Tissue Diagnostics Market Size, Share & Trends Analysis Report By Technology (IHC {Instruments [Slide Staining Systems, Tissue Microarrays, Tissue Processing Systems, Slide Scanners, Other products], Consumables [Reagents, Antibodies, Kits]}, In-Situ Hybridization {Instruments, Consumables, Software}, Primary and Special Staining, Digital Pathology and Workflow {Whole Slide Imaging, Image Analysis Informatics, Information Management System Storage and Communication}, Anatomic Pathology {Instruments [Microtomes and Cryostat microtomes, Tissue processors, Automatic strainers, Other products], Consumables [Reagents and Antibodies, Probes and Kits, Others]}), By Applications (Breast Cancer, Prostate Cancer, Gastric Cancer, Non-Small Cell Lung Cancer, Other Cancers), By End-User (Hospitals, Research Laboratories, Pharmaceutical Organizations , Contract Research Organizations (CROs)) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global tissue diagnostics market size was worth USD 5,185.23 million in 2022. It is estimated to reach an expected value of USD 9,375.02 million by 2031, growing at a CAGR of 6.8% over the forecast period (2023–2031). Factors such as advancements in imaging techniques and increasing affordability of diagnostic, significantly drives the tissue diagnostics market demand by 2031.

Tissue analysis provides important information which is deficient in understanding using molecular techniques. Pharmaceutical companies rapidly adopt companion diagnostic tests for securing first-line therapy designations for their formulations. Cohorts likely to benefit from targeted therapeutics have increased the significance of tissue diagnostics in developing precision medicine. Examining and analyzing tissue samples from the human body to identify diseases gauge their severity, and direct treatment choices are referred to as tissue diagnostics. It is a crucial part of clinical pathology and significantly impacts medicine.

The diagnosis of numerous conditions, such as cancer, inflammatory disorders, infectious diseases, and autoimmune conditions, depends heavily on tissue diagnostics. It aids in determining prognosis, forecasting therapeutic outcomes, and providing useful data to guide personalized treatment decisions.

Market Dynamics

Global tissue diagnostics market drivers

Increasing cancer prevalence and advancements in imaging techniques and increasing affordability of diagnostic

Cancer is considered one of the primary causes of death worldwide. As per NIH-National Cancer Institute, new cancer cases are expected to rise to 23.6 million by 2030. Furthermore, the number of deaths due to non-communicable diseases is also increasing. According to WHO, approximately 40 million people die from non-communicable diseases yearly, accounting for around 70% of all deaths worldwide. In order to prevent diseases such as cancer, early diagnosis is very important. Early detection of the disease in patients can offer well-planned treatment to patients as well as higher chances of their survival. Early cancer detection in patients involves clinical examinations, imaging, genetic testing, and other laboratory tests. These factors are expected to boost the tissue diagnostics market growth over the forecast period.

Advancements in imaging techniques and increasing affordability of diagnostic

Advancements in imaging techniques are expected to influence the tissue diagnostics market. Breast cancer is considered one of the most common types of cancer in women globally. With technological improvements in imaging techniques, the sensitivity of detection and diagnosis of breast cancer has also improved. In addition, techniques such as molecular imaging and autofluorescence-based diagnostics benefit cancer patients over conventional technologies. These techniques help reduce the need for biopsy, offering a non-invasive diagnosis. The decreasing cost of sequencing and technological advancements in companion diagnostics and biomarkers are expected to improve the growth of this market in the coming years.

Global tissue diagnostics market restraint

High costs associated with r&d and clinical trials

Developing diagnostics and therapeutics for cancer patients is risky for pharma and biotech companies as it involves a lot of investment in research and development. The costs incurred to obtain clinical validation and regulatory approval for a diagnostic test or a drug therapy must be borne by the companies looking forward to commercializing the product. Furthermore, failure in clinical trials or lack of evidence data for a new diagnostic test or drug therapy significantly increases the cost to the industry players. As a solution, the industry needs to focus on ways to reduce the high failure rates. This factor has a negative impact on the market. However, developing efficient regulatory frameworks and increasing public-private partnerships are expected to help counter this bottleneck.

