The tissue diagnostics market is projected to grow at a CAGR of 7.16% to reach US$6.385 billion by 2025 from US$4.216 billion in 2019. Cancer is a major public health and economic issue and its burden is set to spiral. With over 18 million cases in 2018, 29 million cases by 2040 are expected due to the aging and growth of the population [Source: WHO]. Recognized as one of the global standards for cancer diagnosis, tissue diagnostics are integral to obtain the biological aspects of tumors. Moreover, with an increased incidence of cancer, the market for tissue diagnostics markets has witnessed a promising growth and is further estimated to grow during the forecast period. Moreover, there is a growing adoption rate pertaining to the automated tissue-based diagnostic systems due to its reported capabilities of swift diagnosis of tumors, by research institutions. For example. F. Hoffmann-La Roche Ltd partnered with West Clinic Cancer Center in 2019 with the objective to enhance patient care by employing Roche’s BenchMark ULTRA Automated Advanced Staining System that is used for immunohistochemical testing or in-situ hybridization enabling a faster diagnosis of tumors. Moreover, the revenue generation in the market is being propelled by the increasing focus of prime market players to develop advanced tissue-diagnostic based companion diagnostic tests. To this end, PD-L1 IHC 22C3 pharmDx assay, which is a qualitative immunohistochemical assay to identify non-small cell lung cancer, that was designed by Agilent in partnership with Merck received the FDA approval. Moreover, the anatomic pathology workflow is consistently evolving and are gradually being automated to a great extent. This transition from manual to automation is giving rise to novel solutions. Further, the rise in the standardization of processes in laboratories concomitantly the incorporation of automated molecular diagnostic technologies and incorporation of bioinformatics have led to a paradigm shift in pathology workflow and has enabled clinicians to prioritize critical cases, reduce the turnaround time and enhance patient outcomes. To this extent, in 2019, Alverno Laboratories in partnership with Royal Phillips integrated Philips' IntelliSite Pathology Solution in the clinical laboratories intending to improve laboratory efficiency, quality, and patient safety which exemplifies the benefits of adoption of digital pathology solution thereby contributing to the surge in the segment. In view of the above it is expected that during the forecast period, the technology segment of digital pathology will witness a meteoric growth. This is also in part due to the growing preference rate of whole-slide imaging (WSI) among the pathologies, which is one of the prime factors responsible for the growth of this subsegment. The rationale behind such a preference is that specific features of tumors can now be extracted by WSI thereafter enabling the quantification of each component of the features and support diagnosis of cancer simultaneously provide a clinical diagnosis of tumors. For example, Nikon Instruments Inc. launched a digital slide scanning system, OS-15-N, in partnership with OptraSCAN. In 2019. Again, during the same year, IntelliSite Pathology Solution by Philips was introduced across India by the HealthCare Global Enterprises Ltd.
In view of the application, the segment of Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide followed by breast cancer. Regarding both sexes combined, globally, lung cancer continues to be the most commonly diagnosed cancer (2.1 million, 12% of the total)?and the leading cause of cancer death (1.8 million, 18%) because of its poor prognosis. Female breast cancer is the second most common cancer overall (2.1 million, 12%) but the fifth leading cause of cancer death (627,000, 7%) because of its relatively favorable prognosis. As such, it is the most prevalent cancer worldwide (6.9 million women living within 5 years of their breast cancer diagnosis. About one in twenty females will be diagnosed with breast cancer throughout their lifetime, although this number varies significantly by country.2 Incidence rates are elevated in Australia/New Zealand, Europe, and North America, notably in Belgium (113 cases per 100,000 female population) and Luxembourg (109) in Europe, and Australia (94). In contrast, incidence rates in sub-Saharan African regions, particularly in Eastern (30 cases per 100,000 female population) and Middle Africa (28), as well as South-Central Asia (26), were considerably lower. Further, the lifetime risk of breast cancer among females in high-income countries can be up to three times that in low-income countries [ Source: WHO]. To this end, in 2020 Exact Sciences Corp. (NASDAQ: EXAS) announced that it would be presenting data to demonstrate the clinical value of the Oncotype DX Breast Recurrence Score® test and exemplify the research progress made by Exact Sciences' Mayo Clinic collaboration toward smarter solutions across the cancer continuum. Further, during the same year, OncBioMune Pharmaceuticals, Inc. (OTC PINK: OBMP) announced the successful completion of its purchase of all the assets of Avant Diagnostics, Inc. which provides personalized medicine data through its Theralink®assays, initially for breast cancer, to assist the treating physician in a data-driven process for treatment decision support and to help enable predictive biomarker-based patient therapy selection. Besides development pertaining to breast cancers, during the same year, Veracyte, Inc. (Nasdaq: VCYT) which is a global genomic diagnostics company, announced that De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter ® Dx LymphMark ™ Assay, a novel, genomic lymphoma subtyping test.