U.S. Tissue Diagnostics Market Size, Industry Report, 2033
The U.S. tissue diagnostics market size was valued at USD 2.46 billion in 2023 and is projected to surpass around USD 3.61 billion by 2033, registering a CAGR of 3.92% over the forecast period of 2024 to 2033.
The U.S. tissue diagnostics market presents a dynamic landscape characterized by technological advancements, increasing demand for accurate disease diagnosis, and a growing aging population. Tissue diagnostics involves the analysis of tissue samples to diagnose diseases, particularly cancer. In recent years, innovations such as digital pathology and molecular diagnostics have transformed the field, enabling more precise and efficient diagnosis. With the prevalence of chronic diseases on the rise, there is a growing need for early detection and personalized treatment strategies, further fueling the demand for tissue diagnostics. Additionally, heightened awareness among patients about the importance of early diagnosis, coupled with rising healthcare expenditure, contributes to market growth. Collaborations between research institutions, healthcare providers, and diagnostic companies drive innovation, leading to the development of advanced tissue diagnostic solutions. Government initiatives aimed at improving healthcare infrastructure and accessibility also play a pivotal role in shaping the market landscape. Overall, the U.S. tissue diagnostics market continues to evolve, promising continued progress in disease diagnosis and patient care.
| Report Attribute | Details |
| Market Size in 2024 | USD 2.55 Billion |
| Market Size by 2033 | USD 3.61 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 3.92% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| 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 growth of the U.S. tissue diagnostics market is propelled by several key factors. Firstly, advancements in technology, such as digital pathology and molecular diagnostics, have revolutionized tissue analysis, enabling more accurate and efficient diagnosis of diseases like cancer. Secondly, an aging population leads to an increased prevalence of chronic diseases, driving the demand for tissue diagnostics for early detection and personalized treatment. Additionally, rising healthcare expenditure and awareness among patients about the benefits of early diagnosis further contribute to market growth. Moreover, collaborations between research institutions, healthcare providers, and diagnostic companies foster innovation and the development of novel tissue diagnostic solutions. Lastly, favorable government initiatives and policies aimed at improving healthcare infrastructure and access to diagnostic services also stimulate market expansion. These factors collectively drive the growth of the U.S. tissue diagnostics market, promising continued advancement in disease diagnosis and patient care.
The Immunohistochemistry (IHC) segment dominated the market in 2023 accounting for a revenue share of 35.02%. 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.
The breast cancer application segment accounted for the highest revenue share of over 55% in 2023. 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 4.03% from 2024 to 2033. 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.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Tissue Diagnostics market.
By Technology & Product
By Application
Cross-segment Market Size and Analysis for Mentioned Segments
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Additional Countries (Apart
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Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers