U.S. Tissue Diagnostics Market Size, Share & Trends Analysis Report By Technology & Product (IHC, Primary & Special Staining), By Application (Breast Cancer, NSCLC), And Segment Forecasts, 2025 - 2030
U.S. Tissue Diagnostics Market Growth & Trends
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.
U.S. Tissue Diagnostics Market Report Highlights
- 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.
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Segment Definitions
- 1.2.1. Technology & Product
- 1.2.2. Application
- 1.2.3. End Use
- 1.2.4. Regional Scope
- 1.2.5. Estimates and forecasts timeline
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR’s internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.2. Approach 1: Commodity flow approach
- 1.7.3. Volume price analysis (Model 2)
- 1.7.4. Approach 2: Volume price analysis
- 1.8. List of Secondary Sources
- 1.9. List of Primary Sources
- 1.10. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Regional outlook
- 2.4. Competitive Insights
- Chapter 3. U.S. Tissue Diagnostics Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Emerging solutions pertaining to digital tissue diagnostics
- 3.2.1.2. Advancements in imaging techniques and increasing affordability of diagnostics
- 3.2.1.3. Growth of personalized therapeutics and diagnostics
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Presence of non-value-based reimbursement policy and high costs associated with usage of tissue diagnosis
- 3.3. U.S. Tissue Diagnostics Market Analysis Tools
- 3.3.1. Industry Analysis - Porter’s
- 3.3.1.1. Bargaining power of suppliers
- 3.3.1.2. Bargaining power of buyers
- 3.3.1.3. Threat of substitutes
- 3.3.1.4. Threat of new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic landscape
- 3.3.2.3. Social landscape
- 3.3.2.4. Technological landscape
- 3.3.2.5. Environmental landscape
- 3.3.2.6. Legal landscape
- Chapter 4. U.S. Tissue Diagnostics Market: Technology & Product Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. U.S. Tissue Diagnostics Market: Technology & Product Movement Analysis
- 4.3. U.S. Tissue Diagnostics Market by Technology & Product Outlook (USD Million)
- 4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
- 4.5. Immunohistochemistry
- 4.5.1. Immunohistochemistry Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2. Instruments
- 4.5.2.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2.2. Slide Staining Systems
- 4.5.2.2.1. Slide Staining Systems Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2.3. Tissue Microarrays
- 4.5.2.3.1. Immunohistochemistry Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2.4. Tissue Processing Systems
- 4.5.2.4.1. Tissue Processing Systems Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2.5. Slide Scanners
- 4.5.2.5.1. Slide Scanners Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.2.6. Other Products
- 4.5.2.6.1. Other Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.3. Consumables
- 4.5.3.1. Consumables Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.3.2. Reagents
- 4.5.3.2.1. Reagents Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5.3.3. Antibodies
- 4.5.3.3.1. Antibodies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.6. In situ Hybridization
- 4.6.1. In situ Hybridization Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.6.2. Instruments
- 4.6.2.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.6.3. Consumables
- 4.6.3.1. Consumables Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.6.4. Software
- 4.6.4.1. Software Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.7. Primary & Special Staining
- 4.7.1. Primary & Special Staining Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.7.2. H&E Staining
- 4.7.2.1. H&E Staining Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.7.3. Special Staining
- 4.7.3.1. Special Staining Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.8. Digital Pathology and Workflow
- 4.8.1. Digital Pathology and Workflow Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.8.2. Whole Slide Imaging
- 4.8.2.1. Whole Slide Imaging Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.8.3. Image Analysis Informatics
- 4.8.3.1. Image Analysis Informatics Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.8.4. Information Management System Storage & Communication
- 4.8.4.1. Information Management System Storage & Communication Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9. Anatomic Pathology
- 4.9.1. Anatomic Pathology Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.2. Instruments
- 4.9.2.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.2.2. Microtomes & Cryostat Microtomes
- 4.9.2.2.1. Microtomes & Cryostat Microtomes Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.2.3. Tissue Processors
- 4.9.2.3.1. Tissue Processors Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.2.4. Automatic Strainers
- 4.9.2.4.1. Automatic Strainers Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.2.5. Other Products
- 4.9.2.5.1. Other Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.3. Consumables
- 4.9.3.1. Consumables Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.3.2. Reagents & Antibodies