Global tissue diagnostics market opportunities

Growth of personalized therapeutics and diagnostics

Personalized medicine is becoming the hallmark of cancer treatment, and its application and use are also expanding to other fields. It is a constantly emerging approach toward personalizing the treatments based on the individual genetic buildup of the patient. This field considers the development of diagnostic tests such as companion diagnostics, tissue diagnostics, biomarkers discovery, and targeted therapies, which are beneficial over conventional diagnostic and therapeutic technologies. Growing realization about the significance of personalized medicine has led to increased demand for using human tissue. The personalized medicine arena has greatly relied on human tissue to develop innovative tests for application in patient care.

According to the Personalized Medicine Coalition, the number of personalized medicines in the market over four years has increased significantly, reaching more than double between 2016-2020. The number of approved personalized medicines reached 286 in 2020, which accounted for 25% of the new drugs approved in 2019 by the FDA. Such a considerable increase in personalized medicine is anticipated to influence tissue diagnostics development directly.

Regional Analysis

Region-wise, the global tissue diagnostics market share is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North america dominates the global market

North America is the most significant global tissue diagnostics market shareholder and is estimated to exhibit a CAGR of 5.2% during the forecast period. The high prominence of cancer, growing demand for personalized medicine, well-developed healthcare facilities, and availability of novel diagnostics techniques can be attributed to the high market share held by North America. Growing morbidity and mortality due to cancer have increased the need to develop novel therapies, thereby driving growth in this region. Similarly, the growing implementation of digital pathology services with advanced imaging tools, increasing activities by various organizations, rising awareness about regular health screening, and favorable government reimbursement policies are other drivers of the North American market.

In addition, the region's approvals and commercialization of products have supplemented the market growth. For instance, in May 2021, Hologic Inc. received premarket approval (PMA) from the U.S. FDA for ThinPrep Genesis Processor. This instrument offers a combination of sample aliquoting and cytology processing with improved workflow. Revenue growth is anticipated to increase as a result of an increase in regulatory approvals.

Europe is estimated to exhibit a CAGR of 6.9% during the forecast period. Cancer is a problem that affects people's health all over the European Union. According to WHO, Europe has more than 1.92 million deaths and 3.71 million new cancer cases yearly. Hence there is a need for large-scale adoption of advanced diagnostic solutions. In addition, the European market is expected to grow due to the rise in the aging population and increased access to healthcare. For instance, in August 2021, Unilabs, a Swiss company, in collaboration with Ibex Medical Analytics, announced the launch of a new AI-powered digital pathology platform across 16 European countries. Such initiatives are expected to propel market growth.

Similarly, in September 2021, Roche announced the launch of digital pathology open environment. The new workflow allows researchers and physicians to share images for better analysis. The platform is compatible with whole slide imaging technology. Such companies are anticipated to accelerate the European market growth.

In Asia-Pacific, the major factors contributing to this growth are large untapped markets of emerging economies in the region. The market is majorly driven because of the rise in cancer incidence across the region. According to The Cancer Atlas, eastern, southern, and southeastern Asia contributes 44% of global cancer cases and 51% of cancer deaths. China dominates the cancer burden in the region, followed by India, Japan, Indonesia, and the Republic of Korea. The region's top three applications for cancer tissue diagnostics include breast, lung, and prostate cancer. However, Japan is technologically well-versed, and the penetration and adoption of benchtop analyzers are higher in Japan, attributing to a larger share of this market.

In addition, the large regional population and untapped potential in the region have resulted in the business shift of global firms. This region offers relatively inexpensive manufacturing and operating units for conducting research and diagnosis, driving market growth.

