Cancer Diagnostics Market Seen Reaching $41.5 Billion by 2031, Wissen Research Says

More patients, more testing

The report's starting point is demand. 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. Each patient may need screening, diagnosis, staging, molecular characterization and follow-up, which keeps adding load on diagnostic tools.

Wissen Research says the faster change is in how testing is 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.

Mammography, CT, MRI and tissue pathology remain the backbone. Pathology stays central because examining tissue and cells under the microscope is how a cancer is confirmed, and immunohistochemistry adds protein-level detail that helps identify the tumor type and the right therapy.

Molecular tools, liquid biopsy and AI

According to the National Cancer Institute, an advanced diagnosis now tells clinicians where the cancer is, how far it has spread, what type it is and which genetic and molecular changes could influence treatment. Next-generation sequencing (NGS) based comprehensive genomic profiling lets labs look at several biomarkers from a single sample. The report notes that the FDA's list of companion diagnostics is increasingly populated with NGS and liquid biopsy tests.

Liquid biopsy can pick up signs of cancer in blood or other body fluids instead of requiring a tissue sample each time. The NCI describes uses that include diagnosis, treatment decisions, tracking response and spotting recurrence. The FDA has already approved liquid biopsy companion diagnostics, including NGS tests that analyze circulating DNA from plasma.

The report is cautious, however. 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 applies to multi-cancer detection tests, where the NCI is still studying how they should fit into screening.

AI tools are being built for medical imaging, digital pathology, and lesion detection and classification. The report adds that the FDA has approved AI systems for medical use.

Growth drivers and challenges

The report lists several drivers:

• More patients to test: demographic change is expanding the number of people needing screening, diagnosis, staging and monitoring.
• Earlier detection: the WHO says earlier detection leads to better treatment outcomes, and screening for breast, cervical, colorectal and lung cancer keeps demand steady.
• Precision oncology: molecular testing is used to profile tumors and find markers that decide treatment.
• Genomic testing and liquid biopsy: NGS profiling checks multiple genetic changes at once.
• AI and digitalization: AI is being developed for imaging, pathology and complex diagnostic data.
• Asia Pacific build-out: new hospitals, labs, cancer hospitals and public screening programs are widening access.

Challenges remain. Developers contend with diagnostic accuracy, sample quality, tumor heterogeneity, biomarker variability, false positives and negatives, turnaround time, reimbursement, data interoperability and regulatory requirements. Molecular testing can be limited by scarce tissue, liquid biopsy has to detect very low concentrations of tumor material, and AI tools need the right datasets and proper clinical validation. A test can also reveal a biomarker without proving that using it improves patient outcomes, which is why clinical utility matters for newer approaches such as multi-cancer detection.

Deals and market structure

The report cites three recent deals. On September 28, 2026, Leica Biosystems, a subsidiary of Danaher Corporation, completed its acquisition of StatLab Medical Products, widening its anatomic pathology portfolio. On July 27, 2026, Siemens Healthineers AG and Vanderbilt Health entered an $87 million multi-year partnership to modernize diagnostic imaging and radiation oncology. On May 7, 2026, F. Hoffmann-La Roche Ltd agreed to acquire PathAI for up to $1.05 billion, including $750 million upfront and milestone payments. The report says these deals put money behind pathology, imaging and AI-enabled workflows.

IVD testing held the largest share by product type in 2025, and diagnosis and disease characterization held the largest share by application. North America held the largest regional share in 2025, while 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 fragmented across emerging molecular, liquid biopsy, digital pathology and AI-enabled applications. The report names F. Hoffmann-La Roche, Danaher, Abbott Laboratories, Thermo Fisher Scientific and Siemens Healthineers as the top five players.

What it means

For labs, hospitals and diagnostics companies, the report suggests that growth will come from adding molecular, digital and AI layers on top of established imaging and pathology rather than replacing them. Tissue testing keeps its role, and newer methods such as liquid biopsy and multi-cancer detection still need evidence of clinical utility before they are used more broadly. The forecasts are Wissen Research's own estimates.