The global tissue diagnostics market size was estimated at USD 3.9 billion in 2018 andis poised to exhibit a CAGR of 6.6% during the forecast period. Increase in worldwide volume of diagnostic tests conducted across hospitals and laboratories has boosted the market. Future growth prospects of tissue diagnostic products are highly dependent on the paradigm shift toward companion diagnostics.
As companion diagnostics development is attaining lucrative pace, the convergence of both the diagnostic and pharmaceutical industry has resulted in the incorporation of tissue diagnostic technologies in several drug development processes, resulting in greater revenue generation for this market. For example, in December 2016, Leica Biosystems signed an agreement with Bayer to develop companion diagnostic tests based on immunohistochemistry and RNA scope for cancer therapies.
Factors such as process standardization for anatomic pathology laboratory and improvement in laboratory workflows are driving industry growth. One of the significant innovations in the market is the inception of automated tissue diagnostics, which has enhanced assay performance and has effectively addressed issues associated with the lesser number of pathologists available for assistance.
In addition to this, investments in histology and cytology and changes pertaining to reimbursement structure are likely to impact the long-term viability of products and their usage. Improved reimbursement scenario would enable pathology equipment manufacturers to step up for development of novel solutions and overcome productivity challenges
However, increase in consolidation among laboratories and hospitals is expected to escalate the pressure on vendors and is anticipated to adversely affect the customer base in this market. This, in turn, would result in high market competition amongst vendors for fewer accounts.
Tissue diagnostic tests involve implementation of different technologies for disease identification and prediction. Over the years, numerous advanced technologies have been launched into the market for monitoring of cancer progression based on the principle of tissue-based diagnosis. These include evolution in staining reagents as well as advances in benchtop platforms.
Immunohistochemistry (IHC) is considered to be the most profitable segment under tissue diagnostics. IHC is preferred over traditional special enzyme staining methods owing to its specificity in providing a broad difference between different types of cancer unlike conventional methods, which only identify a limited number of enzymes, tissue structures, and proteins.
Currently, penetration of digital pathology is lower in small-scale laboratory settings as these are relatively slower in adopting digital pathology technologies as a consequence of factors such as affordability and availability of skilled personnel. However, with the approval of Philips’ system in 2017 and launch of software platforms like QuPath in 2016, adoption of digital pathology technologies is anticipated to increase lucratively in the coming years.
Tissue analysis provides crucial information that cannot be availed by virtue of conventional molecular assays. Hence, tissue diagnostic testing continues to serve as one of the gold standards for cancer diagnosis and is utilized in cancer prognosis.
Breast cancer accounted for the largest revenue share in the global tissue diagnostics market owing to highest incidence rate. Furthermore, presence of research initiatives carried out for breast cancer is supportive for the attributed share of the segment. Such efforts, coupled with governments pushing to develop effective products for breast cancer diagnosis, have helped build up enough genetic knowledge and momentum in the sector.
However, absence of commercialized diagnostic tests for non-small lung cancer detection other than those done with the help of a biopsy generates enormous untapped growth opportunities for new players in the market. Companies such as Roche and Exosome Diagnostics are developing protocols based on IHC as well as FISH for cancer detection caused by mutations in different genes.
The dominance of hospitals in the global market can be attributed to the high efficiency of hospitals to integrate novel technologies, coupled with a large volume of procedures carried out for disease diagnosis, monitoring, and treatment.
In several hospitals and clinics, physicians have been switching from conventional testing procedures to tissue diagnostic tests. Long turnover time associated with conventional processes is boosting the adoption rate of tissue diagnostic tests as these aid in reducing the timelines.
CROs are expected to witness the fastest growth owing to increasing pressure on pathology laboratories to cater to customer requirements within stipulated timelines. Furthermore, budget constraints faced by small to medium sized laboratories has generated potential avenues for CROs operating in the diagnostics sector.
North America accounted for the largest revenue share in the global market owing to presence of key participants in U.S. and higher customer accessibility to services in pathology laboratories and hospitals. The market is also driven by higher incidence rate of cancer in this region.
Asian countries are expected serve as a lucrative source of revenue during the forecast period and the region is expected to emerge as the second largest market, following North America, in the foreseeable future. This is due to the presence of several potential subjects in the region, along with improvements in spending power of customers.
The fragmented nature of the market can be attributed to presence of a substantial number of large and medium-to-small players in the space. Advent of other diagnostic modes such as liquid biopsy has compelled market participants to expand their product portfolio.
For example, in March 2017, Fimmic Oy (Fimmic) launched the WebMicroscope Platform, a cloud-based image analysis solution that embraces deep learning AI for analysis of digital pathology samples. The primary objective behind the introduction of novel products by companies is to reinforce their respective market presence.
Base year for estimation
Actual estimates/Historical data
2014 - 2017
2019 - 2025
Revenue in USD Million and CAGR from 2019 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, Germany, France, Spain, China, Japan, India, Brazil, Mexico, 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 latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global tissue diagnostics market report on the basis of technology, application, end use, and region:
Technology Outlook (Revenue, USD Million, 2014 - 2025)
Slide Staining Systems
Tissue Processing Systems
In Situ Hybridization
Primary & 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, 2014 - 2025)
Non-Small Cell Lung Cancer
End-use Outlook (Revenue, USD Million, 2014 - 2025)
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
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