Market Overview:

The market for Tissue Diagnostics was valued at approximately USD 5.55 Billion in 2023. Over the course of the forecast period (2024–2031), the market is expected to develop at a compound annual growth rate (CAGR) of 7.15%, reaching a value of USD 9.48 Billion by 2031.

Tissue diagnostics is still the gold standard for cancer diagnosis because it can record the anatomy of malignancies. The growing incidence of cancer means that there will be significant growth opportunities in the tissue diagnostics industry over the projected timeframe. Demand is very high on the market. The tissue diagnostics industry has suffered greatly as a result of COVID-19. During the pandemic, routine medical procedures, like diagnostic testing, were held down because healthcare resources were focused on managing the virus.

The demand for services and goods related to tissue diagnostics temporarily decreased as a result of the epidemic. But as things got better and healthcare systems adjusted to the new normal, the market started to bounce again. The market for tissue diagnostics in the post-pandemic era was driven by the continued high need for precise diagnosis and surveillance of a variety of disorders, including cancer.

Anatomic pathology is changing rapidly as a result of the sharp rise in cancer incidence. Consequently, this is fostering the ongoing expansion of the clinical pathology domain. Anatomical and also molecular pathology are constantly convergent, and liquid biopsies are being used more frequently to diagnose cancer. As computational pathology gets traction, integrated bioinformatics and analytics become more and more crucial. The availability of increasingly sophisticated equipment over the past 20 years has transformed the tissue diagnostics sector and made life easier for pathologists and medical professionals.

In addition to the global cancer burden increasing, new technologies and advancements in tissue diagnostics (TDx) will boost pathology efficiency—a need for more accurate cancer detection and treatment. For instance, in March 2023, Alverno Laboratories and Ibex Medical Analytics—the industry leader in AI-powered cancer diagnosis—announced a new partnership. The goal is to extend the use of Ibex's artificial intelligence suite, Galen, throughout the whole Alverno network in Indiana and Illinois. The implementation will enable Alverno pathologists to give their patients the best possible care by utilizing AI-powered solutions for cancer diagnosis across a variety of tissue types.

Tumor diagnoses can be made more quickly by research institutes due to an increase in the prevalence of automated tissue-based diagnostic tools. To enhance the classification of gliomas along with other malignancies in the nervous systems, MilliporeSigma stated in January 2023 that it would be broadening its range of antibodies for tissue diagnostics. Investments in R&D like this will guarantee market expansion.

Market Dynamics:

Market Drivers:

Rising Incidence of Cancer and Chronic Diseases

• The increasing prevalence of chronic illnesses and cancer worldwide is driving the tissue diagnostics industry. The millions of fresh infections of cancer are discovered worldwide each year, making it a major source of sickness and mortality. Furthermore, a rise in the prevalence of long-term diseases including obesity, immunological difficulties, and cardiac ailments is being attributed to older adults, a lack of exercise, and dietary changes. Tissue diagnostics offers important information regarding tissue morphology, cell structure, & biomarker expression, which is crucial for the prompt identification, diagnosis, and treatment of cancer and other disorders. In tissue diagnostics, methods including histology, immunohistochemistry, & molecular diagnostics are frequently employed to describe tissue samples, find disease indicators, and inform therapeutic choices. The demand for tissue diagnostic tests and technological advancements that enable early diagnosis, customized treatment planning, & therapeutic response monitoring is rising as healthcare systems strive to enhance patient outcomes and reduce the burden of disease. Growth & investment in the tissue diagnostics market are being driven by the rising incidence of chronic illnesses and cancer, as well as by improvements in tissue diagnostic methods and biomarker identification.

Advancements in Digital Pathology and Imaging Technologies

• The development of digital pathology & imaging technologies is driving the tissue diagnostics industry and changing the way tissue samples are handled, evaluated, and processed in research and clinical lab environments. Glass slides and also tissue samples are digitally scanned as part of digital pathology, which makes digital images accessible, storable, and analyzable via computer systems and image processing algorithms.  Furthermore, to automate repetitive tasks, support pathologists in diagnostic interpretation, and extract useful insights from massive datasets, digital pathology systems are incorporating emerging technologies like whole slide imaging (WSI), artificial intelligence (AI), and also machine learning (ML). The use of tissue diagnostic tests as well as services for research, diagnostics, and pharmaceutical development is growing as a result of these developments in digital pathology and also imaging technologies, which are being adopted by clinical laboratories, pathology practices, colleges and universities, and also biopharmaceutical companies. The market for tissue diagnostics is anticipated to grow and change in response to the changing requirements of researchers and healthcare providers as the need for digital pathology solutions—which is fueled by the need for efficiency, accuracy, & scalability in tissue diagnostics—continues to rise.

Market Trends:

Rapid Adoption of Digital Pathology Solutions

• Digital pathology technologies are being rapidly adopted in the Tissue Diagnostics market. Glass slides & tissue samples are digitized in digital pathology to allow for remote access, storage, and evaluation of digital images through the use of computer systems & image analysis algorithms. The necessity for remote diagnostics, collaboration, and efficient workflow are some of the elements driving this trend. Digital pathology solutions facilitate collaboration among geographically distributed teams and enable remote consultation with specialists by providing pathologists and researchers with the flexibility to view and analyze tissue samples from any location. Furthermore, by automating operations like as slide scanning, image processing, and reporting, digital pathology technologies improve productivity and decrease turnaround times in laboratories. Advanced machine learning (ML) and artificial intelligence (AI) technologies are also expanding the capacity of digital pathology systems by enabling automated pattern identification, image analysis, and diagnostic support.

Increasing Demand for Companion Diagnostics

• the rise of interest in companion diagnostics. Tests known as companion diagnostics are created in tandem with targeted therapies in order to monitor a patient's response to a particular treatment or to determine which individuals are most likely to benefit from it. In order to find particular biomarkers or genetic alterations linked to therapy efficacy, resistance mechanisms, or disease prognosis, these procedures analyze tissue samples. In customized medicine, companion diagnostics are essential because they minimize side effects, optimize therapeutic outcomes, and guide treatment decisions. In addition cancer treatment approaches closer to precision medicine, companion diagnostics become more crucial in helping to tailor treatment regimens for individual patients. Furthermore, advancements in genomic profiling technologies such as next-generation sequencing (NGS) & multiplexed immunohistochemistry (IHC) have expanded the spectrum of biomarkers that may be analyzed in tissue the specimens.

Market Restraining Factors:

Complex Regulatory Environment and Reimbursement Challenges

• The complicated regulatory framework and difficulties with reimbursement that come with tissue diagnostic services and tests include the tissue diagnostics market. Strict regulatory criteria are put on tissue diagnostic tests, such as histopathology, immunohistochemistry, & molecular diagnostics, by regulatory bodies including the European Medicines Agency (EMA). The new tissue testing approvals & clearances can be difficult, expensive, and time-consuming to get. They need to be supported by thorough clinical validation research, quality assurance procedures, and adherence to safety, effectiveness, and performance standards set by the regulations. Furthermore, regulatory guidelines can alter market access and also reimbursement for tissue diagnostic tests, causing uncertainty for labs, manufacturers, and healthcare providers. Examples of these changes include the implementation of new biomarker testing requirements or adjustments to reimbursement codes. Furthermore, differences in prior authorization procedures, coding requirements, and reimbursement rates for tissue diagnostic services may result from payer and region-specific policies & coverage decisions made by public and private payers.

Key Industry Developments:

• In July 2023, Quest Diagnostics introduced AmeriPath, a cutting-edge tissue-based prostate cancer diagnostic test, via its subspecialty pathology division. The novel tissue-based test was created in partnership with Envision Sciences, an Australian company, according to the company. Its goal is to meet the urgent clinical demand for tests that can distinguish between cases of prostate cancer in men that may be aggressive.

Report Coverage

The report will cover the qualitative and quantitative data on the global Tissue Diagnostics Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations:

Tissue Diagnostics Market Players Analysis:

• Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Thermo Fisher Scientific Inc.
• Siemens
• Danaher
• bioMérieux SA
• QIAGEN
• BD
• Merck KGaA
• GE Healthcare
• BioGenex
• Cell Signaling Technology, Inc.
• Bio SB
• DiaGenic ASA
• Agilent Technologies

Tissue Diagnostics Market Players & Competitor Analysis: The report covers the key players of the industry including Company Profile, Product Specifications, Production Capacity/Sales, Revenue, Price and Gross Margin 2022-2031 & Sales with a thorough analysis of the market’s competitive landscape and detailed information on vendors and comprehensive details of factors that will challenge the growth of major market vendors.