Segmental Analysis

The global tissue diagnostics market has been segmented into technology, application, and end-user.

Based on technology, the global tissue diagnostics market is segmented into Immunohistochemistry (IHC) technology, in-situ hybridization, special staining, and digital pathology and workflow. 

The Immunohistochemistry (IHC) segment dominates the global market and is estimated to exhibit a CAGR of 6.02% during the forecast period. IHC technology is widely used for clinical research and cancer diagnostics and therapeutics development. Immunohistochemistry is one of the most important tools/technologies used for examining tissues/specimens for early diagnosis of disease, prognosis, and therapy response prediction in cancer patients. It is a special staining process that uses enzymes or fluorescent dyes in biopsies performed on tissues or specimens obtained from cancer patients.

With the help of IHC technology, it becomes easier for the technician to identify if the cancer is benign or malignant along with the tumor stage. Immunohistochemistry is preferred over traditional special enzyme staining methods because the conventional methods only identify a limited number of enzymes, tissue structures, and proteins. At the same time, immunohistochemistry tests are specific and helpful in telling the difference between different types of cancer. IHC is considered the most profitable sub-segment under tissue diagnostics.

Based on application, the global tissue diagnostics market is divided into breast cancer, prostate cancer, gastric cancer, non-small cell lung cancer, and other cancer types. 

The breast cancer segment owns the highest market share and is predicted to exhibit a CAGR of 6.91% during the forecast period. The increasing incidence of breast cancer due to changes in lifestyle and the rapidly aging global population provide lucrative growth opportunities to the segment. Breast cancer is classified into three types, i.e., Hormone Receptor (HR), Human Epidermal Growth Factor Receptor (HER2), and Triple Negative Breast Cancer (TNBC). Technologies such as the MarginProbe system aid in identifying cancer cells in the margins of excised tissue that are removed during surgical intervention. In addition, the launch of novel products is expected to strengthen the existing market portfolio. The segment's progress is also aided by improvements in genomic testing tools to better understand a tumor's genetic makeup.

Prostate cancer is considered the fourth most common in both genders combined and the second most common in men. According to the American Cancer Society, about 248,531 new cases of prostate cancer and about 34,131 deaths from prostate cancer are estimated in the United States in 2021. There are multiple types of prostate cancer, such as acinar adenocarcinoma, ductal adenocarcinoma, and small-cell prostate cancer, to name a few.

In addition to physical examinations, the tests such as the PSA test and PCA3 test can be done to diagnose prostate cancer in patients. Metastatic prostate cancer and advanced prostate cancer type such as Metastatic Castration-Resistant Prostate Cancer (MCRPC) can spread to other body parts, like lymph nodes and bones of the patient's body. They would thrive in a low-testosterone environment. As a result, a lot of research is being done on early disease detection and prevention.

Based on end-user, the global market for tissue diagnostics has been further segmented into hospitals, research laboratories, pharmaceutical organizations, and contract research organizations (CROs).  

The hospital segment is the highest contributor to the market and is predicted to grow at a CAGR of 7.01% during the forecast period. Due to the higher consumption rates and utility of tissue diagnostic products, devices, accessories, and analytical services by healthcare professionals and hospital laboratories, hospitals are considered the most lucrative segment for tissue diagnostics and disease monitoring. The presence of laws about using tissue samples in hospitals boosts the revenue implementation of tissue diagnostic products in hospitals.

Recent Developments

• February 2023- Guardant Health and AnHeart Therapeutics announced a collaboration to Develop Guardant360® CDx and Guardant360 TissueNext™ as Companion Diagnostics for Taletrectinib in Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer. The collaboration is Guardant Health’s first to explore both tissue- and blood-based assays as companion diagnostics (CDx).
• January 2023- Thermo Fisher Scientific and AstraZeneca announced the collaboration on developing a new solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib). This collaboration is part of a global, multiyear agreement that the companies entered in September 2021.