- 4.9.3.2.1. Reagents & Antibodies Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.3.3. Probes & Kits
- 4.9.3.3.1. Probes & Kits Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.9.3.4. Others
- 4.9.3.4.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 5. U.S. Tissue Diagnostics Market: Application Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. U.S. Tissue Diagnostics Market: Application Movement Analysis
- 5.3. U.S. Tissue Diagnostics Market by Application Outlook (USD Million)
- 5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
- 5.5. Breast Cancer
- 5.5.1. Breast Cancer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.6. Non-Small Cell Lung Cancer
- 5.6.1. Non-Small Cell Lung Cancer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.7. Prostate Cancer
- 5.7.1. Prostate Cancer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.8. Gastric Cancer
- 5.8.1. Gastric Cancer Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.9. Other Cancers
- 5.9.1. Other Cancers Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 6. U.S. Tissue Diagnostics Market: End Use Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. U.S. Tissue Diagnostics Market: End Use Movement Analysis
- 6.3. U.S. Tissue Diagnostics Market by End Use Outlook (USD Million)
- 6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
- 6.5. Hospitals
- 6.5.1. Hospitals Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6. Research Laboratories
- 6.6.1. Research Laboratories Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.7. Pharmaceutical Organizations
- 6.7.1. Pharmaceutical Organizations Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.8. CRO
- 6.8.1. CRO Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- Chapter 7. Competitive Landscape
- 7.1. Market Participant Categorization
- 7.2. Recent Developments & Impact Analysis by Key Market Participants
- 7.3. Company Market Share Analysis, 2024
- 7.4. Key Company Profiles
- 7.4.1. Merck KGaA
- 7.4.1.1. Company overview
- 7.4.1.2. Financial performance
- 7.4.1.3. Product benchmarking
- 7.4.1.4. Strategic initiatives
- 7.4.2. Thermo Fisher Scientific, Inc
- 7.4.2.1. Company overview
- 7.4.2.2. Financial performance
- 7.4.2.3. Product benchmarking
- 7.4.2.4. Strategic initiatives
- 7.4.3. F. Hoffmann-La Roche Ltd
- 7.4.3.1. Company overview
- 7.4.3.2. Financial performance
- 7.4.3.3. Product benchmarking
- 7.4.3.4. Strategic initiatives
- 7.4.4. Abbott Laboratories
- 7.4.4.1. Company overview
- 7.4.4.2. Financial performance
- 7.4.4.3. Product benchmarking
- 7.4.4.4. Strategic initiatives
- 7.4.5. Siemens Healthineers AG
- 7.4.5.1. Company overview
- 7.4.5.2. Financial performance
- 7.4.5.3. Product benchmarking
- 7.4.5.4. Strategic initiatives
- 7.4.6. Danaher
- 7.4.6.1. Company overview
- 7.4.6.2. Financial performance
- 7.4.6.3. Product benchmarking
- 7.4.6.4. Strategic initiatives
- 7.4.7. bioMérieux SA
- 7.4.7.1. Company overview
- 7.4.7.2. Financial performance
- 7.4.7.3. Product benchmarking
- 7.4.7.4. Strategic initiatives
- 7.4.8. QIAGEN
- 7.4.8.1. Company overview
- 7.4.8.2. Financial performance
- 7.4.8.3. Product benchmarking
- 7.4.8.4. Strategic initiatives
- 7.4.9. Becton, Dickinson & Company (BD)
- 7.4.9.1. Company overview
- 7.4.9.2. Financial performance
- 7.4.9.3. Product benchmarking
- 7.4.9.4. Strategic initiatives
- 7.4.10. Agilent Technologies, Inc
- 7.4.10.1. Company overview
- 7.4.10.2. Financial performance
- 7.4.10.3. Product benchmarking
- 7.4.10.4. Strategic initiatives
- 7.4.11. General Electric Company
- 7.4.11.1. Company overview
- 7.4.11.2. Financial performance
- 7.4.11.3. Product benchmarking
- 7.4.11.4. Strategic initiatives
- 7.4.12. BioGenex
- 7.4.12.1. Company overview
- 7.4.12.2. Financial performance
- 7.4.12.3. Product benchmarking
- 7.4.12.4. Strategic initiatives
- 7.4.13. Cell Signaling Technology, Inc
- 7.4.13.1. Company overview
- 7.4.13.2. Financial performance
- 7.4.13.3. Product benchmarking
- 7.4.13.4. Strategic initiatives
- 7.4.14. Bio SB
- 7.4.14.1. Company overview
- 7.4.14.2. Financial performance
- 7.4.14.3. Product benchmarking
- 7.4.14.4. Strategic initiatives
- 7.4.15. DiaGenic ASA
- 7.4.15.1. Company overview
- 7.4.15.2. Financial performance
- 7.4.15.3. Product benchmarking
- 7.4.15.4. Strategic initiatives
- 7.4.16. Sakura Finetek Japan Co., Ltd
- 7.4.16.1. Company overview
- 7.4.16.2. Financial performance
- 7.4.16.3. Product benchmarking
- 7.4.16.4. Strategic initiatives
- 7.4.17. Abcam plc
- 7.4.17.1. Company overview
- 7.4.17.2. Financial performance
- 7.4.17.3. Product benchmarking
- 7.4.17.4. Strategic initiatives
- 7.4.18. Enzo Life Sciences, Inc
- 7.4.18.1. Company overview
- 7.4.18.2. Financial performance
- 7.4.18.3. Product benchmarking
- 7.4.18.4. Strategic initiatives
- 7.4.19. VITRO SA (Master Diagnóstica)
- 7.4.19.1. Company overview
- 7.4.19.2. Financial performance
- 7.4.19.3. Product benchmarking
- 7.4.19.4. Strategic initiatives
- 7.4.20. TissueGnostics GmbH
- 7.4.20.1. Company overview
- 7.4.20.2. Financial performance
- 7.4.20.3. Product benchmarking
- 7.4.20.4. Strategic initiatives
Research Assistance
Download our eBook: How to Succeed Using Market Research
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
Download eBook