U.S. Tissue Diagnostics Market Size to Hit Around USD 5.71 Bn By 2032
The U.S. tissue diagnostics market size was exhibited at USD 3.89 billion in 2022 and is projected to hit around USD 5.71 billion by 2032, growing at a CAGR of 3.92% during the forecast period 2023 to 2032.
Key Takeaways:
U.S. Tissue Diagnostics Market Report Scope
| Report Attribute | Details |
| Market Size in 2023 | USD 4.04 Billion |
| Market Size by 2032 | USD 5.71 Billion |
| Growth Rate From 2023 to 2032 | CAGR of 3.92% |
| Base Year | 2022 |
| Forecast Period | 2023 to 2032 |
| Segments Covered | Technology & Product, Application |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key 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 |
The market is collectively driven by emerging solutions pertaining to digital tissue diagnostics, advancements in imaging techniques & increasing affordability of diagnostics, and growth of personalized therapeutics & diagnostics. The use of digital slides has significantly increased in recent years, owing to its associated benefits including flexible magnification and remote access to slides. The growing emphasis on precision medicine is supported by several organizations & companies in the U.S., which is expected to contribute to the market growth. Moreover, the development in genome sequencing techniques and diagnostic tools can be attributed to the growth of personalized medicine over the years.
Companies are supporting the development of precision medicine with novel oncology solutions. For instance, in May 2020, QIAGEN launched new oncology solutions, such as the QCI Interpret One software solution for genomic profiling of tumors. The advancements in imaging techniques are expected to positively influence the market growth. According to Breastcancer.org, breast cancer is the most common type of cancer diagnosed among American women. In 2021, it is estimated that around 30% of the new cases of cancer in women would be breast cancers.
However, significant efforts are being made to curb the spread of the disease, which has emphasized the importance of innovation in the field of pathology. In addition, researchers are focusing on studying the morphological bases of the COVID-19 disease, which is expected to boost the market growth. For instance, in December 2020, researchers reported the occurrence of histological changes in frontal lobes and olfactory bulbs of the brain, which may be owing to COVID-19 related anosmia.
With technological improvements in imaging techniques, the sensitivity of detection and diagnosis of breast cancer has also improved. Technological expansion in breast tissue analysis includes procedures for evaluating gene expression, cellular biochemistry, and molecular biology using digital methods, tomosynthesis, CAD, and other methods. The global COVID-19 pandemic has affected several aspects in pathology laboratories, such as specimen workflow, biosafety protocols, laboratory staffing, laboratory finances, and resident training.
The specimens for histology were collected and processed by standard procedures involving embedding in paraffin, and later staining with hematoxylin and eosin. However, the presence of a non-value-based reimbursement policy and high costs associated with the usage of tissue diagnosis is anticipated to act as a restraint for the market. Several factors are contributing to the high cost of clinical research in the U.S. including administrative staff costs, clinical procedure costs, and site monitoring costs.
Technology & Product Insights
The Immunohistochemistry (IHC) segment dominated the market in 2022 accounting for a revenue share of 33.02%. The IHC technology is widely used for clinical research & development of cancer diagnostics and therapeutics; which is attributed to the high share of the segment. IHC is one of the most important tools/technologies used for examining tissues/specimens for early diagnosis of disease, prognosis, and prediction of therapy response in cancer patients.
It is widely preferred over traditional special enzyme staining methods as the conventional methods only identify a limited number of enzymes, tissue structures, and proteins. Whereas IHC tests are specific and helpful in highlighting the distinction between different types of cancer. It is considered the most profitable sub-segment under tissue diagnostics. Slide staining systems have been the key contributors to the revenue generated by the IHC segment.
A major trend is the adoption of automated systems for staining IHC samples. The use of automated staining systems avoids any errors that may occur during manual work. For instance, the MY-2300 Immuno-Histo Stainer developed by IHC World, LLC functions automatically and has stable, accurate, and reliable performance. As the system is easily operated, it enhances working efficiency and helps in handling multiple specimens simultaneously.
On the contrary, digital pathology and workflow are set to grow at a rapid pace during the forecast period due to the increasing adoption of digital pathology technologies in big as well as small laboratories. Digital software that is being developed by leading market participants is primarily used with scanners offered by the same company. The development of software that can be used with scanners from different companies is expected to propel the adoption of digital pathology technology in small-scale labs.
