Revenue Forecast

The global tissue diagnostics market is projected to grow from $6.79 billion in 2023 to $10.92 billion in 2029, with a CAGR of 8.2% during the study period.

The Impact of the Top 3 Strategic Imperatives on the Global Tissue Diagnostic Industry

Transformative Mega Trends

• With companies such as Foundation Medicine (which Roche acquired) using genetic profiling to customize cancer treatments, the tissue diagnostics sector is shifting toward precision diagnostics. Genetic profiling makes personalized medicines possible by identifying specific genetic changes and tumor biomarkers.
• Companies develop tissue-based companion diagnostics (CDx) tests alongside therapies, such as ALK rearrangement testing, PD-L1 testing, HER2 testing, and MSI-H-/dMMR testing. These tests use immunohistochemistry (IHC) on tissue samples and are becoming more necessary as the need for targeted treatments grows. Tissue diagnostics validated biomarkers can guide treatment selection, significantly supporting CDx test development.

Disruptive Technologies

• Whole slide imaging (WSI) is transforming pathology by enabling high-quality digital acquisition and storage of tissue slides. This technology enhances accessibility and collaboration, allowing pathologists to review and analyze slides remotely.
• Leica Biosystems integrates AI with WSI, which uses advanced image analytics for primary diagnostics (e.g., tumor markers) and/or diagnostic patients (i.e., tumor markers) and allows for integration results in more precise and effective tissue biomarker analytics and cancer diagnosis.
• A major advancement in digital pathology is the application of WSI and AI, which provide faster research and diagnosis, enhanced image quality, and ease of use.

Internal Challenges

• Most large industry players cater to these technological advancements. Still, the mid-size and small players in the tissue diagnostic industry face significant internal challenges, such as integrating advanced technologies (e.g., AI and digital pathology). Integrating these technologies requires large investments, and there's a limited knowledge base available.
• Robust data management systems and a change in organizational culture are also needed to adopt advanced technologies.
• The complex regulatory environment, with its protracted approval procedures and ongoing relationships with regulatory authorities, is more challenging for smaller companies with limited resources.

Scope of Analysis

• This research service provides an overview of the global tissue diagnostics market and a 5-year global market revenue forecast from 2023 to 2029.
• The geographical scope of this global study focuses on four regions: North America (NA); Europe; Asia-Pacific (APAC); and the Middle East, North Africa, and South Asia (MENASA) and Latin America.
• The revenue forecasts involve a technology segment breakdown (pre-analytical staining, advanced staining, and integrated computational pathology and anatomical pathology laboratory information systems (ICP-APLISs) for the global market. Additionally, the report provides regional and end-user analysis (clinical laboratories, pharmaceutical companies, and contract research organizations [CROs]).
• Tissue diagnostics is a methodology for assessing tissue samples that doctors obtain during a patient’s medical procedure. Traditionally, health professionals stain tissue specimens from biopsies with dyes or markers and observe them under a microscope to check for cell structure abnormalities. Although health professionals use other novel technologies (e.g., digital pathology) to assess tissue samples, tissue diagnostics techniques are still the gold standard in cancer diagnosis.

Segmentation

By Technology

• Pre-analytical

   

  • Tissue Embedding Equipment
  • Tissue Processing Systems
  • Microtomes/Cryostats
  • Cover Slipping Machines
  • Hematoxylin and Eosin Staining (H&E)
  • Routine Stains

• Advanced Staining

  • IHC (immunohistochemistry) and In Situ Hybridization (ISH) Slide Stainers
  • IHC/ISH Staining System
  • IHC/ISH/SS (Special Stains) Reagent Kits
• ICP-APLIS
  • Anatomical Pathology Management Module
  • Computational Pathology Module
  • Storage and Deployment Options

By End User

• Clinical Laboratories Clinical laboratories are facilities conducting tissue tests for disease diagnosis and management. They include hospitals, diagnostic centers, and independent and academic laboratories.
• Pharmaceutical Companies This segment includes pharmaceutical companies involved in drug development that utilize tissue diagnostics to identify biomarkers and assess efficacy.
• CROs This segment includes companies offering tissue diagnostic services for clinical trial management and biomarker analysis.

By Region

• NA

• Europe
• APAC
• MENASA & Latin America

Competitive Environment

Key Competitor by Technology

Pre-analytical and Advance Staining

• Roche Diagnostics
• Danaher Corporation - Leica Biosystems
• Agilent Technologies, Inc.
• Merck KGaA - Millipore
• Sakura Finetek
• Abbott Laboratories (Abbott)
• ThermoFisher Scientific
• Abcam Plc
• Cell Signaling Technology
• BioGenex
• Bio-Optica Milano S.p.A
• Histo-Line Laboratories
• Enzo Life Sciences Inc
• BD Biosciences
• A.Menarini Diagnostics
• Dakewe
• CellPath Ltd
• Medite Medical GmbH
• Diapath S.P.A
• Milestone SRL
• RMC Boeckeler
• Hamamatsu Photonics
• Biocare Medical

ICP-APLIS

• Autoscribe Informatics Inc.
• Cerner Corporation
• CliniSys Group
• CompuGroup Medical SE & Co. KGaA
• Dorays Lab Ltd.
• Epic Systems Corporation
• LabVantage Solutions, Inc.
• LabWare, Inc.
• LigoLab Information System, LLC
• Novopath Group
• Sysmex Corporation
• Orchard Software Corporation
• Philips Healthcare (a division of Koninklijke Philips N.V.)
• SCC Soft Computer
• PHC Holdings Corporation
• Tissuelogics
• Xifin Laboratory Informatics Management System (LIMS)
• Technidata AG
• Novopath
• Zendo LIMS

Revenue Forecast