Tissue Diagnostics Market Size and Outlook 2031

Report Description

Forecast Period	2027-2031
Market Size (2025)	USD 5.83 Billion
CAGR (2026-2031)	8.59%
Fastest Growing Segment	Reagents and Consumables
Largest Market	North America
Market Size (2031)	USD 9.56 Billion

Market Overview

The Global Tissue Diagnostics Market will grow from USD 5.83 Billion in 2025 to USD 9.56 Billion by 2031 at a 8.59% CAGR. Tissue diagnostics encompasses the removal and analysis of biological tissue samples to detect and identify diseases such as cancer. The primary drivers propelling market growth include the rising prevalence of oncology cases and an aging global population that requires frequent medical interventions. Furthermore, the shift toward personalized healthcare stimulates demand for precise biomarker analysis to tailor therapeutic strategies. According to the American Cancer Society, in 2025, an estimated 2,041,910 new cancer cases are expected to be diagnosed in the United States, illustrating the intensifying burden that necessitates advanced diagnostic infrastructure.

However, a significant challenge impeding market expansion is the shortage of skilled pathologists and laboratory professionals required to interpret complex samples. This workforce scarcity restricts diagnostic throughput and increases turnaround times, creating a bottleneck that hinders the broader adoption of advanced tissue diagnostic solutions across healthcare systems globally.

Key Market Drivers

The primary engine of the Global Tissue Diagnostics Market is the rising global prevalence of cancer and chronic diseases. As the burden of oncology cases intensifies, there is a parallel escalation in the volume of tissue biopsies required for definitive diagnosis and staging. This demand is further amplified by the aging global population, which is naturally more susceptible to cellular mutations and chronic conditions that mandate histopathological examination. According to The Lancet, September 2025, in a study analyzing the global burden of disease, it was projected that the annual number of new cancer cases worldwide will rise to over 30 million by 2050, underscoring the critical need for scalable diagnostic capabilities. This intensifying caseload necessitates robust tissue processing, advanced staining workflows, and high-throughput platforms to effectively manage the influx of patient samples and ensure timely therapeutic decisions.

Simultaneously, the integration of artificial intelligence and digital pathology solutions is reshaping market dynamics by enhancing diagnostic precision and workflow efficiency. Laboratories are increasingly adopting automated scanning and AI algorithms to assist pathologists in detecting subtle morphological patterns, thereby reducing human error and alleviating workload pressures caused by workforce shortages. According to CAP TODAY, September 2025, in a report on industry momentum, the adoption rate of digital pathology within United States diagnostic practices has reached the range of 15 to 20 percent, signaling a definitive shift from traditional microscopy to digitized operations. This technological transition is bolstered by sustained investment in healthcare research; according to the National Cancer Institute, in 2025, the agency requested a total budget of approximately $7.8 billion to support extensive cancer research and infrastructure development, fostering an environment conducive to continued diagnostic innovation.

Download Free Sample Report

Key Market Challenges

The shortage of skilled pathologists and laboratory professionals represents a substantial barrier to the growth of the Global Tissue Diagnostics Market. Because tissue analysis requires expert interpretation to identify complex disease markers, a lack of qualified personnel creates an unavoidable operational bottleneck. When laboratories cannot fully staff their anatomic pathology departments, diagnostic throughput slows significantly, leading to delayed patient reports and an inability to handle surging case volumes. This operational constraint directly hampers market revenue, as diagnostic service providers are unable to scale their output to meet the intensifying clinical demand.

Highlighting the severity of this workforce gap, according to the American Society for Clinical Pathology, in 2025, anatomic pathology departments experienced the highest overall vacancy rate of 28.5% compared to other laboratory sectors. This statistic indicates that nearly one-third of the critical roles required for tissue diagnostics remain unfilled. Such a profound deficit limits the adoption of high-volume testing and advanced biomarker analyses, effectively capping the market’s expansion as healthcare systems struggle to bridge the gap between diagnostic needs and available expertise.

Key Market Trends

The expansion of tissue-based companion diagnostics for precision oncology is fundamentally altering the market as pharmaceutical collaborations drive the development of assays essential for targeted therapies. This trend represents a strategic shift from merely detecting disease presence to defining specific molecular targets, necessitating high-precision immunohistochemistry and in situ hybridization tools. Diagnostic providers are increasingly securing revenue through co-development deals that directly link specific tissue biomarkers to immune checkpoint inhibitors and targeted drugs. Highlighting the financial impact of this demand, according to Agilent Technologies, November 2025, in the 'Fourth-Quarter Fiscal Year 2025 Financial Results', the Life Sciences and Diagnostics Markets Group reported revenue of $755 million, marking a 15% increase year-over-year driven largely by momentum in diagnostic partnerships.

Simultaneously, the emergence of spatial biology is equipping researchers with the ability to map cellular interactions within the tumor microenvironment without destroying tissue architecture. Unlike traditional bulk sequencing, this approach preserves the spatial context of immune and tumor cells, which is critical for understanding mechanisms of drug resistance and immune evasion. The rapid scientific validation of these platforms is evident in their widespread adoption for translational research and complex tissue profiling. According to Akoya Biosciences, May 2025, in the 'First Quarter 2025 Financial Results', the cumulative number of publications citing the company’s spatial biology technology reached 1,891, representing a significant 44.7% increase compared to the prior year period.

Segmental Insights

Industry analysis identifies Reagents and Consumables as the fastest-growing segment in the Global Tissue Diagnostics Market, primarily driven by recurring consumption patterns. Unlike instruments which involve one-time capital expenditures, consumables such as antibodies, kits, and probes require frequent replenishment to support the rising volume of cancer biopsies and histological tests globally. This growth is further accelerated by the expansion of personalized medicine. Specifically, the authorization of companion diagnostic assays by regulatory bodies like the U.S. Food and Drug Administration (FDA) mandates the use of specialized reagent panels, directly fueling continuous demand within this sector.

Regional Insights

North America maintains a leading position in the global tissue diagnostics market, driven primarily by the rising incidence of cancer and the subsequent demand for accurate disease detection. This dominance is supported by a well-established healthcare infrastructure that facilitates early diagnosis and effective treatment planning. Additionally, the strong presence of major diagnostic manufacturers in the United States accelerates the availability of testing solutions. The market is further bolstered by favorable regulatory approvals from the U.S. Food and Drug Administration and ongoing awareness programs regarding cancer screening promoted by institutions such as the American Cancer Society.

Recent Developments

In July 2024, Danaher Corporation announced the establishment of two new Centers of Innovation in Diagnostics to accelerate the development and commercialization of companion and complementary diagnostics. These facilities, certified under the Clinical Laboratory Improvement Amendments and the College of American Pathologists, are designed to serve as hubs for collaborative research with pharmaceutical and academic partners. One of the centers is hosted by Leica Biosystems, a subsidiary of Danaher specializing in anatomic pathology, to leverage its expertise in tissue-based diagnostics. The initiative focuses on simplifying the complex process of bringing precision treatments to market by minimizing assay transfer times and supporting global clinical trial deployment.
In May 2024, Sakura Finetek Europe launched the Tissue-Tek xPrint LP Laser Cassette Printer, a new instrument designed to advance automation and efficiency in pathology laboratories. This system utilizes laser technology to print high-resolution text and barcodes directly onto tissue cassettes, eliminating the need for consumable ink ribbons or cartridges. The printer is engineered to withstand common laboratory chemicals such as alcohol and xylene, ensuring the durability of specimen identification throughout the histology process. With a printing speed of up to 2.5 seconds per cassette and a resolution of 2,500 dots per inch, this product aims to improve sample traceability and workflow productivity in tissue diagnostics settings.
In February 2024, Roche entered into an exclusive collaboration with PathAI to develop artificial intelligence-enabled digital pathology algorithms specifically for the companion diagnostics space. Under the terms of this agreement, PathAI acts as the sole external algorithm development partner for Roche’s AI-powered companion diagnostics for a pre-specified period. The initiative combines Roche's extensive portfolio in tissue diagnostics with PathAI's technological capabilities to create an integrated, end-to-end solution for biopharmaceutical partners. This cooperation is designed to accelerate the development of precision therapeutics and streamline the transition to digital pathology as a standard for biomarker characterization and patient diagnosis in clinical laboratories.
In January 2024, Agilent Technologies Inc. announced a strategic agreement with Incyte to collaborate on the development of companion diagnostics for hematology and oncology programs. This partnership integrates Agilent’s expertise in immunohistochemistry and diagnostic assay development with Incyte’s portfolio of targeted therapeutics. The collaboration aims to support the commercialization of precision medicine products by enabling the identification of patients who are most likely to benefit from specific treatments. By leveraging Agilent's global regulatory and commercial capabilities, the companies intend to facilitate the development and potential registration of novel diagnostic tests in the United States and Europe, thereby expanding the availability of personalized healthcare solutions.

Key Market Players

Nanoscribe GmbH & Co. KG
Stratasys Ltd.
3D Systems Inc.
EOS GmbH
Renishaw PLC
Exone Company.
Formlabs Inc.,
Materialise NV.
SLM Solutions Group AG
Oxferd Performance Materials, Inc.

By Product	By Application	By Technology	By Region
Instruments Reagents and Consumables	Breast Cancer Prostate Cancer Gastric Cancer Other Cancers	Immunohistochemistry In-Situ Hybridizations Digital Pathology and Workflow Management Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Tissue Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Tissue Diagnostics Market, By Product:

Instruments
Reagents and Consumables

Tissue Diagnostics Market, By Application:

Breast Cancer
Prostate Cancer
Gastric Cancer
Other Cancers

Tissue Diagnostics Market, By Technology:

Immunohistochemistry
In-Situ Hybridizations
Digital Pathology and Workflow Management
Others

Tissue Diagnostics Market, By Region:

North America

United States
Canada
Mexico

Europe

France
United Kingdom
Italy
Germany
Spain

Asia Pacific

China
India
Japan
Australia
South Korea

South America

Brazil
Argentina
Colombia

Middle East & Africa

South Africa
Saudi Arabia
UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Tissue Diagnostics Market.

Available Customizations:

Global Tissue Diagnostics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Detailed analysis and profiling of additional market players (up to five).

Global Tissue Diagnostics Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

1. Product Overview

1.1. Market Definition

1.2. Scope of the Market

1.2.1. Markets Covered

1.2.2. Years Considered for Study

1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study

2.2. Baseline Methodology

2.3. Key Industry Partners

2.4. Major Association and Secondary Sources

2.5. Forecasting Methodology

2.6. Data Triangulation & Validation

2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market

3.2. Overview of Key Market Segmentations

3.3. Overview of Key Market Players

3.4. Overview of Key Regions/Countries

3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Tissue Diagnostics Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Product (Instruments, Reagents and Consumables)

5.2.2. By Application (Breast Cancer, Prostate Cancer, Gastric Cancer, Other Cancers)

5.2.3. By Technology (Immunohistochemistry, In-Situ Hybridizations, Digital Pathology and Workflow Management, Others)

5.2.4. By Region

5.2.5. By Company (2025)

5.3. Market Map

6. North America Tissue Diagnostics Market Outlook

6.1. Market Size & Forecast

6.1.1. By Value

6.2. Market Share & Forecast

6.2.1. By Product

6.2.2. By Application

6.2.3. By Technology

6.2.4. By Country

6.3. North America: Country Analysis

6.3.1. United States Tissue Diagnostics Market Outlook

6.3.1.1. Market Size & Forecast

6.3.1.1.1. By Value

6.3.1.2. Market Share & Forecast

6.3.1.2.1. By Product

6.3.1.2.2. By Application

6.3.1.2.3. By Technology

6.3.2. Canada Tissue Diagnostics Market Outlook

6.3.2.1. Market Size & Forecast

6.3.2.1.1. By Value

6.3.2.2. Market Share & Forecast

6.3.2.2.1. By Product

6.3.2.2.2. By Application

6.3.2.2.3. By Technology

6.3.3. Mexico Tissue Diagnostics Market Outlook

6.3.3.1. Market Size & Forecast

6.3.3.1.1. By Value

6.3.3.2. Market Share & Forecast

6.3.3.2.1. By Product

6.3.3.2.2. By Application

6.3.3.2.3. By Technology

7. Europe Tissue Diagnostics Market Outlook

7.1. Market Size & Forecast

7.1.1. By Value

7.2. Market Share & Forecast

7.2.1. By Product

7.2.2. By Application

7.2.3. By Technology

7.2.4. By Country

7.3. Europe: Country Analysis

7.3.1. Germany Tissue Diagnostics Market Outlook

7.3.1.1. Market Size & Forecast

7.3.1.1.1. By Value

7.3.1.2. Market Share & Forecast

7.3.1.2.1. By Product

7.3.1.2.2. By Application

7.3.1.2.3. By Technology

7.3.2. France Tissue Diagnostics Market Outlook

7.3.2.1. Market Size & Forecast

7.3.2.1.1. By Value

7.3.2.2. Market Share & Forecast

7.3.2.2.1. By Product

7.3.2.2.2. By Application

7.3.2.2.3. By Technology

7.3.3. United Kingdom Tissue Diagnostics Market Outlook

7.3.3.1. Market Size & Forecast

7.3.3.1.1. By Value

7.3.3.2. Market Share & Forecast

7.3.3.2.1. By Product

7.3.3.2.2. By Application

7.3.3.2.3. By Technology

7.3.4. Italy Tissue Diagnostics Market Outlook

7.3.4.1. Market Size & Forecast

7.3.4.1.1. By Value

7.3.4.2. Market Share & Forecast

7.3.4.2.1. By Product

7.3.4.2.2. By Application

7.3.4.2.3. By Technology

7.3.5. Spain Tissue Diagnostics Market Outlook

7.3.5.1. Market Size & Forecast

7.3.5.1.1. By Value

7.3.5.2. Market Share & Forecast

7.3.5.2.1. By Product

7.3.5.2.2. By Application

7.3.5.2.3. By Technology

8. Asia Pacific Tissue Diagnostics Market Outlook

8.1. Market Size & Forecast

8.1.1. By Value

8.2. Market Share & Forecast

8.2.1. By Product

8.2.2. By Application

8.2.3. By Technology

8.2.4. By Country

8.3. Asia Pacific: Country Analysis

8.3.1. China Tissue Diagnostics Market Outlook

8.3.1.1. Market Size & Forecast

8.3.1.1.1. By Value

8.3.1.2. Market Share & Forecast

8.3.1.2.1. By Product

8.3.1.2.2. By Application

8.3.1.2.3. By Technology

8.3.2. India Tissue Diagnostics Market Outlook

8.3.2.1. Market Size & Forecast

8.3.2.1.1. By Value

8.3.2.2. Market Share & Forecast

8.3.2.2.1. By Product

8.3.2.2.2. By Application

8.3.2.2.3. By Technology

8.3.3. Japan Tissue Diagnostics Market Outlook

8.3.3.1. Market Size & Forecast

8.3.3.1.1. By Value

8.3.3.2. Market Share & Forecast

8.3.3.2.1. By Product

8.3.3.2.2. By Application

8.3.3.2.3. By Technology

8.3.4. South Korea Tissue Diagnostics Market Outlook