Application Insights
The breast cancer application segment accounted for the highest revenue share of over 53% in 2022. Tissue diagnostics are crucial in evaluating breast cancer in patients. The most commonly used tissue biopsy tests for breast cancer include fine-needle aspiration biopsy, core needle biopsy, and surgical biopsy. Companies have developed companion diagnostics to prevent the poor prognosis of breast cancer variants that have limited treatment options. For instance, in November 2020, the U.S. FDA approved Agilent Technologies, Inc.’s PD-L1 IHC 22C3 pharmDx that helps in the identification of triple-negative breast cancer in patients, which can be treated with KEYTRUDA (pembrolizumab).
Whereas tissue diagnostics is set to gain immense traction across gastric cancer and Non-Small Cell Lung Cancer (NSCLC) applications. The gastric cancer application segment is expected to grow at a CAGR of 4.05% from 2023 to 2032. Innovations in the detection of cancers in samples/specimens are expected to drive the segment growth. Biopsy techniques have gained immense traction in the diagnosis of stomach ulcers. Researchers & companies are focusing on developing companion diagnostic tests for the identification of gastric cancer.
For instance, in April 2020, VENTANA HER2 Dual ISH DNA Probe Cocktail assay was introduced by Roche, which helps detect the HER2 biomarker in gastric cancer and breast cancer. Hence, despite decreasing incidence & mortality rate due to gastric cancer, researchers & companies are engaging in identifying biomarkers for efficient diagnosis. In current clinical practices, tissue diagnostics is the gold standard for diagnosing NSCLC.
Negative results in liquid biopsy tests do not necessarily rule out the presence of an oncogenic alteration; hence, it is essential to carry out tissue-based analysis for further confirmation. In addition, companies operating in the market are engaged in developing specific tests and tools for the detection of NSCLC, which is expected to drive the market. For instance, in January 2020, QIAGEN N.V. and Amgen developed a tissue-based thera screen test for the identification of NSCLC patients with KRAS G12C mutation.
Key Companies & Market Share Insights
Industry participants are focusing on novel product development collaborations with other participants to sustain market competition and gain a competitive edge. For instance, in January 2021, F. Hoffmann-La Roche Ltd. launched the CE-IVD digital automated algorithms for pathology, uPath HER2 Dual ISH image analysis and uPath HER2 (4B5) image analysis for diagnosis of breast cancer. These algorithms facilitate the quick determination of whether the tumors are positive for HER2 biomarkers.
In August 2020, Thermo Fisher Scientific, Inc. signed an agreement with (HTI) Hengrui Therapeutics, Inc., a U.S. subsidiary of a Chinese pharmaceutical company, for developing a Companion Diagnostic (CDx) for identifying NSCLC by using Oncomine Precision Assay. The assay helps in the detection of around 50 cancer-related biomarkers from FFPE tumor tissues or liquid biopsy specimens. Some key participants operating in the U.S. tissue diagnostics market include:
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Tissue Diagnostics market.
By Technology & Product
By Application
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
1.7.1 Objective 1:
1.7.2 Objective 2:
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
3.1.1 Parent market outlook
3.1.2 Related/ancillary market outlook
3.2 Market Trends & Outlook
3.3 Market Dynamics
3.3.1 Market Drivers Analysis
3.3.1.1 Emerging solutions pertaining to digital tissue diagnostics
3.3.1.2 Advancements in imaging techniques and increasing affordability of diagnostics
3.3.1.3 Growth of personalized therapeutics and diagnostics
3.3.2 Market restraint Analysis
3.3.2.1 Presence of non-value based reimbursement policy and high costs associated with usage of tissue diagnosis
3.4 COVID-19 Impact Analysis
3.5 Penetration & Growth Prospect Mapping for Applications, 2023
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
4.2.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry, 2020 - 2032
4.2.2 Instruments
4.2.2.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry instruments, 2020 - 2032
4.2.2.2 Slide Staining Systems
4.2.2.2.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry slide staining systems, 2020 - 2032
4.2.2.3 Tissue Microarrays
4.2.2.3.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry tissue microarrays, 2020 - 2032
4.2.2.4 Tissue Processing Systems
4.2.2.4.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry tissue processing systems, 2020 - 2032
4.2.2.5 Slide Scanners
4.2.2.5.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry slide scanners, 2020 - 2032
4.2.2.6 Other Products
4.2.2.6.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry other products, 2020 - 2032
4.2.3 Consumables
4.2.3.1 U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry consumables, 2020 - 2032
4.2.3.2 Reagents
4.2.3.2.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry reagents, 2020 - 2032
4.2.3.3 Antibodies
4.2.3.3.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry antibodies, 2020 - 2032
4.2.3.4 Kits
4.2.3.4.1 The U.S. tissue diagnostics market estimates and forecast for Immunohistochemistry kits, 2020 - 2032
4.3 In situ Hybridization
4.3.1 The U.S. tissue diagnostics market estimates and forecast for In Situ Hybridization (ISH), 2020 - 2032
4.3.2 Instruments
4.3.2.1 The U.S. tissue diagnostics market estimates and forecast for ISH instruments, 2020 - 2032
4.3.3 Consumables
4.3.3.1 The U.S. tissue diagnostics market estimates and forecast for ISH consumables, 2020 - 2032
4.3.4 Software
4.3.4.1 The U.S. tissue diagnostics market estimates and forecast for ISH software, 2020 - 2032
4.4 Primary & Special Staining
4.4.1 The U.S. tissue diagnostics market estimates and forecast for Primary & special staining, 2020 - 2032
4.4.2 H&E Staining
4.4.2.1 The U.S. tissue diagnostics market estimates and forecast for H&E Staining, 2020 - 2032
4.4.3 Special Staining
4.4.3.1 The U.S. tissue diagnostics market estimates and forecast for SPECIAL Staining, 2020 - 2032
4.5 Digital Pathology and Workflow
4.5.1 The U.S. tissue diagnostics market estimates and forecast for Digital pathology and workflow, 2020 - 2032
4.5.2 Whole Slide Imaging
4.5.2.1 The U.S. tissue diagnostics market estimates and forecast for whole slide imaging, 2020 - 2032
4.5.3 Image Analysis Informatics
4.5.3.1 The U.S. tissue diagnostics market estimates and forecast for image analysis informatics, 2020 - 2032
4.5.4 Information Management System Storage & Communication
4.5.4.1 U.S. tissue diagnostics market estimates and forecast for information management system storage & communication, 2020 - 2032
4.6 Anatomic Pathology
4.6.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology, 2020 - 2032
4.6.2 Instruments
4.6.2.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology instruments, 2020 - 2032
4.6.2.2 Microtomes &Cryostat Microtomes
4.6.2.2.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology microtomes & cryostat microtomes, 2020 - 2032
4.6.2.3 Tissue Processors
4.6.2.3.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology tissue processors, 2020 - 2032
4.6.2.4 Automatic Strainers
4.6.2.4.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology automatic strainers, 2020 - 2032
4.6.2.5 Other Products
4.6.2.5.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology other products, 2020 - 2032
4.6.3 Consumables
4.6.3.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology consumables, 2020 - 2032
4.6.3.2 Reagents &Antibodies
4.6.3.2.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology reagents & antibodies, 2020 - 2032
4.6.3.3 Probes &Kits
4.6.3.3.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology probes & kits, 2020 - 2032
