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US Tissue Diagnostics Market Size, Share & Trends Analysis Report by Technology & Product (IHC, Primary & Special Staining), Application (Breast Cancer, NSCLC), and Segment Forecasts, 2021-2028

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    Report

  • 157 Pages
  • June 2021
  • Region: United States
  • Grand View Research
  • ID: 5351647
Description Jump to:
The U.S. tissue diagnostics market size is estimated to reach USD 2.81 billion by 2028, registering a CAGR of 3.91% over the forecast period. 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


  • The IHC segment held the highest revenue share of over 28% in 2020. The segment’s dominance is attributed to the wide acceptance of IHC across clinical laboratories for different workflows
  • These workflows include tissue examination targeted toward disease prognosis and anticipating therapeutic response among patients with cancer
  • The digital pathology segment is anticipated to register the fastest CAGR during the forecast period mainly due to heavy investments in infrastructure as well as an onsite server for image digitization
  • In addition, the lack of skilled pathologists has propelled the demand for automated systems in disease diagnosis, thereby boosting the segment growth
  • An increase in the prevalence of breast cancer along with the launch of novel products dedicated to breast cancer detection have led to the dominance of this application segment
  • Moreover, the advent of genomic technologies aimed at gaining a better understanding of the genetic markup of a tumor is further offering lucrative growth opportunities to companies
  • The market players are investing significantly in novel product development and acquisition of small players to increase their revenue share


