Immunohistochemistry Market Size and Outlook 2031

Report Description

Forecast Period	2027-2031
Market Size (2025)	USD 2.71 Billion
CAGR (2026-2031)	7.01%
Fastest Growing Segment	Diagnostics
Largest Market	North America
Market Size (2031)	USD 4.07 Billion

Market Overview

The Global Immunohistochemistry Market is projected to grow from USD 2.71 Billion in 2025 to USD 4.07 Billion by 2031 at a 7.01% CAGR. Immunohistochemistry is a microscopic diagnostic technique that utilizes antibodies to identify specific antigens within tissue sections for disease detection and research. The market growth is primarily supported by the rising global incidence of cancer and the increasing reliance on personalized medicine that necessitates precise biomarker analysis. This escalating disease burden drives the continuous demand for the accurate histopathological assessments provided by these assays. 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. This substantial volume of projected diagnoses highlights the critical need for robust pathology solutions to support effective treatment planning.

One significant challenge impeding market expansion is the substantial capital investment required for automated staining platforms and specific reagents. These high operational costs often deter smaller laboratories and medical facilities in developing economies from adopting advanced diagnostic infrastructure. Furthermore, inconsistent reimbursement schemes for complex pathology tests can limit accessibility for patients and reduce the financial viability for service providers, which ultimately restricts the broader adoption of these essential diagnostic tools across global markets.

Key Market Drivers

The rising global incidence of cancer and chronic diseases acts as the primary catalyst for the Immunohistochemistry Market, fundamentally increasing the volume of tissue biopsies requiring analysis. As patient numbers grow, pathology laboratories face mounting pressure to perform accurate histological examinations to determine malignancy and tumor origin, directly scaling the consumption of antibodies, reagents, and staining platforms. This trend necessitates broader diagnostic access across international health systems to manage the escalating disease burden. According to the Canadian Cancer Society, June 2024, in the 'Canadian Cancer Statistics 2024' report, an estimated 247,100 new cancer cases were projected to be diagnosed in Canada in 2024, underscoring the expanding clinical demand that necessitates robust immunohistochemical testing workflows globally.

Concurrently, the increasing adoption of companion diagnostics in drug development is reshaping the market by integrating immunohistochemistry into the prescription process for targeted therapies. Pharmaceutical companies now heavily rely on these assays to identify patients eligible for specific biologic treatments, such as those targeting HER2 or PD-L1 markers, thereby elevating the technique from a research tool to a critical clinical necessity. According to the Personalized Medicine Coalition, February 2024, in the 'Personalized Medicine at FDA: The Scope & Significance of Progress in 2023' report, personalized medicines accounted for more than one-third of all new drug approvals in 2023, reflecting the pivotal role of biomarker-driven development. This strategic shift fuels sustained commercial activity, evidenced by major industry players maintaining strong revenue streams; for instance, according to Roche, in 2025, the company's Diagnostics division reported annual sales of CHF 14.3 billion for the previous financial year.

Download Free Sample Report

Key Market Challenges

The substantial capital investment required for automated staining platforms and specific reagents constitutes a formidable barrier to the growth of the global immunohistochemistry market. Advanced diagnostic infrastructure demands significant upfront expenditure, which disproportionately affects smaller laboratories and healthcare facilities in developing regions. These entities often lack the budgetary capacity to acquire the necessary instrumentation, thereby stalling the widespread implementation of precise histopathological assessments. Consequently, the inability to absorb these high operational costs creates a disparity in diagnostic capabilities, directly limiting the market’s penetration into emerging economies where the disease burden is often highest.

Furthermore, the financial viability of adopting these diagnostic tools is heavily compromised by inconsistent and declining reimbursement schemes. When pathology services face reduced compensation, laboratories are forced to deprioritize capital-intensive upgrades such as advanced IHC systems. This financial strain is substantiated by recent industry data regarding reimbursement cuts. According to the American Society for Clinical Pathology, in late 2024, the finalized Physician Fee Schedule for the 2025 calendar year reduced average payment rates by 2.8 percent. Such reductions in reimbursement, coupled with rising inflationary operational costs, constrict the profit margins required for service providers to invest in essential diagnostic technologies, thereby hampering overall market expansion.

Key Market Trends

The Integration of Artificial Intelligence in Digital Pathology is fundamentally altering the Global Immunohistochemistry Market by enhancing workflow efficiency and diagnostic precision. Laboratories are increasingly transitioning from traditional glass slide reviews to digital platforms, allowing AI algorithms to quantify biomarker expression with superior reproducibility compared to manual assessment. This technological shift addresses the critical shortage of pathologists by automating routine slide screening, thereby reducing turnaround times for complex cancer cases. The trend toward digitization is gaining measurable traction; according to Gestalt Diagnostics, December 2024, in the 'Digital Pathology at 10% Adoption' article, the adoption rate of digital pathology systems in laboratories has reached approximately 10 percent, signaling a pivotal move toward technology-driven diagnostics.

Rising Demand for Multiplex Immunohistochemistry Assays is simultaneously reshaping the market, driven by the need to comprehensively profile the tumor microenvironment in immuno-oncology. Unlike traditional single-marker staining, multiplexing enables the simultaneous detection of multiple distinct biomarkers on a single tissue section, providing granular insights into immune cell spatial arrangement and interaction. This capability is indispensable for developing and prescribing checkpoint inhibitors, prompting research institutions and pharmaceutical developers to invest heavily in advanced staining solutions. Reflecting this growing usage, according to Standard BioTools, October 2024, in the 'Q3 2024 Earnings' report, consumables revenue increased by 13 percent year-over-year, underscoring the expanding consumption of reagents required for high-parameter tissue analysis.

Segmental Insights

The Diagnostics segment is currently the fastest-growing application within the Global Immunohistochemistry Market, driven primarily by the rising global prevalence of chronic diseases, specifically cancer. This growth is accelerated by the increasing adoption of immunohistochemistry in precision medicine to identify specific biomarkers for targeted therapies. Furthermore, the continuous approval of companion diagnostic assays by regulatory authorities, such as the US Food and Drug Administration, supports clinical uptake. Consequently, healthcare providers are increasingly relying on these diagnostic tools to ensure accurate disease detection and patient stratification, thereby fueling significant expansion within this market sector.

Regional Insights

North America holds a dominant position in the global immunohistochemistry market, driven primarily by the rising prevalence of cancer and chronic diseases across the region. This market leadership is supported by established healthcare infrastructure and substantial investment in research and development by key industry participants. Furthermore, the sector benefits from favorable regulatory frameworks, including product approvals from the U.S. Food and Drug Administration, which accelerate the commercialization of diagnostic solutions. Comprehensive reimbursement policies also play a critical role in encouraging the widespread adoption of these essential testing methods in clinical settings.

Recent Developments

In August 2025, Agilent Technologies announced that its MMR IHC Panel pharmDx (Dako Omnis) received FDA approval as a companion diagnostic for colorectal cancer. This test was specifically designed to identify mismatch repair deficient patients who were eligible for treatment with certain immunotherapy regimens. As the only FDA-approved immunohistochemistry panel for this specific diagnostic indication on the Dako Omnis automated staining solution, the launch represented a key development in the field. The approval facilitated more accurate patient selection and enabled clinical laboratories to implement a validated, automated workflow that supports oncologists in making critical precision medicine decisions.
In April 2025, Roche received FDA Breakthrough Device Designation for its VENTANA TROP2 (EPR20043) RxDx Device. This innovative assay combined immunohistochemistry with a digital pathology algorithm to assist in determining patient treatment eligibility for non-small cell lung cancer. It represented the first time such a designation was granted to a computational pathology companion diagnostic device. The development highlighted the company's commitment to integrating artificial intelligence with traditional staining techniques to enhance diagnostic precision and support the identification of patients most likely to benefit from targeted therapeutic interventions.
In January 2025, Leica Biosystems entered into a strategic partnership with Molecular Instruments to integrate HCR Pro RNA-ISH technology onto the BOND RX research staining systems. This collaboration aimed to combine automated immunohistochemistry and immunofluorescence protocols with advanced RNA in situ hybridization capabilities on a single platform. The integration allowed researchers to simultaneously detect RNA and protein targets within the same tissue sample, thereby preserving precious tissue and providing deeper spatial insights. The move was intended to accelerate discovery workflows and enhance the utility of automated staining instruments in translational research.
In September 2024, Biocare Medical announced a strategic partnership with Ensigna Biosystems to advance spatial biology and multiomics applications. The collaboration leveraged Biocare’s automated ONCORE Pro X staining platform alongside Ensigna’s specialized histopathology services to develop integrated solutions for pharmaceutical and biotechnology researchers. By combining high-quality reagents and automated instrumentation with expert assay development, the companies aimed to support the growing demand for complex tissue profiling. This initiative focused on enabling more robust detection capabilities and accelerating the development of novel therapeutic strategies through enhanced spatial analysis.

Key Market Players

Thermo Fisher Scientific Inc
F. Hoffmann-La Roche Ltd.
Merck KGaA
Danaher Corporation
PerkinElmer U.S. LLC
Bio-Rad Laboratories, Inc.
Cell Signaling Technology, Inc.
Bio SB
Agilent Technologies, Inc.
Abcam Limited

By Product	By Application	By End User	By Region
Antibodies Equipment Reagents Kits	Diagnostics Cancer Infectious Diseases Cardiovascular Diseases Autoimmune Diseases Diabetes Mellitus Nephrological Diseases Research	Hospitals & Diagnostic Laboratories Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

Immunohistochemistry Market, By Product:

Antibodies
Equipment
Reagents
Kits

Immunohistochemistry Market, By Application:

Diagnostics
Cancer
Infectious Diseases
Cardiovascular Diseases
Autoimmune Diseases
Diabetes Mellitus
Nephrological Diseases
Research

Immunohistochemistry Market, By End User:

Hospitals & Diagnostic Laboratories
Research Institutes
Others

Immunohistochemistry 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 Immunohistochemistry Market.

Available Customizations:

Global Immunohistochemistry 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 Immunohistochemistry 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 Immunohistochemistry Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Product (Antibodies, Equipment, Reagents, Kits)

5.2.2. By Application (Diagnostics, Cancer, Infectious Diseases, Cardiovascular Diseases, Autoimmune Diseases, Diabetes Mellitus, Nephrological Diseases, Research)

5.2.3. By End User (Hospitals & Diagnostic Laboratories, Research Institutes, Others)

5.2.4. By Region

5.2.5. By Company (2025)

5.3. Market Map

6. North America Immunohistochemistry 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 End User

6.2.4. By Country

6.3. North America: Country Analysis

6.3.1. United States Immunohistochemistry 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 End User

6.3.2. Canada Immunohistochemistry 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 End User

6.3.3. Mexico Immunohistochemistry 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 End User

7. Europe Immunohistochemistry 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 End User

7.2.4. By Country

7.3. Europe: Country Analysis

7.3.1. Germany Immunohistochemistry 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 End User

7.3.2. France Immunohistochemistry 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 End User

7.3.3. United Kingdom Immunohistochemistry 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 End User

7.3.4. Italy Immunohistochemistry 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 End User

7.3.5. Spain Immunohistochemistry 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 End User

8. Asia Pacific Immunohistochemistry 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 End User

8.2.4. By Country

8.3. Asia Pacific: Country Analysis

8.3.1. China Immunohistochemistry 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 End User

8.3.2. India Immunohistochemistry 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 End User

8.3.3. Japan Immunohistochemistry 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 End User

8.3.4. South Korea Immunohistochemistry 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 End User

8.3.5. Australia Immunohistochemistry 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 End User

9. Middle East & Africa Immunohistochemistry 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 End User

9.2.4. By Country

9.3. Middle East & Africa: Country Analysis

9.3.1. Saudi Arabia Immunohistochemistry 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 End User

9.3.2. UAE Immunohistochemistry 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 End User

9.3.3. South Africa Immunohistochemistry 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 End User

10. South America Immunohistochemistry 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 End User

10.2.4. By Country

10.3. South America: Country Analysis

10.3.1. Brazil Immunohistochemistry 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 End User

10.3.2. Colombia Immunohistochemistry 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 End User

10.3.3. Argentina Immunohistochemistry 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 End User

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 Immunohistochemistry 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. Thermo Fisher Scientific Inc

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. F. Hoffmann-La Roche Ltd.

15.3. Merck KGaA

15.4. Danaher Corporation

15.5. PerkinElmer U.S. LLC

15.6. Bio-Rad Laboratories, Inc.

15.7. Cell Signaling Technology, Inc.

15.8. Bio SB

15.9. Agilent Technologies, Inc.

15.10. Abcam Limited

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 Immunohistochemistry Market in 2025?

Which is the dominating region in the Global Immunohistochemistry Market?

Which is the fastest growing segment in the Global Immunohistochemistry Market?

What is the expected growth rate of the Global Immunohistochemistry Market?