SHERIDAN, Wyo., Oct. 15, 2026 /PRNewswire/ -- The global cancer diagnostics market is valued at USD 29.3 billion in 2026 and is projected to reach USD 41.5 billion by 2031, growing at a CAGR of 7.2% over the forecast period (2026–2031), according to a new study by Wissen Research.

The starting point is simple: more people need testing. The International Agency for Research on Cancer (IARC) counted about 20 million new cancer cases and 9.7 million cancer deaths worldwide in 2022, and expects annual new cases to pass 35 million by 2050. Every one of those patients may need screening, diagnosis, staging, molecular characterization, and follow-up, so the load on diagnostic tools keeps building.

What is changing faster is how the testing gets done. Diagnosis that once leaned mostly on imaging and a pathologist's reading of tissue is becoming a layered process that also draws on digital pathology, molecular and genomic tests, liquid biopsy, and AI.

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Diagnosis Is Becoming a Stack: Imaging and Pathology Now Share the Work With Molecular and AI Tools

Mammography, CT, MRI, and tissue pathology are still the backbone of cancer diagnosis. Pathology in particular remains central, since examining tissue and cells under the microscope is how a cancer is confirmed, and immunohistochemistry adds protein-level detail that helps pin down the tumor type and the right therapy. What the report highlights is the layer being added on top. According to the National Cancer Institute, an advanced diagnosis now tells clinicians not only where the cancer is and how far it has spread, but also what type it is and which genetic and molecular changes could influence treatment.

That is where precision oncology comes in. Molecular testing is used to profile tumors and find markers that guide treatment, and next-generation sequencing based comprehensive genomic profiling lets labs look at several biomarkers from a single sample. The FDA's list of companion diagnostics, which identify patients likely to benefit from a particular therapy, those at risk of severe side effects, or how well a treatment is working, is increasingly populated with NGS and liquid biopsy tests. AI is joining the mix as well. Tools are being built for medical imaging, digital pathology, and lesion detection and classification, the FDA has approved AI systems for medical use, and the NCI continues to advance research on AI in cancer imaging.

Liquid Biopsy Is Moving Up, But Tissue Isn't Going Anywhere

Liquid biopsy is fast becoming an important tool because it can pick up signs of cancer in blood or other body fluids instead of requiring a tissue sample each time. The NCI describes it as testing blood for cancer cells or pieces of tumor DNA, with uses that include diagnosis, treatment decisions, tracking response, and spotting recurrence. The FDA has already approved liquid biopsy companion diagnostics, including tests that use NGS to analyze circulating DNA from plasma.

The report is careful about the limits, though. Liquid biopsy is not yet ready to replace tissue-based diagnostics across the board, and questions about sensitivity, specificity, clinical utility, and validation remain open. The same caution applies to multi-cancer detection tests, where the NCI is still studying how they should fit into screening and what they would mean for patient outcomes.

What's Fueling Growth in the Cancer Diagnostics Market

- More patients to test: Demographic change is expanding the number of people who need screening, diagnosis, staging, and monitoring.

- A push for earlier detection: The WHO separates early diagnosis in people with symptoms from screening in people without them, and says earlier detection leads to better treatment outcomes. Screening for breast, cervical, colorectal, and lung cancer keeps imaging, cytology, and other tests in steady demand.

- Precision oncology: Molecular testing is now used to profile tumors and find markers that decide treatment, lifting demand for molecular and biomarker diagnostics.

- Genomic testing and liquid biopsy: NGS-based profiling checks multiple genetic changes at once, while liquid biopsy looks at tumor-derived DNA in blood or other fluids.

- AI and digitalization: AI is being developed for medical imaging, digital pathology, lesion detection and classification, and handling complex diagnostic data.

- Asia Pacific build-out: New hospitals, diagnostic labs, and cancer hospitals, along with public screening programs, are widening access to modern diagnostics across the region.

Challenges Facing the Cancer Diagnostics Market

A new cancer test has to clear a high bar before it earns clinical trust. Developers contend with diagnostic accuracy, sample quality, tumor heterogeneity, biomarker variability, false positives and false negatives, turnaround time, reimbursement, data interoperability, and regulatory requirements. Each technology has its own version of the problem. Molecular testing can be limited by scarce tissue and by tumors that contain genetically distinct populations. Liquid biopsy has to detect very low concentrations of tumor material. AI tools for imaging and pathology need the right datasets and proper clinical validation.

There is also a harder question behind the technical ones. A test can reveal a biomarker or an abnormality without proving that using it improves patient outcomes, which is why clinical utility matters so much for newer approaches such as multi-cancer detection.

Recent Strategic Developments in the Cancer Diagnostics Market

On September 28, 2026, Leica Biosystems, a subsidiary of Danaher Corporation, completed its acquisition of StatLab Medical Products. The deal widens Leica's anatomic pathology portfolio across specimen collection, preparation, staining, digital imaging, and AI-enabled diagnosis, strengthening its end-to-end pathology capabilities and supporting faster, more standardized cancer diagnostic workflows.

On July 27, 2026, Siemens Healthineers AG and Vanderbilt Health entered an $87 million multi-year partnership to modernize diagnostic imaging and radiation oncology. The agreement covers MRI, CT, molecular imaging, and interventional radiology systems, and advances AI-enabled radiology, personalized medicine, and workflow automation.

On May 7, 2026, F. Hoffmann-La Roche Ltd entered a definitive agreement to acquire PathAI for up to $1.05 billion, including $750 million upfront and milestone payments. The acquisition was expected to strengthen Roche's digital pathology and AI capabilities by integrating PathAI's AI-powered pathology platform with Roche's oncology diagnostics and companion diagnostics portfolio.

Taken together, the three deals put money behind pathology, imaging, and AI-enabled workflows.

Key Insights from Cancer Diagnostics Market Analysis

- IVD testing held the largest share by product type in 2025, reflecting how widely laboratory testing is used for diagnosis, disease characterization, biomarker assessment, and treatment decisions. The category covers kits and reagents, PCR and NGS instruments, in situ hybridization, immunohistochemistry, and other laboratory technologies.

- Diagnosis and disease characterization held the largest share by application in 2025, because malignancy has to be confirmed and its biology characterized before treatment begins. Molecular and genomic testing identifies mutations, gene fusions, biomarker expression, microsatellite instability, and mismatch-repair status that can steer treatment choice.

- North America held the largest regional share in 2025, supported by advanced medical infrastructure, established cancer-screening programs, advanced imaging and laboratory technology, molecular diagnostics, and a number of global diagnostic and medical-device leaders.

- Asia Pacific is the fastest-growing region, driven by a rising cancer burden, better healthcare infrastructure, and investment in diagnostic facilities.

- The market is moderately consolidated in established diagnostic technologies but remains fragmented across emerging molecular, liquid biopsy, digital pathology, and AI-enabled applications, where major diagnostic and life-sciences companies compete alongside specialized molecular-diagnostic and oncology-focused technology companies.

Key Players in the Cancer Diagnostics Market

Leading companies in the cancer diagnostics market are focusing on medical imaging, pathology, molecular diagnostics, genomic testing, companion diagnostics, liquid biopsy, cancer screening, digital pathology, artificial intelligence, and expansion of precision-oncology testing.

The report names F. Hoffmann-La Roche, Danaher, Abbott Laboratories, Thermo Fisher Scientific, and Siemens Healthineers as the top five players, with established positions across pathology, molecular diagnostics, genomic testing, medical imaging, biomarker testing, laboratory diagnostics, and precision oncology. Recent moves show where several of them are heading:

- Roche (Switzerland): digital pathology, AI, and companion diagnostics, reinforced by its agreement to acquire PathAI.

- Danaher (US): anatomic pathology through Leica Biosystems and its StatLab acquisition.

- Siemens Healthineers (Germany): diagnostic imaging and radiation oncology, including its partnership with Vanderbilt Health.

- Abbott (US) and Thermo Fisher Scientific (US): also in the top five, and, along with GE HealthCare and Hologic, among the companies the report points to as active in North America.

Other companies covered in the report include QIAGEN, Illumina, Agilent Technologies, Becton Dickinson, Exact Sciences, Guardant Health, Natera, GRAIL, and Tempus AI.

Regional Analysis and Growth Opportunities

North America leads the cancer diagnostics market. The U.S.