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Table of Contents

Chapter 1 Methodology and Scope
1.1 Research Assumptions
1.2 Research Methodology
1.3 Information Procurement
1.4 Information or Data Analysis
1.5 Market Formulation and Validation
1.6 U.S. Market: CAGR Calculation
1.7 Objectives
Chapter 2 Executive Summary
2.1 Segment Outlook
2.2 Market Summary
Chapter 3 U.S. Tissue Diagnostics Market: Market Variables, Trends, and Scope
3.1 Market Lineage Outlook
3.2 Market Trends & Outlook
3.3 Market Dynamics
3.4 COVID-19 Impact Analysis
3.5 Penetration & Growth Prospect Mapping for Applications, 2020
3.6 U.S Tissue Diagnostics Market-SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
3.7 Industry Analysis - Porter’s
Chapter 4 U.S. Tissue Diagnostics Market: Technology & Product Business Analysis
4.1 U.S. Tissue Diagnostics Market: Technology & Product Movement Analysis
4.2 Immunohistochemistry
4.3 In situ Hybridization
4.4 Primary & Special Staining
4.5 Digital Pathology and Workflow
4.6 Anatomic Pathology
Chapter 5 U.S. Tissue Diagnostics Market: Application Business Analysis
5.1 U.S. Tissue Diagnostics Market: Application Analysis
5.2 Breast Cancer
5.3 Non-Small Cell Lung Cancer (NSCLC)
5.4 Prostate Cancer
5.5 Gastric Cancer
5.6 Other Cancers
Chapter 6 Company Profile
6.1 Strategy Framework
6.2 Market Participation Categorization
6.3 Company Profiles
List of Tables
Table 1 CPT codes for IHC (CBR201610)
Table 2 Comparative analysis of ISH software
Table 3 Commonly used special stains in microbiology applications
Table 4 Commonly used special stains in detection of nucleic acids
Table 5 Multipurpose special stains
Table 6 Expanding applications of tissue examinations
Table 7 The U.S. tissue diagnostics market estimates and forecast, by technology& product, 2017-2028 (USD Million)
Table 8 The U.S. tissue diagnostics market estimates and forecast, by immunohistochemistry, 2017-2028 (USD Million)
Table 9 The U.S. tissue diagnostics market estimates and forecast, by immunohistochemistry consumables, 2017-2028 (USD Million)
Table 10 The U.S. tissue diagnostics market estimates and forecast, by immunohistochemistry instruments, 2017-2028 (USD Million)
Table 11 The U.S. tissue diagnostics market estimates and forecast, by ISH, 2017-2028 (USD Million)
Table 12 The U.S. tissue diagnostics market estimates and forecast, by anatomic pathology, 2017-2028 (USD Million)
Table 13 The U.S. tissue diagnostics market estimates and forecast, by anatomic pathology consumables, 2017-2028 (USD Million)
Table 14 The U.S. tissue diagnostics market estimates and forecast, by anatomic pathology instruments, 2017-2028 (USD Million)
Table 15 The U.S. tissue diagnostics market estimates and forecast, by digital pathology instruments, 2017-2028 (USD Million)
Table 16 The U.S. tissue diagnostics market estimates and forecast, by application, 2017-2028 (USD Million)
List of Figures
Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research
Fig. 4 Market research approaches
Fig. 5 Value chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Commodity flow analysis
Fig. 9 Market segmentation and scope
Fig. 10 Market summary, 2020 (USD Million)
Fig. 11 Related/ancillary market outlook
Fig. 12 Market trends & outlook
Fig. 13 Market driver relevance analysis (Current & future impact)
Fig. 14 Traditional pathology workflow vs. digital pathology workflow
Fig. 15 Market restraint relevance analysis (Current & future impact)
Fig. 16 Penetration & growth prospect mapping for applications, 2020
Fig. 17 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 18 Porter’s Five Forces Analysis
Fig. 19 The U.S. tissue diagnostics market: Technology & product outlook and key takeaways
Fig. 20 The U.S. tissue diagnostics market: Technology & product movement analysis
Fig. 21 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry, 2017-2028 (USD Million)
Fig. 22 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry instruments, 2017-2028 (USD Million)
Fig. 23 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry slide staining systems, 2017-2028 (USD Million)
Fig. 24 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry tissue microarrays, 2017-2028 (USD Million)
Fig. 25 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry tissue processing systems, 2017-2028 (USD Million)
Fig. 26 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry slide scanners, 2017-2028 (USD Million)
Fig. 27 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry other products, 2017-2028 (USD Million)
Fig. 28 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry consumables, 2017-2028 (USD Million)
Fig. 29 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry reagents, 2017-2028 (USD Million)
Fig. 30 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry antibodies, 2017-2028 (USD Million)
Fig. 31 The U.S. tissue diagnostics market estimates and forecast for immunohistochemistry kits, 2017-2028 (USD Million)
Fig. 32 The U.S. tissue diagnostics market estimates and forecast for in situ hybridization (ISH), 2017-2028 (USD Million)
Fig. 33 The U.S. tissue diagnostics market estimates and forecast for ISH instruments, 2017-2028 (USD Million)
Fig. 34 The U.S. tissue diagnostics market estimates and forecast for ISH consumables, 2017-2028 (USD Million)
Fig. 35 The U.S. tissue diagnostics market estimates and forecast for ISH software, 2017-2028 (USD Million)
Fig. 36 The U.S. tissue diagnostics market estimates and forecast for primary & special staining, 2017-2028 (USD Million)
Fig. 37 Troubleshooting of H&E staining, Part A
Fig. 38 Troubleshooting of H&E staining, Part B
Fig. 39 The U.S. tissue diagnostics market estimates and forecast for H&E staining, 2017-2028 (USD Million)
Fig. 40 The U.S. tissue diagnostics market estimates and forecast for special staining, 2017-2028 (USD Million)
Fig. 41 The U.S. tissue diagnostics market estimates and forecast for digital pathology and workflow, 2017-2028 (USD Million)
Fig. 42 The U.S. tissue diagnostics market estimates and forecast for whole slide imaging, 2017-2028 (USD Million)
Fig. 43 The U.S. tissue diagnostics market estimates and forecast for image analysis informatics, 2017-2028 (USD Million)
Fig. 44 The U.S. tissue diagnostics market estimates and forecast for information management system storage & communication, 2017-2028 (USD Million)
Fig. 45 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology, 2017-2028 (USD Million)
Fig. 46 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology instruments, 2017-2028 (USD Million)
Fig. 47 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology microtomes & cryostat microtomes, 2017-2028 (USD Million)
Fig. 48 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology tissue processors, 2017-2028 (USD Million)
Fig. 49 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology automatic strainers, 2017-2028 (USD Million)
Fig. 50 U.S. tissue diagnostics market estimates and forecast for anatomic pathology other products, 2017-2028 (USD Million)
Fig. 51 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology consumables, 2017-2028 (USD Million)
Fig. 52 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology reagents & antibodies, 2017-2028 (USD Million)
Fig. 53 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology probes & kits, 2017-2028 (USD Million)
Fig. 54 The U.S. tissue diagnostics market estimates and forecast for anatomic pathology others, 2017-2028 (USD Million)
Fig. 55 The U.S. tissue diagnostics market: Application definitions & scope
Fig. 56 The U.S. tissue diagnostics market: Application analysis
Fig. 57 Breast cancer statistics, U.S., 2020
Fig. 58 The U.S. tissue diagnostics market estimates and forecast for breast cancer, 2017-2028 (USD Million)
Fig. 59 Liquid biopsy vs tissue biopsy: NSCLC diagnostics
Fig. 60 The U.S. tissue diagnostics market estimates and forecast for non small cell lung cancer (NSCLC), 2017-2028 (USD Million)
Fig. 61 The U.S. tissue diagnostics market estimates and forecast for prostate cancer, 2017-2028 (USD Million)
Fig. 62 The U.S. tissue diagnostics market estimates and forecast for gastric cancer, 2017-2028 (USD Million)
Fig. 63 The U.S. tissue diagnostics market estimates and forecast for other cancers, 2017-2028 (USD Million)
Fig. 64 Strategy framework
Fig. 65 Market participation categorization

Companies Profiled

  • 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 Pages157
PublishedJune 2021
Forecast Period2020 - 2028
Estimated Market Value ( USD ) in 2020 $ 2.07 Billion
Forecasted Market Value ( USD ) by 2028 $ 2.81 Billion
Compound Annual Growth Rate3.9%
Regions CoveredUnited States
No. of Companies Mentioned20

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