Tissue Diagnostics Market Segmentation Analysis:

By Technology

• Immunohistochemistry
• In Situ Hybridization
• Primary & Special Staining
• Digital Pathology and Workflow
• Anatomic Pathology

By Application

• Breast Cancer
• Non-small Cell Lung Cancer
• Prostate Cancer
• Gastric Cancer
• Other

By End-use

• Hospitals
• Research Laboratories
• Pharmaceutical Organizations
• Contract Research Organizations (CROs)

The report also helps in understanding Global Tissue Diagnostics Market dynamics, structure by analyzing the market segments, and project the Global Tissue Diagnostics Market size. Clear representation of competitive analysis of key players by type, price, financial position, product portfolio, growth strategies, and regional presence in the Global Tissue Diagnostics Market make the report investor’s guide.

Segmentation Analysis:

The market is divided into segments based on By Technology, By Application, By End-use.

By Technology

Based on the Technology of the market is segmented into Immunohistochemistry, In Situ Hybridization, Primary & Special Staining, Digital Pathology and Workflow, Anatomic Pathology.

The market is split into five segments based on technology: digital pathology & workflow, primary & special staining, in-situ hybridization, immunohistochemistry, and anatomic pathology. With the highest revenue share of 28.76% in 2022, immunohistochemistry (IHC) is a widely used technique in clinical research and the development of cancer diagnoses and treatments. Since IHC clearly shows differences between various tumor types, it is generally chosen over traditional enzyme staining methods. On the other hand, only a small number of tumor tissue structures, enzymes, and proteins are detected by standard approaches.

The fastest-growing CAGR is anticipated for digital pathology and workflow over the projected timeframe. One of the main reasons propelling the segment growth is the rise in pathologists' use of whole-slide imaging (WSI). With the purpose of enhancing cancer detection and offering useful clinical measurements for tumors, WSI extracts particular features from tumors and quantifies each component of these traits. Important market participants are implementing strategic initiatives to increase the variety of products they offer. For example, Roche introduced Digital Pathology Open Environment in September 2021, which makes it easier for software developers to combine their image analysis tools with Roche's corporate software for tumor tissue, uPath.

By Application

Based on the Application of the market is categorised into Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Cancer, Other Cancers.

Breast cancer accounted for the largest portion of the tissue diagnostics market in 2022, with a revenue share of 50.15%. Tissue diagnostics are crucial to the detection, diagnosis, and planning of treatment for breast cancer, which are important worldwide health issues. More and more breast tissue samples are being examined by means of advanced techniques such as immunohistochemistry and in situ hybridization, which enable precise tumor characterization. The demand for tissue diagnostics services and products made specifically for the identification and management of breast cancer has surged as a result of this trend.

Prostate cancer is expected to grow at the quickest pace over the course of the projected period. Prostate cancer biomarkers have been identified with amazing success thanks to the development of genetic technology, which has driven the profitable expansion of the market. The development of tissue diagnostic tests has been facilitated by the discovery of biomarkers, providing opportunities for the segment's growth. Prostate cancer can also be diagnosed using a variety of diagnostic techniques, such as immunohistochemistry (IHC) tests from Roche and NeoGenomics Laboratories.

Regional Snapshots:

By region, Insights into the markets in North America, Europe, Asia-Pacific, and the rest of the world are provided by the study. North America accounted for 45.87% of the tissue diagnostics market due to the region's high cancer incidence. To lower the number of cancer cases and raise demand for cancer detection in the local market, several public measures have been put in place. Cancer prevention in this domain is the focus of the Cancer Prevention and Control Research Network, the principal project of the Centers for Disease Control and Prevention. For the creation of novel tests, human tissue is a crucial component of personalized medicine.

The Asia Pacific region is anticipated to expand profitably throughout the projection period due to the increased number of international companies offering a wide range of tissue diagnostic tests. For instance, Indica Labs and Hamamatsu Photonics K.K. declared in October 2022 that they will collaborate to develop better integrated processes for digital pathology.

Tissue Diagnostics Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report:

The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.

The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.

The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.

Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.

The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions:

• How much the global Tissue Diagnostics Market valued?
• Which region has the largest share in 2024 for the global Tissue Diagnostics Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Tissue Diagnostics Market:

• Historic year: 2019- 2022
• Base year: 2023
• Forecast: 2024 to 2031
• Representation of Market revenue in USD Million

Tissue Diagnostics Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: