Sheridan – October 15, 2026 -- 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, a CAGR of 7.2%, according to a new study by Wissen Research.
Demand starts with patient volume. The International Agency for Research on Cancer 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.
Molecular and AI tools are being layered onto imaging and pathology
Mammography, CT, MRI and tissue pathology remain the backbone of diagnosis. Next-generation sequencing (NGS) based comprehensive genomic profiling now lets labs assess several biomarkers from a single sample. The FDA's list of companion diagnostics is increasingly populated with NGS and liquid biopsy tests, and AI tools are being built for imaging, digital pathology and lesion detection.
Liquid biopsy gains FDA-approved companion diagnostics but cannot yet replace tissue
The FDA has approved liquid biopsy companion diagnostics, including NGS tests that analyze circulating DNA from plasma. The report cautions that questions on sensitivity, specificity, clinical utility and validation remain open. The National Cancer Institute is still studying how multi-cancer detection tests should fit into screening.
Roche, Danaher and Siemens Healthineers commit capital to pathology, imaging and AI
- On May 7, 2026, F. Hoffmann-La Roche agreed to acquire PathAI for up to $1.05 billion, including $750 million upfront plus milestone payments.
- On July 27, 2026, Siemens Healthineers and Vanderbilt Health entered an $87 million multi-year partnership covering MRI, CT, molecular imaging and interventional radiology systems.
- On September 28, 2026, Danaher subsidiary Leica Biosystems completed its acquisition of StatLab Medical Products, extending its anatomic pathology portfolio from specimen collection to AI-enabled diagnosis.
North America led in 2025 while Asia Pacific grows fastest
In vitro diagnostic (IVD) testing held the largest share by product type in 2025. Diagnosis and disease characterization held the largest share by application. North America held the largest regional share, supported by established screening programs and a concentration of global diagnostic and device leaders. Asia Pacific is the fastest-growing region, driven by a rising cancer burden and investment in hospitals, labs and public screening programs.
The market is moderately consolidated in established diagnostic technologies but remains fragmented across molecular, liquid biopsy, digital pathology and AI-enabled applications. The report names Roche, Danaher, Abbott Laboratories, Thermo Fisher Scientific and Siemens Healthineers as the top five players.
Validation, reimbursement and clinical utility remain hurdles for new tests
Developers face diagnostic accuracy, sample quality, tumor heterogeneity, false positives and negatives, turnaround time, reimbursement, data interoperability and regulatory requirements. Molecular testing can be limited by scarce tissue, while liquid biopsy must detect very low concentrations of tumor material. AI tools need suitable datasets and clinical validation. The report also stresses that a test can reveal a biomarker without proving it improves patient outcomes, which is why clinical utility weighs heavily on multi-cancer detection.
Other companies covered include QIAGEN, Illumina, Agilent Technologies, Becton Dickinson, Exact Sciences, Guardant Health, Natera, GRAIL and Tempus AI.