8.3.4.1. Market Size & Forecast

8.3.4.1.1. By Value

8.3.4.2. Market Share & Forecast

8.3.4.2.1. By Product

8.3.4.2.2. By Application

8.3.4.2.3. By Technology

8.3.5. Australia Tissue Diagnostics Market Outlook

8.3.5.1. Market Size & Forecast

8.3.5.1.1. By Value

8.3.5.2. Market Share & Forecast

8.3.5.2.1. By Product

8.3.5.2.2. By Application

8.3.5.2.3. By Technology

9. Middle East & Africa Tissue Diagnostics Market Outlook

9.1. Market Size & Forecast

9.1.1. By Value

9.2. Market Share & Forecast

9.2.1. By Product

9.2.2. By Application

9.2.3. By Technology

9.2.4. By Country

9.3. Middle East & Africa: Country Analysis

9.3.1. Saudi Arabia Tissue Diagnostics Market Outlook

9.3.1.1. Market Size & Forecast

9.3.1.1.1. By Value

9.3.1.2. Market Share & Forecast

9.3.1.2.1. By Product

9.3.1.2.2. By Application

9.3.1.2.3. By Technology

9.3.2. UAE Tissue Diagnostics Market Outlook

9.3.2.1. Market Size & Forecast

9.3.2.1.1. By Value

9.3.2.2. Market Share & Forecast

9.3.2.2.1. By Product

9.3.2.2.2. By Application

9.3.2.2.3. By Technology

9.3.3. South Africa Tissue Diagnostics Market Outlook

9.3.3.1. Market Size & Forecast

9.3.3.1.1. By Value

9.3.3.2. Market Share & Forecast

9.3.3.2.1. By Product

9.3.3.2.2. By Application

9.3.3.2.3. By Technology

10. South America Tissue Diagnostics Market Outlook

10.1. Market Size & Forecast

10.1.1. By Value

10.2. Market Share & Forecast

10.2.1. By Product

10.2.2. By Application

10.2.3. By Technology

10.2.4. By Country

10.3. South America: Country Analysis

10.3.1. Brazil Tissue Diagnostics Market Outlook

10.3.1.1. Market Size & Forecast

10.3.1.1.1. By Value

10.3.1.2. Market Share & Forecast

10.3.1.2.1. By Product

10.3.1.2.2. By Application

10.3.1.2.3. By Technology

10.3.2. Colombia Tissue Diagnostics Market Outlook

10.3.2.1. Market Size & Forecast

10.3.2.1.1. By Value

10.3.2.2. Market Share & Forecast

10.3.2.2.1. By Product

10.3.2.2.2. By Application

10.3.2.2.3. By Technology

10.3.3. Argentina Tissue Diagnostics Market Outlook

10.3.3.1. Market Size & Forecast

10.3.3.1.1. By Value

10.3.3.2. Market Share & Forecast

10.3.3.2.1. By Product

10.3.3.2.2. By Application

10.3.3.2.3. By Technology

11. Market Dynamics

11.1. Drivers

11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)

12.2. Product Launches (If Any)

12.3. Recent Developments

13. Global Tissue Diagnostics Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry

14.2. Potential of New Entrants

14.3. Power of Suppliers

14.4. Power of Customers

14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Nanoscribe GmbH & Co. KG

15.1.1. Business Overview

15.1.2. Products & Services

15.1.3. Recent Developments

15.1.4. Key Personnel

15.1.5. SWOT Analysis

15.2. Stratasys Ltd.

15.3. 3D Systems Inc.

15.4. EOS GmbH

15.5. Renishaw PLC

15.6. Exone Company.

15.7. Formlabs Inc.,

15.8. Materialise NV.

15.9. SLM Solutions Group AG

15.10. Oxferd Performance Materials, Inc.

16. Strategic Recommendations

17. About Us & Disclaimer

Report Description

Table of content

Figures and Tables

Frequently asked questions

What was the market size of the Global Tissue Diagnostics Market in 2025?

Which is the dominating region in the Global Tissue Diagnostics Market?

Which is the fastest growing segment in the Global Tissue Diagnostics Market?

What is the expected growth rate of the Global Tissue Diagnostics Market?