to the incorporation of Artificial Intelligence (AI)-based bioinformatics in oncology diagnostics, interpretation, and diagnostic tests. The AI algorithms are able to handle massive amounts of complex biological data, like genomic sequences or imaging outcomes, and can detect patterns and markers related to the presence of cancer. This analysis of biological data with AI can provide an earlier diagnosis of malignancies that would not have otherwise been detected by conventional methods and recommend treatments effectively. For example, AI screeners are reported as having a sensitivity of 89.9% and specificity of 89.2% for identifying normal mucosa to oral cancerous lesions. Therefore, having accurate and focused diagnostic tests means patients can have timely opportunities to begin treatment with less time wasted.

In addition, AI can provide better differentiation of malignant versus benign lesions, reducing the occurrence of false positives and unnecessary biopsies. Furthermore, because AI systems are constantly learning, their diagnostic models will also be learning and developing; new cancer types will only add to their effectiveness as a diagnostic tool. On a clinical level, AI will help to improve workflow by reducing the need to repeat the same administrative tasks, allowing the health worker the time to treat patients and help them with more complex decisions. In conclusion, AI-based bioinformatics will only continue to improve the accuracy of oncology diagnostics and opportunities for personalised care through more effective workflows.

How does growing demand for multi-cancer early detection panels create market expansion opportunities?

The Oncology-Based Molecular Diagnostics Market is expanding, fueled by an increase in the demand for multi-cancer early detection (MCED) panels that are providing real opportunities for growth in the market. MCED panels enable the early detection of multiple cancers from one blood sample, facilitating earlier diagnosis and treatment. The U.S. National Cancer Institute reports that early detection of localized cancers leads to improved treatment and higher survival rates. MCED panels are proving useful for cancers that are not screenable or that have limited screening tools. Genomic technologies are aiding detection, integrated into the cancer diagnostics market, including next-generation sequencing, which is allowing for extensive tumor DNA analysis and multi-cancer detection.

Artificial Intelligence is further offering advances to optimize MCED panels by aiding in the interpretation of substantive data and improving turnaround time. The growth of cancer across the globe reinforces the need for innovative early detection approaches in cancer. Both private and public sector stakeholders have invested and promoted R&D to spur the commercialization and implementation of MCED through access and need-based policies to support access to cancer diagnostics and improve healthcare disparities. Overall, original MCED panels are the key driver in the oncology-based molecular diagnostics market, as patients will benefit from a pathway toward early detection, personalized treatments, and improved patient outcomes while driving globally broader development and uptake of these important diagnostic products.

What are the key market segments in the Oncology-Based Molecular Diagnostics industry?

Based on the product type, the Oncology-Based Molecular Diagnostics Market is classified into Kits & Reagents, Instruments & Platforms, Companion Diagnostics (CDx), Laboratory Developed Tests (LDTs), Consumables, and Software & Bioinformatics Tools. Kits and reagents are typically used for sample preparation and molecular testing and include important investments in ensuring a reliable process for accurate detection of cancer biomarkers. Instruments and platforms are advanced devices like sequencers and PCR machines that produce high-throughput testing and precise analysis.

Companion Diagnostics (CDx) are tests that identify specific genetic mutations that encourage targeted therapies, such as for cancer pharmacotherapy. Laboratory Developed Tests (LDTs) include tests that are developed within clinical laboratories and used for specific testing requirements. Consumables include test items in the workflow relied on routinely, such as pipettes, plates, and reagents. The key role for software and bioinformatics tools is to aid in analyzing, understanding, and managing complex genomic information. Together, the product types can demonstrate the core strength of oncology molecular diagnostics and push forward the potential for innovative personalized oncology healthcare.

Based on the application, the Oncology-Based Molecular Diagnostics Market is classified into Next-Generation Sequencing, Polymerase Chain Reaction, Chromogenic in situ Hybridization, Microarrays, Methylation & Epigenetic Assays, Immunoassays, and Spatial Transcriptomics. Next-generation sequencing allows the full genomic profiling and the identification of mutations in various cancers. Polymerase chain reaction enables amplification of certain sequences of DNA or RNA to be rapidly and accurately analyzed. Chromogenic in situ hybridization assists in visualizing the abnormalities of genes in a tissue sample. Microarrays enable the analysis of thousands of genes at a time to determine their pattern of expression and to identify biomarkers.

Methylation & epigenetic assays are tested to determine the changes in the DNA that regulate the activity of the genes, and this enables the realization of the tumor behavior. Proteins and antigens involved in cancer development are recognized by immunoblotting and can be utilized to assist in diagnosis and treatment follow-up. Spatial transcriptomics visualizes the expression of genes in the tissue structure and enhances the understanding of the tumor microenvironment. All these technologies combined create the basis of enhanced molecular diagnostics to facilitate precision and personalized malignancy treatment.

Which regions are leading the Oncology-Based Molecular Diagnostics market, and why?

The North America Oncology-Based Molecular Diagnostics Market is leading due to the advanced healthcare infrastructure and access to innovation and technologies in diagnostics. Because of accelerated regulatory approvals, comprehensive reimbursement policies, and high awareness of molecular testing, the U.S. drives this market overall. Breast cancer testing leads the oncology-based diagnostics market, as there is considerable research published on diagnostic and prognostic factors, such as early detection and personalized therapies for breast cancer patients.

Newer technologies, such as next-generation sequencing and polymerase chain reaction, are improving the overall accuracy and efficiency of molecular diagnostics. The application of artificial intelligence and machine learning is advancing the ability to interpret complex data and support individualized treatment decisions that are quickly generated. Partnerships exist between diagnostic companies and pharmaceutical businesses, and together they are developing more companion diagnostics, as there is the opportunity for funding and innovation through government programs. As in any market, there are always challenges to overcome, such as cost and regulatory approval processes, but North America is paving growth and is still the trendsetter in oncology-based molecular diagnostics.

The Asia Pacific Oncology-Based Molecular Diagnostics Market is growing due to the growing amounts of funds spent on health infrastructure by nations like China, India, and Japan. This is driving the increasing demand for early-stage screening, detection, and tailored personalized treatment with rising cancer rates throughout the Asia Pacific. Advanced technologies in molecular diagnostics, such as next-generation sequencing and polymerase chain reaction, are also improving the diagnostic accuracy and efficiency of current standardization operations and are being increasingly utilized as a means to accurately guide the diagnosis and treatment of cancer in patients. It appears the mean consumer preference is moving towards non-invasive liquid biopsy, in which the genomic studies do not involve painful tissue extraction and allow continuous monitoring through the public realm of convenience, as testimonials by previous cancer patients have encouraged further genomic monitoring diagnostics.

Government measures with funds utilized by countries in the Asia-Pacific Region are bolstering efforts to improve the development and access to, and affordability of, molecular diagnostics. There are reciprocal relationships formed between cancer-focused diagnostics companies and large pharmaceutical corporations for the purpose of piloting companion diagnostics in targeted medication therapy. Furthermore, internal and external issues are still prevalent, such as high costs, regulations, reimbursement, and necessary internal systems and structures. Nevertheless, as the Asian-Pacific market is going through a continuous growth process, the entire region is primed for an economic apex, enhancing cancer detection, outcomes, and personalized treatment interventions.

What does the competitive landscape of the Oncology-Based Molecular Diagnostics market look like?

The Oncology-Based Molecular Diagnostics Market is a very competitive industry, with major companies diversifying to create better and easier means for early detection of cancer and, therefore, enhanced means for personal treatment. Companies are focused on developing new diagnostic technologies that include next-gen sequencing, polymerase chain reaction, and liquid biopsy, which allow for non-invasive means of diagnosis. We are also seeing increasing collaboration/partnerships between diagnostic companies and pharmaceutical companies, particularly in the realm of companion diagnostics to be used alongside targeted therapy. Precision medicine will increase the demand for molecular tests that find specific genetic mutations and biomarkers in many types of cancer over the next few years. The demand will be even greater in regions like North America that have advanced health care infrastructure and good acceptance of new diagnostic testing as prospects increase for precision medicine. Asia Pacific represents one of the most emerging markets because of growing cancer rates and investment in health care infrastructure.

Whilst the oncology-based molecular diagnostics market will continue to grow, it is common that there will also come more challenges in regard to the cost of performing tests and complex regulatory obstacles that may impede the adoption of the new diagnostic testing in both regions. Continued Research and Development (R&D) and technological improvement will remain significant; there is the ever-increasing competition and need for differentiation (in what is likely to remain a close competitive field). We have also seen GlaxoSmithKline (GSK), a major pharmaceutical company, re-enter the oncology space to sell two precision therapies for gynecological cancers, which will increase competition in the oncology-based molecular diagnostics space. More specifically, in this context, the prospect of personalized treatment indicates that personalized treatment (or companion diagnostics) will continue to grow, which may also lead to increasing advances within the field of molecular diagnostics for cancer. Overall, the competitive industry landscape may likely continue to drive advancements in technology and opportunities for the improvement of cancer detection and treatment for patients.

Oncology-Based Molecular Diagnostics Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the Oncology-Based Molecular Diagnostics industry?

• In July 2025, Illumina Inc. launched the next generation of its TruSight Oncology 500 assay, enhancing comprehensive genomic profiling capabilities to accelerate access to precision oncology.
• In June 2025, QuidelOrtho announced a strategic shift in its molecular diagnostics approach, revealing its plan to acquire full ownership of LEX Diagnostics following FDA clearance of the latter's platform, a deal expected to close in late 2025 or early 2026.

Report Coverage:

By Product Type

• Kits & Reagents
• Instruments & Platforms
• Companion Diagnostics (CDx)
• Laboratory Developed Tests (LDTs)
• Consumables
• Software & Bioinformatics Tools

By Cancer Type

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Ovarian Cancer
• Hematologic Malignancies
• Melanoma
• Others

By Sample Type

• Tissue Biopsy
• Liquid Biopsy
• Urine
• Buccal Swab
• Cerebrospinal Fluid (CSF)
• Bone Marrow Aspirate

By Technology

• Next-Generation Sequencing
• Polymerase Chain Reaction
• Chromogenic In Situ Hybridization
• Microarrays
• Methylation & Epigenetic Assays
• Immunoassays
• Spatial Transcriptomics

By Test Purpose

• Early Detection
• Molecular Characterization
• Prognostic Testing
• Companion Diagnostics
• Therapy Monitoring
• Minimal Residual Disease (MRD) & Recurrence Monitoring
• Pharmacogenomics
• Others

By End User

• Hospitals & Oncology Centers
• Central Laboratories
• Academic & Research Institutes
• Clinical Research Organizations (CROs) & Pharma Companies
• Community Clinics
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Illumina, Inc.
• QIAGEN N.V.
• F. Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc.
• Danaher Corporation
• Abbott Laboratories
• Becton, Dickinson and Company
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Hologic, Inc.
• Siemens Healthineers AG
• Sysmex Corporation
• PerkinElmer, Inc.
• Guardant Health, Inc.
• Exact Sciences Corporation

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