4.6.3.4 Others
4.6.3.4.1 The U.S. tissue diagnostics market estimates and forecast for Anatomic pathology others, 2020 - 2032
Chapter 5 U.S. Tissue Diagnostics Market: Application Business Analysis
5.1 U.S. Tissue Diagnostics Market: Application Analysis
5.2 Breast Cancer
5.2.1 The U.S. Tissue Diagnostics Market estimates and forecast for Breast Cancer, 2020 - 2032
5.3 Non-Small Cell Lung Cancer (NSCLC)
5.3.1 The U.S. Tissue Diagnostics Market estimates and forecast for Non-Small Cell Lung Cancer (NSCLC), 2020 - 2032
5.4 Prostate Cancer
5.4.1 The U.S. Tissue Diagnostics Market estimates and forecast for prostate cancer, 2020 - 2032
5.5 Gastric Cancer
5.5.1 The U.S. Tissue Diagnostics Market estimates and forecast for Gastric Cancer, 2020 - 2032
5.6 Other Cancers
5.6.1 The U.S. Tissue Diagnostics Market estimates and forecast for Other Cancers, 2020 - 2032
Chapter 6 Company Profile
6.1 Strategy Framework
6.2 Market Participation Categorization
6.3 Company Profiles
6.3.1 Merck KGaA
6.3.1.2 Company overview
6.3.1.2.1 Bio Reliance
6.3.1.2.2 Sigma-Aldrich Co. LLC
6.3.1.3 Financial Performance
6.3.1.4 Product benchmarking
6.3.1.5 Strategic initiatives
6.3.2 Thermo Fisher Scientific, Inc.
6.3.2.1 Company overview
6.3.2.1.1 Life Technologies Corporation
6.3.2.1.2 Affymetrix, Inc.
6.3.2.2 Financial Performance
6.3.2.3 Product benchmarking
6.3.2.4 Strategic initiatives
6.3.3 F. Hoffmann-La Roche Ltd
6.3.3.1 Company overview
6.3.3.2 Financial Performance
6.3.3.3 Product benchmarking
6.3.3.4 Strategic initiatives
6.3.4 Abbott Laboratories
6.3.4.1 Company overview
6.3.4.1.1 Alere
6.3.4.2 Financial Performance
6.3.4.3 Product benchmarking
6.3.4.4 Strategic initiatives
6.3.4.4.1 Strategic initiatives (Alere)
6.3.5 Siemens Healthineers AG
6.3.5.1 Company overview
6.3.5.2 Financial Performance
6.3.5.3 Product benchmarking
6.3.5.4 Strategic initiatives
6.3.6 Danaher
6.3.6.1 Company overview
6.3.6.1.1 Beckman Coulter, Inc.
6.3.6.2 Financial Performance
6.3.6.3 Product benchmarking
6.3.6.4 Strategic initiatives
6.3.7 bioMérieux SA
6.3.7.1 Company overview
6.3.7.2 Financial Performance
6.3.7.3 Product benchmarking
6.3.7.4 Strategic initiatives
6.3.8 QIAGEN
6.3.8.1 Company overview
6.3.8.2 Financial Performance
6.3.8.3 Product benchmarking
6.3.8.4 Strategic initiatives
6.3.9 Becton, Dickinson & Company (BD)
6.3.9.1 Company overview
6.3.9.2 Financial Performance
6.3.9.3 Product benchmarking
6.3.9.4 Strategic initiatives
6.3.10 Agilent Technologies, Inc.
6.3.10.1 Company overview
6.3.10.2 Financial Performance
6.3.10.3 Product benchmarking
6.3.10.4 Strategic initiatives
6.3.11 General Electric Company (GE Healthcare)
6.3.11.1 Company overview
6.3.11.1.1 Cytiva
6.3.11.2 Financial Performance
6.3.11.3 Product benchmarking
6.3.11.4 Strategic initiatives
6.3.12 BioGenex
6.3.12.1 Company overview
6.3.12.2 Financial Performance
6.3.12.3 Product benchmarking
6.3.12.4 Strategic initiatives
6.3.13 Cell Signaling Technology, Inc.
6.3.13.1 Company overview
6.3.13.2 Financial Performance
6.3.13.3 Product benchmarking
6.3.13.4 Strategic initiatives
6.3.14 Bio SB
6.3.14.1 Company overview
6.3.14.2 Financial Performance
6.3.14.3 Product benchmarking
6.3.14.4 Strategic initiatives
6.3.15 DiaGenic ASA
6.3.15.1 Company overview
6.3.15.2 Product benchmarking
6.3.16 Sakura Finetek Japan CO., LTD.
6.3.16.1 Company overview
6.3.16.2 Financial Performance
6.3.16.3 Product benchmarking
6.3.16.4 Strategic initiatives
6.3.17 Abcam plc
6.3.17.1 Company overview
6.3.17.2 Financial Performance
6.3.17.3 Product benchmarking
6.3.17.4 Strategic initiatives
6.3.18 Enzo Life Sciences, Inc.
6.3.18.1 Company overview
6.3.18.2 Financial Performance
6.3.18.3 Product benchmarking
6.3.18.4 Strategic initiatives
6.3.19 VITRO SA (Master Diagnóstica)
6.3.19.1 Company overview
6.3.19.2 Financial Performance
6.3.19.3 Product benchmarking
6.3.19.4 Strategic initiatives
6.3.20 TissueGnostics GmbH
6.3.20.1 Company overview
6.3.20.2 Financial Performance
6.3.20.3 Product benchmarking
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