Overview
Global Tissue Diagnostics Market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031, growing with a CAGR of YY % during the forecast period 2024-2031.
Tissue diagnostics are essential for the diagnosis of various types of cancer, including breast cancer, lung cancer, prostate cancer, and many others. Pathologists analyze tissue samples obtained through biopsies or surgical resections to identify malignant cells and determine the stage and grade of the cancer, which is crucial for treatment planning and prognosis.
Tissue diagnostics play a crucial role in solid organ transplantation by evaluating donor organ suitability and assessing the presence of rejection or complications in transplant recipients. Pathologists examine tissue biopsies from donor organs and transplant recipients to monitor graft function, detect rejection episodes, and guide immunosuppressive therapy.
Market Dynamics: Drivers and Restraints
Rising prevalence of cancer cases
Cancer is one of the leading causes of morbidity and mortality worldwide. The rising incidence of cancer, driven by factors such as aging populations, lifestyle changes, and environmental factors, fuels the demand for tissue diagnostics for early detection, diagnosis, and treatment planning. As the incidence of cancer increases, there is a higher demand for accurate and timely diagnosis.
Tissue diagnostics play a crucial role in confirming cancer diagnoses, determining cancer subtypes, and assessing the extent and stage of the disease. This drives the demand for tissue biopsy procedures and pathology services. Thus, rise of cancer cases helps to boost the market growth. For instance, according to World Health Organization 2023, estimated that, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths.
The most common cancers are breast, lung, colon and rectum and prostate cancers. Cancer-causing infections, such as human papillomavirus (HPV) and hepatitis, are responsible for approximately 30% of cancer cases in low- and lower-middle-income countries. Additionally, advances in digital pathology, next-generation sequencing, and molecular testing have improved the accuracy, efficiency, and throughput of tissue analysis. This has led to the development of new diagnostic assays and platforms, driving market expansion.
Market Dynamics: Restraint
Challenges in sample collection and handling
Tissue specimens for diagnostics are typically obtained through invasive procedures such as biopsies, surgical resections, or autopsies. These procedures carry inherent risks, including bleeding, infection, and complications related to anesthesia. Patient reluctance or physician hesitation to perform invasive procedures may limit the availability of tissue specimens for diagnostic purposes, particularly in certain patient populations or clinical settings.
Collection and handling of tissue specimens require technical expertise and proper training to ensure adherence to standardized protocols and best practices. Inadequate training among healthcare professionals, particularly in resource-limited settings or underserved regions, may result in suboptimal sample collection techniques, leading to specimen inadequacy or degradation and affecting the reliability of diagnostic results. Thus, the above factors restrain the market growth.
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Segment Analysis
The global tissue diagnostics market is segmented based on product type, technology, application, end-user and region.
The digital pathology segment from the product type segment accounted for approximately 31.21% of share
Digital pathology supports research efforts by enabling the creation of large-scale digital pathology archives and biobanks. Researchers can access annotated tissue samples and associated clinical data for retrospective studies, biomarker discovery, and validation of novel diagnostic assays and therapeutic targets.
Additionally, the key companies strategies like product launches, partnerships and others helps to boost the segment growth. For instance, in February 2024, PathAI Inc., partnered with Roche Tissue Diagnostics (RTD) that will bring AI-enabled interpretation to companion diagnostics. Under this agreement, PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.
Additionally, in April 2023, Xyall and Indica Labs had entered into a global strategic partnership designed to bridge the gap between histology and molecular pathology. It unites Xyall’s unique automated tissue dissection solutions with Indica Labs’ AI-powered, diagnostic digital pathology platform. Selecting tumor tissue is at the heart of molecular diagnostic testing. The collaboration will enable molecular laboratories to benefit from a fully digital and automated workflow for tissue macro dissection for molecular diagnostic testing, providing increased throughput and accuracy at lower operational cost. Thus, the above factors helps to boost the segment growth.

Geographical Analysis
North America accounted for approximately 42.14% of the market share in 2022
North America, particularly the United States and Canada, boasts advanced healthcare infrastructure with a strong network of hospitals, diagnostic laboratories, and research institutions. The availability of state-of-the-art facilities and advanced diagnostic technologies fosters the adoption of tissue diagnostics and drives market growth. North America has been at the forefront of personalized medicine initiatives, which aim to tailor medical treatment to individual patients based on their unique genetic makeup, biomarker profiles, and disease characteristics.
For instance, in April 2023, BOSTON OM1, had launched PhenOM, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. Tissue diagnostics play a critical role in identifying predictive biomarkers and molecular targets for targeted therapies, driving market growth in the region.

COVID-19 Impact Analysis
During the pandemic, many non-urgent medical procedures, including elective surgeries and routine screenings, were postponed or canceled to prioritize resources for COVID-19 patients and minimize the risk of viral transmission. This led to delays in cancer diagnosis and treatment, affecting the demand for tissue diagnostics services and products.
Research efforts and funding priorities shifted towards COVID-19-related research during the pandemic, diverting resources and attention away from other areas, including cancer research and biomarker discovery. This may have slowed down the development and validation of new tissue diagnostics assays and technologies, affecting innovation in the field.
The long-term impact of the COVID-19 pandemic on cancer diagnostics remains to be fully understood. Delays in cancer screening, diagnosis, and treatment during the pandemic may lead to a backlog of cases, increased disease severity at diagnosis, and changes in cancer epidemiology. These factors could influence the demand for tissue diagnostics and shape future trends in cancer diagnosis and management.
Market Segmentation
By Product Type

  • Consumables
  • Instruments


By Technology

  • Immunohistochemistry
  • In Situ Hybridization
  • Digital Pathology
  • Special Staining
  • Others


By Application

  • Breast Cancer
  • Gastric Cancer
  • Lymphoma
  • Prostate Cancer
  • Others


By End-User

  • Hospitals
  • Pharmaceutical Companies
  • Research Laboratories
  • Ambulatory Surgical Centers
  • Others


By Region

  • North America


o U.S.
o Canada
o Mexico

  • Europe


o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe

  • South America


o Brazil
o Argentina
o Rest of South America

  • Asia-Pacific


o China
o India
o Japan
o South Korea
o Rest of Asia-Pacific

  • Middle East and Africa


Competitive Landscape
The major global players in the market include Abbott Laboratories, Thermo Fisher Scientific Inc, QIAGEN, F. Hoffmann-La Roche Ltd, Danaher Corporation, Agilent Technologies, Sakura Finetek Japan Co, Abcam, Sysmex Corporation, Bio-Genex Laboratories among others.
Why Purchase the Report?

  • To visualize the global tissue diagnostics market segmentation based on product type, technology, application, end-user and region as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of tissue diagnostics market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as excel consisting of key products of all the major players.


The global tissue diagnostics market report would provide approximately 69 tables, 58 figures and 187 Pages.
Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies