The global tissue diagnostics market size was valued at USD 4.2 billion in 2019 and is expected to register a CAGR of 5.9% over the analysis period. Tissue diagnostics continues to serve as one of the gold standards for cancer diagnosis as these technologies capture the biological context of tumors. With an increasing incidence of cancer, the market for tissue diagnostics has witnessed high demand with lucrative growth opportunities in the near future.
A rise in the adoption rate of automated tissue-based diagnostic systems by the research institutes enables them to perform a faster diagnosis of tumors. For instance, in September 2019, West Clinic Cancer Center partnered with F. Hoffmann-La Roche Ltd. to improve patient care by using Roche’s BenchMark ULTRA Automated Advanced Staining System. This system is used for in situ hybridization or immunohistochemical testing to enable faster diagnosis of tumors.
A rise in the focus of key players to develop advanced tissue-diagnostic based companion diagnostic tests drives revenue generation in the market for tissue diagnostics. For instance, in April 2019, Agilent received the FDA approval for its PD-L1 IHC 22C3 pharmDx assay designed to identify non-small cell lung cancer. It is a qualitative immunohistochemical assay designed in partnership with Merck.
Anatomic pathology workflow continues to evolve from highly manual procedures to automated workflows, consequently driving the demand for novel solutions. Process standardization in pathology laboratories, incorporation of bioinformatics, and automated molecular diagnostic technologies have effectively addressed the issues pertaining to the lack of pathologists.
The paradigm shift from conventional pathology to digital pathology has allowed the clinicians to prioritize critical cases, reduce the turnaround time of tests, and enhance patient outcomes. For instance, in May 2019, Alverno Laboratories in partnership with Royal Phillips implemented Philips' IntelliSite Pathology Solution in its clinical laboratories to enhance laboratory efficiency, quality, and patient safety. This, in turn, surges the adoption rate of digital pathology solutions.
Immunohistochemistry (IHC) is widely applied in clinical research and development of cancer diagnostics and therapeutics, resulting in the largest revenue share in 2019. IHC is largely preferred over conventional enzyme staining techniques as it specifically provides variations between different types of tumors. Whereas, the conventional methods detect only a restricted number of tissue structures, enzymes, and proteins of tumors.
Digital pathology is estimated to witness the fastest growth rate during the forecast period. An increase in the adoption rate of whole-slide imaging (WSI) among the pathologists, serves as one of the key factors driving the segment growth. WSI extracts specific features of tumors and quantifies each component of these features to further support the cancer diagnosis and provide informative clinical measures for tumors.
Key vendors also play a major role in broadening the usage of digital technology by offering new and improved products. For instance, in March 2019, Nikon Instruments Inc. launched a digital slide scanning system, OS-15-N, in partnership with OptraSCAN. Similarly, in April 2019, the HealthCare Global Enterprises Ltd. introduced FDA approved Philips’ IntelliSite Pathology Solution across India. It is a digital pathology solution for in-vitro diagnostics.
The breast cancer segment accounted for the largest share in terms of revenue in 2019 owing to high incidence rates of breast cancer globally, caused due to increase in inheritance and family history. Besides, several research initiatives coupled with the support of the government and private centers, further drive the development of effective products for the diagnosis of breast cancer. This, in turn, is surging the tissue diagnostics market for this application.
For instance, a research study published in March 2019 validated the CanAssist-Breast test. It is a prognostic immunohistochemistry test to predict recurrence risk in the early stages of hormone-receptor-positive breast carcinoma. This research was supported by Rajiv Gandhi Cancer Institute and Research Centre, Tata Memorial Centre, and Sapien Biosciences Pvt. Ltd. in India.
Remarkable progress in prostate cancer biomarker discovery due to advancements in genomic technologies has driven segment growth at a lucrative pace. The biomarker discovery has assisted the development of tissue diagnostic assays, thus providing opportunities for segment growth. Several diagnostic solutions for prostate cancer diagnosis are also available, such as immunohistochemistry (IHC) assays provided by Roche and NeoGenomics Laboratories.
Hospitals dominated the end-use segment in 2019, in terms of revenue generation, due to the high consumption and utility rates of tissue diagnostic solutions by hospitals. The physicians are increasingly switching to tissue-based diagnostic testing techniques from conventional testing procedures. This is because tissue diagnostic tests reduce timelines when compared to conventional methods.
Hospitals are also undergoing agreement models for better disease diagnostics, thus propelling segment growth. For instance, in August 2019, the Taipei Veterans General Hospital (Taiwan) signed an agreement with Philips to install the IntelliSite Pathology Solution of the company in the hospital. This agreement transformed pathology tissue inspection to digital diagnostics in the hospital.
Contract research organizations (CROs) are anticipated to witness lucrative growth. CROs provide research support, clinical trial services, manage trials, and functions of companies and healthcare providers, which face budget constraints. A rise in the number of clinical trials and extensive research studies in the field of cancer therapy has significantly driven the demand for services provided by CROs. This has accelerated the revenue generation for this segment.
The high incidence rate of cancer is one of the major factors attributive to the largest revenue share of North America. The presence of several public programs aims to minimize cancer incidence and raise the demand for cancer diagnosis supplements in the regional market for tissue diagnostics. The Cancer Prevention and Control Research Network is a flagship program by the Centers for Disease Control and Prevention that focuses on cancer prevention in this region.
Personalized medicine greatly relies on the use of human tissue for the development of innovative tests. An increase in the adoption of sequencing technologies and healthcare IT systems in the clinical workflow has significantly expanded personalized medicine, which further drives the usage of tissue diagnostics. The Precision Medicine Initiative in U.S. further expands the personalized medicine industry.
Asia Pacific is estimated to witness a lucrative growth rate in near future due to an increase in access to several tissue diagnostic assays provided by international companies. For instance, in April 2019, HalioDx SAS signed an agreement with Genecast for the commercialization of HalioDx’s Immunoscore diagnostic assay in China. This initiative increased the availability of this product for colon cancer patients in China.
The key participants operating in the market for tissue diagnostics include F. Hoffmann-La Roche Ltd.; Abbott Laboratories; Thermo Fisher Scientific Inc.; Siemens; Danaher;bioMérieux SA; QIAGEN; Becton, Dickinson and Company; Merck KGaA; GE Healthcare; BioGenex; Cell Signaling Technology, Inc.; Bio SB; DiaGenic ASA; and Agilent Technologies.
The market for tissue diagnostics is considered to be fragmented due to the presence of several small, medium, and large participants in the marketspace. The advent of novel diagnostic models by key players to enhance their product portfolio has raised the competitiveness in the market for tissue diagnostics.
For instance, in January 2019, Roche launched its novel uPath enterprise software for digital pathology for personalized pathology workflows. The uPath software reduces the image rendering times, provides automated image analysis, and enhances the workflow for sharing cases among the pathologists.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million & CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, MEA
U.S., Canada, Germany, France, Spain, China, Japan, India, Brazil, Mexico, and South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global tissue diagnostics market report on the basis of technology and product, application, end use, and region:
Technology and Product Outlook (Revenue, USD Million, 2016 - 2027)
Slide Staining Systems
Tissue Processing Systems
In Situ Hybridization
Primary and Special Staining
Digital Pathology and Workflow
Whole Slide Imaging
Image Analysis Informatics
Information Management System Storage & Communication
Microtomes & Cryostat Microtomes
Reagents & Antibodies
Probes & Kits
Application Outlook (Revenue, USD Million, 2016 - 2027)
Non-small Cell Lung Cancer
End-Use Outlook (Revenue, USD Million, 2016 - 2027)
Contract Research Organizations (CROs)
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East and Africa (MEA)
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The most common concern for the governments of all Covid-19 hit nations is the excruciating need to screen for and test large numbers of patients for possible Sars-Cov-2 infection. As a result, most of them are facing major shortages in the supply for diagnostic kits to test for the virus. Diagnostics virology entities are under immense pressure to provide reliable testing kits, and there is a surge in demand for in-vitro or point-of-care testing capacities by labs across a large number of countries. The report will account for Covid19 as a key market contributor.