The U.S. tissue diagnostics market size is estimated to reach USD 4.40 billion by 2030, registering a CAGR of 8.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. Pivotal factors supplementing the market growth include continuous rise in the cases of cancer, growth in organ transplantation & donation, and increased acceptance toward personalized medicine & companion diagnostics in the U.S. Increase in the number of research activities targeted toward the development of novel tissue diagnostics solutions is also expected to drive the market.
The field of anatomic pathology has witnessed a paradigm shift, which can be attributed to the exponential growth in cancer incidence in the U.S., thereby expanding the clinical pathology industry. Also, steady convergence of molecular pathology with anatomic pathology, steep adoption of novel biopsies for cancer detection, and integration of digital technologies is expected to collaboratively make a positive impact on market growth.
Tissue analysis provides significant information, which is difficult to understand using conventional molecular techniques. Currently, companion diagnostic tests are rapidly being adopted by pharmaceutical companies for obtaining first-line therapy designations/approvals for their products. In addition, their use in the identification of patient cohorts, which are likely to benefit from targeted therapeutics, has increased the significance of tissue diagnostics in the development of precision medicine.
In addition, the field of tissue diagnostics has witnessed gradual evolution with the introduction of upgraded technologies, including Fluorescence In Situ Hybridization (FISH), Immunohistochemistry (IHC), Immunofluorescence (IF), comparative genomic hybridization, and Next-Generation Sequencing (NGS). Key players are focused on identifying novel biomarkers and developing assays for advanced cancer diagnosis. Furthermore, companies are conducting biomarker pathologist training programs to boost the adoption rate of modern pathological solutions.
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Based on technology & product, the immunohistochemistry segment led the market with the largest revenue share of 27.74% in 2024.
Based on application, the breast cancer segment led the market with the largest revenue share of 50.45% in 2024. Tissue diagnostics play a vital role in assessing breast cancer in patients.
Based on end use, the hospitals segment led the market with the largest revenue share of 37.82% in 2024. The usage of tissue diagnostic systems and services in hospitals & clinics has increased over the years.
Grand View Research has segmented the U.S. tissue diagnostics market on the basis of technology & product, application, and end-use:
U.S. Tissue Diagnostics Technology & Product Outlook (Revenue, USD Million, 2018 - 2030)
Immunohistochemistry
Instruments
Slide Staining Systems
Tissue Microarrays
Tissue Processing Systems
Slide Scanners
Other Products
Consumables
Reagents
Antibodies
Kits
In situ Hybridization
Instruments
Consumables
Software
Primary & Special Staining
H&E Staining
Special Staining
Digital Pathology & Workflow
Whole Slide Imaging
Image Analysis Informatics
Information Management System Storage & Communication
Anatomic Pathology
Instruments
Microtomes & Cryostat Microtomes
Tissue Processors
Automatic Strainers
Other Products
Consumables
Reagents & Antibodies
Probes & Kits
Others
U.S. Tissue Diagnostics Application Outlook (Revenue, USD Million, 2018 - 2030)
Breast Cancer
Non-Small Cell Lung Cancer
Prostate Cancer
Other Cancers
Gastric Cancer
U.S. Tissue Diagnostics End Use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals
Research Laboratories
Pharmaceutical Organizations
CRO
List of Key Players of U.S. Tissue Diagnostics Market
Merck KGaA
Thermo Fisher Scientific, Inc.
F. Hoffmann-La Roche Ltd.
Abbott Laboratories
Siemens Healthineers AG
Danaher
bioMérieux SA
QIAGEN
Becton, Dickinson & Company (BD)
Agilent Technologies, Inc.
General Electric Company (GE Healthcare)
BioGenex
Cell Signaling Technology, Inc.
Bio SB
DiaGenic ASA
Sakura Finetek Japan Co., Ltd.
Abcam plc
Enzo Life Sciences, Inc.
VITRO SA (Master Diagnóstica)
TissueGnostics GmbH
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