Global Tissue Diagnostics Market Insights Forecasts to 2033

• The Global Tissue Diagnostics Market Size was Valued at USD 4.9 Billion in 2023
• The Market Size is Growing at a CAGR of 8.22% from 2023 to 2033
• The Worldwide Tissue Diagnostics Market is Expected to Reach USD 10.8 Billion by 2033
• Asia Pacific is Expected to Grow the fastest during the forecast period.

The Global Tissue Diagnostics Market Size is Anticipated to Exceed USD 10.8 Billion by 2033, Growing at a CAGR of 8.22% from 2023 to 2033.

Market Overview

In tissue diagnostics, diseases such as cancer are found by analyzing microscopic samples of tissues in the body. Tissue samples are obtained by physicians during biopsies or operations. After that, these samples are examined under a microscope to search for any unique structures or cells. An essential tool for the diagnosis, tracking, and treatment of various cancer situations is tissue diagnostics. Biopsies, which include removing a sample from a location of interest, such as skin, tissue, or a tumor, are used to identify illness signs and symptoms. It is working in the evaluation and diagnosis of several illnesses, such as hereditary disorders, infectious diseases, cancer, and autoimmune disorders. Tissue diagnostics assist medical professionals in accurately diagnosing patients and selecting the most appropriate course of treatment. Various methods and tools are used in tissue diagnostics, including cytogenetics, molecular pathology, in situ hybridization, histology, and immunohistochemistry. Tissue diagnostics is a field of medicine that deals with the inspection and analysis of tissue samples taken from patients. It is sometimes referred to as histopathology or surgical pathology. It is an essential component of diagnosing several illnesses, such as cancer and other conditions. The need for tissue diagnostics has increased due to rising healthcare costs and increased public knowledge of diseases like cancer and other illnesses. Due to important market drivers including the increased incidence of different cancer types, including lung and breast cancer, the tissue diagnostics market is expected to grow throughout the forecast period. The rising cancer rate in developed countries is driving growth in the tissue diagnostics market.

Report Coverage

This research report categorizes the market for the global tissue diagnostics market based on various segments and regions forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the global tissue diagnostics market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the global tissue diagnostics market.

Driving Factors

The continued trend of automation of diagnostic laboratory operations across major healthcare markets has led to an increase in the use of digital pathology systems by healthcare practitioners worldwide. Additionally, increased laboratory efficiency is essential for patients and healthcare professionals to diagnose diseases accurately and quickly to develop efficient treatment plans. A more timely and cost-effective way for laboratory professionals to diagnose diseases is by using digital and automated methods more often. Effective diagnostic methods are desperately needed, as the illness burden continues to rise due to aging populations and changing lifestyles. Early detection is crucial for optimal treatment outcomes, as seen by the growing size of the cancer market caused by the increase in demand. Molecular testing and tissue samples are two methods that are used in tissue diagnostics to help determine the kind of cancer and help guide therapy decisions.

Restraining Factors

The extant approval process for tissue diagnostic instruments and supplies by the FDA presents a significant challenge for firms seeking to launch new products. Many of these are classified as Class III, meaning that they need thorough Premarket Approval (PMA), which is the most stringent application process that examines safety and efficacy. In between, in vitro diagnostic (IVD) products are subject to a different regulation in the upcoming Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will introduce higher standards on CE marking, which is essential for the ability to legally market these products.

Market Segmentation

The global tissue diagnostics market share is classified into product, technology, and application.

• The consumables segment dominates the market with the largest market share through the forecast period.

Based on the product, the global tissue diagnostics market is categorized into consumables and instruments. Among these, the consumables segment dominates the market with the largest market share through the forecast period. This segment is predicted to grow as a result of increasing R&D spending by top pharmaceutical companies, as well as increased funding from the public and private sectors for life sciences and cancer research.

• The immunohistochemistry (IHC) segment is anticipated to grow at the fastest CAGR growth through the forecast period.

Based on the technology, the global tissue diagnostics market is categorized into Immunohistochemistry (IHC), in situ hybridization (ISH), digital pathology & workflow, and special staining. Among these, the immunohistochemistry (IHC) segment is anticipated to grow at the fastest CAGR growth through the forecast period. IHC uses a combination of immunological, anatomical, and biochemical approaches to test specific antigens in tissue using antibodies. Antibodies having a high degree of specificity are used to bind to antigens and detect them. The diagnosis of aberrant cells makes extensive use of this technology.

• The breast cancer segment accounted for the largest revenue share through the forecast period.

Based on the application, the global tissue diagnostics market is categorized into breast cancer, prostate cancer, gastric cancer, and others. Among these, the breast cancer segment accounted for the largest revenue share through the forecast period. Tissue diagnostics are important for the identification, diagnosis, and treatment planning of breast cancer, a major global health concern. To precisely characterize cancers, advanced techniques like in situ hybridization and immunohistochemistry are being working more and more to study samples of breast tissue. The need for tissue diagnostics services and solutions designed especially for the detection and treatment of breast cancer has increased as a result of this development.

Regional Segment Analysis of the Global Tissue Diagnostics Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the global tissue diagnostics market over the predicted timeframe.

North America is anticipated to hold the largest share of the global tissue diagnostics market over the predicted timeframe. Many government efforts are in place to reduce cancer cases and increase the need for cancer diagnosis in the region. A landmark project of the Centers for Disease Control and Prevention, the cancer prevention and control research institute focuses on cancer prevention in that region. tissue diagnostics are used more frequently as a result of the substantial expansion of customized medicine brought about by the increased use of sequencing technologies and healthcare systems in clinical workflow. North America's personalized medicine market is growing thanks in part to the precision medicine initiative in the United States.

Asia Pacific is expected to grow at the fastest CAGR growth of the global tissue diagnostics market during the forecast period. Due to the greater use of several tissue diagnostic assays offered by foreign companies, the Asia-Pacific region is anticipated to grow at a profitable rate during the projection period. Asia Pacific has experienced a rise in public knowledge of health issues and an introduction to the newest technologies on the market. This supports the expansion of the region's new healthcare facilities as well as the hospitals' infrastructure.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global tissue diagnostics market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

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

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Development

• In July 2023, Quest Diagnostics launched a novel tissue-based prostate cancer biomarker test, AmeriPath, through its subspecialty pathology business. As per the company, the new, tissue-based test was developed in collaboration with Australia-based Envision Sciences. It is intended to address the pressing clinical need for tests to help identify and differentiate potentially aggressive cases of prostate cancer in men.

• In June 2023, In Marana, Roche Tissue Diagnostics is establishing a 60,000-square-foot facility next to an existing distribution center as part of its expansion into the production of cancer-detecting apparatus and tests. Relocating from Roche's main campus in Oro Valley, the new facility will contain all instrument manufacturing operations. To fulfill the rising demand for its products, the company is moving to enhance production capacity.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2033. Spherical Insights has segmented the global tissue diagnostics market based on the below-mentioned segments: 

Global Tissue Diagnostics Market, By Product  

• Consumables
• Instrument

Global Tissue Diagnostics Market, By Technology

• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)
• Digital Pathology & Workflow
• Special Staining

Global Tissue Diagnostics Market, By Application

• Breast Cancer
• Prostate Cancer
• Gastric Cancer
• Other

Global Tissue Diagnostics Market, By Region

• North America
  • US
  • Canada
  • Mexico

• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa