Tissue Diagnostics Market by Product, Technology, Indications, End-User

List of Tables

[196 Pages Report] The Tissue Diagnostics Market size was estimated at USD 8.30 billion in 2023 and expected to reach USD 8.94 billion in 2024, at a CAGR 7.76% to reach USD 14.02 billion by 2030.

Tissue diagnostics is a medical field that involves examining and analyzing tissue samples from a patient's body to diagnose diseases or conditions. It is crucial in diagnosing and treating various medical conditions, including cancer and other tissue-related diseases. Tissue diagnostics has applications across several clinical areas and is crucial in personalized medicine for assisting in early disease detection. An increase in global cancer prevalence rates and an aging population drive the demand for tissue diagnostic services. Advancements in genomics have led to the identification of numerous biomarkers associated with diseases, which have further spurred the need for accurate diagnostic tests. However, high costs associated with diagnostic instruments and services might impede their adoption by small-scale healthcare providers or low-resource settings. The lack of skilled professionals capable of interpreting complex test results and insufficient pathologists worldwide could hinder market expansion. Technological advances such as artificial intelligence (AI) integration with digital pathology have opened up new opportunities for the market players. AI-based algorithms can aid pathologists in detecting subtle morphological changes within tissues that may be easily overlooked. Additionally, growing investments from governments and private organizations towards healthcare infrastructure are expected to provide more avenues for growth in this sector.

KEY MARKET STATISTICS
Base Year [2023]	USD 8.30 billion
Estimated Year [2024]	USD 8.94 billion
Forecast Year [2030]	USD 14.02 billion
CAGR (%)	7.76%

Product: Proliferating use of tissue-processing systems for efficient processing and analyzing diagnosing tissue samples

Accessories are crucial in ensuring precise tissue diagnosis by complementing the function of instruments and consumables. Accessories typically refer to a wide range of supplementary products and components used with the primary tissue diagnostic instruments and equipment. These accessories enhance tissue diagnostic tools and devices' performance, efficiency, and functionality. Consumable products detect specific biomarkers essential for various steps in tissue sample preparation, staining, analysis, and storage. They are integral to the day-to-day operations of tissue diagnostic laboratories. The tissue diagnostics market encompasses various instruments and equipment for collecting, processing, analyzing, and diagnosing tissue samples. These instruments are essential for accurately assessing tissue specimens and play a crucial role in fields such as pathology, histology, and clinical diagnostics. Tissue diagnostic software solutions enable the processing, storing, and analyzing digital images obtained from scanned slides. Machine learning algorithms and artificial intelligence are utilized in diagnostics programs to facilitate remote consultations between pathologists. These advanced technologies provide more accurate and precise diagnoses, ensuring enhanced patient care and treatment outcomes.

Technology: Adoption of digital pathology technology for the management of digitized histological samples through computer technology

Digital pathology uses computer technology to manage information generated from digitized histological samples. Digital pathology systems enable efficient diagnosis, interpretation, image analysis, storage, and sharing of digital slides. The increased accuracy and reduced turnaround time make it an essential tool for pathologists worldwide. Immunohistochemistry (IHC) is a method utilized to detect specific proteins in tissue samples through antigen-antibody interactions using enzyme-labeled antibodies as markers. This method plays a vital role in diagnosing various diseases, such as cancer, by identifying specific biomarkers associated with tumor cells or surrounding tissues. In situ hybridization (ISH) is a technique that detects specific RNA or DNA sequences within cells in tissue samples. This method helps evaluate gene expression patterns, chromosomal abnormalities, and copy number variations. Fluorescence in situ hybridization utilizes fluorescent probes for detection. Special staining techniques visualize specific cellular components or highlight certain structures within histological samples. Digital pathology offers significant advantages in terms of efficiency, accuracy, and collaboration potential, while IHC and ISH are crucial for understanding the molecular characteristics of tissues and detecting specific biomarkers. Special staining techniques provide additional insights into cellular structures not visible through conventional methods.

Indications: Exponential use of tissue diagnostics in the detection and characterization of numerous cancer types

Tissue diagnostics play a pivotal role in the early detection and characterization of breast cancer, allowing personalized therapies to improve patient outcomes. Techniques such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are widely used to identify hormone receptor status, guiding targeted therapy decisions. Identifying different subtypes of gastric cancer using tissue diagnostics assists clinicians with prognosis prediction and therapy selection. IHC is commonly employed to detect molecular biomarkers such as HER2 overexpression that directs the use of targeted therapies such as trastuzumab. Accurate diagnosis and subtyping of lymphoma are crucial for appropriate treatment planning since it comprises a heterogeneous group of malignancies involving immune system cells. Tissue diagnostic techniques can identify specific cell markers to differentiate between Hodgkin's and non-Hodgkin's lymphomas or even identify subtypes within these categories. Tissue diagnostics helps identify genetic alterations such as EGFR mutations, ALK rearrangements, and PD-L1 expression levels that can guide treatment decisions. Prostate cancer is the second most common cancer among men globally. Tissue diagnostics are crucial for determining the pathological grade of tumors through Gleason scoring and evaluating prognostic markers such as Ki-67 and PTEN loss.

End-User: Significant utilization of tissue diagnostics in clinical pathology laboratories to improve patient care quality

The primary need for tissue diagnostics in clinical pathology laboratories is to detect and diagnose various diseases at the molecular level. It helps pathologists identify biomarkers associated with specific diseases using techniques such as immunohistochemistry (IHC), in situ hybridization (ISH), and hematoxylin (H&E) staining. Contract research organizations (CROs) require tissue diagnostics services for preclinical and clinical research studies for pharmaceutical companies and biotechnology firms. These organizations prioritize cost-effectiveness, scalability, and turnaround times in choosing tissue diagnostic solutions. Tissue diagnostics are critical for patient diagnosis, treatment selection, and disease monitoring in hospital settings. Hospitals require reliable diagnostic solutions that provide accurate results with a minimal turnaround time to improve patient care quality while minimizing costs. Pharmaceutical companies utilize tissue diagnostics for drug development and clinical trials, necessitating solutions that identify target populations for precision medicine, optimize patient stratification, and evaluate treatment response in real-time. Academic and research institutions require cutting-edge tissue diagnostic solutions to investigate disease mechanisms, discover novel biomarkers, and advance therapeutic development. These laboratories prefer innovative technologies supporting high-throughput analysis and multiplexing capabilities.

Regional Insights

The Americas has a significant landscape in the tissue diagnostics market owing to advanced healthcare infrastructure and extensive research funding by the key manufacturers in the development of diagnostics tests. The manufacturers in the region have observed numerous patents issued by the FDA for innovations in tissue diagnostics technology. The EMEA region has observed a developing landscape in the tissue diagnostics market due to significant investments made by the government to support research initiatives for early diagnosis of diseases such as cancer to improve diagnostic techniques. Government standards and regulations on the safety and quality of tissue diagnostics consumables have also contributed to the market growth in the region. South Africa is a hub for innovation within the African continent, with several ongoing research initiatives focused on developing efficient diagnostic tools that cater to local disease prevalence patterns. APAC region in the market has a developing growth due to technological advancements, investment in research and development of state-of-the-art tissue diagnostic technologies, increasing cancer incidence, and government initiatives encouraging local manufacturing of diagnostic equipment, fostering innovation within the country's tissue diagnostics industry.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Tissue Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Tissue Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Tissue Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Abcam Plc, Agilent Technologies, Inc., Atlas Antibodies AB, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, Biogenex Laboratories Inc., BioIVT, LLC, bioMerieux SA, Cardinal Health, Inc., Castle Biosciences, Inc., Cell Signaling Technology, Inc., Diagnostic BioSystems Inc., F. Hoffmann-La Roche Ltd, Leica Biosystems by Danaher Corporation, McKesson Corporation, Merck KGaA, MILESTONE MEDICAL Srl, PathAI, Inc., Pfizer Inc., PROGEN Biotechnik GmbH, QIAGEN N.V., Quest Diagnostics Incorporated, Sekisui Diagnostics, LLC, Siemens Healthineers AG, SLEE medical GmbH, and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the Tissue Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Accessories
- Consumables
  - Antibodies
  - Kits
  - Probes
  - Reagents

Instruments
- Scanners
- Slide-staining Systems
- Tissue Microarrays
- Tissue-processing Systems

Software

Technology
- Digital Pathology & Workflow
- Immunohistochemistry
- In Situ Hybridization
- Special Staining

Indications
- Breast Cancer
- Gastric Cancer
- Lymphoma
- Non Small Cell Lung Cancer
- Prostate Cancer

End-User
- Clinical Pathology
- Contract Research Organization
- Hospitals
- Pharmaceutical Organizations
- Research Laboratories

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Tissue Diagnostics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Tissue Diagnostics Market?

3. What are the technology trends and regulatory frameworks in the Tissue Diagnostics Market?

4. What is the market share of the leading vendors in the Tissue Diagnostics Market?

5. Which modes and strategic moves are suitable for entering the Tissue Diagnostics Market?

Product Code: MRR-03142C0401D5

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing incidence of cancer worldwide
  - 5.1.1.2. Growing use of personalized medicine
  - 5.1.1.3. Government initiatives to increase awareness regarding effective and early cancer diagnosis
- 5.1.2. Restraints
  - 5.1.2.1. High cost involved in tissue diagnosis and reimbursement issues
- 5.1.3. Opportunities
  - 5.1.3.1. Inception of digital pathology and automated tissue diagnostics
  - 5.1.3.2. Innovative technologies and instruments development in tissue diagnostic field
- 5.1.4. Challenges
  - 5.1.4.1. Limitations associated with tissue diagnostics procedures coupled with privacy concerns
5.2. Market Segmentation Analysis
- 5.2.1. Product: Proliferating use of tissue-processing systems for efficient processing and analyzing diagnosing tissue samples
- 5.2.2. Technology: Adoption of digital pathology technology for the management of digitized histological samples through computer technology
- 5.2.3. Indications: Exponential use of tissue diagnostics in the detection and characterization of numerous cancer types
- 5.2.4. End-User: Significant utilization of tissue diagnostics in clinical pathology laboratories to improve patient care quality
5.3. Market Trend Analysis
- 5.3.1. Significant emphasis on securing approvals for tissue diagnostic technologies in the Americas
- 5.3.2. Government initiatives to encourage early detection and screening of chronic diseases in the APAC region
- 5.3.3. Revolutionary advancements in tissue diagnostic technologies in the EMEA region
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter's Five Forces Analysis
- 5.6.1. Threat of New Entrants
- 5.6.2. Threat of Substitutes
- 5.6.3. Bargaining Power of Customers
- 5.6.4. Bargaining Power of Suppliers
- 5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis

6. Tissue Diagnostics Market, by Product

6.1. Introduction
6.2. Accessories
6.3. Consumables
6.4. Instruments
6.5. Software

7. Tissue Diagnostics Market, by Technology

7.1. Introduction
7.2. Digital Pathology & Workflow
7.3. Immunohistochemistry
7.4. In Situ Hybridization
7.5. Special Staining

8. Tissue Diagnostics Market, by Indications

8.1. Introduction
8.2. Breast Cancer
8.3. Gastric Cancer
8.4. Lymphoma
8.5. Non Small Cell Lung Cancer
8.6. Prostate Cancer

9. Tissue Diagnostics Market, by End-User

9.1. Introduction
9.2. Clinical Pathology
9.3. Contract Research Organization
9.4. Hospitals
9.5. Pharmaceutical Organizations
9.6. Research Laboratories

10. Americas Tissue Diagnostics Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Tissue Diagnostics Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Tissue Diagnostics Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. PathAI Announces Expansion of BioPharma Lab to Provide End-to-End Central Pathology and Histology Services
- 13.3.2. Ibex Raises USD 55 Million in Series C Funding to Drive Global Adoption of AI for Cancer Diagnosis
- 13.3.3. Quest Diagnostics Launches Novel Prostate Cancer Test Aimed at Improving Diagnosis and Grading
- 13.3.4. Cytelabs expanding diagnostic services to hospitals and patients across south India
- 13.3.5. Bio-Techne Buys Lunaphore to Boost Cancer Diagnostics Through Spatial Biology
- 13.3.6. Lunaphore Secures Chf 40 Million to Boost Portfolio of Tissue Diagnostics Solutions
- 13.3.7. Launch of Optimer-Fc as a New Reagent Solution for Immunohistochemistry
- 13.3.8. Ibex and Alverno Laboratories Sign Multi-Year, Multi-Tissue Expansion Agreement of AI for Cancer Diagnosis
- 13.3.9. Roche Expands Collaboration with Janssen to Advance Personalized Healthcare Through Companion Diagnostics
- 13.3.10. Guardant Health to Integrate Lunit's Ai-Based Scoring Algorithm for Pd-L1 into its Portfolio to Enhance Cancer Biomarker Detection
- 13.3.11. Epredia and Aiforia Join RegenMed Hub Innovation Accelerator, Expanding PHC Group Presence in Regenerative Medicine Partnership Will Pave the Way for New RegenMed Clinical Trials Catalyst Program
- 13.3.12. Microsoft Strikes Partnership with Paige to Advance Cancer Diagnostics and Treatment
- 13.3.13. Agilent and Akoya Biosciences Announce Partnership to Drive Multiplex Tissue Assay Development for Biopharma Applications
- 13.3.14. Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device
- 13.3.15. ROCHE tissue diagnostics celebrates marana expansion project

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio