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U.S. Tissue Diagnostics Market Size, Share & Trends Analysis Report By Technology & Product, By Application, And Segment Forecasts, 2025 - 2030

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  • 120 Pages
  • December 2024
  • Region: United States
  • Grand View Research
  • ID: 6040836
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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. 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.

Why should you buy this report?

  • Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players worldwide.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segment and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listing for you to stay ahead of the curve
  • COVID-19's impact and how to sustain in these fast-evolving markets

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Table of Contents

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. 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
List of Tables
Table 1 List of Secondary Sources
Table 2 List of Abbreviations
Table 3 U.S. Tissue Diagnostics market, by Technology & Product, 2018 - 2030 (USD Million)
Table 4 U.S. Tissue Diagnostics market, by Application, 2018 - 2030 (USD Million)
Table 5 U.S. Tissue Diagnostics market, by End Use, 2018 - 2030 (USD Million)
List of Figures
Fig. 1 Information procurement
Fig. 2 Primary research pattern
Fig. 3 Market research approaches
Fig. 4 Value chain-based sizing & forecasting
Fig. 5 Market formulation & validation
Fig. 6 U.S. tissue diagnostics market segmentation
Fig. 7 Market driver analysis (current & future impact)
Fig. 8 Market restraint analysis (current & future impact)
Fig. 9 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 10 Porter’s five forces analysis
Fig. 11 U.S. tissue diagnostics market, technology & product outlook key takeaways 2024 & 2030 (USD Million)
Fig. 12 U.S. tissue diagnostics market, application outlook key takeaways 2024 & 2030 (USD Million)
Fig. 13 U.S. tissue diagnostics market, end use outlook key takeaways 2024 & 2030 (USD Million)
Fig. 14 Immunohistochemistry market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 15 Instruments market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 16 Slide Staining Systems market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 17 Tissue Microarrays market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 18 Tissue Processing Systems market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 19 Slide Scanners market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 20 Other Products market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 21 Consumables market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 22 Reagents market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 23 Antibodies market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 24 Kits market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 25 In situ Hybridization market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 26 Instruments market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 27 Consumables market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 28 Software market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 29 Primary & Special Staining market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 30 H&E Staining market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 31 Special Staining market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 32 Digital Pathology and Workflow market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 33 Whole Slide Imaging market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 34 Image Analysis Informatics market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 35 Information Management System Storage & Communication market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 36 Anatomic Pathology market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 37 Instruments market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 38 Microtomes &Cryostat Microtomes market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 39 Tissue Processors market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 40 Automatic Strainers market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 41 Other Products market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 42 Consumables market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 43 Reagents & Antibodies market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 44 Probes & Kits market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 45 Others market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 46 Breast Cancer market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 47 Non-Small Cell Lung Cancer market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 48 Prostate Cancer market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 49 Gastric Cancer market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 50 Other Cancers market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 51 Hospital market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 52 Research Laboratories market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 53 Pharmaceutical Organizations market revenue estimates and forecasts, 2018 - 2030 (USD Million)
Fig. 54 CRO market revenue estimates and forecasts, 2018 - 2030 (USD Million)

Companies Mentioned

  • 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

Methodology

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Table Information

Report AttributeDetails
No. of Pages120
PublishedDecember 2024
Forecast Period2024 - 2030
Estimated Market Value ( USD ) in 2024 $ 2.76 billion
Forecasted Market Value ( USD ) by 2030 $ 4.4 billion
Compound Annual Growth Rate8.3%
Regions CoveredUnited States
No. of Companies Mentioned20

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About the Tissue Test Market

The Tissue Test market within the context of Diagnostics is a segment of the medical industry that focuses on the analysis of tissue samples to detect and diagnose diseases. Tissue tests are used to detect a wide range of conditions, from cancer to infectious diseases. They are often used to confirm a diagnosis or to monitor the progression of a disease. Tissue tests can also be used to detect genetic abnormalities or to identify the presence of certain proteins or other molecules. Tissue tests are typically performed in a laboratory setting, using a variety of techniques such as immunohistochemistry, flow cytometry, and polymerase chain reaction. The results of these tests can be used to inform treatment decisions and to monitor the effectiveness of treatments. Some companies in the Tissue Test market include Roche Diagnostics, Abbott Laboratories, Becton Dickinson, and Siemens Healthineers. Show Less Read more

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